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UNCONTROLLED COPY
QUALITY
ASSURANCE
PROGRAM PLAN
B C LABORATORIES, INC.
4100 ATLAS COURT
BAKERSFIELD, CA 93308
(661) 327-4911
FAX (661) 327-1918
www.bclabs.com
Carolyn Jackson Sara Guron
CEO/President Quality Assurance Officer
(661) 327-4911 Ext. 213 (661) 327-4911 Ext. 288
Effective Date: January 08, 2016
UnControlled Copy:
Issued to:
Printed Date:
Location:
UNCONTROLLED COPY
QUALITY ASSURANCE PROGRAM PLAN OF
B C LABORATORIES, INC.
Approved by
Signed by
Date
CEO/President:
Technical Director:
Quality Assurance
Officer:
UNCONTROLLED COPY
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
TABLE OF CONTENTS
TABLE OF CONTENTS
PAGE i
SECTION
CONTENTS
# of PAGES
REVISION
DATE
PAGE #
I.
Introduction
2
13
03/17/16
1-1 thru 1-2
II.
Organization, Responsibilities,
Communication and Redundancy
14
29
03/17/16
2-1 thru 2-14
III.
Quality Assurance Objectives
1
10
01/08/16*
3-1
IV.
Sampling Procedures
8
20
01/08/16
4-1 thru 4-8
V.
Sample Custody
6
18
01/08/16
5-1 thru 5-6
VI.
Facilities
4
20
01/08/16
6-1 thru 6-4
VII.
Personnel / Training
4
16
01/08/16*
7-1 thru 7-4
VIII.
Records / Documents
11
13
03/17/16
8-1 thru 8-11
IX.
Instrumentation
19
31
01/08/16
9-1 thru 9-19
X.
Calibration Procedures and Frequency
20
26
01/08/16*
10-1 thru 10-20
XI.
Analytical Procedures
9
22
01/08/16*
11-1 thru 11-9
XII.
Data Reduction, Validation and
Reporting
14
21
01/08/16*
12-1 thru 12-14
XIII.
Analytical Quality Control
5
16
01/08/16*
13-1 thru 13-5
XIV.
Performance and Systems Audit
7
21
01/08/16
14-1 thru 14-7
XV.
Data Assessment Procedures
6
18
03/17/16
15-1 thru 15-6
XVI.
Preventive Maintenance
6
13
01/08/16*
16-1 thru 16-6
XVII.
Corrective Action/Quality
Improvement
8
14
01/08/16
17-1 thru 17-8
XVIII.
QA Reports to Management
1
8
01/08/16*
18-1
XIX.
Suppliers / Subcontractors
3
9
01/08/16*
19-1 thru 19-3
XX
Security
3
7
01/08/16*
20-1 thru 20-3
XXI
Code of Ethics
3
8
01/08/16*
21-1 thru 21-3
Appendix
A. SOP Listing
B. Established MDL/PQL's
C. Employee Evaluation
D. QC Logic Flow Diagrams
E. Process Flow Diagrams
F. Ethics Agreement
G. Flag Index
H. Employee SOP Acknowledgement and Agreement Form
A-1 thru A-5
B-1 thru B-21**
C-1 thru C-3*
D-1 thru D-17 *
E-1 thru E-16*
F-1*
G-1 thru G-5*
H-1 thru H-5
Figures
1. Personal Signatures and Initials Identification
2. Laboratory Organizational Chart
3. Bottle Order Form
2-13
2-14
4-5
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QUALITY ASSURANCE PROGRAM PLAN TABLE OF CONTENTS
TABLE OF CONTENTS
PAGE ii
4. Example of Chain-of-Custody Form 5. Cooler Receipt Form 6. Laboratory Floor Plan 7. Internal Assessment Schedule 8. Preventative Maintenance Schedule Example 9. System Improvement Report Form
5-5 5-6 6-4
14-3 thru 14-5 16-6 17-7
Tables
1. Analysis Reference Chart 2 500 Series Semi-Volatile Organics 3. 8000 Series Semi-Volatile Organics 4. 8000 Series Volatile Organics 5. Metal Methodologies 6. Organic Methodologies 7. Inorganic Methodologies 8. Level of QC Effort
4-5 thru 4-7 10-15 thru 10-1610-17 thru 10-1810-19 thru 10-20
11-7 11-8 11-9 13-5
Note: * = The following QAPP Sections have been Reviewed on 01/08/2016 (No Changes were needed) * * = MDL’S listed in the Appendix B of the QAPP may not be the current MDL’S. Please contact BC Labs to confirm sensitivity.
*** = The sections in red were updated in March of 2016
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ACRONYMS
ACRONYMS
PAGE iii
AA Atomic Absorption
AAI Auto-analyzer
BCL BC Laboratories, Inc.
CERLA Comprehensive Environmental Response,
Compensation, and Liability Act.
BFB Bromofluorobenzene
CCB Continuing Calibration Blank
CCC Calibration Check Compound
CCV Continuing Calibration Verification
CLP Contract Laboratory Program
COC Chain of custody
CRDL Contract Required Detection Limit
CV Cold Vapor
DOD Department of defense
DOE Department of energy
DFTPP Decafluorotriphenylphosphine
DQO Data Quality Objective
Dup Duplicate
EB Equipment Blank
ELAP Environmental Laboratory Accreditation
Program
GC Gas Chromatography/Chromatograph
GC/MS Gas Chromatography/Mass Spectrometry
GFAA Graphite Furnace Atomic Absorption
GHAA Gaseous Hydride Atomic Absorption
IC Ion Chromatography/Chromatograph
ICP Inductively Coupled Plasma
ICP/MS Inductively Coupled Plasma/Mass
Spectrometry
ICS Interference Check Sample
ICV Initial Calibration Verification
IDC Initial Demonstration of Competency
IS Internal Standard
LCL Lower Control Limit
LCS Laboratory Control Sample
LOD Limit of Detection
LOQ Limit of Quantitation
MB Method Blank
MCL Maximum Contaminant Level
MDL Method Detection Limit
MS Matrix Spike
MSD Matrix Spike Duplicate
PB Preparation Blank
PQL Practical Quantitation Limit
QAPP Quality Assurance Program Plan
QA/QC Quality Assurance/Quality Control
RCRA Resource Conservation Recovery Act
RFP Request for Proposal
RFQ Request for Quotation
RL Reporting Limit
RLS Reporting Limit Standard
RPD Relative Percent Difference
RSD Relative Standard Deviation
RSO Radiological Safety Officer
SAP Sampling Analysis Program
SIF System Improvement Form
SM Standard Methods
SMC System Monitoring Compound
SOP Standard Operating Procedure
SOW Statement of Work
SPCC System Performance Check Compound
SRM Standard Reference Material
STLC Soluble Threshold Limit Concentration
TB Trip/Travel Blank
TCLP Toxicity Characteristic Leaching
Procedure
TOX Total Organic Halides
TQM Total Quality Management
TRPH Total Recoverable Petroleum
Hydrocarbons
TTLC Total Threshold Limit Concentration
UCL Upper Control Limit
WET Waste Extraction Test
WPS Word Processing Specialist
ZHE Zero Headspace Extraction
UCMR Unregulated Contaminated Monitoring
Regulation
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BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
INTRODUCTION
SECTION I
REVISION NO. 13
EFFECTIVE DATE: 03/22/16
Page 1-1
1.0 OBJECTIVES
The primary objectives of the BC Laboratories, Inc. (BCL) Quality Assurance Program Plan (QAPP) are to provide
QA/QC guidelines to 1) assure the data produced is of known quality, 2) ensure our organization is capable of
providing results which are of value to our customers, 3) ensure the system can consistently perform under adverse
conditions, and to 4) comply with quality goals and objectives as set forth in government and industry standards.
1.1 POLICY STATEMENT
B C Laboratories Inc. is an organization committed to providing legally defensible data that is technically valid
and in accordance with professional standards, project goals, and government regulations. The management
and staff at B C Laboratories, Inc. are committed to use all available resources to supply accurate, precise,
timely and fully documented results. BCL=s goal is to provide analytical results and services which are of value
to our customers.
1.2 COMPONENTS OF THE QUALITY PROGRAM
Our overall program can be broken down into five essential parts: 1) Preclusion, 2) Assessment, 3) Validation,
4) Corrective Action, and 5) Improvement.
PRECLUSION: This is comprised of an orderly program of positive actions taken before and during analyses
to ensure that analytical systems are functioning properly. Components include quality control planning,
training, documented and approved methodologies, calibration of instrumentation, instrument maintenance,
comprehensive standardization, control charting, internal and external monitoring.
ASSESSMENT: This includes all components of determining analytical performance. Components include
matrix duplicates, matrix spikes, matrix spike duplicates, post spikes, blank spikes, blank spike duplicates,
laboratory control samples, calibration checks, calibration blanks, method blanks and surrogate additions.
Inclusion of all or some of these components and their frequencies are method dependent. B C Laboratories'
standard operating procedures (SOP's) contain all pertinent information concerning respective QC criteria
needed for assessment and approval of data. The adequacy of the QC program is measured through internal and
external auditing and client feedback on customer surveys.
VALIDATION: This consists of all the steps taken to ensure that generated analytical data is complete and
correct. Steps include maintenance of sample tracking and data processing systems, technical review of raw
data and final results review and approval by management staff.
CORRECTIVE ACTION: The actions rendered to determine the causes of quality defects and restore proper
function of the analytical system. This includes troubleshooting techniques, re-evaluations of analyses and/or
methodologies, dilution, calculation checks and continued training of analysts.
IMPROVEMENT: Actions taken to improve standard quality baselines. Steps include assessing windows of
improved performance, total quality management training of personnel, and research / development.
1.3 OTHER SOURCES FOR QUALITY GUIDELINES
Since BCL=s scope of work is very diversified, pertinent Standard Operating Procedures (SOP's) are used at the
bench level to provide guidance and direction. Specific project plans are developed to narrow the scope of
work, and thus provide QA/QC protocols on a limited scale and provide for possible modifications to standard
practice.
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QUALITY ASSURANCE PROGRAM PLAN
INTRODUCTION
SECTION I
REVISION NO. 13
EFFECTIVE DATE: 03/22/16
Page 1-2
1.4 REVISION PRACTICES
The QA Officer is responsible for the maintenance of the QAPP. Review of this plan should take place by each
department supervisor and President before the end of each calendar year. All revisions and additions are
submitted to the word processing specialist for entry, and then each revision is reviewed by pertinent personnel.
Once final approval is granted, the revision number is sequentially increased by one and the date of approval is
recorded. All revised sections are distributed to persons who have controlled copies of the QAPP.
1.5 SUMMARY
BC Laboratories, Inc. is an organization committed to providing useful, legally defensible and technically valid
results to all of our clients. Incorporating a commitment from upper management, TQM training, process
control and improvement, and a system of constant monitoring of the work process assures us of satisfying our
goals. Our QAPP provides the guidelines to achieve our goals.
1.6 BC Laboratories, Inc. Certifications
BCL Certifications
Expiration
Date
Oregon NELAP - Accreditation Certification # 4032-002 04/22/2016
DoD-ELAP - United States Department of Defense Environmental Laboratory Accreditation
Program Certificate # L14-199-R1. ISO/IEC 17025:2005 DOD QSM version 5.0. July 2013
07/10/2016
CA ELAP (SWRCB) - State of California, Department of Health Services, Environmental
Laboratory Accreditation Program (ELAP) Certificate No 1186
05/31/2016
Alaska – The State of Alaska, Department of Environmental Conservation Certificate # UST-101 04/04/2016
Nevada - State of Nevada, Department of Conservation + Natural Resources; Division of
Environmental Protection. Certification # CA000142012-1 07/31/2016
DOE - Department of Energy, Consolidated Audit Program (CAP)
County Sanitation Districts of Los Angeles County Laboratory ID No 10199
Vendor Approval list - Shell Global Solutions, Benzene Waste NESHAP Audit
1.7 REFERENCE DOCUMENTS
BC Laboratories, Inc. in its continuing effort to maintain a quality laboratory environment references Good
Laboratory Practices and DOE 414.1.
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BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ORGANIZATION, RESPONSIBILITIES, COMMUNICATION AND REDUNDANCY
SECTION II
REVISION NO. 29
EFFECTIVE DATE: 03/15/16
PAGE 2-1
2.0 RESPONSIBILITIES
Job responsibilities must be properly designated in order to efficiently conduct work, manage processes and plan for improvement and
change. General job responsibilities and job requirements are addressed in the BC Laboratories, Inc. Job Description Manual.
Responsibilities outlined here in this document, cover those duties which may not be covered in detail in the Job Description Manual.
(See section 2.3 for Specific Responsibilities)
2.0.1 Approval Verifications
The responsibility of approval of final work lies with middle and upper management (Please refer to pg.2-13). Page
(2-13) illustrates examples of signatures and initials of persons with the authority of final approval.
2.1 ORGANIZATION
The structural organization of the laboratory is illustrated in Figure 2. The laboratory has five analytical operation
groups; Inorganics, Metals, Organics (Volatiles, Semi-Volatiles) and Petroleum. These groups are supported by six
departments which include Sales and Marketing, Laboratory Information Management System, Client Services,
Safety, QA/QC, and Human and Resources.
2.2 COMMUNICATIONS
The effectiveness of any organization can, in large part, be measured by the efficiency of the communications
systems. Communication paths and flow are constantly evolving by increased use of technology and heightened
focus on customer satisfaction.
2.2.1 Communication Systems
2.2.1.1 Board Meetings and Biweekly Executive Committee Meetings
Discussions on lab direction, major business and labor decisions and policy.
2.2.1.2 Biweekly Technical Department Manager Meeting:
Held as a forum to 1) discuss decisions from board meetings, 2) review analytical department
capacities and late work, 3) review potential new projects, 4) discuss any quality improvement
ideas, and 5) to initiate project/process planning.
2.2.1.3 Minutes from Executive Committee Meeting:
Posted to communicate topics covered to employees.
2.2.1.4 Department Meetings:
Held on a regular schedule or on as needed basis. Used to convey pertinent information within
respective departments.
2.2.1.5 Project Planning Meetings:
Scheduled meeting with the purpose of planning and organizing projects.
2.2.1.6 Laboratory Memos:
Posted records that inform employees of information of interest or reiteration of policy.
2.2.1.7 Training Modules:
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Structured sessions, which are designed to increase quality through basic skill and knowledge.
2.2.1.8 Laboratory literature
2.2.1.8.1 Employee Policy Manual - Outlines the employee benefit package and the laboratory
rules of conduct.
2.2.1.8.2 QAPP - Contains the protocols, parameters and policies of BCL=s quality system.
2.2.1.8.3 SOP=s - Approved, controlled documents, which describe the operative for given
procedures.
2.2.1.8.4 Chemical Hygiene Plan - The safety compliance guide, which outlines all laboratory
safety policies and safety engineering plans.
2.2.1.8.5 Injury and Illness Prevention Plan - Protocols on the prevention and handling of
workplace injuries.
2.2.1.8.6 Customer surveys - Forms which provide for customer feedback regarding quality, price,
and service.
2.2.1.8.7 System Improvement Forms - Vehicle by which quality improvement and corrective
action can be communicated and addressed by all employees.
2.2.1.8.8 Quality Assurance Protocols Manual (QAPM) - Acts as a bench working manual.
2.2.1.8.9 Employee Safety Manual. Manual that outlines safety rules and policies.
.
2.2.1.8.10 Affirmative Action Plan for minorities and women - the principles of equal employment
opportunity
2.2.1.8.11 Substance Abuse Policy Manual - protocol to provide a drug-free environment.
2.2.1.9 Comments section of client=s LIMS files and laboratory bench sheets - Information regarding
non-standard client-specific practices or requirements.
2.2.1.10 Internal E-mail:
Mechanisms used to communicate information on an informal level.
2.2.1.11 External E-mail:
Mechanisms used to communicate and transfer client information.
2.2.1.12 Sales correspondence:
Informal transfer of pertinent information obtained during sales calls.
2.2.1.13 Client Service correspondence:
Information obtained by project coordinators and managers during the course of verbal and electronic
correspondence.
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2.2.1.14 Client training seminars:
Training sessions conducted by the labs that provide clients with valuable information regarding
internal processes or other important information.
2.2.1.15 Complaint Forms:
Forms that are used to document incidences of client initiated quality failures.
2.2.1.16 External Seminars:
Informational gatherings, which would hopefully provide information regarding industry trends
and changes, or provide value through advanced training.
2.2.1.17 BCLABNET
Program used as a client service tool. Website used to expand our market and to act as a
mechanism for services such as result status, historical data archiving and correspondence.
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2.3 SPECIFIC RESPONSIBILITIES
I CEO/President
(Allocate and secure capital to support laboratory activities and staff.)
Appointed Deputy (Vice President)
1. Procurement
2. Insurance Policy Maintenance
3. Business direction and development.
4. Director of the Business Plan.
5. Supervisor of all Department Supervisors, Accounts Payable/Receivable,
Maintenance Technicians, QA/QC and Human Resources /Health & Safety Coordinator
6. Capital Management
A Accounts Payable / Receivable/Billing Clerks
1. Client account maintenance.
2. Collections.
3. Financial Records.
4. Invoicing.
5. Distributing / mailing of invoices.
B Maintenance Technicians
1. Laboratory maintenance chores.
2. Installation of laboratory hoods.
3. Maintenance of laboratory supplies.
4. Maintenance of the waste disposal site.
C. HR/Health & Safety Coordinator/Radiological Safety Officer
1. Maintenance of the Safety Program.
2. Oversees the Waste Disposal Program.
3. Injury response.
4. Spill response.
5. Fire response.
6. Employees and upper management liaison, new hires coordinator
7. Radiological Safety Officer (RSO)
D. Quality Control
E. Laboratory Coordinator
II Vice President
Appointed Deputy (President)
1. Development of sampling program plans.
2. Field Service Purchasing.
3. Marketing strategies, analysis and sales efforts.
4. Supervision of all Business Development Specialist
8. RFQ and quote completions using the LIMS Quote Program.
9. Quality Improvement of Processes.
10. Monitoring capacities.
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PAGE 2-5
11. Maintenance of Marketing Materials.
A. Business Development Specialist
1. Sales
2. Initial Client Contact
3. Set prospect meetings, presentations and close sales
B. Marketing and Sales Coordinator
1. Quote completions using the LIMS Quote Program.
2. To provide the laboratory information for use in benchmarking.
2. Review Sales Contract
III. Technical Director/Radiological Safety Officer
Appointed Deputy (Director of Human Resources)
1. Oversees day-to-day activities of the laboratory
2. Provides leadership, by example, establishing and maintaining quality standards and in conjunction with the
Director of Human Resources, hire, counsel, discipline, provide training and monitor performance of those
reporting to the Technical Director
3. Responsible for all analytical and technical activities of the laboratory
4. Responsible for the accuracy and quality of all data reported by the laboratory
5. Final Report approval
6. Delegates Quality Improvement of Processes
7. Works in conjunction with managers of laboratory to attain company goals for growth
8. Radiological Safety Officer (RSO)
9. Compliance with DoD QSM and ISO 17025:2005
IV. Laboratory Coordinator
Appointed Deputy (Technical Director)
1. Program management and operations director.
2. RFP and bid approval - Sales
3. Final Report Approval.
4. Delegates Quality Improvement of Processes.
5. Resource person for laboratory personnel
6. Handle issues relating to analytical reports and quality control and dealing with analytical testing questions
7. Assist client service teams with reporting results in nonstandard formats and electronic deliverables.
8. Work with Technical Director, Supervisors, and Team Leaders to direct activities in the analytical portion of
the lab.
9. Provide input and perspective to President from the analytical and LIMS areas of the laboratory
10. Train in the use of the LIMS.
11. Assist LIMS Manager in development of new features or refines existing features of the LIMS
12. Define Quality Control processing tests in the LIMS.
13. Maintain MDL, PQL, and validation parameters in the LIMS
V. LIMS Manager
Appointed Deputy (Laboratory Coordinator)
1. LIMS development, modification, and maintenance
2. LIMS training
3. Data reporting formatting
4. Electronic Data archiving and securement
5. Electronic Data Deliverables
6. LIMS equipment and supply approval
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7. Supervision of LIMS Assistant
8. Delegate Quality Improvement of Processes
A. LIMS Programmer
1. LIMS Training
2. Electronic Data Deliverables formatting
3. LIMS Maintenance
4. Data Processing
5. Programming
6. Writing SOPs
7. Website Maintenance
B LIMS Specialist
1. Repair and troubleshoot computers and printers
2. Routine maintenance of computers and printers
3. Purchasing supplies.
4. Creating and editing report definitions.
5. Maintain documentation of all repairs, troubleshooting and maintenance of computers and printers
VI. Semi-Volatile Organics Manager
Appointed Deputy (Technical Director)
1. Supervision and management of all organics testing analysts and preparation technicians
2. Sample throughput and scheduling (prioritization)
3. Turnaround / holding time monitoring
4. Method and chemistry consultation
5. Data review, approval, and interpretation
6. Method development
7. Adherence of work to project specific goals
8. SOP Development and review
9. Instrument / supply procurement
10. Training
11. Quality Improvement of Processes
A. Semi-Volatiles Organics Preparation Technicians
1. Sample preparation and extraction in accordance to QC protocols
2. Documentation of tasks.
a. Preparation Logs
b. Bench worksheets
c. Reagent Logs
d. Maintenance Log
3. Documentation review
4. SOP development
5. Training
B. Organic Method Analysts
1. Sample analysis in accordance to QC protocols.
2. Reporting of sample results onto bench worksheets.
3. Analysis and instrument documentation.
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a. Instrument maintenance
b. Ordering instrument supplies
c. Analysis records
(1) Run / Analysis Log
(2) Standard Logs
(3) Reagent Logs
(4) Maintenance Logs
4. Temporary data storage
5. Temporary data storage
6. Method development
7. SOP development
8. Training
VII Volatile Organics Manager
Appointed Deputy (Technical Director)
1. Supervision and management of all organics testing analysts and preparation technicians
2. Sample throughput and scheduling (prioritization).
3. Turnaround / holding time monitoring.
4. Method and chemistry consultation. Data review, approval, and interpretation.
5. Method development.
6. Adherence of work to project specific goals.
7. SOP Development and review.
8. Instrument / supply procurement.
9. Training.
10. Quality Improvement of Processes.
A. Organic Method Analysts
1. Sample analysis in accordance to QC protocols.
2. Reporting of sample results onto bench worksheets.
3. Analysis and instrument documentation.
a. Instrument maintenance.
b. Ordering instrument supplies.
c. Analysis records.
(1) Run / Analysis Log.
(2) Standard Logs.
(3) Reagent Logs. Maintenance Logs
4. Temporary data storage
5. Method development
6. SOP development
7. Training
VIII. Petroleum Department Manager
Appointed Deputy (Project Manager)
1. Supervision and management of all Petroleum testing
2. Development of sampling program plans
3. Sample throughput and scheduling (prioritization).
4. Turnaround / holding time monitoring.
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5. Method and chemistry consultation. Data review, approval, and interpretation.
6. Method development.
7. Adherence of work to project specific goals.
8. SOP Development and review.
9. Instrument / supply procurement.
10. Training.
11. Work in conjunction with laboratory director to company’s growth and goals
12. Quality Improvement of Processes.
IX. Inorganic Department Manager
Appointed Deputy (Lab Coordinator)
1. Supervision and management of all Inorganic Preparation/Sample receiving// Microbiology, metals/wet
chemistry and miscellaneous testing analysts
2. Sample throughout and scheduling (prioritization)
3. Turnaround / holding time monitoring
4. Method and chemistry consultation
5. Data review, approval, and interpretation
6. Method development
7. Adherence of work to project specific goals
8. SOP Development and review
9. Instrument procurement
10. Training
11. Quality Improvement of Processes
A. Inorganics Team Leaders
1. Sample analysis in accordance to QC protocols
2. Reporting of sample results onto bench worksheets
3. Analysis and instrument documentation
a. Instrument maintenance
b. Ordering instrument supplies
c. Analysis records
(1) Run / Analysis Log
(2) Standard Logs
(3) Reagent Logs
(4) Maintenance Logs
4. Temporary data storage
5. Technical data review
6. Method development
7. SOP development
8. Training
B. Metals and Wet Chemistry Methods Analysts
1. Sample analysis in accordance to QC protocols
2. Calculation and reporting of sample results onto bench worksheets
3. Analysis and instrument documentation
a. Instrument maintenance
b. Ordering instrument supplies
c. Analysis records
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(1) Run / Analysis Log
(2) Standard Logs
(3) Reagent Logs
(4) Maintenance Logs
d. Temporary data storage
e. Technical data review
f. Method development
g. SOP development
h. Training
4. Data Processing
C. Preparation and/or Misc. Analytical Technicians
1. Sample preparation, digestion, and extraction in accordance to QC protocols
2. Documentation of tasks
a. Preparation Logs
b. Bench worksheets
c. Reagent Logs
d. Maintenance Logs
3. Documentation review
4. SOP development
5. Training
6. Various Wet Chemistry testing
7. Data Processing
D. Microbiology Methods Analysts
1. Sample analysis in accordance to QC protocols
2. Reporting of sample results onto bench worksheets
3. Analysis and instrument documentation
a. Instrument maintenance
b. Ordering instrument supplies
c. Analysis records
(1) Run / Analysis Log
(2) Standard Logs
(3) Reagent Logs
(4) Maintenance Logs
4. Temporary data storage
5. Technical data review
6. Method development
7. SOP development
8. Training
E. Sample Control Specialists
1. Sample numbering
2. Entering samples into designated holding areas
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PAGE 2-10
3. Distribute copies of COC=s
4. Liaison between sample receiving and client services
F. Sample Custodian
1. Receiving samples (signing and reviewing Chain of Custody)
2. Assigning Submission numbers
3. Distribution of samples with short holding times
4. Distribution of samples with rush status
5. Completion of cooler receipt forms
6. Secondary sample tracking
X. Director of Human Resources/Health and Safety Coordinator/Radiological Safety Officer
Appointed Deputy (Technical Director)
1. Provide leadership, by example, establishing and maintaining quality standards. In conjunction with the
Technical Director and Department Managers, hire, counsel, discipline, provide training and monitor
performance of those reporting to the Department Manager
2. Review all performance evaluation forms for all employees
3. Maintain a current list of all personnel with their names, status, titles, hire dates, and educational level.
4. Maintain payroll information on all employees
5. Originate new employee personnel files and maintain all employee personnel files and forms according to
company policy, federal and state regulations
6. Employee timecard and eligibility records
7. Manage an effective operation to insure the attainment of the Company’s goals and objectives to provide
quality service to both internal and external clients.
8. Employee Health Benefits Director.
9. 401K Plan Administrator.
10. Responsible for all aspects of BC Laboratories, Inc. Safety Program including Chemical Hygiene Plan,
Injury and Illness Prevention Program, Fire Prevention Plan, Waste Disposal Practices, Respiratory
Protection Plan, Substance Abuse Testing Program, and Employee Safety Manual.
11. Laboratory Training Coordinator.
12. Radiological Safety Officer (RSO)
XI. Quality Assurance Officer
Appointed Deputy (Technical Director)
1. Development and maintenance of QAP.
2. Management of internal audit programs
3. SOP development and maintenance
4. Correspondence with clients concerning audit results
5. Data validation
6. Project Plan Development
7. TQM Training
8. QC Reporting
9. QA Monitoring
10. Final report approval
11. Qualifying subcontractors
12. Quality Improvement of Processes
13. Qualifying instruments and apparatus
14. System capability
15. Supervision of QA Specialist & Word Processor
16. Compliance with DoD QSM and ISO 17025:2005
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QUALITY ASSURANCE PROGRAM PLAN
ORGANIZATION, RESPONSIBILITIES, COMMUNICATION AND REDUNDANCY
SECTION II REVISION NO. 29
EFFECTIVE DATE: 03/15/16
PAGE 2-11
A. QA/QC Specialist
1. QC Reporting.
2. QA Monitoring.
3. Data Processing.
4. Control Chart Maintenance.
5. Final report formatting.
6. Data storage
B. Word Processor
1. Processing correspondence
2. Processing, creating, and distributing Bids / Intro Package
7. Processing, creating, and distributing Logbooks
4. Bacteriological Reporting
5. Overflow reporting
6. Processing controlled documents
XII Customer Services Manager
Appointed Deputy (Project Manager)
1. Supervise day-to-day activities of the Receptionist
2. Liaison between the client and the laboratory staff
3. Project organization and maintenance
4. Supervision of Receptionist, Project Coordinators, Head Field Service Technician, Field Service Technicians,
Courier, Bottle Prep Technician and Log-In Specialist (Sample Receiving)
5. Data / Report review
6. Data Deliverables Packaging
7. Method Consultant
8. Supervision of Field Services Personnel
9. Quality Improvement of Processes
10. Bottle orders
11. Project checklist completions
12. Field Service Job and task organization, and scheduling.
13. Liaison between the project manager and field service personnel
14. Field service duties.
A. Project Manager
1. Liaison between the client and the laboratory staff.
2. Project organization and maintenance.
3. Data / Report review.
4. Data Deliverables Packaging.
5. Bottle orders.
6. Project checklist completion.
7. Field Service scheduling.
B. Receptionist
1. Answer and direct phone calls.
2. Maintenance of visitor tracking log.
3. Bacteriological reporting.
4. Data tracking.
5. Some invoice tracking.
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QUALITY ASSURANCE PROGRAM PLAN
ORGANIZATION, RESPONSIBILITIES, COMMUNICATION AND REDUNDANCY
SECTION II REVISION NO. 29
EFFECTIVE DATE: 03/15/16
PAGE 2-12
6. Clerical Supply Procurement
C. Field Service Technicians
1. Courier duties.
2. Soil and water sampling.
3. Maintenance of instrumentation, safety equipment, sampling equipment and vehicles.
D. Courier
E. Sample Receiving
1. Review of Submission (COC and paperwork).
2. Work with client service for specific project info.
3. Phone Back-up
4. Subcontract COC's and Samples
5. Receive sample from walk-in Clients, Fed-Ex & UPS
F. Data Entry Specialists
1. Generate reports (Bacteriological)
2. Filing COC's - Subcontract COC's.
3. Phone back-up.
G. Bottle / Container Preparation Specialist
1. Preparing preservatives.
2. Washing containers.
3. Preparing bottle orders.
4. Shipping containers.
5. Monitoring TB water.
In cases of key personnel absences, the noted appointed deputy or contingency person will assume the absent key person's
responsibilities limited to workload scheduling and other duties necessary to continue operations.
2.4 In the absent of technical Director (manager) for a period of time exceeding fifteen (15) consecutive calendar days, the
laboratory will designate another full-time staff member meeting the qualifications of the technical director (manager) to
temporarily perform the function.
In the absence of technical director (manager) for a period of time exceeding thirty-five (35) consecutive calendar days, the
primary accreditation body will be notified in writing
2.5 WORK CESSATION
The QA officer is vested with the authority to independently stop work in response to quality problems. If the QA officer is not
available, his/her backup can assume this responsibility.
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PAGE 2-13
FIGURE 1
PERSONNEL SIGNATURES/INITIALS IDENTIFICATION
NAME
TYPED
INITIALS
SIGNATURE
SIGNED
INITIALS
EMPLOYME
NT DATE
Carolyn Jackson
CEJ
05/25/62
Keith Vogel
KEV
10/01/86
Richard Penner
RLP
09/30/91
Marna Atencio
MSA
07/01/72
Stuart Buttram
SGB
06/01/87
Sara Guron
SKG
06/13/00
Tina Green
TG
05/23/93
Steve Bennett
SPB
09/07/90
Jatinder Riar
JKR
05/05/95
Teresa Shaw
TMS
04/20/89
Shelly Maritt
SLM
06/16/99
Robert Cortez
RDC
02/08/12
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SECTION II REVISION NO. 29
EFFECTIVE DATE: 03/15/16
PAGE 2-14
Laboratory Organizational ChartCompany Structure
Business Development
Specialist
President / CEO
Production Departments
CustomerService Manager
LIMS Manager Inorganics
Manager
Quality Assurance
Officer
Project Manager
Field Services Technician
Courier
LIMS Programmer
Quality Assurance Specialist
Metals Supervisor
HR Director / Health & Safety Coordinator
Non - Production Departments
Volatiles
Manager
Semi - VolatilesOrganic Manager
Analyst II
Analyst I
Lab Technician II
Lab Technician I
Sample Custodian
Analyst II
Analyst I
Analyst II
Analyst I
Lab Technician II
Lab Technician I
Safety Assistants
MaintenanceLaboratory
Coordinator
Technical Director
ServiceTechnician
&Billing Clerk
Receptionist
Sample Receiving
Bottle Prep
WordProcessor
LIMS Specialist
Board of Directors
Semi Volatiles Extraction Supervisor
WetChem
Supervisor
Marketing & Sales
Coordinator Accounts Payable/Receivalble
Vice-President
Specialist
Organic
Specialist
Rev. 2015
PetroleumManager
And Radiological Safety Officer
And Radiological Safety Officer
Sample Control
Specialist
Data EntrySpecialist
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BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
QUALITY OBJECTIVES
SECTION III
REVISION NO. 10
EFFECTIVE DATE: 01/08/16
PAGE 3-1
3.0 QUALITY OBJECTIVES
Quality assurance (QA): objectives are set to provide external parameters that chemist and their instruments must meet to insure the
integrity of data, confidence of regulatory agencies, and its’ clients. Parameters include PE’s, audits and meeting EPA mythology
requirement.
Quality Control (QC): objectives of internal systems are to insure that the laboratory, it’s chemist and their instruments meet the parameters
defined in the QA program on a daily basis. QC parameters include preparation blank, surrogate, spikes, duplicates, laboratory control
samples, travel blanks, temperature checks, preservation confirmation, and accurate record keeping insuring policies are followed:
Specific Parameters:
Accuracy - Defined as the degree to which the analytical measurement reflects the true value present. Surrogate, ICV, CCV, RLS, LCS
and matrix spike recoveries will be used to measure accuracy. See section 13.4 for the algorithm used to measure accuracy.
Precision - Defined as the measure of mutual agreement among individual measurements of the same pollutant in a sample, secured under
the same analytical protocols. Laboratory precision will be expressed as relative percent difference (RPD). The goals for precision are
related to the proximity of the sample to the detection limit. At or less than five (5) times the PQL, the precision goal will be expressed in
absolute concentration (quantitation limit) terms. See section 13.4 for the algorithm used to compute the relative percent difference.
Representativeness - Dependent upon the sampling plan. Assessment of site and collection representativeness is done by subcontracted
or laboratory field service personnel. Procedures to ensure representativeness will be determined prior to the initiation of individual projects.
Comparability - Defined as the extent to which samples can be verified or duplicated by another independent laboratory or compared
against results previously found. Comparability will be assessed through parallel studies, round robin programs and internal and external
audit results. Acceptable levels of comparability will be addressed in specific project plans.
Completeness - Defined as the percentage of valid data obtained, as judged by objectives, compared to the total amount of data collected.
QC parameters that shall be assessed for quantitative determinations of completeness shall include initial calibrations, continuing
calibrations, surrogate percent recovery, RPD's of duplicates, percent recovery and RPD for matrix spike recoveries, percent recovery for
laboratory control samples, and holding times. The requirement for the quantitative assessment of completeness is 90%.
Sensitivity - Established practical quantitation limits (PQL's) and method detection limits based on procedures outlined in Appendix B of
40 CFR Part 136, have been documented for analytes of interest. (See Appendix B) Please note that these detection limits are established
under ideal conditions, i.e., matrices used for detection limit studies are "clean" soils and deionized laboratory water. MDL studies must be
performed annually for each matrix type - water and soil. MDL=s and PQL=s must meet standards set in SW-846, EPA 500 series methods,
EPA 600 series methods and standard methods 18th
edition. Special provisions may be necessary in cases of project specific goals, which
exceed the aforementioned standards. MDL/PQL derivation procedures are addressed in the QA Protocols Manual.
Note: = The following QAPP Sections have been Reviewed on 01/08/2016 (No Changes were made)
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QUALITY ASSURANCE PROGRAM PLAN
SAMPLING PROCEDURES
SECTION IV REVISION NO. 20
EFFECTIVE DATE: 01/08/16
PAGE 4- 1
4.0 SAMPLING PROCEDURES
Proper collection, preservation and storage of samples is needed to ensure sample integrity and representativeness. Samples are
collected by trained, experienced field personnel according to guidelines established by Standard Methods for the Examination of
Water and Wastewater, Test Methods for Evaluating Solid Waste (SW-846), and 40 CFR Part 136. The Field Services Standard
Operating Procedures (SOP) Appendix A, displays the scope of capabilities of our Field Services Department. All protocols for proper
sample collection and handling are addressed in respective Field Service SOP's.
4.1 DOCUMENTATION
Proper documentation, including use of Sampling Logs, Field Logs and Chain-of-Custody forms are maintained throughout
sampling procedures. Field measurements are recorded in ink in bound Field Logs with entries signed by respective field service
personnel. Field sample information is entered directly into the LIMS upon receipt by a representative of the Sample Control
Department. A chain of custody form must be properly completed to track samples in from the field.
4.2 SAMPLE CONTAINERS
All samples collected have proper containers and preservatives with which they are associated. All containers used are typically
made of plastic or glass. All BCL glass containers are ordered pre-certified. Only polyethylene containers are received uncertified
and prepared in-house. All in-house prepared containers are monitored for artifacts on a quarterly basis or whenever new lot #
containers are used.
Table 1 displays information on proper containers, preservatives and holding times.
4.2.1 SAMPLE BOTTLE / CONTAINER PROCESSING
Preservatives are routinely analyzed before usage. Documentation exists to trace the preservative used for each
sample submitted in a laboratory supplied containers.
1. Containers are prepared.
2. Preservatives are made as needed
A. Reagent - grade chemicals are used.
B. Once the preservative is made, it is given a batch ID.
C. The preservative is tested before use by testing an aliquot brought up to volume in a proper sample
container.
D. The preservative test is logged into the LIMS.
E. The preservative is analyzed for constituents of concern.
F. If all constituents of concern are not detected, the preservative can be used. If detections are found, the
process must be reinitiated.
3. A reagent log is kept on file to record chemicals used.
4. Records are filed with all regular sample submissions
4.2.2 TRIP BLANKS
Trip blanks are used to identify the presence of volatile compound contamination attributable to transfer across a
sample container septum during shipping and storage of samples. A trip blank is a sample of Analyte-free matrix
that is transported from the laboratory to the field with sample containers, then stored during sampling and finally
transported back to the laboratory with the samples. The trip blank is then treated as an environmental sample in the
laboratory with the following exceptions:
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1. Analyze trip blanks only when detections are found in associated samples.
2. Analyze according to specific project protocols.
4.2.1.1 Trip blank Preparation
Trip blank matrix is prepared in the laboratory by purifying deionized water. k Deionization of laboratory water can
be broken into two major steps, macro and micro polishing. Tap water is passed through large resin beds then
polished by being passed through a second set of micro resin beds and a carbon cartridge. After purification, the
water is collected into a large glass bottle, which is fitted with a carbon filter. A sample, labeled with the batch
number and date, is then taken in a 40 ml VOA and analyzed for volatiles by GC/MS. If any Analyte concentrations
are found above 1 g/L, the process is re-initiated.
4.2.1.2 Monitoring
Every week the stored trip blank water must be analyzed to assure integrity. A sample is taken and labeled with the
date and the batch number followed with a letter from the alphabet, which corresponds to the number of samplings
after the initial sampling.
Example: Batch 215 initialized and sampled on 05/23/97.
The following weeks= sample is labeled - Batch 215A 05/30/97.
If any target analytes are quantified above 2.0 g/L, a new trip blank batch should be processed.
4.2.3 EQUIPMENT BLANK
A sample of deionized water, which is poured over or through field sampling equipment. This water is processed as
an environmental sample in the laboratory for the use of verifying whether or not the decontamination of field
equipment was adequate.
4.3 HOLDING TIMES
Samples should be analyzed as soon as possible after collection. The times listed in Table 1 are the maximum time limits that
the samples may be held before requested analyses are initiated. Analyses conducted beyond proper sample holding times are
to be considered minimum values. Samples may be held for longer periods if the permittee, or monitoring laboratory has data
on file to show that the specific types of samples under study are stable for a longer time, and has received a variance from the
person in authority. A permittee, or monitoring laboratory is obligated to hold samples for shorter times if knowledge exists
showing necessity of maintenance of sample stability. Our goal is to meet every holding time.
4.4 SAMPLE / CONTAINER ORDERING
Completing a bottle order is the responsibility of Client Service personnel. An order is completed by entering all pertinent
information from the client into the LIMS. The bottle order form is generated and submitted to the bottle preparation
technician. The bottle preparation technician completes the tasks listed on the bottle preparation form and acknowledges
completion with the ordering party. Sample containers are now available for client pick up, shipping or courier submittal. A
copy of the bottle order form is included for each respective bottle order and should be submitted back to the laboratory after
field activities. An example of a Bottle Order Form is given in Figure 3. The bottle ordering process flow chart is located in
Appendix E.
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SECTION IV REVISION NO. 20
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PAGE 4- 3
Sampling
Location
Location
ID
Number
Matrix
Depth
(units)
Analytical
Parameter
# Samples
(include
field
duplicates)
Sampling
SOP #
Sample
Volume
Container
s #, size,
type
Preservation
(chemical,
temperature,
light
protected)
Maximum
Holding
Time:
Preparation/
analysis
Water
Quality
Inorganic Water Surface Nitrate as N
One per site BCGEN048 8 oz Plastic None 48 hours
Water
Quality
Inorganic Water Surface Ortho-
Phosphate as P
One per site BCGEN051 8 oz Plastic None 48 hours
Water
Quality
Inorganic Water Surface Turbidity One per site BCGEN014 8 oz. Plastic
bottle
None 48 hours at 4
°C, dark
Water
Quality
Inorganic Water Surface Ammonia as N One per site BCGEN061 8 oz Plastic H2SO4 28 days
Water
Quality
Inorganic Water Surface Metals (200.8) One per site BCMET037 Quarts Plastic None 28 days
Water
Quality
Inorganic Water Surface TDS One per site BCGEN013 Quarts Plastic None 7 days
Water
Quality
Inorganic Water Surface TSS One per site BCGEN022 Quarts Plastic None 7 days
Water
Quality
Inorganic Water Surface Residual
Chloride
One per site BCGEN010 8 oz Plastic None Immediately
Water
Quality
Semi-
Volatile
Water Surface 1664 Oil &
Grease
One per site BCORG026 1 L Amber HCl 28 days
Water
quality
Inorganic Water Surface Nitrates as N One per site BCGEN048 8 oz Plastic None 48 hours at 4
°C, dark
Water
quality
Inorganic Water Surface Ortho-
phosphate as P
One per site BCGEN051 8 oz Plastic None 48 hours at 4
°C, dark
Water
quality
Inorganic Water Surface Total nitrogen One per site BCGEN055 8 oz Jar None 48 hours at 4
°C, dark
Water
quality
Inorganic Water Surface Organic
nitrogen
One per site Calculation 8 oz Jar None 48 hours at 4
°C, dark
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Sampling
Location
Location
ID
Number
Matrix
Depth
(units)
Analytical
Parameter
# Samples
(include
field
duplicates)
Sampling
SOP #
Sample
Volume
Container
s #, size,
type
Preservation
(chemical,
temperature,
light
protected)
Maximum
Holding
Time:
Preparation/
analysis
Water
quality
Inorganic Water Surface Ammonia as N One per site BCGEN061 8 oz Plastic H2SO4 28 days
Water
quality
Inorganic Water Surface Nitrite as NO2 One per site BCGEN055 8 oz Jar None 48 hours at 4
°C, dark
Water
quality
Inorganic Water Surface Total Kjeldahl
nitrogen
One per site BCGEN059 8 oz Plastic H2SO4 28 days
Water
quality
Inorganic Water Surface Total
phosphorous
One per site BCGEN060 8 oz Plastic H2SO4 28 days
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Bottle Order Form
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EFFECTIVE DATE: 01/08/16
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Table 1 MAXIMUM HOLDING TIME AND CONTAINER CHART
GENERAL / INORGANIC CHEMISTRY
ANALYSIS WATER (< 6°C) SOIL
(< 6°C)
Max HT1 in Days
(unless noted) Min Sample Quantity2
Container Type Preservative Container Water Soil Water (ml) Soil (gm)
Alkalinity Pint P -- 8 oz. jar 14 -- 100 10
Ammonia (NH3) Pint P H2SO4; pH<2 8 oz. jar 28 28 100 5
BOD Quart (H) P -- 8 oz. jar 48 Hrs. 48 Hrs. 1000 150
Bromide Pint P -- 8 oz. jar 28 28 50 30
Chloride Pint P -- 8 oz. jar 28 28 50 30
Chlorine (Residual) Pint (H) P -- -- 15 Min. -- 500 --
COD Pint P H2SO4 pH<2 8 oz. jar 28 28 50 25
Color Pint AG/P -- -- 48 Hrs. -- 100 --
Cyanide (Total) Pint P NaOH; pH>12 8 oz. jar 14 14 200 20
Cyanide (Reactive) Pint P -- 8 oz. jar ASAP ASAP 50 50
Dissolved Oxygen Quart (H) P -- -- 15 Min. -- 500 --
Dissolved Organic Carbon 4 oz. AG -- -- 28 -- 100 --
Electrical Conductivity (EC) Pint P -- 8 oz. jar 28 28 200 --
Flashpoint Pint AG -- 8 oz. jar -- -- 500 100
Fluoride Pint P -- 8 oz. jar 28 28 50 30
Gross Alpha Quart P HNO3 <2 or Upres 8 oz. jar 6 Mo. 6 Mo. 1000 250
Gross Beta Quart P HNO3 <2 or Upres 8 oz. jar 6 Mo. 6 Mo. 1000 250
Hardness Pint P -- -- 28 -- 200 --
Hexavalent Chromium (Cr+6) 2 oz. P Borate/HCO3/CO3 -- 5 30 Days till Ext. 50 --
Pint P -- 8 oz. jar 24 Hrs. 7 Days to run 50 20
Iodide Pint P -- 8 oz. jar ASAP 28 Days 50 30
Nitrate/Nitrite (NO3/NO2) 2oz p H2SO4; pH <2 8 oz. jar 28 28 Days After Ext. 50 30
Nitrite (NO2) Pint P -- 8 oz. jar 48 Hrs. 48 Hrs. After Ext. 50 30
Nitrate as NO3 Pint P -- 8 oz. jar 48 Hrs. 48 Hrs. After Ext. 50 30
Odor Pint AG -- -- -- -- 500 --
ORP Pint (H) P -- -- ASAP -- 100 --
Perchlorate Pint P -- 8 oz. jar 28 28 50 30
pH Pint P -- 8 oz. jar 15 Min. -- 100 50
Phenols 4 oz. A H2SO4; pH <2 8 oz. jar 28 28 200 10
Total Phosphorous Pint P H2SO4; pH <2 8 oz. jar 28 28 100 10
Ortho- Phosphorous Pint P -- 8 oz. jar 48 Hrs. 48 Hrs. After Ext. 50 30
TDS Quart P -- -- 7 -- 500 --
TSS Quart P -- -- 7 -- 1000 --
Settleable Solids Quart P -- -- 48 Hrs. -- 1000 --
Total Solids Quart P -- 8 oz. jar 7 7 500 50
Specific Gravity Pint P -- 8 oz. jar 28 28 500 10
Sulfate Pint P -- 8 oz. jar 28 28 50 30
Sulfide (Total) Pint P Zn Acetate 8 oz. jar 7 -- 200 --
Sulfide (Reactive) Pint P -- 8 oz. jar ASAP ASAP 50 50
Surfactants (MBAS) Quart P -- -- 48 Hrs. -- 500 --
Coliforms 8 oz. GN Na2S2O3 -- 6, 30 Hr. -- 125 --
Total Kjeldahl Nitrogen (TKN) Pint P H2SO4; pH <2 8 oz. jar 28 28 100 10
Total Organic Carbon (TOC) 4 oz. A H2SO4; pH <2 8 oz. jar 28 28 100 25
Total Organic Halide (TOX) Pint A H2SO4; pH <2 8 oz. jar 7 Not specified 500 50
Turbidity Pint AG, P -- -- 48 Hrs. -- 50 --
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TABLE 1 (CONTINUED) MAXIMUM HOLDING TIME AND CONTAINER CHART
METALS
ANALYSIS Container Type Preservative Max HT (1) Min. Sample Vol.
(mls)(2)
WATER
Total Metals Pint P HNO3 6 Months ( 28 Days -Hg/Si) 100
Dissolved Filtered in Field Pint P HNO3 6 Months ( 28 Days -Hg/Si) 100
Dissolved not filtered Quart P 6 Months ( 28 Days -Hg/Si) 250
Organic Lead Quart AG Chill to <°6 C 14 Days 1000
200.8 Copper and Lead5 Quart P HNO3 in lab pH<2 6 Months 1000
ANALYSIS Container Type Preservative Max HT1 Min Quantity (gms)2
SOIL
Total Metals 8 oz. Jar G Chill to <°6 C 6 Months ( 28 Days -Hg) 50
WET/STLC As needed G Chill to <°6 C 6 Months ( 28 Days -Hg) 50
TCLP As needed G Chill to <°6 C 6 Months ( 28 Days -Hg) 150
SPLP As needed G Chill to <°6 C 6 Months ( 28 Days -Hg) 150
Hexavalent Chromium 8 oz. Jar G Chill to <°6 C 30 Days / 7 Days from Ext. 50
Organic Lead 8 oz. Jar G Chill to <°6 C 14 Days 50
ORGANIC CHEMISTRY
ANALYSIS
WATER (< 6°C)
SOIL (<
6°C)
Max HT(1) in Days
(unless noted)
Water Soil
Min Sample
Quantity(2)
Container Type Preservative Container Extract Analysis Extract Analysis Water Soil (gms)
504 2x VOA G Na2S2O3 (3) 8 oz. Jar 14 1 14 14 1 VOA 10
508 Liter AG Na2S2O3 (3) 8 oz. Jar 7 14
1 L 50
524.2/ TCP/THMS 2x VOA (H) G Ascorbic/HCl in field -- -- 14 -- -- 1 VOA --
525.2/507 Liter AG Na2SO3/HCl in field -- 14(4) 30 -- -- 1 L --
548 2 x 250ml AG Na2S2O3 (3) -- 7 21 -- -- 200 mls --
549 Liter AP Na2S2O3 (3) -- 7 21 -- -- 200 mls --
552.3 125 ml AG NH4Cl -- 14 28 -- -- 1 VOA --
556 2 x VOA A NH4Cl/CuSO4 -- 7 40 -- -- 1 VOA --
632 Liter AG (3) 8 oz. Jar 7 40 14 40 1 L 50
8015B Gasoline Range 2x VOA (H) G HCl(3) 8 oz. Jar 14 14 -- 14 1 VOA 10
8015B Diesel Range Liter AG -- 8 oz. Jar 14 40 14 40 1 L 50
8015 Ethanol/Methanol
2x VOA (H) G -- 8 oz. Jar -- 14 -- 14 1 VOA 10
8021 BTEX/MTBE 2x VOA (H) G HCl(3) 8 oz. Jar -- 14 -- 14 1 VOA 10
8081/8082/608 Liter AG Na2S2O3 (3) 8 oz. Jar 7 40 14 40 1 L 50
8141 Liter AG (3) 8 oz. Jar 7 40 14 40 1 L 50
8151/615/515.1 Liter AG Na2S2O3 (3) 8 oz. Jar 7 40 14 40 1 L 50
8260/8240/624 2x VOA (H) G Ascorbic (6)/HCl in field 8 oz. Jar -- 14 -- 14 1 VOA 10
8270/625 2 x Liter AG (3) 8 oz. Jar 7 40 14 40 1 L 50
8310/610 Liter AG -- 8 oz. Jar 7 40 14 40 1 L 50
8330 Liter AG -- 8 oz. Jar 7 40 14 40 1 L 50
1664 Oil and Grease Liter AG HCl 8 oz. jar 28 -- 28 -- 1 L 50
1664 TPH Liter AG HCl 8 oz. jar 28 -- 28 -- 1 L 50
TCLP Volatiles 8 oz. G -- 8 oz. Jar 14 7 14 7 1 L 50
TCLP Semi Volatiles Liter (Each test) AG -- 8 oz. Jar 7 40 14 Days until TCLP Leaching
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A= Amber
AG= Amber Glass with Teflon lined Cap
AP= Amber Plastic
G= Glass
GN= Sterilized Glass or Nalgene
H= Headspace Free
HT= Holding Time
P= Plastic
VOA= 40 ml Glass Vials with Teflon lined Cap
TABLE 1 (CONTINUED) MAXIMUM HOLDING TIME AND CONTAINER CHART
AIR / VAPOR ANALYSIS
Container
Keep from Light Max HT1 Min Mass (L)
ASTM D-1946 Fixed Gases Tedlar Bag 3 1
Summa Canister 30 5
25C Landfill Gases TGNMO Tedlar Bag 3 1
Summa Canister 30 5
TO-3 TPH Gas Tedlar Bag0. 3 1
Summa Canister 30 5
TO-14A/TO-15 VOCs Tedlar Bag 3 1
Summa Canister 30 5
NOTES:
(1) = Calculated from time the sample is collected.
(2) = Amount needed to achieve normal method detection limits or regulatory requirements.
(3) = Samples containing residual chlorine must be dechlorinated at the time of sampling.
(4)= 7 Days if Diazonin is requested.
(5)= First Draw sample after 6 - 12 Hour idle period.
(6)= Ascorbic only if from chlorinated source
Fill all containers as much as possible.
TCLP and STLC extractions cannot be conducted on acid-treated containers.
Keep all Air/Vapor samples out of light.
8 oz. Jars all have Teflon lined Caps
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QUALITY ASSURANCE PROGRAM PLAN
SAMPLE CUSTODY
SECTION V REVISION NO. 18
EFFECTIVE DATE: 01/08/16 PAGE 5- 1
5.0 SAMPLE CUSTODY
All samples must remain under custody from the time of sample collection to the time of sample disposal. A sample is considered
under custody if:
1) It is in one's or a team=s possession verified by some form of documentation, or
2) It was in one's possession and he/she locked it or placed it in a sealed container to prevent tampering, or
3) It is within the laboratory grounds.
5.1 CHAIN-OF-CUSTODY PROCEDURES
5.1.1 Samples will be collected, transported, and received under Chain-Of-Custody (COC) protocols consistent with
procedures established by the EPA for litigation-related practices. The Chain-of-Custody record will validate the
transfer of samples among client personnel, BCL Field Personnel, and/or BCL Sample Control Personnel.
5.1.2 Upon receipt at the laboratory, the Sample Custodian is the primary person who will assume sample custody. If the
Sample Custodian is not available, any person from the Sample Control Department will be able to handle initial or
secondary custody procedures.
5.1.3 The COC record is the documentation supporting the integrity of a sample from data collection to data reporting. COC
procedures must be followed for all samples from which analytical results may be obtained and introduced as evidence
in litigation.
5.2 COOLER RECEIPT FORM
5.2.1 Cooler Receipt Forms will be used to document the condition and availability of samples on arrival at the laboratory.
The temperature of the air inside sample coolers and/or the temperature of samples is recorded on the Cooler Receipt
Form. Sample shipping, type numbers, condition, and containment is also recorded on this form.
5.3 SAMPLE LABELS AND CUSTODY SEALS
5.3.1 If sample containers originated from the laboratory, the sample labels will include fields for the following information:
5.3.1.1 Laboratory Name (defaulted)
5.3.1.2 Sample ID
5.3.1.3 Sampler ID
5.3.1.4 Date and Time of sampling
5.3.1.5 Method (defaulted)
5.3.1.6 Preservative if applicable (defaulted)
5.3.1.7 Preservative batch number if applicable (entered by lab personnel prior to shipping to client)
5.3.2 Some sample labels are color coded to indicate preservative types:
5.3.2.1 Yellow - Sulfuric acid
5.3.2.2 Red - Nitric acid
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QUALITY ASSURANCE PROGRAM PLAN
SAMPLE CUSTODY
SECTION V REVISION NO. 18 EFFECTIVE DATE: 01/08/16 PAGE 5- 2
5.3.2.3 Green - Sodium Hydroxide
5.3.2.4 Blue - HCl
5.3.2.5 Brown - Zinc Acetate
5.3.6 Custom Labels
Custom labels are provided for according to specific project plans or under an additional service agreement.
5.3.4 Custody Seals
Custody seals will be used to assure tampering of samples has not taken place before submission to the laboratory.
Information on the custody seal includes the date when the container/cooler was sealed and the signature of the sampler
or relinquisher. Custody seals should be placed at the proper point of opening on coolers or containers such that the
sample contained within the cooler or receptacle cannot be tampered with without tearing the custody seal. The seals
have adhesive backing and should be partially covered with packaging tape to prevent accidental tearing during normal
container handling. Broken custody seals will be noted in the comments section of the COC record and the Cooler
Receipt Form.
5.4 CUSTODY RECORD
5.4.1 All sample shipments must be accompanied by a COC record (see Figure 4 an example of a COC form with information
on how to complete entries). Information on the COC record includes:
5.4.1.1 Package contents
5.4.1.2 Sample identification numbers
5.4.1.3 Sampling Location
5.4.1.4 Date and time of sample collection
5.4.1.5 Requested analyses
5.4.1.6 Project or task information
5.4.1.7 Billing Information
5.4.1.8 Sample tracking
5.4.1.9 Sample Type
5.4.2 The COC record should be completed by the client unless project specific protocols dictate otherwise. Information on
the COC should be consistent with wording written on the sample labels and seals.
5.4.3 The original COC is submitted back to the client as part of the data deliverables package.
5.5 CUSTODY TRANSFER
5.5.1 When transferring custody, the relinquisher must record the time and date of transfer, then acknowledge by placing
his/her signature in the "relinquished by" field. The receiver must then assume custody by signing the "received by"
field, then record the date and time of sample receipt.
5.5.2 The original COC record will accompany the shipment, and a copy will be retained by the client (if the client or a client
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QUALITY ASSURANCE PROGRAM PLAN
SAMPLE CUSTODY
SECTION V REVISION NO. 18 EFFECTIVE DATE: 01/08/16 PAGE 5- 3
representative is available). The signed original COC record must be obtained by the Sample Custodian after the
samples have been received and their condition checked.
5.6 INTERNAL CUSTODY
5.6.1 The sample receiving custodian will accept custody of the shipped samples and verify that the information on sample
labels match the descriptions as noted on the COC. Pertinent information concerning sample condition, shipment,
pickup, and couriers will also be checked. The Cooler Receipt Form (See Figure 5) will be completed by the Sample
Receiving Custodian, prior to transferring samples and paperwork to Sample Log-In Custodian. If problems are
encountered at this stage, the Sample Receiving Specialists will 1) inform the concerned Project Manager or client
service representative, 2) hold logging proceedings, and 3) wait for guidance.
5.6.2 Possible Problems
5.6.2.1 COC descriptions do not match sample labels.
5.6.2.2 Samples were received at temperatures outside the 0 - 6C interval.
5.6.2.3 Sample condition problems
5.6.2.3.1 VOA vials have not been properly filled.
5.6.2.3.2 Sample container is inappropriate.
5.6.2.3.3 Sample container received broken.
5.6.2.3.4 Inappropriate preservatives used.
5.6.2.3.5 Insufficient sample volume or mass submitted.
5.6.2.4 Samples were received past holding times.
5.6.2.5 Number of samples does not match the COC.
5.6.2.6 Sample descriptions are not legible
5.6.3 If problems are not encountered, the samples are logged into a ledger and given a unique laboratory number. The
custodian will then transfer the sample(s) to the appropriate secured refrigerators. Samples are logged into refrigerators
by bar-coding system. Information on the bar code scanner include sample ID's, date and time of logging, relinquisher
initials, sample removal date and time, and receiver initials. All environmental samples are maintained in refrigerators
during the entire analytical process, unless project specific goals warrant otherwise.
5.6.4 In cases where sample splitting, compositing, and/or other processing is necessary, the sample splitter will assume
custody by scanning the appropriate refrigerator number. When sample splitting/processing is complete, the sample
splitter will check the original samples back into the proper refrigerator(s) and place split portions into designated split
sample refrigerators.
5.6.5 Laboratory personnel are responsible for the care and custody of samples from the time of submittal till the time of
transfer of custody for final disposal. Laboratory sample disposal is tracked with the use of the Sample Tracking
Scanner. Samples are kept for at least thirty (30) days after analyses have been completed. If samples are required to be
retained for longer periods of time, they are stored in refrigerators until all holding time restrictions have been exceeded
(six months, then they are transferred to on site sea trains). Approval of sample disposal must be granted by the client
before disposal of archived samples can be initiated.
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QUALITY ASSURANCE PROGRAM PLAN
SAMPLE CUSTODY
SECTION V REVISION NO. 18
EFFECTIVE DATE: 01/08/16
PAGE 5-4
5.7 DIGEST/EXTRACT CUSTODY
Transfer of custody of sample digests and extracts from the preparation team and the analyst team is documented on respective
preparation logs. A member of the preparation team and a member of the analyst team must record their initials to authorize the
transfer of custody. The date of the transfer is also recorded. If custody transfer of prepared samples cannot immediately take
place, the preparation technician must place the digests or extracts in a designated holding area. The preparation technician
should then initial and date the preparation log to acknowledge the relinquishing of prepared samples to the holding area. The
analyst can then assume custody at their convenience by initialing and dating the preparation log. Once analysis is complete, it is
the responsibility of the analyst, except for hazardous waste metals testing, to ensure that prepared sample extracts and digests are
given to the disposal persons for proper waste streaming. See the QA Protocols Manual for additional details.
5.8 WASTE DISPOSAL
Waste disposal procedures were based on the requirements set in the state Hazardous Waste Control Law in the Health and
Safety Code 25100 through 25250 and Title 22 regulations. Most tests utilized generate some type of hazardous waste which
must be collected and properly disposed. Other possible forms of waste in the laboratory are samples, reagents, standards, other
substances used in various capacities. Waste, designated into waste streams, must be collected in suitable properly labeled
containers. These containers are then submitted to the maintenance department for discharge into drums. Drums, secured with
secondary containment, are housed in the waste facility until either the storage time restriction is due or the storage drum is full.
Consult the Waste Disposal SOP for details
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QUALITY ASSURANCE PROGRAM PLAN
SAMPLE CUSTODY
SECTION V REVISION NO. 18
EFFECTIVE DATE: 01/08/16
PAGE 5-5
FIGURE 4
Laboratories, Inc.
Sample
#
Description Date
SampledTime
Sampled
Analysis Requested
Attn:
Street Address:
City, State, Zip:
Phone: Fax:
Email Address:
Project
Description:
Project Code:
Sampler(s):
Tur
naro
und
# of
wor
k da
ys*
Soil
Was
tew
ater
Gro
undw
ater
Dri
nkin
g W
ater
Slud
ge
Sample Matrix
NotesOther
Client:
Report To:
Chain of Custody Form
BC Laboratories, Inc. - 4100 Atlas Ct. - Bakersfield, CA 93308 - 661.327.4911 - Fax: 661.327.1918 - www.bclabs.com
Page ___ of ___
1. Relinquished By
2. Relinquished By
3. Relinquished By 3. Received By
1. Received By
2. Received By
Date
Date Date
Date
Date Date
Time
Time
Time
Time
Time
Time
Cost Center:______________________________________
Submission #:
Are there any tests with holding times
less than or equal to 48 hours?
BC
Client:
Address:
City: State Zip
Billing
*Standard Turnaround = 10 work days
Attn:
San Joaquin
Yes No
EDD Format Options
MBU Site
CVX RCRA
Geotracker 5 File
(CA Default)
Geotracker 2 File
Other (Specify)
Comments:
EMC
Global ID:___________________________________________
Check the appropriate sample
Use this field to
convey any special
information such as
sample hazards and/or
non-standard
turnarounds
Must be completed by
the submitting party
Please complete to
assure proper invoicing
Enter sample description. Please
verify that sample descriptions and
dates match the like information
on respective sample containers
The report will be sent
to this address under
this person's attention
Enter project
information
Enter sample dates
and times
Check for standard
turnaround
Please refer to page 2 for
Analysis Legend.
Use the legend on
Page 2 to reference
analytical methods
Check the appropriate
EDD Format.
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QUALITY ASSURANCE PROGRAM PLAN
SAMPLE CUSTODY
FIGURE 5
SECTION V REVISION NO. 18
EFFECTIVE DATE: 01/08/16
PAGE 5-6
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BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN FACILITIES
SECTION VI
REVISION NO. 20
EFFECTIVE DATE: 01/08/16
PAGE 6-1
6.0 FACILITY
The facility was specially designed to alleviate those undesirable factors, which would affect quality in a
detrimental way. Emphasis was placed on 1) minimizing cross contamination potentials, 2) providing extensive
bench space and considerable refrigerated sample storage areas to ensure effective sample handling processes, 3)
maximizing sample and data flow processes, and 4) ensuring a safe working environment.
Laboratory features:
1) (2) Walk-In and (4) large wall reach-in refrigerators
2) (6) Fire proof data storage rooms
3) Chemical storage rooms
4) Two-story storage area
5) Hazardous Waste drum storage facility
6) 8/9 eye - safety showers
7) (3) hood rooms (24 hoods)
8) Conference room with reference library
9) Bottle preparation room
10) Automated sample submission doors
11) Sample split room
12) (3) Compressed Gas storage rooms
13) Kern Securities fire and security systems
14) On site maintenance department
15) Separate volatiles rooms: GC, GC/MS
16) (1) Warehouse Data Storage with 2 Accounting Offices
The laboratory was built on a large lot which is company owned to accommodate expansion. Figure 6
displays the laboratory floor plan.
6.1 ORGANICS LABORATORY
6.1.1 Separate semi-volatiles and volatiles laboratories.
6.1.2 Semi- Volatiles
6.1.2.1 Separate HPLC, and GC/MS Laboratories
6.1.2.2 Gases piped in from gas storage room.
6.1.2.3 1,600 sq. ft. of working area.
6.1.3 Volatiles
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SECTION VI
REVISION NO. 20
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PAGE 6-2
6.1.3.1 Located in the NW corner of the facility (Extractions located in the SE corner).
6.1.3.2 Two separate laboratories, GC-GC/MS.
6.1.3.3 Maintained under positive pressure.
6.1.3.4 Special carbon filters are integrated into the ventilation systems.
6.1.3.5 2,500 sq. ft. of working space.
6.1.3.6 One (1) Laboratory hood
6.1.4 Extractions
6.1.4.1 Laboratory equipped with 10 ventilated hoods.
6.1.4.2 400 cubic ft. refrigerator.
6.1.4.3 750 sq. ft. of working space.
6.2 WET CHEMISTRY LABORATORY
6.2.1 3,200 sq. ft. of laboratory space.
6.2.2 560 cubic ft. of refrigerator space.
6.2.3 Preparation area segregated from analytical laboratory.
6.2.4 Six (6) laboratory hoods.
6.3 METALS LABORATORY
6.3.1 Separate preparation areas (soil / water).
6.3.2 Two analytical laboratories (ICP,ICP-MS / GFAA-AA, CV)
6.3.3 Gases piped in from gas storage room.
6.3.4 2,200 sq. ft. of working space.
6.3.5 500 cubic ft. refrigerator.
6.3.6 Seven (7) laboratory hoods.
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SECTION VI
REVISION NO. 20
EFFECTIVE DATE: 01/08/16
PAGE 6-3
6.4 LOG-IN DEPARTMENT
6.4.1 1,000 sq. ft. of working space.
6.4.2 100 cubic ft. of refrigerator space.
6.4.3 One (1) laboratory hood.
6.5 RECORD KEEPING
6.5.1 Nine (9) Sea - Trains for data and equipment storage and warehouse for Data Storage
6.5.2 Fireproofed data storage room for temporary storage of data
6.6 WASTE DISPOSAL AREA
6.6.1 Built from the ground up to be a waste disposal storage unit.
6.6.2 Secondary containment for individual waste containers.
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QUALITY ASSURANCE PROGRAM PLAN FACILITIES
SECTION VI
REVISION NO. 20
EFFECTIVE DATE: 01/08/16
PAGE 6-4
4100 Atlas CourtBakersfield, CA 93308
BCL FLOOR PLAN
1
2 3
45
6 7 8
91011
12 13 14
15
1620 23 26
17
19
21
18
29
30 32
33
31A
22
24
25
27
28
A A
A
A35 36
38
34
37N
S
EW
39 4041
Seatrains (ST)
MR
WR
OSR
MR WR
W
42
43
Field Service LIMS
13456 279 BC LABORATORIES INC.
WF
WF
W
Field Service
47a
(A/R) Office
44(A/P) Office
45 46A/P & A/R Storage
Warehouse Storage
47
4116 Atlas Ct.
Bakersfield CA 93308
H EA
OS
TEL
GW
Crash
PCB
Area
AWPhenolic HgNaOH
WW
OIS
SA
AW
AW
HCS
CS
CS
WW
8
0
KEY
Administrative Office
ST #1 QC Raw DataST #2 Client Service Raw DataST #3 Field ServiceST #4 Gen-Chem (Sample Storage)ST #5 LimsST #6 Gen-Chem Sample StorageST #7 Gen-Chem Sample StorageST #8 Acct Receivables/PayablesST #9 CLP Raw Data
Air TestingGC/MS Volatiles/GCSample SplittingGC/MS VolatilesCompressed Air DryerMaintenance OfficeGas StorageGas StorageGas StorageICP LabGC/MS VolatilesMetals Digestion (Solid)Walking/RefrigeratorElectrical Room Atomic Absorption LabBottle Prep
BacteriologyWet Chemistry DepartmentGC/MS Volatile Lab Inorganic Dept.Inorganic Dept.
Metals Digestion (Water/Solid)
GC/MS Semi-Volatiles LabTPH LabPesticides/PCB’s LabGC LabHPLC LabOrganic ExtractionQA/QC/Word Processing Dept.Sample Receiving DeptClient Services/Log-In Dept.ReceptionLobbyComputer RoomBreak RoomConference RoomHR/Safety DirectorPresident’s OfficeAcct Office (A/R)
Misc Receiving AreaSample Storage
ST Seatrains
123456789
101112
151413
1617181920212223242526272829303132333435363738394041
43
Acct Office (A/P)Field Service Trailer
42
AHazardous Waste StorageHWalk-in RefrigeratorMen RestroomsWomen RestroomsWater FountainOffice Supply Storage Room
WFOSR
WMRWR
Acct Office (A/P)44A/P_A/R Storage Room45
Warehouse Storage47QC Storage Room47a
Acct Office (A/R)46
Storage
File Name: S:\WPDoc\Word Docs\LABDOCS\Vision\BCL Floor Map
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BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
PERSONNEL / TRAINING
SECTION VII
REVISION NO. 16
EFFECTIVE DATE: 01/08/16
PAGE 7-1
7.0 PERSONNEL
BC Laboratories, Inc. is staffed by qualified, experienced and well-educated personnel. Brief résumés on key
personnel are located in our Statement of Qualifications manual. Job descriptions are in process to be finalized
for all laboratory positions. Each position requires specific qualifications to be met. The training program is
structured to ensure that curricula addresses specific needs of employees and the organization.
7.1 QUALIFICATIONS
Technical positions require minimum educational standards and experience to be met. Each analyst
must perform an initial demonstration of competency (IDC) before analyses solely generated by the
concerned analyst can be reported to clients. These IDCs will follow guidance as listed in SW-846,
Method for the Determination of Metals in Environmental Samples, Methods for the Determination of
Organic Compounds in Drinking Water, and Standard Methods, 19th
edition.
Training is conducted by persons with a solid background in respective subject matter. Module training
is presented by individuals who are technically competent and qualified in instructional techniques.
7.2 INTERNAL TRAINING PROGRAM
Basic skills and training knowledge are conducted through in-house programs and/or subcontract
programs. The in-house program includes an initial orientation, on the job training and a training
module program, which covers various aspects of laboratory operations.
In House Training Modules (offered as needed and/or biennial). See the QAPM. (Ethics training is
annual)
MODULE
TOPICS
JOB TITLES
(attendance is
required)
TRAINER
A-1
Initial Orientation
LIMS
Ethics
Sexual Harassment
Orientation
For New Hires
Steven Bennett
Basic Laboratory Operations
Introduction to Quality Control
Introduction to Laboratory Analyses
Glassware
Types
Volumetric Measurements
Using Burettes and Pipettes
Calibration
Safety, Cleaning, and Storage
Analytical Procedures
Analysis Terms
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QUALITY ASSURANCE PROGRAM PLAN
PERSONNEL / TRAINING
SECTION VII
REVISION NO. 16
EFFECTIVE DATE: 01/08/16
PAGE 7-2
MODULE
TOPICS
JOB TITLES
(attendance is
required)
TRAINER
Procedures and Methods Instrument
ation
Data Generation
Linear Measurement
Temperature Measurements
B Laboratory Math I
Weighing and Measuring
Units of Measurement
Mass Measurements
Significant Figures and Rounding
Percents
Exponential Numbers
Analyst/Prep Technician
Richard Penner
C-1
Quality Assurance, Quality Control
Concepts
Parameters
Basic Tasks
Measurement and Assessment
Documentation and Audits
Corrective Logic
All
Sara Guron
C-2
Data Management
Recordkeeping Procedures
Responsibilities
Storage
All
Sara Guron
C-3
System Improvement-Corrective Action
Continuous Improvement
When to Initiate Corrective Procedures
Procedures
Identifying the Error
Implementing Corrective Action
Demonstrating Corrective Action
Closure
Documentation
All
Sara Guron
D
Ethics
Industry Standards
Case Studies
Code of Ethics Policy
All
Sara Guron
E
Sexual Harassment
All
Steven Bennett
F LIMS I
Logging on through Passwords
Security
Features
Policy
All
Keith Vogel
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QUALITY ASSURANCE PROGRAM PLAN
PERSONNEL / TRAINING
SECTION VII
REVISION NO. 16
EFFECTIVE DATE: 01/08/16
PAGE 7-3
Training module attendance is job dependent. Each job description has associated minimum training
requirements; Trainees may need to pass training examinations before acknowledgment of successful
completion of pertinent training modules, which are determined according to job description.
Module training will be appropriately scheduled to accommodate both working shifts. Effort will be
put forth to provide a flexible and workable schedule to prevent any significant disruption of work
flow.
Individual module presentations should be posted on the memo board and near time clock at least one
week prior to each training session. Employees are required to sign the attendance ledger on the
posted schedules.
JOB TITLES
1. President
2. Technical Director
3. Director of Human Resources
4. Health + Safety Officer/Radiological
Safety Officer
5. Service Technician
6. Client/Field Services Manager
7. Project Manager
8. Client Services Representative
9. Field Services Representative
10. Courier
11. Lab Technician I (Non Production Data)
12. Sample Custodian
13. Billing Clerk
14. Receptionist
15. Accounts Payable Clerk
16. Accounts Receivables Clerk
17. Inorganics Manager
18. Supervisor (Production Inorganics)
19. Lab Technician I (Inorganics)
20. Lab Technician I (Organics)
21. Lab Technician II (Inorganics)
22. Lab Technician II (Organics)
23. Analyst I (Inorganics)
24. Analyst I (Organics)
25. Analyst II (Inorganics)
26. Analyst II (Organics)
27. LIMS Manager
29. LIMS Programmer
30. LIMS Specialist
31. Volatile Organic Manager
32. Quality Assurance Officer
33 Quality Assurance Specialist
34. Sales & Marketing Director
35. Salesperson
36. Laboratory Coordinator
37. Semi-Volatile Organic Supervisor
38. Semi-Volatile Extraction Supervisor
39. Word Processor Specialist
7.3 ON THE JOB TRAINING
After the orientation is completed, the trainee will be directed to his/her respective department
supervisor. The department supervisor will initiate on the job training procedures. (See the
Training Procedures in the QAPM).
7.4 INITIAL DEMONSTRATION OF COMPETENCY
Each analyst must perform an initial demonstration of competency (IDC) before analyses solely
generated by the concerned analyst can be reported to clients. These IDC's will follow
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EFFECTIVE DATE: 01/08/16
PAGE 7-4
guidance as listed in SW-846, Methods for the Determination of Metals in Environment
Samples, Methods for the Determination of Organic Compounds in Drinking Water, and
Standard Methods, 19th edition. Each analyst must undergo an annual demonstration of
capability. This can be accomplished by passing a yearly audit sample. If a given analyst does
not run an annual audit sample then all analysts can perform 4 ICV=s or LCSW=s to satisfy an
annual demonstration of capability requirement.
7.5 EXTERNAL TRAINING PROGRAM
External training is conducted through manufacturer=s instrument training programs, various
independent seminars, California State University at Bakersfield (CSUB), and Bakersfield
College. External training is addressed under the Educational Assistance section of the
Employee Policy Manual.
Each supervisor is encouraged to attend at least one outside services seminar or training
session, which would enhance his/her job performance or knowledge. In order to attend,
supervisors must be granted an approval by the President.
7.6 SAFETY
Safety training begins with the new employee orientation. Quarterly safety meetings are held
to provide for continuing training regarding safety- related updates and to ensure safe working
conditions by providing reiterated safety practice and policy information. All employees,
unless absence is approved by the Health and Safety Coordinator, are required to attend
quarterly meetings. Meeting schedules can be found posted in the memo board. Additional
information is listed in the Safety Module Training SOP.
7.7 PERFORMANCE EVALUATIONS
To monitor employee progress and efficiency, department supervisors evaluate each specialist
annually. These annual screenings are conducted on a one-on-one basis with supervisors rating
employee performance on various job-related subjects. During these interviews, goals are set
to provide for deficiencies, or to help employees further their training and skills. Evaluation
forms used are exclusive for each laboratory department. (See Appendix C to see an example
of an evaluation form.)
7.8 EMPLOYMENT
BC Laboratories, Inc. offers a comprehensive benefit package for each employee to ensure a
productive and efficient work force. All agreements and particulars are addressed in the BC
Laboratories, Inc. Employee Policy Manual.
Note: This section was reviewed on 1/08/16 (No changes were needed)
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BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
RECORDS / DOCUMENTS
SECTION VIII
REVISION NO. 13
EFFECTIVE DATE: 03/22/16
PAGE 8-1
8.0 RECORDS
Documentation is the heart of every viable QA/QC Program. Without adequate documentation
the ability to defend generated data is impossible. The purpose of documentation for viable
QA/QC programs is to provide the ability to defend and recreate steps taken associated with
each sample from sampling to final submittal and disposal. Documentation falls into two
categories: 1) documents providing assurance of data quality objectives, and 2) documents
providing information pertaining to contingent processes to support activities concerning sample
and sample data handling. Necessary documentation includes:
8.1 SAMPLE CONTROL RECORDS
8.1.1 Chain of Custody - A record verifying the custody of samples and requested and
associated analyses. The COC will be generated by the person(s) in the field.
Completion of this record is addressed in the LOG-IN SOP BCSAM002.
8.1.2 Laboratory Sample Tracking
8.1.2.1 The COC records identify all individuals who physically handled individual
sample.
8.1.2.2 COC received by the laboratory, the laboratory personnel are responsible for care
and custody of the sample
8.1.2.3 Cooler Receipt Form - Record of samples submitted and their disposition,
condition, and number.
8.1.2.4 Internal Chain of Custody Ledger - Record of initial sample tracking record.
8.1.2.5 Sample Split Log - Record of sample preparation of solid matrices prior to
analytical manipulations.
8.1.2.6 Water Tracking Log - Used to track internal sample custody in the Metals
Department.
8.1.2.7 Sample Disposal Log - Tracks sample route from temporary storage to disposal.
8.1.2.8 Archive Refrigerator Log - Record of internal sample tracking for archived
samples.
8.1.3 Refrigerator Logs - Logs which track internal sample custody used in the Organics’, Wet
Chemistry, and Metals Departments.
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8.1.4 Sample Control Approval Form - Provides a review of the log-in process on a
submission basis, also used to verify sample condition.
8.1.5 Preservative Reagent Log - Record of preservative preparation.
8.2 SUPPORT DOCUMENTATION RECORDS
8.2.1 Phone Records - Record of phone correspondence between laboratory personnel and
clients.
8.2.2 Sample Tracking Logs - Record of sample tracking via project coordinators.
8.2.3 Archived Files Request Log - Used to document requests for archived files.
8.2.4 Subcontract COC Log - Record of sample tracking of submissions to a subcontractor.
8.2.5 Shipping Logs (Federal Express / UPS / DHL) - Used to track shipping of samples
and/or data supplies.
8.2.6 Requisition Form - Procurement record.
8.2.7 Maintenance Request Form - Record of scheduled maintenance.
8.3 TECHNICAL RECORDS
8.3.1 Records of original observations, data calibration records, staff records (including
training, IDC, and Performance evaluation)
8.3.2 Maintenance and Disposal of Data records.
8.3.3 Log of names, Initials and signatures for all individuals who are responsible for signing
or initialing any laboratory record are maintained by a laboratory.
8.4 CONTROLLED DOCUMENTS
There is a necessity in maintaining certain documents under a controlled status. Documents
under control will assure 1) proper use of procedures 2) use of the latest version of the
document 3) document review before use and 4) persons requiring the document will receive
and use an approved copy.
8.4.1 Controlled Documents
8.4.1.1 The Quality Assurance Program Plan
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8.4.1.2 Quality Assurance Protocols Manual
8.4.1.3 SOPs (refer to Appendix A for a list of SOPs)
8.4.1.4 LIMS SOP
8.4.1.5 Chemical Hygiene Plan (CHP)
8.4.1.6 Illness and Injury Prevention Plan (IIPP)
8.4.1.7 Safety Manual
8.4.1.8 Employee Policy Manual
8.4.1.8 Substance Abuse Policy
8.4.1.10Laboratory Logbooks (maintenance, standards/reagents)
8.4.2 EXTERNAL SOURCES
8.4.2.1 STANDARDS AND (PJLA) POLICIES/PROCEDURES
8.4.2.1.1 PL-1 Policy on Proficiency Testing Requirements-(Revision 1.13 Revised 7/2015)
8.4.2.1.2 PL-2 Measurement Traceability Policy-(Revision 1.8 Revised 6/2013)
8.4.2.1.3 PL-3 Policy on Measurement Uncertainty-(Revision 1.8 Revised 7/2015)
8.4.2.1.4 PL-4 Calibration Scopes of Accreditation-(Revision 1.4 Revised 6/2013)
8.4.2.1.5 SOP-3- Accreditation Symbol Procedure-(Revision 1.6 Revised 11/2015)
8.4.2.1.6 SOP-9- Complaint Procedure-(Revision 1.4 Revised 3/2013)
8.4.2.1.7 SOP-11- Suspension, Withdrawal or Reduction of Accreditation-
(Revision 1.6 Revised 5/2014)
8.4.3 Process - Document control will be handled through the QA/QC Department and the
Word Processor Specialist (WPS). The Word Processor Specialist will handle all test
processing and record keeping. Approvals will be granted by the QA Officer and/or
pertinent department supervisors.
8.4.3.1 Text Entry - When a document has been produced and approved by pertinent
supervisors outside the LIMS or laboratory document parent directory (WP
Version 8.0 or MS Word 2007), it must be entered and maintained in:
8.4.3.1.1 [S:\WPDOCS\WordDocs\LAB_DOCS\QAPP]
8.4.3.1.2 [S:\WPDOCS \WordDocs\LAB_DOCS\SOPS]
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8.4.3.1.3 [S:\WPDOCS \WordDocs\LAB_DOCS\SOPS\LIMSOP]
8.4.3.1.4 [S:\WPDOCS \WordPerfect\LAB_DOCS\LOGBOOKS]
8.4.3.1.5 [S:\WPDOCS \WordDocs\LAB_DOCS\QAPM]
8.4.3.1.6 [S:\WPDOCS \WordDocs\LAB_DOCS\Safety Manuals
8.4.3.1.7 [S:\WPDOCS \WordDocs\LAB_DOCS\Employee Policy Manual]
8.4.3.1.7 [S:\WPDOCS \WordDocs\LAB_DOCS\Illness and Injury Prevention
Plan (IIPP)]
8.4.3.1.8 [S:\WPDOCS \WordDocs\LAB_DOCS\Substance Abuse Testing
Policy (SATP)]
8.4.3.1.9 [S:\WPDOCS \WordDocs\LAB_DOCS\Chemical Hygiene Plan
(CHP)]
The (draft) document will be processed by the WPS and approved by pertinent
personnel.
8.4.3.2 Approvals - Approvals are documented on Approval Log sheets and document
title pages. Document title page approvals are handled by the WPS.
Parameters checked by the WPS are:
8.4.3.2.1 Complete Document
8.4.3.2.2 Correct Document
8.4.3.2.3 Document print quality
Once approved, the document is submitted to the receiving party. An approval log
sheet is initialed and/or signed by the receiving party and information on this
transaction is documented in an Access Database, LIMS record or a suitable word
processing/spreadsheet program. Approvals of SOPs are documented on Approval
Log sheets. All procedures are reviewed and approved by the QA Officer and
pertinent department supervisors.
8.4.3.3 Maintenance of control documents
8.4.3.3.1 SOP=s, Logbooks, QAPM, and the QAPP. Maintenance
information is located in the QA Protocols Manual.
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8.4.3.3.2 Employee Company policy, revisions are handled through the
Director of Human Resources.
8.4.3.3.3 LIMS SOPs are handled by the LIMS Supervisor.
8.4.3.3.4 Administrative Records
8.4.3.3.4.1 Personal qualifications, training records
8.4.3.3.4.2 Records of demonstration of capability
8.4.3.3.4.3 Log of names, Initial and signatures for all
individuals responsible for signing and
initialing laboratory records
8.5 PROTOCOL
Proper procedures for completing forms and records can be found in specific method SOP's.
8.5.1 General Practices
8.5.1.1 Use only indelible ink.
8.5.1.2 Complete each record. Do not leave empty fields. Line through fields not used or “Z”
out non-filled space.
8.5.1.3 Use proper correction techniques; lined through error then date and initial.
8.6 ANALYTICAL / INSTRUMENT RECORDS
8.6.1 Bench Worksheets (Analytical Data Forms) - Used to record analytical results and
support information.
8.6.2 Extraction Log - Record of sample extraction.
8.6.3 Digestion Log - Record of sample digestion.
8.6.4 Filtration Log - Used to document sample filtration.
8.6.5 Analysis Logs (Run Log) - Record of the sample analytical sequence on respective
instrumentation and can include other QC information.
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8.6.6 Maintenance Log - Used to document routine maintenance and subcontract repair of
instrumentation.
8.6.7 Standards Log - Record of standards preparation.
8.6.8 Reagent Log - Record of reagent preparation and use.
8.6.9 Raw data - Printouts, charts, and chromatograms produced by instrumentation also will
include handwritten records for instrumentation without printing capabilities.
8.6.10 ELEMENT Print out- Records of instrument processing and laboratory corrective
activities.
8.6.11 QC Sheets - Used to document QC and batching capability.
8.7 RAW DATA RECORDS
All raw data records are maintained by the QA/QC Department. The QA/QC Department
obtains records in the following manner:
8.7.1 Organics Department
8.7.1.1 Instrument data is kept by respective analysts until one(1) data file box
(approximately 30 analytical runs) is full. Custody of the file box of instrument
runs should be released within one month to the QA/QC Department. This is
the temporary storage phase. Data custody is documented on a ledger. The file
box is maintained in the QC Dept hallway. This is the secondary storage phase.
After secondary storage, file boxes are also stored and maintained at 4116 Atlas
Ct in Bakersfield.
8. 7.1.2 Approval by the President for record destruction must be made and
documented before any data destruction is to commence.
8. 7.1.3 Records including maintenance, extraction, analytical, reagent, and
standards logs are released to the QA/QC department approximately one (1)
month after the final entry is made into pertinent logs. The QA/QC
Department assumes custody by recording pertinent information into a
ledger, then stores records and documents in designated boxes which are
maintained in the QC Dept hallway. When boxes are full, they are
transferred to on site sea-trains or final storage location is 4116 Atlas Ct in
Bakersfield.
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8. 7.1.4 Tapes and disks are stored temporarily near respective instruments then
indefinitely in the Data Storage Room. Custody is maintained by the
QA/QC Department.
8. 7.2 Inorganics Department
8. 7.2.1 Record maintenance for ICP and ICP-MS follows the same
practices as Organic's records. AA, Hg by CV, and GFAA records
are stored in files by month in file storage cabinets and data boxes
in the Metal's area. Records in these cabinets are removed on a
yearly basis by Metal's Department personnel and released to the
QA/QC Department. Records, in file boxes, are stored in the QC
Dept hallway then eventually to on site sea-trains or QC warehouse
4116 Atlas Ct, in Bakersfield CA.
8. 7.2.2 Logs are maintained in the same manner as Organic's logs.
8. 7.2.3 Disks are stored near respective instruments temporarily then
indefinitely in the Data Storage Room. Custody is maintained by
the QA/QC Department.
8. 7.2.4 Record maintenance is similar to storage procedures for the metals
department.
8. 7.2.5 Logs are maintained in the same manner as Organic's logs.
8. 7.2.6 Tapes are stored temporarily near respective instruments then
indefinitely in the Data Storage Room. Custody is maintained by
the QA/QC Department.
8. 7.3 Sample Control Department, Field Services Department, Client Services
Department
8. 7.3.1 All records are released to the QA/QC Department on an as
needed basis. Records are stored temporarily in the Lab’s Hallway by
the QC Department then transferred to their designated location.
Final storage locations are either on site sea-trains or the storage
building on 4116 Atlas Ct in Bakersfield.
8. 7.4 Data Control Department
8. 7.4.1 Submission files which include case narratives, check sheets, bench
worksheets, chain of custody records, QA/QC reports, and possibly
copies of spreadsheets, extraction log sheets, instrument printouts,
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and other records, are filed in the Data Office. The data filing
specialist assumes and maintains custody of submission files.
8. 7.5 LIMS Department
8. 7.5.1 Records from the LIMS which include data processing records,
programs, and data modification records are maintained by the
LIMS Department until lack of storage space necessitates
transferred of records to the QA/QC Department. These records are
stored in on site sea-trains and onsite warehouse then moved to
4116 Atlas Ct in Bakersfield.
8. 7.5.2 Program projects and LIMS modifications are put into individual
folders numbered with a unique project number. Folders are stored
in boxes in sequential order. Boxes are kept in LIMS manager’s
office for one year then transferred to the LIMS department sea-
train (the final Aresting place=). Microsoft Outlook is used to track
projects and keep brief summaries of work performed.
8. 7.5.3 System back-up tapes are maintained by the LIMS Department
Supervisor on and off site. On site storage is the Computer Room
and an in on-site safe; offsite storage is a climate controlled book
storage unit.
8.8 QA/QC RECORDS
8.8.1 Technical Review Sheets – Analysis sequence which guide reviewers to parameters
of interest. This is a record of technical review.
8. 8.2 Organic secondary data review is documented by analysis sequence sheet.
8. 8.3 Balance Monitoring Log - Use to document analytical and top-loading balance
calibration on a daily basis and weekends only designated balances(See SOP
BCQC008 for balance monitoring)
8. 8.4 Refrigerator and Freezer Monitoring Log - Use to document refrigerator and Freezers
temperatures on a daily basis.
8. 8.5 Oven Monitoring Log - Use to monitor oven temperatures on a work basis.
8. 8.6 Thermometer Calibration Check Log - Record of thermometer external checks
against a NIST reference thermometer.
8. 8.7 Waterbath Logs - Record of waterbath temperature during analysis.
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8. 8.8 Auto-diluter Calibration Record - Gravimetric checks of auto-diluter volume
deliveries.
8. 8.9 Data Custody Log - Record of custody of data.
8. 8.10 Spreadsheets and Access Databases- Use to track controlled documents
8. 8.10.1 Audits
8. 8. 10.2 IDC - Initial Demonstration of Competency Forms
8. 8. 10.3 Instruments Tracking
8. 8. 10.4 Raw Data Custody
8. 8. 10.5 SIF=s
8. 8.10.6 Sample Custody
8. 8. 10.7 Logbooks
8.9 RECORD / DOCUMENT STORAGE
8.9.1 Data Storage Log - Record of custody of instrument data.
8. 9.2 Archived In/Out Raw Data Log - Used to document custody of In/Out Archived Raw
Data.
8. 9.3 Electronic records are maintained to document 1) all LIMS activities, and 2) analytical
activities on IC's, GC's, GC/MS's, ICP's and the ICP-MS's. Electronic records are in the
form of tapes and disks.
8. 9.4 All records are backed up in dual process: one is data (hardcopy) file box and the other
is raw data CDs. Sample control records, Analytical/Instrument records, QA/QC
records and support documentation records received in a QA/QC.
Department are documented in a raw data management storage log with date affective,
instrument #, date relinquished/received custody of records with analyst initial. Each
data file box/data CD is assigned a number in a sequential order per year (e.g. 09-000 or
09CD000) numbers are entered into raw data Microsoft Access Database. However,
Internal audits, management reviews, corrective and preventive actions (SIFs) are kept
in an on-site fireproof record storage for seven (7) years.
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8. 9.5 Data is transferred to a CD on a monthly basis for each instrument and all CDs are
stored in fire proof storage in a sequential order per year. In case, substitution of lost
and /or replacement of damaged records can be retrieved from the back-up CDs.
8.9.6 MAINTENANCE OF RECORDS:
Data file records are stored and retained in such a way that they are readily retrievable
in a facility and off-facility storage, 4116 Atlas Ct in Bakersfield, which provides a
suitable environment to prevent damage and or loss of records.
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8.10 STORAGE RECORDS
After creation, records are stored in the onsite sea-trains or QC warehouse at 4116 Atlas Ct in
Bakersfield which is used for final storage of records. Records are kept for at least seven (7)
years, unless particular project specific protocols mandate otherwise. All destructive records
are moved to inactive file.
8.10.1 Closure of BC Laboratory
8.10.1.1 In case of permanent laboratory closure all records associated with analytical
data will stored off-site archived record storage until time limit has been
exceeded.
8.11 DATA ARCHIVAL
Final data are in the following forms:
Hardcopy
Submission files
Raw data
Support data
Diskette
Data disks
Tapes
All records, except submission files, are submitted to and archived by QA/QC Department
personnel. Submission file archival procedures are conducted by the filing specialist.
8.11.1 Hardcopy Archival
All hardcopy files are collected into boxes which are sequentially numbered by the filing
specialist or QA/QC personnel. Box ID's are then entered into a spreadsheet with the
following corresponding data:
Box number
Box contents
Instrument number
Analysis code
Custody date
All boxes are temporarily stored on site, until storage space is exhausted, then
transferred to the 4116 Atlas Ct in Bakersfield.
8. 11.2 Diskette
Diskettes are stored in the onsite raw data storage room. Each diskette is labeled and
stored in a box which is also labeled. All information is kept in spreadsheet form.
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8. 11.3 Data disks
Imaged data is maintained on hard drive type disks. Back up disks are labeled and kept
in an on-site safe. The LIMS Department is responsible for storage of these disks.
8. 11.4 Tapes
Tapes are used to archive both instrument data and LIMS files. All instrument tapes are
labeled by respective analysts then submitted to the QA/QC Department for storage.
Instrument tapes are stored in labeled boxes in the raw data storage room.
LIMS backup tapes are maintained by LIMS Department personnel. One of the six sets
of tapes is kept off site to provide additional security in case of catastrophic events.
8.12 CONTROLLED ACCESS OF RECORD
All secondary data storage areas are maintained under lock and key. Warehouse storage is
electronically secured thus persons requiring retrieval of data must adhere to protocol in order
to obtain access.
8.12.1 Procedure
Contact the respective person(s) responsible for particular archived items. Have the
responsible person document custody procedures, and then assume custody. The person
who assumes custody is now responsible for all items in hand until documentation of
return of items is complete.
Submission files
Contact: Data filing specialist
Custody documentation: Internal COC out cards & Altered Completed Files Form
Raw data hardcopies
Contact: QA/QC Department personnel
Custody documentation: Internal COC logbook
Diskette
Contact: QA/QC Department personnel
Custody documentation: Internal COC logbook
Data Disks
Contact: LIMS Department personnel
Custody documentation: Internal COC logbook
Tapes
Contact: QA/QC Department personnel
Custody documentation: Internal COC logbook
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8.12.2 Limitation of Access
The person(s) responsible for maintenance of archived data has the right of refusal of
access, thus President and/or Supervisor approval may be needed in order to access
data.
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9.0 INSTRUMENTATION
9.1 Wet Chemistry
9.1.1 Ion Chromatographs
Instrument ID Analysis Year in
Service
Method
Dionex Model DX500
LC20 CE (CE01 Chromatography Enclosure)
CD20 (CD03/CD04 Conductivity Detector)
IP25 (IP01/IP02 Peak Net Software )
AS 40 (AS52/AS46 Automated sampler)
EG01/EG02 Eluent
IC1 /IC2
Chloride, Nitrate, Sulfate
Bromide, Fluoride
2000 EPA-300.0
IC-04
Dionex Ion Chromatograph (AD-02)
AS 40 (AS47 Autosampler)
IP 25 (IP03 Isocratic Pump)
LC 20 (CE03 Chromatography Enclosure)
PC 10 (PC01 Pneumatic Controller)
Dionex VWD (AD02 Absorbance Detector)
EG04 (Eluent)
IC4 Hexavalent Chromium
2005 EPA-218.6/
SW-7199
IC5
AS40 (AS58 Automated Sampler)
LC20 (CE04 Chromatography Enclosure)
IC25 (IP05 Ion Chromatography)
EG09 (Eluent)
IC5 Chloride, Nitrate, Sulfate
Bromide, Fluoride
2009 EPA-300.0
IC-06
Dionex Model ICS 2100
AS 64 Automated Sampler
EG10 Eluent Generator
IC6
Perchlorate
Iodide/Thiosulfate
2012
EPA-314.0
IC-07
Dionex Model IC 25
AS 47 Automated Sampler
EG40 Eluent Generator 1(EG-03A, EG-03B)
LC25 Chromatography oven (CE-02)
IC7
Volatile Fatty Acid
2013
EPA-300.0
IC-08
Dionex Model IC 25
AS 57 Automated Sampler
EG40 Eluent Generator 1(EG-11)
LC25 Chromatography oven (CE-05)
CD06 Conductivity Detector
IP06 Isocratic Pump
PC02 Pneumatic Controller
IC8
2014
EPA-300.0
9.1.2 Auto Analyzer Systems
Instrument ID Analysis Year in
Service
Method
Konelab 20
Thermo clinical labsystems
Kone-1 Nitrite, Ortho - phosphate,
Hexavalent Chromium,
Cyanide, Phenols,
Ferrous Iron
2003 EPA-353.2
SW-7196A
EPA-365.1
EPA-335.2
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EPA-420.4
Smart Chem
(Westco Scientific Inst)
SC-1 NH3-N, TKN, NO3/ NO2,
Total.Phosphate
2007 350.1, 351.2,
353.2, 365.4
9.1.3 Other Instruments Instrument
ID
Analysis
Year in
Service
Method
Spectronic 20 Genesys
Spec 06
COD
MBAS
Sulfide
2014
EPA-410.4
EPA-425.1
SM-4500SD Orion Research Analog pH meter 301
Beckman 360 pH/Temp/mv Meter(2)
360
pH in water samples
2000
EPA-150.1,9045,
9040
YSI Model 3100-115V Conductivity Meter
CND-4
Electrical Conductivity
2013
EPA-120.1
Hach DBR 200 COD Reactor
COD03
COD
2008
EPA-410.4
Hach Model DRB200
COD04
COD
2011
EPA-410.4
Hach Model 2100N Turbidimeter
Turb-01
Turbidity
2003
EPA-180.1
Hach Model 2100N Turbidimeter
Turb-04
Turbidity
2013
EPA-180.1
YSI Model 57 Oxygen Meter
IMHOFF Cone
Thermolyne (Auto Mixer)
YSI-57
BOD, C-BOD, Dissolved O2
Seattleable Solids
TKN, Total. P
1990
SM-5210B
EPA-360.1
EPA-160.5
Brinkman Digital Buret
BDB
Alkalinity (HCO3, CO3, OH)
1995
EPA-310.1
Aurora Model 1030
Auto Sampler 1088
TOC-2
TOC Analysis
2006
EPA-415.1
Metrohm
PEA 1R
pH, EC, OH, CO3,HCO,
2008
EPA-150.1,
9040, 120.1,
9050, 310.1, SM
2320 B Metrohm
PEA 1C
pH, EC, OH, CO3,HCO
2008
EPA-150.1,
9040, 120.1,
9050, 310.1, SM
2320 B
9.2 Metals
9.2.1 Inductively Coupled Argon Plasma / Mass Spectrometer
Instrument ID Analysis Year in
Service
Method
Perkin Elmer
Elemental Scientific ICP-MS(SC2DXS)
PE-EL2 Metals 2011 EPA 200.8
SW 6020B
Perkin Elmer Elan 9000
ICPMS (P2160412)
PE-EL 3 16 Routine metals;Additional metals
available upon request
2014 EPA-200.8/6020
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9.2.2 Inductively Coupled Argon Plasma
Instrument ID Analysis
Year in
Service
Method
Perkin Elmer Optima 4300DV PE-OP2 Metals 2004 EPA 200.7
SW 6010B
Perkin Elmer Optima 8300DV PE-OP3 Metals 2014 EPA 200.7
SW 6010B
9.2.3 Graphite Furnace Atomic Absorption Spectrophotometers
Instrument ID Analysis
Year in
Service
Method
Perkin Elmer SIMAA 6000
Auto sampler 72
Zeeman Background
AA Winlab Software
Perkin Elmer
Furnace Cooling
System FCSO1
PE-1 Chromium
2000 EPA-200.9
9.2.4 Mercury Analyzers
Instrument
ID
Analysis
Year in
Service
Method
Quick Trace Mercury Analyzer M-6100
CETAC1
Mercury
2004
SW-7470A/245.1 &
SW-7471A
9.2.5 Flash Point Instrument
ID
Analysis
Year in
Service
Method
Koehler, K16200 Flash Point Unit FP#1 Pensky Martin
Closed Cup
Manual Flash Test
2012
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9.3 ORGANICS
9.3.1 GC/MS - Semi Volatiles Instrument
ID
Analysis
Year in
Service
Method
HP 5972 Series GC System
HP 5890 Series Autosampler
HP Tray ASTR08
HP7976 AS71
HP Chemstation with Enviroquant
MS-B1
Semi-Volatiles
1994
EPA-625
EPA-8270C
HP 5972 Series GC System
HP 59822B IAG02
HP GC System injector
HP 5890 Series Autosampler
HP Tray ASTR06
HP Chemstation with Enviroquant
MS-B2
Semi-Volatiles
1994
EPA-625
EPA-8270C
Varian 4000 GC / MS
Varian CP-8400
Autosampler
MS-B3
Synthetic Organic
Compounds
2007
EPA-548
HP 6890 Series GC System
GC System injector 7673
HP 5973 Mass Selective Detector
MS-B4
8270 NDMA, 8270 SIM,
PNA, 1,4-Dioxane
2003
EPA 8270C
HP 6890 Series GC, 7673 Injector
MS-B6
525, 507, 548(TBD)
2012
EPA-525
EPA-507 HP 6890 Series GC System
HP 5973 Mass Spectrometer 7673 Injector
HP GC System injector 7673
MS-B7
LUFT GC-MS, Diluent,
Motor Oil, Crude, Diesel,
8270 SIM, PNA
2013
Luft GC-MS
EPA 8270C
9.3.2 GC/MS - Volatiles
Instrument
ID
Analysis
Year in
Service
Method
HP 5890 II Series GC System
HP 5972 Series (MSD)
Tekmar 3100 Concentrator
Tekmar Dohrmann Solatek 72
HP Chemstation with Enviroquant
MS-V2
Volatiles
2009
EPA-8240B
Soil**
EPA-8260B
Soil**
HP 5890 II Series GC System
HP 5972 Series (MSD)
Tekmar 3000 Concentrator
Tekmar Dohrmann Solatek 72
HP Chemstation with Enviroquant
MS-V3
Volatiles
1993
EPA-8240B Soil
EPA-8260B Soil
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HP 6890 Series GC System
HP 5973 Series (MSD)
Tekmar 3100 Concentrator
Tekmar Dhormann Aqua Tek 70
HP Chemstation with Enviroquant
MS-V5 Volatiles 1999 EPA-8240B
EPA-8260B**
521.2
HP 5890 II Series GC System
HP 5972 Series (MSD)
Tekmar Aqua Tek 70
Tekmar 3100 Concentrator
HP Chemstation with Enviroquant
MS-V6
Volatiles
2000
EPA-524.2(SIM
1,2,3-TCP)
HP 5890 II Series GC System
HP 5972 Series (MSD)
Tekmar Dhormann Aqua Tek 70
Tekmar 3100 Concentrator
HP Chemstation with Enviroquant
MS-V7
Volatiles
2001
EPA-601/602**
EPA-624**
HP 5890 II Series GC System
HP 5972 Series (MSD)
OI Analytical eclipse Model 4660 Concentrator
OI Analytical 4551-A Sampler
HP Chemstation with Enviroquant
MS-V10
Volatiles
2001
EPA-8260B
Short List
HP 5890 II Series GC System
HP 5972 Series (MSD)
OI Analytical eclipse Model 4660 Concentrator
OI Analytical 4551-A Sampler
HP Chemstation with Enviroquant
MS-V12
Volatiles
2003
EPA-8260B
Short List
Agilen Technologies 6890N Network GC System
Agilen Technologies 5973 (MSD)
Tekmar Dhormann Aqua Tek 70
Tekmar 3100 Concentrator
HP Chemstation with Enviroquant
MS-V13
Volatiles
2003
EPA-8240B
EPA-8260B
HP 6890 Series GC System
HP 5973 Series (MSD)
Tekmar Dhormann Aqua Tek 70
Tekmar 3000 Concentrator
HP Chemstation with Enviroquant
MS-V14
Volatiles
2013
EPA-524.2
EPA-8260B
EPA-8240B
EPA-8260B SIM
** DOD Project Specific
9.3.3 Air Room Testing Instrument
ID
Analysis
Year in
Service
Method
MS-A1 HP 6890 Series GC System
MSD-19 HP Agilent 5973
PCT-1 Preconcentrator 7100AR
AS-62 Autosampler 7405
CCI-A1 Canister Cleaner 3100A
MS-A1
a TO-14V Full
a TO-15V Full
2009
TO-14A
TO-15
MS-A2 Agilent 6890 N
MSD-18 Agilent 5973N
MS-A2
a TO-3V Full
2009
TO-3
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AS-60 Autosample and Pre. Concentrator model
7032AB-L MS-A3 Agilent 6890
MSD-20 Agilent 5973 Mass Selective Detector
AS-63 Autosampler model 7032AQ-L
MS-A3
a TO-3V Full
2009
TO-3
GC-A1 Agilent 6890 N (TCD/FID)
AS-59 Autosampler 7032 AB-L
DD-10 Dynamic Dilutor(4600A)
GC-A1
a 3CV fixed gasses
a A-D 1946 fixed gasses
2009
3C Fixed
Gases
9.3.4 Gas Chromatography
Instrument
ID
Analysis
Year in
Service
Method
HP 5890 Series II Dual FID
HP 7673 Dual Tower Autosampler
HP Chemstation with GC-Enviroquant
GC-2
Diesel
Fuel Fingerprint
Carbon Ranges
1991
8015M
HP 5890 Series II Dual ECD
HP 6890 Injector
HP Chemstation with GE-Enviroquant
GC-3
Haloacetic Acids
Formaldehyde
2008
2009
EPA-552.3
EPA-556.1
Varian 3300 Dual ECD
Varian 8200 Autosampler
HP Chemstation with GC-Enviroquant
GC-4
DBCP and EDB
1989
EPA-504.1
HP 5890 Series II Split/Splitless Injector
HP 7673 Autosampler
HP Chemstation with GC-Enviroquant
GC-5
Diesel
1989
8015 M
HP 5890 Series II
HP GC System
HP Chemstation with GC-Enviroquant
HP 7673 injector
HP Controller
GC-8
Chlorinated herbicides
1990
EPA-515.1
EPA-8150
EPA-8151A
615
HP 5890 Series II Dual FID
HP 7673 Dual Tower Autosampler
HP Chemstation with GC-Enviroquant
HP 7673 injector
GC-12
Methanol, Ethanol
1992
8015 DI
HP 5890 Series II Dual FID
HP 7673 Dual Tower Autosampler
HP Chemstation with GC-Enviroquant
HP Controller
GC-13
Diesel
1992
8015M
HP 6890 Series
HP 6890 Autosampler
HP Chemstation with GC-Enviroquant
GC-14
pesticides
2011
EPA-508
EPA-608
EPA-8082
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HP Controller HP 6890 Series II
HP 6890 Autosampler
HP Chemstation with GC-Enviroquant
GC-15
pesticides
2012
EPA-508
EPA-608
EPA-8082 HP 6890 Series II
HP 6890 Autosampler
HP Chemstation with GC-Enviroquant
GC-17
pesticides
2013
EPA-508
EPA-608
EPA-8080
EPA-8081A
EPA 8082 HP 6890 Series II
HP 6890 Autosampler
HP Chemstation with GC-Enviroquant
GC-18
Organophosphorus pesticides
2015
EPA-8140
EPA-8141A
9.3.5 Gas Chromatography - Volatiles
Instrument
ID
Analysis
Year in
Service
Method
Varian 3400 GC-V1 RSK-175
RSK-175 FULL
1991 Methane, Ethene,
Ethane
Mehane,Ethene,
Ethane, Propane HP 5890 Series II with PID and FID
Tekmar 3000 Concentrator
Tekmar Precept II Autosampler
HP Chemstation with GC-Enviroquant
GC-V8
BTEX, MTBE, TPH (gas)
1998
EPA-8020,
8021B
8015M
5035 HP 5890 Series II with PID and FID
Tekmar 3100 Sample Concentrator
Aqua Tek 70 Auto Sampler
HP Chemstation with GC-Enviroquant
GC-V9
BTEX, MTBE, TPH (gas)
2013
EPA-8020,
8021B
8015M
9.3.6 PETROLEUM Instrument
ID
Analysis
Year in
Service
Method
Grabner, Minivap VPXpert PE#1 Vapor Pressure 2012 Petroleum
Agilent 6890, FPD PE#2 Sulfur Compounds 2012 Petroleum
Agilent/Wesson 6890, Dual TCD, FID PE#4 Fixed Gases, C1-C6+
Hydrocarbons
2012 Petroleum
Thermo Scientific, 2839
High Temp Water Bath
PE#5 Various 2012 Petroleum
IEC, HN Centrifuge PE#6 Centrifuse Procedures Unknown Petroleum
TOX-100 AM743931
PE#7 Organic Chlorides
Total Sulfur
2013 Petroleum
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PAC OptiDIst 04071 PE#8 Distillations 2013 Petroleum
Density Meter-DMA4500M
PE#9 API Gravity, Density and
Specific Gravity
2013 Petroleum
Viscometer-SVM3000 PE#10 Viscosity 2013 Petroleum
9.3.7 HPLCs Instrument
ID
Analysis
Year in
Service
Method
HP 1050 Model 79856A
Quarternary Eluent Pump
HP 1100 Series
Autosampler
Multiwavelength UV Detector
HP Chemstation with GC-Enviroquant
LC-14
Polynuclear Aromatic
Hydrocarbons
Carbamate and Urea-containing
Pesticides
Nitroaromatic and Nitramines
1994
EPA-610
EPA-8310
EPA-632
EPA 8330
EPA 549
9.3.8 Instrument
Instrument ID Analysis Year in
Service
Method
SPE - DEX (main)
(Controller Extractor)
Horizon Technology
model - SPE - 100
Serial - 06 - 0489
SPE - DEX 525 Extraction 2007 525 Extraction
Extractor SPE 03
model - SPE - 4790
SPE - DEX 525 Extraction 2007 525 Extraction
Extractor SPE 04
model - 06 - 0799
SPE - DEX 525 Extraction 2007 525 Extraction
Extractor SPE 05
model - 06 - 0797
SPE - DEX 525 Extraction 2007 525 Extraction
Extractor SPE 06
model - 06 - 0802
SPE - DEX 525 Extraction 2007 525 Extraction
Extractor SPE 07
model - 06 - 0798
SPE - DEX 525 Extraction 2007 525 Extraction
Extractor SPE 08
model - 06 - 0800
SPE - DEX 525 Extraction 2007 525 Extraction
Extractor SPE 09
model - 06 - 0801
SPE - DEX 525 Extraction 2007 525 Extraction
Extractor SPE 10
model - 06 - 0796
SPE - DEX 525 Extraction 2007 525 Extraction
9.3.9 Other Instruments
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Instrument ID Analysis Year in
Service
Method
OA-SYS (Heating System Blue M)
Precision Scientific (Coliform Incubator
Bath)
1992
3510
3550
3580
9.3.10
Instrument ID
Analysis
Year in
Service
Method
Liquid-Liquid Extractor 2 LLE-2 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 3 LLE-3 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 4 LLE-4 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 5 LLE-5 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 6 LLE-6 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 7 LLE-7 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 8 LLE-8 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 9 LLE-9 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 10 LLE-10 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 11 LLE-11 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 12 LLE-12 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 13 LLE-13 3520
Continuous Liquid-Liquid
Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 14 LLE-14 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 15 LLE-15 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
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Liquid-Liquid Extractor 16 LLE-16 3520
Continuous Liquid-
Liquid Extraction
2008 3520
Continuous Liquid-
Liquid Extraction
Liquid-Liquid Extractor 17 LLE-17 3520
Chiller Recirculation
2008 Chiller
Recirculation
Liquid-Liquid Extractor 18 LLE-18 3520
Chiller Recirculation
2008 Chiller
Recirculation
Liquid-Liquid Extractor 18 LLE-18 3520
Liquid Extraction
2008 Liquid
Extraction
9.4 Microbiology Instrument
ID
Model
Analysis
Year in Service
Incubator - VWR Model(1)
102
1565
5.5.5 or 10 Tube
1989
Incubator - VWR Model (2)
102
1565
1989
Incubator - ASP Model (3)
American Scientific
103
IS-81
5.5.5 or 10 Tube
1989
Autoclave (1)
Marketforge Sterilmatic (2)
AMS001
STM-E
STM-EL
1600 Tubes of media (3200)
1990
WaterBath
Thermo Scientific (Precision)
W13
2862
10/20 Tube Samples
2008
Quebec Colony Counter
Capacity/100
Potential Capacity/200
QCC001
3330
Colony Counter
1980
IDEX Spectroline
IDEXX
IDXS001
CM-10
Total Coliform E. Coli Colliert
presence/Absence
1996
IDEXX
Quanti Tray Sealer Model 2X
IDXT001
2X
Total Coliform E. Coli Colliert
presence/Absence
2003
9.4.1 BACTERIOLOGICAL EQUIPMENT Equipment
Manufacture
Model
Date Last
Maintenance
pH Meter Orion Research 301 Per Use
Balance Mettler Toledo JB3002-L-G/A 7/16/2013
Conductivity Meter YSI 3100 Per Use Incubator
VWR 1565
Monthly VWR 1565
American Scientific IS-81
WaterBath
Thermo Scientific (Precision) 2862 Quarterly
Refrigerator North Star - As Needed Autoclave
Marketforge Sterilmatic STM-E Weekly/Monthly
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STM-EL
Hot Air Over VWR 1370FM Per Use/Monthly
Colony Counter Darkfield Quebec 3330 Per Use Ultraviolet Light 254 nm
IDEX Spectroline
IDEXX
EA-160 Per Use
9.5 ORGANICS
9.6 Field Service-Sampling Equipment
1. 2'= Grunfos Pump with hydralic Reel and Control Box
for pumping water out of monitor wells.
2. ProAir Air compressor, 20 gal, 5 HP model # PRFB5020VP
3. Genetac megaforce 6500 generator model No. 1006-0
4. Quik-E-bailer model 300DC For taking water out of monitor wells
5. Dissolved oxygen meter model 51B, serial # 13633 for Field Do=s *
6. Turbidity meter model 2008 serial # 1914-3593 *
7. H2S monitor model HS-82A serial # HS7568
8. H2S Continuos Monitor TXL01
9. Oakton pH/conductivity and temperature meter serial # 35858 – PH11
10. Oakton pH/conductivity and temperature meter serial # 510764– PH15
11. Oyster pH/conductivity and temperature meter serial # 976858– PH16
12. Sensidyne gastec pumpkit model # 800 *
For testing H2S in the field.
13. Airchek sampler model 224-PCXR7 serial # 523231 *
Sampling air in the field.
14. 2'= Grunfos Pump with Hand Reel and Control Box
for dumping water out of monitor wells.
15. Scott 2.2 self contained breathing apparatus serial # 39700110 *
16. 3-extra oxygne tanks for Scott 2.2 SCBA=s *
17. ISCO 3210 ultrasonic flow meter serial # 09748-025
Measuring the amount of water that has flowed during a certain amount
of time
18. Scott 2.2 self contained breathing apparatus serial # 39800176 *
19. Scott 2.2 self contained breathing apparaturs serial # 39700096 *
20. ISCO 3700 24 hr water sampler serial # 09421-074
21. ISCO 2700 24 hr water sampler serial # 06112-097
22. CLT01
23. 2-chlorine test kits model CN-70
24. 3-Hand soil Auyers and extentions
25. Sigma 24 hr auto sampler model # 1350 serial # F07937875 *
26. Gas meter and air sampling canister serial # 27515 *
27. Gas meter and air sampling canister serial # 1197501 *
28. Gas meter and Air sampling canister serial #1197500 *
29. 5 cooling coils and hoses for sampling Hot samples to cool them
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down before sampling *
30. O2,lel,H2S monitor model 6x82 serial # 13545 *
31. 4 ISCO batteries and 2 chargers
32. Clam shell sampler for sludge
33. Half-face respirator Scott 66M
34. Half-face respirator North 770030 Series M *
35. Full Face respirator Scott P/N 802451-01 *
36. Half-face respirator Scott 66M
37. Vacuum pump serial # 1190 model # 2Z866
38. Gas Powered soil Auger and extensions *
Note: * = These equipments are available for use.
9.7 Support Equipment & Supplies
9.7.1 Laboratory Information Management System (LIMS)
1. Hardware
1. Compaq Proliant ML530
1. Intel Pentium XEON 1 Ghz Processor
2. 1 Gb SDRAM
3. Hot Plug Drive Cage - Ultra 2
4. Integrated Ultra 2 SCSI Controller
5. Compaq Smart Array 431 Controller
6. RAID 5 with Online Spare Setting
7. 1.44 Mb Floppy Disk Drive
8. Five 18.2 Wide Ultra 3 SCSI Hot pluggable drive
9. 32x CD-ROM
10. Compaq 10/100 TX UTP NIC
11. Compaq 40/80 Gb DLT Drive-Internal
12. Automatic Server recovery
13. Compaq Insight Server Manager
14. 3 year Limited Warranty
2. Compaq Smart Array 431 Controller
3. ML530 Hot Pluggable Redundant Power Supply
4. Device ID: 11001
5. Serial Number; D043FPW1K126
2. Installed Software
1. Novell Netware 5.1 with Service Pack 2.0A
1. 105 user license
2. Serial Number = 300792721
Activation Key = 2D27C68EFE2CB72F
3. Serial Number = 400439667
Activation Key = 4B5669AA6C9E1D16
2. Arev NLM 5.0
3. Backup Exec for Netware Version 8.5 Revision 3012 Multi-Server Mode (by
Veritas)
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4. Inoculate - IT Version 4.5 100 User (Not used)
3. Volumes
Volume Name Drive
Size, MB
Major Contents
SYS
G:
3000
System Files, Email In-Box
APPS
F:
20000
LIMS Database, Raw Data
DOCS
H:
8002
Client EDDs, Word Document, Control Charts
QUE
Q:
2000
Print Job Queues
WEB_APPS
W:
18000
Web Pages, User Home Directories, Quotes, Time Clock, Quotes, Misc
Printers
1. Laser Jet Printers 84
2. Ink Jet Printer 7
3. Dot Matrix Printers 2
4. Label Printers 10
5. PC – Pentium 2 1
6. PC – Pentium 3 8
7. PC – Pentium 4 43
8. PC – Pentium Dual Core 48
9. PC – Pentium Quad Core 3
10. PC – Lap tops 13
4. Scanners 2
I.
Servers - Novell File Server
LIMS SOP 0521
Purpose
This file server is used for user authentification, print
services, file services, and hosts the Legacy Arev LIMS
database.
II. Configuration
A. Information
1. Server Name SRV_BCLABS
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2. Device ID 11001
3. Serial Number D043FPW1K126
B. Hardware
1. Compaq Proliant ML530
a. Intel Pentium XEON 1Ghz Processor
b. 1 Gb SDRAM
c. Hot Plug Drive Cage - Ultra 2
d. Integrated Ultra 2 SCSI Controller
e. Compaq Smart Array 431 Controller
f. RAID 5 with Online Spare Setting
g. 1.44 Mb Floppy Disk Drive
h. Five 18.2 Wide Ultra 3 SCSI Hot Pluggable Drives
i. 32x CD-ROM
j. Compaq 10/100 TX UTP NIC
k. Compaq 40/80 Gb DLT Drive - Internal
l. Automatic Server Recovery
m. Compaq Insight Server Manager
n. 3 year Limited Warranty
2. Compaq Smart Array 431 Controller
3. ML530 Hot Pluggable Redundant Power Supply
C. Installed Software
1. Novell Netware 5.1 with Service Pack 2.0A
a. 105 user license
b. Serial Number = 300792721Activation Key =
2D27C68EFE2CB72F
c. Serial Number = 400439667Activation Key =
4B5669AA6C9E1D16
2. Arev NLM 5.0
3. Backup Exec for Netware Version 8.5 Revision 3012
Multi-Server Mode (by Veritas)
4. Inoculate-IT Version 4.5 100 User (Not used)
D. Volumes
Volume Name Drive Size, MB Major Contents
SYS G: 3000 System Files, Email In-Box
APPS F: 20000 LIMS Database, Raw Data
DOCS H: 8002 Client EDDs, Word Documents, Control Charts QUE Q: 2000 Print Job Queues
WEB_APPS W: 18000
Web Pages, User Home Directories, Quotes, Time Clock,
Quotes, Misc
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Servers – Windows SQL Server (Test)
LIMS SOP 0522a
I. Purpose
This file server is used exclusively as a Test SQL database server.
II. Configuration
A. Information
1. Server Name: BCL_LIMS_Pinos
2. Device ID: 11002
3. Serial Number: 6J32LOG55C002
4. IP Address 192.168.168.008
B. Hardware
1. Compaq Proliant ML570 G2
Intel Xeon 2.00 GHz processor
4 GB RAM (2x1024, 2x512, 4x256)
Two 6x1” Drive cages (holds up to 12 1” hard drives)
Integrated Dual Wide-Ultra 3 Controller
Smart Array 5304/256MB Four Channel Controller (RAID)
RAID 5 with online spare
Four 36.4GB pluggable Ultra3 SCSI hard drives
AIT 100 GB tape drive, hot pluggable
NC3163 Fast Ethernet 10/100 WOL PCI
NC7131 Gigabit Server Adapter, 64-bit/66MHz, PCI, 10/100/1000-T
Two redundant 600W hot pluggable power supplies
Redundant hot pluggable fan
1.44MB floppy disk drive
48X CD-ROM drive
Compaq Insight Server Manager
3-year limited warranty
C. Installed Software
1. Windows 2000 Server plus 5 CALs
2. Microsoft SQL Server 2000 Enterprise (1 processor)
Servers - Windows SQL Server (Test)
LIMS SOP 522b
I. Purpose
This file server is used exclusively as a Test SQL database server
II. Configuration
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A. Information
1. Server Name Bcl_Lims_Slate
2. Device ID: 11003
3. Serial Number: 6J35LG52R00H
4. IP Address 192.168.168.007
B. Hardware
1. Compaq Proliant ML310
a. Intel Pentium 4 2.53 GHz processor
b. 1 GB RAM (4x256, PC2100 ECC DDR SDRAM)
c. Integrated Single Channel Ultra3 SCSI Adapter
d. Smart Array 642 Controller (RAID) (RAID 1 setting)
e. 36.4GB Ultra3 SCSI 10,000 rpm Hard Drive
f. 1.44MB Floppy Disk Drive
g. High speed IDE CD-ROM Drive
h. Compaq NC7760 PCI Gigabit Server Adapter (Integrated/Imbedded)
i. SmartStart and Insight Manager
j. 1-year Limited Warranty
2. Drive Cage
a. ML3xx Two Bay Hot Plug SCSI Drive Cage
b. 3 146.8 GB 10K Pluggable Universal Hard Drives
C. Installed Software
1. Windows Server 2003 Standard Edition plus 5 CALs
2. Microsoft SQL Server 2000 Standard Edition
Servers - Windows SQL Server (Production)
LIMS SOP 522e
I. Purpose
This file server is used exclusively as a Production SQL database server
II. Configuration
A. Information
1. Server Name Bcl_Lims_Shasta
2. Device ID: 11005
3. Serial Number: USE907N25C
4. IP Address: 192.168.168.10
B. Hardware
1. HP Proliant ML370 G5 Tower Server
a. Intel Quad core Xeon E5440 2.83 GHz processor
b. 32 GB RAM (8x4GB, PC2-5300, DDR2, 667 MHz)
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c. Smart Array P400-Series 512MB (RAID 6 setting)
d. Eight 72GB SAS SFF Single Port 15K rpm Pluggable Hard Drive
e. 1.44MB Floppy Disk Drive
f. High speed IDE DVD/CD-ROM Drive
g. HP Gigabit Server Adapter (Integrated/Imbedded)
h. HP Redundant Hot Plug Power Supply
i. HP Redundant Hot Plug Fan
j. 3-year On-Site 24x7 6-hour call-to-repair warranty
C. Installed Software
1. Windows Server 2003 Enterprise Edition plus 25 CALs
2. Microsoft SQL Server 2000 Enterprise Edition UNCONTROLLED COPY
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9.8 Laboratory Water System
Instrument Year in Service
Ionics Deionized Water System 1990
Ionics Nanopure Water System 1990
9.9 Glassware
Instrument Year in Service
Class A for Reagent and Standard Preparation 1990
Various Calibrated Units 1990
9.10 Diluters
Instrument Year in Service
Hamilton Microlab 500 Series (Diluters #’s 4) 2000
Hamilton Microlab 500 Series (Diluters #’s 6) 2001
Hamilton Microlab 500 Series (Diluters #’s 7) 2003
Hamilton Microlab 500 Series (Diluters #’s 8) 2006
Hamilton Microlab 500 Series (Diluters #’s 9) 2008
9.6.5 Refrigerators
Instrument Year in Service
Northstar Walk-In 1987
Rancho Reach-In (2) 1990
Traulsen Reach-In (1) 1987
Nor lake (1) 1987
Refrigerator: Monitowoc(1), Zero Zone(1), VWR Scientific(2), Reach In (1), GE(4),
Magic chef(1), Sears Cold Spot(1), McCall(1), Ardco (1), FRIGIDAIRE (GM)
Freezer: Box Freezer(1), Cold Spot(1), Whirlpool(1), GE(3), Montgomery Ward(1)
9.11 Ovens
Instrument Year in Service
Fisher Scientific (3)(#’s 17, 20, 10) 1987
VWR (2)(#’s 19& 22) VWR Scientific (1) (#’s 16) 1987
Precision Scientific (2)(#’s 13) 1987
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Instrument Year in Service
Thermo Precision Scientific(2)(#’s 19&21) 2008
Thermo Precision Scientific(2)(#’s 23) 2009
9.12 Misc Equipment Instrument
Year in Service
Balance- Mettler Toledo
Top Loading
ML3001E/03(#29)
2012
Balance- Sartorius
Sartorius ED124S (#28)
2011
Balance- Sartorius
ED224S (#27)
2009
Balance-Mettler Toledo
Analytical
AB 204-S (#25)
1987
Balance-Ohaus Precision Standard
Top-Loading
Scout Pro SP202(2) (#24 & 23), TS4KD (#16)
1988
Balance-Mettler Toledo
Top-Loading
PE3600, PL300 (#10 & 12)
1988
Balance-Mettler Toledo
Top-Loading
PB3002-S, BD202, PB1502-S (#19, 13 & 21)
2000
Balance-Denver Instrument
Analytical
Denver Model A160 (#8)
2000
Balance-Mettler Toledo
JB3002-L-G/A(#26)
2008
Mettler Toledo
Analytical
PB303 (#8)
2000
Balance-Ohaus Precision Standard
Top-Loading
TS400 (#16 & 11)
2008
Balance-Ohaus Precision Standard
Top-Loading
TS400 (#30)
2014
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9.13 Safety
Instrument Qty
Laboratory Hoods 24
Fire Extinguishers
Halon
Combined Class ABC
36
Eye/Safety Showers 8/9
Chemical Spill kit 3
First Aid Kits 6
Fire Blanket 1
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10.0 INTRODUCTION
Outlined in this section are procedures, criteria, and frequency for the calibration of instrumentation
and protocols regarding standards, reagents and QC materials. Calibration processes are described in
further detail in respective method SOP's: Calibration procedures and criteria in specific SOP=s
supersede information listed in this document.
10.1 MATERIALS
Pre-qualification of standard stocks, reagents and support equipment or parts are addressed in
section XIX.
10.1.1 Standards
Accurate standards, stock purity and subsequent diluted aliquots, are required for
sound, accurate results. Standards are used as references by which all results are
derived or as accuracy verification checks (i.e. gravimetric based testing or flashpoint).
Protocols for standards are addressed in the QA Protocols manual.
10.1.2 Reagents
Use of properly prepared and bias-controlled reagents is essential in obtaining high
integrity results. Stock reagents must meet method specific purity requirements and as
well as concentration requirements. Information regarding reagent protocols are
addressed in the QA Protocols manual.
10.2 INITIAL CALIBRATION OF INSTRUMENTS
10.2.1 A minimum of five calibration standards for organics and a minimum of 3 calibration
standards for Inorganics should be prepared for each parameter of interest. One of the
calibration standards should be at a concentration near, but above, the MDL. Other
standards should correspond to the range of concentrations found in real samples but
should not exceed the linear range. Each standard should contain each Analyte for
detection be method.
10.2.2 Initial calibration points used shall be a subset of the original set. It should be noted
that only high point of the curve may be deleted. The low point is at the PQL and the
Mid-point of the initial calibration cannot be deleted. In addition, the minimum
linearity of the curve shall be determined either be a linear regression correlation
coefficient greater than or equal to 0.995 or by relative standard deviation (%RSD) of
20% for each Analyte. The calibration points cannot be re-analyzed more than once.
If the criteria is not met corrective action must be taken to correct the problem and a
new 6-point calibration curve MUST be generated. The curve, once generated, must
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have its accuracy verified by the second source standard (ICV) from different vendors.
10.3 CALIBRATION OF INSTRUMENTS
10.3.1 Inductively Coupled Plasma (ICP)
The ICP units are calibrated at the beginning of each day. Three standards, comprised
of various concentrations of metals, and a calibration blank are used in the calibration
process. The instruments are profiled before each run to maximize efficiency of
instrument performance.
Immediately after calibration, a check standard prepared from an external source is
analyzed to verify standardization process. Values must fall within acceptable limits
or recalibration must commence. After an acceptable check standard is run, an
instrument blank is analyzed of which all elemental results must be below the practical
quantitation level, or reevaluation of instrument parameters must take place, and/or
corrective action procedures must be employed.
An Interference check is run at the beginning and end of all sample runs to monitor
spectral interference associated with Ca, Mg, Fe and Al. All instrument readings of the
interference check must fall below the absolute value of each respective practical
quantitation limit. Continuing calibration verifications (check standards) and
continuing calibration blanks are run after every ten samples and the end of each run.
QC purposes: for ICP 6010B, a group of twenty samples are batched together. All
standards are prepared from NIST traceable sources.
METHOD
ICV
CRITERIA
CCV
FREQUENCY
CCB
FREQUENCY
LINEAR
RANGE STUDY
6010B
90-110%
Recovery
10%
10%
Annual
200.7
95-105%
Recovery
5%
5%
Annual
10.3.2 Inductively Coupled Plasma - Mass Spectrometer (ICP - MS)
The instrument is optimized each day before use, following manufacturer’s
specifications and criteria. After all optimization criteria are met the instrument is
calibrated with a blank and three standards, linearity criteria is set at r 0.995. An
ICV followed by an ICB is run and if these values are outside established limits the
instrument should be recalibrated before samples are run. Continuing calibration
verification and calibration blanks are run after every ten samples and at the end of
each run. All standards used are prepared from NIST traceable sources.
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METHOD 200.8:
ICV CRITERIA
CCV
CRITERIA
CCV
FREQUENCY
CCB
FREQUENCY
Linear Range
Study
90-110% Recovery
85-115%*
Recovery
10%
10%
Annual
*For analysis of additional samples to continue, CCV's must be from 90-110% of their
expected values.
RF = AxCis
AisCx
10.3.3 Gas Chromatograph - Mass Spectrometer (GC/MS)
Each GC/MS system must be hardware tuned to meet the criteria listed in each
respective method. Analyses should not begin until all these criteria are met.
Background subtraction should be straightforward and designed only to eliminate
column bleed or instrument background ions. GC/MS tuning standard should also be
used to assess GC column performance and injection port inertness. For semi-volatiles
degradation of DDT to DDE and DDD should be less than 20%. Benzedrine and
Pentachlorophenol should be present at their normal responses and no peak tailing
should be visible. Peak tailing for 625's involve checking Benzedrine and
pentachlorophenol's peak tailing. Benzedrine must be <3 and pentachlorophenol must
be <5. If degradation is excessive and/or poor chromatography is noted, retention time
of 0.80-1.20 relative to one of the internal standards. Use the base peak ion from the
specific internal standard as the primary ion for quantitation. The injection port may
require cleaning. It may also be necessary to cut off the first 6-12" of the guard
column.
The internal standards should permit most of the components of interest in a
chromatogram to have for semi-volatiles analyze 1 l of each calibration standard
(Containing internal standards) and tabulate the area of the primary characteristic ion
against concentration for each compound. Calculate response factors for each
compound as follows:
Where: Ax = Area of the characteristic ion for the compound being measured.
Ais = Area of the characteristic ion for the specific internal standard.
Cx = Concentration of the compound being measured (g/ml).
Cis = Concentration of the specific internal standard (g/ml).
The Average RF should be calculated for each compound. The percent relative
standard deviation (%RSD = 100[SD/aveRF]) should also be calculated for each
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compound. The %RSD for each individual Calibration Check Compound (CCC) must
be less than 30%. The relative retention times of each compound in each calibration
run should agree with 0.06 relative retention time units (RRT). Construct calibration
curves of area versus concentration using first or higher order regression fit of the five
calibration points. The validity of the calibration is verified by the calculation of
percent drift of CCCs. The percent drift of all CCCs must be < 20%.
A system performance check must be performed to ensure that minimum average RF's
are met before the calibration curve is used. SPCC's typically have very low RFs (0.1-
0.2) and do tend to decrease in response as the chromatographic system begins to
deteriorate or the standard goes bad. They are usually the first to show poor
performance. Therefore, they must meet the minimum requirement when the system is
calibrated.
Daily GC/MS Calibration
Prior to analysis of samples, the GC/MS tuning standard must be analyzed. The meeting of tuning
criteria must be demonstrated prior to each 12-hour shift.
A calibration standard at the mid-level concentration containing all analytes, including all required
surrogates, must be performed prior to every 12-hr shift. If duplicate calibration standards are
analyzed, both must be evaluated and reported.
System Performance Check Compounds: A system performance check must be made prior to every
12-hr shift. If the SPCC criteria are met, a comparison of response factors is made for all
compounds. This is the same check that is made during the initial calibration step. If the minimum
response factors are not met, the system must be evaluated, and corrective action must be taken
before sample analysis begins. Some possible problem areas are standard degradation, inlet port
contamination, head of column contamination, or active sites in the chromatographic system. This
check must be met before analysis begins.
Calibration Check Compounds: After the system performance check is met, CCC's are used to
check the validity of the initial calibration. The percent difference in RF's is calculated for each
CCC. If the %D for each CCC is less than 20%, the initial calibration is assumed to be valid. If the
criteria is not met for any CCC (>20% difference), corrective action must be taken. If no source of
the problem can be determined after corrective action has been taken, a new six-point curve must be
generated. This criterion MUST be met before sample analysis begins.
The internal standard response and retention times in the calibration check standard must be
evaluated immediately after or during data acquisition. If the retention time for any internal
standard changes by more than 30 sec. from the last calibration check (12 hr), the chromatographic
system must be inspected and adjustments made as necessary. If the area for any internal standard
base ion has changed by more than a factor of two (-50% to +100%) from the last daily calibration
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standard check, the mass spectrometer must be inspected for malfunctions and corrections must be
made, as appropriate.
10.3.4 Gas Chromatographs (GC)
For each Analyte of interest, prepare calibration standards at a minimum of five
concentrations by adding volumes of one or more stock standards of a volumetric flask
and diluting to volume with an appropriate solvent. One of the external standards should
be at a concentration near, but above, the method detection limit. The other
concentrations should correspond to the expected range of concentrations found in real
samples or should define the working range of the detector. (See Tables 2-4)
Inject each calibration standard using the technique that will be used to introduce the actual samples
into the gas chromatograph (e.g. 2-5 L injections, purge-and-trap, etc.). Tabulate peak height or
area responses against the mass injected. The results can be used to prepare a calibration curve for
each analyte. Alternatively, for samples that are introduced into the gas chromatograph using a
syringe, the ratio of the response to the amount injected, defined as the calibration factor (CF), can
be calculated for each analyte at each standard concentration. If the percent relative standard
deviation (%RSD) of the calibration factor is less than 20% over the working range, linearity
through the origin can be assumed, and the average calibration factor can be used in place of a
calibration curve.
*For multi response pesticides/PCB's, use the total area of all peaks used for quantitation.
The working calibration curve or calibration factor must be verified on each working day by the
injection of one or more calibration standards. If duplicate calibration standards are analyzed, both
must be evaluated and reported. The frequency of verification is dependent on the detector.
Detectors, such as the electron capture detector, that operate in the sub-nanogram range are more
susceptible to changes in detector response caused by GC column and sample effects. Therefore,
more frequent verification of calibration is necessary. The flame ionization detector is much less
sensitive and requires less frequent verification. If the response for any Analyte varies from the
predicted response by more than 15%, a new calibration curve must be prepared for that Analyte,
if quantitation takes place.
Percent Difference = R1-R
2
R1
X 100
Where: R1 = Calibration Factor from the initial curve.
R2 = Calibration Factor from succeeding analyses of the CCV.
Calibration Factor Total Area of Peak
concentration of the standard
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Retention Time Windows
Before establishing windows, make sure the GC system is within optimum operating conditions.
Make three injections of all single component standard mixtures and multi-response products (i.e.
PCB's) throughout the course of a 72 hour period. Serial injections over less than a 72 hour period
result in retention time windows that are too tight.
Calculate the standard deviation of the three retention times (use any function of retention time;
including absolute retention time, or relative retention time) for each single component standard.
For multi-response products, choose one major peak from the envelope and calculate the standard
deviation of the three retention times for that peak. The peak chosen should be fairly immune to
losses due to degradation and weathering in samples.
Plus or minus three times the standard deviation of the retention times for each standard will be
used to define the retention time window; however, the experience of the analyst should weigh
heavily in the interpretation of the chromatograms. For multi-response analytes (i.e. PCB's), the
analyst should use the retention time window, but should primarily rely on pattern recognition.
In those cases where the standard deviation for a particular standard is zero, substitute the standard
deviation of a close eluting, similar compound to develop a valid retention time window.
10.3.5 Graphite Furnace Atomic Absorption (GFAA) Gaseous Hydride Atomic Absorption
(GHAA) and Atomic Absorption (AA)
Instruments are calibrated before each sample run using a calibration blank and at least
three standards. Calibration standards are prepared from NIST traceable sources.
Calibration standards for trace level analyses must be prepared daily.
TECHNIQUE
CCV CRITERIA
CCV
FREQUENCY
ICV CRITERIA
LINEARITY
WATER
SOIL
WATER
SOIL
GHA*/AA/GFAA
90-110
80-120
10%
90-110
(95-105)
for GFAA
90-110
r 0.995
10.3.6 Continuous Flow Instruments
A minimum of three (3) standards and a blank must be used for initial calibration. A set
of initial calibration standards must be analyzed for each analytical run. Linearity
criteria is set at r 0.995. An external calibration standard must be analyzed to verify
the accuracy of the working stock standard and the calibration curve. The CCV and ICV
% recovery criteria is set at 90-110%. Frequency of calibration verification is 10%.
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10.3.7 SPECTROPHOTOMETERS
A minimum of three (3) standards and a blank must be used for initial calibration. A set
of initial calibration standards must be analyzed for each analytical run. Linearity
criteria is set at r 0.995 and/or %RSD 20%. An external calibration standard must
be analyzed to verify the accuracy of the working stock standard and the calibration
curve. This external calibration standard, the ICV, must be within 10% of the known
value. If this criteria is met, sample analysis can commence. CCV's must be analyzed at
a 10% frequency and must meet the same accuracy criteria as the ICV. Wavelength
checks are done on a semi-annual basis.
10.3.8 pH Meters
All pH meters are calibrated before each use using two buffer solutions. If acidic
samples are to be measured, buffer solutions pH-4 and pH-7 are used while buffer
solutions pH-7 and pH-10 are used to calibrate for basic samples. Buffers are to be
discarded after use. Accuracy requirement is set at known value 0.05 pH units.
10.3.9 Specific Ion Meter
The specific ion meter is calibrated before each use using appropriate traceable EPA
standards. Two calibration standards are used to establish calibration range.
Recalibration must be done if sample concentrations fall outside the calibration range.
Accuracy and frequency criteria are set at 90-110% and 10% respectively.
10.3.10 Ion Chromatograph
A minimum of three (3) standards and a blank must be used for initial calibration.
Linearity criteria is set at r 0.995. An external calibration standard must be analyzed
to verify the accuracy of the working stock standard and a calibration curve. This
external calibration standard, the ICV, must be within 10% of the known value. If this
criterion is met, sample analysis can commence. CCV's are analyzed at the beginning of
each workday and at a 10% frequency. When the CCV criterion of 10% recovery of
the known value is exceeded, corrective action procedures must be initiated.
10.3.11 Mercury by Cold Vapor
A minimum of a blank and five standards must be used to generate an initial calibration
curve. Linearity criteria is set at r 0.995. A calibration curve should be prepared for
every hour of continuous sample analysis.
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METHOD
ICV CRITERIA
CCV CRITERIA
CCV
FREQUENCY
7470
95-105% Recovery
90-110% Recovery
10%
7471
90-110% Recovery
80-120% Recovery
10%
10.3.12 Balances
Two (2) S-1 class weights are used for daily calibration of each top-loading and
analytical balance. The S-1 class weights are calibrated every two years. Acceptable
ranges are noted on each respective Balance Logbook. The Balances Annual calibration
service is conducted by Watson Brothers.
10.3.13 Thermometers
Thermometers are calibrated against a reference thermometer on an annual or quarterly
basis. Thermometers are compared at the temperature of working thermometer use. See
the thermometer calibration SOP for details. The reference thermometer calibration is
verified annually.
10.3.14 Micro-Pipettes
Each micro-pipette is calibrated for each day of use. The calibration process involves a
gravimetric check of water delivered at specified volumes. See the QA Protocols
Manual for details.
10.3.15 Auto-Diluters
Quarterly calibration is conducted on each auto-diluter by QA personnel. Calibration
involves weighing water delivered at specific speeds and volumes on an analytical
balance. Data is processed to verify the best case scenario for each dilution scheme and
verify diluter performance.
10.4.1 Measurement quality objectives for laboratory measurements
Group Parameter Accuracy Precision Recovery Target
Reporting
Limits
Completeness
Water quality and
stormwater quality –
First Flush, Urban
Watch
Nitrates as N 80 – 120% + 10% 90 – 110% 0.1 mg/L 90%
Water quality and
stormwater quality –
Ortho-
phosphate as P
90 – 110% +10% 90 – 110% 0.02 mg/L 90%
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Group Parameter Accuracy Precision Recovery Target
Reporting
Limits
Completeness
First Flush, Urban
Watch
Water quality and
stormwater quality –
First Flush, Urban
Watch
Turbidity NA NA NA 0.1 NTU 90%
Water quality and
stormwater quality –
First Flush, Urban
Watch
Ammonia as N 90 – 110% + 10% 90 – 110% 0.05 mg/L 90%
Water quality and
stormwater quality –
First Flush, Urban
Watch
Metals (200.8)
Cu
Ni
Pb
Zn
70 – 130% + 20% 85 – 115% Various 85%
Water quality and
stormwater quality –
First Flush, Urban
Watch
TDS NA + 10% 90 – 110% 10 mg/L 90%
Water quality and
stormwater quality –
First Flush, Urban
Watch
TSS NA + 10% NA 0.5 mg/L 90%
Water quality and
stormwater quality –
First Flush, Urban
Watch
Residual
Chloride
NA + 10% NA 0.1 mg/L 90%
Water quality and
stormwater quality –
First Flush, Urban
Watch
1664 Oil &
Grease
78 – 114% + 18% 78 – 114% 5 mg/L 80%
Water quality Nitrates as N 80 – 120% + 10% 90 – 110% 0.1 mg/L 90%
Water quality Ortho-
phosphate as P
90 – 110% +10% 90 – 110% 0.02 mg/L 90%
Water quality Total nitrogen NA NA NA NA Calculation
Water quality Organic
nitrogen
NA NA NA NA Calculation
Water quality Ammonia-
nitrogen
90 – 110% + 10% 90 – 110% 0.05 mg/L 90%
Water quality Total Kjeldahl
nitrogen
80-120% + 20% 80-120% 0.2 mg/L 80%
Water quality Nitrite as NO2 90 – 110% + 10% 90 – 110% 0.17 mg/L 90%
Water quality Total
phosphorous
80-120% + 20% 80-120% 0.05 mg/L 80%
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10.4.2 Laboratory Analytical Methods
Analyte/
Instrumentation
Laboratory /
Organization
Project Action
Limit (units,
wet or dry
weight)
Project
Quantitation
Limit (units,
wet or dry
weight)
Analytical Method Achievable Laboratory Limits
Analytical
Method/ SOP
Modified
for Method
yes/no
MDLs (1)
Method (1)
Nitrate as N
(Dionex DX-100
IC) for First Flush,
Water Quality and
Urban Watch
BC Labs
Inc.
Based on
concentration
level
0.1 mg/L EPA Method
300.0
No 0.014 mg/L 0.1 mg/L
Orthophosphates as
P(Kone 1) for First
Flush, Water
Quality and Urban
Watch
BC Labs Inc Based on
concentration
level
0.02 mg/L SM 4500-P E No 0.0041 mg/L 0.02 mg/L
Turbidity for Water
Quality
BC Labs Inc Based on
concentration
level
0.1 NTU SM 2130B No 0.1 NTU 0.1 NTU
Ammonia as N
(Smart-Chem)
BC Labs
Inc.
Based on
concentration
level
0.05 mg/L SM-4500-D No 0.025 mg/L 0.05 mg/L
Dissolved Metals:
Metals (200.8)
ICP_MS
Cu, Ni, Pb, Zn
BC Labs Inc NA NA EPA-200.8 No Cu – 0.35 µg/L
Ni – 0.14 µg/L
Pb – 0.16 µg/L
Zn – 1.6 µg/L
Cu – 2.0 µg/L
Ni – 2.0 µg/L
Pb – 1.0 µg/L
Zn – 5.0 µg/L
TDS BC Labs Inc Based on
concentration
level
10 mg/L SM2540C No 10 mg/L 10 mg/L
TSS BC Labs
Inc.
Based on
concentration
level
0.5 mg/L SM2540D No 0.5 mg/L 0.5 mg/L
Residual Chloride BC Labs Inc Based on
concentration
level
0.1 mg/L SM4500-C/G No 0.1 mg/L 0.1 mg/L
1664 Oil & Grease BC Labs Inc Based on
concentration
level
5 mg/L EPA1664 No 1.4 mg/L 5 mg/L
Total Kjeldahl
nitrogen
BC Labs Inc Based on
concentration
level
0.2 mg/L EPA 351.2 No 0.056 mg/L 0.2 mg/L
Total nitrogen BC Labs Inc NA NA NA NA Calculation Calculation
Organic nitrogen BC Labs Inc NA NA NA NA Calculation Calculation
Nitrite as NO2 BC Labs Inc Based on
concentration
level
0.17 mg/L EPA 353.2 No 0.0048 mg/L 0.17mg/L
Total phosphorous BC Labs Inc Based on
concentration
level
0.05 mg/L EPA 365.4 No 0.016 mg/L 0.05mg/L
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10.4.3 Analytical QC for water quality, stormwater and Urban Watch monitoring
Matrix: Water
Sampling SOP: BCGEN048,BCGEN051, BCGEN014,
BCGEN061, BCMET037, BCGEN013, BCGEN022,
BCGEN010, BCORG026, BCGEN059, BCGEN060,
BCGEN058
Analytical Parameter(s): Nitrates as N, orthophosphates as
P, TDS, TSS, oil & grease, dissolved metals, turbidity,
residual chlorine, ammonia-nitrogen, TKN, Nitrite as N,
Total Phosphorus
Analytical Method/SOP Reference: Nitrate (EPA 300.0),
Orthophosphates (SM 4500-P E), TDS (SM2540C), TSS
(SM-4500-D), Oil & Grease (EPA1664), Dissolved Metal
(EPA 200.8). Turbidity (SM 2130B), Residual
Chloride(SM4500-C/G), Ammonia Nitrogen(SM4500-
NH3D), TKN (EPA 351.2), Total Phosphorous (EPA
365.4), Nitrite as N (EPA 353.2).
# Sample locations: Various
Laboratory QC Frequency/Number Acceptance Limits
Method Blank One per batch < TRL
Reagent Blank One per new lot < TRL
Storage Blank NA
Instrument Blank: Dissolved
metals
One per day of analysis < TRL
Lab. Duplicate
One per batch or one per 10
samples
Orthophosphates: RPD ≤ 10%
Nitrates: RPD < 10%
Turbidity: < 10%
TDS: RPD ≤ 10%
TSS: RPD < 10%
Metals (200.8): < 20%
Residual Chlorine: RPD ≤ 10%
1664 Oil & Grease: RPD < 18%
Ammonia as N: < 10%
Lab. Matrix Spike One per batch or one per 10
samples
Orthophosphates: recovery 90-110%
Nitrates: recovery 80-120%
Turbidity: NA
TDS: NA
TSS: NA
Metals (200.8): recovery 70-130% RPD
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Residual Chlorine: NA
1664 Oil & Grease recovery 78-114%: RPD
Ammonia as N Recovery 90-110%: RPD ≤ 10%
Matrix Spike Duplicate One per batch or one per 10
samples
Orthophosphates: 90-110%, RPD ≤ 10%
Nitrates: 80-120%, ≤ 10%
Turbidity: NA
TDS: NA
TSS: NA
Metals (200.8): recovery 70-130% RPD ≤ 20%
Residual Chlorine: NA
1664 Oil & Grease recovery 78-114%: RPD < 18%
Ammonia as N Recovery 90-110%: RPD ≤ 10%
Lab. Control sample One per batch or one per 10
sample
Orthophosphates: 90-110%
Nitrates: 90-110%
Turbidity: NA
TDS: 90-110%
TSS: NA
Metals (200.8): 85-115%
Residual Chlorine: NA
1664 Oil & Grease recovery 78-114%
Ammonia as N: 90-110%
Surrogate NA NA
Internal Standards NA NA
Others: NA NA
10.4.4 Testing, inspection, maintenance of analytical laboratory
Equipment /
Instrument
SOP reference Calibration Description and Criteria Frequency of
Calibration
Responsible
Person
BC Labs: Nutrient
analysis
BC Labs SOP External calibration with 6 standards covering the
range of sample concentrations prior to sample
analysis. At low end, the lowest standard at or near
the MDL. Linear regression > 0.995. Calibration
verification every 10 samples after initial
calibration. Standard source different than that used
for initial calibration. Recovery 90 – 110%.
Nitrate as N
Daily
Ortho-phosphate:
Once per batch
LDI
TDC
BC Labs: Turbidity BC Labs SOP NA NA
Ammonia as N BC Labs SOP External calibration with 6 standards covering the
range of sample concentrations prior to sample
analysis. At low end, the lowest standard at or
near the MDL. Linear regression > 0.995.
Calibration verification every 10 samples after
initial calibration. Standard source different than
that used for initial calibration. Recovery 90 –
110%.
Daily CDR
Metals (200.8) BC Labs SOP External calibration with 3 standards covering the
range of sample concentrations prior to sample
Daily PPS
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Equipment /
Instrument
SOP reference Calibration Description and Criteria Frequency of
Calibration
Responsible
Person
analysis. At low end, the lowest standard at or
near the MDL. Linear regression > 0.995.
Calibration verification every 10 samples after
initial calibration. Standard source different than
that used for initial calibration. Recovery 90 –
110%.
TDS BC Labs SOP Sample Duplicate and Laboratory Control
analyzed every 10 samples to confirm system is in
control.
90-110% RML
TSS BC Labs SOP Sample Duplicate and Laboratory Control
analyzed every 10 samples to confirm system is in
control.
10% RML
Residual Chlorine BC Labs SOP NA NA MSA
1664 Oil & Grease BC Labs SOP Sample QC (MS\MSD, LCS & MB) analyzed
every 20 samples to confirm instrument is in
control.
1 per 20 samples JAK
BC Labs: Ammonia
as N
BC Labs SOP External calibration with 6 standards covering the
range of sample concentrations prior to sample
analysis. At low end, the lowest standard at or
near the MDL. Linear regression r2> 0.995.
Calibration verification every 10 samples after
initial calibration. Standard source different than
that used for initial calibration. Recovery 90 –
110%.
Daily SDU
BC Labs: Total
nitrogen
BC Labs SOP External calibration with 6 standards covering the
range of sample concentrations prior to sample
analysis. At low end, the lowest standard at or
near the MDL. Linear regression r2> 0.995.
Calibration verification every 10 samples after
initial calibration. Standard source different than
that used for initial calibration. Recovery 90 –
110%.
Daily SDU
BC Labs: Organic
nitrogen
BC Labs SOP External calibration with 6 standards covering the
range of sample concentrations prior to sample
analysis. At low end, the lowest standard at or
near the MDL. Linear regression r2> 0.995.
Calibration verification every 10 samples after
initial calibration. Standard source different than
that used for initial calibration. Recovery 90 –
110%.
Daily SDU
BC Labs: Nitrite as
NO2
BC Labs SOP External calibration with 6 standards covering the
range of sample concentrations prior to sample
analysis. At low end, the lowest standard at or
near the MDL. Linear regression r2> 0.995.
Calibration verification every 10 samples after
initial calibration. Standard source different than
that used for initial calibration. Recovery 90 –
110%.
Daily SDU
BC Labs: Total
Kjeldahl nitrogen
BC Labs SOP External calibration with 6 standards covering the
range of sample concentrations prior to sample
Daily SDU
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Equipment /
Instrument
SOP reference Calibration Description and Criteria Frequency of
Calibration
Responsible
Person
analysis. At low end, the lowest standard at or
near the MDL. Linear regression r2> 0.995.
Calibration verification every 10 samples after
initial calibration. Standard source different than
that used for initial calibration. Recovery 90 –
110%.
BC Labs: Total
phosphorous
BC Labs SOP External calibration with 6 standards covering the
range of sample concentrations prior to sample
analysis. At low end, the lowest standard at or
near the MDL. Linear regression r2> 0.995.
Calibration verification every 10 samples after
initial calibration. Standard source different than
that used for initial calibration. Recovery 90 –
110%.
Daily SDU
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Table 2 Cont. 500 Series Semi-Volatile Organics
Revision Date: 04/15/11 SGB
Method Parameters
Method
HT
days
ICC/IC
V <%
Rsd
CCV
<%
Diff
Solvent
used
Exch.
sol.
Conc.
vol
(mls)
Conc.
Type
Detector
Type
Inst
ID
# Smps
per QC
LPC
y/n
CCV TIme
RUN
HT
Comments
504.1
14
20/30
30
Hex
None
2
none
ECD
GC-4
10
y
12Hrs/10Smp
1
LPC is an MDL check
standard
508 7 20/20 20 MeCl MTBE 10 Turbo ECD GC-1 10 y 8Hrs/10Smp 14
515.1
14
20/20
20
MeCl
10
Turbo
ECD
GC-8
10
y
8Hrs/10Smp
28
507/525.2
14**
30/30
30
MeCl
MTBE
1
Turbo
GC-MS
MS-B3
20
Tune
12Hrs
30
SPE
547
14
10/15
20
None
None
DInj
.
None
FLUOR
10
y
8Hrs/10Smp
-
548
7
30/20
20
SPE
None
1
N-
Evap
GC-MS
10
n
8Hrs
14
549.1 7 20/20
20 SPE None
None
10
None
UV
10
Tune
n
8Hrs/10Smp
21
Int. Std >70% last CCV
& >50% of ICC
** If Diazinon is an analyte HT is 7 days.
Laboratory Performance Check
Sensitivity
Column Performance
Column Resolution
Breakdown
508
515.1
Chlorpyrifos
0.002ppm
Dinoseb 0.004ppm
DCPA 0.05 ppm
0.8 < PGF < 1.15
4-Nitrophenol 1.6 ppm
0.7 < PGF < 1.05
Chlorothalonil & D-BHC
R > 0.5
4-Nitrophenol & 3,5-Dichlorobenzoic acid
R > 0.4
Endrin < 20%
pp=-DDT < 20%
None
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Legend
DInj = Direct Injection
ECD = Electron Capture Detector
SPE = Solid Phase Extraction
Turbo = Turbovap
NEvap = Nitrogen Evaporation
Fluor = Fluorescence Detector
UV = UltraViolet Detector
Tune = Tuned to DFTPP Method Criteria
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Table 3 Cont. 8000 Series Semi-Volatile Organics
Revision Date: 7/12/04 SGBSW-846 Update 4
Method Parameters
Method
Semi-Volatile
Compounds
HT
days
W/S
ICC/ICV
<% Rsd
CCV
<%
Diff
Solven
used
Exchange
solvent
Conc.
vol(mls)
Conc.
Type
Detector
Type
Inst ID
CCV
Freq.
LPC
y/n
#
Smps
QC
RUN
HT
Comments
8015M
8080A/8081
A/8082
8140/8141A
8150B/8151A
8310
8270C
Diesel Range
Organochloride
pesticides
Organophosphorus
pesticides
Chlorinated acid
herbicides
PAH=s
BNA
14/14
7/14
7/14
7/14
7/14
7/14
20/15
20/15
20/15
20/15
20/15
15/20
15
15
15
15
15
20
MeCl
MeCl
MeCl
MeCl
MeCl
MeCl
None
Hex
Hex
Hex
1:1ACN/OFW
None
5
10
5
10
4
1
Turbo
Turbo
Turbo
Turbo
K-D
K-D
FID
ECD
TSD
ECD
Fluor/UV
GC/MS
GC-2, 5,12,13
GC-1,14,15
GC-7
GC-8
HPLC-14
MS-B1,B2,B4,B5
10smp
10smp
10smp
10smp
10smp
12Hrs
n
y
n
n
n
Tune
20
20
20
20
20
20
40
40
40
40
40
40
DDT/Endrin
Breakdown
<15%
ICC: If %
RSD >15, use
best fit
regression
Semi-Volatile Mass Spectrometry Tune/CCV Requirements
Method: 8270C
Tuning Compound: Decafluorotriphenylphosphine (DFTPP) LPC Requirements:
Tune Frequency: Every 12 Hr Shift DDT Breakdown: <20%
CCV Frequency: Every 12 Hr Shift Pentachlorophenol: Normal response
Internal Standard Requirements: Benzidine: Normal response
EICP area: (-50% to +100%) of last daily CCV Peak tailing:
Retention time: <30 sec. from last daily CCV (within 12 Hrs) Pentachlorophenol PGF <5.0
CCC Requirements: %RSD of ICC: <30% Benzidine PGF <3.0
% D of CCV: <20%
Compounds: Acenaphthene Fluoranthene 2-Nitrophenol Di-n-Octylphthalate
1,4-Dichlorobenzene Benzo(a)pyrene Phenol
Hexachlorobutadiene 4-Chloro-3-methylphenol Pentachlorophenol
N-Nitrosodiphenylmine 2,4-Dichlorophenol 2,4,6-Trichlorophenol
SPCC Requirements: N-Nitroso-di-n-propylamine RF>0.050
Hexachlorocyclopentadiene RF>0.050 Surrogate Requirements: See established limits
2,4-Dinitrophenol RF>0.050
4-Nitorphenol RF>0.050
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8000 Series Organics Legend
Tune = Tuned to DFTPP (8270B) and BFB (8240B & 8260A) Method Criteria
ECD = Electron Capture Detector
FID = Flame Ionization Detector
TSD = Thermionic Specific Detector
Fluor = Fluorescence Detector
UV = Ultraviolet Detector
ELCD = Electrolytic Conductivity Detector
PID = Photo Ionization Detector
EICP = Extracted Ion Current Profile
Turbo = Concentrated by Turbovap
K-D = Concentrated by Kuderna-Danish apparatus
BNA = Base neutral acid extractables
PAH=s = Polynuclear Aromatic Hydrocarbons
ICC = Initial Calibration Curve
ICV = Initial Calibration Verification
CCV = Continuing Calibration Verification
CCC = Calibration Check Compound
SPCC = System Performance Check Compound
PGF = Peak Gaussian Factor
LPC = Laboratory Performance Check
RF = Response Factor
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Table 4 Cont. 8000 Series Volatile Organics
Revision Date: 04/08/11 SGBSW-846 Update 4
Method Parameters
Method
Volatile
Compounds
HT
days
W/S
ICC/ICV
<% Rsd
CCV
<%
Diff
Detector
Type
Inst ID
#
Smps
per
QC
CCV
Freque
ncy
Tune
Comments
8020A/8021B
8015M
8260B
Aromatic
Gasoline
Range
Various
7/14
7/14
7/14
20/15
20/15
15/30
15
15
20
PID
FID
GC-MS
GC-V4 - V8
GC-V4 - V8
MS-V2-MS-
V7, MS-V10,
V12, V13
20
20
20
10 Smp
10 Smp
12Hrs
N
Tune
ICC: If % RSD>15, use best fit regression
ICC: If % RSD>15, use best fit regression
Volatile Mass Spectrometry Tune/CCV Requirements
Method: 8240B Method: 8260B
Tuning Compound: 4-Bromofluorobenzene Tuning Compound: 4 -Bromofluorobenzene
Tune Frequency: Every 12 Hr Shift Tune Frequency: Every 12 Hr Shift
CCV Frequency: Every 12 Hr Shift CC V Frequency: Every 12 Hr Shift
Internal Standard Requirements: Internal Standard Requirements:
EICP area: (-50% to +100%) of last daily CCV EICP area: (-50% to +100%) of last daily CCV
Retention time: <30 sec. from last daily CCV (within 12 Hrs) Retention time: <30 sec. from last daily CCV (within 12 Hrs)
CCC Requirements: %RSD of ICC: <30% CCC Requirements: %RSD of ICC: <30%
% D of CCV: <20% % D of CCV: <20%
Compounds: 1,1-Dichloroethene Toluene Compounds: 1,1-Dichloroethene Toluene
Chloroform Ethylbenzene Chloroform Ethylbenzene
1,2-Dichloropropane Vinyl Chloride 1,2-Dichloropropane Vinyl Chloride
SPCC Requirements: Chloromethane RF>0.300 SPCC Requirements: Chloromethane RF>0.100
1,1-Dichloroethane RF>0.300 1,1-Dichloroethane RF>0.100
Bromoform RF>0.100 Bromoform RF>0.100
1,1,2,2-Tetrachloroethane RF>0.300 1,1,2,2-Tetrachloroethane RF>0.300
Chlorobenzene RF>0.300 Chlorobenzene RF>0.300
Surrogate Requirements: See established limits Surrogate Requirements: See established limits
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8000 Series Organics Legend
Tune = Tuned to BFB Method Criteria
ELCD = Electrolytic Conductivity Detector
FID = Flame Ionization Detector
PID = Photo Ionization Detector
ICC = Initial Calibration Curve
ICV = Initial Calibration Verification
CCV = Continuing Calibration Verification
CCC = Calibration Check Compound
SPCC = System Performance Check Compound
EICP = Extracted Ion Current Profile
LPC = Laboratory Performance Check
RF = Response Factor
Note: This section has been Reviewed on 01/08/2016 (No Changes were made)
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PAGE 11-1
11.0 ANALYTICAL PROCEDURES
BC Laboratories, Inc. conducts approved methodologies which have been promulgated by Federal and State legislators,
and ASTM and in-house methods for non-regulated analyses.
References
Drinking Waters - 40 CFR Parts 131, 143 Methods for the Determination of Metals in Environmental
Samples(EPA/600/R-94/111, May 1994, Methods for the Determination of Inorganic Substances in Environmental
Samples (EPA/600/R-93/August 1993), Methods for the Determination of Organic Compounds in Drinking Water
(EPA/600/4-88/039, EPA/600/4-90/020), Methods for the Chemical Analyses of Water and Wastewater (EPA-600 4-79-
020), and Standard Methods for the Examination of Water and Wastewater, 18th Edition (1992), Standard Methods for
the Examination of Water and Wastewater, 19th Edition.
Waste waters - 40 CFR Part 136, Standard Methods for the Examination of Water and Wastewater, Methods for the
Chemical Analyses of Water and Wastewater, Methods for the Determination of Metals in Environmental Samples
(EPA/600/R-94/111, May 1994), Methods for the Organic Chemical Analysis of Municipal and Industrial Wastewater.
Soils, sludges, wastewater, hazardous waste, and solids - SW-846 Federal Register Test Methods for Evaluating Solid
Waste Physical/Chemical Methods, Third Edition, Update I, II, & III.
Fuels - LUFT Manual, State Water Resources Control Board and the SB 1764 (1994) Advisory Committee.20
Each method has been outlined in respective laboratory standard operating procedures (SOP's). Information such as
procedural steps for conducting analysis, standard and reagent preparation, documentation, safety, and quality control are
included in each analytical SOP. Refer to Appendix A for listing of SOP=s. Table 5-7 list methods conducted on-site.
11.1 SOP CREATION
Department Supervisor's, the Technical Director, and/or the QA Officer will determine the person(s) responsible
for SOP creation, and then delegate the task. The template below will be used as guidance for analytical SOP's:
SOP TEMPLATE
1.0 SCOPE AND APPLICATION
2.0 SUMMARY OF METHOD
3.0 INTERFERENCE AND THEIR CORRECTIVE ACTION
4.0 APPARATUS AND MATERIALS
4.1 APPARATUS
4.2 INSTRUMENT PARAMETERS
5.0 REAGENTS AND STANDARD SOLUTIONS
5.1 REAGENTS - NAME AND SOURCE
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5.2 SOLUTIONS - DILUTION SCHEMES
5.3 WORKING STANDARDS
5.4 SPIKES
6.0 SAMPLE COLLECTION, PRESERVATION AND HANDLING
7.0 PROCEDURE
8.0 QUALITY CONTROL
8.1 DETERMINATION OF IDL, MDL, AND PQL
8.2 METHOD BLANKS
8.3 QC SETS - DUPLICATES & SPIKES
8.4 CONTROL CHARTS
8.5 LOG BOOKS
9.0 CALCULATIONS
10.0 FORMS
10.1 QC SHEET
10.2 OTHER FORMS
11.0 METHOD PERFORMANCE
12.0 GENERAL MAINTENANCE
13.0 WASTE MANAGEMENT
14.0 POLLUTION PREVENTION
15.0 SAFETY
16.0 REFERENCES
Non-analytical SOP=s do not follow a standard format, however these documents should contain sufficient detail to
ensure processes can be carried out completely and competently. Non-analytical SOP=s should contain but are not
limited to the following selections: Scope and Application, Summary of Method, Materials, Procedure, Forms and
References. When completed by the responsible party, the SOP is entered into the LIMS via the word processor.
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SOP identification will be by method number, technique, and a laboratory/department sequential numbering
identification (i.e., BCGEN001, BCGEN002 ...etc.). The word processing specialist will return the SOP to the
author for corrections. When corrections are completed, the SOP will be reviewed by the Department Supervisor.
When the supervisor review and correction phase is complete, the QA Officer will conduct a final review and
approval.
11.2 CONTROL OF SOP'S AND LOGBOOKS
In order to receive a copy of an SOP, a request must be made to the QA officer, Department Supervisor, or
Technical Director. One of these persons will inform the word processor specialist to generate the requested SOP.
Records pertaining to SOP retrieval will be kept by the word processor.
Record: SOP ID.
File Name
Issued To
Received by
Revision Number
Controlled Copy Number
Date Issued
SOP Location
Relinquished by
The SOP will be generated with an approval by the word processing specialist. Logbooks requests are honored by
the Word Processing Specialist. Logbook request sheets are located at the word processing station. Once a
logbook is created, the Word Processing Specialists records the following information:
QC Tracking Number
WPS Tracking Code
Logbook Name
Logbook Number
Issued To
Date of generation
Relinquished by
Accepted by
The Word Processing Specialist will then review the logbook and acknowledge final approval by initialing and
dating the logbook cover.
11.3 DEPARTURE FROM SOP
In cases where it is necessary to depart from standard practice, approval must be granted by the department
supervisor and the Quality Assurance Officer. Departures for standard procedures must be documented on all
affecting final reports.
11.3.1 Documentation - Document nonstandard practice on affecting worksheet(s). Client notification must be
made and documented before departure can be granted. Affected final reports must have a comment
which alludes to the modification of method.
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11.3.2 Approvals from the client must be verified in order to close the deviation of standard practice.
11.4 ASSESSMENT AND HANDLING OF NEW/ADDITIONAL WORK
11.4.1 Summary
Project information must be legible and obtained in a timely fashion to allow necessary modifications to be
made prior to projects initiation. Information is obtained from QAPPs, SAPs, CDAPs, or subsets of the
aforementioned formats, or from projects initiation forms completed by laboratory interviewers. The
information is translated into the appropriate language then discussed through supervisor meetings.
Discussion topics:
* Confirmation of amount of new/additional work
* Baseline capacities
* Potential capacities
* Labor
* Instrumentation
* Certification/Methods
* Materials
* Implementation
* Monitoring
* Responsibilities
* Deliverables
Once discussed, accommodations addressing pertinent concerns are made in each department. The Project
Manager verifies that all project specific work requirements are secured; especially all non-routine tasks. Project
Initiation Forms are then completed and distributed to affecting department supervisors, and if possible, to
pertinent clients before initiation of sampling. Performance monitoring will be conducted by the QA/QC
Department to measure compliance with project specifications and customer satisfaction.
The LIMS will act as the tool used to confirm analytical capabilities.
11.4.2 Responsibilities
Sales and Marketing
1. Obtain project deliverables information
2. Confirm the amount of work and compare to the capability/capacity of the laboratory
3. Confirm type of work (DOD, DOE, RCRA, CERLA, etc)
4. Monitor project quotes
5. Establish probabilities of project awards
6. Identify project initiation date
7. Obtain project method specifications
8. Obtain quality goals
9. Act as liaison between laboratory and client until award is granted
10. Submit all pertinent information to Client Services Department
Project Coordinator
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1. Obtain project information from Sales and Marketing or client.
2. Translate project information.
3. Assign projects to project managers.
4. Provide guidance in project handling.
5. Provide guidance on completing Project Checklist Form.
Project Manager
1. Gather project information into a Project Initiation Form.
2. Distribute project initiation forms.
3. Modify project initiation forms as needed.
President
1. Facilitate brainstorm sessions.
2. Allocate resources.
3. Approve laboratory system modifications.
4. Approve instrumentation purchases.
5. Approve labor allowances.
6. Secure and allocate resources.
7. Approve purchases of materials and instruments.
Department Manager
1. Assess department capacities.
2. Review and approve prospective work.
3. Coordinate with project coordinator.
4. Initiate IDCs or IDPs for new analysts and/or methods.
QA Officer
1. Monitor performance.
2. Provide method guidance.
LIMS Manager
1. Write programs to handle project specific requirements.
2. Update, increase, and modify LIMS capabilities.
11.4.3 Procedure
Sales and Marketing representative produces bid packages then rates the probability of an award by
obtaining information through contracts and/or correspondence with bid proprietors. When awards are
confirmed, a request for project information is made, if not already available in RFPs or RFQs, by a
representative of Sales and Marketing or the Project Coordinator. The Project Coordinator gathers all project
information then translates this information into BC Laboratories' language. Translation will be discussed
during supervisor meetings and on a one-to-one basis. A project Quotation Form, which is completed
through the LIMS or by hand, is created then distributed to all pertinent personnel.
11.5 CAPACITY
Capacities are functions based by method, # of instruments, # of analysts, # of work shifts, potential # of
samples analyzed per 8 hour shifts, sample matrix, and baseline levels of continuous work.
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Daily capacity is figured by finding the number of samples which can be analyzed (excluding CCV's,
Curve Stds, blanks, LCS's and MS's) on one instrument by one analyst during an eight hour work shift.
Actual capacity will vary based on time of year, workload, analyst vacations, and instrument configuration
for multiple Analyte analysis, instrument performance, and analyst performance. To adjust this daily
capacity, take the average amount of samples analyzed per year and divide by the number of work days in a
year, then subtract this number from the daily capacity. This will give us available capacity.
Quarterly capacity will be assessed more accurately detailing available capacity during high workload periods.
This can be found by finding the average daily workload during quarterly monitoring periods.
Projected workload is based on number of analyses and turnaround time.
Projected workload = Number of analyses
Turnaround Time (days)
In order to verify if additional workload can be handled, find the daily capacity and/or the quarterly capacity,
projected workload (analyses per day) and place in the following algorithm:
Available capacity - projected workload
If this number is positive, the additional workload can be approved. If negative, available capacity must be
increased through more instrumentation, more labor, and/or modified system changes.
11.6 METHOD QUALIFICATION
Each new method must be pre-qualified prior to use. Prequalification entails meeting reporting and performance
criteria outlined in the ELAP manual AData Package Guidelines@. Further details can be found in the QA Protocols
Manual.
11.7 USE OF NON-STANDARD METHODS
In order to utilize methods which are non-referenceable or deviate significantly from referenced methods, we are
required to obtain client and/or regulatory agency approval. If regulatory approval is needed, the QA Officer will
initiate the process of obtaining method exceptions. Approvals by our clients must be documented in writing on a
record which is recognized by our system. All data associated with non-standard methods should be flagged on
affected final reports.
11.8 USE OF DIFFERENT METHOD VERSIONS
In cases of combined analytical methods, the most stringent requirements for each of the various calibration and
quality control steps must be incorporated in the merged procedure. All instruments are set up to accommodate the
most stringent QC requirements for like methods so reporting can be a function of sample matrix or project method
reporting protocol. Sample results reported under particular methods must be referenced correctly on final reports
either in the heading or in a comments section.
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TABLE 5 METAL METHODOLOGIES
SECTION XI
REVISION NO. 22
EFFECTIVE DATE: 01/08/16
PAGE 11-7
METALS
ICP
METHODOLOGY
AA/GHA/CV
METHODOLOGY
GFAA
METHODOLOGY
ICP/MS
METHODOLO
GY Aluminum
EPA 200.7, 6010B,
Antimony
EPA 200.7, 6010B
EPA 200.8/6020
Arsenic
EPA 200.7, 6010B
EPA 200.8/6020
Barium
EPA 200.7, 6010B
EPA 200.8/6020
Beryllium
EPA 200.7, 6010B
EPA 200.8/6020
Boron
EPA 200.7, 6010B
Cadmium
EPA 200.7, 6010B
EPA 200.8/6020
Calcium
EPA 200.7, 6010B
Cobalt
EPA 200.7, 6010B
EPA 200.8/6020
Copper
EPA 200.7, 6010B
EPA 200.8/6020
Chromium
EPA 200.7, 6010B
EPA 200.9
EPA 200.8/6020
Iron
EPA 200.7, 6010B
Lead
EPA 200.7, 6010B
EPA 200.8/6020
Lithium
EPA 200.7, 6010B
EPA 200.8/6020
Magnesium
EPA 200.7, 6010B
Manganese
EPA 200.7, 6010B
EPA 200.8/6020
Mercury
EPA 245.1, SW7471A,
SW7470A
Molybdenum
EPA 200.7,6010B
EPA 200.8/6020
Nickel
EPA 200.7,6010B
EPA 200.8/6020
Potassium
EPA 200.7,6010B
Selenium
EPA 200.7,6010B
EPA 200.8/6020
Silica
EPA 200.7,6010B
Silver
EPA 200.7,6010B
EPA 200.8/6020
Sodium
EPA 200.7,6010B
Strontium
EPA 200.7,6010B
Tin
EPA 200.7,6010B
EPA 200.8/6020
Titanium
EPA 200.7,6010B
Thallium
EPA 200.7,6010B
EPA 200.8/6020
Vanadium
EPA 200.7,6010B
EPA 200.8/6020
Zinc
EPA 200.7,6010B
EPA 200.8/6020
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TABLE 6 ORGANIC METHODOLOGIES
SECTION XI REVISION NO. 22
EFFECTIVE DATE: 01/20/14
PAGE 11-8
ANALYSIS
WATER METHODOLOGY
SOIL, OIL, SLUDGE
METHODOLOGY Purgeables (GC)
EPA 8021B, EPA 8015B
EPA 8021B, EPA 8015B
Purgeables (GC / MS)
EPA 524.2, EPA 624, EPA 8240B,
EPA 8260B, EPA 601/602 by GC/MS
EPA 8260B
EDB / DBCP
EPA 504.1
EPA 504M
Pesticides, Herbicides (GC)
EPA 608,EPA 515, EPA 508
EPA 8080A, EPA 8081A, EPA
8082,
EPA 8141A, EPA 8140, EPA 525.2,
EPA 8150B, EPA 8151A Gasoline Residue
LUFT Manual 8015M
LUFT Manual 8015M
Diesel Residue
LUFT Manual 8015M
LUFT Manual 8015M
PCB's
EPA 608, EPA 625
EPA 8082
Phenols
EPA 525.2
EPA 8270C
Title 22
State Method
Priority Pollutants (GC/MS)
EPA 625, EPA 525.2
EPA 8270C
Oil and Grease
EPA 1664
EPA 1664
TPH
EPA 1664
EPA 1664
Pesticides, Herbicides (HPLC),
Carbamates
EPA 632
EPA 632
PAH's
EPA610
EPA 8310
Explosives
EPA8330
EPA8330
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ANALYSIS
WATER METHODOLOGY
SOIL, OIL, SLUDGE
METHODOLOGY Alkalinity
EPA 310.1, SM2320B
Chloride
EPA 300.0
EPA 300.0
Chromium VI
SW 7196A, SM 3500Cr D, 218.6
SW7196A, SW7199
Corrosivity
EPA 150.1
SW9040
Conductivity
EPA 120.1, SM2510B
SW9050
Cyanide
EPA335.1,EPA 335.3, EPA 335.2,
EPA 335.4
SW9012A, SW9010,SECTION 7.3,SW846
Fluoride
EPA 300.0
EPA 300.0
Nitrogen Forms
EPA 350.1, EPA 353.2,SM4500-NH3H
EPA 300.0, EPA 351.2,SM4500-NO3F
EPA 350.1, EPA 353.2,
EPA 300.0, EPA 351.2 Bacteriologicals
SM9215B,SM 9221A,B,C, 9221C,E, 9223
SM 9221B, 9221C,E, SM9215B
D.O.
EPA 360.1, SM4500-OG
N/A
Bromide
EPA 300.0
EPA 300.0
Chlorine Residue
SM 4500CLB F, EPA 330.4
Color
EPA 110.2
N/A
pH
EPA 150.1, SW9040, SW9045,
SM4500H+B, EPA 305.1, SM2310B
SW9045C, SW9040B
Phenols
EPA 420.4
SW9066
Phosphorous
EPA 365.1, EPA 365.4, SM4500PF
Sulfur Forms
EPA 376.1, EPA 376.2, SM4500-S,D,E
SW9030, SW 7.3.4.2
Sulfate
EPA 300.0
EPA 300.0
BOD
EPA 405.1, SM5210B
COD
EPA 410.4, SM5220D
TOC
SM5310C
SW 9060
Residue
EPA 160.1 - SM2540B-SM2540F
MBAS
EPA 425.1, SM5540C
Odor
EPA 140.1
Turbidity
EPA 180.1, SM2130B
Perchlorate
EPA 314.0
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DATA REDUCTION, VALIDATION, AND REPORTING
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12.0 SUMMARY
It is the responsibility of the analyst to conduct initial data reduction procedures by using calculations referenced in State
and Federally recognized methodologies and within respective SOP=s. The tools used to reduce data include Excel
spreadsheets, Dionex AI-450 software, HP Chemstation software, calculators, Enable database software, LIMS
processing programs and instrument programs.
Validation and verification processes include analyst reviews, technical reviews, supervisor reviews, project management
reviews, QA department reviews, data processing checks, and final approvals. See the appropriate flowcharts in
Appendix D.
Results are entered onto laboratory bench worksheets, then introduced into the LIMs via a data processing system . (BC
participates in CLP like projects, which requires raw data from COC to injection log with analytical report. At least 10%
of data packages are reviewed thoroughly by QA/QC officer to ensure integrity of the data. Raw data is verified through
element analytical reports and validated with LIMS statistical data calculations.
12.1 REDUCTION
12.1.1 Organics Department
12.1.1.1 GC/HPLC
Data is processed via HP Chem software reduced by hand if necessary and recorded onto
worksheets. When dual column confirmation is used, it is BC Laboratories policy to report values
from the primary column. However, clients may specify in writing that the higher of the two
confirmed results be reported. The reduced data is electronically transferred to the LIMS. The
LIMS performs statistical calculations (% recoveries % RPD, % found, etc) and sample
calculations.
12.1.1.2. GC/MS
All data is processed and reduced on manufacturer's software. Sample analyses are processed via
data systems enviroquant and Varian's enviropro. Results are then recorded onto worksheets. The
reduced data is electronically transferred to the LIMS. The LIMS performs statistical calculations
(% recoveries % RPD, % found, etc) and sample calculations in test solutions sample weights,
extract volume and sample dilution.
12.1.1.3 TRPH
Data is recorded onto QC bench sheets, reduced by hand, then recorded onto worksheets.
Calibration factors are used in the linear regression model which is used to reduce data. The
reduced data is electronically transferred to the LIMS. The LIMS performs statistical calculations
(% recoveries % RPD, % found, etc) and sample calculations in test solutions sample weights,
extract volume and sample dilution.
12.1.2 Metals Department
12.1.2.1 ICP, ICP/MS, GFAA, AA
Instrument data is reduced on manufacturer's software. All dilutions are accounted for on
laboratory worksheets. The reduced data is electronically transferred to the LIMS. The LIMS
performs statistical calculations (% recoveries % RPD, % found, etc) and sample calculations in
test solutions sample weights, extract volume and sample dilution.
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12.1.2.2 Hg by cold vapor
The method of least squares, using chart line versus concentration, is used as the linear regression
model. Results are reduced onto a QC bench sheet then entered onto worksheet. The reduced
data is electronically transferred to the LIMS. The LIMS performs statistical calculations (%
recoveries % RPD, % found, etc) and sample calculations in test solutions sample weights, extract
volume and sample dilution.
12.1.3 General Chemistries
12.1.3.1 IC
Data is reduced via the use of manufacturer's software. Values are recorded onto a QC
bench sheet then transferred to worksheets. The reduced data is electronically transferred
to the LIMS. The LIMS performs statistical calculations (% recoveries % RPD, % found,
etc) and sample calculations in test solutions sample weights, extract volume and sample
dilution.
12.1.3.2 Meters, titrimetric and gravimetric tests.
Data is recorded onto QC bench sheets then transferred to worksheet. The reduced data is
electronically transferred to the LIMS. The LIMS performs statistical calculations (%
recoveries % RPD, % found, etc) and sample calculations in test solutions sample weights,
extract volume and sample dilution.
12.1.3.3 Optical Analyses
The method of least squares, using chart line versus concentration, is used as the linear
regression model. Results are reduced on QC log sheets then transferred onto worksheets.
The reduced data is electronically transferred to the LIMS. The LIMS performs statistical
calculations (% recoveries % RPD, % found, etc) and sample calculations in test solutions
sample weights, extract volume and sample dilution.
12.1.4 Data acquisition by the LIMS
Methods which have been linked to the LIMS are processed in the following manner:
1) Instrument readings are either hand entered or electronically transferred into the LIMS
2) Review of data entry
3) Data is processed and posted
4) Review of processing
5) A result file is created
The reduced data is electronically transferred to the LIMS. The LIMS performs statistical
calculations (% recoveries % RPD, % found, etc) and sample calculations (final results driven from
Analyte concentration in test solutions sample weights, extract volume and sample dilution.)
Electronic transfer of data is currently used as QC tool by providing parallel reporting. Data from
worksheets supersede electronically processed data unless worksheet data is proven discrepant.
12.1.5 Calculations
12.1.5.1 % Relative Abundance
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Abundance of X
Abundance of Y x 100%
12.1.5.2 Relative Response Factor
RRF = Ax
Ais x
Cis
Cx
Mean Relative Response Factor
RRF =
5
ji=1
RRFi
5
Where: RRFi="i"th Relative Response factor
A = Area of the characteristic ion
C = Concentration
is = Internal standard
x = Analyte of interest
12.1.5.3 Standard Deviation
S =
n
ji=1
(xi x )2
n-1
Where: S = Standard deviation of RRF's
X = Mean of RRF's
X = Sample reading
n = number of samples
12.1.5.4 % Relative Standard Deviation
% RSDSD
RFx
x
100%
Where: RSD = Relative Standard Deviation
RFX = Mean of 5 initial RRF=s for a compound.
SD = Standard Deviation of RRF=s.
12.1.5.5 Percent Difference
%D =
RRFi
- RRFc
RRFi
x 100
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Where: RRFi = average RRF from initial calibration
RRFc = RRF from continuing calibration standard
12.1.5.6 Percent Drift
%( )
DiftC C
Cx
C
1
1
100
Where: C1 = Calibration check compound standard concentration
Cc = Measured concentration using selected quantitation method.
12.1.5.7 Percent Recovery (Surrogates)
%Recovery = Concentrationªamount found
Concentrationªamount spiked x 100
12.1.5.8 Percent Recovery (matrix spikes)
% Recovery = SSR -SR
SA X 100
Where: SSR = Spiked Sample Result
SR = Sample Result
SA = Spike Added
12.1.5.9 Calculations for matrix spike recoveries for non-prepared samples are as
follows:
MSR x y sample result sample result
spike levelx
/
100
Where: MSR = matrix spike result
X = mls of spike
y = total mls (spike + sample)
or,
MSR sample result x y
spike levelx
* /1
100
Where: MSR = matrix spike result
x = mls of spike
y = total mls (spike + sample)
12.1.5.10 Relative percent difference (matrix spikes)
RPD = |MSR -MSDR |
1ª2(MSR +MSDR ) X 100%
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Where: RPD = Relative Percent Difference
MSR = Matrix Spike Recovery
MSDR = Matrix Spike Duplicate Recovery
12.1.5.11 Concentration (waters) volatile. GC/MS
Fgªl = Ax x Is x Df
Ais x RRF x Vo
Concentration (low level soils) volatiles
Fgªkg = Ax x Is
Ais x RRF x Ws x D
Concentration (med level soils) volatiles (dry weight basis)
Fgªkg = Ax x Is x Vt x 1000 x Df
Ais x RRF x Va x Ws x D
Where: Ax = Area of characteristic ion for compound
Ais = Area of characteristic ion for internal standard
Is = Amount of internal standard added (ng)
RRF = Daily relative response factor for compound
Vo = Volume of water purged (mL)
Ws = Weight of sample (g)
D = (100%- Moisture) / 100% - conversion to dry weight (optional)
Vt = Volume of methanol (mL)
Vi = Volume of extract added (l) for purging
Df = Dilution factor
Va = Volume of the aliquot of the methanol extract (l) added to reagent water for
purging.
12.1.5.12 PQL Adjustment
Adjusted PQL = Non-adjusted PQL x sample Df
FgªL = Ax x Is x Vt x Df
Ais x RRF x Vo x D
12.1.5.13 Concentration semi-volatiles (water) GC/MS
FgªL = A
x x I
s x V
t x Df
Ais x RRF x V
o x D
Concentration (soils)
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ICS %R = FoundSolutionAB
TrueSolutionAB x 100
LCS %R = LCS Found
LCS True x 100
Fgªkg = Ax x Is x Vt x Df
Ais x RRF x Vi x Ws x D
Where: Ax = Area of characteristic ion for compound
Ais = Area of characteristic ion for internal standard
Is = Amount of internal standard added (ng)
RRF= Daily relative response factor for compound
Vo = Volume of water purged (mL)
Vi = Volume of extract injected (l)
Vt = Volume of concentrated extract (l)
Df = Dilution factor
D = (100-% Moisture) / 100% - conversion to dry weight (optional)
Ws = Weight of Sample (g)
12.1.5.14 ICV / CCV Recoveries
%R = Found
True x 100
Where: Found = Concentration of Analyte measured in the analysis
True = Concentration of Analyte in ICV or CCV source.
12.1.5.15 ICP Interference Check Sample (ICS)
Where: Found Solution AB = Concentration of Analyte measured in the analysis of solution AB
True Solution AB = Concentration of each Analyte in solution AB
12.1.5.16 Laboratory Control Sample
Where: LCS Found = Concentration (in g/l for aqueous; mg/kg for solid) of each Analyte
measured in the analysis of LCS solution.
LCS True = Concentration (in g/l for aqueous; mg/kg for solid) of each Analyte in the
LCS source.
12.1.6 Manual Integration Policy
1. All lone> 90% baseline peaks are to be integrated valley to valley.
2. All peaks with adjacent peaks < 90% resolved will be integrated baseline to baseline, dropping a
perpendicular at the minimum.
3. All peaks with shoulders will be integrated in the best manner possible. Analyst’s judgment.
(Tangential skim or dropping a perpendicular.)
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4. In a busy Chromatogram, the analyst=s judgment as to the best integration technique will supersede
above.
5. All manual re-integrations are printed and reviewed during the raw data review process.
Acknowledgement of review is either on instrument printouts or technical review sheets.
6. No peak shaving is to be observed or practiced.
7. Manual integrations are documented by the software being use. HP chemstation places an Am@ by
each peak that is manually integrated. The Dionex software states that the run was reprocessed and
the date upon which the reprocess occurred.
8. For DoD projects, peaks that require manual integration will be printed before and after adjustment.
The date, the reason for the manual integration and the signature/initials of the person performing
the manual operation will be noted on the chromatograph. The following flags must be noted on the
manual integration are (B) Baseline Adjustment – moving peak start to end. (P) Peak correction –
misidentification correction and (R) Rider Removal – splitting of secondary peaks or tails. Please
see DoD QSM version4.2, June 2003 for detail.
12.2 VALIDATION
QC parameters to be checked to validate results:
12.2.1 Volatiles (GC, GC/MS)
Holding Times
GC/MS Instrument performance check
Initial Calibration
Continuing Calibration
Blanks
Batching
Surrogate spikes
Matrix spikes/matrix spike duplicate
Laboratory control sample
Internal standards (if applicable)
Compound Identification and Chromatography
Compound Quantitation and reporting limits
Tentatively identified compounds (if applicable)
System performance
Retention Times
Overall assessment of data
12.2.2 Semi-volatiles (GC, GC/MS)
(Same list as volatiles)
12.2.3 TRPH
Holding times
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Initial calibration
Continuing calibration
Blanks
Batching
Matrix spikes/matrix spike duplicate
Laboratory control sample
Quantitation and reporting limits
System performance
Overall assessment of data
12.2.4 Gravimetric Testing
Holding times
Blanks
Batching
Duplicates
Laboratory control sample
Quantitation and reporting limits
System performance
Overall assessment of data
12.2.5 Metals (ICP, GFAA, GHA, AA)
Holding times
Initial calibration
Continuing calibration
Blanks
Batching
ICP Interference check sample
Laboratory control sample
Duplicate sample
Matrix spike/ matrix spike duplicate
Post spikes (if applicable)
Quantitation and reporting limits
System performance
Overall assessment of data
12.2.6 Metals (Hg)
Holding times
Initial calibration
Continuing calibration
Blanks
Batching
Laboratory control sample
Duplicate sample
Matrix spike/ matrix spike duplicate
Post spike (if applicable)
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Quantitation and reporting limits
System performance
Overall assessment of data
12.2.7 Metals (ICP-MS)
Holding times
Short-term stability check
Initial calibration
Continuing calibration
Blanks
Batching
Surrogate spikes
Duplicate
Matrix spike/ matrix spike duplicate
Laboratory control sample
Post spike (if applicable)
Internal standards
Compound Quantitation and reporting limits
System performance
Overall assessment of data
12.2.8 Titrimetric Testing
Holding times
Blanks
Batching
Duplicates
Matrix spikes/matrix spike duplicate (if applicable)
Laboratory control sample
Quantitation and reporting limits
System performance
Overall assessment of data.
12.2.9 Colorimetric Testing
Holding times
Initial calibration
Continuing calibration
Blanks
Batching
Duplicates
Matrix spikes/matrix spike duplicate (if applicable)
Laboratory control sample
Quantitation and reporting limits
System performance
Overall assessment of data.
12.2.10 Ion Chromatography
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Holding times
Initial calibration
Continuing calibration
Blanks
Batching
Duplicates
Matrix spikes/matrix spike duplicate
Laboratory control sample
Compound identification and chromatography
Compound quantitation and reporting limits
Retention Times
System performance
Overall assessment of data.
12.2.11 Meter
Holding times
Calibration
Blanks
Batching
Matrix spikes/matrix spike duplicate (if applicable)
Laboratory control sample
Quantitation and reporting limits
System performance
Overall assessment of data
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12.3 REPORTING
All reports generated by BC Laboratories include information necessary for proper sample, client identification
and complete result reporting. Report packages include: Cover sheets that contain information pertaining to
sampling procedures and analysis requested; report sheets displaying analytical results, methods used, PQL's,
concentration units and report approval signatures; Chain-of-Custody documents and QC report if requested.
All reports released are:
Complete
Neatly typewritten and presented
Associated with a unique project or lab number
BC Laboratories, Inc. will make all necessary corrections if the above criteria are not met.
Specialized reporting formats are available upon request for specific project requirements.
12.3.1 Reporting Procedures for Qualified Data
12.3.1.1 Holding time exceeded. If holding times are exceeded, qualify results as estimated. Add a
comment to the final report and/or other pertinent deliverables which explains the qualifier.
12.3.1.2 GC/MS Initial Calibration Incompliance - If %RSD is greater than 20.0% and initial
calibration RRF's greater than or equal to 0.05, qualify positive results as estimated, and
non-detected target compounds using professional judgment. If any initial calibration RRF
is less than 0.05, qualify positive results that have acceptable mass spectral identification as
estimated and non-detected analytes as unusable.
12.3.1.3 GC/MS Continuing Calibration Incompliance - If the %D is outside 20.0% criterion and
the continuing calibration RRF is greater than or equal to 0.05, qualify positive results as
estimated. If the %D is outside 20.0% criterion and the continuing calibration RRF is
greater than or equal to 0.05:
Qualify non-detect target compounds as estimated if -20%.
Do not qualify non-detect target compounds if +20%.
12.3.1.4 Blanks Incompliance - If a compound is detected in the sample and in the blank, the sample
result is qualified if the sample concentration is less than ten (10) times the associated PQL.
Report method blank bias for associated sample concentrations >10 times the respective
PQL=s. Results must not be corrected by subtracting any blank value, unless method
references state otherwise.
12.3.1.5 Surrogate Incompliance - If a surrogate has a recovery greater than the upper acceptance
limit, detected target compounds are qualified while results for non-detected target
compounds should not be qualified.
If a surrogate has a recovery greater than or equal to 10% but less than the lower acceptance
limit, detected target compounds are qualified while non-detected compounds quantitation
limits are qualified as approximated.
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If surrogate recovery is less than 10% and less than the lower acceptance limit, detected
compounds are qualified and non-detected target compounds may be qualified as unusable.
12.3.1.6 Matrix Spike/Matrix Spike Duplicate Incompliance - No action is taken on MS/MSD data
alone unless informed professional judgement is used in conjunction with other QC criteria.
In matrix evaluation, QC acceptance criteria should be used to compare MS/MSD
recoveries to DoD LCS limits. If MS results are outside the LCS limits, data should be
evaluated to determine the source of error and to determine if there is any matirix
interference or analytical error.
12.3.1.7 Laboratory Control Samples Incompliance - Action on the LCS recovery should be based
on both the number of compounds that are outside of the recovery and the magnitude of the
exceedance of the criteria. If the LCS recovery criteria are not met, then the LCS results
should be used to qualify samples data for the specific compounds that are in the LCS
solution. If the LCS recovery is greater than the UCL, then positive results for the
particular compounds should be qualified. If LCS compounds are below associated LCL's,
then affected results should be rated unusable. If more than half the compounds in the LCS
are not within the required recovery criteria, then all of the associated detected target
compounds should be qualified and all associated non-detected target compounds should be
qualified unusable. Please note that the proximity of recoveries to 100% should be
considered in assessment. All of the methods analytes laboratory=s in-house limits are
calculated from the laboratory=s historical data. Laboratory=s in-house limits are established
as part of their quality control system to evaluate trends and monitor laboratory
performance. When laboratory=s in-house limits are outside the DoD limits, laboratory in-
house limits must be reported, even if the LCS of the preparatory batch fall within the DoD
specified limits.
12.3.1.8 Internal Standard Incompliance - If an IS area count is outside -50% or +100% of the area
for associated standard; positive results for compounds quantitated using that IS should be
qualified, non-detected compounds quantitated using an IS area count greater than 100%
should not be qualified, non-detected compounds quantitated using an IS area count less
than 50% are reported with an approximated quantitation limit.
12.3.1.9 Initial Calibration Incompliance (GC) - If %RSD is greater than 20%, qualify all positive
results as estimated and use professional judgment in assessing non-detect target analytes.
12.3.1.10 Continuing Calibration Incompliance - If % diff is greater than 15%, qualify positive
results as estimated. If % diff is less than -15%, qualify positive results as estimated and
approximate the non-detect target analytes quantitation limits. For DOE/DOD work, if
the CCV standard or surrogate analyzed acceptance criteria are high only samples that
are non-detected may be reported. All positive samples affected by unacceptable CCV
will be reanalyzed after a new calibration curve has been established. If the CCVs
surrogate acceptance criteria are low, samples may be reported if they exceed Maximum
Regulatory Limit (MRL). Otherwise, all samples affected by unacceptable CCV will be
reanalyzed after a new calibration curve has been established and accepted. The
surrogate recoveries in the method blank and the instrument blank must be within
criteria for the analytical sequence to be valid.
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PAGE 12-13
12.3.1.11 Initial Calibration Incompliance (Inorganics) - If the minimum number of standards
were not used for initial calibration, or if the instrument was not calibrated daily and
each time the instrument was set up, qualify the data as unusable. Please note that Ion
Chromatography procedures mandate that an initial curve is validated by continuing
calibration checks. If the correlation coefficient is <0.995, qualify results as estimated.
12.3.1.12 Continuing Calibration Incompliance (Inorganics) - If the CCV or ICV %R falls outside
the acceptance windows, use professional judgement to qualify all associated data.
12.3.1.13 Interference Check Sample - For samples with concentrations of Al, Fe, Ca, and Mg
which are comparable to or greater than their respective levels in the Interference Check
Sample:
1) If the ICS recovery for an element is >120%, qualify detected results.
2) If the ICS recovery for an element falls between 50 and 79%, qualify detected and
non-detected results.
3) If ICS recovery results are <50%, qualify data as unusable.
12.3.1.14 Duplicate Incompliance - If duplicate analysis results for a particular analyte fall outside
the appropriate control windows, qualify the results for that analyte in all associated
samples of the same matrix as estimated.
12.3.1.15 Post Spike Incompliance - If sample absorbance is <50% of the post digestion spike
absorbance then:
1) If the post spike recovery is not within 85-115%, qualify results as estimated.
2) If method of standard additions is required but has not been done, qualify the
sample results as estimated.
3) If MSA spike levels are not appropriate, qualify data, and
4) If MSA correlation coefficient is <0.995, qualify data as estimated.
12.3.2 Use of flags
In cases where data must be qualified, data qualifiers (flags) must be used. Please see Appendix G
for index of flags.
12.4 ROUNDING RULES FOR REPORTING DATA
12.4.1 Significant figure and rounding rules for inorganic=s analyses.
Significant figures are method specific and response specific.
Rounding off numbers is the process of dropping digits that are not significant. In order to round off
a number to a particular place holder (for example, to the nearest 10) one looks at the next smallest
place holder (the 1's place). If the next smallest place holder is a 6, 7, 8 or 9, then increase the
preceding digit by one and drop the digits to the right (if to the right of the decimal) or replace them
with zeros (if to the left of the decimal). If the next smallest place holder is a 1, 2, 3 or 4, then do not
change the preceding digit and drop the digits to the right or replace with zeros. If the next smallest
place holder is a 5 and any number to the right of the 5 is not zero, then treat it as 6, 7, 8 or 9 as
above. If the next smallest place holder is a 5 and all digits to the right of this digit are zero, then
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round the preceding digit to the nearest even number (0, 2, 4, 6, 8) and drop the digits to the right or
replace with zeros. Thus, 2.250001 becomes 2.3 and 2.250000 becomes 2.2, and 6.750 becomes
6.8.
When rounding values, do not round off values that have been previously rounded. In other words,
do not round off during a preliminary calculation. Carry as many digits as possible until the final
value has been calculated and then round off as needed.
12.4.2 Significant figure and rounding rules for organic=s analyses.
Two significant figures are used as a rule for organics. Rounding rules are the same as for Inorganics
testing.
Note: This section has been reviewed on 01/08/2016 (No Changes were made)
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SECTION XIII
REVISION NO. 16
EFFECTIVE DATE: 01/08/16
PAGE 13-1
13.0 QC PARAMETERS
Required QC parameters will vary according to method, specific project requirements, and/or sample matrices
encountered.
Table 8 illustrates generalized criteria. QC parameter requirements in specific SOP=s supersede those listed in Table 8.
QC Parameters for Wet Chemistry testing
Sample/Sample Duplicate
Matrix Spike/Matrix Spike Duplicate
Laboratory Control Sample-Water or Solid
Method Blank
Exceptions:
pH, EC, TDS
Sample/Sample Duplicate
Laboratory Control Sample
TSS, Settleable Solids
Sample/Sample Duplicate
QC Parameters for Metals testing
Sample/Sample Duplicate
Matrix Spike/Matrix Spike Duplicate
Laboratory Control Sample-Water or Solid
Method Blank
Post Spike
QC Parameters for Organics testing
Matrix Spike/Matrix Spike Duplicate
Laboratory Control Sample
Method Blank
Surrogate
Exceptions:
Oil and Grease, Total Recoverable Petroleum Hydrocarbons
Sample/Sample Duplicate
Matrix Spike/Matrix Spike Duplicate
Laboratory Control Sample
Method Blank
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13.1 BATCHING
A group of samples of similar matrix that behave similarly with respect to the procedures being employed.
The number of samples in a batch may never exceed 20, (consult SOP to verify maximum batch size). All
samples in a batch must be processed as a unit with the same method sequence and the same lots of reagents
and standards. The manipulations common to each sample in a batch must be performed simultaneously or in
a continuous sequence without significant interruption. If an analytical sequence contains more than one
distinct step, such as a preparation procedure, quality control samples required by the method for the batch
must be assigned and prepared in the initial step. This group of samples is called a preparation batch, and
must contain all quality control samples required by the method, including (PB/MB, Dup, MS, MSD, LCS,
other). A preparation batch must not contain more than twenty field samples. Laboratory QC samples
processed in the preparation batch are not counted in the maximum batch size of 20. If the instrumental
analysis of the samples in one preparation batch is not performed in a continuous sequence, the method blank
from the preparation batch must be analyzed with each set of samples from the same preparation batch. If re-
analyses are required (e.g. to perform dilutions) it is not necessary to include the method blank in the
reanalysis.
13.2 LABELING CONVENTIONS
Unique batch identifiers are needed to properly coordinate referencing of QC parameters to associated
work order. Preparation sets which are processed into the LIMS are labeled by batch #, date and set
number. All prepared samples within the batch are associated automatically by the LIMS. If preparation
tasks are not processed into the LIMS, preparation batches are labeled on individual preparation logs. QC
parameters are labeled by a combination of 1) QC parameters type, 2) batch #, 3) Sample number, 4) date
and 5) file #.
13.3 QC PARAMETER CONTROL LIMITS
Control limits are calculated from recoveries of laboratory control samples and/or matrix spikes. A minimum
of twenty observations should be used to calculate control limits. 500 and 600 series methods mandate
calculation of control limits with the statistical use of the word "control" in mind.
Control Limits = Mean Recovery 3 s
s is the standard deviation of the recoveries
The SW-846 series calculation for control limits are as follows:
Control Limits (Matrix Spikes) = Mean Recovery 3 s
s is the standard deviation of the recoveries
Control Limit (for surrogates) = Mean Recovery 3 s
s is the standard deviation of the recoveries
In order to monitor trends in the analytical process, the latest thirty to forty observations are used to calculate
laboratory control sample control limits. New control limits are compared to previously calculated limits to
track possible trends. Comparisons are made on the means, UCL, LCL and numbers of outliers.
When calculating control limits for matrix spikes, the database will be continually added to until major
modifications occur to a method.
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% RECOVERY = X - B
T 100
There exist many variables that would cause new control limits to be initiated.
Variables: 1. New Analyst
2. New Preparation Tech
3. Method Modification
4. Instrument Modification
5. Reagent and/or standard vendor change
Control limits are subject to change without notification.
Control limits are calculated by analysts using QA Admin in Element then select Control Chart.
13.3.1 CLP projects: SW-846 control limits or CLP projects specific limits are reported. If any of the
compound CLP control limits are not available then in-house calculated control limits are used.
RPD calculation of MS/MSD Analysis
100)( 21
xX
XXRPD
Where: X = Amount of Analyte found in Matrix Spike
X = Amount of Analyte found in Matrix Spike Duplicate
X = Mean Value of Analyte found in X1 and X2.
13.4 CALCULATIONS
Precision
Precision is defined as the measure of mutual agreement among individual measurements of the same
pollutant in a sample secured under the same analytical protocols. Field and lab precision will be expressed as
relative percent difference where:
*RDP calculation of MS/MSD, RPD is calculated using MS/MSD final concentration of spiked sample.
RPD = *x1 - x2*
X H 100
RPD = Relative percent difference between MS/MSD final concentrations
||= Absolute value of the difference between MS/MSD X1 and X2
X = Mean value of MS/MSD results, X1 and X2
The goals for precision are related to the proximity of the sample value to the detection limit. At or less than
five times the practical quantitation limit, the precision goal will be expressed in absolute concentration
(quantitation limit terms).
Accuracy
Accuracy is defined as the degree to which the analytical measurement reflects the true value present.
Overall accuracy will be estimated by recovery performance of spiking events, internal standards and control
samples. Accuracy will be measured as percent recovery where:
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X = measured concentration in sample after spiking
B = background concentration in sample
T = concentration of spike added to sample
If the sample concentration is below the MDL, zero (0) will be used in the calculation. In all other cases, the
sample concentration must be used to calculate percent recovery. When the sample concentration is greater
than four (4) times the spike level, the percent recovery result will be expressed as "High Mean". Percent
recovery for selected inorganic method soil matrix samples may use the average of the sample and sample
duplicate in the percent recovery equation.
13.5 COMPLETENESS
Completeness shall be evaluated qualitatively and quantitatively if necessary to meet specific project
requirements. The qualitative evaluation of completeness shall be determined as a function of all events
contributing to the sampling event including items such as correct handling of chain of custody forms, etc.
The quantitative description of completeness shall be defined as the percentage of Contract controlled QC
parameters that are acceptable.
QC parameters that shall be assessed for quantitative determinations of completeness shall include initial
calibrations, continuing calibrations, surrogate percent recovery for organics analyses, analysis of laboratory
duplicates for Relative Percent Difference (RPD), analysis of Matrix Spike/Matrix Spike Duplicate analyses
for percent recovery and RPD, and analysis of Laboratory Control Samples for percent recovery, and holding
times. The requirement for the quantitative assessment of completeness shall be 90%. The 90% standard
shall be applied to the entire list of parameters described above such that a minimum of 90% of the data for
each analytical method is associated with acceptable quality control criteria as described above and in other
sections of this document. The quantitative assessment of completeness shall be calculated for each
analytical method as the ratio of acceptable sample results to all sample results. For multi-Analyte methods
(organics analyses) each analysis of the aggregate of analytes shall be considered a single sample result. The
requirement for holding times shall be 100%. If any sample exceeds the holding time specified by EPA SW
846 (or other guidance documents for other analyses), that sample should be re-sampled and reanalyzed,
unless redirected by the client.
13.6 CORRECTIVE ACTION
Corrective Action will be initiated for instances of QC parameter in compliance. The extent and steps of
corrective action procedures will vary according to project requirements or individual client protocols.
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TABLE 8 LEVEL OF QC EFFORT
QC TERM
MATRIX
FREQUENCY
CRITERIA
CHEMISTRY
Duplicate
Water
10% or 1 per batch, whichever is greater
<10% RPD above 5 times PQL, if <5
times PQL, PQL.
Inorganic
Soil/
Wastewater
5% for solid and wastewater matrices
<20% RPD above 5 times PQL, If <5
times PQL, 2 x PQL. Matrix
Spike, Matrix
Spike Dupl.
Water
10% or 1 per batch, whichever is greater
Within defaulted Control Limits
Inorganic except TSS, TDS, Color, Odor,
Turbidity, pH, Conductivity
Soil/other 5% or 1 per batch, whichever is greater
Within defaulted Control Limits
Solid Matrix Metals, Solid Matrix Inorganics
5% or 1 per batch, whichever is greater
Within Control Limits
Organic
LCS
NA
1 per batch
90 - 110% Recovery or Within Control
Limits
Wet Chemistry
1 per batch
85 - 115% Recovery or Within Control
Limits
Metals, Wet Chemistry (Prepared Samples)
1 per batch Within Control Limits Organic
ICV / CCV
NA
10%
90 - 110% Recovery, for CCV
95 - 105% Recovery, for ICV (See SOPs)
Inorganic, except Hg on solids
200.7, 7470, GFAA for waters Every 12 hours
See SOP
GC/MS
10% 15% diff 8000 Series except for GC/MS and 500/600 series
CCB NA Run after ICV and each CCV <PQL Inorganic, Organic Preparation/Met
hod Blank
NA
1 per batch or 20 (whichever more frequent)
<PQL or
<2 PQL for DoD ELAP (Navy) work.
Please refer to DoD QSM version 2 June
2002.
Inorganic, Organic
Initial
Calibration
NA
Before each sample run and/or when CCV unacceptable >0.995 Corr. Coeff. Inorganic When CCV unacceptable, when target compounds out
<20% RSD or regression model Organic except GC/MS
<15% RSD/If >15% RSD-use linear
regression
GC/MS
Note: This section has been reviewed on 01/08/2016 (No Changes were made)
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PERFORMANCE AND SYSTEMS AUDIT
SECTION XIV
REVISION NO. 21 EFFECTIVE DATE: 01/08/16
PAGE 14-1
14.0 PERFORMANCE AUDITS (Proficiency Testing)
In order to validate BC Laboratories, Inc. method performance accuracy and comparability to standards of the
environmental laboratory industry, a program of external and internal performance evaluations must be
incorporated into the Quality Program. Comparability studies are through external PE sample analyses, while
internal assessments are conducted to validate and maintain control of the analytical system.
14.1 EXTERNAL PERFORMANCE EVALUATION SAMPLES
BC Laboratories, Inc. is involved in 1)the Absolute Standards Water Supply and Water Pollution
performance evaluation studies, 2)the NPDES DMR PE studies, 3) a program of PE samples for soil
matrices through Absolute Standards, 4) an internal PE sample assessment through purchased standards
from Absolute Standards, 5) ERA Microbiology Evaluation Study and 6) Mixed Analyte Performance
Evaluation Program. PT studies are performed every six month interval. WS and WP are done in January
and July along with AK PT Studies. RCRA (Soil) are performed in April and October.
Air Testing Analysis PT provider is Sigma-Aldrich. These are schedule in April and October.
All performance sample studies are completed (i.e., we participate in every WS, WP and DMR QA PE/PT
Study). This is not a necessity since one compliant Analyte result per PE study will validate that parameter
for one year. Each PE sample is analyzed to validate continuous control of the analytical system.
14.1.1 Scope of Analytical Parameters
14.1.1.1 Water Supply - Corrosively, MBAS, Silica, Perchlorate, DOC, Vanadium, GAD, PCB,
Tert-Butyl Alcohol, Metals, Mercury, pH, Inorganics, Alkalinity & Sodium, Turbidity,
Residual Chlorine, Nitrite, Nutrients, Cyanide, TOC, Bromide, Hardness, Standard Plate
Count, MicrobE, Regulated Volatiles, Halomethanes, Unregulated Volatiles, Regulated
Pesticides, Toxaphene, Chlordane, EDB/DBCP, Regulated Semivolatiles, Regulated
Herbicides.
14.1.1.2 Water Pollution - PAHs, Boron, Surfactants, Acidity, Bromide, Nitrite, Settable Solids,
Volatile Solids, Silica, Sulfide, Turbidity, Carbamates, pH, Hardness, Demand, Simple &
Complex Nutrients, Cyanide, Phenolics, Grease & Oil, TRC, Trace Metals, Mercury,
Minerals, Tin and Titanium, Hexavalent Chromium, MicrobE, Volatiles, PCBs, Pesticides,
Chlordane, Toxaphene, Herbicides, Base Neutrals and Acids.
14.1.1.3 (DMR – QA Study) - pH, Hardness, Demand Group, Simple & Complex Nutrients,
Cyanide, Phenolics,Oil & Grease, Total Residual Chlorine (TRC), Trace Metals, and
Mercury.
14.1.1.4 Soil Series-Gasoline in Soil & Water, Diesel in Soil & Water, TPH in Soil & Water, BTEX
in Soil & Water, Trace Metals, Cyanide, Hexavalent Chromium, Base/Neutrals & Acids,
Pesticides, Chlordane, Toxaphene, Volatiles, Herbicides, PCBs, Organophosphorous
Pesticides, Ready to Use Volatiles, PAHs, Nitroaromatics & Nitramines, Corrosivity, and
Anions
14.1.1.5 MAPEP-Semi-Volatile Organics
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14.1.1.6 As stated on SOP BCSAM005 BC Laboratories will not accept any sample that
may contain “Radioactive Material” above background levels.
14.2 SYSTEMS AUDIT
14.2.1 Internal
Systems audits will be conducted on a annual basis and will cover 1) parameters outlined on the
Internal Assessment Schedule (Figure 7), 2) LIMS, 3) invoicing, 4) conformance to methodology
of Inorganic/Organic and SOP procedural outline, and 5) other tasks with performance objectives.
A completed Systems Audit Report will be submitted to the General Manager annually. Topics of
concern which arise during the year will be addressed at the quarterly Supervisor's Meetings.
14.2.2 External
External based audits are conducted by representatives of the state of California, and other private or
government entities.
14.3 ACTION
The QA Officer is responsible for completing annual systems audits and initiating subsequent corrective
actions as needed. If corrective action is required, the QA Officer has the authority to delegate
responsibilities and to initiate progressive discipline if tasks are not completed sufficiently to restore
acceptable performance of the analytical system. Corrective action documentation will illustrate tasks,
responsibilities, time frames, and will validate restoration of the process to a controlled status. Corrective
action documentation and System Improvement Forms are stored in the QA/QC Department and in
pertinent files.
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FIGURE 7
SECTION XIV
REVISION 21
EFFECTIVE DATE: 01/08/16 PAGE 14- 3
ASSESSMENTS
TASK
DOCUMENTATION
TASK COMPLETION
TIME WINDOW Balance Calibration
Secure service from Watson Bros.
Calibration Sheets,
Balance Stickers
June - July
Balance Calibration
Daily Monitoring - Two range
Balance Logbooks
Each Workday
Class S-1 Weight
Calibration
Secure service from Watson Bros.
Calibration Sheets,
Weights Sticker
March-April, every two
years Working
Thermometer Checks
Check working thermometers against a
NIST traceable thermometer
Thermometer
Calibration Log
Mercury in glass - Dial-
type-annual –
March-April Reference
Thermometer
Calibration
Secure service from Tektronix
Calibration Sheets,
Thermometer Sticker
Nov.-Dec.
Working
Thermometer
Monitoring
Daily Monitoring of refrigerators,
waterbaths, incubators, auto claves, and
ovens
Respective Logbooks
Each Workday, Each
Monday for 24 hr dial-
type thermometers for
TCLP and Walk-In
refrigerators Auto-diluter
Calibration
Gravimetric check of volume deliveries for
auto diluters
Diluter Calibration
Worksheets
March, June, Sept, Dec.
Micro-pipette
Calibration
Gravimetric check of volume deliveries of
micro-pipettes
Preparation
Logbooks/Run Logs
Each Workday
Non-Class-A
Glassware calibration
Gravimetric check of volume delivery
Weight written on the
glassware
Before use after purchase-
semi-annual if in use. Corrective Action
Audit
Secure PE samples from ERA + Absolute
Standards
PE Summary Reports
When needed
LIMS
Check for any anomalies in reporting of
results, methods, formats, etc.
Evaluate data processing, resources, and
EDD's.
Annual Internal Audit
Report
Jan-Dec
Field Services
Check for: correctness of preserved
container submittals, safety compliance,
maintenance schedules of vehicles and
other equipment. Conduct client
interviews and review SOP's and Field
documentation.
Annual Internal Audit
Report
Jan-Dec
Sales and Marketing
Review submitted bids.
Conduct client interviews.
Annual Internal Audit
Report
Jan.-Dec.
Client Services
Review the following: Project Initiation
Forms, Non-Conformance Reports and
SOPs. Conduct client interviews
Annual Internal Audit
Report
Jan.-Dec.
Non-Conformances
Review SIFs
Annual Internal
Jan.-Dec.
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ASSESSMENTS
TASK
DOCUMENTATION
TASK COMPLETION
TIME WINDOW
SIFs Report/Database Instruments Support
Equipment
Verify fitness for use
Spreadsheet
Jan.-Dec.
Login Department
Review sample receipt forms, non
conformance reports, and SOP's.
Evaluate chain of custody procedures and
sample "cradle to grave" system.
Audit the bottle preparation area.
Annual Internal Audit
Report
Jan.-Dec.
Preparation
Department
Review SOP's for conformance to method
and practice. Check and evaluate
documentation for: control charting,
preparation logs, run logs, maintenance
logs, standard and reagent logs. Evaluate
new processes.
Review System Improvement Forms.
Annual Internal Audit
Report
Jan.-Dec.
Inorganics
Department
Review SOP's for conformance to method
and practice. Check and evaluate
documentation for: control charting,
preparation logs, run logs, maintenance
logs, standard and reagent logs. Evaluate
new processes.
Review System Improvement Forms.
Annual Internal Audit
Report
Jan.-Dec.
Organics Department
Review SOP's for conformance to method
and practice. Check and evaluate
documentation for: control charting,
preparation logs, run logs, maintenance
logs, standard and reagent logs. Evaluate
new processes.
Review System Improvement Forms.
Annual Internal Audit
Report
Jan.-Dec.
Data Control
Department
Review the process and pertinent SOP's
Audit the retrieval of data
Annual Internal Audit
Report
Jan.-Dec.
Record Keeping
Review the system and pertinent SOP's.
Inspect data storage areas.
Annual Internal Audit
Report
Jan - Dec
Training
Review orientation documentation.
Obtain information of training done from
external sources.
Review attendance of internal QA/QC
Training. Check for IDC's for pertinent
personnel
Annual Internal Audit
Report,
QA/QC Outline and
Training Sheets.
Database
Attendance
External Training
Documentation
Jan.-Dec.
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ASSESSMENTS
TASK
DOCUMENTATION
TASK COMPLETION
TIME WINDOW Annual Internal Audit
Report
Complete into final form
Annual Internal Audit
Report
Nov - Dec
Supervisor or
authorized personnel
Review of standards, reagents and
maintenance log will be performed at least
in a monthly basis. Review of logbooks
for completeness, legibility purposes. All
Wet Chemistry analysis for all manual
tests review is performed in the Element as
a supervisor review. All non-manual tests
(e.g. metals) logbooks review performed
as stated above.
Annual Internal Audit
Report
Monday -- Friday
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INTERNAL ASSESSMENT SCHEDULE
FIGURE 7
SECTION XIV
REVISION 21
EFFECTIVE DATE: 01/08/16 PAGE 14- 6
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INTERNAL ASSESSMENT SCHEDULE
FIGURE 7
SECTION XIV
REVISION 21
EFFECTIVE DATE: 01/08/16 PAGE 14- 7
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QUALITY ASSURANCE PROGRAM PLAN
DATA ASSESSMENT PROCEDURES
SECTION XV
REVISION NO. 18 EFFECTIVE DATE: 03/17/16
PAGE 15-1
15.0 SCOPE
This section identifies the required concentration range and data on sensitivity (detection limits), precision, and
accuracy. Analytical data quality requirements for accuracy and precision established for each measurement
parameter will be based on (1) prior knowledge of the specific measurement system used and (2) method
validation studies employing replicate analyses, spikes, standards, recoveries, and project-specific requirements.
15.1 ACCURACY - ORGANICS AND GENERAL CHEMISTRY
Accuracy will be evaluated through the collection and analysis of matrix spike and matrix spike duplicate
(MS/MSD) samples, laboratory control samples (LCS), and by spiked samples with surrogate compounds,
where applicable. QC criteria for GC/MS analyses (surrogate recoveries, LCS recoveries, MS/MSD
recoveries and RPD) must conform to the Contract Specifications, SW-846, and CLP standards. Accuracy
is a quantitative parameter of the bias in a measurement system. Sources of error include the sampling
process, field contamination, preservation, handling, sample matrix, sample preparation, and analysis
techniques. Accuracy is calculated as follows:
! For measurements where matrix spikes are used:
%R = 100% x
S-U
Csa
%R = percent recovery
S = measured concentration in spiked aliquot
U = measured concentration in unspiked aliquot
Csa = actual concentration of spike added
MSR x y sample result sample result
spike levelx
/
100
Where: MSR = matrix spike result
x = mls of spike
y = total mls (spike + sample)
or MSR sample result * 1 x / y
spike levelx 100
Where: MSR = matrix spike result
x = mls of spike
y = mls of spike + mls of sample
! For situations where a surrogate or standard reference material (SRM) is used instead of or in addition
to matrix spikes:
%R =
C
M
Ca
x 100%
%R = percent recovery
Cm = measured concentration of SRM
Ca = actual concentration of SRM
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DATA ASSESSMENT PROCEDURES
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REVISION NO. 18 EFFECTIVE DATE: 03/17/16
PAGE 15-2
For GC and GC/MS each sample, spike, and blank will contain surrogate compounds to validate individual
sample preparation and analysis. If surrogate recoveries are not within the control limits, the following
procedure will apply. Calculations, surrogate solutions, and internal standards will be checked for errors. If
no errors are found, instrument performance will be checked. If an instrument performance problem is
identified, the problem will be corrected and the sample reanalyzed. If no instrument problem is found, the
sample will be reanalyzed if sufficient sample and time are left on holding time. If, upon reanalysis, the
recovery is again not within the designated control limits, the data will be flagged appropriately.
A matrix spike/ matrix spike duplicate pair will be prepared and analyzed along with each preparation batch
(not to exceed 20 samples per batch). The matrix spike and matrix spike duplicate samples will be spiked
with a mid-range concentration of a series of method target compounds, while a third aliquot of the sample
will be analyzed unspiked. Routine general chemistry listing will include a duplicate of the unspiked sample
(see SOP=s) Accuracy will be measured in terms of percent recovery of each MS/MSD. Analyses not
meeting the laboratory quality control criteria will be re-extracted/reanalyzed once unless it can be
documented that the failure (such as a calculation error) was not associated with the samples, or that matrix
effects were the cause and LCSs were acceptable.
Analysis of a benign matrix (ASTM Type II water, baked sand), spiked with the same solution used for
matrix spikes, is used to validate the accuracy of the analytical system under ideal matrix conditions. This
QC parameter, known as the Laboratory Control sample is a required QC sample, which is prepared and
analyzed with each batch at a frequency set per method. LCS validity is assessed through percent recoveries
compared against statistically based control limits unless general criteria has been defaulted. If any LCS
analytes are outside acceptable limits, associated sample data should be considered estimated, thus the entire
batch should be considered estimated, thus the entire batch should be reprepared and reanalyzed unless it can
be proven that effects can solely be attributed to the LCS and no other QC indicators show possible quality
compromise. If reanalysis is not feasible, data will be flagged accordingly.
15.2 ACCURACY - INORGANICS
Accuracy for Inorganics analyses will be evaluated through the collection and analysis of matrix spike
samples and laboratory control samples. QC criteria for metals analyses, will conform to standards specified
by the contract specifications, SW-846, and CLP. Matrix spikes will be prepared and analyzed along with
each preparation batch (not to exceed 20 samples per batch). The matrix spike samples will be spiked with a
mid-range concentration of the method target compounds, while an aliquot of the sample will be analyzed
unspiked. The matrix spike for Inorganics analyses will be an analytical spike - a spike of the solution being
prepared prior to the preparation procedure. Accuracy will be measured in terms of percent recovery of each
of the spiked components (as indicated in the formula for matrix spikes). MS analyses not meeting the
laboratory quality control criteria will be re-prepared/reanalyzed unless it can be discerned that the failure
was not associated with the samples (such as a calculation error) or that matrix effects were the cause and
LCSs were acceptable.
Analysis of a benign matrix (ASTM Type II water, baked sand), spiked with the same solution used for
matrix spikes, is used to validate the accuracy of the analytical system under ideal matrix conditions. This
QC parameter, known as the Laboratory Control sample is a required QC sample, which is prepared and
analyzed with each batch at a frequency set per method. LCS validity is assessed through percent recoveries
compared against statistically based control limits unless general criteria has been defaulted. If any LCS
analytes are outside acceptable limits, associated sample data should be considered estimated, thus the entire
batch should be considered estimated, thus the entire batch should be reprepared and reanalyzed unless it can
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PAGE 15-3
RPD - (C
1-C
2) x 100%
(C1 + C
2)2
be proven that effects can solely be attributed to the LCS and no other QC indicators show possible quality
compromise. If reanalysis is not feasible, data will be flagged accordingly.
Post-digestion spikes are prepared by adding a known amount of analyte to an aliquot of sample. If the
analyte concentration is below the detection limit for all samples in the batch, the sample is spiked at a
concentration equivalent to approximately 10 to 20 times the PQL. Acceptance limits for percent recovery
for the post-digestion spike are 85 to 115 percent. Failure to meet the acceptance criteria requires corrective
action, which may include dilution and respiking of the sample or reanalysis of all samples in the batch by
the method of standard addition (MSA). If dilution is performed to further reduce physical interferences, an
acceptable post-digestion spike must be performed on the diluted sample.
15.3 SENSITIVITY
Method detection limit studies will be performed annually as described in 40 CFR 136 Appendix B.
Practical quantitation limits will be determined as a concentration approximately three to five times the
standard deviation of the low level spikes used for the method detection limit study, or set at levels of
confidence as determined by our specialists. PQL levels must not exceed those levels set in respective
method references listed in section XI.
15.4 PRECISION
Precision will be evaluated through the collection and analysis of field and laboratory duplicate samples and
matrix spike duplicates. Laboratory duplicate samples not meeting quality control criteria will be re-
extracted/reanalyzed once, unless it is determined that the RPD of the reanalysis will not significantly differ
from the primary analysis. For organics analyses, failure of different matrix spike compounds to meet QC
criteria on successive runs will constitute failure and satisfy the requirement for reanalysis.
Precision is a quantitative parameter of the variability of a group of measurements compared to their average
value. Sampling precision is evaluated from field duplicate samples and analytical precision is evaluated
from matrix spike duplicate samples and split samples. Precision is calculated in terms of the relative
percent difference as follows:
Where: RPD = relative percent difference
C1 = larger of the two observed values
C2 = smaller of the two observed values
In cases where duplicate concentrations are in close proximity to detection or quantitation limits, precision
will be assessed in concentration terms. This assessment will be used in cases where the sample or the
sample duplicate concentration is less than or equal to five (5) times the PQL for the Analyte of concern.
Refer to the Method Blank assessment flowchart in Appendix D for further details.
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PAGE 15-4
Example:
PQL = 0.2 mg/L
Sample value = 0.4 mg/L
Duplicate value = 0.5 mg/L
Precision control = 0.2 (PQL)
Both 0.4 and 0.5 are less than five (5) times 0.2.
0.5 - 0.4 = 0.1 mg/L
0.1 is less than 0.2 (precision control), therefore precision requirement was met.
Laboratory duplicates will be performed for all inorganic analyses at a rate of 1 in 20 (1 for each batch up to
a maximum of 20) for soils/waters under SW-846 methodologies and 1 in 10 for waters under other
references. Precision for organics analyses may be determined by the analysis of matrix spike/matrix spike
duplicate samples at a rate of 1 in 20 (1 for each batch to a maximum of 20). RPD is based on the difference
between sample value and sample duplicate value which is a source of uncertainty measurements. In this
situation uncertainty measurement is 0.1 mg/L. The Laboratory analytical measurement uncertainty is
represented by the LCS Control Limits
15.5 There are many aspects of the sampling and analysis process which can contribute to analytical uncertainty.
The representativeness of the sample and aliquots taken from the submitted sample, the accuracy of
calibration stock solutions and dilutions made from them, the stability of the analyte within the sample
matrix and other factors which are difficult if not impossible to measure may all contribute to uncertainty of
analytical results in samples. However, within the somewhat controlled environment of the laboratory we
can use a statistical analysis of the Laboratory Control Sample (LCS) to make an estimate of the uncertainty
of a given analysis. The LCS is a clean matrix with an established Analyte concentration which is carried
through the entire preparation and testing procedure with each analytical batch of samples. Over time the
routine analysis of the LCS provides us with data with which we can estimate the uncertainty of that analysis.
After approximately 30 analyses of the LCS, the standard deviation is calculated and assuming a normal
distribution of those values, 95% of them should fall within 2 standard deviations of the mean. The
Laboratory will use a band of 2 sample standard deviations as the estimate of analytical uncertainty for any
given analysis.
The following chart of analytes and their uncertainties will be updated on an annual basis. The sample
standard deviation is calculated by taking the square root of the sum of squared deviations from the mean
divided by one less than the number of measurements. The estimate of uncertainty does not take into
account the possibility of higher or lower uncertainty based on different Analyte concentrations and many
other factors that will affect real world samples.
Analyte Method Average σn-1 Uncertainty
Benzene EPA 8260 98 3.73 7.46
1,4-Dichlorobenzene EPA 8270 81.4 7.05 14.1
1,1,1Trichloroethane EPA 624 102 4.91 9.82
1,2-Dibromoethane EPA 8260 99.2 5.15 10.3
Acetone EPA 8260 91.7 5.73 11.5
1,2-Dibromoethane TO-15 89 9.8 20
Vynyl Chloride EPA 624 95.6 5.82 11.6
1,3-Butadiene TO-15 94 7.94 16
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REVISION NO. 18 EFFECTIVE DATE: 03/17/16
PAGE 15-5
Dis Mercury EPA 7470A 102 5.04 10.0
Total Recoverable EPA 200.7 98.7 4.02 8.04
Total Iron EPA 6010 109 4.15 8.30
Total Recoverable Chromium EPA 6020 105 3.69 7.38
Dissolved Calcium EPA 200.7 101 1.93 3.86
Bromide EPA 300.0 101 4.02 8.0
Chloride EPA 300.0 103 3.03 6.0
Sulfate EAP 300.0 102 2.98 6.0
Nitrite as N EAP 353.2 102 2.82 5.6
Ortho-Phosphate EPA 365.1 102 3.47 6.94
COD EPA 410.4 100 3.3 6.6
TOC SM5310C 102 1.66 3.32
Ammonia as N EPA 350.1 104 3.83 7.66
Hexavalent Chromium EPA 7199 101 3.52 7.04
TPH-Diesel EPA-8015B 77.5 6.85 13.7
Bolstar EPA 8141A 87.9 20.3 40.6
2,3-DB EPA 8151A 81.7 16 32
15.6 LABORATORY CONTROL SAMPLE (LCS)
Acceptability of batch runs will depend heavily on the analyte recovery(s) of the LCS. (See Section 12.0 for
acceptance protocol and Appendix D for corrective logic.) Laboratory Control Sample can be matrix dependant,
but in lieu of appropriate matrix, accuracy can be validated through the recovery of the Laboratory Control Sample
Water (LCSW). The Laboratory Control Sample is a sterile sample which has been spiked and brought through the
entire analytical process.
15.7 MONITORING OF LCSW
The Laboratory Control Sample Water is the QC spiked parameter of choice to be monitored through control
charting.
15.7.1 Charting of Multi-Analyte Methods - In cases where charting organic multi-Analyte methods is not
feasible, a select subset of analytes should be identified and charted. Those analytes chosen should
represent the entire retention time range and must represent normal analytical activity or performance
(i.e. do not chart abnormally stable or unstable analytes).
15.7.2 Development of Control Charts
A minimum of 30 data points is required in order to administer statistical manipulations to a
particular QC parameter. Once at least twenty values are obtained, the standard deviation and mean
of the data set can be calculated. The mean plus or minus two sigma will define warning limits while
the mean plus or minus three sigma will represent control limits or the extremes of the acceptable
range. Please contact the QA Officer for guidance or for additional charting options.
15.7.4 Maintenance of Control Charts
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SECTION XV
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PAGE 15-6
15.7.4.1 Electronic Charting
Instrument data which is processed via Element, control limits are calculated by analyst using
QA admin in Element then select control charts. Recalculations of control limits shall be
monitored on an on-going basis (at least quarterly) for shifts in mean recovery, changes in
standard deviation, and development of trends. The recalculated limits should be submitted to
the QA/QC Department for LIMS updating.
15.7.4.2 Calculation Controls
It is important that control limits are properly calculated to correctly assessed control of the
system and to validate presence of interferences and bias.
General Rules
1 Include all recoveries unless outliers are validated.
2 If significant changes are made, reestablish control limits by initiating a new data set.
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PREVENTATIVE MAINTENANCE
SECTION XVI
REVISION NO. 13
EFFECTIVE DATE: 01/08/16
PAGE 16-1
16.0 SCOPE
Preventive maintenance is an orderly program of positive actions (equipment cleaning, lubricating, reconditioning,
adjustment and/or testing) done to prevent the failure of measurement systems or support equipment. The goal is
to ensure the analytical system is in control and to prevent any nonconformance from occurring before tasks are
initialed. Use of preventive maintenance schedules for each analytical measurement system and support equipment
type aids in the foretelling of possible problems. Documentation of preventive procedures is through Preventive
Maintenance Logs.
Preventive Maintenance Logs are maintained for all instrumentation and equipment. These logs are stored near
respective instrumentation and are maintained by responsible analysts or technicians. Figure 8 displays an example
of a preventive maintenance schedule.
16.1 GENERAL PROCEDURES
Preventive maintenance will be performed by qualified personnel. Records of repairs, adjustments, and
calibrations will be maintained and available for inspection. The records will document and state the return
to control of instruments after repair or maintenance. Periodic checks of Preventive Maintenance Logs and
schedules will be performed by department supervisors. Documentation of these checks will consist of
approval initials on pertinent logs.
If an instrument is not working properly and cannot be restored by laboratory personnel, a service call to the
manufacturer will be made. Approval of a service call must be made by the concerned department
supervisor before initiation. Documentation of each service call will be maintained in respective Preventive
Maintenance Logs.
16.2 TAGGING OUT
In cases when instrumentation or equipment is not operational, they must be labeled out of service, do not
use. A sign with the aforementioned label will be affixed to non-operational instruments or equipment by
department supervisors or the QA Officer. All out - of - calibration equipments tagged or segregated will not
be used, until they have been re-calibrated. Equipment found out - of - calibration will be repaired or
replaced. Responsibility of the removal of warning signs is designated to either department supervisors or
the QA Officer.
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PREVENTATIVE MAINTENANCE
SECTION XVI
REVISION NO. 13
EFFECTIVE DATE: 01/08/16
PAGE 16-2
16.3 GENERAL PREVENTIVE MAINTENANCE CHECKS
EQUIPMENT MONITORING
Equipment
Check Acceptance
Criteria
Frequency
Top-loading
balances
Verify accuracy with weights calibrated against
certified class-S weights
0.02 g
Daily or with each use
Analytical balances
Verify accuracy with weights calibrated against
certified class-S weights
0.0005g
Daily or with each use
Thermometers
Verify accuracy against NIST-certified thermometer,
or if purchased with certificate of traceability, check
for mercury separation daily.
+1.0C
Annually
Temporary storage
refrigerators
Verify temperature within range.
0C-6C
Daily
Long-term storage
refrigerators
Verify temperature within range.
0C-6C
Daily
Freezers
Verify temperature within range.
≤ -10C
Daily
Water baths
Verify temperature within range.
60-80C
80-90C
Daily or with each use
Ovens
Verify temperature within range.
105C2C
Daily or with each use
Fume hoods
Check fan condition and velocity.
Monthly Safety showers
Inspect for working order.
N/A
Monthly
Fire extinguishers
Pull pin in place.
Gauge reads
full.
Monthly
Eyewash stations
Inspect for working order.
N/A
Monthly
PREVENTATIVE MAINTENANCE CHECKS AND SERVICES: GAS CHROMATOGRAPH
Items to be Inspected
Probable Problem
Service Interval
Procedure (Internal)* Line fuses (GC)
Inactive GC, blown fuse
As required
Replace fuse
Splitless injector for capillary
columns heater or sensor
Failure to heat
As required
Replace heater or sensor
Injector septum in the GC
Leaks, septum bleed
Weekly, as needed
Replace as required
Injector liner
Poor chromatography, active sites
As required
Clean, inspect, or replace
as required Carrier gas connections and
couplings
Leakage
As required
Tighten or replace fittings
Carrier gas filter in GC
Poor baseline
As required
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PREVENTATIVE MAINTENANCE
SECTION XVI
REVISION NO. 13
EFFECTIVE DATE: 01/08/16
PAGE 16-3
PREVENTATIVE MAINTENANCE CHECKS AND SERVICES: GAS CHROMATOGRAPH
Items to be Inspected
Probable Problem
Service Interval
Procedure (Internal)*
Filter flow controller Dirty filter Every 3 months Replace filter Capillary column
Poor chromatography
As required
Inspect or replace as
needed Detector heater/sensor
GC not ready
As required
Replace heater or sensor
Autosampler Syringe
Poor reproducibility / leaking
Daily
Inspect or replace
* Applicable procedures are presented in the Varian or Hewlett Packard operator manual.
ROUTINE PREVENTATIVE MAINTENANCE: GC LABORATORY INSTRUMENTATION
Instrument
Routine Maintenance Performed
Frequency GC/ECD
Replace septum, check syringe
Replace injection port liner
Swab injector port with a series of 4 solvents
Every 72 hours or as needed
Every 72 hours
Every 72 hours HPLC
Column flushed with methanol
Daily
Spectrophotometer
Replace lamps
Wavelength check
6 mos
6 mos
PREVENTATIVE MAINTENANCE CHECKS AND SERVICES: MASS SPECTROMETER
Items to be Inspected
Probable Problem
Service Interval
Procedure (Internal) Glass jet separator
Obstruction or glass breakage
As required
Clean or replace
Glass jet separator ferrules
Leaks
As required
Replace
Vacuum Manifold
Gross leaks, persistent pressure due
to degassing of trapped gases in the
vacuum system, faulty CAL gas
pressure, faulty switch
As required
Inspect
Quadrapole mass analyzer
Failure to pass tune; dirty
As required
Inspect, replace or clean
Electron multiplier
Low sensitivity
As required
Replace
Vacuum pumps
Locks up
Every 3 months
Purge weekly and replace
oil Turbo pump
Dirty oil
Bimonthly
Purge weekly and replace
oil Vacuum system filter
Excessive use, dirty filter
As required
Clean and inspect
Ion source
Lack of sensitivity, irregular peak
shape, no autotune
3-6 months
Clean and inspect
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SECTION XVI
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EFFECTIVE DATE: 01/08/16
PAGE 16-4
PREVENTATIVE MAINTENANCE CHECKS AND SERVICES: GC/MS INTERFACE OVEN
Items to be Inspected
Probable Problem
Service Interval
Procedure (Internal) Capillary interface tubing
Plugged
As required
Clean, inspect, or replace
Separator divert fitting
Leakage
Every 3 months
Tighten or replace
Vacuum divert valve
Clogged
Every 3 months
Clean, inspect, or replace
PREVENTATIVE MAINTENANCE CHECKS AND SERVICES: COMPUTERS
Items to be Inspected
Problem
Service Interval
Procedure (Internal) Fan
Faulty fan rotation
As required
Inspect or replace
Output signal
Failure to boot
As required
Check and verify
Adjustable DC
Low voltage
As required
Check and verify
Disk drive
Crash
As required
Inspect or replace; check
software
ROUTINE PREVENTATIVE MAINTENANCE: GC/MS LABORATORY INSTRUMENTATION
Instrument
Routine Maintenance Performed
Frequency Volatile GC/MSs
Change septum, column maintenance, clean
injection port liner, backflush purge and trap
device, change trap.
As needed; checked each shift
Semivolatiles GC/MSs
Change septum, clean or replace injection port
liner, clean injection port, perform column
maintenance.
Every 12 hours, as needed
ROUTINE PREVENTATIVE MAINTENANCE: Inorganics Laboratory Instrumentation
Instrument
Routine Maintenance Performed
Frequency AA
Check and clean air filter.
Check cuvettes.
Check drain lines.
Daily
Daily
Daily ICP
Clean torch.
Check and clean filters.
Clean nebulizer chamber area.
Replace pump tubing.
As required, minimum weekly
As required, minimum weekly
As required, minimum weekly
As required, minimum weekly ICP-MS
Replace worn reagent tubing lines
As needed; checked daily
Autoanalyzers
Check and replace work pump tubing.
Clean platens
Wash manifolds
Clean pump roller cage
As needed
Daily
Weekly
3 months
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EFFECTIVE DATE: 01/08/16
PAGE 16-5
Clean pump fan
Lubricate pump gears
Replace redundant tubing lines
Replace lamps
Replace photomultiplier tubes
3 months
3 months
6 months
6 months
Annually Leeman
Change pump tubings
Change redundant tubing
Change sample probe
Replace optical cell
Weekly
Every 2-3 months
As needed
Monthly IC's
Conductivity
System pressure
Leak check
Regenerate level
Guard column
Sep. column
Bed support
Daily
Daily
Daily
Daily
As needed
As needed
As needed Spectrophotometer
Wavelength Checks
Every 6 months
ROUTINE PREVENTATIVE MAINTENANCE: Organic=s Laboratory
Instrument
Routine Maintenance Performed
Frequency Total organic carbon
analyzer
Change septum
Change permeater
Change pump tubing.
Check gas flow rate.
Change glass, wool and sodium hydroxide in
scrubber.
Clean dust out of electronics cabinet.
Clean sample cell on IR detector.
Empty water trap.
Monthly
Every 3 months
Daily
Daily
Monthly
Every 3 months
Semiannually
Daily IR
System check
Noise check
Clean cell windows
Daily
Daily
Monthly
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Table 8.0 Maintenance Log
DAY
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
INITIALS
DAILY
Clean Platens
Empty Waste Containers
Wipe Spills
Dispose of Sample Cups
WEEKLY
Wipe Pump Rollers
Clean Manifolds - KemWash
MONTHLY
Clean Wash Reservoir
160-200 HRS
Change Pump Tubing
400 HRS
Clean Pump Roller Cage
Clean Pump Fan
Lubricate Pump Gears
6 MONTHS
Replace Wash Res. Tubing
Replace Cart. Drain Tubing
Replace Transmission Tubing
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CORRECTIVE ACTION/QUALITY IMPROVEMENT
SECTION XVII
REVISION NO. 14
EFFECTIVE DATE: 01/08/16
PAGE 17- 1
17.0 DEFINITIONS
17.0.1 Corrective Action (CA)
A process by which a critical error is corrected in such a way as to prevent future errors of the same
nature or type.
Some examples of when to initiate corrective action:
S Calculation errors.
S Client Request.
S Out of control trend
S Significant QA/QC anomalies
S Unacceptable PE results.
S Poor curve linearity.
S Dilution error (if sample is diluted).
S Equipment malfunction.
S Improper methodology for sample matrix.
S Contamination.
S Incorrect report formatting.
S Clerical discrepancies.
S Invoicing problems.
S Field service problems.
S Inherent or chronic problems with methodology.
17.0.2 System Improvement Form (SIF)
A term used to describe a preemptive positive action or process modification, which increases the level
of quality and customer satisfaction.
17.1 Corrective Action Process
(Corrective and preventive action steps for reporting and correcting problems for non conformance
measurement or instruments)
1. Identify the problem: A problem must be identified in a clear and concise term.
2. Evaluation (Root Cause): A root cause of the problem must be determined to see whether the problem
is local or systematic.
3. Extent of Problem: Extent of the problem must be specific to the area of the problem; so that it can be
addressed appropriately.
4. Develop Action: Develop a through action plan to address the problem in question
5. Implementation of Corrective Action: A plan needs to be designed that reflect how this plan was
implemented that demonstrates the outcome of implementation.
6. Expected Completion Date: A problem expected completion date ought to be assigned
7. Evaluate of Effectiveness of Corrective Action: Develop a plan (test) to evaluate the effectiveness of
the corrective action
8. Criteria for Verification: A criteria needs to be set up in order to verify whether your action was
effective
9. Documentation: All Corrective Action must be documented for future reference
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CORRECTIVE ACTION/QUALITY IMPROVEMENT
SECTION XVII
REVISION NO. 14
EFFECTIVE DATE: 01/08/16
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PROCESS
Implement
Corrective
Action(s)
Demonstrate
correction of
the problem
Close the
corrective action
process
(documentation)
END
Identify what
went wrong
Identify the
root cause
Extent of
problem
Develop Action
Expected
Completion Date
Evaluate the
effectiveness of
Corrective Action
Please refer to Appendix D for background on initiation of analytically based corrective action.
17.1.1 Determining the Root Cause
Quality problems can be the result of complex causes. Once a problem has been identified in a
process, the potential causes need to be determined before any corrective actions are taken.
The cause and effect diagram is one of the tools that can be used to identify all of the potential causes.
The cause and effect diagram is also used to describe the relationship between the various causes of
variation. This half of the diagram is the cause side. The right side of the diagram lists the problem or
quality characteristic to be improved. This half is the effect side. The major purpose of the cause and
effect diagram is to identify the relationships that exist between each of the various causes and to
determine their overall effect on the problem.
All things vary. That is, each result or item differs to some degree from the others produced by the
process. These differences are the result of various causes in the process. Causes of variation can be
categorized as common or assignable.
Common causes of variation result from normal events operating within the process. Common causes
cannot be eliminated entirely, but their effect on the quality of items can be controlled. Assignable
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EFFECTIVE DATE: 01/08/16
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causes, on the other hand, are the result of abnormal or unnatural events in the process. Assignable
causes can be detected, corrected, and eliminated.
Common causes of variation are usually group into five major categories; people, machinery, methods,
materials, and environment.
People: Since every person is unique, individual performance and perceptions vary from one person to
the next. Even when established procedures are used to perform a specific task, no two people
perform tasks in the exact same manner. Given this, variation occurs as a result of the people involved
in the process.
Machinery (instrumentation): The performance of instrumentation and equipment used in processes
changes daily. These changes are due to mechanical functions, wear, calibration, and so on. Variation
naturally occurs as a result of equipment, instrumentation and so on.
Methods: On the surface, method of operation appears to be fairly consistent, yet differences exist.
These differences may occur between shifts, supervisors, pressures, location, and so on. The methods
used in a process are based on interpretation. Various interpretations of methods affect the variation of
the process.
Materials: The basic composition and measurements of raw materials vary. In addition the materials
delivered by various suppliers also vary. Therefore, the materials used in any process vary to some
degree.
Environment: The events that naturally make up the environment, such as organizational culture,
management, humidity, temperature, pollution, and so on, all affect the variation in the process.
When these factors are combined in a process, a certain level of variation will occur in the process.
These causes of variation are referred to as common cause variation, which cannot be entirely
eliminated.
In addition to common cause variation in the process, assignable causes may also be present.
Assignable causes of variation are the result of abnormal or unnatural events. Any factor outside the
realm of a common cause can be defined as an assignable cause.
Examples of assignable causes:
Environmental factors such as air conditioner breakdowns, power outages, or abnormally high levels
of pollution.
Measurement devices or gauge malfunctions.
Equipment malfunctions.
Whenever an attempt is made to condense or reduce the amount of time normally required doing a job
or performing a given task, variation in the process increases.
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SECTION XVII
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EFFECTIVE DATE: 01/08/16
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For the most part, both common and assignable causes of variation are present in all processes. These
combined levels of variation directly affect the quality of the items produced by the process. The
higher the level of variation, the poorer the quality. To improve quality, the variation should be
eliminated and common cause variation can be reduced by improving the process continuously.
The cause and effect diagram can be used to identify the causes of variation in the process. This information
allows you to identify the major causes of variation that can be controlled or eliminated. The net effect of
these efforts will enable you to reduce variation in the process and improve quality.
Constructing a Basic Cause-and-Effect Diagram
Step 1: Identify a problem or quality characteristic.
Once a specific problem has been identified, draw a box on the right side of the paper and write the
problem in the box.
Step 2: Draw on a line pointing to the problem identified.
After one problem has been identified, draw a perpendicular horizontal line pointing to the problem.
Step 3: Determine the major causes of the problem.
Identify the major causes of the problem that have been identified and list each major cause in a box
around the main line. Then draw an arrow pointing toward the main line.
Step 4: Determine the minor causes of the problem.
Minor causes are the causes associated with each major cause. Isolate each major cause and determine
all the factors that contribute to each major cause. Then list each minor cause around the main line.
Then draw an arrow pointing to the major cause.
Step 5: Identify the sub-causes for each minor cause.
The primary purpose of the cause and effect diagram is to illustrate the interactions among various
causes of variation in a given process. Therefore, it is necessary to break each cause down, in a step-by-
step fashion, from the most major to the most minor aspects of each cause. For example, if equipment
is listed as the major cause, a piece of equipment could be listed a minor cause; the condition of the
equipment could be a sub cause; and the measurements or characteristics or calibration could be another
sub cause. List all of the sub causes around the minor cause and draw an arrow from the sub cause to
the minor cause to illustrate their relationship.
Step 6: Review the cause-and-effect diagram.
When you review the diagram, be sure that all of the items contributing to the problem have been
identified.
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CORRECTIVE ACTION/QUALITY IMPROVEMENT
SECTION XVII
REVISION NO. 14
EFFECTIVE DATE: 01/08/16
PAGE 17- 5
17.3 DOCUMENTATION
Documentation of corrective action and quality improvement will be in the form of System Improvement
Forms (SIF) (See Figure 9), Complaint Forms and Corrective Action/Quality Improvement Reports.
17.3.1 Any person can initiate a Corrective Action and Quality Improvement measure. System Improvement
Forms are available through each department supervisor and the QA Officer. Each field on the SIF
must be completed or addressed.
Field Information
SIF # {SIF}-{Date}-{Extension}: Enter SIF-date (MM-DD-YY) - extension = 01, 02, 03.
Initiated by: Anyone can initiate.
Date: Date of initiation of the form.
Responsible party for restoring the system: Either a person or group of persons.
Non-Conformance type: Circle the category, which best describes the problem.
Work stoppage Required? Yes/No Client Notification Required? Yes/No Authorized by Date
Description/Observation of Non-Conformance/Non-Performance: Identify the problem.
Underlying Cause: Describe the root cause.
Corrective Action/Quality Improvement: Document corrective procedures or quality improvement
suggestions.
Client Notification: Company Name, Contact Name, Date Contacted
Client Code: Information can be found in the LIMS.
Project Code/Name: Information in Project checklists and Project Quotes. See Client Services
Description of how client=s work was impacted
Verification of corrective procedures: Proof that system is in control.
Comments:
Date system returned to a controlled status: Date after evidence proves system is in control.
Initials of person closing corrective action: Either the person(s) responsible for corrective action or
pertinent department supervisor.
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SECTION XVII
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SIF Processing
1. Notifying department supervisor and QA Officer. (Quality Improvement suggestions will be
discussed during supervisor meetings)
2. Close the CA/QI task (complete the SIF)
3. Submit the original SIF to the QA officer (Keep a copy)
4. SIF information is entered into a database.
17.4 CORRECTIVE ACTION/SYSTEM IMPROVEMENT FORM
A corrective action process is being implemented in a QAPP/QAPM to address issues identified in a system
and prevent the reoccurrence of similar issues. BC Laboratories, Inc. (BCL) system issues are being tracked
through corrective action/system improvement form (SIF). All corrective action issues occurred should be
handled through SIFs (customer complaint, internal audits) nonconformance of external assessments. SIFs are
tracked into SIF spreadsheet and hard copy to be filed in a binder. SIF/corrective action completion varies by
extent of the problem and main focus will be to resolve corrective action in a timely manner.
17.5 FOLLOW UP
In cases where data of questionable quality has been submitted, the client must be advised by written
notification. Research must be done to verify the scope of the problem in order to notify affected clients. The
Client Service Representative or QA Officer will be responsible for the correspondence and closure of each
matter.
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QUALITY ASSURANCE PROGRAM PLAN
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SECTION XVII
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EFFECTIVE DATE: 01/08/16
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EFFECTIVE DATE: 01/08/16
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QUALITY ASSURANCE PROGRAM PLAN
QA REPORTS TO MANAGEMENT
SECTION XVIII
REVISION NO. 8
EFFECTIVE DATE: 01/08/16
PAGE 18-1
18.0 QUALITY ASSURANCE REPORTS
Quality Assurance reports, prepared by the Quality Assurance Officer, are issued on a quarterly basis. The
purpose of these quarterly updates is to give an indication of overall laboratory performance and quality of work.
These reports contain information pertaining to the overall performance of the laboratory. Annual internal audit
reports are also completed to measure laboratory performance during the previous three month spans.
Information is gathered from internal and external audit results, control charts, monitoring programs and
supervisor/analyst interviews. Situations such as equipment malfunctions, new or updated QC techniques, revised
analytical procedures, corrective action activities, and any significant QC or performance evaluations will also be
addressed in the report. Copies of these reports are available upon request.
The QA Officer maintains a direct line of communication with upper management to relay quality related
information, therefore eliminating conflict of interest influence from concerned parties.
Note: This section was reviewed on 01/08/16 (No changes were made)
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QUALITY ASSURANCE PROGRAM PLAN
SUPPLIERS / SUBCONTRACTORS
SECTION XIX
REVISION NO. 9
EFFECTIVE DATE: 01/08/16
PAGE 19-1
19.0 SUPPLIERS
All supplies, devices and instrumentation purchased by BC Laboratories must meet requirements, set by BC
Laboratories and suppliers, as to their intended use. Methods for acceptance include:
1) Review of manufacturing process control data.
2) Source verification.
3) Receipt inspection.
4) Pre-installation and post installation testing.
5) Review of certificates and conformance.
6) Pilot runs.
Before a purchased item can be used; procurement specification, inspection and test requirements are to be
satisfied.
19.1 QUALIFICATIONS
Products of suppliers must conform to known performance standards or compare against recognized
referenceable specifications.
Standards
NIST traceable.
Certificates of Constituency.
Lot numbers.
Expiration dates.
Reagents
NIST traceable.
Certificate of Analysis (Impurity tolerances).
Lot number.
Expiration date.
Containers
Certificates of Analysis (if applicable)
Volume checks (if applicable)
Bias (acceptable for intended use)
Integrity (breakage, leaks, etc.)
Devices
Meets acceptable tolerances (manufacturer, BC Laboratories)
Secondary supply acceptable (pipette ends, tubing, etc.)
Acceptable for intended use.
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SUPPLIERS / SUBCONTRACTORS
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REVISION NO. 9
EFFECTIVE DATE: 01/08/16
PAGE 19-2
Instrumentation
Method requirements.
Manufacturer requirements.
Acceptable for intended use.
Secondary supply acceptable.
Clerical
BC Laboratories requirements for intended use.
19.2 PROCESS
Purchases are initiated by persons completing requisition forms, which can be obtained from department
supervisors. The department supervisor will review the prospective purchase and if acceptable, will
approve the purchase. When purchases are received, the department supervisor or QA/QC department will
inspect the item(s) and conduct qualification procedures. The receiving of the purchased item(s) are
confirmed by Accounts Receivable.
19.2.1 Reagent Qualification - When reagents are received, the Fitness for Use Program will initiate testing
as appropriate for the intended use of the material that may affect the quality of environmental test
for cleanliness. All testing must be verified and approved before materials can be used, unless
documentation can be produced by the manufacturer which will validate purity. For DoD ELAP
(Navy) projects no target analytes are detected above 2 the PQL.
19.2.2 Standard Qualification
Standards which have been purchased from a particular vendor for the first time will be cross
checked against the standard in use to validate its accuracy and to verify purity. The responsible
analyst will contact the Department Supervisor or the QA Officer after completion of the
comparability study. All testing must be verified and approved before standard can be used, unless
documentation can be produced by the manufacturer, which will validate purity.
19.2.3 Support Equipment Qualification
Support equipment will be checked for fitness of use through performance checks conducted by
pertinent analysts and/or the QA Officer. Conformance to manufacturer's specifications and tolerances
will be used to access fitness.
19.2.4 Instrumentation Qualification
Instrument performance will be accessed through performance evaluation sample analyses and an
MDL studies. Department supervisor with one or two analysts are trained on instrument operations
by a manufacturer's representative. Verification of fitness will be validated through an initial
demonstration of competency.
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SUPPLIERS / SUBCONTRACTORS
SECTION XIX
REVISION NO. 9
EFFECTIVE DATE: 01/08/16
PAGE 19-3
19.3 SUBCONTRACTORS
Subcontractors must meet or pass the following requirements:
1) Certification for the analytes or tests of interest.
2) PE Sample or Parallel Samples (Submitted by BC Laboratories).(if available)
3) Acceptable QAPP, SOQ and/or pertinent SOP.
4) Acceptable staff. (Experience / academics)
5) WP/WS PE sample results.
Approvals from clients must be verified before the use of a subcontract laboratory. Our clients may have
policy or project specific requirements regarding subcontractors. The DoD ELAP (Navy) policy requires
that samples be subcontracted only to other DoD ELAP (Navy) approved laboratories. The DoD ELAP
(Navy) must be advised in writing of any plans to subcontract sample. Please refer to DoD QSM version
4.2, June 2003.
All BC Laboratories certified analytical reports reference subcontract work if applicable, by flagging
subcontracted work appropriately. The original report from the subcontract lab is included in the data
deliverables package.
Subcontractors will be assessed on an annual basis by our obtaining of annual PE results conducted through
the state or reputable auditing firms, subcontractor status will be defined and maintained by the QA Officer.
Status Types: Prepared - All information acceptable, All PE samples acceptable, No associated
complaints.
Acceptable - All information acceptable, All PE samples acceptable, complaint on file.
Pending - Incomplete information and/or incomplete performance rating.
Not acceptable - Incomplete information, PE=s not acceptable.
Note: This section has been reviewed on 1/08/16 (No changes were needed
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QUALITY ASSURANCE PROGRAM PLAN
SECURITY
SECTION XX
REVISION NO. 8
EFFECTIVE DATE: 03/17/16
PAGE 20-1
20.0 SECURITY
20.1 Facility
Facility security is assured through controlled limited access and a subcontracted security monitoring system. All
doors except the front door are locked during normal daylight working hours. Facility access after the first shift via
the front entrance is controlled by LOGIN personnel or the swing shift team leader. This door is locked at 1800
hours. Entrance door in the back of the lab is equipped with a combination type lock to prevent access by
subcontractors and any undesirable. All entrances have signs posted which say "Authorized Personnel Only",
"Protected Area, No Trespassing" or "Employees Only".
A security alarm system, which is equipped with motion sensors, smoke detectors and forced entry sensors, is
maintained by Kern Securities, Inc. Initial entry and final exit of the facility is acknowledged by access code
and password. Kern Securities representatives will call the lab in cases of unusual activity.
20.2 The Perimeter
A chain link fence surrounds the back parking lot of the laboratory grounds. Both gates of the fence are
locked at 1800 hours by swing shift personnel.
20.3 Visitors
All visitors are required to sign the visitor=s log which is kept by the receptionist. Information on this log
includes the visitor's name, the time of entrance and exit from the lab, and the organization which the visitor is
affiliated. Visitors must have proper personnel protective equipment before being escorted into the operations
area.
20.4 Sample Storage
Samples are stored in refrigerators throughout the lab. Access is granted to all pertinent lab personnel.
Custody documentation is in the form of refrigerator logs which must be completely filled out prior to
receiving samples. The archive refrigerator can be used for high security sample storage. In order to access
high security samples, each employee must contact the LOGIN Supervisor or the lead sample custodian. The
employee will then be escorted to the archive refrigerator where custody procedures can take place.
Procedures are outlined in the LOGIN SOP. Custody of extracts and digests remain under preparation
technicians until these prepared items are submitted to analysts. Analysts who assume possession of extracts
and/or digests will take responsibility for the care and security of the aforementioned items. Once analyses
are completed, the analyst will initiate digest and extract storage and/or disposal procedures.
20.5 Confidential Information
20.5.1 Submission files
Maintenance of submission files is the responsibility of the Data Filing Clerk. In order to access a
submission file, an employee of the laboratory must complete custody procedures by signing an out
card. Submission files should be returned as soon as possible.
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REVISION NO. 8
EFFECTIVE DATE: 03/17/16
PAGE 20-2
20.5.2 Raw Data
Maintenance of archived raw data is the responsibility of the QA Department. In order to access raw
data, an employee of the laboratory must complete custody procedures by completing an out card.
QA personnel will retrieve the data as requested. Data should be returned as soon as possible. Raw
data remains under secured conditions in on-site sea trains and in the raw data storage room at 4116
Atlas Ct in Bakersfield.
20.6 Access and Modification of Data
Change of data must be accompanied by some form of documentation to provide an audit trail.
20.6.1 Data prior to client submittal
20.6.1.1 Bench level
Data modifications are acknowledged by following proper correction techniques:
1) Line through the data being modified
2) Record the modified information
3) Record the date of modification and initial accordingly
4) Use indelible ink
Following through the reporting process to find any potential impacts associated with the
modification(s).
20.6.1.2 Clerical Level
Follow the same correction procedures as listed under 20.6.1.1 whenever applicable.
Changes made to certified analytical reports (CARs) are tracked by the LIMS, thus when
submitting CARs to data entry for corrections, it is not necessary to acknowledge by dating
and initialing modified results. Since modified CARs must be approved by a supervisor,
the original report must accompany the modified report to illustrate change of information
prior to approval signature.
20.6.2 Submitted Data
Changes made to reported data is tracked electronically by the LIMS and clerically by the completion
of AAltered Completed Files Forms.@
20.6.2.1 Bench Level
Procedures outlined in Section 20.6.1.1 are followed. A System Improvement Form may
be initiated to document necessary corrective procedures.
20.6.2.2 Clerical Level
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SECURITY
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REVISION NO. 8
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PAGE 20-3
Modified reports are acknowledged by labeling each report as "revised" near the laboratory
sample ID. Revisions are sequentially numbered as necessary. Refer to the Data Control
SOP for more detailed procedures.
20.7 LIMS Audit Trail
All modifications to reports and processed data is tracked by the LIMS. Each morning all data changes are
printed by the LIMS Department. These records are organized and maintained by the LIMS department until
submittal to the QA department for final storage.
Note: This section has been Reviewed on 01/08/2016 (No Changes were made)
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QUALITY ASSURANCE PROGRAM PLAN
CODE OF ETHICS POLICY
SECTION XXI
REVISION NO. 8
EFFECTIVE DATE: 01/08/16
PAGE 21-1
21.0 CODE OF ETHICS
21.1 It is imperative that all staff members of BC Laboratories agree to abide to the following code of ethics.
To cooperate in elevating and maintaining the professional status of our laboratory.
To deal honestly and openly with our clients, the public and fellow employees.(Appendix B F)
To abide with all components of the Ethics and Integrity Agreement (Appendix B F) at all times.
Under no circumstances will dishonest action be tolerated at BC Laboratories, Inc. Irreparable damage can
result from dishonest acts, thus immediate termination may result for anyone falsifying data, concealing poor
data, concealing mistakes, and/or providing misleading or inaccurate information. Some examples of
falsifying data include:
Knowingly reporting inaccurate preparation and/or analysis date/times
Altering data to pass quality control requirements
Reporting data that was never properly produced
Purposefully not following known BC Laboratories, Inc. procedures
All staff members must tell the truth at all times regarding analytical and informational data. We can deal
with mistakes and isolated incidents of late and/or rejected data, but we cannot cope with acts of dishonesty
that would put the laboratory in peril.
We encourage that all staff members contact the QA Officer if any questions arise on whether or not
questionable actions are appropriate or not. Resolution may come at this level or may be handled at the
President level.
Remember that a single dishonest act can cast suspicion on the lab and everyone who works here. One lie can
lead to another which then increases exposure, thus leading to more dishonest acts. No amount of corrective
action or quality control can erase doubts of clients or potential clients after an act of deception. In our
industry, honesty and integrity are of utmost importance and our clients depend on us to produce defensible
data.
All staff members (BCL Personnel) are required to attend an Ethics training (Module D) conducted by BC
Laboratories, Inc. on an annual basis.
Additionally, all staff members must comply with the following sections involving client confidentiality and
corporate issues.
21.2 Confidential Information
Employees may become privy to confidential information (that is , information not available to the public)
concerning the affairs and business transactions of BC Laboratories, Inc. , its present and prospective
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CODE OF ETHICS POLICY
SECTION XXI
REVISION NO. 8
EFFECTIVE DATE: 01/08/16
PAGE 21-2
customers, its suppliers, its shareholders and other employees. Safeguarding confidential information is
essential to the conduct of the company=s business. Therefore, caution and discretion are required in the use
of such information. It should be shared only with those who have a legitimate or legal need to know.
Information concerning a customer may be released, with the consent of the customer involved; to third
parties, organizations, or governmental bodies that seek it. All other requests for information concerning a
customer ( other than routine credit inquiries, including requests pursuant to legal process (such as subpoenas
or court orders), must be promptly referred to the President. No information may be released, nor should the
customer involved be contacted until so authorized by the President. Failure to follow these procedures can
result in civil penalties against BC Laboratories, Inc.
21.2.1 Client Data Confidentially
During the course of daily work employees may have access to analytical results. In order to maintain
complete client confidentially; employees agree not to copy, reproduce, or communicate in any
manner these results to anyone but the party indicated on the COC unless proper approval has been
granted. Additionally any work approved to leave the laboratory or information gathered outside of
the laboratory regarding clients shall not be copied and shall be brought back to the Lab in its entirety.
Any notes, pages, or reports no longer required are to be shredded on site.
21.3 Competition
In its many business activities, the company engages in vigorous, but fair and ethical, competition.
Discussions and agreements, oral or written, with competitors concerning pricing or other competitive
practices are not permitted. Care should be taken to ensure that, in meetings of trade associations and other
industry groups, competitive practices are not discussed without prior legal clearance.
21.4 Contributions and Donations
The company=s policy regarding contributions and donations provides that disbursements of corporate funds
will be made in full compliance with all applicable laws, and that no disbursements of corporate funds will be
made, either directly or indirectly to any organization which fosters or encourages racial, religious, class or
other prejudices.
21.5 Reporting of Irregularities
Employees who become aware of known or suspected irregularities should report them promptly and
confidentially to their supervisor who is responsible for reporting for further handling by the following
organizations:
21.5.1 Internal Auditing
Is responsible for those investigations requiring account and/or auditing techniques into such matters
as embezzlement, misappropriation of company property involving the alteration of company records,
improprieties by employees and persons in contractual relations with BC Laboratories contractors,
consignees, agents, etc.....
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QUALITY ASSURANCE PROGRAM PLAN
Code of Ethics Policy
SECTION XXI
REVISION NO. 8
EFFECTIVE DATE: 01/08/16
PAGE 21-3
21.5.2 Board of Directors
Is responsible for those investigations requiring skills in the techniques of detection, interrogation and
surveillance concerning such matters as bribes, burglaries, conflicts of interest, misappropriation of
company property not involving the alteration of company records, unlawful use of confidential
information, commingling of products, sales of competitors= products under the BC Laboratories
label, threats or acts of violence/terrorism, and vandalism.
Note: This section has been reviewed on 1/08/16 (No changes were needed)
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APPENDICES
Appendix A SOP Listing
Appendix B Established MDL/PQL’s
Appendix C Employee Evaluation
Appendix D QC Logic Flow Diagrams
Appendix E Process Flow Diagrams
Appendix F Ethics and Data Integrity Agreement
Appendix G Comments (flags)
Appendix H Employee SOP Acknowledgement and Agreement
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APPENDIX A
APPENDIX A
S:\WP DOCS\WORD Doc\LAB_DOCS\QAPP\QAPPA010816
REVISED 01/22/16
PAGE A-1
SOP #
SAVED AS
TITLE
REV.
REVIEWED DATE
BCDOC002
COCR4
Chain of Custody
4
03/30/15
BCDOC004
XLOGR6
Extraction Log
6
07/27/15
BCDOC007
VOL_GCRLR6
Volatiles GC Run Log
6 01/19/16
BCDOC008
VOL_STANR5
Volatiles Standard Log
5
01/19/16
BCDOC010 DETERTCPR1 1, 2, 3 – TCP DRINKING WATER BY P & TRAP
GC/MS
1 09/25/15
BCDOC011 XREAGLOGR2 Extractions Reagent Log 2 07/27/15
BCDOD001 DODR2 Department of Defense (DOD) Compliance 2 09/15/15
BCDOE004
REAGPFR4
REAGENT PURITY/FITNESS FOR USE
4
07/27/15
BCFS001
FSGCMSR3
EPA 8020/8240/8270
3
03/23/15
BCFS002
FSSITESPR2
Site Specific Plan for Field Service
2
03/23/15
BCFS004
FSOPEXR2
SOIL SAMPLING IN OPEN EXCAVATION
2
03/23/15
BCFS006
FSMSGR3
FIELD MEASUREMENTS ON SURFACE AND
GROUNDWATER
3
03/23/15
BCFS007
FSPMWBR3
SAMPLING MONITOR WELLS WITH A BAILER
3
03/23/15
BCFS008
FSMPDWR3
SAMPLING DOMESTIC WELLS
3 03/23/15
BCFS009
FSMPLVORCR3
SAMPLING FOR VOLATILE ORGANIC
COMPOUNDS
3
03/23/15
BCFS012
FSWATLMR1
WATER LEVEL MEASUREMENT
1
03/23/15
BCFS013
FSGENIFPR2
GENERAL INSTRUCTIONS FOR FIELD
PERSONNEL
2
03/23/15
BCFS014
FSMPLCDR2
SAMPLE CONTROL AND DOCUMENTATION
2
03/23/15
BCFS015
FSMPLCPR2
SAMPLE CONTAINERS AND PRESERVATION
2
03/23/15
BCFS016
FSGHNDPSR1
GUIDE TO SAMPLING HANDLING, PACKAGING,
AND SHIPPING OF SAMPLES
1
03/23/15
BCFS017
FSGEQUIPDR1
GENERAL EQUIPMENT DECONTAMINATION
1
03/23/15
BCFS018
FSCALIFR2
CALIBRATION & MAINTENANCE OF FIELD
INSTRUMENTS USED IN MEASURING
PARAMETERS OF SURFACE AND GROUND
WATER AND SOILS
2
03/23/15
BCGEN004
ALKALSOPR7
Carbonate, Bicarbonate, Alkalinity, 310.1/SM 2320B
7
12/03/15
BCGEN005
COLOR5
Color/ 110.2/SM 2120B
5
11/30/15
BCGEN007
DSOXYGENR5
Dissolved Oxygen/360.1 SM4500-06
5
11/30/15
BCGEN009
SETTEABLR7
Settleable Solids/160.5/SM 2540
7
* 11/30/15
BCGEN010
CHLORINER6
Residual Chlorine/330.4/SM 4500-CLF
6
12/09/15
BCGEN011
ECR6
Specific Conductance (EC)9050 120.1 SM 2510B
6
11/30/15
BCGEN013
TDSR8
Total Dissolved Solids Filterable Residue 160.1/SM
2540C
8
12/09/15
BCGEN014
TURBIDITR5
Turbidity/180.1/SM 2130B
5 01/20/16
BCGEN016
WCBACTERREV13
Bacteriology
13 12/09/15
BCGEN017
BODR8
Analyte: Biochemical Oxygen 405.1 SM5210B
8
01/20/16
UNCONTROLLED COPY
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PAGE A-2
SOP #
SAVED AS
TITLE
REV.
REVIEWED DATE
BCGEN020
SULF376_1R7
Sulfide/376.1
7 11/30/15
BCGEN021
MBASR8
MBAS/EPA 425.1/ SM 5540C
8
12/18/15
BCGEN022
TSSR6
Total Suspended Solids/EPA 160.2/SM 2540 D
6 12/18/15
BCGEN024
ODOR6
Odor/EPA 140.1/SM 2150
6
12/09/15
BCGEN026
COD410_4R8
Chemical Oxygen Demand Colormetric,
Manual/410.4/SM 5220D
8
12/18/15
BCGEN033
PHREV8
PH/EPA 150.1/9040
8
12/09/15
BCGEN035
REACTSULREV7
Reactive Sulfide\\EPA Method 7.3.4.1
7
12/18/15
BCGEN039
WCTOCR15
Total Organic Carbon (TOC)/ SW 5310C/EPA 415.1
15
12/09/15
BCGEN040
SULF376_2R7
Sulfide Method 376.2
7
12/18/15
BCGEN043
160.4R5
Fixed and Volatile Solids, 160.4/SM 2540E
5
12/09/15
BCGEN044
GLASSWR6
General Glassware Washing
6
12/18/15
BCGEN046
TOTRESR4
Total Residue 160.3 SW 2540B
4
12/18/15
BCGEN048
EPA300R10
Determination of Anion in water and solid by Dionex IC
DX500/EPA 300.0
10 11/30/15
BCGEN049
EPA314R9
Perchlorate / 314.0
9
12/18/15
BCGEN050
DEWAPR2
Deionized Water Production
2
11/30/15
BCGEN051
KLORTH_365.1R5
ORTHOPHOSPHATE EPA 365.1 5 11/30/15
BCGEN052
KLHEXACROMR6
HEXAVALENT CHROME
6
11/30/15
BCGEN053
PhSOLIDR4
EPA METHOD 9040B, 9045C
4
12/09/15
BCGEN055
KLNOR5
KONELAB NITRITE NITROGEN EPA 353.2
5
01/08/16
BCGEN056
HEXCR_218_6R7
HEXAVALENT CHROMIUM EPA 218.6/7199
7
02/18/15
BCGEN057 KLNCYR7 KONELAB CYANIDE EPA 335.2/335.4/9012A 7 11/30/15
BCGEN058 SC_NO3-NR4 SMARTCHEM,NITRATE-NITRITE/EPA 353.2 4 11/30/15
BCGEN059 SC_TKN-NR5 SMARTCHEM TOTAL KJELDAHL NITROGEN 5 12/18/15
BCGEN060 SC_TOT_PR4 SMARTCHEM TOTAL PHOSHPHOROUS EPA
365.4/SM 4500-P
4 11/30/15
BCGEN061 SC_NH3-NR4 SMARTCHEM AMONIA-NITROGEN/EPA 350.1 4 01/08/16
BCGEN062 KLPHENOLR5 KONELAB TOT. Rec. PHENOLICS EPA 420.4 5 11/30/15
BCGEN063 REACTCYANR1 REACTIVE CYANIDE\\EPA METHOD 7.3.3.2 1 11/30/15
BCGEN065 METROHMR2 ELECTICAL CONDUCTIVITY, pH, ALKALINITY //
EPA 9050/120.1/SM 2510B, EPA 9040/150.1/SM
4500HB, EPA 310.1 / SM 2320B
2 11/30/15
BCGEN066 CO2_R1 Free Carbon Dioxide in Water 1 01/20/16
BCGEN067 ORP_R1 Oxidation-Reduction Potential in Water//ASTM D1498 1 01/20/16
BCGEN069 FLASHPOINTR0 Flash Point by Pensky-Martens Closed Tester/ASTM D-
93, EPA Method 1010
0 01/20/16
BCGEN070 IGNIT_EPA1030R0 IGNITABILITY OF SOLIDS-EPA Method 1030 0 04/01/15
BCGEN071 EPA300M-FATTYAR0 DETERMINATION OF ORGANIC ACIDS IN
WATER BY DIONEX IC/EPA 300.0M
0 04/20/15
BCGEN072 pHSM4500-HBR0 DETERMINATION OF ORGANIC ACIDS IN 0 12/09/15
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PAGE A-3
SOP #
SAVED AS
TITLE
REV.
REVIEWED DATE
WATER BY DIONEX IC/EPA 300.0M
BCHRC001
HUMRSR4
HUMAN RESOURCE COORDINATOR
4
11/16/15
BCLIMS001 BASR1 BATCHES AND SEQUENCE 0911 - 0913 1 06/01/15
BCLIMS002 DESR1 DATA ENTRY 0921 - 0923 1 06/01/15
BCLIMS003 BCELMCALCR3 BCELM CALCULATORS 0931 - 0932 3 06/01/15
BCLIMS004 DTSR3 DATA TOOL 0941 3 06/01/15
BCLIMS005 DRSR3 DATA REVIEW 0951 - 0955 3 06/01/15
BCLIMS006 SCSR2 SAMPLE CONTROL 1030 - 1035 2 06/01/15
BCLIMS007 BARCODER1 BAR CODE 1 06/01/15
BCLIMS008 RDSR0 Data Processing-0960-0964 0 06/01/15
BCLIMS009 EDSCLPR0 CLP REPORTING 1060-1064 0 06/01/15
BCLIMSOP LIMSOPR10 LIMS MANUAL 10 04/20/15
BCMDL001 MDL_SSR1 Lab-Wide MDL Spreadsheet use 1 12/10/15
BCMET010
HG_747015
MERCURY (Hg) // EPA 7470A/EPA 245.1
15
12/09/15
BCMET011
HG_7471R19
MERCURY (Hg) // EPA 7471 / 245.5
19
12/09/15
BCMET013
6010METALR19
Determination of Metals and Trace Elements in Water
and Waste Waters by ICP-AES 200.7/6010
19
02/18/15
BCMET025
MOISTURER3
% Moisture/ % Solids
3
04/01/15
BCMET037
6100ELANR13
EPA METHOD 200.8 USING ELAN 6100 ICP-MS 13
12/09/15
BCMET038
EPA6020R12
EPA6020
12 05/19/15
BCMGT001
MGTRO
Management Review
0
01/19/16
BCMGT002
DATAINTRO Data Integrity Policy
0
01/19/16
BCMIC001
WORKLOADR3
Assessment and Handling of new additional work
3
03/30/15
BCMIS002
WASTEDR12
Waste Disposal
12
04/02/15
BCMIS007
XROUMAINR4
Extractions Routine Maintenance
4
07/27/15
BCMIS009
SHIPPINGR9
Shipping
9
03/30/15
BCORG001
549.2R7
EPA 549.2 Diquat and Paraquat
7
01/21/16
BCORG002
515815R13
EPA 515.1, 615, 8150B, 8151
13
09/18/15
BCORG003
TPHGASB21
TPH(GA) BTEX/8015M,8020, and 8021B
21
08/20/15
BCORG004
8140R10
EPA METHOD 8140/8141/614
10
01/20/16
BCORG005
TPHFELR14
TPH(FUELS)/ EPA 8015M
14
01/19/16
BCORG006 548R6 Determination of Endothal in drinking water 6 01/19/16
BCORG008
525_2R5
Determination of Organic Compounds in Drinking
Water by Liquid-Solid Extraction and Capillary Column,
Gas Chromatography/Mass Spectrometry.
5
09/18/15
BCORG009
504R12
EPA 504.1
12 01/21/16
BCORG011
8310REV14
Polynuclear Aromatic Hydrocarbons by HPLC/EPA
8310/610
14 01/21/16
BCORG014
508R15
Organchlorine Pesticides and PCB=s by Gas
Chromatography EPA 508/608/8080/8081
15
01/20/16
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SOP #
SAVED AS
TITLE
REV.
REVIEWED DATE
BCORG016 ZHEREV7 Zero Head Space Extraction for Volatiles/EPA 1311 7 09/25/15
BCORG018
632R5
High Performance Liquid Chromatography for
Carbamate and Urea Pesticides in Wastewater/EPA 632
5
09/18/15
BCORG019
8082R14
Gas Chromatography for Polychlorinated Biphenyls
EPA 8082
14 01/21/16
BCORG020 625827R16
GC/MS for Semi-Volatiles/EPA 625/8270
16
4/14/15
BCORG025
5035R6 Closed System Purge & Trap (5035) 6
01/19/16
BCORG026
EPA1664R9
Method 1664
9
01/08/16
BCORG029
8330R10
Nitroaromatics & Nitroamines by High Perfomance
Liquid Chromatography Method 8330
10
09/18/15
BCORG040
ORGCR3
ORGANIC GLASSWARE CLEANING
3
09/25/15
BCORG042
525_2SPER3
SOLID PHASE EXTRACTION/EPA METHOD 525.2
3
04/13/15
BCORG045
8260TPHR6
EPA METHOD 8260 TPPH
6
01/06/16
BCORG047
ExprescreeningR1
Extract Pre-screening
1
09/25/15
BCORG049
624R14
EPA METHOD 624
14
07/15/15
BCORG051
8240_8260R11
EPA METHOD 8240/8260
11
08/20/15
BCORG053
8270SIMR5
EPA 8270 SIM PNA
5 09/18/15
BCORG054
524R8
EPA 524.2
8
12/07/15
BCORG055
GCMSLUFTR4
GC/MS FOR SEMI-VOLATILES//LUFT TPH
4
09/18/15
BCORG056
ORGVAPR2
MERCURY AND ORGANIC VAPOR MONITOR
ANALYSIS
2
11/16/15
BCORG057 SCREENXPLR0 SCREENING FOR EXPLOSIVES IN SOIL 0 01/21/16
BCORG058 DETERHAA5R4 DETERMINATION OF HAA5 IN WATER BY
LIQUID, LIQUID MICROEXTRACTION
4 10/16/15
BCORG059 METHETHR3 EPA 8015B Methanol-Ethanol 3 09/18/15
BCORG060 556R3 EPA METHOD 556 3 9/18/15
BCORG061 AIRTO14_15R3 AIR TESTING METHOD TO-14A AND TO-15 3 10/16/15
BCORG062 CANISTER2 CANISTER CLEANING 2 9/25/15
BCORG063 DYNAMICR0 DYNAMIC DILUTION 0 09/25/15
BCORG064 FIXGASR4 FIXED GAS ANALYSIS 4 08/20/15
BCORG065 SYRINGER1 Glass Syringe Accuracy Determination 1 9/25/15
BCORG066 SULF307.91MR1 307.91M SULFUR COMPOUNDS METHOD 1 10/16/15
BCORG067 RSK175M_R3 RSK-175 -Dissolved Gas Analysis in Water for
Methane/Ethane/Ethene
3 01/06/16
BCORG068 TO3-R1 AIR TESTING METHOD TO-3 1 08/20/15
BCORG069 AK101R1 AK 101: Determination of Gasoline Organics 1 01/19/16
BCORG070 AK102_103R2 AK102: Determination of Diesel Range Organics 2 01/19/16
BCPREP001
EX3510R15
Extractions-Waters by EPA 3510 & All Methods
15
07/27/15
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REV.
REVIEWED DATE
BCPREP002
OR3550R13
Organics Extractions - EPA 3550/Ultrasonic Extractions
All Methods
13
07/27/15
BCPREP004
3580RV10
Organics Extractions/EPA 3580//Dilution Extraction/All
Methods
10
01/21/16
BCPREP006
3010R10
Acid Digestion of Aqueous Samples and Extracts for
Total Metals for Analysis by ICP Spectroscopy/Method
3010A
10
12/09/15
BCPREP008
TCLP_EXTR2
TCLP Extraction
2
12/18/15
BCPREP009 SPLP_EXTR0 Synthetic Precipitation Leaching Procedure EPA 1312 0 11/30/15
BCPREP011 WET_EXTR2 Wet Extraction 2 01/04/16
BCPREP013
EPA9095R3
Paint Filter Liquids Test / EPA Method 9095B
3 03/16/15
BCPREP014
SPLITR6
Splitting and Refrigerating Samples
6 05/19/15
BCPREP015
3050R17
ACID DIGESTION OF SEDIMENTS, SLUDGES AND
SOILS FOR ANALYSIS OF TOTAL METALS BY ICP,
AND ICP-MS SPECTROSCOPY / METHOD 3050B
17
11/24/15
BCPREP016
SILICA-3630cR5
Silica Gel Cleanup for PAH=s\EPA 3630C
5
07/27/15
BCPREP017
2002BLOKR6
Hot Block Digestion of Water Total Recoverable Metal
Method 2002.2
6
12/18/15
BCPREP018
FREELIQDETR2
Free Liquid Determination
2
01/04/16
BCPREP019 3060AR1 EPA METHOD 3060A 1 01/04/16
BCPREP020
SILICA-3630MR1
Silica Gel Cleanup for EPA 3630 Modified
1
09/25/15
BCPREP021
EPA1320R0
METHOD 1320 MULTIPLE EXTRACTION
PROCEDURE
0
12/02/15
BCPROC001 PROCPR7 PROCUREMENT PROCESS 7 01/15/16
BCQC002
QCTHRMR19
QC - Thermometer Monitoring
19
09/15/15
BCQC005
QCFRDGR16
QC - Refrigerator Monitoring
16
09/15/15
BCQC007
QCOVENR13
QC - Oven Monitoring
13
09/15/15
BCQC008
QCBLNCR17
QC - Balance Monitoring
17
09/15/15
BCQC009
QCINTAUR8
INTERNAL AUDITS
8
09/15/15
BCQC010
QCSUVEASAR8
Supply Vendor and Analytical Subcontractor Approval
8 09/15/15
BCQC011
QCDILMONR5
QC-DILUTER MONITORING
5
09/15/15
BCQC012 QCCLPR3 CONTRACT LABORATORY PROTOCOL 3 09/15/15
BCQC013 QCEPPENDORFR0 QC - EPPENDORF PIPETTE CALIBRATION 0 01/05/16
BCREC001
RECEPTR6
RECEPTIONIST
6
03/30/15
BCSAF001
EMERGRESR9
Emergency Response and Evacuation Plan
9
03/12/15
BCSAF002
FIRPREVR2
Fire Prevention Plan
2
04/01/15
BCSAF003
RESPREVR6
Respiratory Prevention Plan
6
01/19/16
BCSAF004
LABCRAGTRCKR5
Laboratory Sample/Laboratory Waste Cradle to Grave
Tracking
5
04/01/15
BCSAF005
LABSMPCTCKR4
Laboratory Sample Cradle to Grave Tracking
4
04/01/15
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REV.
REVIEWED DATE
BCSAF006 FORKLIFTR2 FORKLIFT OPERATION & TRAINING 2 11/16/15
BCSAF007
SAFETRAINR2
SAFETY MODULE TRAINING 2 04/01/15
BCSAF008
QLFITESTR1
Qualitative Respiratory Fit Testing (QLFT)
1
11/16/15
BCSAF009
BENZAWARER0 BENZENE AWARENESS PROGRAM
0
01/19/16
BCSAF010
BLOODBPECPR0
Blood Borne Pathogen Exposure Control Plan
0
01/19/16
BCSAF011
LADDERSAFR0
Portable ladder safety 0 04/01/15
BCSAF012
H2SPROGR0
Hydrogen Sulfide (H2S) Safety Program
0
01/19/16
BCSAF013
HEATIPROGR0
HEAT AND ILLNESS PREVENTION PROGRAM
0
07/07/15
BCSAL001
SALESR2
ACCOUNTS RECEIVABLE
2
04/01/15
BCSAL002
Sales&MrkngR0
SALES AND MARKETING
0
01/21/16
BCSAM002
LOGISLR15
Sample Log-in Prep
15
03/30/15
BCSAM005
LOGISRV20
Sample Receiving
21 01/11/16
BCSAM009 EMPLTRNGR14 Employee Training 14 11/16/15
BCSER001
BOTPRER14
Bottle Prep 14
12/7/15
BCSER002
CUSTCOMMR5 Customer Communications
5
03/30/15
BCSER003
CONFIDENR4
Customer Confidentiality
4
03/30/15
BCSER004
COURIER4
Courier Service
4
03/30/15
BCSER006
COCTRACKR3
COC & Tracking
3
03/30/15
BCSER007
DATAPAKR5
Data Packing
5
03/30/15
BCSER012
BAY&NCAR2
Courier Service
2
03/30/15
BCSER013
BENCHCMR3
Customer/Project Specific Information Communications
to the Bench/Analysts Level
4
03/30/15
BCSER014
LLNLEDDR1
LLNL EDD TRANSFER
1 03/30/15
BCWOR001
WORDPROCR14
Word Processing Department
14
04/01/15
D= DRAFT * = In the process of being Review
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PREFERRED DRINKING WATER METHODS FOR METALS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-1
Please note that MDL=s change on an annual basis. Appropriate analyses are updated in Element that is affected by New
MDL study results. Please contact the QA Officer to confirm sensitivity.
SYMBOL
ANALYT
METHOD
TECHNIQUE
PQL (g/L)
MDL (g/L)
Sb
Antimony
200.8
ICP-MS
2
0.087
As
Arsenic
200.8
ICP-MS
2
0.61
Be
Beryllium
200.8
ICP-MS
1
0.14
Cd
Cadmium
200.8
ICP-MS
1
0.02
Cu
Copper
200.8
ICP-MS
2
0.35
Pb
Lead
200.8
ICP-MS
1
0.16
Hg
Mercury
200.8
ICP-MS
0.2
0.058
Hg
Mercury
245.1
CV
0.2
0.04
Ni
Nickel
200.8
ICP-MS
2
0.14
Se
Selenium
200.8
ICP-MS
2
0.23
Sn
Tin
200.8
ICP-MS
1
0.099
Tl
Thallium
200.8
ICP-MS
1
0.046
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QUALITY ASSURANCE PROGRAM PLAN
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APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-2
SYMBOL
ANALYTE
METHOD
TECHNIQUE
PQL (g/L)
MDL (g/L)
AS
Arsenic
200.7
.2
ICP
50
20
Be
Beryllium
200.7
ICP
10
0.37
Cu
Copper
200.7
ICP
10
1.8
Cr
Chromium
200.8
ICP-MS
3
0.85
Mo
Molybdenum
200.8
ICP-MS
1
0.19
Se
Selenium
200.7
ICP
100
9.9
Ag
Silver
200.8
ICP-MS
1
0.042
Tl
Thallium
200.7
ICP
100
24
V
Vanadium
200.8
ICP-MS
3
0.92
Mn
Manganese
200.8
ICP-MS
1
0.27
Co
Cobalt
200.8
ICP-MS
1
0.23
Zn
Zinc
200.8
ICP-MS
5
1.6
Ba
Barium
200.8
ICP-MS
1
0.33
Cr
Chromium
200.9
GFA
1
0.23
Cd
Cadmium
200.7
ICP
10
4
Ni
Nickel
200.7
ICP
10
1.8
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APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-3
SYMBOL
ANALYTE
METHOD
TECHNIQUE
PQL (g/L)
MDL (g/L)
Al
Aluminum
200.7
ICP
50
15
Sb
Antimony
200.7
ICP
100
14
Ba
Barium
200.7
ICP
10
1.4
Be
Beryllium
200.7
ICP
10
0.37
B
Boron
200.7
ICP
100
16
Cd
Cadmium
200.7
ICP
10
4
Ca
Calcium
200.7
ICP
50
5.9
Co
Cobalt
200.7
ICP
50
3.2
Cu
Copper
200.7
ICP
10
1.8
Cr
Chromium (3+6)
200.7
ICP
10
1.2
Cr+6
Hexavalent Chromium
7196A
Colorimetric
2
1
Fe
Iron
200.7
ICP
50
28
Mg
Magnesium
200.7
ICP
50
19
Mn
Manganese
200.7
ICP
10
3.7
Hg
Mercury
245.1
CV
0.2
.022
Mo
Molybdenum
200.7
ICP
50
5.8
Ni
Nickel
200.7
ICP
10
1.8
K
Potassium
200.7
ICP
1000
110
Ag
Silver
200.7
ICP
10
1.9
Na
Sodium
200.7
ICP
500
120
Sr
Strontium
200.7
ICP
10
0.44
Ti
Titanium
200.7
ICP
10
0.73
V
Vanadium
200.7
ICP
10
2.3
Zn
Zinc
200.7
ICP
10
6.1
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ALTERNATIVE GROUNDWATER/WASTEWATER METHODS FOR METALS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-4
SYMBOL
ANALYTE
METHOD
TECHNIQUE
PQL (g/L)
MDL (g/L)
Sb
Antimony
200.8
ICP-MS
2
0.085
As
Arsenic
200.7
ICP
50
20
Be
Beryllium
200.8
ICP-MS
1
0.22
Cu
Copper
200.8
ICP-MS
2
0.48
Mo
Molybdenum
200.8
ICP-MS
1
0.087
Se
Selenium
200.7
ICP
100
9.9
Ag
Silver
200.8
ICP-MS
1
0.075
Ba
Barium
200.8
ICP-MS
1
0.084
Cd
Cadmium
200.8
ICP-MS
1
0.09
Li
Lithium
200.8
ICP-MS
1
0.11
Cr
Chromium
200.8
ICP-MS
3
0.82
Co
Cobalt
200.8
ICP-MS
1
0.073
Mn
Manganese
200.8
ICP-MS
1 0.81
Ni
Nickel
200.8
ICP-MS
2
0.49
V
Vanadium
200.8
ICP-MS
3
0.97
Pb
Lead
200.7
ICP
50
4.1
Sn
Tin
200.7
ICP
50
4.9
Cr
Chromium
200.9
GFA
1
0.13
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APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-5
SYMBOL
ANALYTE
METHOD
TECHNIQUE
PQL (mg/kg)
MDL (mg/kg)
Al
Aluminum
6010B
ICP
5.0
1.3
Sb
Antimony
6010B
ICP
5.0
0.5
As
Arsenic
6010B
ICP
1
0.38
Ba
Barium
6010B
ICP
0.5
0.077
Be
Beryllium
6010B
ICP
0.5
0.05
B
Boron
6010B
ICP
5
0.5
Cd
Cadmium
6010B
ICP
0.5
0.5
Ca
Calcium
6010B
ICP
25
2.5
Co
Cobalt
6010B
ICP
2.5
0.25
Cu
Copper
6010B
ICP
1
0.12
Cr
Chromium (3+6)
6010B
ICP
0.5
0.06
Fe
Iron
6010B
ICP
5
3.7
Pb
Lead
6010B
ICP
2.5
0.25
Mg
Magnesium
6010B
ICP
2.5
0.77
Mn
Manganese
6010B
ICP
0.5
.05
Hg
Mercury
7471A
CV
.16
0.012
Mo
Molybdenum
6010B
ICP
2.5
0.25
Ni
Nickel
6010B
ICP
.5
0.058
K
Potassium
6010B
ICP
50
5
Se
Selenium
6010B
ICP
1
0.51
Ag
Silver
6010B
ICP
.5
0.05
Na
Sodium
6010B
ICP
25
2.5
Sr
Strontium
6010B
ICP
0.5
0.05
Ti
Titanium
6010B
ICP
0.5
0.16
Tl
Thallium
6010B
ICP
5
0.73
V
Vanadium
6010B
ICP
0.5
0.05
Zn
Zinc
6010B
ICP
2.5
0.25
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ALTERNATIVE SOIL METHODS FOR METALS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16 PAGE B-6
SYMBOL
ANALYTE
METHOD
TECHNIQUE
PQL (mg/kg)
MDL (mg/kg)
Hg
Mercury
7470A
CV
0.16
0.012
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Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-7
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER (mg/L)
SOIL
(mg/kg)
WATER (mg/L)
SOIL (mg/kg)
Alkalinity
EPA 310.1
SM2320B
Titrimetric
4.1 mg/L as
CaCO3
NA
4.1
NA
Ammonia - N (distilled)
EPA 350.1
SM4500-NH3N
Colorimetric
0.05
10
0.025
5
Ammonia - N (distilled)
EPA 350.1
SM4500-NH3N
Colorimetric
0.05
-
0.02
-
BOD
SM 5210B
EPA 405.1
Membrane
Electrode
1.0
30
1.0
30
Bromide
EPA 300.0
IC
0.1
1
0.049
0.36
Chloride
EPA 300.0
IC
0.5
5
0.037
0.33
COD
SM5220D,
EPA 410.4
Colorimetric
25
200
3.5
100
Cyanide
EPA 335.1,
EPA335.4/9010
Color - Man
0.0032
1.0
0.005
0.5
Cyanide
EPA 335.2,
EPA335.3/9012A
Color - Auto
0.005
NA
0.0032
NA
Dissolved Oxygen
EPA 360.1
SM 4500-G
Membrane
Electrode
0.5
NA
0.5
NA
EC
EPA9050/120.1
Meter
1mhos/cm
NA
1mhos/cm
NA
Fluoride
EPA 300.0
IC
0.05
0.5
0.011
0.081
Hex. Chromium
EPA 7196A
Colorimetric
0.002
1.0
0.001
0.5
MBAS
SM5540C,
EPA 425.1
Colorimetric
0.1
0.05
0.039
0.02
Nitrate - N
EPA 300.0
IC
0.1
1
0.018
0.11
Nitrate/Nitrite-N
EPA 353.2
Colorimetric
0.1
0.5
0.05
0.12
Nitrite - N
SM4500-NO3F
EPA 353.2
Colorimetric
0.05
0.5
0.01
0.12
Phenols
EPA 420.2
Colorimetric
10
0.5
5
0.25
pH
EPA 9045
EPA 9040 / 150.1
Meter
0.05
0.05
0.05
0.05
Total phosphorus
EPA 365.4
Colorimetric
0.05
10
0.02
4
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EFFECTIVE DATE 01/08/16
PAGE B-8
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER (mg/L)
SOIL
(mg/kg)
WATER (mg/L)
SOIL (mg/kg)
Ortho-Phosphate
SM4500-PF
EPA 365.1
Colorimetric
0.02
0.2
0.01
0.1
Residual Chlorine
EPA330.4 /
SM 4500cl F
Tit. DPD
0.1
NA
0.1
NA
Settleable Solids
SM2540F
EPA 160.5
IMHOFF CONE
0.1
NA
0.1
NA
Total Dissolved Solids
SM2540C
EPA 160.1
Grav.
10
NA
10
NA
Total Suspended Solids
SM2540D
EPA 160.2
Filter
0.5
NA
0.5
NA
Sulfate
EPA 300.0
IC
1
10
0.11
0.79
TKN
EPA 351.2
Colorimetric
0.2
40
0.1
20
TOC
SM5310C
EPA 415.1
Carbon Analyzer
1.0
NA
0.37
NA
Perchlorate
EPA 314.0
IC
0.004
.04
.00046
.003
Total Solids
EPA 160.3,SM2540B
Grav
10
NA
10
NA
Volatile Solids
EPA 160.4
Grav
10
NA
10
NA
Sulfide
EPA 376.1, 376.2,
SM4500S-D,E
Spectronic 20
Genesys
1
0.1
0.5
.05
Turbidity
EPA 180.1, SM2130B
Hach meter
0.1NT. Unit
NA
0.1 NT.
Units
NA
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APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-9
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
2,4-D
515/615/8151A
GC ECD
.4
.020
.012
.00098
2,4-DB
515/615/8151A
GC ECD
3
.04
.011
.002
DALAPON
515/615/8151A
GC ECD
10
.01
.58
.00058
DICAMBA
515/615/8151A
GC ECD
.08
0.002
.074
.000061
DICHLOROPROP
515/615/8151A
GC ECD
.5
0.02
.021
.00011
DINOSEB
515/615/8151A
GC ECD
.2
.007
.031
.000064
2,4,5-T
515/615/8151A
GC ECD
.09
.003
.005
.000053
2,4,5-TP
515/615/8151A
GC ECD
.07
.003
.0036
.000065
BENTAZON*
515/615/8151A
GC ECD
.8
.050
.031
.00082
PENTACHLOROPHENOL*
515/615/8151A
GC ECD
0.05
0.002
.0012
.000011
PICLORAM
515/615/8151A
GC ECD
0.05
0.003
.003
.0025
ALPHA-BHC
508/608/8080/8081A
GC ECD
0.005
.0005
.0017
.000047
HCB (HEXACHLOROBENZENE)*
508/608/8080/8081A
GC ECD
0.02
.002
.0051
.00029
BETA-BHC
508/608/8080/8081A
GC ECD
0.005
.0005
.0037
.00025
GAMMA-BHC
508/608/8080/8081A
GC ECD
0.005
.0005
.0017
.000060
DELTA-BHC
508/608/8080/8081A
GC ECD
0.005
.0005
.0009
.000076
CHLOROTHALONIL*
508/608/8080/8081A
GC ECD
0.024
------
0.05
-----
HEXACHLOROCYCLOPENTADIENE*
508/608/8080/8081A
GC ECD
0.0032
------
0.05
-----
HEPTACHLOR
508/608/8080/8081A
GC ECD
0.005
.0005
.0044
.00019
ALDRIN
508/608/8080/8081A
GC ECD
0.005
.0005
.0014
.00024
HEPTACHLOR EPOXIDE
508/608/8080/8081A
GC ECD
0.005
.0005
.0019
.00025
ENDOSULFAN I
508/608/8080/8081A
GC ECD
0.005
.0005
.0016
.000081
PP-DDE
508/608/8080/8081A
GC ECD
0.005
.0005
.0015
.000068
DIELDRIN
508/608/8080/8081A
GC ECD
0.005
.0005
.0021
.000054
ENDRIN
508/608/8080/8081A
GC ECD
0.005
.0005
.0022
.000044
ENDOSULFAN II
508/608/8080/8081A
GC ECD
0.005
.0005
.0031
.00015
PP-DDD
508/608/8080/8081A
GC ECD
0.005
.0005
.0024
.000047
ENDRIN ALDEHYDE
508/608/8080/8081A
GC ECD
0.01
.0005
.0022
.000043
ENDOSULFAN SULFATE
508/608/8080/8081A
GC ECD
0.005
.0005
.0019
.000063
PP-DDT
508/608/8080/8081A
GC ECD
0.005
.0005
.0019
.000055
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APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-10
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
METHOXYCHLOR
508/608/8080/8081A
GC ECD
0.005
.0005
.0036
.00014
KEPONE*
508/608/8080/8081A
GC ECD
0.01
.005
.016
.0025
MIREX*
508/608/8080/8081A
GC ECD
0.01
0.0005
.0016
.00026
CHLORDANE
508/608/8080/8081A
GC ECD
.5
.05
.38
.015
TOXAPHENE
508/608/8080/8081A
GC ECD
2.0
.05
.42
.0074
ALL PCB'S
508/608/8080/8082
GC ECD
0.2
0.01
0.1
0.005
TREFLAN*
508/608/8080/8081A
GC ECD
0.01
0.0005
-----
-----
AZINPHOS METHYL
8140/8141A
GC TSD
.2
.01
.055
.0019
BOLSTAR
8140/8141A
GC TSD
.2
.01
.055
.0014
CHLORPYRIFOS
8140/8141A
GC TSD
.2
.01
.024
.0008
COUMAPHOS
8140/8141A
GC TSD
.2
.01
.054
.0022
DEMETON
8140/8141A
GC TSD
.2
.01
.026
.0015
DIAZINON
8140/8141A
GC TSD
.2
.01
.044
.0006
DICHLORVOS
8140/8141A
GC TSD
.2
.01
0.07
.0062
DISULFOTON
8140/8141A
GC TSD
.5
.01
.039
.0011
ETHOPROP
8140/8141A
GC TSD
.2
.01
.025
.0008
FENSULFTHION
8140/8141A
GC TSD
.2
.01
.088
.0054
FENTHION
8140/8141A
GC TSD
.2
.01
.033
.001
MERPHOS
8140/8141A
GC TSD
.2
.01
.058
.0011
MEVINPHOS
8140/8141A
GC TSD
.2
.01
.053
.0014
NALED
8140/8141A
GC TSD
.2
.01
.072
.0017
PARATHION METHYL
8140/8141A
GC TSD
.2
.01
.074
.0021
PHORATE
8140/8141A
GC TSD
.2
.01
.041
.0006
RONNEL
8140/8141A
GC TSD
.2
.01
.067
.0016
STIROPHOS
8140/8141A
GC TSD
.2
.01
.046
.0025
TOKUTHION
8140/8141A
GC TSD
.2
.01
.032
.001
TRICHLORONATE
8140/8141A
GC TSD
.2
.01
.038
.0011
MALATHION*
8140/8141A
GC TSD
.2
.01
.063
.003
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APPENDIX B
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PAGE B-11
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
THIONAZIN*
8140/8141A
GC TSD
.2
.01
.041
.0014
HEXACHLOROCYCLOPENTADIENE
525.2
GC/MS
3
-----
1
-----
DIMETHYLPHTHALATE
525.2
GC/MS
1.0
-----
.038
-----
ACENAPHTHYLENE
525.2
GC/MS
0.1
-----
.037
-----
DIETHYLPHTHALATE
525.2
GC/MS
3.0
-----
.19
-----
FLORENE
525.2
GC/MS
2.0
-----
.029
-----
HEXACHLOROBENZENE
525.2
GC/MS
1.0
-----
.016
-----
SIMAZINE
525.2
GC/MS
.3
-----
.07
-----
ATRAZINE
525.2
GC/MS
.3
-----
.05
-----
PENTACHLOROPHENOL
525.2
GC/MS
1.0
-----
.35
-----
LINDANE
525.2
GC/MS
0.1
-----
0.039
-----
PHENANTHRENE
525.2
GC/MS
0.1
-----
.022
-----
ANTHRACENE
525.2
GC/MS
0.1
-----
.085
-----
ALACHLOR
525.2
GC/MS
0.2
-----
.13
-----
HEPTACHLOR
525.2
GC/MS
0.1
-----
.059
-----
DI-N-BUTYLPHTHALATE
525.2
GC/MS
1.0
-----
.18
-----
ALDRIN
525.2
GC/MS
0.5
-----
.039
-----
HEPTACHLOR EPOXIDE
525.2
GC/MS
0.1
-----
.055
-----
GAMMA-CHLORDANE
525.2
GC/MS
0.5
-----
0.128
-----
PYRENE
525.2
GC/MS
0.1
-----
.024
-----
ALPHA-CHLORDANE
525.2
GC/MS
0.5
-----
0.094
-----
TRANS-NANOCHLOR
525.2
GC/MS
.2
-----
.048
-----
ENDRIN
525.2
GC/MS
1
-----
.75
-----
BUTYLBENZYLPHTHALATE
525.2
GC/MS
4
-----
3.9
-----
DI(2-ETHYLHEXYL)ADIPATE
525.2
GC/MS
1.0
-----
0.250
-----
BENZ(A)ANTHRACENE
525.2
GC/MS
.2
-----
.042
-----
CHRYSENE
525.2
GC/MS
0.3
-----
.044
-----
DI(2-ETHYLHEXYL)PHTHALATE
525.2
GC/MS
4.0
-----
1.631
-----
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APPENDIX B
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EFFECTIVE DATE 01/08/16
PAGE B-12
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
BENZO(B)FLUORANTHENE 525.2 GC/MS 0.3 ----- .063 -----
BENZO(K)FLUORANTHENE
525.2
GC/MS
0.3
-----
.053
-----
BENZO(A)PYRENE
525.2
GC/MS
.1
-----
.026
-----
PERYLENE
525.2
GC/MS
0.4
-----
0.206
-----
INDENO(1,2,3-CD)PYRENE
525.2
GC/MS
0.3
-----
.028
-----
DIBENZ(A,H)ANTHRACENE
525.2
GC/MS
0.3
-----
.016
-----
BENZO(G,H,I)PERYLENE
525.2
GC/MS
0.3
-----
.034
-----
METHOXYCHLOR
525.2
GC/MS
.3
-----
.036
-----
AMINOCARB
632
HPLC UV
5
-----
1.0
-----
BARBAN
632
HPLC UV
5
-----
.71
-----
CARBARYL
632
HPLC UV
20
-----
11
-----
CARBOFURAN
632
HPLC UV
20
-----
6.4
-----
CHLORPROPHAM
632
HPLC UV
1
-----
.73
-----
DIURON
632
HPLC UV
1
-----
.3
-----
FENURON
632
HPLC UV
1
-----
.37
-----
FENURON TCA*
632
HPLC UV
2
-----
1.0
-----
FLUOMETURON
632
HPLC UV
1
-----
.8
-----
LINURON
632
HPLC UV
.5
-----
.16
-----
METHIOCARB
632
HPLC UV
5
-----
1.0
-----
METHOMYL
632
HPLC UV
5
-----
1.4
-----
MEXACARBATE
632
HPLC UV
5
-----
1.0
-----
MONURON
632
HPLC UV
.5
-----
.16
-----
NEBURON
632
HPLC UV
.30
-----
.15
-----
OXAMYL
632
HPLC UV
5
-----
.64
-----
PROPHAM
632
HPLC UV
3
-----
1.4
-----
PROPOXUR
632
HPLC UV
20
-----
8.1
-----
SIDURON
632
HPLC UV
1
-----
.35
-----
SWEP
632
HPLC UV
5
-----
1.0
-----
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APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-13
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
EDB (ETHYLENE DIBROMIDE) 504.1 GC ECD 0.01 .35 .0016 .088
DBCP (1,2-DIBROMO-3-
CHLOROPROPANE)
504.1
GC ECD
0.01
.35
.0023
.084
AR-1260
8080/8082
GC ECD
0.2
0.01
.024
.0022
AR-1254
8080/8082
GC ECD
0.2
0.01
.042
.00078
AR-1248
8080/8082
GC ECD
0.2
0.01
.025
.0012
AR-1242
8080/8082
GC ECD
0.2
0.01
.095
.0016
AR-1232
8080/8082
GC ECD
0.2
0.01
.09
.0012
AR-1221
8080/8082
GC ECD
0.2
0.01
.089
0.005
AR-1016
8080/8082
GC ECD
0.2
0.01
.048
.0027
NAPHTHALENE
610/8310
HPLC UV
1
.005
.23
.000225
ACENAPHTHYLENE
610/8310
HPLC UV
2
.05
.32
.000313
ACENAPHTHENE
610/8310
HPLC UV
3
.1
.55
.000542
FLUORENE
610/8310
HPLC UV
.4
.01
.045
.000044
PHENANTHRENE
610/8310
HPLC UV
.1
.01
.025
.000025
ANTHRACENE
610/8310
HPLC UV
.02
.001
.012
.000012
FLUORANTHENE
610/8310
HPLC UV
0.4
.02
.068
.000067
PYRENE
610/8310
HPLC UV
.6
.02
.098
.000097
BENZO(A)ANTHRACENE
610/8310
HPLC UV
.2
.01
.035
.000035
CHRYSENE
610/8310
HPLC UV
.3
.01
.029
.000028
BENZO(B)FLUORANTHENE
610/8310
HPLC UV
0.1
.06
.03
.00003
BENZO(K)FLUORANTHENE
610/8310
HPLC UV
0.2
.01
.072
.000072
BENZO(A)PYRENE
610/8310
HPLC UV
.4
.02
.031
.000031
DIBENZ(A,H)ANTHRACENE
610/8310
HPLC UV
.1
.06
.31
.0003
BENZO(G,H,I)PERYLENE
610/8310
HPLC UV
.5
.02
.11
.0001
INDENO(1,2,3-CD)PYRENE
610/8310
HPLC UV
0.2
.01
.063
.000062
N-NITROSODIMETHYLAMINE
625/8270C
GC/MS
2
0.1
.053
.038
PYRIDINE*
625/8270C
GC/MS
10
.5
.22
.0021
UNCONTROLLED COPY
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ORGANIC METHODS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-14
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
PHENOL 625/8270C GC/MS 2 0.1 .30 .057
ANILINE
625/8270C
GC/MS
5
0.2
1.8
.023
BIS(2-CHLOROETHYL)ETHER
625/8270C
GC/MS
2
0.1
.49
.049
2-CHLOROPHENOL
625/8270C
GC/MS
2
0.1
.39
.052
1,3-DICHLOROBENZENE
625/8270C
GC/MS
2
0.1
.35
.052
1,4-DICHLOROBENZENE
625/8270C
GC/MS
2
0.1
.25
.051
1,2-DICHLOROBENZENE
625/8270C
GC/MS
2
0.1
.35
.042
BENZYL ALCOHOL
625/8270C
GC/MS
2
0.1
.44
.054
2-METHYLPHENOL
625/8270C
GC/MS
2
0.1
1.3
.052
BIS(2-CHLOROISOPROPYL)ETHER
625/8270C
GC/MS
2
0.1
.57
.049
4-METHYLPHENOL
625/8270C
GC/MS
2
.2
1.4
.12
N-NITROSO-DI-N-PROPYLAMINE
625/8270C
GC/MS
2
0.1
.88
.052
HEXACHLOROETHANE
625/8270C
GC/MS
2
0.1
.29
.046
NITROBENZENE
625/8270C
GC/MS
2
0.1
.37
.046
ISOPHORONE
625/8270C
GC/MS
2
0.1
.31
.047
2-NITROPHENOL
625/8270C
GC/MS
2
0.1
.33
.047
2,4-DIMETHYLPHENOL
625/8270C
GC/MS
2
0.1
1.5
.047
BIS(2-CHLOROETHOXY)METHANE
625/8270C
GC/MS
2
0.1
1.6
.049
2,4-DICHLOROPHENOL
625/8270C
GC/MS
2
0.1
.37
.054
BENZOIC ACID
625/8270C
GC/MS
10
.5
.61
.035
1,2,4-TRICHLOROBENZENE
625/8270C
GC/MS
2
0.1
0.26
.050
NAPHTHALENE
625/8270C
GC/MS
2
0.1
.30
.047
4-CHLOROANILINE
625/8270C
GC/MS
2
0.1
.99
.037
HEXACHLOROBUTADIENE
625/8270C
GC/MS
1
0.1
.40
.050
4-CHLORO-3-METHYLPHENOL
625/8270C
GC/MS
5
0.2
.39
.053
2-METHYLNAPHTHALENE
625/8270C
GC/MS
2
0.1
.27
.056
HEXACHLOROCYCLOPENTADIENE
625/8270C
GC/MS
2
0.1
.36
.034
2,4,6-TRICHLOROPHENOL
625/8270C
GC/MS
5
0.2
.47
.071
UNCONTROLLED COPY
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ORGANIC METHODS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-15
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
2,4,5-TRICHLOROPHENOL 625/8270C GC/MS 5 0.2 .37 .063
2-CHLORONAPHTHALENE
625/8270C
GC/MS
2
0.1
.41
.059
2-NITROANILINE
625/8270C
GC/MS
2
0.1
.82
.053
DIMETHYPHTHALATE
625/8270C
GC/MS
2
0.1
.32
.061
2,6-DINITROTOLUENE
625/8270C
GC/MS
2
0.1
.48
.052
ACENAPHTHYLENE
625/8270C
GC/MS
2
0.1
.32
.058
3-NITROANILINE
625/8270C
GC/MS
2
0.1
1.6
.050
ACENAPHTHENE
625/8270C
GC/MS
2
0.1
.35
.065
2,4-DINITROPHENOL
625/8270C
GC/MS
10
0.5
.35
.022
4-NITROPHENOL
625/8270C
GC/MS
2
0.2
.35
.054
DIBENZOFURAN
625/8270C
GC/MS
2
0.1
.37
.062
2,4-DINITROTOLUENE
625/8270C
GC/MS
2
0.1
.39
.052
2-NAPHTHYLAMINE
625/8270C
GC/MS
20
3
5.3
.047
DIETHYLPHTHALATE
625/8270C
GC/MS
2
0.1
.34
.080
FLUORENE
625/8270C
GC/MS
2
0.1
.36
.044
4-CHLOROPHENYL-PHENYL ETHER
625/8270C
GC/MS
2
0.1
.33
.061
4-NITROANILINE
625/8270C
GC/MS
2
0.2
.82
.052
4,6-DINITRO-2-METHYLPHENOL
625/8270C
GC/MS
10
.5
2.5
.028
N-NITROSODIPHENYLAMINE
625/8270C
GC/MS
2
0.1
.42
.061
ALPHA-BHC
625/8270C
GC/MS
2
0.1
.42
.060
BETA-BHC
625/8270C
GC/MS
2
0.1
.46
.058
GAMMA-BHC
625/8270C
GC/MS
2
0.1
.35
.058
DELTA-BHC
625/8270C
GC/MS
2
0.1
.28
.058
HEPTACHLOR
625/8270C
GC/MS
2
0.1
.53
.046
ALDRIN
625/8270C
GC/MS
2
0.1
.47
.057
HEPTACHLOR EPOXIDE
625/8270C
GC/MS
2
0.1
.24
.060
ENDOSULFAN I
625/8270C
GC/MS
10
.2
2.3
.049
PP-DDE
625/8270C
GC/MS
3
0.1
.52
.055
UNCONTROLLED COPY
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ORGANIC METHODS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-16
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
DIELDRIN 625/8270C GC/MS 3 0.1 .52 .022
ENDRIN
625/8270C
GC/MS
2
.2
0.68
.047
ENDOSULFAN II
625/8270C
GC/MS
10
.2
1.6
.049
PP-DDD
625/8270C
GC/MS
2
0.1
.38
.052
ENDRIN ALDEHYDE
625/8270C
GC/MS
10
.5
3.6
.054
ENDOSULFAN SULFATE
625/8270C
GC/MS
3
0.1
.67
.055
PP-DDT
625/8270C
GC/MS
2
0.1
.36
.046
4-BROMOPHENYLPHENYL ETHER
625/8270C
GC/MS
2
0.1
.40
.067
HEXACHLOROBENZENE
625/8270C
GC/MS
2
0.1
.35
.064
PENTACHLOROPHENOL
625/8270C
GC/MS
10
0.2
.55
.062
PHENANTHRENE
625/8270C
GC/MS
2
0.1
.29
.070
ANTHRACENE
625/8270C
GC/MS
2
0.1
.27
.067
DI-N-BUTYLPHTHALATE
625/8270C
GC/MS
2
0.1
.40
.0088
FLUORANTHENE
625/8270C
GC/MS
2
0.1
.30
.066
BENZIDINE
625/8270C
GC/MS
20
3
4.7
1.5
PYRENE
625/8270C
GC/MS
2
0.1
.29
.060
BUTYBLENZYLPHTHALATE
625/8270C
GC/MS
2
0.1
.32
.060
BENZO(A)ANTHRACENE
625/8270C
GC/MS
2
0.1
.34
.057
3,3´-DICHLOROBENZIDINE
625/8270C
GC/MS
10
0.2
1.5
.044
CHRYSENE
625/8270C
GC/MS
2
0.1
.30
.063
BIS(2-ETHYLHEXYL)PHTHALATE
625/8270C
GC/MS
4
0.2
.98
.068
DI-N-OCTYLPHTHALATE
625/8270C
GC/MS
2
0.1
.41
.081
BENZO(B)FLUORANTHENE
625/8270C
GC/MS
2
0.1
.38
.061
BENZO(K)FLUORANTHENE
625/8270C
GC/MS
2
0.1
.47
.064
BENZO(A)PYRENE
625/8270C
GC/MS
2
0.1
.45
.053
INDENO(1,2,3-CD)PYRENE
625/8270C
GC/MS
2
0.1
.47
.075
DIBENZ(A,H)ANTHRACENE
625/8270C
GC/MS
3
0.1
.48
.058
BENZO(G,H,I)PERYLENE
625/8270C
GC/MS
2
0.1
.56
.046
UNCONTROLLED COPY
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ORGANIC METHODS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-17
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
DIESEL 8015-M GC FID 200 10 31 2.6
KEROSENE
8015-M
GC FID
200
10
51
2.2
JP-4
8015-M
GC FID
200
10
100
5
JP-5
8015-M
GC FID
200
10
100
5
JP-6
8015-M
GC FID
200
10
100
5
JP-8
8015-M
GC FID
200
10
100
5
MOTOR OIL
8015-M
GC FID
500
20
90
10
WASTE OIL
8015-M
GC FID
500
20
200
10
CRUDE OIL
8015-M
GC FID
500
20
72
4.6
STODDARD
8015-M
GC FID
200
20
100
5
HYDRAULIC OIL
8015-M
GC FID
500
20
200
10
BENZENE
602/624/8240B
GC/MS
0.5
0.005
.31
.0014
BROMODICHLOROMETHANE
601/624/8240B
GC/MS
0.5
0.005
.3
.0011
BROMOFORM
601/624/8240B
GC/MS
0.5
0.005
.27
.0023
BROMOMETHANE
601/624/8240B
GC/MS
1
.005
.49
.0019
CARBON TETRACHLORIDE
601/624/8240B
GC/MS
0.5
0.005
.31
.0018
CHLOROBENZENE
601/624/8240B
GC/MS
0.5
0.005
.26
.0011
CHLOROETHANE
601/624/8240B
GC/MS
.5
.005
.27
.0016
CHLOROFORM
601/624/8240B
GC/MS
0.5
0.005
.3
.0011
CHLOROMETHANE
601/624/8240B
GC/MS
.5
.005
.32
.0017
DIBROMOCHLOROMETHANE
601/624/8240B
GC/MS
0.5
0.005
.28
.00096
1,2-DCB
601/624/8240B
GC/MS
0.5
0.005
.27
.00091
1,3-DCB
601/624/8240B
GC/MS
0.5
0.005
.29
.0012
1,4-DCB
601/624/8240B
GC/MS
0.5
0.005
.28
.0013
1,1-DICHLOROETHANE
601/624/8240B
GC/MS
0.5
0.005
.3
.0012
1,2-DICHLOROETHANE
601/624/8240B
GC/MS
0.5
0.005
.26
.00099
1,1-DICHLOROETHENE
601/624/8240B
GC/MS
0.5
0.005
.32
.0017
1,2-DICHLOROETHENE (TOTAL)
601/624/8240B
GC/MS
.1
.01
.58
.0029
UNCONTROLLED COPY
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ORGANIC METHODS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-18
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
1,2-DICHLOROPROPANE 601/624/8240B GC/MS 0.5 0.005 .26 .00079
CIS-1,3-DICHLOROPROPENE
601/624/8240B
GC/MS
0.5
0.005
.27
.00085
TRANS-1,3-DICHLOROPROPENE
601/624/8240B
GC/MS
0.5
0.005
.24
.0011
ETHYLBENZENE
602/624/8240B
GC/MS
0.5
0.005
.27
.0013
METHYLENE CHLORIDE
601/624/8240B
GC/MS
1
0.01
.24
.0024
1,1,2,2-TETRACHLORETHANE
601/624/8240B
GC/MS
0.5
0.005
.26
.0013
TETRACHLOROETHENE (PCE)
601/624/8240B
GC/MS
0.5
0.005
.3
.0013
TOLUENE
602/624/8240B
GC/MS
0.5
0.005
.29
.0012
1,1,1-TRICHLOROETHANE
601/624/8240B
GC/MS
0.5
0.005
.3
.0012
1,1,2-TRICHLOROETHANE
601/624/8240B
GC/MS
0.5
0.005
.24
.0012
TRICHLOROETHENE (TCE)
601/624/8240B
GC/MS
0.5
0.005
.29
.0013
TRICHLOROFLUOROMETHANE
601/624/8240B
GC/MS
0.5
0.005
.29
.0017
VINYL CHLORIDE
601/624/8240B
GC/MS
.5
.005
.31
.0021
XYLENES (TOTAL)
602/624/8240B
GC/MS
.5
0.01
.78
.0037
TRIHALOMETHANES (TOTAL)
601/624/8240B
GC/MS
2
.02
1.2
.0054
ACETONE*
624/8240B
GC/MS
10
.02
6.2
.015
2-BUTANONE*
624/8240B
GC/MS
10
0.2
1.45
0.0084
METHYL ISOBUTYL KETONE*
624/8240B
GC/MS
10
0.05
3.4
0.0064
ACRYLAMIDE*
624/8240B
GC/MS
50
0.05
-----
-----
ACROLEIN*
624/8240B
GC/MS
20
0.05
3.7
.00048
ACROLONITRILE*
624/8240B
GC/MS
50
.02
2
.0062
ETHANOL*
624/8240B
GC/MS
250
1
57
.13
METHYL-T-BUTYL ETHER*
624/8240B
GC/MS
0.5
0.005
0.13
0.0012
BENZENE
524.2/8260B
GC/MS
0.5
0.005
.12
.0014
BROMOCHLOROMETHANE
524.2/8260B
GC/MS
0.5
0.005
.18
.0009
BROMODICHLOROMETHANE
524.2/8260B
GC/MS
0.5
0.005
0.13
.0011
BROMOFORM
524.2/8260B
GC/MS
0.5
0.005
.22
.0023
BROMOMETHANE
524.2/8260B
GC/MS
1.0
0.005
.31
.0019
UNCONTROLLED COPY
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ORGANIC METHODS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-19
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
CARBON TETRACHLORIDE 524.2/8260B GC/MS 0.5 0.005 .089 .0018
CHLOROBENZENE
524.2/8260B
GC/MS
0.5
0.005
.11
.0011
CHLOROETHANE
524.2/8260B
GC/MS
0.5
0.005
.12
.0016
CHLOROFORM
524.2/8260B
GC/MS
0.5
0.005
.098
.0011
CHLOROMETHANE
524.2/8260B
GC/MS
0.5
0.005
.14
.0017
DIBROMOCHLOROMETHANE
524.2/8260B
GC/MS
0.5
0.005
.12
.00096
1,2-DCB
524.2/8260B
GC/MS
0.5
0.005
.13
.00091
1,3-DCB
524.2/8260B
GC/MS
0.5
0.005
.14
.0012
1,4-DCB
524.2/8260B
GC/MS
0.5
0.005
.12
.0013
1,1-DICHLOROETHANE
524.2/8260B
GC/MS
0.5
0.005
.11
.0012
1,2-DICHLOROETHANE
524.2/8260B
GC/MS
0.5
0.005
.098
.00099
1,1-DICHLOROETHENE
524.2/8260B
GC/MS
0.5
0.005
.12
.0017
CIS-1,2-DICHLOROETHENE
524.2/8260B
GC/MS
0.5
0.005
.11
.0014
TRANS-1,2-DICHLOROETHENE
524.2/8260B
GC/MS
0.5
0.005
.14
.0015
1,2-DICHLOROPROPENE
524.2/8260B
GC/MS
0.5
0.005
.11
.00079
CIS-1,3-DICHLOROPROPENE
524.2/8260B
GC/MS
0.5
0.005
.086
.00085
TRANS-1,3-DICHLOROPROPENE
524.2/8260B
GC/MS
0.5
0.005
.11
.0011
ETHYLBENZENE
524.2/8260B
GC/MS
0.5
0.005
.13
.0013
METHYLENE CHLORIDE
524.2/8260B
GC/MS
1
0.01
.16
.0024
1,1,2,2-TETRACHLORETHANE
524.2/8260B
GC/MS
0.5
0.005
.22
.0011
TETRACHLOROETHENE (PCE)
524.2/8260B
GC/MS
0.5
0.005
0.11
.0013
TOLUENE
524.2/8260B
GC/MS
0.5
0.005
.12
.0012
1,1,1-TRICHLOROETHANE
524.2/8260B
GC/MS
0.5
0.005
.27
.0012
1,1,2-TRICHLOROETHANE
524.2/8260B
GC/MS
0.5
0.005
.12
.0012
TRICHLOROETHENE (TCE)
524.2/8260B
GC/MS
0.5
0.005
.13
.0013
TRICHLOROFLUOROMETHANE
524.2/8260B
GC/MS
0.5
0.005
.14
.0017
VINYL CHLORIDE
524.2/8260B
GC/MS
0.5
0.005
.14
.0021
XYLENES (TOTAL)
524.2/8260B
GC/MS
1
0.01
.33
.0037
UNCONTROLLED COPY
BC LABORATORIES, INC.
QUALITY ASSURANCE PROGRAM PLAN
ORGANIC METHODS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-20
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
TRIHALOMETHANES (TOTAL) 524.2/8260B GC/MS 2 .02 .47 .0054
2,2-DICHLOROPROPANE
524.2/8260B
GC/MS
0.5
0.005
.14
.0013
1,1-DICHLOROPROPANE
524.2/8260B
GC/MS
0.5
0.005
.11
.0015
1,2-DIBROMOETHANE
524.2/8260B
GC/MS
0.5
0.005
.13
.0011
1,1,1,2-TETRACHLOROETHANE
524.2/8260B
GC/MS
0.5
0.005
.19
.0013
STYRENE
524.2/8260B
GC/MS
0.5
0.005
.15
.0012
ISOPROPYLBENZENE
524.2/8260B
GC/MS
0.5
0.005
.15
.0014
1,2,3-TRICHLOROPROPANE
524.2/8260B
GC/MS
1
0.005
.42
.0026
N-PROPYLBENZENE
524.2/8260B
GC/MS
0.5
0.005
.11
.0012
BROMOBENZENE
524.2/8260B
GC/MS
0.5
0.005
.09
.0008
O-CHLOROTOLUENE
524.2/8260B
GC/MS
0.5
0.005
0.15
.00091
P-CHLOROTOLUENE
524.2/8260B
GC/MS
0.5
0.005
.16
.0011
1,3,5-TRIMETHYLBENZENE
524.2/8260B
GC/MS
0.5
0.005
.093
.0015
T-BUTYLBENZENE
524.2/8260B
GC/MS
0.5
0.005
.097
.0013
1,2,4-TRIMETHYLBENZENE
524.2/8260B
GC/MS
0.5
0.005
.14
.0012
SEC-BUTYLBENZENE
524.2/8260B
GC/MS
0.5
0.005
0.12
.0013
P-ISOPROPYL TOLUENE
524.2/8260B
GC/MS
0.5
0.005
0.12
.0014
N-BUTYLBENZENE
524.2/8260B
GC/MS
0.5
0.005
.19
.0015
1,2,4-TRICHLOROBENZENE
524.2/8260B
GC/MS
0.5
0.005
.18
.0015
HEXACHLOROBUTADIENE
524.2/8260B
GC/MS
0.5
0.005
.31
.0017
1,2,3-TRICHLOROBENZENE
524.2/8260B
GC/MS
0.5
0.005
.19
.0012
NAPHTHALENE
524.2/8260B
GC/MS
0.5
0.005
.27
.0013
BENZENE
8020/8021B
GC PID
0.3
0.005
.033
.00074
TOLUENE
8020/8021B
GC PID
0.3
0.005
.047
.00098
ETHYL-BENZENE
8020/8021B
GC PID
0.3
0.005
.033
.00087
XYLENES (TOTAL)
8020/8021B
GC PID
.6
0.01
.12
.0031
MTBE*
8020/8021B
GC PID
1
.02
.033
.00065
Oil and Grease
EPA 1664
Grav.
5
50
1.9
27
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ORGANIC METHODS
APPENDIX B
Revision 8
EFFECTIVE DATE 01/08/16
PAGE B-21
ANALYTE
METHOD
TECHNIQUE
PQL
MDL
WATER
(g/L)
SOIL (mg/kg)
WATER (g/L)
SOIL (mg/kg)
TPH-GASOLINE
8015-M
GC FID
50
1
9.3
0.1
HMX
8330
HPLC
5
.5
.53
.097
RDX
8330
HPLC
5
.5
.29
.14
1,3,5-Trinitrobenzene
8330
HPLC
5
.5
.47
.086
1,3-Dinitrobenzene
8330
HPLC
5
.5
.34
.089
Tetryl
8330
HPLC
5
.5
.98
NA
Nitrobenzene
8330
HPLC
5
.5
.48
.21
2,4,6-Trinitrotoluene
8330
HPLC
5
.5
.71
.13
4-Amino-2,6-Dinitrotoluene
8330
HPLC
5
.5
.8
NA
2,4-Dinitrotoluene
8330
HPLC
5
.5
.38
.032
2,6-Dinitrotoluene
8330
HPLC
5
.5
1.2
NA
2-Nitrotoluen
8330
HPLC
5
.5
1.1
NA
3-Nitrotoluene
8330
HPLC
5
.5
1.2
NA
4-Nitrotoluene
8330
HPLC
5
.5
.62
NA
* ALL COMPOUNDS THAT HAVE AN ASTERISK BESIDE THEM ARE NOT NORMALLY RUN BY THIS METHOD BUT CAN
BE UPON REQUEST.
Note: Appropriate analyses are updated in element with new MDL study result.
Note: Appendix B has been Reviewed on 01/08/2016 (No Changes were made)
MDL’S listed in this Appendix B may not be the current MDL’S. Please contact
BC Labs to confirm sensitivity.
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APPENDIX C
APPENDIX C Rev. 5 EFFECTIVE DATE 01/08/16 PAGE 1
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APPENDIX C
APPENDIX C Rev. 5 EFFECTIVE DATE 01/08/16 PAGE 2
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APPENDIX C
APPENDIX C Rev. 5 EFFECTIVE DATE 01/08/16 PAGE 3
Note: Appendix C was review on 01/08/16 (No changes were made)
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-1
Analyze initial calibration standards
r> or = to 0.995?Please note that r should be
>0.999.
Initiate Corrective
Action
Options
Recalibrate,Reanalyze the standard(s) which adversely affect linearity, Prepare new standards,Correct instrumentation malfunctions,Calibrate at a more appropriate level,Notify Supervisor
No
Continue analytical run
Analyze the ICV
ICV % recovery within 90-110%
window?
Initiate Corrective
Action
Options
Recalibrate, Prepare new standard(s),Correct instrumentation malfunctions,Notify Supervisor
No
Yes
Yes
Initial Calibration Logic for Continuous Flow, IC, Ion Specific,
TOC and Manual Spectrometer Methods
Calculate the correlation coefficient
(r)
Reanalyze the ICVICV % recovery within 90-110%
window?
No
yes
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-2
Analyze at least five calibration standards at different concentration
levels
%RSD < or = 15 for all analytes?
Analyze the ICV
±30%diff or ±30%drift criteria
met?
Continue the run
Reanalyze the standard(s) which adversely affect
linearity and recalculate %RSD.
%RSD criteria met for all analytes?
Initiate Corrective Procedures
(SIF)Options
Prepare new standards,Correct instrumentation malfunctions,
Consult Supervisor,Review SOP,
Review calculations,Check maintenance log for a record
on replacement components
No
Yes
Yes
Reanalyze the ICV %diff criteria met?
Initiate Corrective
Action(SIF)
No
Yes
No
Options
Verify standards,Generate a new initial calibration
curve,Correct instrument malfunctions,
Consult the supervisor,Prepare new standards,
Check for calculation errors,Reevaluate instrument setup,
Consult the SOP
Initial Calibration Logic for GC/MS Methods
Create a least squares linear regression model
for the analyte which does not meet linearity
protocols.Do not force zero.
Calculate the mean RSD using all RSD values for all analytes of the
curve or go directly to *.
Mean RSD < 15%?
r > 0.99?
Notify the client by adding a comment
which states that there is greater uncertainty for analytes of which the %RSD is greater
than 15.
Create a quadratic or or 3rd order polynomial
regression model Do Not Force Zero
Please note:Quadratic curve: 6 standards
3rd order polynomial curve: 7 standards
COD > 0.99?
Yes
No
Yes
No
Yes
Quantitation must take
place within calibration
range.
No
Yes
Quantitation must take
place within calibration
range.
No
SPCC and CCC criteria met?
Yes
Corrective Action is required
No
*
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-3
Analyze initial calibration standard(s)
after profiling the instrument.
Is the RSD < or = to 3% for all analytes of interest?
Initiate Corrective
Action
Options
Re-profile,Reanalyze the standard(s), Correct instrumentation malfunctions,Notify Supervisor
No
Continue analytical run
Analyze the CCV standard(s).
ICV % recovery within 95-105% window?
Initiate Corrective
Action
Options
Recalibrate, Prepare new standard(s),Correct instrumentation malfunctions,Notify Supervisor
No
Yes
Yes
Initial Calibration Logic for ICP Methods
Check the RSD of the 4 integrations for
analytes of interest.
Reanalyze the ICV ICV % recovery within 95-105% window?
No
yes
Analyze the ICV standard(s).
CCV % recovery within 90-110% window? Reanalyze the CCV CCV % recovery within
90-110% window?
Yes
No
Initiate Corrective
Action
Options
Recalibrate, Prepare new standard(s),Correct instrumentation malfunctions,Notify Supervisor
No
If instrument was re-profiled
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-4
Analyze at least five calibration standards at different concentration
levels
%RSD < or = 20 for all analytes?
Analyze the ICV
±15%diff or ±15%drift criteria
met?
Continue the run
Reanalyze the standard(s) which adversely affect
linearity and recalculate %RSD.
%RSD criteria met for all analytes?
Initiate Corrective Procedures
(SIF)Options
Prepare new standards,Correct instrumentation malfunctions,
Consult Supervisor,Review SOP,
Review calculations,Check maintenance log for a record
on replacement components
No
Yes
Yes
Reanalyze the ICV %diff criteria met?
Initiate Corrective
Action(SIF)
No
Yes
No
Options
Verify standards,Generate a new initial calibration
curve,Correct instrument malfunctions,
Consult the supervisor,Prepare new standards,
Check for calculation errors,Reevaluate instrument parameter
setup,Consult the SOP
Initial Calibration Logic for GC/HPLC Methods
Create a least squares linear regression model
for the analyte which does not meet linearity
protocols.Do not force zero.
Calculate the mean RSD using all RSD values for all analytes of the
curve.
Mean RSD < 20%?
r > 0.99?
Notify the client by adding a comment
which states that there is greater uncertainty for analytes of which the %RSD is greater
than 20.
Create a quadratic or or 3rd order polynomial
regression model Do Not Force Zero
Please note:Quadratic curve: 6 standards
3rd order polynomial curve: 7 standards
COD > 0.99?
Yes
No
Yes
No
Yes
Quantitation must take
place within calibration
range.
No
Yes
Quantitation must take
place within calibration
range.
No
If time permits, you may
not choose to follow the
proceeding steps.
Notify the department
supervisor or the team
leader before proceeding
Optional ProcessPlease contact the Department Supervisor
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-5
Analyze continuing calibration verification
standard
±20%diff or ±20%drift criteria met?
Generate a new initial calibration
curve
Correctinstrumentation malfunctions as necessary,
Consult Supervisor, as necessary,
Yes
Continue analytical run
GC/MS Continuing Calibration Logic
Use professional judgement in the assessment of continuing the run.Contact the department supervisor for guidance and/or approval.
Calculate the mean %diff or
mean %drift of all analytes in the
curve
Mean %diff or %drift <20?
No
Were there any detections for analytes that failed %diff/%drift criteria in any environmental or
QC sample?
Reanalyze the samples with constituency
between two(2) CCVs that are compliant for
the analytes of interest.
Flag the PQLs for low recovered analytes.
Flag - V11
NoWere any CCV
analyte recoveries low?
Yes
Yes
No
Yes
Option: If no hits were detected
in any samples and the
recoveries for analytes in
the CCV outside the ±20%
window are high, you may
continue the run.
General RulesDo not make any system modifications prior to analyzing any CCV.
CCVs should be analyzed once every twelve hours prior to sample analysis.
An ICV may be used as the initial CCV after a new set of calibration standards.
CCVs are incremented until a new curve has been approved. (ex. CCV1, CCV2, etc.)
If adverse conditions are known or suspected at any time during the analytical run, analysts should reanalyze samples during the time of adverse conditions even if CCV(s) are compliant.
Reanalyze the CCV
SPCC and CCC criteria met?
Yes
SPCC and CCC criteria met?Yes
No
Evaluate the %diff/%drift for non-CCCs
No
No
Use professional judgement in the assessment of continuing the run.Contact the department supervisor for guidance and/or approval.
If not feasible, flag data PQL-9G or add a comment which denotes calibration status related to the sample of interest.
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-6
Analyze continuing calibration verification
standard
±15%diff or ±15%drift criteria met?
Initiate Corrective
Action
Options
Generate a new initial calibration curve
Prepare new standards,Correct instrumentation malfunctions,
Consult Supervisor,See SOP,
Qualify data if necessary
No
Yes
Continue analytical run
GC/HPLC Continuing Calibration Logic
Use professional judgement in the assessment of continuing the run.Contact the department supervisor for guidance and/or approval.
Calculate the mean %diff or
mean %drift of all analytes in the
curve
Mean %diff or %drift <15?
No
Were there any detections for analytes that failed %diff/%drift criteria in any environmental or
QC sample?
Reanalyze the samples with constituency
between two(2) CCVs that are compliant for
the analytes of interest.
Flag the PQLs for low recovered analytes.
Flag - V11
NoWere any CCV
analyte recoveries low?
Yes
Yes
No
Yes
Option: If no hits were detected
in any samples and the
recoveries for analytes in
the CCV outside the ±15%
window are high, you may
continue the run.
General RulesDo not make any system modifications prior to analyzing any CCV.
CCV frequency is ten(10) percent. CCVs must be analyzed before and after every ten samples or less. Samples are defined as any aliquot injected into the instrument other than a calibration standard used in the calibration curve, ICV, ICB, CCV, CCB, or IB.
An ICV may be used as the initial CCV after a new set of calibration standards.
CCVs are incremented until a new curve has been approved. (ex. CCV1, CCV2, etc.)
If adverse conditions are known or suspected at any time during the analytical run, analysts should reanalyze samples during the time of adverse conditions even if CCV(s) are compliant.
Reanalyze the CCV
±15%diff or ±15%drift
criteria met?Yes
No
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-7
Analyze the continuing calibration verification
standard
%recovery within acceptable limits and
%RSD <5%?
Initiate Corrective
ActionCCV analysis is not
acceptable.Previous samples
must be reanalyzed.
Some Options
Recalibrate, verify calibration and analyze samples associated
with the incompliant CCV.
Reanalyze the CCV, if compliant, reanalyze all samples associated
with the incompliant CCV.
Prepare new standards,
Correct instrumentation malfunctions,
Consult Supervisor,
Qualify data if necessary, the supervisor must be infomed in
cases of qualifying data
No
Yes
Continue analytical runResults are acceptable
Continuing Calibration Logic for ICP
Methods
Reanalyze the CCV
Please note that no special modifications should be made to the instrument or CCV standard prior to the analysis of any CCV
which is used to validate prior samples.
CCV frequency is ten(10) percent. CCVs must be analyzed before and after every ten samples or less. Samples are defined as
any aliquot other than calibration standards, an ICV, ICB, CCV or CCB
Results of samples which were associated with an incompliant CCV are considered estimated at best. Please consult the
department supervisor in cases of reporting results with associated incompliant CCV(s).
If adverse conditions are known at any time during an analytical run, analysts should reanalyze samples during the time of
adverse conditions even if CCV(s) are compliant.
All samples following the last acceptable CCV must be reanalyzed.
Yes
%recovery within acceptable limits and %RSD
<5%?
No
Were any samples analyzed between the
incompliant and compliant CCVs?
Reanalyze all samples between
two acceptable CCVs
No
Yes
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-8
Analyze the continuing calibration verification
standard
%recovery within acceptable limits?
Initiate Corrective
ActionCCV analysis is not
acceptable.Previous samples
must be reanalyzed.
Some Options
Recalibrate, verify calibration and analyze samples associated
with the incompliant CCV.
Reanalyze the CCV, if compliant, reanalyze all samples associated
with the incompliant CCV.
Prepare new standards,
Correct instrumentation malfunctions,
Consult Supervisor,
Qualify data if necessary, the supervisor must be informed in
cases of qualifying data
No
Yes
Continue analytical runResults are acceptable
Continuing Calibration Logic for Continuous
Flow, IC, TOC, Ion Specific, and Manual
Spectrometer Methods
Reanalyze the CCV
Please note that no special modifications should be made to the instrument or CCV standard prior to the analysis of any CCV which is used to
validate prior samples.
CCV frequency is ten(10) percent. CCVs must be analyzed before and after every ten samples or less. Samples are defined as any aliquot other than
a calibration standard used in the calibration curve, ICV, ICB, CCV or CCB.
Results of samples which were associated with an incompliant CCV are considered estimated at best. Please consult the department supervisor in
cases of reporting results with associated incompliant CCV(s).
If adverse conditions are known at any time during an analytical run, analysts should reanalyze samples during the time of adverse conditions even
if CCV(s) are compliant.
All samples following the last acceptable CCV must be reanalyzed.
No
%recovery within acceptable limits?
Reanalyze all samples between two
acceptable CCVs.
Were any samples analyzed between the
incompliant and compliant CCVs?
Yes
Yes
No
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-9
Analyze the continuing calibration verification
standard
%recovery within acceptable limits and %RSD(if applicable)
<10%?
Initiate Corrective
ActionCCV analysis is not
acceptable.Previous samples
must be reanalyzed.
Some Options
Recalibrate, verify calibration and analyze samples associated
with the incompliant CCV.
Reanalyze the CCV, if compliant, reanalyze all samples associated
with the incompliant CCV.
Prepare new standards,
Correct instrumentation malfunctions,
Consult Supervisor,
Qualify data if necessary, the supervisor must be infomed in
cases of qualifying data
No
Yes
Continue analytical runResults are acceptable
GFAA, AA, CV and GHAA Continuing
Calibration Logic
Reanalyze the CCV
Please note that no special modifications should be made to the instrument or CCV standard prior to the analysis of any CCV
which is used to validate prior samples.
CCV frequency is ten(10) percent. CCVs must be analyzed before and after every ten samples or less. Samples are defined as
any aliquot other than calibration standards, an ICV, ICB, CCV or CCB
Results of samples which were associated with an incompliant CCV are considered estimated at best. Please consult the
department supervisor in cases of reporting results with associated incompliant CCV(s).
If adverse conditions are known at any time during an analytical run, analysts should reanalyze samples during the time of
adverse conditions even if CCV(s) are compliant.
All samples following the last acceptable CCV must be reanalyzed.
Yes
If instrument reslope was performed before CCV analysis;Is the absolute value of the reslope blank absorbance
greater than the PQL standard absorbance?
Yes
Hg by CV technique?
No
No
%recovery within acceptable limits and
%RSD(if applicable) <10%?
No
Were any samples analyzed between the
incompliant and compliant CCVs?
Were any samples analyzed between the
incompliant and compliant CCVs?
Reanalyze all samples between
two acceptable CCVs
Yes
No
Yes
Yes
No
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-10
Prepare an analytical batch
Are recoveries within acceptable
limits?
Continue analysis of the analytical batch
Initiate Corrective Procedures
Reanalyze the Laboratory Control
Sample
Analyze the Laboratory Control Sample
Within acceptable limits?
Yes
No
Yes
Corrective Action Logic for Laboratory Control
Samples
Check prior position runs,Check for carryover,Check instrumentation, Check calibration, (sensitivity, linearity, etc.),Check spike soln. (integrity, conc.),Check dilution scheme,Look for contamination sources,Check digestion/extraction logother
Initiate Quality
Improvement form,
Check for reagent bias,Check glassware cleaning procedures,Check for cross contamination possibilities,Check the source standard,Evaluate the preparation procedure,Validate calibration,Review SOP
See Dept Supervisor, QA Officer, or Project Manager
for guidance.Analyze the analytical/Prep
batch if guidance not available and no reason for
discrepancy is known.
Reprepare the entire analytical
batch
No
CA_LCS.vsdRev. 3
05/05/06
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-11
Recovery(ies) acceptable?
Continue analysis of the analytical batch
Initiate Corrective Procedures
Reanalyze the Laboratory Control
Sample
Analyze the Laboratory Control Sample
Acceptable?
Yes
No
Yes
Options
Check instrumentation, Check calibration, (sensitivity, linearity, etc.),Check spike soln. (integrity, conc.),Verify micro-pipette calibration,Look for contamination sources,other
Initiate Quality Improvement form,
Check for reagent bias,Check glassware cleaning
procedures,Check for cross
contamination possibilities,Check the source standard,
Evaluate the preparation procedure,
Validate calibration,Review SOP,
Consult the Department Supervisor
See Dept Supervisor, QA Officer, or Project Manager for guidance.Analyze the analytical batch if guidance not available and no reason for discrepancy can be found.
Initiate corrective ActionNo
Analyze 1 LCSW per every 20 samples.The LCSW should be spiked to the midpoint of the calibration curve unless noted otherwise in the respective SOPThe LCSW must be acceptable in order to report data.Use time logic when batching LCSWs with samples.
Corrective Action Logic for Laboratory Control
Samples
(unprepared LCS's)
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-12
Analyze matrix spike/matrix spike duplicate
Accuracy/Precision Controls Met?
Analyze the entire analytical batch
Laboratory Control Sample Compliant?
Report data properly.
Instrument Problems?
Initiate Corrective Action/ Restore
acceptable instrument performance/
Reanalyze matrix spike/matrix spike
duplicate
Qualify affected data when accuracy and/or precision requirements
are not metAccuracy/Precision Controls met?
Refer to Specific Project QC
Requirements
Yes
No
Yes
Re-extract/Re-prepare the analytical
batch, Initiate corrective
action
No
Analyze the sample used for spiking
purposes
Concentration >4 times the spike level?
Analyze MS/MSD and/or sample/duplicate to
validate precision.(Dilute if necessary)
Yes
No
LCS compliant?
Yes
Re-extract/Re-prepare
the analytical batch if
applicable
No
Yes
No
Certain projects will require confirmation of matrix interferences by repreparing and reanalyzing the analytical batch in cases of MS/MSD failure.If time or workload allows, reprepare and reanalyze the set if no project specific requirements are documented.
Project specific qualifiersLaboratory qualifiersComments
Initiate documentation of corrective action,
Notify the Department Supervisor
Corrective Action Logic for Matrix Spikes
Laboratory Control sample must be compliant,Please refer to the corrective action flowchart for LCSs.
No
See Corrective Action Logic Flowchart for Laboratory
Control Samples
Yes
Precision in control?
yes
Continue the run. Flag data appropriately.
Ues professional judgement in deciding whether or not to initiate corrective action
No
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-13
Prepare an analytical batch
Concentration < 0.5(PQL)?
Continue analysis of the analytical batch.
Check instrumentation for contamination
sources. Evaluate the preparation process
Reanalyze the method blank
Analyze the method blank
Concentration < the 0.5(PQL)?
No
Yes
Assessment of Method Blanks
Check prior position runs,Check for carryover,
Check instrumentation
Options
Initiate Quality Improvement form,
Check for reagent bias,Check glassware cleaning
procedures,Check for cross
contamination possibilities,other
Corrective action may not be necessary,
See MB Assessment
Check instrumentation, environment and/or sample
containment for contamination sources.
Evaluate the preparation process.
(May be necessary to stop the analytical run.)
NoContinue
analytical run(See MB Assessment)
Use professional judgement when deciding to continue or stop the runTypically the method blank
concentration will be reported as "trace"
Are sample results >10x the
PQL?
NO
Report data with the appropriate qualifier
Reprepare the analytical batch for all samples that were <10
times the PQL(See MB Assessment)
Yes
Yes
0.5(PQL)<MB<PQL?
0.5(PQL)<MB<PQL?
If the MB concentration was between 0.5(PQL) and the PQL, contact contact the Department Supervisor before the initiation of repreparation
Method blank Assessment:Qualify data if bias would significantly affect sample results.General, if the MB is > or = to 10% of the sample concentration, this should be considered as a significant bias. Consult the department supervisor when qualifying data.
Yes
Yes
Consult with the department
supervisor. Continue the anaytical run
No
Should open a QIF
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-14
Batching Procedure for Prepared Samples
Samples are prepared together in a
preparation batch
Analyze QC samples
Anlayze the balance of the preparation batch and batch together
Are the MB and LSC compliant?
Make instrument corrections if
necessary, then reanalyze QC samples.
Are the MB and LSC compliant?
It is very good practice to analyze the entire prepared batch on one instrument over the course of one day.
Yes
No
Yes
Re-prepare the entire preparation batch
No
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-15
QC sample matrices defined
(water or soil)
Evaluate constituency given the available information. Also
evaluate background as noted from the method blank and/or indicative
CCBs/IBs
Are samples from the same submission or
field origin as the sample spiked?
Batching Logic for Unprepared Samples
Are samples relatively close in
constituency?
Batch together
Batch option is open, however batching
samples from the same submission will ease data processing and
reporting
Does the constituency,matrix,
and relative instrument conditions of given samples match the
sample spiked?
Batch together
Batch together with the QC sample that most closely
resembles the given samples in matrix and constituency, and is affected in the same magnitude by the relative
instrument conditions.
Are the given samples within the calibration block as the samples
spiked?
Evaluate constituency given the available information. Also
evaluate background as noted from the method blank and/or indicative
CCBs/IBs
Yes
No Yes
No
Yes
No
Yes
No
Run completed
Initially, samples must be batched according to matrix type: Aqueous - Non-Aqueous
Matrix here is more specific than aqueous/non-aqueous
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-16
Obtain the analyte response(s) which will be used for reporting.
Is the analyte concentration(s)
below its associated MDL?
Is the analyte concentration(s) equal to or above its associated
MDL and below its IQL?
Is the analyte concentration equal to or above the IQL and
below the PQL?
Report analyte concentration(s) as
"none detected".
Report the concentration or note the concentration as a
"trace" and attach the appropriate flag (A7).
Does the sample require the MDL/PQL
(trace) reporting format?
Report the concentration with lab defaulted PQL/MDL.
Yes
No
Yes
Yes
No
No
Yes
Low Level Reporting Policy Flowchart
Reduce the response(s) to final concentration terms.
Find the sample analyte MDL(s)/IQL(s)/PQL(s) by factoring in any sample dilutions and/or sample weight to
volume ratios which differ from those used for the analyte MDL/PQL study.
Does the sample require special reporting
limit that is below the PQL?
Does the sample require the MDL/PQL
(trace) reporting format?
Report the concentration or note the concentration as a
"trace" and attach the appropriate flag (A7).
No No
Report analyte concentration(s) as
"none detected" with lab defaulted PQL(s).
Does the sample require reporting limits
below laboratory PQLs?No
Report the IQL or MDL as the Reporting Limit.
Yes
Does the sample require reporting limits
below laboratory PQLs?
YesYes
The analyte concentration must be at or above the PQL.
No
No
Please verify the method of reporting a trace - Text or value
Please verify the method of reporting a trace - Text or value
Yes
Use the sample MDL as the reporting limit and
report the concentration with an appropriate flag
(A8).
Report the concentration and report the IQL as the
PQL or use the client specified reporting limit.
Yes
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APPENDIX D
APPENDIX D EFFECTIVE DATE 01/08/16
PAGE D-17
Note: This section was review on 01/08/16 (No changes were made)
Notes Q02/Q03
Matrix spikes are outside QC Limits.Accuracy and/or
Precision
Flag all concerned analytes with note
Q03.
Are spike recoveries low?
Flag positive concerned sample
results with note Q03.No
Yes
Precision or Accuracy Controls
Exceeded?
Flag concerned analytes with note
Q02.
Are results with associated
incompliant QC positive?
Use descretion in determining if effects
will be significant.
Accuracy
Precision Yes
No
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-1
Process Samples Data
Bottle Order
LOG-IN
Preparation/Analysis
Data Reduction/Processing
Data Review
Data Submittal
Laboratory Assumes Custody
Refrigerator Containment
Internal COC
Secondary Containment
Archive
Disposal
Submission Files
Raw Data
Diskettes
Tapes
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-2
Sample
Receiving
Preparation
Department
Supervisor
LOGIN
Preparation
Department
Technicians
Analytical
Department
Supervisors
Analysts
CommunicationWork Orders, Hardcopy Work Lists, On-Screen Work Lists, COCs
COCs for short holding/turnaround times and 5-day or less rushes are
distributed
Samples are logged into the
system
Enter samples into the sample
flow(see rush process)
Enter samples into the sample flow (see rush
process)
Rush
Work orders are automatically
generated
Work is monitored
Non-Prep analyses is completed
LIMS
Monitoring
QA
Department
Work is monitored
Preparation is completed
Samples are collected into
method specific LIMS
work lists
Samples are collected into
method specific LIMS
work lists
Approval
ApprovalApproval
Approval
Approval
Work lists are printed or
observed on-screen
Work lists are printed or
observed on-screen
Preparation information
is processedApproval
Analysis information
is processed
Prepped analyses is completed
Worklists are
updated
Worklists are
updated
Day 1
Split samples (if applicable)
Day 2 Day 7
If QC is not acceptable
Turnaround time,
Redundant entry
Holding time,Turnaround time,
Redundant sample prep
Holding time,Turnaround time,
Redundant analysis,LCS failuresMB failures
Day 6Day 5Day 4Day 3
Performance data is
assessed.
Performance data is
assessed.
Performance data is
assessed.
2 hours
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-3
A request for bottles isissued by the Client
Representative.
A Bottle Order Form iscompleted by the
Project Manager.Bottles are processedaccording to COCs.
The Bottle Order Formand COC are
submitted to theSample Control
Supervisor
The Bottle Prep. Tech.completes the bottle
orderBottle order is checked by
peer review
The completed bottleorder is placed in the
Sample ReceivingArea.
Containers and coolersare transported to
designated site or kept inSample Receiving Area
until the ClientRepresentative assumes
custody
Bottle Orders arechecked by the Client
Representative
Bottle OrderCorrect?
End
Yes
No
Bottle Ordering
Flowchart
Sample Labels arecollated and submittedwith the Bottle OrderForm and COC to the
Bottle PreparationTech.
Do sampleanalyses andsample labels
match?
No
Yes
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APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-4
Complete Chain of
Custody Form
Take a representativetemperature of the
sample(s)
Unpack ice chests and/or place all samples in
order on the backcounter
Cross-check samplelabel descriptions withthe COC. Also discern
any sample integrityproblems
Conduct proper samplecustody procedures by
logging samples intorefrigerators and completing
sample refrigerator logs.Use the "Distribution" stampon the COC to acknowledge
COC distribution.
Are samples on anaccelerated turnaround
or are holding times inperil?
Place original COC'saccordingly in the
LOGIN tray.
Complete the CoolerReceipt Form (CRF).
Submit COC and CRFto Client Services
Submit a copy of theCOC with a note
stating the problem toClient Services.
Make a copy of theCOC and submit to the
appropriate ClientService representative.
Problems?
Number the samples (if possible) and stamp theCOC with the "numbering
checked by" stamp. Have apeer review the numbering
and acknowledge byinitialing the stamp. Place
samples in the LOGINrefrigerator until problem is
resolved.
Make a copy of theCOC for theappropriate
departments andconduct sample
custody procedures
Temperature withinthe acceptable
range?
See Client ServiceSample ReceivingAnomaly Handling
Flow Chart
No
Yes
Yes
No
Yes
Number the samples(if possible) and stamp theCOC with the "numbering
checked by" stamp. Have apeer review the numbering
and acknowledge byinitialing the stamp.
No
Sample Receiving Flowchart
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-5
Client Servicesreceives a copy of a
COC from the SampleCustodian
Is the problemrelated to sample
integrity ornumber?
Client service attemptscontact w ith the client
COC anomalies inregards toanalyses?
Quote or any otherproject information
available?
Client contacted?
Inf ormation is communicatedto Sample Custodian.
Inf ormation and/orconf irmation of c lient
requests are written on theoriginal COC (if project
protocols allow).
Correspondance isdocumented on a
Phone Log.Y es Y es
No
No
Y es Y es
No
Can the problembe solved reliably
w ithout clientcontact?
Yes No
No
Go to the appropriatestep of the particular
f low chart.
Sample Receiving Anomaly Handling Flow Chart
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-6
Analyst secures samples following internal tracking
procedures
Is Sample Preparation required?
Water or Soil?
Sample Preparation Tech secures samples
following internal tracking procedures
Sample Preparation is conductedTesting is conducted
Data is reduced Digests or extracts are submitted to analysts
Sample Splitting is conducted
Organic Testing? Volatiles?Soil
Water No
YesYes
No
No
Yes
Basic Sample Preparation Process Flow
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-7
AnalyticalWorksheet(s) areturned into Client
Services
Analyses are markedout on ProjectCoordinator
Acknowledgements.Dates are recorded.
Worksheets aresubmitted to DataControl. Dates are
recorded.
Worksheets and CARs
are submitted to ClientServices
Fax Required?
CARs and worksheetsare submitted to Data
Control
CARs and worksheets areplaced into submission files.The appropriate analysis iscrossed off and dated on the
acknowledgement form.
CARs are faxed. Thefax record is placed
into the worksheet file
Analyses are markedout on ProjectCoordinator
Acknowledgements.Dates are Recorded.
Are all submissionanalyses
completed?
Continue the processuntil all CARs arechecked off on the
acknowledgement form
Remove the submissionfile and complete the
Data Control CompletedSubmission Logbook.Dates are Recorded.Complete submissionlogout on the LIMS.
The Submission folder
is submitted to Client
Services
Coversheet or CaseNarrative is produced. Allappropriate deliverables arecopied and placed into a pre-addressed envelope, or sentby courier if required. Dates
are recorded.
Is QC ReportingRequired?
The entiresubmission file is
turned into theinvoice clerk.Dates arerecorded.
See InvoiceProcess Flowchart
See TheQC
ReportingFlow chartDates arerecorded.
See the Data
Control Flow Chart
Completed Worksheet Flow Diagram
No
No
No
Yes
Yes
No
CorrectionsRequired?
Yes
Yes
Is custom reportingrequired? EDDs?
Custom Reportand/or EDDs
are produced.See EDD
Process Flowchart
No
Yes
Is custom invoicingrequired?
Custom
invoices are
produced.
Yes
No
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR... IT'S TIME FOR...
IT'S TIME FOR...
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-8
Obtain COCs fromtrays. Prioritize
Logging.
Initiate Log-inprocedures
Ambiguous or lackof information?
The original COC anda note with specific
questions is submittedto client services. Seethe Logging AnomalyHandling Flow Chart
Complete samplelogging procedure.
Print worksheets
Organics?
Metals Rushes?
Place worksheets inorange manila
folders.
Distribute paperworkto the appropriate
areas
Go to Prep/AnalysisFlow Charts
Place worksheets inblue/red/plain colored
folders.
All other tests(wet chem,non-rush metals) do notrequire manila folders.Organize by submission.
Discrepanciesfound?
Submit organizedworksheets to the DataControl Supervisor for
review
Worksheets are datedand initialed by the
Data ControlSupervisor
Yes
Yes
No
No
No
Thediscrepantworksheets
arecorrected
Yes
No
Yes
Sample Log-in Procedures
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
Dates/Times shouldbe recorded
Dates should be
recorded
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EFFECTIVE DATE 01/08/16
PAGE E-9
Worksheets are placedin the black bin in theData Control Room
Worksheets are date -stamped
Worksheets areprioritized and placed
into stacking trays
A portion of work istaken by Data Control
Specialists for dataentry. The samplenumber is entered.
Data from the entireportion of worksheets
taken are entered into theLIMS. Comments areused to decipher theextent of data entry.
Are processedvalues in the
system?
Submit the worksheets tothe appropriatesupervisor for
investigation. Appropriatechanges are made (if
applicable).
Do processed valuesmatch worksheet
values?
The worksheets areseparated to prepare for
printing. Printing tasks arebased on knowledge, a
cheat sheet and/or printingcategory description
LLNL Reports?
Report requiresState Forms?
Reports need to beprinted on recycled
paper?
Place landscape letterheadinto printer cartridge as
needed. Print report thenturn the printer off then on.Place standard letterhead
printer cartridge into printerIf appropriate.
Place plain paper into aprinter cartridge as
needed. Print report thenplace standard letterheadprinter cartridge into the
printer if appropriate.
Standard Report?
Worksheets andprinted reports are
collected into folders.
Folders are placed intothe proofreading bin orsubmitted to a peer for
review.
Discrepanciesfound?
Folders are distributedto the General
Manager and/or Dept.Supervisors for
approval.
Place recycled paper intoa printer cartridge as
needed. Print report thenplace standard letterheadprinter cartridge into the
printer if appropriate.
Place standard letterheadprinter cartridge into theprinter as needed. Print
report then placestandard letterhead
printer cartridge into theprinter if appropriate.
Discrepanciesfound?
See the appropriate step inthe Completed Worksheet
Flow Diagram.
No
Yes
Yes
Yes
Yes
Yes
No
No
Yes No
Yes
Yes
Data Control Flow Chart
IT'S TIME
FOR...
IT'S TIME
FOR...
IT'S TIME
FOR...
IT'S TIME
FOR...
IT'S TIME
FOR...
IT'S TIME FOR...
IT'S TIME FOR...
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-10
Bench Level Review
Technical Review
Department SupervisorReview
Project CoordinatorReview
Report ApprovalReview
QA/QC Review
Project CoordinatorFinal Review
Conducted by bench analyst:1. QC Parameters - MBs,
dupls, MS/MSD, LCS,Calibration, instrumentperformance
2. Holding times3. Project Protocol4. Data Processing
Conducted by the Dept.Sup., Peer, Team Leader,or QA Dept Personnel,1. Comprehensive (100%)
review of raw data andreporting
2. Documented onspecialized checklists
Conducted by the TechnicalDirector, Dept Sup. or theQA Officer
1. Transcription of results2. Overall integrity of the
final report
Conducted by the QA/QCDept personnel during QCReporting procedures.(Approximately 50 % of thetotal work)
1. DQOs2. Reasonableness of data3. Report formating4. QC Reporting
Data Deliverables
Conducted by respectiveDept. Sup.
1. Transcriptions onto worksheets2. DQOs3. Methodology4. Reasonableness of results
Conducted by ProjectManager or Coordinator
1. DQOs2. Report formating3. Reasonableness of
results
Data Review Process
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APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-11
Laboratory assumes custody
(Documented on the Chain of Custody Form)
Samples are placed in the appropriate refrigerators.
(Documented on refrigerator logs)
Prep/Analysis conducted
(Document custody on refrigerator logs and preparation/run logs)
Samples are removed from refrigerators after analyses are complete
(Document removal on refrigerator logs)
Containers are stored in on-site Sea-Trains for at least thirty days
(Document custody on a sample tracking log)
Sample disposal is conducted
(Documented on a sample tracking log)
Waste disposal container/drum
contents is profiled or verified
Waste disposal carriers remove waste containers and
transport to proper designations
(documented on manifests)
Laboratory
assumes
custody(documented on
Chain of Custody
Forms)
Samples are
housed in the
walk-in
refrigerator(Documented on the
refrigerator log)
Samples
requiring
inorganic's
testing are split
and housed in
reach in
refrigerators(documented on
refrigerator logs)
Samples and
splits are
removed from
cold storage after
analyses are
completed, and
processed
according to
waste type
Samples are held
in boxes for at
least 30 days
then disposed of
through proper
waste streams(Documented on
sample tracking logs)
Sample TrackingAqueous Matrices
Sample TrackingNon-Aqueous Matrices
Documented on refrigerator logs and on sample tracking logs.
Prep/Analysis
Conducted(document custody on
refrigerator logs and
preparation/run logs)
Samples are placed back into refrigerators from which they were
taken.(Document on refrigerator logs)
Documented in the LIMS
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-12
Data Collection Station
File Server
Instrument Work Station
Internet or
IntranetHardcopy Reports
Client Local or Network StationAuthorization/Data
Request Station
Data Processing Station
Data is produced by the
instrument
Data is collected into the LIMS.
Data is then processed by data
processing specialists
Data is stored and accessed
Data
Diskette
Op
tio
ns
Data Processing for Electronic Data Delivery
Instrument have direct
and/or indirect links to
the Laboratory
Information
Management System
(LIMS)
All data processing is
reviewed by a second
person
All electronic data is reviewed prior to final submittal
All files on diskettes are verified as to type and content.
Virus checks are conducted on all disks
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-13
Orientation All new employees
IDC ChecklistOn the Job
TrainingAll new analysts or a change
in responsibility
Training Process
Orientation
Checklist
Internal
Training Modules
Continuous Training
Based on job description
Certificates of
Completion
Enter the external
training programEmployee discretion
Diploma, Certificate
of Completion,
Record of attendance
Continuous Training
Training Documentation
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EFFECTIVE DATE 01/08/16
PAGE E-14
Analyze at least five calibration standards at different concentration
levels
%RSD < or = 20 for all analytes?
Analyze the ICV
±15%diff or ±15%drift criteria
met?
Continue the run
Reanalyze the standard(s) which adversely affect
linearity and recalculate %RSD.
%RSD criteria met for all analytes?
Initiate Corrective
Procedures(SIF)Options
Prepare new standards,Correct instrumentation malfunctions,
Consult Supervisor,Review SOP,
Review calculations,Check maintenance log for a record
on replacement components
No
Yes
Yes
Reanalyze the ICV %diff criteria met?
Initiate Corrective
Action(SIF)
No
Yes
No
Options
Verify standards,Generate a new initial calibration
curve,Correct instrument malfunctions,
Consult the supervisor,Prepare new standards,
Check for calculation errors,Reevaluate instrument parameter
setup,Consult the SOP
Initial Calibration Logic for GC/HPLC MethodsIC_GCHPLC.vsd
Rev. 404/07/05
Create a least squares linear regression model
for the analyte which does not meet linearity
protocols.Do not force zero.
Calculate the mean RSD using all RSD values for all analytes of the
curve.
Mean RSD < 20%?
r > 0.99?
Notify the client by adding a comment
which states that there is greater uncertainty for analytes of which the %RSD is greater
than 20.
Create a quadratic or or 3rd order polynomial
regression model Do Not Force Zero
Please note:Quadratic curve: 6 standards
3rd order polynomial curve: 7 standards
COD > 0.99?
Yes
No
Yes
No
Yes
Quantitation must take
place within calibration
range.
No
Yes
Quantitation must take
place within calibration
range.
No
If time permits, you may
not choose to follow the
proceeding steps.
Notify the department
supervisor or the team
leader before proceeding
Optional ProcessPlease contact the Department Supervisor
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EFFECTIVE DATE 01/08/16
PAGE E-15
Instrument run is completed
The analyst reviews the data
Problems found?Problems are
documented on a review sheet
Reviewed data with the review sheet are
submitted back to the analyst
Analyst collects worksheets
Analyst enters results and other information
onto worksheets
The analyst submits the analytical run to a
peer for review
Worksheets are submitted to the Dept Supervisor for review
and approval.
Go to the Completed Worksheet Flow
Diagram
Instrument run is completed
Analyst downloads the run onto the LIMS
The analyst reviews the run and completes
a review sheet
The analytical run and the review sheet is submitted
to a data processing specialist (DPS).
The analytical run is processed and
reviewed by a Data Processing Specialist.
The processed run information and raw
data is submitted to a designated technical
reviewer.
The technical reviewer reviews the raw data and the processed
information.
Problems with the analytical run?
Information is communicated to the analyst and corrective
action is initiated (if applicable).
The processed run, raw data and review sheets
are submitted to the analyst for approval. All
disagreements are midigated by the Dept.
Supervisor.
Problems with the data processing?
Information is communicated to the DPS and corrective action is initiated (if
applicable).
Results are posted.
Sample and QC results are sent
electronically to the Department Supervisor
for review and approval.
Certified analytical reports are printed
No
Yes
Yes
No
No
Analytical Review, Reporting and Approval Flow chart for ICP Analyses
Current Process Proposed/Parallel ProcessIT'S TIME FOR...
IT'S TIME FOR...
Dates are recorded
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
Dates/times should be recorded
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EFFECTIVE DATE 01/08/16
PAGE E-16
24 Hours
BC Laboratories, Inc.
Samples are submitted by Client Representatives and chain of custody procedures are initiated
Lab analytical worksheets are filled out by the Bac-T analyst
Well
100 mls of sample set up with with Colilert reagent. Sample is kept in an incubator for 24 hours. If yellow color is formed, sample is positive for total coliform. A check for fluorescence is conducted to indicate presence of E. Coli.
Wastewater Samples 5,5,5 with Lauryl Tryptose Broth (presumptive) followed by Total Coliform confirmation (Brilliant Green Bile)Presumptive Test takes 24 - 48 hours, confirmation another 24 - 48 hours.
48 Hours
Disposal
Media/samples are autoclaved prior to disposal
Notification
Positives are called in by a BC Laboratories, Inc. Representative
Reports
Certified analytical reports are mailed.
Interpretation and Action
Corrective action, if necessary is conducted by Client personnel
Disclosure
State government is notifed on results and/or actions taken
Process Quality ControlBacteriological
Testing
Positive/negative culture controls on each lot of Colilert productIncubator temperature checked twice per day.Thermometers checked annually against NIST reference thermometer.Certified sample containers
Positive/negative culture controls for each media.Pipet sterility checkAutoclave sterility checksAutoclave temperature and temperature distribution checksMedia control check after autoclave
Note: This section was review on 01/08/16 (No changes were made)
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-1
Process Samples Data
Bottle Order
LOG-IN
Preparation/Analysis
Data Reduction/Processing
Data Review
Data Submittal
Laboratory Assumes Custody
Refrigerator Containment
Internal COC
Secondary Containment
Archive
Disposal
Submission Files
Raw Data
Diskettes
Tapes
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-2
Sample
Receiving
Preparation
Department
Supervisor
LOGIN
Preparation
Department
Technicians
Analytical
Department
Supervisors
Analysts
CommunicationWork Orders, Hardcopy Work Lists, On-Screen Work Lists, COCs
COCs for short holding/turnaround times and 5-day or less rushes are
distributed
Samples are logged into the
system
Enter samples into the sample
flow(see rush process)
Enter samples into the sample flow (see rush
process)
Rush
Work orders are automatically
generated
Work is monitored
Non-Prep analyses is completed
LIMS
Monitoring
QA
Department
Work is monitored
Preparation is completed
Samples are collected into
method specific LIMS
work lists
Samples are collected into
method specific LIMS
work lists
Approval
ApprovalApproval
Approval
Approval
Work lists are printed or
observed on-screen
Work lists are printed or
observed on-screen
Preparation information
is processedApproval
Analysis information
is processed
Prepped analyses is completed
Worklists are
updated
Worklists are
updated
Day 1
Split samples (if applicable)
Day 2 Day 7
If QC is not acceptable
Turnaround time,
Redundant entry
Holding time,Turnaround time,
Redundant sample prep
Holding time,Turnaround time,
Redundant analysis,LCS failuresMB failures
Day 6Day 5Day 4Day 3
Performance data is
assessed.
Performance data is
assessed.
Performance data is
assessed.
2 hours
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PAGE E-3
A request for bottles isissued by the Client
Representative.
A Bottle Order Form iscompleted by the
Project Manager.Bottles are processedaccording to COCs.
The Bottle Order Formand COC are
submitted to theSample Control
Supervisor
The Bottle Prep. Tech.completes the bottle
orderBottle order is checked by
peer review
The completed bottleorder is placed in the
Sample ReceivingArea.
Containers and coolersare transported to
designated site or kept inSample Receiving Area
until the ClientRepresentative assumes
custody
Bottle Orders arechecked by the Client
Representative
Bottle OrderCorrect?
End
Yes
No
Bottle Ordering
Flowchart
Sample Labels arecollated and submittedwith the Bottle OrderForm and COC to the
Bottle PreparationTech.
Do sampleanalyses andsample labels
match?
No
Yes
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-4
Complete Chain of
Custody Form
Take a representativetemperature of the
sample(s)
Unpack ice chests and/or place all samples in
order on the backcounter
Cross-check samplelabel descriptions withthe COC. Also discern
any sample integrityproblems
Conduct proper samplecustody procedures by
logging samples intorefrigerators and completing
sample refrigerator logs.Use the "Distribution" stampon the COC to acknowledge
COC distribution.
Are samples on anaccelerated turnaround
or are holding times inperil?
Place original COC'saccordingly in the
LOGIN tray.
Complete the CoolerReceipt Form (CRF).
Submit COC and CRFto Client Services
Submit a copy of theCOC with a note
stating the problem toClient Services.
Make a copy of theCOC and submit to the
appropriate ClientService representative.
Problems?
Number the samples (if possible) and stamp theCOC with the "numbering
checked by" stamp. Have apeer review the numbering
and acknowledge byinitialing the stamp. Place
samples in the LOGINrefrigerator until problem is
resolved.
Make a copy of theCOC for theappropriate
departments andconduct sample
custody procedures
Temperature withinthe acceptable
range?
See Client ServiceSample ReceivingAnomaly Handling
Flow Chart
No
Yes
Yes
No
Yes
Number the samples(if possible) and stamp theCOC with the "numbering
checked by" stamp. Have apeer review the numbering
and acknowledge byinitialing the stamp.
No
Sample Receiving Flowchart
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-5
Client Servicesreceives a copy of a
COC from the SampleCustodian
Is the problemrelated to sample
integrity ornumber?
Client service attemptscontact w ith the client
COC anomalies inregards toanalyses?
Quote or any otherproject information
available?
Client contacted?
Inf ormation is communicatedto Sample Custodian.
Inf ormation and/orconf irmation of c lient
requests are written on theoriginal COC (if project
protocols allow).
Correspondance isdocumented on a
Phone Log.Y es Y es
No
No
Y es Y es
No
Can the problembe solved reliably
w ithout clientcontact?
Yes No
No
Go to the appropriatestep of the particular
f low chart.
Sample Receiving Anomaly Handling Flow Chart
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QUALITY ASSURANCE PROGRAM PLAN
APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-6
Analyst secures samples following internal tracking
procedures
Is Sample Preparation required?
Water or Soil?
Sample Preparation Tech secures samples
following internal tracking procedures
Sample Preparation is conductedTesting is conducted
Data is reduced Digests or extracts are submitted to analysts
Sample Splitting is conducted
Organic Testing? Volatiles?Soil
Water No
YesYes
No
No
Yes
Basic Sample Preparation Process Flow
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-7
AnalyticalWorksheet(s) areturned into Client
Services
Analyses are markedout on ProjectCoordinator
Acknowledgements.Dates are recorded.
Worksheets aresubmitted to DataControl. Dates are
recorded.
Worksheets and CARs
are submitted to ClientServices
Fax Required?
CARs and worksheetsare submitted to Data
Control
CARs and worksheets areplaced into submission files.The appropriate analysis iscrossed off and dated on the
acknowledgement form.
CARs are faxed. Thefax record is placed
into the worksheet file
Analyses are markedout on ProjectCoordinator
Acknowledgements.Dates are Recorded.
Are all submissionanalyses
completed?
Continue the processuntil all CARs arechecked off on the
acknowledgement form
Remove the submissionfile and complete the
Data Control CompletedSubmission Logbook.Dates are Recorded.Complete submissionlogout on the LIMS.
The Submission folder
is submitted to Client
Services
Coversheet or CaseNarrative is produced. Allappropriate deliverables arecopied and placed into a pre-addressed envelope, or sentby courier if required. Dates
are recorded.
Is QC ReportingRequired?
The entiresubmission file is
turned into theinvoice clerk.Dates arerecorded.
See InvoiceProcess Flowchart
See TheQC
ReportingFlow chartDates arerecorded.
See the Data
Control Flow Chart
Completed Worksheet Flow Diagram
No
No
No
Yes
Yes
No
CorrectionsRequired?
Yes
Yes
Is custom reportingrequired? EDDs?
Custom Reportand/or EDDs
are produced.See EDD
Process Flowchart
No
Yes
Is custom invoicingrequired?
Custom
invoices are
produced.
Yes
No
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR... IT'S TIME FOR...
IT'S TIME FOR...
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-8
Obtain COCs fromtrays. Prioritize
Logging.
Initiate Log-inprocedures
Ambiguous or lackof information?
The original COC anda note with specific
questions is submittedto client services. Seethe Logging AnomalyHandling Flow Chart
Complete samplelogging procedure.
Print worksheets
Organics?
Metals Rushes?
Place worksheets inorange manila
folders.
Distribute paperworkto the appropriate
areas
Go to Prep/AnalysisFlow Charts
Place worksheets inblue/red/plain colored
folders.
All other tests(wet chem,non-rush metals) do notrequire manila folders.Organize by submission.
Discrepanciesfound?
Submit organizedworksheets to the DataControl Supervisor for
review
Worksheets are datedand initialed by the
Data ControlSupervisor
Yes
Yes
No
No
No
Thediscrepantworksheets
arecorrected
Yes
No
Yes
Sample Log-in Procedures
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
Dates/Times shouldbe recorded
Dates should be
recorded
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APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-9
Worksheets are placedin the black bin in theData Control Room
Worksheets are date -stamped
Worksheets areprioritized and placed
into stacking trays
A portion of work istaken by Data Control
Specialists for dataentry. The samplenumber is entered.
Data from the entireportion of worksheets
taken are entered into theLIMS. Comments areused to decipher theextent of data entry.
Are processedvalues in the
system?
Submit the worksheets tothe appropriatesupervisor for
investigation. Appropriatechanges are made (if
applicable).
Do processed valuesmatch worksheet
values?
The worksheets areseparated to prepare for
printing. Printing tasks arebased on knowledge, a
cheat sheet and/or printingcategory description
LLNL Reports?
Report requiresState Forms?
Reports need to beprinted on recycled
paper?
Place landscape letterheadinto printer cartridge as
needed. Print report thenturn the printer off then on.Place standard letterhead
printer cartridge into printerIf appropriate.
Place plain paper into aprinter cartridge as
needed. Print report thenplace standard letterheadprinter cartridge into the
printer if appropriate.
Standard Report?
Worksheets andprinted reports are
collected into folders.
Folders are placed intothe proofreading bin orsubmitted to a peer for
review.
Discrepanciesfound?
Folders are distributedto the General
Manager and/or Dept.Supervisors for
approval.
Place recycled paper intoa printer cartridge as
needed. Print report thenplace standard letterheadprinter cartridge into the
printer if appropriate.
Place standard letterheadprinter cartridge into theprinter as needed. Print
report then placestandard letterhead
printer cartridge into theprinter if appropriate.
Discrepanciesfound?
See the appropriate step inthe Completed Worksheet
Flow Diagram.
No
Yes
Yes
Yes
Yes
Yes
No
No
Yes No
Yes
Yes
Data Control Flow Chart
IT'S TIME
FOR...
IT'S TIME
FOR...
IT'S TIME
FOR...
IT'S TIME
FOR...
IT'S TIME
FOR...
IT'S TIME FOR...
IT'S TIME FOR...
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QUALITY ASSURANCE PROGRAM PLAN
APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-10
Bench Level Review
Technical Review
Department SupervisorReview
Project CoordinatorReview
Report ApprovalReview
QA/QC Review
Project CoordinatorFinal Review
Conducted by bench analyst:1. QC Parameters - MBs,
dupls, MS/MSD, LCS,Calibration, instrumentperformance
2. Holding times3. Project Protocol4. Data Processing
Conducted by the Dept.Sup., Peer, Team Leader,or QA Dept Personnel,1. Comprehensive (100%)
review of raw data andreporting
2. Documented onspecialized checklists
Conducted by the TechnicalDirector, Dept Sup. or theQA Officer
1. Transcription of results2. Overall integrity of the
final report
Conducted by the QA/QCDept personnel during QCReporting procedures.(Approximately 50 % of thetotal work)
1. DQOs2. Reasonableness of data3. Report formating4. QC Reporting
Data Deliverables
Conducted by respectiveDept. Sup.
1. Transcriptions onto worksheets2. DQOs3. Methodology4. Reasonableness of results
Conducted by ProjectManager or Coordinator
1. DQOs2. Report formating3. Reasonableness of
results
Data Review Process
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APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-11
Laboratory assumes custody
(Documented on the Chain of Custody Form)
Samples are placed in the appropriate refrigerators.
(Documented on refrigerator logs)
Prep/Analysis conducted
(Document custody on refrigerator logs and preparation/run logs)
Samples are removed from refrigerators after analyses are complete
(Document removal on refrigerator logs)
Containers are stored in on-site Sea-Trains for at least thirty days
(Document custody on a sample tracking log)
Sample disposal is conducted
(Documented on a sample tracking log)
Waste disposal container/drum
contents is profiled or verified
Waste disposal carriers remove waste containers and
transport to proper designations
(documented on manifests)
Laboratory
assumes
custody(documented on
Chain of Custody
Forms)
Samples are
housed in the
walk-in
refrigerator(Documented on the
refrigerator log)
Samples
requiring
inorganic's
testing are split
and housed in
reach in
refrigerators(documented on
refrigerator logs)
Samples and
splits are
removed from
cold storage after
analyses are
completed, and
processed
according to
waste type
Samples are held
in boxes for at
least 30 days
then disposed of
through proper
waste streams(Documented on
sample tracking logs)
Sample TrackingAqueous Matrices
Sample TrackingNon-Aqueous Matrices
Documented on refrigerator logs and on sample tracking logs.
Prep/Analysis
Conducted(document custody on
refrigerator logs and
preparation/run logs)
Samples are placed back into refrigerators from which they were
taken.(Document on refrigerator logs)
Documented in the LIMS
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APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-12
Data Collection Station
File Server
Instrument Work Station
Internet or
IntranetHardcopy Reports
Client Local or Network StationAuthorization/Data
Request Station
Data Processing Station
Data is produced by the
instrument
Data is collected into the LIMS.
Data is then processed by data
processing specialists
Data is stored and accessed
Data
Diskette
Op
tio
ns
Data Processing for Electronic Data Delivery
Instrument have direct
and/or indirect links to
the Laboratory
Information
Management System
(LIMS)
All data processing is
reviewed by a second
person
All electronic data is reviewed prior to final submittal
All files on diskettes are verified as to type and content.
Virus checks are conducted on all disks
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-13
Orientation All new employees
IDC ChecklistOn the Job
TrainingAll new analysts or a change
in responsibility
Training Process
Orientation
Checklist
Internal
Training Modules
Continuous Training
Based on job description
Certificates of
Completion
Enter the external
training programEmployee discretion
Diploma, Certificate
of Completion,
Record of attendance
Continuous Training
Training Documentation
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-14
Analyze at least five calibration standards at different concentration
levels
%RSD < or = 20 for all analytes?
Analyze the ICV
±15%diff or ±15%drift criteria
met?
Continue the run
Reanalyze the standard(s) which adversely affect
linearity and recalculate %RSD.
%RSD criteria met for all analytes?
Initiate Corrective
Procedures(SIF)Options
Prepare new standards,Correct instrumentation malfunctions,
Consult Supervisor,Review SOP,
Review calculations,Check maintenance log for a record
on replacement components
No
Yes
Yes
Reanalyze the ICV %diff criteria met?
Initiate Corrective
Action(SIF)
No
Yes
No
Options
Verify standards,Generate a new initial calibration
curve,Correct instrument malfunctions,
Consult the supervisor,Prepare new standards,
Check for calculation errors,Reevaluate instrument parameter
setup,Consult the SOP
Initial Calibration Logic for GC/HPLC MethodsIC_GCHPLC.vsd
Rev. 404/07/05
Create a least squares linear regression model
for the analyte which does not meet linearity
protocols.Do not force zero.
Calculate the mean RSD using all RSD values for all analytes of the
curve.
Mean RSD < 20%?
r > 0.99?
Notify the client by adding a comment
which states that there is greater uncertainty for analytes of which the %RSD is greater
than 20.
Create a quadratic or or 3rd order polynomial
regression model Do Not Force Zero
Please note:Quadratic curve: 6 standards
3rd order polynomial curve: 7 standards
COD > 0.99?
Yes
No
Yes
No
Yes
Quantitation must take
place within calibration
range.
No
Yes
Quantitation must take
place within calibration
range.
No
If time permits, you may
not choose to follow the
proceeding steps.
Notify the department
supervisor or the team
leader before proceeding
Optional ProcessPlease contact the Department Supervisor
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EFFECTIVE DATE 01/08/16
PAGE E-15
Instrument run is completed
The analyst reviews the data
Problems found?Problems are
documented on a review sheet
Reviewed data with the review sheet are
submitted back to the analyst
Analyst collects worksheets
Analyst enters results and other information
onto worksheets
The analyst submits the analytical run to a
peer for review
Worksheets are submitted to the Dept Supervisor for review
and approval.
Go to the Completed Worksheet Flow
Diagram
Instrument run is completed
Analyst downloads the run onto the LIMS
The analyst reviews the run and completes
a review sheet
The analytical run and the review sheet is submitted
to a data processing specialist (DPS).
The analytical run is processed and
reviewed by a Data Processing Specialist.
The processed run information and raw
data is submitted to a designated technical
reviewer.
The technical reviewer reviews the raw data and the processed
information.
Problems with the analytical run?
Information is communicated to the analyst and corrective
action is initiated (if applicable).
The processed run, raw data and review sheets
are submitted to the analyst for approval. All
disagreements are midigated by the Dept.
Supervisor.
Problems with the data processing?
Information is communicated to the DPS and corrective action is initiated (if
applicable).
Results are posted.
Sample and QC results are sent
electronically to the Department Supervisor
for review and approval.
Certified analytical reports are printed
No
Yes
Yes
No
No
Analytical Review, Reporting and Approval Flow chart for ICP Analyses
Current Process Proposed/Parallel ProcessIT'S TIME FOR...
IT'S TIME FOR...
Dates are recorded
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
IT'S TIME FOR...
Dates/times should be recorded
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APPENDIX E
APPENDIX E
EFFECTIVE DATE 01/08/16
PAGE E-16
24 Hours
BC Laboratories, Inc.
Samples are submitted by Client Representatives and chain of custody procedures are initiated
Lab analytical worksheets are filled out by the Bac-T analyst
Well
100 mls of sample set up with with Colilert reagent. Sample is kept in an incubator for 24 hours. If yellow color is formed, sample is positive for total coliform. A check for fluorescence is conducted to indicate presence of E. Coli.
Wastewater Samples 5,5,5 with Lauryl Tryptose Broth (presumptive) followed by Total Coliform confirmation (Brilliant Green Bile)Presumptive Test takes 24 - 48 hours, confirmation another 24 - 48 hours.
48 Hours
Disposal
Media/samples are autoclaved prior to disposal
Notification
Positives are called in by a BC Laboratories, Inc. Representative
Reports
Certified analytical reports are mailed.
Interpretation and Action
Corrective action, if necessary is conducted by Client personnel
Disclosure
State government is notifed on results and/or actions taken
Process Quality ControlBacteriological
Testing
Positive/negative culture controls on each lot of Colilert productIncubator temperature checked twice per day.Thermometers checked annually against NIST reference thermometer.Certified sample containers
Positive/negative culture controls for each media.Pipet sterility checkAutoclave sterility checksAutoclave temperature and temperature distribution checksMedia control check after autoclave
Note: This section was review on 01/08/16 (No changes were made)
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QUALITY ASSURANCE PROGRAM PLAN
APPENDIX F
APPENDIX F
EFFECTIVE DATE 01/08/16
PAGE F-1
Ethics Agreement
BC Laboratories, Inc.
ETHICS AND DATA INTEGRITY AGREEMENT
I. I, (Name), State that I understand
the high standards of integrity required of me with regard to the duties I perform and
the data I report in connection with my employment at BC Laboratories, Inc.
II. I agree that in the performance of my duties at BC Laboratories, Inc:
a. I shall not intentionally report data values that are not the actual values
obtained;
b. I shall not intentionally report the dates and times of
samples/standards/reagent preparation that are not the actual dates and
times of samples/standards/reagents preparation.
c. I shall not intentionally report the dates and times of data analyses that are
not the actual dates and times of data analyses.
d. I shall not intentionally represent another individual=s work as my own; and
e. I shall abide by the Code of Ethics Policy listed in the BC Laboratories, Inc.
QAPP (Located in the Conference Room).
III. I agree to inform BC Laboratories, Inc. of any accidental reporting of non-authentic
data by myself in a timely manner.
IV. I agree to inform BC Laboratories, Inc. of any accidental or intentional reporting of
non-authentic data by other employees.
(Signature)
(Date)
Note: Appendix F was review on 01/13/15 (No changes were made)
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QUALITY ASSURANCE PROGRAM PLAN
APPENDIX G
APPENDIX G
EFFECTIVE DATE: 01/08/16
PAGE G-1
USER FLAGS Qualifiers
*A Absent
*Fail Fail
*I Not Ignitable
*P Present
*Pass Pass
*R [Custom Value]
< <[Custom Value]
<=2 <= 2
<1 < 1
<1.1 < 1.1
<2 < 2
> >[Custom Value]
> 140 >140
>23 > 23
A01 PQL's and MDL's are raised due to sample dilution.
A02 The difference between duplicate readings is less than the PQL.
A03 The sample concentration is more than 4 times the spike level.
A04 Method of Standard Additions used to calculate result.
A05 Unable to report specific MPN due to insufficient dilutions.
A06 The sample was preserved within 24 hours of the collection time.
A09 PQL's were raised due to high concentration of target analytes requiring sample dilution.
A10 PQL's and MDL's were raised due to matrix interference.
A11 PQL's and/or MDL's were raised due to inadequate sample size received.
A12 PQL's were raised due to high concentrations of hydrocarbons present requiring sample dilution.
A14 All phenolic compound results are affected due to low phenol surrogate recoveries caused by matrix.
A17 Surrogate not reportable due to sample dilution.
A18 Surrogate not reportable due to matrix interference.
A19 Surrogate is high due to matrix interference. Interferences verified through second extraction/analysis.
A20 Surrogate is low due to matrix interference. Interference verified through second extraction/analysis.
A22 Associated surrogate recovery is low.
A23 Associated surrogate recovery is high.
A26 Sample received past holding time.
A39 Sample received at pH greater than 2.
A40 Initial calibration linearity criteria not met.
A41 Results confirmed by GC/MS.
A43 Primary/Confirmation column ratios do not agree, results may be biased.
A48 Matrix spike interferences may be associated with this analyte.
A51 Chromatogram not typical of Diluent.
A52 Chromatogram not typical of diesel.
A53 Chromatogram not typical of gasoline.
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APPENDIX G
APPENDIX G
EFFECTIVE DATE: 01/08/16
PAGE G-2
USER FLAGS Qualifiers
A54 Chromatogram not typical of kerosene.
A55 Chromatogram not typical of crude oil.
A56 Chromatogram not typical of stoddard solvent.
A57 Chromatogram not typical of motor oil.
A58 Chromatogram not typical of hydraulic oil.
A59 Results calculated on a dry weight basis.
A61 Result is estimated a coeluting compound is also present at same retention time.
A66 Method blank for {%1} detected at {%2}.
A68 Presence of MTBE not confirmed by GC/MS.
A70 Surrogate recovery calculated from the confirmation column due to matrix interferences on the primary column.
A71 TBOS result subtracted from diesel range for final diesel result.
A72 PQL's and/or MDL's were raised due to high moisture content.
A74 A negative reading whose absolute value is greater than the MDL was obtained for the method blank.
A79 Prepared by EPA Method 5035.
A81 The result is below the calibration limit of the instrument. Due to the calibration technique used, a numerical result cannot be reported.
A83 Result based on tentatively identified compound search.
A84 Compound is a Non-Target Analyte
A85 Analyte is a Tentatively Identified Compound
A87 Carry over from a previously analyzed sample.
A88 Unable to report specific number. Insufficient dilutions to accommodate high concentration.
A89 TPH C4-C12
A90 TPPH does not exhibit a "gasoline" pattern. TPPH is entirely due to MTBE.
A91 TPH does not exhibit a "gasoline" pattern. TPH is entirely due to MTBE.
B Analyte found in blank sample (CLP Flag)
B01 Analyte detected in the Continuing Calibration Blank (CCB) at a level greater than the PQL.
B02 Analyte detected in the Continuing Calibration Blank (CCB) at a level between the PQL and 1/2 the PQL.
B03 Analyte detected in the Continuing Calibration Blank (CCB) at a level between the PQL and the MDL.
B04 The batch size for the Continuing Calibration Blank (CCB) exceeds the control limit.
B05 The time interval between Continuing Calibration Blank exceeds the control limit.
B06 The number of consecutive analyses of the Continuing Calibration Blank exceeds the control limit.
B07 The analytical sequence did not contain a Continuing Calibration Blank at the end.
C01 The calibration curve did not contain the minimum number of standards.
C02 The relative standard deviation of the calibration curve response factors exceeds the control limit.
C03 The correlation coefficient for the calibration was below the minimum control limit.
C04 The standards for the calibration were not analyzed on the same day.
C05 The standards for the calibration were not analyzed consecutively.
C06 The average of the calibration curve response factors exceeds the control limit.
C07 The response factor for a System Performance Check Compound (SPCC) is below the acceptable limit.
C08 The relative standard deviation of the calibration curve response factors for a Calibration Check Compound (CCC) exceeds the control limit.
D Dilution Used (CLP Flag)
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APPENDIX G
APPENDIX G
EFFECTIVE DATE: 01/08/16
PAGE G-3
USER FLAGS Qualifiers
D01 Recovery of a standard ath the PQL exceeded the control limit.
F1 Diesel range is C12-C14
F2 Motor Oil range is C25-C36
F3 WD-40 range is C8-C16
F4 Av Gas range is C6-C12
F5 Jet Fuel JP8 range is C6-CC14
F6 Kerosene range is C10-C20
FT01 Field sampled by certified personnel
I1 Baseline adjustment
I2 Peak correction
I3 Rider removal
I4 Retention time
J Estimated Value (CLP Flag)
L01 The Laboratory Control Sample Water (LCSW) recovery is not within laboratory established control limits.
L02 The Laboratory Control Sample Water (LCSW) recovery is not within method established control limits.
L03 The batch size for the Laboratory Control Sample Water (LCSW) exceeds the control limit.
L04 The matrix of the sample does not match the Laboratory Control Sample Water (LCSW)
L05 The Laboratory Control Sample Water (LCSW) was not analyzed prior to all the samples in the batch.
L06 The relative percent difference between the Laboratory Control Sample Water (LCSW) and the LCSW Duplicate exceeds the control limit.
L07 The Laboratory Control Sample (LCS) recovery is not within laboratory established control limits.
L08 The relative percent difference between the Laboratory Control Sample (LCS) and the LCS Duplicate exceeds the control limit.
L21 The Laboratory Control Sample Soil (LCSS) recovery is not within laboratory established control limits.
L22 The Laboratory Control Sample Soil (LCSS) recovery is not within method established control limits.
L23 The batch size for the Laboratory Control Sample Soil (LCSS) exceeds the control limit.
L24 The matrix of the sample does not match the Laboratory Control Sample Soil (LCSS)
L25 The Laboratory Control Sample Soil (LCSS) was not analyzed prior to all the samples in the batch.
L26 The relative percent difference between the Laboratory Control Sample Soil (LCSS) and the LCSS Duplicate exceeds the control limit.
M01 Analyte detected in the Method Blank at or above the PQL.
M02 Analyte detected in the Method Blank at a level between the PQL and 1/2 the PQL.
M03 Analyte detected in the Method Blank at a level between the PQL and the MDL.
M04 The batch size for the Method Blank exceeds the control limit.
M05 The Method Blank was not analyzed prior to all the samples in the batch.
M06 The internal standard on the Method Blank was not within the control limits.
M07 The surrogate recovery on the Method Blank for this compound was not within the control limits.
N01 This analyte exceeded the PQL in the beginning interference check standard.
N02 Recovery of this analyte in the beginning spiked interference check standard was not within the control limits.
N03 The beginning interference check standard was not analyzed prior to this sample.
N11 This analyte exceeded the PQL in the ending interference check standard.
N12 Recovery of this analyte in the ending spiked interference check standard was not within the control limits.
N13 The ending interference check standard was not analyzed after this sample.
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APPENDIX G
APPENDIX G
EFFECTIVE DATE: 01/08/16
PAGE G-4
USER FLAGS Qualifiers
ND ND
NoObO No Obs Odor
NR Non-Reactive
NR2 Non-Reactive
NTA Non Target Analyte
P01 Post spike recovery was not within the control limits.
P02 The batch size for the Post Spike exceeds the control limit.
P03 The relative percent difference between the duplicate Post Spikes exceeds the control limit.
PD Sample container was preserved on [Custom Value]
pH1:1 pH result reported on a 1:1 dilution of sample
pH1:2 pH result reported on a 1:2 dilution of sample
pH1:3 pH result reported on a 1:3 dilution of sample
pHdil pH result reported on a 1:[Custom Value] dilution of sample
pHsat pH result reported on a saturated paste of sample
pHstr pH result reported on a straight aliquot of sample
Q01 Sample precision is not within the control limits.
Q02 Matrix spike precision is not within the control limits.
Q03 Matrix spike recovery(s) is (are) not within the control limits.
Q04 The batch size for the QC set exceeds the control limit.
Q05 The matrix of the sample does not match that of the spike samples.
Q06 The dilutions of the quality control set are not consistent.
R01 The sample result is between the MDL and PQL.
R11 Per client request the reported PQL is less than the laboratory PQL but above the laboratory MDL.
S01 Sample result is not within the quantitation range of the method.
S02 The relative percent difference between duplicate instrument readings exceeds the control limit.
S03 A negative reading whose absolute value is greater than the PQL was obtained for the sample.
S04 The instrument reading for the sample was not a numeric value.
S05 The sample holding time was exceeded.
S06 There was an excessive amount of time between the prior sample and this sample in the analytical run.
S07 This sample result may contain carry over from the prior analytical sample.
S08 The internal standard on the sample was not within the control limits.
S09 The surrogate recovery on the sample for this compound was not within the control limits.
S10 The analyte in the Method Blank is greater than the laboratory PQL and the sample result is less than 10 times the Method Blank.
S11 The analyte in the Method Blank is greater than the laboratory PQL but the sample result is greater than 10 times the Method Blank.
S12 The Method Blank bias is greater than the PQL
U Analyte Not Detected at or above the reporting limit (CLP Flag)
V01 The Initial Calibration Verification (ICV) recovery is not within established control limits.
V02 Not all of the calibration standards were analyzed prior to the Initial Calibration Verification (ICV).
V03 The internal standard on the Initial Calibration Verification (ICV) was not within the control limits.
V11 The Continuing Calibration Verification (CCV) recovery is not within established control limits.
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PAGE G-5
USER FLAGS Qualifiers
V12 More than the acceptable numbers of samples were analyzed between Continuing Calibration Verification (CCV) standards.
V13 The time interval between Continuing Calibration Verification standards exceeds the control limit.
V14 The Continuing Calibration Verification (CCV) standard was reanalyzed more than the acceptable number of times.
V15 There was no Continuing Calibration Verification (CCV) at the end of the analytical sequence.
V16 The internal standard on the Continuing Calibration Verification (CCV) was not within the control limits.
V17 The percent deviation between the Continuing Calibration Verification (CCV) and the original calibration exceeds the control limit.
V18 The instrument response for a System Performance Check Compound (SPCC) on the Continuing Calibration Verification (CCV) is below
the control limit. V19 The relative standard deviation of the calibration curve response factors for a Calibration Check Compound (CCC) in the Continuing
Calibration Verification (CCV) exceeds the control limit.
V20 For EPA 200.8 analyses the acceptable recovery is 85% - 115% for a CCV following sample analysis.
W1 Analysis performed by Weck Laboratories, Inc.
Z1 [Custom Value]
Z2 [Custom Value]
Z3 [Custom Value]
Z4 [Custom Value]
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APPENDIX H
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SOPs Table List Of SOP (Initial The SOP that pertains to your Job duties or responsibilities)
Inorganic Dept.
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCGEN004 ALKALSOPR7 Carbonate, Bicarbonate, Alkalinity, 310.1/SM 2320B 7
BCGEN005 COLOR5 Color/ 110.2/SM 2120B 5
BCGEN007 DSOXYGENR5 Dissolved Oxygen/360.1 SM4500-06 5
BCGEN009 SETTEABLR7 Settleable Solids/160.5/SM 2540F 7
BCGEN010 CHLORINER6 Residual Chlorine/330.4/SM 4500-CLF 6
BCGEN011 ECR6 Specific Conductance (EC)9050 120.1 SM 2510B 6
BCGEN013 TDSR8 Total Dissolved Solids Filterable Residue 160.1/SM 2540C 8
BCGEN014 TURBIDITR5 Turbidity/180.1/SM 2130B 5
BCGEN016 WCBACTERRev13 Bacteriology (Coliform/Fecal) 13
BCGEN017 BODR8 Analyte: Biochemical Oxygen 405.1 SM5210B 8
BCGEN020 SULF376_1R7 Sulfide 376.1/SM 4500/9030 7
BCGEN021 MBASR8 MBAS/EPA 425.1/ SM 5540C 8
BCGEN022 TSSR6 Total Suspended Solids/EPA 160.2/SM 2540 D 6
BCGEN024 ODOR6 Odor/EPA 140.1/SM 2150 6
BCGEN026 COD410_4R8 Chemical Oxygen Demand Colormetric, Manual/410.4/SM 5220D 8
BCGEN033 PHREV8 PH/EPA 150.1/9040 8
BCGEN035 REACTSULREV7 Reactive Sulfide\\EPA Method 7.3.4.1 7
BCGEN039 WCTOCR15 Total Organic Carbon (TOC)/ SW 5310C/EPA 415.1 15
BCGEN040 SULF376_2R7 Sulfide Method 376.2 7
BCGEN043 160.4R5 Fixed and Volatile Solids, 160.4/SM 2540E 5
BCGEN044 GLASSWR6 General Glassware Washing 6
BCGEN046 TOTRESR4 Total Residue 160.3 SW 2540B 4
BCGEN048 EPA300R10 Determination of Anion in water and solid by Dionex IC DX500/EPA 300.0 (9056) 10
BCGEN049 EPA314.0R9 Perchlorate / 314.0 9
BCGEN050 DEWAPRODR2 Deionized Water Productiion-Nanopure water 2
BCGEN051 KLORTH_365.1R5 ORTHOPHOSPHATE EPA 365.1 5
BCGEN052 KLHEXACROMR6 KONELAB HEXAVALENT CHROMIUM-7196 A 6
BCGEN053 PhSOLIDR4 EPA METHOD 9040C, 9045D 4
BCGEN055 KLNOR5 KONELAB NITRITE NITROGEN EPA 353.2 5
BCGEN056 HEXCR_218.6R6 HEXAVALENT CHROMIUM EPA 218.6/7199 6
BCGEN057 KLNCYNR7 KONELAB CYANIDE EPA 335.2/33.4/9012A/SM4500-CN-G, I (same as 9010) 7
BCGEN058 SC_NO3-NR4 Smartchem Nitrogen, Nitrate-Nitrite/EPA Method 353.2 4
BCGEN059 SC_TKN-NR5 Smartchem Total Kjeldahl Nitrogen/EPA Method 351.2 5
BCGEN060 SC_TOT_PR4 Smartchem Total Phosphorus/EPA Method 365.4/SM 4500-P 4
BCGEN061 SC_NH3-NR4 Smartchem Ammonia - Nitrogen/EPA method 350.1 (SM-4500-NH3-G) 4
BCGEN062 KLPHENOLR5 Konelab Total Recoverable Phenolics EPA 420.4 5
BCGEN063 REACTCYANR1 Reactive Cyanide\\EPA Method 7.3.3.2 1
BCGEN064 SC_PHENOLR0 Smartchem Total Recoverable Phenolics EPA 420.4 (Inactive SOP 4-13-10) 0
BCGEN065 METROHMR2 Electrical Conductivity, pH, Alkalinity// EPA 9050/120.1/SM 2510B, EPA 9040/150.1/SM 4500HB, EPA 310.1/ SM 2320B 2
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Inorganic Dept.
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCGEN066 CO2_R1 Free Carbon Dioxide in Water-SM4500 1
BCGEN067 ORP_R1 Oxidation-Reduction Potential in Water 1
BCGEN068 SM3500_FeR0 SM 3500 FeD - Ferrous Iron 0
BCGEN069 FLASHPOINTR0 Flash Point by Pensky-Martens Closed Tester/ASTM D-93, EPA Method 1010 0
BCGEN070 IGNIT_EPA1030R0 IGNITABILITY OF SOLIDS-EPA Method 1030 0
BCGEN071 EPA300M-FATTYAR0
DETERMINATION OF ORGANIC ACIDS IN WATER BY DIONEX IC/EPA 300.0M (Fatty Acid) 0
BCGEN072 pHSM4500-HBR0 pH Method-SM 4500 H&B (Agar Media) 0
BCPREP006 3010R10 Acid Digestion of Aqueous Samples and Extracts for Total Metals for Analysis by ICP Spectroscopy/Method 3010A 10
BCPREP008 TCLP_EXTR2 TCLP Extraction 2
BCPREP009 SPLP_EXTR0 SYNTHETIC PRECIPITATION LEACHING PROCEDURE (SPLP) EPA 1312 (Inorganic TTLC) 0
BCPREP011 WET_EXTR2 Wet Extraction-STLC 2
BCPREP014 SPLITR6 Splitting and Refrigerating Samples 6
BCPREP015 3050R17 Acid Digestion of Sediments, Sludges and solids for analysis by FLAA or ICP Spectroscopy/Method 3050A 17
BCPREP017 2002BLOKR6
HOT BLOCK DIGESTION OF WATERS FOR TOTAL RECOVERABLE METALS FOR ANALYSIS BY GFAA, ICP SPECTROSCOPY, OR ICP MASS SPECTROSCOPY METHOD 200.2 / 3005 6
BCPREP018 FREELIQDETR2 Free Liquid Determination (TCLP) 2
BCPREP019 3060AR1 EPA METHOD 3060A 1
BCPREP021 EPA1320R0 METHOD 1320 MULTIPLE EXTRACTION PROCEDURE 0
BCSAM002 LOGISLR15 Sample Loging - In - Prep (BarCode Scanning) 15
Metals Dept.
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCMET006 EPA200GFR8 GRAPHITE FURNACE EPA 200/7000A 8
BCMET010 HG_7470R15 MERCURY (Hg) // EPA 7470A/EPA 245.1 15
BCMET011 HG_7471R19 MERCURY (Hg) // EPA 7471 / 245.5 19
BCMET013 6010METALR19 Determination of Metals and Trace Elements in Soil, Water and Waste Waters by ICP-AES 200.7/6010 19
BCMET025 MOISTURER3 % Moisture/ % Solids/SM2540G 3
BCMET035 METSPE1R10 (Sb, As, Pb, Se) EPA 200.9/7000A PE-1 10
BCMET037 6100ELANR13 EPA METHOD 200.8 USING ELAN 6100 ICP-MS 13
BCMET038 EPA6020AR12 EPA 6020A 12
Extraction Dept.
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCDOC004 XLOGR6 Extraction Log 6
BCDOC011 XREAGLOGR2 Extractions Reagent Log 2
BCDOE004 REAGPFR4 REAGENT PURITY/FITNESS FOR USE 4
BCMIS007 XROUMAINR4 Extractions Routine Maintenance 4
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Extraction Dept.
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCORG016 ZHEREV7 Zero Head Space Extraction for Volatiles/EPA 1311 (Volatile TTLC) 7
BCORG026 EPA1664R9 Method 1664- Oil and Grease 9
BCORG040 ORGCR3 ORGANIC GLASSWARE CLEANING 3
BCORG047 ExtrtPreScreeninR1 Extract Pre-screening 1
BCORG057 SCREENXPLR0 SCREENIN FOR EXPLOSIVES IN SOIL 0
BCORG065 SYRINGER1 Glass Syringe Accuracy Determination 1
BCPREP001 EX3510R15 Extractions-Waters by EPA 3510 & All Methods 15
BCPREP002 OR3550r13 Organics Extractions - EPA 3550/Ultrasonic Extractions All Methods 13
BCPREP016 SILICA-3630CR5 Silica Gel Cleanup for PAH's\EPA 3630C 5
BCPREP020 SILICA-3630MR1 Silica Gel Cleanup for EPA 3630-Modified 1
Semi-Volatiles
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCORG001 549.2R7 Epa 549.2 Diquat and Paraquat 7
BCORG002 515815R13 EPA 515.1, 615, 8150B, 8151 13
BCORG004 8140R10 EPA METHOD 8140/8141/614 10
BCORG005 TPHFELR14 LUFT TPH(FUELS)/ EPA 8015M-Diesel (FFP)(Hydraulic Oil/Motor, Mineral Oil)(DRO) 14
BCORG006 548R6 Determination of Endothal in drinking water 548 6
BCORG008 525_2R5 Determination of Organic Compounds in Drinking Water by Liquid-Solid Extraction and Capillary Column, Gas Chromatography/Mass Spectrometry. EPA 525.2 5
BCORG009 504R12 EPA 504.1 (Instrument GC-04) 12
BCORG011 8310REV14 Polynuclear Aromatic Hydrocarbons by HPLC/EPA 8310/610 14
BCORG014 508R15 Organchlorine Pesticides and PCB's by Gas Chromatography EPA 508/608/8080/8081 15
BCORG018 632R5 High Performance Liquid Chromatography for Carbamate and Urea Pesticides in Wastewater/EPA 632 5
BCORG019 8082R14 Gas Chromatography EPA 8082-PCB Water 14
BCORG020 625827R15 GC/MS for Semi-Volatiles/EPA 625/8270(PAH, Phthalates, Phenols) 15
BCORG029 8330R10 Nitroaromatics and Nitroamines by High Performance Liquid Chromatography Method 8330 (Explosives) 10
BCORG042 525_2SPER3 SOLID PHASE EXTRACTION/EPA METHOD 525.2 3
BCORG053 8270SIMR5 EPA 8270C SIM PNA/NDMA 5
BCORG055 GCMSLUFTR4 GC/MS FOR SEMI-VOLATILES/ 8015B Diesel-TPH 4
BCORG058 DETERHAA5R4 Determination of HAA5 in Drinking Water by Liquid, Liquid Microextraction-552 4
BCORG059 8015B-METHETHR3 EPA Method 8015B-Methanol and Ethanol 3
BCORG060 556R3 EPA METHOD 556 3
BCORG070 AK102_103R2 AK102 & 103: Determination of Diesel and Motor Oil Range Organics (DRO C10-C25 & RRO C25-C36) 2
BCORG071 AK103R0 AK103: Residual Range Organics 0
Volatiles
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCDOC007 VOL_GCRLR6 Volatiles GC Run Log 6
BCDOC008 VOL_STANR5 Volatiles Standard Log 5
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BCDOC010 DETERTCPR1 1, 2, 3 – TCP DRINKING WATER BY P & TRAP GC/MS 1
BCORG003 TPHGASR21 LUFT TPH(GA) BTEX/8015M,8020,8021B,602(Gasoline-GRO) 21
BCORG025 5035R6 Closed System Purge & Trap (5035) (same as (5030A)) 6
BCORG045 8260PPHR6 EPA METHOD 8260 TPPH 6
BCORG049 624R14 EPA METHOD 624 14
BCORG051 8240_8260R11 EPA METHOD 8240/8260w/s 11
BCORG054 524R8 EPA METHOD 524.2 8
BCORG056 ORGVAPR2 Mercury and Oragnic Vapor Monitor Analysis 2
BCORG061 AIRTO14_15R3 AIR TESTING METHOD TO-14A AND TO-15 3
BCORG062 CANISTER2 Canister Cleaning 2
BCORG063 DYNAMICR0 DYNAMIC DILUTION 0
BCORG064 FIXGASR4 FIXED GAS ANALYSIS -Air Testing 3C/ASTM D-1946 4
BCORG066 SULF307.91R1 307.9 M Sulfur Compunds Methods 1
BCORG067 RSK175M_R3 RSK-175 -Dissolved Gas Analysis in Water for Methane/Ethane/Ethene 3
BCORG068 TO3_R1 AIR TESTING METHOD TO-3 1
BCORG069 AK101R1 AK101: Determination of Gasoline Range Organics (GRO C6-C10) 1
QC Dept
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCQC002 QCTHRMR19 QC - Thermometer Monitoring 19
BCQC005 QCFRDGR16 QC - Refrigerator Monitoring 16
BCQC007 QCOVENR13 QC - Oven Monitoring 13
BCQC008 QCBLNCR17 QC - Balance Monitoring 17
BCQC011 QCDILMONR5 QC-DILUTER MONITORING 5
BCQC013 QCEPPENDORFR0 QC - EPPENDORF PIPETTE CALIBRATION 0
Client Service
SOP ID SAVED AS SOP TITLE REV
Analyst Int.
BCDOC002 COCR4 Chain of Custody 4
BCMIS009 SHIPPINGR9 Shipping 9
BCREC001 RECEPTR6 RECEPTIONIST 6
BCSAM005 LOGISRV21 Sample Receiving 21
BCSER001 BOTPRER14 Bottle Prep (bottleware) 14
BCSER006 COCTRACKR3 COC & Tracking 3
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Employee SOP Acknowledgement and Agreement Form
Personnel Training Record
Of
Standard Operation Procedure (SOPs)
This is to acknowledge and agree that I have read and understand the latest version of Standard
Operation Procedure(s) applicable to my job responsibilities/duties (See appendix H SOP
Table).
_______________________________ ______________________
Employee Name (Print) Date
____________________________
Employee Signature
_______________________________ ______________________
Supervisor Name (Print) Date
____________________________
Supervisor Signature
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SECTION VI REVISION 7 EFFECTIVE DATE 01/08/16 Page VI-1
Quality
Assurance
Protocols
Manual
BC Laboratories, Inc.
4100 Atlas Court
Bakersfield, CA 93308
Carolyn Jackson Sara Guron
President Quality Assurance Officer
(661) 327-4912 Ext. 213 (661) 327-4912 Ext. 288
Effective Date: 01/08/2016 .
UnControlled Copy:
Issued to:
Date:
Location:
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QUALITY ASSURANCE PROTOCOLS MANUAL
TABLE OF CONTENTS
QUALITY ASSURANCE PROTOCOL MANUAL OF
B C LABORATORIES, INC.
Approved by Signed by
Date
CEO/President:
Technical Director:
Quality Assurance
Officer:
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QUALITY ASSURANCE PROTOCOLS MANUAL
TABLE OF CONTENTS
Table of Contents
1 Introduction ...................................................................................................................... I-1 thru I-4
2 Definition of Terms ....................................................................................................... II-1 thru II-6
3 Training ....................................................................................................................... III-1 thru III-7
3.1 Overview
3.2 Orientation
3.3 Process
3.4 Internal Training Program
3.5 External Training Program
3.6 Safety
3.7 Performance Evaluations
3.8 Employment
4 Laboratory Information Management System............................................................ IV-1 thru IV-5
4.1 Introduction
4.2 Access
4.3 General Rules
4.4 Crashes
5 Creation, Modification, Distribution and Maintenance of
Laboratory Controlled Documents ................................................................................ V-1 thru V-6
5.1 Scope and Application
5.2 Creation
5.3 Modification
5.4 Distribution
5.5 Management
6 Sample Procedure ...................................................................................................... VI-1 thru VI-5
6.1 Overview
6.2 Sample Containers
6.3 Sample Storage Before Analysis
6.4 Preservation Techniques
6.5 Holding Times
6.6 Analysis Reference Chart
7 Custody .................................................................................................................... VII-1 thru VII-9
7.1 Scope and Application
7.2 Summary
7.3 Potential Problems
7.4 Custody
7.5 Secured Facility
7.6 Alarm System
7.7 Visitors
7.8 Sample Custody Procedures
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8.0 Standard and Reagent Handling ............................................................................ VIII-1 thru VIII-4
8.1 Introduction
8.2 Qualification
8.3 Receiving
8.4 Preparation
8.5 Expiration Date
8.6 Preservation and Storage
8.7 Documentation
8.8 Disposal
9.0 Glassware ................................................................................................................... IX-1 thru IX-7
9.1 Overview
9.2 Types
9.3 Glassware Colors
9.4 Cleaning
9.5 Organics Testing
9.6 High Concentration Samples
9.7 Metals
9.8 Wet Chemistry
9.9 How to Measure Containment
9.10 Delivery and Containment Glassware Types
10.0 Measuring ..................................................................................................................... X-1 thru X-2
10.1 Weight
10.2 Accuracy
10.3 Safety
10.4 Containment
10.5 Cross-Contamination
10.6 Capacity
10.7 Alignment
10.8 Appropriateness
10.9 Liquids Measuring
10.10 Important Safety Practices
11.0 Microliter Pipette Calibration .................................................................................... XI-1 thru XI-3
11.1 Scope and Application
11.2 Summary of Method
11.3 Apparatus and Materials
11.4 Procedure
11.5 Compliance Limits
11.6 Documentation
11.7 References
12.0 MDL/PQL Determinations ...................................................................................... XII-1 thru XII-8
12.1 Scope and Application
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12.2 Summary of Method
12.3 Required Apparatus and Materials
12.4 Reagents and Standards
12.5 General MDL/PQL Procedure
12.6 Procedures by Test
12.7 Detection Limits for Soil Matrix
12.8 Documentation, Approval and Reporting
12.9 References
13.0 Reporting ............................................................................................................. XIII-1 thru XIII-10
13.1 Reporting Procedures for Qualified Data
13.2 Rounding Rules for Reporting Data
13.3 Quality Control Parameter Evaluation
13.4 Low Level Reporting
13.5 Manual Integration
13.6 Manual Integration Labeling
14.0 Audit Handling Procedures .................................................................................. XIV-1 thru XIV-3
14.1 Scope and Application
14.2 Summary of Method
14.3 Apparatus and Materials
14.4 Reagents and Standard Solutions
14.5 Solution Preparation
14.6 Working Standards
14.7 Sample Collection, Preservation and Handling
14.8 Procedure
14.9 Forms
14.10 Safety
15.0 Technical Reviews .................................................................................................. XV-1 thru XV-2
15.1 Scope and Application
15.2 Summary of Method
15.3 Materials
15.4 Procedure
15.5 Quality Control
16.0 Control Charting .................................................................................................. XVI-1 thru XVI-2
16.1 Introduction
16.2 Monitoring of LCSW
16.3 Development of Control Charts
16.4 Maintenance of Control Charts
16.5 Calculation Controls
17.0 Corrective Action/Quality Improvement ........................................................... XVII-1 thru XVII-7
17.1 Introduction
17.2 When to Initiate
17.3 Determining the Root Cause
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17.4 Constructing a Basic Cause-and-Effect Diagram
18.0 Preventive Maintenance .................................................................................. XVIII-1 thru XVIII-3
18.1 Overview
18.2 Part Maintenance
18.3 Preventive Maintenance Schedules
18.4 Preventive Maintenance Logs
18.5 Service Contracts
18.6 Service Calls
18.7 Tagging Out
18.8 Verification of Working Status
19.0 Procurement ......................................................................................................... XIX-1 thru XIX-3
19.1 Overview
19.2 Responsibilities
19.3 Requisition Forms
19.4 Supply Receiving
19.5 Standard Receiving
19.6 Reagent Receiving
19.7 Receiving Products Which Can be Calibrated
20.0 Method Modifications ........................................................................................... XX-1 thru XX-12
20.1 Introduction
20.2 Modification Process
21.0 Security ................................................................................................................ XXI-1 thru XXI-3
21.1 Security System
21.2 How to Obtain an Access Code
21.3 How to Obtain a Password
21.4 How to Activate/Deactivate the Security System
21.5 How to Use the Intercom
21.6 What to do When Working Odd Hours
21.7 How to Contact Kern Securities
21.8 How to Answer Phone Calls
21.9 Responsibility
21.10 Keys
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INTRODUCTION
SECTION I REVISION 3 EFFECTIVE DATE 01/08/16 Page I-1
The intention of the QA Protocols Manual (QAPM) is to act as a working laboratory protocol/process
reference. This reference contains information essential to control various laboratory processes and to
communicate quality policy to the bench level. Designed as a policy communication tool, the QAPM,
administered by the QA Officer, is an integral part of the QA system.
The QAPM can be considered an organized collection of SOPs, which are needed by all employees to
conduct those common tasks, which are not addressed in detail in individual analytical SOPs. Because
of the difficulty in maintaining the system and at the same time increase communication and thus
promote improved quality. BCL employees should refer to this guide prior to contacting their
department supervisor or QA Officer when questions arise regarding quality, policy or procedure.
This manual is maintained under a controlled status, thus only one copy will be distributed to each
employee. All updates will be processed and distributed by the QA/QC department. Please refer to
Section V for more details on controlled documentation. BCL employees should keep this manual on
site to refer and use at will.
The quality program consists of five essential components:
1) Prevention
2) Assessment
3) Validation
4) Corrective Action
5) Improvement.
The QAPM falls into the prevention category since it was designed to communicate policy, provide
essential information, and promote good laboratory practices. If used properly, the QAPM will reduce
the chance for error and promote better understanding. Section I of the QAPP discusses the components
of the quality system in more detail.
The QA Officer is responsible for the maintenance of the QAPM. Review of this plan should take place
each year. All revisions and additions will be reviewed and approved prior to distribution. Once
approved, affected section revision number(s) are sequentially incremented and the approval date is
updated accordingly. All revised sections are distributed to laboratory personnel. Acknowledgement of
receipt signatures is required as a record of transfer of information.
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INTRODUCTION
SECTION I REVISION 3 EFFECTIVE DATE 01/08/16 Page I-2
Figure 1.1 illustrates how the QAPM fits into the QA document scheme.
QAPP
QAPM
SOPs
Polic
y
Proc
edur
e
Less detailed
Detailed
Figure 1.1
Establishes Quality
Policy and Goals.
Describes the quality
system.
Practical analyst working
manual for those
procedures other than
analytical methods
which are critical to the
order and control of the
quality system.
Written procedures
which describes
practices for a given
procedure or activity.
As noted above, SOPs should supply the most detailed information in regards to specific tasks, thus
SOPs are referenced by this manual and the QAPP. SOPs are distributed on an as needed basis to the
supervisor/analyst that the SOP directly affects. Access to SOPs is limited and specific rules will apply
(see section V).
The QAPP, on the other hand, is less detailed but provides the standards by which our quality system
must operate. Quality policy, set through goals and objectives, is stated and mandated to comply with
regulatory, client, project and internal requirements.
Objectives: To provide QA/QC guidelines to:
1) assure the data produced is of known quality
2) ensure our organization is capable of providing results which are of value to our customers
3) ensure the system can consistently perform under adverse conditions
4) Comply with quality goals and objectives set forth in government and industry standards.
Policy Statement: BC Laboratories, Inc. is an organization committed to providing data that is
technically valid and in accordance with professional standards and government regulations. The
management and staff of BC Laboratories, Inc. are committed to use all available resources to supply
accurate, precise, timely and fully documented results which should withstand legal challenge. BCL’s
goal is to provide analytical results and services which are of value to our customers.
Employees are encouraged to access the QAPP by contacting their department supervisor or the QA
Officer.
Please note that if conflicts exist among or between this manual and other documents, employees are
urged to contact their department supervisor and/or the QA Officer to resolve the differences.
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ACRONYMS
SECTION I REVISION 4 EFFECTIVE DATE 1/13/15 Page I-3
AA Atomic Absorption LOD Limit of Detection
AAII Auto Analyzer LOQ Limit of Quantitation
BCL BC Laboratories, Inc. MB Method Blank
BFB Bromofluorobenzene MCL Maximum Contaminant Level
CCB Continuing Calibration Blank MDL Method Detection Limit
CCC Calibration Check Compound MS Matrix Spike
CCV Continuing Calibration Verification MSD Matrix Spike Duplicate
CLP Contract Laboratory Program PQL Practical Quantitation Limit
COC Chain of Custody QAPP Quality Assurance Project Plan
CRDL Contract Required Detection Limit QAPM Quality Assurance Protocols Manual
CRMDL Contract Reporting Method Detection
Limit
QAPP Quality Assurance Program Plan
CRPQL Contract Reporting Practical
Quantitation Limit
RFP Request for Proposal
CV Cold Vapor RFQ Request for Quotation
DFTPP Decafluorotriphenylphosphine RL Reporting Limit
DLR Detection Limit Reporting RLS Reporting Limit Standard
DQO Data Quality Objective RPD Relative Percent Difference
Dup Duplicate RSD Relative Standard Deviation
EB Equipment Blank SIF System Improvement Form
GC Gas Chromatography/Chromatograph SM Standard Methods
GC/MS Gas Chromatography/Mass
Spectrometry
SMC System Monitoring Compound
GFAA Graphite Furnace Atomic Absorption SOP Standard Operating Procedure
GHAA Gaseous Hydride Atomic Absorption SOW Statement of Work
IB Instrument Blank SPCC System Performance Check Compound
IC Ion Chromatography/Chromatograph SRM Standard Reference Material
ICB Initial Calibration Blank STLC Soluble Threshold Limit Concentration
ICP Inductively Coupled Plasma TB Trip/Travel Blank
ICP/MS Inductively Coupled Plasma/Mass
Spectrometry
TCLP Toxicity Characteristic Leaching
Procedure
ICV Initial Calibration Verification TOX Total Organic Halides
IDC Initial Demonstration of Competency TTLC Total Threshold Limit Concentration
IDL Instrument Detection Limit UCL Upper Control Limit
IS Internal Standard WET Waste Extraction Test
LCL Lower Control Limit WPS Word Processing Specialist
LCS Laboratory Control Sample ZHE Zero Headspace Extraction
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CONVERSION TABLES
SECTION I REVISION 4 EFFECTIVE DATE 1/13/15 Page I-4
Temperature Given In °C °K °F
°C C C + 273.15 1.8C + 32
°K K – 273.15 K 1.8K + 459.4
°F 0.556F – 17.8 0.556F + 255.3 F
Factor Prefix Symbol
10-12 Pico p
10-9 Nano n
10-6 Micro µ
10-3 Milli m
103 Kilo k
To Convert Into Multiply
µg/L (ppb) mg/l (ppm) 0.001
mg/L (ppm) µg/L (ppb) 1000
µg/kg (ppb) mg/kg (ppm) 0.001
mg/kg (ppm) µg/kg (ppb) 1000
µg/ml (ppm) mg/l (ppm) 1
µg/g (ppm) mg/kg (ppm) 1
Note: Section I was review on 01/08/16 (No changes were made)
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DEFINITION OF TERMS
SECTION II REVISION 3 EFFECTIVE DATE 01/08/16 Page II-1
Aliquot-a measured portion of a sample taken for analysis
Analytical Sample-any solution or media introduced into an instrument or analyzed on an apparatus
excluding instrument calibration, initial calibration verification, initial calibration blank,
continuing calibration verification, and continuing calibration blank.
Background Correction-a technique to compensate for variable background contribution to the
instrument signal in the determination of trace elements
Batch-a set of environmental samples and QC samples of similar matrix which are processed: 1) as a
unit, 2) within a prescribed 24 hour time span, 3) with the same method manipulations and 4)
with the same lots of reagents and standards. Batch size is method dependent with a maximum
number of field samples per batch set at 20. QC samples, such as method blanks, laboratory
control samples, duplicates, and matrix spikes, are not counted when figuring batch size.
Calibration-the establishment of an analytical curve based on the absorbance, emission, intensity, or
other measured characteristic of known standards. The calibration standards must be prepared
using the same type of acid or concentration of acids as used in the sample preparation.
Calibration Factor-a factor derived by taking the response of an analyte or set of analytes in a standard
divided by the concentration of the standard. Used in calculation models not using least squares
techniques.
Case Narrative-portion of the data package which includes project codes, sample and field information,
and descriptive documentation of any problems encountered in processing the sample, along with
problem resolution or qualifying narratives.
Continuing Calibration Blank-(CCB) an instrument blank analyzed after each continuing calibration
verification. Used to monitor and verify the instrument baseline.
Continuing Calibration Verification-(CCV) a mid-point standard prepared from a separate source than
that of the standard curve. Used to verify accuracy of the standard curve. (4)
Control Limits-control limits may be specified in a reference method (either as mandatory or guidance
limits), or may be developed by the laboratory using internal performance data. Control limits
represent acceptance criteria for determining whether an analytical system is in control. Also
described as a range within a specific measurement, results must fail to be compliant. Control
limits may be mandatory, requiring corrective action if exceeded, or advisory, requiring that
noncompliant data be flagged.
Correlation Coefficient-a number (r) which indicates the degree of dependence between two variables.
The more dependent they are, the closer the value to one. Determined on the basis of the least
squares line.
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DEFINITION OF TERMS
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Data Quality Objective-(DQO) project specific requirements which supercede internal quality goals.
Detection Limit Standard-a standard analyzed at the practical quantitation level. Used to verify daily
instrument low level performance.
Dilution-having combined a diluent and a concentrated source to produce less concentrated solution.
Dilution Factor-numerical representation of a dilution. If a dilution is not made, the dilution factor is 1.
The number which you multiply a diluted sample result to derive the final result.
Dissolved Metals-analyte elements which have not been digested prior to analysis and which will pass
through a 0.45 µm filter.
Duplicate-a sample which is one of two replicates. Used to measure sample precision. Types of
duplicates include field, matrix, and matrix spike duplicates. Laboratory duplicates are prepared in
the laboratory as split samples, and carried through the entire measurement process as independent
samples.
Equipment/Rinsate Blank-analyte-free water which is poured over or into field sampling equipment.
Used to monitor equipment cleanliness and the adequacy of the decontamination process. (4)
Field Blank-aliquot of analyte-free water or solvent brought to the field in a sealed container. Opened
in the field to monitor conditions at the time of sampling. (4)
Field Sample-a portion of material received to be analyzed.
Holding Time-the storage time allowed between sample collection and sample analysis when the
designated preservation and storage techniques are employed.
IDL-(Instrument Detection Limit) the smallest signal above background noise that an instrument can
reliably detect. Determined by multiplying the standard deviation of replicate reagent blanks by 3.
The calculation provides for a 99% confidence level that the IDL is not zero (if blank readings
average zero).
Independent Check Standard-a standard solution that is composed of analytes from a different source
that those used in the standards for the initial calibration.
Initial Calibration Blank-(ICB) an instrument blank analyzed after an initial calibration verification.
Used to monitor and verify the instrument baseline.
Initial Calibration Verification-(ICV) a mid-point standard prepared from a separate source than that
of the standard curve. Used to verify accuracy of the standard curve. (4)
Injection-introduction of a sample into the instrument system.
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Instrument Calibration-analysis of analytical standards for a series of different specified
concentrations; used to define the quantitative response, linearity, and the calibration range of the
instrument to target analytes.
Interference Check Sample-a solution containing both interfering and analyte elements of known
concentration that can be used to verify background and interelement correction factors.
Interference Check Standards-standards used to monitor spectral interferences for inductively coupled
argon plasma analysis.
Interferents-substances which affect the analysis for the element of interest.
Internal Standards-compounds added at a known concentration to all GC/MS samples.
Instrument Spike Level-the concentration of the spike addition without consideration to applicable
sample weight ratio, sample volume ratios, or dilution schemes.
IQL- (Instrument Quantitation Limit) a level set lower than accepted analyte PQL’s which still meets
PQL derivation standards. Used as an internal compliance tool for a typical low level reporting.
Laboratory Control Sample-(LCS) a beginning matrix (deionized water, baked sand), spiked with the
same spiking solution used for matrix spikes, is used to validate the accuracy of the analytical
system under ideal matrix conditions. This QC parameter, known as the Laboratory Control
Sample, is a required QC sample which is prepared and analyzed with each batch at a frequency
set per method. The LCS contains the same analytes at the same concentrations as spiked in
matrix spikes. LCS validity is assessed through percent recoveries compared against statistically
based control limits unless general criteria has been defaulted. If any LCS analytes are outside
acceptable limits, associated sample data should be considered estimated, thus the entire batch
should be reprepared and reanalyzed unless it can be proven that effects can solely be attributed
to the LCS and no other QC indicators show possible quality compromise.
Laboratory Performance Check Sample-a solution described in certain drinking water methods which
is used to verify acceptable chromatography.
Linear Range-the concentration range over which the analytical curve remains linear.
Matrix-the predominant material of which the sample to be analyzed is composed. A sample matrix is
either aqueous or non-aqueous as described in the LIMS. Matrix identifying should be more
detailed at the preparation and/or the analytical levels. Detailed descriptions of sample matrices
should be documented in preparation logs.
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DEFINITION OF TERMS
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Matrix Spike/Matrix Spike Duplicate-(MS/MSD) samples with an addition of a predetermined
quantity of stock solution(s) containing certain analytes. The addition of stock takes place before
any preparation steps to verify either matrix effects and/or preparation efficiency.
MCL-(Maximum Contaminant Level) the maximum permissible level of a contaminant in water which
it delivered to any user of a public water system. (2)
MDL-(Method Detection Limit) the lowest concentration level that can be determined to be statistically
different from the blank with consideration placed on routine sample preparation. The MDL is
determined by multiplying the standard deviation of prepared replicate samples spiked at 3 to 5
times the estimated detection limit by a corresponding students’t value. This value is at the 99%
confidence level with n-1 degrees of freedom. See the “Table of Students’t Values at the 99%
Confidence Level” in Appendix B 40 CFR Part 136. (1)
Method of Standard Addition-(MSA) the addition of increments of standard solution (spikes) to
sample aliquots of the same size. Measurements are made on the original and after each
addition. The slope, x-intercept, and y-intercept are determined by least squares analysis.
Modifier-salts used in metals testing which lesson the effects of chemical interferences, viscosity, and
surface tension.
M/Z-mass to charge ratio.
Percent Difference-the percent difference indicates both the direction and the magnitude of the
comparison of two values, one of which is used as a reference.
Percent Drift-used to describe GC/MS calibration status.
Percent Moisture-an approximation of the amount of water in a soil/sediment sample made by drying
an aliquot of the sample.
Performance Evaluation Sample-a sample from an outside source which is used to verify the control
of an analytical method.
Post Spike/Post Spike Duplicate-(PS/PSD) samples, digests or extracts which have been spiked after
the preparation process. Used to evaluate matrix interferences caused from the digest or extract
matrix. (3)
PQL-(Practical Quantitation Limit) the level above which quantitative results may be obtained with a
specific degree of confidence. The value for the PQL 10r (r is the standard deviation obtained
from the MDL study) is recommended, which corresponds to an uncertainty of + 30% in the
measured value.
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DEFINITION OF TERMS
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Preparation Blank (PB)/Method Blank (MB)-an artificial sample designed to monitor the introduction
of artifacts into the process. Reagent water is used as the preparation blank matrix. (3)
Relative Percent Difference-a term used to describe precision.
Relative Response Factor-a measure of the relative mass spectral response of an analyte compared to
its internal standard
Relative Standard Deviation-statistic used to describe the variation among calibration curve standards.
Replicate-a sample prepared by dividing a sample into two or more separate aliquots. (4)
Reporting Limit-the analyte concentration below which a laboratory will not report the analyte as
having been detected. A laboratory’s reporting limit for any given analyte in a specific matrix must
be greater than or equal to the experimentally determined MDL for the same matrix.
Resolution-the separation between peaks on a chromatogram or strip chart. Calculated by dividing the
depth of the valley between peaks by the peak height of the smaller peak being resolved, multiplied
by 100.
Spike Level-concentration of the spike addition. Sample weights and dilution schemes are involved in
the calculation of the spike level.
Standard Curve-curve which plots concentrations of known analyte standard versus the instrument
response to the analyte. (4)
Standard Operating Procedure-SOP is an approved, controlled document which describes practices
for a given procedure or activity, in sufficient detail that a qualified individual could use the SOP to
conduct the procedure.
Stock Solution-a solution which can be diluted to derive standards or reagents.
Surrogate-organic compounds similar to analytes of interest in chemical composition, extraction, and
chromatography, but not normally found in environmental samples. These compounds are
spiked into each sample of a prepared batch and are used to validate accuracy on a sample
specific level. (4)
System Monitoring Compounds-compounds added to every blank, sample, matrix spike, matrix spike
duplicate, and standard for GC/MS analyses. These compounds are brominated or deuterated
compounds not expected to be detected in environmental media.
Target Analytes-compounds or elements which are project of method specified.
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Temperature Blank-a deionized water filled receptacle that accompanies samples in ice chests which is
used to determine temperature upon receipt.
Tentatively Identified Compounds-compounds detected in samples that are not target compounds,
calibrated analytes, responsive analytes, internal standards, system monitoring compounds, or
surrogate.
Total Metals-metal measurement (dissolved and suspended) where the sample is not filtered and
digested prior to analysis. Metals are also considered total if the turbidity of the sample without
filtration is < 1 NTU.
Travel/Trip Blank-a sealed aliquot of analyte-free water which is transported in with field samples.
Used to identify the presence of volatile compound contamination attributable to transfer across a
sample container septum during shipping and storage of samples. (4)
Turnaround Time-the elapsed time expressed in days from the date of receipt of the sample by a
laboratory representative until the date of reporting. The form of the report and the method of
submission of the results are stipulated by the client. Turnaround time can also be expressed as a
time limit by which all results are due.
Twelve Hour Time Period-for GC/MS: the moment of a specific injection of BFB or DFTPP analysis
until twelve hours have elapsed according to the system clock. For GC: the twelve hour time
period in the analytical sequence begins at the moment of the injection of a specified initial or
calibration verification until the end of the twelve hour time period.
(1) 40 CFR Part 136 Appendix B
(2) 40 CFR Part 141
(3) CLP SOW
(4) SW-846, September 1994
(5) Navy Installation Restoration Laboratory Quality Assurance Guide
Note: Section II was reviewed on 01/08/16 (No Changes were made)
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3.1 Overview
One of the key elements of a sound quality system is training. Training allows for effective communication
of policy and procedure and provided a mechanism to increase the knowledge base of the organization.
Training is a continuous process with distinct programs and objectives:
3.1.1 Orientation
Safety
“Right to Know”
Evacuation Process
Fire Prevention
Job Specific Safety
Laboratory Employee Policies
3.1.2 On the Job Training
Job specific duties and responsibilities
Job specific quality control
3.1.3 Internal Training Modules
Laboratory Process Training
Good Laboratory Practices
Continuous Training
Continuous Improvement
General Procedure Training
3.1.4 External Training
Advanced instrument/method/process training
Industry standards
Personal advancement
3.1.5 Safety Meetings
Lab Safety Policy
Safety Awareness
Safe Practices
Each of the aforementioned components of the training program are described in detail in the following
sections.
3.2 Orientation
A safety orientation must be performed for all new permanent employees and temporary employees prior to
job specific duties. When job responsibilities that cross department lines change, department supervisors
must conduct department specific safety orientations. Respective department supervisors are responsible for
conducting orientations for their department employees. The Health and Safety Coordinator can conduct
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orientations in lieu of the department supervisor. The orientation consists of a structured interview, a film
viewing, a laboratory tour and a question/answer session.
3.3 Process
3.3.1 Film Viewing
The film “Laboratory Right to Know” should be viewed prior to the interview. A VCR is available in the
lunchroom. If applicable, the trainee should also view one or more of the following safety films:
Laboratory Spills and Waste
Laboratory Housekeeping and Personal Hygiene
Working with Asbestos
3.3.2 Interview
The Health and Safety Coordinator obtains an orientation kit from the Safety department. The kit includes
the following:
QA Protocols Manual
Employee Safety Manual
Emergency Evacuation Plan
Fire Prevention Plan
Respirator Program Plan
Waste Disposal SOP
Worker’s Compensation Pamphlet
Laboratory Map
MSDS Example
Lab Coat
Safety Glasses
The interview, conducted in an area of limited disruptions, will follow topics found on the Orientation
checklist. Each subject should be discussed thoroughly. The trainee acknowledges discussion of each topic
by initialing the proper space of the orientation form. If certain topics were not discussed or if a full
understanding of the subject is not obtainable or if additional time is required to fulfill the subject matter, the
trainee should not initial the form until he/she is fully confident to do so. All components of the orientation
kit should be distributed during the interview. A copy of the acknowledgement in the back of the
employee’s policy should be signed by the new employee.
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3.3.3 Laboratory Tour
Once the interview is completed, the Health and Safety Coordinator should conduct a tour of the laboratory
which focuses on laboratory safety features. Fire extinguisher and safety/eyewash shower locations should
be pointed out as well as all exits.
3.3.4 Question and Answer
A question and answer session will follow the tour. Once completed, the Health and Safety Coordinator
should place the orientation checklist and laboratory policy in the employee’s file.
3.3.5 On the Job Training
A controlled copy of all pertinent SOPs must be requisitioned from the QA Department then submitted to
the trainee. The trainee should read all pertinent SOPs prior to hands on training. The department
supervisor will conduct on-the-job training or will designate this responsibility to a suitable analyst or
technician. The trainer should demonstrate all aspects of technical and physical skills needed to perform job
specific tasks at or above current efficiency and accuracy levels. When the trainer and/or department
supervisor feels confident that the new employee can conduct job duties competently, the department
supervisor will schedule an initial demonstration of competency, if applicable.
3.3.6 Initial Demonstration of Competency (IDC)
Employees are to complete method specific IDCs before they are allowed to report results solo. IDC
requirements should include all duties and responsibilities associated with specific jobs or methods. IDC
tasks can include:
Preparation of standards
Preparation of reagents
LCSW preparation
LCSW analysis
MDL studies
Data Reduction
Documentation
An IDC form should be completed to acknowledge the trainee is method/task competent. When the form is
completed and approved, the analyst is designated fit for duty. Original IDC forms are placed in employee
IDC/ADC file in QA Department.
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3.4 Internal Training Program
Basic skills and training knowledge are conducted through in-house programs and/or subcontract programs.
The in-house program includes an initial orientation, on the job training module program, which covers
various aspects of laboratory operations.
In-House Training Modules
MODULE TOPICS JOB TITLES
(attendance is required)
TRAINER
A-1 Orientation for New Hires
Basic Laboratory Operations
Math and Science Basics
Introduction to Quality Control
Introduction to Laboratory Analyses
Physical Properties
New Hires Steve Bennett
Glassware
Types
Using Burettes and Pipettes
Calibration
Safety, Cleaning, and Storage
Weighing and Measuring
Mass Measurements
Volumetric Measurements
Linear Measurement
Temperature Measurements
Analytical Procedures
Analysis Terms
Procedure
Data Generation
B Laboratory Math I
Units of Measurement
Significant Figures and Rounding
Percents
Exponential Numbers
Analyst/Prep Technician
Richard Penner
C-1 Quality Assurance, Quality Control
Concepts
Parameters
Basic Tasks
Measurement and Assessment
Documentation and Audits
Corrective Logic
All
Sara Guron
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MODULE TOPICS JOB TITLES
(attendance is required)
TRAINER
C-2
Data Management
Recordkeeping Procedures
Responsibilities
Storage
All Sara Guron
C-3
Quality Improvement-Corrective
Action
Continuous Improvement
When to Initiate Corrective Procedures
Procedures
Identifying the Error
Implementing Corrective Action
Demonstrating Corrective Action
Closure
Documentation
All Sara Guron
D Ethics
Industry Standards
Case Studies
Code of Ethics Policy
All
Sara Guron
E Sexual Harassment All Steve Bennett
F LIMS I
Logging on through Passwords
Security
Features
Policy
All Keith Vogel
Training module attendance is job dependent. Each job description has associated minimum training
requirements. Trainees must pass training examinations before acknowledgement of successful completion
of pertinent training modules.
Module training will be appropriately scheduled to accommodate both working shifts. Effort will be put
forth to provide a flexible and workable schedule to prevent any significant disruption of work flow.
Individual module presentations should be posted on the memo board near the time clock at least one week
prior to each training session. Employees are required to sign the attendance ledger on the posted schedule.
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JOB TITLES
1. President
2. Technical Director
3. Director of Human Resources
4. Health + Safety Officer/Radiological Safety
Officer
5. Service Technician
6. Client/Field Services Manager
7. Project Manager
8. Client Services Representative
9. Field Services Representative
10. Courier
11. Lab Technician I (Non Production Data)
12. Sample Custodian
13. Billing Clerk
14. Receptionist
15. Accounts Payable Clerk
16. Accounts Receivables Clerk
17. Inorganics Manager
18. Supervisor (Production Inorganics)
19. Lab Technician I (Inorganics)
20. Lab Technician I (Organics)
21. Lab Technician II (Inorganics)
22. Lab Technician II (Organics)
23. Analyst I (Inorganics)
24. Analyst I (Organics)
25. Analyst II (Inorganics)
26. Analyst II (Organics)
27. LIMS Manager
29. LIMS Programmer
30. LIMS Specialist
31. Volatile Organic Manager
32. Quality Assurance Officer
33 Quality Assurance Specialist
34. Sales & Marketing Director
35. Salesperson
36. Laboratory Coordinator
37. Semi-Volatile Organic Supervisor
38. Semi-Volatile Extraction Supervisor
39. Word Processor Specialist
3.5 External Training Program
External training is conducted through manufacturer’s instrument training programs, various independent
seminars, California State University Bakersfield (CSUB), and Bakersfield College. External training is
addressed under the Educational Assistance section of the Employee Policy Manual.
Each supervisor is encouraged to attend at least one outside services seminar or training session per year,
which would enhance his/her job performance or knowledge. In order to attend, supervisors must be granted
an approval by the President.
3.6 Safety
Safety training begins with the new employee orientation. Safety meetings are held to provide for
continuing training regarding safety related updates and to ensure safe working conditions by providing
reiterated safety practice and policy information. All employees, unless absence is approved by the Health
and Safety Coordinator are required to attend safety meetings. Additional information is listed in the Safety
Module Training SOP.
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3.7 Performance Evaluations
To monitor employee progress and efficiency, department supervisors evaluate each specialist within three
months of job duties initiated and annually thereafter. These screenings are conducted on a one-on-one
basis with supervisors rating employees’ performance on various job-related subjects. During these
interviews, goals are set to provide for deficiencies or to help employees further their training and skills.
Review of pertinent SOPS should also be covered during the annual review. Evaluation forms used are
exclusive for each laboratory department. Completed performance evaluations are maintained in employee
files.
3.8 Employment
BC Laboratories, Inc. offers a comprehensive benefit package for each employee to ensure a productive and
efficient work force. All agreements and particulars are addressed in the BC Laboratories, Inc. Employee
Policy Manual.
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LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS)
SECTION IV REVISION 4 EFFECTIVE DATE 01/08/16 Page IV-
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4.1 Introduction
The Laboratory Information Management System (LIMS) is a 100-user Novell/Advanced Revelation
computer network with approximately 90 workstations. The laboratory has an equal number of computers
as stand-alone systems such as instrument computers, notebooks, accounts payable and accounts receivable.
The system is developed and maintained by the LIMS Manager and his assistants. The LIMS is a tool by
which laboratory information is processed and reported to our clients. It also serves as an internal and
external communication tool. Most computers utilized in the lab are linked to the LIMS, however there are
some instrument computers which are not directly connected. All general rule specifics outlined in this
section should apply to all computers.
4.2 Access
4.2.1 Password
In order to gain access to the network, one needs to have a password. The LIMS Manager is responsible for
the password maintenance system. New employees must contact the LIMS Manager personally to set up
passwords, which should be six (6) characters or more. The LIMS Manager also needs employee initials.
Three initials are required. If an employee does not have middle initial, use “n” as the middle initial.
Passwords should be set up as soon as possible.
New User Account
User Name:
User Initials (Must be 3 characters)
Password: (Must be 6 or more characters)
Department:
Computer ID: (See label affixed to computer)
4.2.2 LIMS Access Time
LIMS access time for new employees is Monday through Friday, 0730 – 1800. If access time is not
conductive to employee work activities, the employee should contact their department supervisor to approve
modified access time. The department supervisor will contact the LIMS Manager to initiate the change.
4.2.3 Logging On/Off
4.2.3.1 WINDOWS 95 USERS
4.3.1.1 Log-in
a. When prompted for password by Novell, enter your account password.
b. When Windows asks for a password, enter password provided by the
LIMS manager.
c. To access the LIMS, click the icon that contains the word
“ELEMENT”.
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d. The LIMS will ask for a password; enter your account password again.
e. Your supervisor will provide training to use the system.
f. When done, select exit from the main menu.
4.3.1.2 Log-off
a. Make sure you have properly exited from the LIMS software.
b. Click Start, Shut Down, Yes.
c. Leave computer on.
d. Turn monitor off.
4.2.3.2 WINDOWS 3.xx USERS
4.2.3.2.1 Log-in
a. When prompted for name enter, your initials followed by a
space then the word “windows”.
b. When prompted for a password, enter your account
password.
c. You will be logged in, and windows will start.
d. When windows asks for a password, enter password
provided by the LIMS manager.
e. To access the LIMS, click the icon that contains the word
“ELEMENT”.
f. The LIMS will ask for a password; enter your account
password again.
g. Your supervisor will provide training to use the system.
h. When done, select exit from the main menu.
4.2.3.2.2 Log-off
a. Make sure you have properly exited from the LIMS
software.
b. Press alt-F4, click Yes. You will now exit windows.
c. Type “Logout”.
d. Leave computer on.
e. Turn monitor off.
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LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS)
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3
4.2.3.3 DOS USERS
4.2.3.3.1 Log-in
a. When prompted for name, enter your initials followed by a
space, then the word “lims”.
b. When prompted for a password, enter your account
password.
c. You will be logged in, and the LIMS software will start.
d. The LIMS will ask for a password; enter your account
password again.
e. Your supervisor will provide training to use the system.
f. When done, select exit from the main menu.
4.2.3.3.2 Log-off
a. Make sure you have properly exited from the LIMS
software.
b. Type “Logout”.
c. Leave computer on.
d. Turn monitor off.
4.3 General Rules
4.3.1 Foreign software may not be initialized without LIMS Manager Approval.
4.3.2 No foreign floppy disks may be placed into use unless the LIMS Manager has granted
approval. All electronic files (including word processing and spreadsheets) brought to the
LIMS must be scanned for viruses prior to usage on the LIMS.
4.3.3 Employees cannot change any computer stations’ configuration in any way unless the LIMS
Manager has granted approval.
4.3.4 Non-work related internet use must be discussed with the LIMS Manager prior to accessing
the internet.
4.3.5 Non-work related computer use cannot take precedence to work related activities.
4.3.6 Passwords are of exclusive use. Passwords may not be revealed to anyone.
4.3.7 Any hardware or software problems must be reported to the LIMS Department as soon as
possible. Use the form labeled “Crashes” (see page IV-5).
4.3.8 LIMS use is exclusive to BCL employees.
4.3.9 There is no unauthorized entrance allowed in the computer room.
4.3.10 Network non-work related printing is not allowed unless permission is granted by the LIMS
Manager.
4.3.11 When you must leave your computer for more than 15 minutes, your must log off the system
prior to leaving.
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4.3.12 If possible, all documents (WordPerfect, Excel, Visio) must be saved on the File Server (not
on local C: or D: hard drives). If you are in doubt, please contact a staff member of the LIMS
department.
4.4 Crashes
It is imperative that you communicate that your workstation is not in working order to the LIMS staff.
Communication is documented through the “crashes” worksheet. (See next page.) Each workstation crash,
other than network crashes or power failure, must be documented.
Process:
1. Complete the “crashes” worksheet.
2. Contact a member of the LIMS staff.
3. Follow directions given to you by the LIMS staff representative.
If the LIMS personnel are not available, document the crash as accurately as possible, then re-boot your
computer.
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Crashes
Employee:
Date/Time:
Operating System:
Cause: Network OS Application LIMS Program
Other: ________________________________
Description of problem. Must be filled in by the user.
Description of problem. Must be filled in by Keith Vogel or Rick Penner.
Describe how the problem was resolved. Must be filled in by Keith Vogel or Rick Penner.
Note: Section IV was reviewed on 01/08/16 (No changes were made)
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CREATION, MODIFICATION, DISTRIBUTION AND MAINTENANCE OF LABORATORY CONTROLLED DOCUMENTS
SECTION V REVISION 7 EFFECTIVE DATE 01/08/16 Page V-1
5.1 Scope and Application
The following procedures will address the maintenance and control of BCL’s controlled
documentation. Documents under controlled status include:
QAPP – Quality Assurance Program Plan
SOPs – Standard Operating Procedures
Logbooks
Employee Policy
QAPM – Quality Assurance Protocols Manual
A document is considered under control when:
it has been through a structured approval process
material is specifically kept esoteric
distribution is monitored and maintained
periodic or necessary modifications are made, reviewed, and counted
earlier versions are destroyed less at least one copy which is archived
It is extremely important to maintain certain documents under a controlled status in order to assure
information is conveyed accurately and maintained current.
All employees will have controlled documents in their possession, thus it is very important to
understand the process to keep our documentation sound and accurate.
5.2 Creation
5.2.1 QAPP/QAPM
The QAPP should be written and maintained by the QA Officer. The QA Officer should interview
appropriate personnel for information on process while consulting references to validate the
appropriateness of laboratory processes and procedures. The QAPP is revisited at least annually,
however when major modifications are made which would necessitate revisions, all personnel with
information or ownership of the new or revised process should contact the QA Officer to ensure
timely and accurate modifications. The QAPP should be approved by the management staff of BCL
on an annual basis.
5.2.2 SOPs
SOPs should be written by a person who has an adequate level of expertise in the subject matter.
Please see the SOP template in this document for guidance when creating analytically based
Standard Operating Procedures.
Write the SOP in rough draft form. The rough draft should be submitted to the Word Processing
Specialist (WPS) to initiate document maintenance. The WPS will then submit the rough draft to the
author for review. The author should then make any correction(s), if necessary, before submitting
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the SOP to his/her department supervisor. The department supervisor will then make any necessary
changes before submitting the SOP to the QA Officer. The QA Officer will review and make proper
modifications as necessary before submitting the SOP back to the WPS. The same review process
will follow a second time. When all modifications are performed and the SOP is deemed acceptable,
the department supervisor and the QA Officer will sign an approval sheet to verify the acceptability
of the document.
Objectives of Reviews
Analyst Review
Grammar
Content
Department Supervisor Review
Grammar
Accuracy of the procedure to actual process
Content
QA Officer Review
Grammar
Comparability to referenced method
5.2.3 Logbooks
Logbooks should be created by the person(s) with an extensive working knowledge of the process to
be monitored. This will ensure minimal changes, short term and long term. All logbooks designs
are submitted to the WPS for creation. The WPS will then submit the logbook sheet to the creator
for review. The log sheet should be reviewed by respective department supervisors before all
logbooks are formed. When acceptable, log sheets will be numbered sequentially and bound by the
WPS. A descriptive title and logbook number should be documented on a cover sheet for each
logbook.
5.2.4 Employee Manuals
Employee manuals outline workers rules of conduct, policies and benefits. It was written by the
management staff of BCL. This document is reviewed and updated annually by the management
staff of BCL.
5.3 Modification
5.3.1 QAPP
The QA Officer will forward all modifications to the WPS. The WPS will then submit the modified
material to the QA Officer for review. The QA Officer should consult all personnel who are
impacted by the modifications for approval. When approved, the modified section of the QAPP is
distributed to those all personnel who are on the distribution list.
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5.3.2 SOPs
SOPs should be reviewed on at least annually (every year) basis. Prior to respective employee
annual performance evaluations, all pertinent SOPs should be reviewed and modified as necessary.
These SOPs should be brought to the performance evaluation interview to be discussed. All
modified SOPs should then be submitted to the WPS. The same review process will follow as
discussed for SOP creation.
5.3.3 Logbooks
Laboratory logbooks review frequency has been established to be performed on a quarterly basis.
Department supervisor or authorized personnel will review standards, reagents and maintenance log
at least on a monthly basis. Review of logbooks performed for completeness and legibility purposes.
All Wet Chemistry analysis for manual tests review is performed in the element as a supervisor
review. All non-manual test (e.g. metals, organics) logbooks review will follow as stated above.
Keep logbook in appropriate place in the same vicinity where the analysis or prep work is to take
place. When logbooks are completed, get a new one from the word processor and put preceding
number of logbook on the front cover. Give the completed logbook to the quality assurance
department. The quality assurance department then puts the logbook number into a tracking system.
The book then goes into a storage shelf for that particular prep or analysis in the data storage room.
When the data storage shelf is full, the logbooks are stored at the storage facility where they will
remain until a seven year period has passed.
5.3.4 Employee Manual
Modifications are discussed during one or more sessions of supervisor meetings; The Director of
Human Resources gathers the information and makes changes. When acceptable, the Human
resources submit modifications to the WPS for distribution.
5.4 Distribution
5.4.1 QAPP
Distributions of controlled copies of QAPP are distributed to the management staff of BCL.
Uncontrolled copies are readily available to BCL clients; however, controlled copies can be
approved for distribution if absolutely necessary. Controlled copies which are distributed to
department supervisors should be made readily available to all employees. One controlled copy is
assigned to the conference room which is readily available to all employees. It is important that all
BCL employees recognize and understand the policies within the QAPP in order to foster an
environment conducive to quality improvement. Distribution is documented on acknowledgement
sheets which are signed by all personnel receiving controlled copies.
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5.4.2 QAPM
Controlled copies of the QAPM are distributed to the management staff of BCL. Each department
supervisor should request a copy from the QA Officer and/or WPS. The WPS is responsible for
tracking and distribution of the manuals. Distribution is documented on acknowledgement sheets
which are signed by the party receiving a controlled copy.
5.4.3 SOPs
Controlled copy distribution is restricted to all personnel directly associated to respective procedures
and to the pertinent department supervisor. Controlled copies should be restricted within the
laboratory. Clients requesting copies of SOPs should be given the latest approved uncontrolled SOP
version. Documentation of distribution of SOPs is in the form of acknowledgement sheets which are
signed by parties receiving controlled copies.
5.4.4 Employee Manuals
All employees of BCL should be given a controlled copy of the BCL Employee Manual. Employees
are required to sign an acknowledgement which verifies distribution.
5.5 Management
5.5.1 QAPP/QAPM
Distribution acknowledgements are maintained by the Word Processor Specialist (WPS). When all
personnel receive an updated section or version of the QAPP/QAPM, the old revision should be
return to the WPS to be destroyed. The WPS archives all versions of the QAPP in electronic form as
a record of policy and procedure within certain blocks of time. Approval from the QA Officer must
be granted prior to releasing a controlled copy of the QAPP or QAPM. The WPS maintains a
database of the distribution of controlled copies.
5.5.2 SOPs
Distribution acknowledgements are maintained by the WPS. When any BCL personnel receive an
updated section of version of an SOP, the old version is returned to the WPS to be destroyed. The
WPS archives all versions of SOPs in electronic form as a record of policy and procedure within
certain block of time. The WPS maintains a database recording the distribution of controlled copies.
5.5.3 Employee Safety Manual
Distribution and control of the Employee Safety Manual is handled through the Director of Human
Resources and the WPS. Content is managed by the management staff of BCL while PAS is
responsible for document production and archival.
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5.5.5 Logbooks
Keep logbook in appropriate place in the same vicinity where the analysis or prep work is to take
place. Before the logbooks are completed a form needs to fill out a form to request replacements
from the Word Processor Specialist. However, at least one week notice have to be giving to the
WPS for creation of new logbooks. The WPS adds on the cover page a word-processing ID (Exp.
WCS001) and also a QC ID (Exp 13L001). The Word Processor Specialist enters the word-
processing ID and the QC ID into an Access tracking database. The completed logbooks are also
recorded in the access tracking database as received; and then go into a label box (Exp. 12-L018
“Year End 2012”) and store into the QC data storage room. Logbook boxes are kept in to data
storage room for two years and then transfer to the on-site storage facility where they will remain
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STANDARD OPERATING PROCEDURES TEMPLATE
SECTION V REVISION 7 EFFECTIVE DATE 01/08/16 Page V-6
1.0 SCOPE AND APPLICATION*
2.0 SUMMARY OF METHOD*
3.0 INTERFERENCE AND THEIR CORRECTIVE ACTION
4.0 APPARATUS AND MATERIALS*
4.1 APPARATUS
4.2 INSTRUMENT PARAMETERS
5.0 REAGENTS AND STANDARD SOLUTIONS
5.1 REAGENTS – NAME AND SOURCE
5.2 SOLUTIONS – DILUTION SCHEMES
5.3 WORKING STANDARDS
5.4 SPIKES
6.0 SAMPLE COLLECTION, PRESERVATION AND HANDLING
7.0 PROCEDURE*
8.0 QUALITY CONTROL
8.1 DETERMINATION OF IDL, MDL, AND PQL
8.2 METHOD BLANKS
8.3 QC SETS – DUPLICATES & SPIKES
8.4 CONTROL CHARTS
8.5 LOGBOOKS
9.0 CALCULATIONS
10.0 FORMS*
10.1 QC SHEETS
10.2 OTHER FORMS
11.0 METHOD PERFORMANCCE
12.0 GENERAL MAINTENANCE
13.0 WASTE MANAGEMENT
14.0 POLLUTION PREVENTION
15.0 SAFETY
16.0 REFERENCES *SOP sections that should also appear as part of Non-analytical SOP’s.
Note: Section V was reviewed on 01/08/16(No Changes were made)
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SAMPLE PROCEDURES
SECTION VI REVISION 7 EFFECTIVE DATE 01/08/16 Page VI-1
6.1 Overview
There are many aspects regarding the subject of sample handling such as sampling, sample preservation, sample
containment, sample logging, custody, tracking and sample disposal. The following section addresses these issues.
The quality of a sample result is dependant upon how the sample was handled from a physical standpoint as well as
from a documentation perspective. If the sample was mishandled physically, the quality of sample result would be
compromised accordingly. If sample handling documentation is corrupt, the quality would be questionable and thus
would be compromised also. Proper physical handling and documentation of this handling goes hand in hand in
providing for quality results.
6.2 Sample Containers
Excerpts from Standard Methods 19th
edition
The type of sample container is of utmost importance. Containers are typically made of plastic or glass, but one
material may be preferred over the other. For example, silica and sodium may be leached from glass but not plastic,
and trace levels of metals may sorb onto the walls of glass containers. For samples containing organic compounds,
avoid plastic containers except those made of fluorinated polymers such as polytetrafluoroethylene (TFE).
Some volatile compounds in samples may dissolve into the walls of plastic containers or may even leach substances
from plastic. Use glass containers for all organics analyses such as volatile organics, semi-volatile organics,
pesticides, PCBs and oil and grease. Avoid plastics wherever possible because of potential contamination from
phthalate esters contained in the plastics. Container caps, typically plastics, also can be a problem. Use foiled or
teflon-lined lids appropriately.
Refer to the Analysis Reference Chart for appropriate container use per method.
6.3 Sample Storage Before Analysis
Nature of sample changes: Some determinations are more likely than others to be affected by sample storage
before analysis. Certain cations are subject to loss by absorption on, or ion exchange with, the walls of glass
containers. These include aluminum, cadmium, chromium, copper, iron, lead, manganese, silver and zinc, which
are best collected in a separate clean bottle and acidified with nitric acid to pH below 2.0 to minimize precipitation
and absorption on container walls.
Temperature changes quickly; pH may change significantly in a matter of minutes; dissolved gases (oxygen, carbon
dioxide) may be lost. Because changes in such basic water quality properties may occur so quickly, determine
temperature, pH and dissolved gases in the field immediately after taking sample.
Changes in the pH-alkalinity-carbon dioxide balance may cause calcium carbonate to precipitate, decreasing the
values for calcium and total hardness.
Iron and manganese are readily soluble in their lower oxidation states; therefore, these cations may precipitate or
they may dissolve from a sediment, depending on the redox potential of the sample. Micorbiological activity may
be responsible for changes in the nitrate-nitrite-ammonia content, for decreases in phenol concentration and in
BOD, or for reducing sulfate to sulfide. Residual chlorine is reduced to chloride. Sulfide, sulfite, ferrous iron,
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PAGE VI-2
iodide and cyanide may be lost through oxidation. Color, odor and turbidity may increase, decrease or change in
quality. Sodium, silica and boron may be leached from the glass container. Hexavalent chromium may be reduced
to chromic ion.
Biological changes taking place in a sample may change the oxidation state of some constituents. Soluble
constituents may be converted to organically bound materials in cell structures, or cell lysis may result in release of
cellular material into solution. The well-known nitrogen and phosphorus cycles are examples of biological
influences on sample composition.
Zero headspace is important in preservation of samples with volatile organic compounds. Avoid loss of volatile
materials by collecting sample in a completely filled container. Achieve this by carefully filling so the top of the
meniscus is above the top of the bottle rim. Take care not to dilute preservatives by overfilling. Serum vials with
septum caps are particularly useful in that a sample portion for analysis can be taken through the cap by using a
syringe, although the effect of pressure reduction in the headspace must be considered.
Time interval between collection and analysis: In general, the shorted the time that elapses between collection of a
sample and its analysis, the more reliable will be the analytical results. For certain constituents and physical values,
immediate analysis in the field is required. For composited samples it is common practice to use the time at the end
of composite collection as the sample collection time.
It is impossible to state exactly how much elapses time may be allowed between sample collection and analysis; this
depends on the character of the sample, the analyses to be made, and the conditions of storage. Changes caused by
growth of mico-organisms are greatly retarded by keeping the sample in the dark and at a low temperature (<4°C
but above freezing). When the interval between sample collection and analysis is long enough to produce changes
in either the concentration or the physical state of the constituent to be measured, follow the preservation practices
given in the Analysis Reference Chart. Record time elapsed between sampling and analysis, and which
preservative, if any, was added.
6.4 Preservation Techniques
To minimize the potential for volatilization or biodegradation between sampling and analysis, keep samples as cool
as possible without freezing. Preferably pack samples in crushed or cubed ice or commercial ice substitutes before
shipment. Avoid using dry ice because it will freeze samples and may cause glass containers to break. Dry ice may
also effect a pH change in samples. Keep composite samples cool with ice or a refrigeration system set at 6°C
during compositing. Analyze samples as quickly as possible upon arrival at the laboratory. If immediate analysis is
not possible, storage at 0-6°C is recommended for most samples.
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PAGE VI-3
Use chemical preservatives only when they are shown not to interfere with the analysis being made. When they are
used, add then to the sample bottle initially so that all sample portions are preserved as soon as collected. No single
method of preservation is entirely satisfactory; choose the preservative with due regard to the determinations to be
made. Because a preservation method for one determination may interfere with another one, samples for multiple
determinations may need to be split and preserved separately. All methods of preservation may be inadequate when
applied to suspended matter.
Methods of preservation are relatively limited and are intended generally to retard biological action, retard
hydrolysis of chemical compounds and complexes, and reduce volatility of constituents.
Preservation methods are limited to pH control, chemical addition, the use of amber and opaque bottles,
refrigeration, filtration and freezing. The Analysis Reference Chart lists preservation methods by constituent.
6.5 Holding Times
Sample analysis must take place prior to the allotted maximum storage times per method. This maximum storage
time is referred to as the holding time. Our performance goal is to meet 100% of the holding times. Holding times
are regulatory, thus they are extremely important. As stated in an earlier section, analysis should take place as soon
as possible. If we operate just meeting sample holding times, we will be in a precarious position when sample loads
increase, thus try to analyze samples as soon as possible.
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PAGE VI-4
6.6 Table 1 MAXIMUM HOLDING TIME AND CONTAINER CHART
GENERAL / INORGANIC CHEMISTRY
ANALYSIS WATER (< 6°C) SOIL (< 6°C)
Max HT1 in Days
(unless noted) Min Sample Quantity2
Container Type Preservative Container Water Soil Water (ml) Soil (gm)
Alkalinity Pint P -- 8 oz. jar 14 -- 100 10
Ammonia (NH3) Pint P H2SO4; pH<2 8 oz. jar 28 28 100 5
BOD Quart (H) P -- 8 oz. jar 48 Hrs. 48 Hrs. 1000 150
Bromide Pint P -- 8 oz. jar 28 28 50 30
Chloride Pint P -- 8 oz. jar 28 28 50 30
Chlorine (Residual) Pint (H) P -- -- 15 Min. -- 500 --
COD Pint P H2SO4 pH<2 8 oz. jar 28 28 50 25
Color Pint AG/P -- -- 48 Hrs. -- 100 --
Cyanide (Total) Pint P NaOH; pH>12 8 oz. jar 14 14 200 20
Cyanide (Reactive) Pint P -- 8 oz. jar ASAP ASAP 50 50
Dissolved Oxygen Quart (H) P -- -- 15 Min. -- 500 --
Dissolved Organic Carbon 4 oz. AG -- -- 28 -- 100 --
Electrical Conductivity (EC) Pint P -- 8 oz. jar 28 28 200 --
Flashpoint Pint AG -- 8 oz. jar -- -- 500 100
Fluoride Pint P -- 8 oz. jar 28 28 50 30
Gross Alpha Quart P HNO3 <2 or Upres 8 oz. jar 6 Mo. 6 Mo. 1000 250
Gross Beta Quart P HNO3 <2 or Upres 8 oz. jar 6 Mo. 6 Mo. 1000 250
Hardness Pint P -- -- 28 -- 200 --
Hexavalent Chromium (Cr+6) 2 oz. P Borate/HCO3/CO3 -- 5 30 Days till Ext. 50 --
Pint P -- 8 oz. jar 24 Hrs. 7 Days to run 50 20
Iodide Pint P -- 8 oz. jar ASAP 28 Days 50 30
Nitrate/Nitrite (NO3/NO2) 2oz p H2SO4; pH <2 8 oz. jar 28 28 Days After Ext. 50 30
Nitrite (NO2) Pint P -- 8 oz. jar 48 Hrs. 48 Hrs. After Ext. 50 30
Nitrate as NO3 Pint P -- 8 oz. jar 48 Hrs. 48 Hrs. After Ext. 50 30
Odor Pint AG -- -- -- -- 500 --
ORP Pint (H) P -- -- ASAP -- 100 --
Perchlorate Pint P -- 8 oz. jar 28 28 50 30
pH Pint P -- 8 oz. jar 15 Min. -- 100 50
Phenols 4 oz. A H2SO4; pH <2 8 oz. jar 28 28 200 10
Total Phosphorous Pint P H2SO4; pH <2 8 oz. jar 28 28 100 10
Ortho- Phosphorous Pint P -- 8 oz. jar 48 Hrs. 48 Hrs. After Ext. 50 30
TDS Quart P -- -- 7 -- 500 --
TSS Quart P -- -- 7 -- 1000 --
Settleable Solids Quart P -- -- 48 Hrs. -- 1000 --
Total Solids Quart P -- 8 oz. jar 7 7 500 50
Specific Gravity Pint P -- 8 oz. jar 28 28 500 10
Sulfate Pint P -- 8 oz. jar 28 28 50 30
Sulfide (Total) Pint P Zn Acetate 8 oz. jar 7 -- 200 --
Sulfide (Reactive) Pint P -- 8 oz. jar ASAP ASAP 50 50
Surfactants (MBAS) Quart P -- -- 48 Hrs. -- 500 --
Coliforms 8 oz. GN Na2S2O3 -- 6, 30 Hr. -- 125 --
Total Kjeldahl Nitrogen (TKN) Pint P H2SO4; pH <2 8 oz. jar 28 28 100 10
Total Organic Carbon (TOC) 4 oz. A H2SO4; pH <2 8 oz. jar 28 28 100 25
Total Organic Halide (TOX) Pint A H2SO4; pH <2 8 oz. jar 7 Not specified 500 50
Turbidity Pint AG, P -- -- 48 Hrs. -- 50 --
METALS
ANALYSIS Container Type Preservative Max HT (1) Min. Sample Vol.
(mls)(2)
WATER
Total Metals Pint P HNO3 6 Months ( 28 Days -Hg/Si) 100
Dissolved Filtered in Field Pint P HNO3 6 Months ( 28 Days -Hg/Si) 100
Dissolved not filtered Quart P 6 Months ( 28 Days -Hg/Si) 250
Organic Lead Quart AG Chill to <°6 C 14 Days 1000
200.8 Copper and Lead5 Quart P HNO3 in lab pH<2 6 Months 1000
ANALYSIS Container Type Preservative Max HT1 Min Quantity (gms)2
SOIL
Total Metals 8 oz. Jar G Chill to <°6 C 6 Months ( 28 Days -Hg) 50
WET/STLC As needed G Chill to <°6 C 6 Months ( 28 Days -Hg) 50
TCLP As needed G Chill to <°6 C 6 Months ( 28 Days -Hg) 150
SPLP As needed G Chill to <°6 C 6 Months ( 28 Days -Hg) 150
Hexavalent Chromium 8 oz. Jar G Chill to <°6 C 30 Days / 7 Days from Ext. 50
Organic Lead 8 oz. Jar G Chill to <°6 C 14 Days 50
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A= Amber
AG= Amber Glass with Teflon lined Cap
AP= Amber Plastic
G= Glass
GN= Sterilized Glass or Nalgene
H= Headspace Free
HT= Holding Time
P= Plastic
VOA= 40 ml Glass Vials with Teflon lined Cap
TABLE 1 (CONTINUED) MAXIMUM HOLDING TIME AND CONTAINER CHART
ORGANIC CHEMISTRY
ANALYSIS
WATER (< 6°C)
SOIL (<
6°C)
Max HT(1) in Days
(unless noted)
Water Soil
Min Sample
Quantity(2)
Container Type Preservative Container Extract Analysis Extract Analysis Water Soil (gms)
504 2x VOA G Na2S2O3 (3) 8 oz. Jar 14 1 14 14 1 VOA 10
508 Liter AG Na2S2O3 (3) 8 oz. Jar 7 14
1 L 50
524.2/ TCP/THMS 2x VOA (H) G Ascorbic/HCl in field -- -- 14 -- -- 1 VOA --
525.2/507 Liter AG Na2SO3/HCl in field -- 14(4) 30 -- -- 1 L --
548 2 x 250ml AG Na2S2O3 (3) -- 7 21 -- -- 200 mls --
549 Liter AP Na2S2O3 (3) -- 7 21 -- -- 200 mls --
552.3 125 ml AG NH4Cl -- 14 28 -- -- 1 VOA --
556 2 x VOA A NH4Cl/CuSO4 -- 7 40 -- -- 1 VOA --
632 Liter AG (3) 8 oz. Jar 7 40 14 40 1 L 50
8015B Gasoline Range 2x VOA (H) G HCl(3) 8 oz. Jar 14 14 -- 14 1 VOA 10
8015B Diesel Range Liter AG -- 8 oz. Jar 14 40 14 40 1 L 50
8015 Ethanol/Methanol
2x VOA (H) G -- 8 oz. Jar -- 14 -- 14 1 VOA 10
8021 BTEX/MTBE 2x VOA (H) G HCl(3) 8 oz. Jar -- 14 -- 14 1 VOA 10
8081/8082/608 Liter AG Na2S2O3 (3) 8 oz. Jar 7 40 14 40 1 L 50
8141 Liter AG (3) 8 oz. Jar 7 40 14 40 1 L 50
8151/615/515.1 Liter AG Na2S2O3 (3) 8 oz. Jar 7 40 14 40 1 L 50
8260/8240/624 2x VOA (H) G Ascorbic (6)/HCl in field 8 oz. Jar -- 14 -- 14 1 VOA 10
8270/625 2 x Liter AG (3) 8 oz. Jar 7 40 14 40 1 L 50
8310/610 Liter AG -- 8 oz. Jar 7 40 14 40 1 L 50
8330 Liter AG -- 8 oz. Jar 7 40 14 40 1 L 50
1664 Oil and Grease Liter AG HCl 8 oz. jar 28 -- 28 -- 1 L 50
1664 TPH Liter AG HCl 8 oz. jar 28 -- 28 -- 1 L 50
TCLP Volatiles 8 oz. G -- 8 oz. Jar 14 7 14 7 1 L 50
TCLP Semi Volatiles Liter (Each test) AG -- 8 oz. Jar 7 40 14 Days until TCLP Leaching
AIR / VAPOR
ANALYSIS Container
Keep from Light Max HT1 Min Mass (L)
ASTM D-1946 Fixed Gases Tedlar Bag 3 1
Summa Canister 30 5
25C Landfill Gases TGNMO Tedlar Bag 3 1
Summa Canister 30 5
TO-3 TPH Gas Tedlar Bag 3 1
Summa Canister 30 5
TO-14A/TO-15 VOCs Tedlar Bag 3 1
Summa Canister 30 5
NOTES:
TABLE 1 (CONTINUED) MAXIMUM HOLDING TIME AND CONTAINER CHART
(1) = Calculated from time the sample is collected.
(2) = Amount needed to achieve normal method detection limits or regulatory requirements.
(3) = Samples containing residual chlorine must be dechlorinated at the time of sampling.
(4)= 7 Days if Diazonin is requested.
(5)= First Draw sample after 6 - 12 Hour idle period.
(6)= Ascorbic only if from chlorinated source
Fill all containers as much as possible.
TCLP and STLC extractions cannot be conducted on acid-treated containers.
Keep all Air/Vapor samples out of light.
8 oz. Jars all have Teflon lined Caps
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7.1 Scope and Application
This section describes the methods of chain of custody for samples delivered or couriered to the fixed
laboratory, as well as internal laboratory chain of custody of samples and digests/extracts.
7.2 Summary
Chain of custody forms are completed by each client delivering samples to the laboratory. Each COC
contains fields such as Report To, Sample Description, Date and Time Sampled, Matrix, Analysis
Requested, Sample Receipt Conditions, TAT Info, Container Types, Billing Info., Disposal Info.,
Comments, and the Chain of Signatures of Custodians. Each time a sample changes hands between our
client’s personnel or a BC Laboratories courier or BC Laboratories personnel, the COC form is signed and
dated as to when the change of hands took place thus creating a chronological progression of possession of
the sample.
Internal chain of custody for samples is maintained through check out logs indicated on the sample
refrigerators and through disposal logs and manifests. Any individual retrieving and/or replacing samples
document pertinent information onto these logs. Extracts/digest custody transfers are documented on
preparation logs.
7.3 Potential Problems
Sometimes during the shipping or transporting of samples, COCs are rendered illegible due to sample
container breeches or water from ice wetting the COCs. In this case a client must be notified as to the
problem and a new COC is generated by the client. The client keeps a copy of the COC. Our COCs contain
3 copies: white, yellow and pink.
Any time a customer wishes to change any parameter on a COC form, the log-in department or authorized
person does such on our originals and denotes who requested the change, on what date, of which company
and for what reason the change was made. Also the change is initiated and dated as to who at BC
Laboratories made the change and on what the change was actually made.
If samples are received non-intact or are deemed corrupt in some form, the person receiving the samples
must contact a client service representative for resolution.
7.4 Custody
All samples must remain under custody from the time of sample analysis to the time of disposal. A sample
is considered under custody if:
1) It is in one’s possession verified by some form of documentation
2) It was in one’s possession and he/she locked it or placed it in a sealed container to prevent
tampering, or
3) It is within the laboratory grounds.
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7.5 Secured Facility
Please note that in order to define the lab as a “secured” area, we must keep the facility and the facility
grounds under locked conditions and accessed by authorized personnel. Unauthorized people may enter the
facility but only under monitored conditions. All doors and the perimeter fence should be locked by the
night shift supervisor at 1800 hrs.
7.6 Alarm System
The laboratory contracts Kern Securities to maintain the alarm system and to monitor after hours activities.
Employees must enter their numerical code to activate and deactivate the alarm system. The alarm system
needs to be activated by the last person leaving the facility on a given day.
Two codes or passwords are required to fully comply with the alarm system. The numerical code will allow
employees to activate and deactivate the alarm. A password is needed as a second line of security. If
working after hours, employee(s) will be required to disclose their password(s) to Kern Securities
representatives when these representatives call in to verify codes and activities.
In cases when the alarm goes off for no valid reason (i.e. no unauthorized entrance or no fire), the employee
must enter their numerical code into one of the alarm pads which are located at the main entrance and the
side entrance.
Codes and passwords must be obtained from the Director of Human Resources. These codes and passwords
are of exclusive use of each employee. Codes and passwords must not be shared.
7.7 Visitors
All visitors must log in and out of the Visitor Log-In Book which is kept by the receptionist. All
unauthorized people must be escorted by a BC Laboratories employee. Unauthorized people, other than
maintenance or instrument repair people may not be allowed to tamper with any laboratory instruments or
computers. All visitors entering analytical laboratory areas must use proper protective equipment.
7.8 Sample Custody Procedures
7.8.1 Procedure for Recording Sample Temperatures Upon Receipt
Objective: Ensure that personnel responsible for taking sample temperatures understand the importance of
sample temperatures in relation to the validity of data and to ensure that trainees can obtain and record
sample temperatures properly.
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7.8.2 The Importance of Sample Temperatures (0-6°C)
Samples maintained refrigerated to 0-6°C are considered preserved under conditions outlined in State and
Federal Regulations. Any temperature excursions outside 0-6°C allows for data of questionable validity.
The extent of the temperature excursion will determine the level of unreliability of the data.
A temperature range of 0-6°C was set to allow comparability of data and to provide a guideline for good
laboratory and sampling practices which prevent or deter alternative refrigeration/non-refrigeration
scenarios.
7.8.3 The Problem
Regulators tend to look at numbers and fit them into control limits or acceptable limits. If a number is not
within a limit, a regulator can invalidate data sometimes without regard to common sense. This is either
because they are not informed people or the data is highly visible or important and they do not want to stick
their neck out.
Some of our clients make sure potential temperature problems will not be variables by packing samples
properly. When we fail to properly record sample temperatures, we expose ourselves as incompetent. After
all, how easily is it to take a temperature.
7.8.4 Procedure
7.8.4.1 For Brass/Stainless Sleeves
7.8.4.1.1 Use the Thermocouple thermometer (Thermometer #THTTR2).
7.8.4.1.2 Pick a “representative” sample from the cooler.
7.8.4.1.3 Wipe the surface of the sleeve where you intend to take the
temperature. 7.8.4.1.4 Turn the thermometer on.
7.8.4.1.5 Verify the settings on the face of the thermometer are set to
“°C”.
7.8.4.1.6 Place the contact probe onto the sleeve. (Verify the contact
spring within the probe is in contact with the sleeve.)
7.8.4.1.7 Note the temperature. Disregard any zeros preceding whole
numbers.
7.8.4.1.8 Use common sense in judging whether or not the temperature is
accurate.
7.8.4.1.9 If the temperature is outside 0-6°C, either use another sample
(if available) or rotate the sample and take another reading.
7.8.4.1.10 If the temperature is still outside 0-6°C, record the lower
temperature on a Sample Receipt Form. See the section
“Sample Receipt Form Completion.”
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7.8.4.2 For All Other Containers
7.8.4.1.2.1 Use the FLUKE Non-Contact Infrared Thermometer
(Thermometer #208).
7.8.4.1.2.2 Pick a “representative” sample from the cooler.
7.8.4.1.2.3 Wipe the surface of the sample container where you intend
to take the temperature reading.
7.8.4.1.2.4 Press the button on the handle to turn the thermometer on.
7.8.4.1.2.5 The emissivity must be set according to the container type
you intend to take the temperature reading.
7.8.4.1.2.6 To set the emissivity, press the “Menu” button, then press
“Ɛ” and “No” keys to alter the reading until you reach the
desired setting. (See the table below.)
7.8.4.1.2.7 Once the emissivity is set, point laser at a section on the
sample bottle which represents the surface type that the
emissivity was set. (the IR gun has to touch the sample)
7.8.4.1.2.8 Note the “°C” at the upper right portion of the display. The
thermometer is taking readings. If a “°F” is noted, change
the setting to centigrade by pressing the “Menu” button 3
times, then press “C” keys until switches to the right
setting.
7.8.4.1.2.9 Note the temperature. Use common sense in judging
whether or not the temperature is accurate.
7.8.4.1.2.10 If the temperature is outside 0-6°C, first verify the
emissivity reading then check if the low battery warning is
flashing in the display.
7.8.4.1.2.11 If an accurate reading was taken and was outside 0-6°C,
choose another sample and take another temperature
making sure to follow the steps above.
7.8.4.1.2.12 If the temperature is still outside the acceptable range,
record the lower temperature on the Sample Receipt Form.
See the section “Sample Receipt Form Completion.”
7.8.4.1.2.13 For special containers other than the ones listed on the
label, see Emissivity Table on IR gun
Example of IR Gun Label
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Example of Emissivity Settings
Container Type Emissivity Temperature Correction
PE 0.97 Within ±1C range
Amber 0.98 Within ±1C range
Glass Clear 0.98 Within ±1C range
Bac-T Bottle 0.97 Within ±1C range
VOA Vial 0.95 Within ±1C range
*Please check with the QA/QC Department for individual IR gun calibration setting.
If an emissivity setting has not been verified by BCL, use the manufacturer’s guidelines noted in the owner’s
manual.
7.8.5 Sample Receipt Form Completion
7.8.5.1 Field Services Department
7.8.5.1.1 Check off the appropriate shipping information block.
7.8.5.1.2 Complete the Shipping Container section.
7.8.5.1.3 Check the appropriate refrigerant.
7.8.5.1.4 If custody seals were used, check appropriate boxes.
7.8.5.1.5 Enter pertinent information regarding sample temperatures for
each ice chest we are to receive.
7.8.5.1.6 If any anomalies are observed, please enter this information on
the comments section.
Example: Sample temperature was 10°C, but an adequate amount of blue ice was observed. This
information can be entered into comments. “Samples were refrigerated with an adequate amount of
blue ice, however the samples were kept under these conditions for x hours, thus the refrigerant
potential to keep sample temperatures at 0-6°C had been exhausted.
7.8.5.1.7 Any temperatures noted outside 0-6°C must be communicated
to Client Services. Submit the Sample Receipt Form to the
appropriate CSR. If the proper CSR is unavailable, either place
the form on his/her keyboard or submit to Client Service
Manager. Please use common sense…if a CSR is on vacation
don’t place it on his/her keyboard, etc.
7.8.5.1.8 The CSR must initial and date the form.
7.8.5.2 Sample Receiving Department
7.8.5.2.1 Fill in Submission Number and Project Code if available.
7.8.5.2.2 Check off the appropriate shipping information block.
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7.8.5.2.3 Complete the Shipping Container Section.
7.8.5.2.4 Check the appropriate Refrigerant.
7.8.5.2.5 If custody seals were used check the appropriate boxes.
7.8.5.2.6 Complete the sample custody check section.
7.8.5.2.7 Enter pertinent information regarding sample temperatures for
each ice chest we are to receive.
7.8.5.2.8 Complete the sample containers per ice chest section.
7.8.5.2.9 Sign and date the form at the bottom.
7.8.5.2.10 If any anomalies are observed, please enter this information in
the comments section.
Example: Sample temperature was 10°C, but an adequate amount of blue ice was observed. This
information can be entered into comments. “Samples were refrigerated with an adequate amount of
blue ice, however the samples were kept under these conditions for x hours, thus the refrigerant
potential to keep sample temperatures at 0-6°C had been exhausted.
7.8.5.2.11 Any temperatures noted outside 0-6°C must be communicated
to Client Services. Submit the Sample Receipt Form to the
appropriate CSR. If the proper CSR is unavailable, either place
the form on his/her keyboard or submit to Client Service
Manager. Please use common sense…if a CSR is on vacation
don’t place it on his/her keyboard, etc.
7.8.5.2.12 The CSR must initial and date the form.
7.8.6 Client to Laboratory
First, the samples are taken and with all pertinent information labeled by a customer or BC Laboratories
field service department. A chain of custody form is completed by the customer or at the customers request
by BC Laboratories personnel. All pertinent information is entered on the COC form, Report to, Project
info., Matrix, Analyses requested, TAT info., any comments, Billing info., and sample disposal information.
The relinquisher and receiver sign and date the COC at the time of the sample custody switch.
Upon completion of the COC forms the samples are shipped or couriered to the fixed lab, at which time the
samples are received, inspected and dated by the receiving individual.
7.8.7 Within the Laboratory
At the time of receipt the temperature of the sample(s) are taken. The pH of samples needing preservation
are checked and noted by preparation technicians and/or analysts. Also custody seals, if present, are noted.
Any sample breeches or anomalies in shipping containers are also noted. Information is noted on the Log-In
Sample Receipt Form.
Next the samples are assigned a unique laboratory number for identification throughout the labs. These
numbers are checked by a second person. A rubber stamp has been produced to be used to provide a
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template to document number checking.
The sample containers are labeled with this number and all COC information present on the sample
containers is cross checked with the COC itself. If any discrepancies are found, the client is notified and
corrective action takes place. Distribution of samples takes place and is documented on the COC.
All pertinent information such as sampling dates, times, container types and numbers, analyses requested,
sample description, matrices, client specific information, etc. are entered into the LIMS for sample tracking,
data sheet generation, final report generation and billing.
All worksheets for the tests requested are generated by the Log-In department and distributed throughout the
lab.
Samples are stored in refrigerators that have a check-in/out log associated with it. Samples are placed in
shelves and must be logged out when removed, or logged back in when they are returned.
Copies of the COC forms are made to accompany worksheets for each department. The original is kept on
file by client service representatives and then is sent with the final report to the client.
BC Laboratories has the capability of sending pre-completed COC forms along with sample containers to
clients who know what tests are needed in advance of sampling. These forms contain: Customer info.,
Project info., Analyses requested, Matrices, Billing info., as well as sample description pre-entered for a
clients ease of use.
7.8.8 Laboratory to Subcontractors
COCs are completed by BC Laboratories for any samples that are sent out to a subcontract laboratory.
Normal COC procedures are followed.
Non-BC Laboratories COC forms are treated just as our own. All normal COC procedures are followed.
7.8.9 Disposal
7.8.9.1 Aqueous Samples
Once analyses have been completed, samples ready for removal can be logged out of holding refrigerators.
Acknowledgement of final removal of samples from refrigerators is noted on respective refrigerator logs.
Samples are then temporarily stored in various areas within the lab until the person who assumed custody
can relinquish samples to a designated person who has waste archiving/disposal responsibilities. Transfer of
custody should be documented on sample tracking logs. Samples are then archived and temporarily stored
in a sea-train. When appropriate, personnel who have waste disposal responsibilities dispose of samples
according to waste stream type. Waste sample disposal should be documented on sample tracking logs.
7.8.9.2 Non-Aqueous Samples
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Once analyses have been completed, samples ready for removal can be logged out of the walk-in
refrigerators. Acknowledgement of final removal of samples from refrigerators is noted on the walk-in
refrigerator log. Samples and splits are then temporarily stored into boxes which are kept in the caged area
in the back of the laboratory. Tracking of samples and splits into boxes is conducted through the LIMS:
Cursor to “More” enter; then “Misc” enter; then “Sample Storage” enter. Enter box ID, date, then
sample IDs.
Samples are disposed of in boxed lots according to potential hazard approximately 60 days after collected
into boxes. Disposal is recorded into a sample disposal log which cross references waste drum IDs or other
disposal containers to box IDs.
7.8.10 Quality Control
As stated above, all sample information present on sample container is cross checked by sample receiving
personnel. All sample transport containers are checked for: temperature, damage or sample breeches.
Notes of such are placed on COC forms. Custody seals are noted on COC forms. Only indelible ink may be
used to complete a COC form. If an error is made, we request that clients make a single line through the
entry as well as initialing and dating the new entry. BC Laboratories personnel follow this policy. No
changes to a COC form may be made without first contacting the client. When a client requests or OKs a
change, the change is noted, dated and who OK’d the changes is noted. Also, the person physically making
the change to the COC must initial and date the change.
7.8.12 Sample Digest/Extract Tracking
Sample digests and extracts are tracked through digestion and run logs. Analysts acknowledge receiving
prepared samples from sample preparation personnel by signing respective preparation logs. Once in their
possession, analysts must store prepared samples in designated areas until sample analyses are complete.
Prepared samples must be archived into waste containers then disposed of through proper waste streams.
Documentation should be accurate enough to trace digests/extracts to a waste drum or waste receptacle.
7.8.12 Documentation
As mentioned earlier in this section, sample custody and tracking must be documented on chain of custody
forms, refrigerator logs, Sample tracking logs, sample disposal logs and manifests.
7.8.12.1 General Rules Pertaining to Logs:
7.8.12.1.1 Use indelible black ink only.
7.8.12.1.2 Follow proper error correction procedure-line through, initial
and date.
7.8.12.1.3 Write legibly.
7.8.12.1.4 Keep logs away from potential damaging sources like water.
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7.8.12.1.5 Proceed in sequential page order.
7.8.12.1.6 Keep logs in their designated areas.
7.8.12.1.7 Turn logs into the QA/QC Department when full or damaged.
7.8.12.2 How to Obtain Documentation Forms
Chain of Custody Forms – Sample Receiving Area
Logs – The Word Processing Specialist. See Controlled Documents section
Manifests – Copies are kept by the President of BC Laboratories.
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STANDARD AND REAGENT HANDLING
SECTION VIII REVISION 3 EFFECTIVE DATE 01/08/16 Page VIII-1
8.1 Introduction
The quality, validity and documentation of standard materials are critical to data quality since all
identification and quantitation of results, as well as judgment about the quality of data, rely on values for the
standard materials. The following section outlines procedures on how to qualify, prepare, validate, store and
document standards and reagents.
8.2 Qualification
It is extremely important that stock standards and reagents are appropriate for use. There are numerous
purity grades of chemicals and these grades are classified or named differently by vendors. Please refer to
the Purity Translation Table for some guidance on the appropriateness of chemicals for use with your
particular methods. Generally, the less pure a chemical, the less the price. Since some impurities may not
affect certain tests, “general use” chemicals may be appropriate for use.
Whenever possible, chemicals should be NIST traceable and ACS approved. Chemicals should be
purchased from vendors who are ISO 9001 or ISO 9002 certified.
Purity Translation Table
Manufacturer Grade Application
Aldrich ACS Most analytical applications
Baker Baker Analyzed Does not necessarily meet ACS standards. General lab use.
Baker Ultrex/Ultrex II Trace level metals. Ultra high purity.
Baker Instra-Analyzed Trace element analysis.
Baker Analyzed-HPLC HPLC applications
Baker Resi-Analyzed Residue and volatiles analyses
Baker Purified General use. Glassware cleaning.
Baker BAKER General laboratory use
Baker Practical General laboratory use
Baker Technical General laboratory use
Fisher GC Resolv Gas Chromatography
Fisher Optima HPLC, GC, plasma/ICP, spectrophotometery and pesticide residue
analysis
Fisher HPLC HPLC and spectrophotometry procedures
Fisher Pesticide GC with electron capture detector
Fisher Spectranalyzed Ultraviolet and visible wavelength detectors
Fisher TraceMetals Primarily used for digestion of samples prior to ICP analysis
Fisher Certified ACS Plus Analytical application with tighter metal specifications
Fisher Certified ACS Analytical application requiring tight specifications
Fisher Certified General analytical
Fisher Laboratory and
Technical
Manufacturing and general laboratory use
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Malinckrodt ACS Meets requirements of the American Chemical Society Committee
on Analytical Reagents
Malinckrodt AR* General laboratory use
Malinckrodt AR* Primary
Standard
Standardizing volumetric solutions and preparing reference
standards
Malinckrodt AR Select* ACS quality standards for trace metals
Malinckrodt AR Select # Plus Specifically purified by sub-boiling distillation. Nearly all trace
level impurities are less than 1 ppb.
Malinckrodt Nanograde Solvent reagent quality
Malinckrodt StandARd* Atomic absorption
Malinckrodt Technical General industrial use
Malinckrodt UltimAR* Specialty solvents distilled to purity levels exceeding the
requirements for HPLC, TLC, GC and pesticide residue analysis.
Please contact your department supervisor if you are ordering “general use” grade chemicals for new
applications. Please see the procurement section of this manual for details on ordering standards and
reagents.
8.3 Receiving
Immediately upon receipt, standards and reagents must be checked against the requisition form or the
expiring or old standard or reagent to verify suitability. If the standard or reagent is from a different vendor
or if the grade has changed, contact your department supervisor before proceeding.
Standard and reagents must be systematically labeled with the dates of receipt and expiration (if not noted
on the label). Immediately upon opening, standards and reagents must be labeled with the date of opening.
Labeling must be specific and legible enough to discern the difference between receiving, opening and
expiration dates. If information cannot fit onto the container, please use tape as a label flag or provide
information on a small label to direct where label information can be found.
All standards should be received with a Certificate of Analysis. This record acts as a traceability record and
a purity verification. Keep an orderly log of these records in your work area. If you do not receive a
Certificate of Analysis with the ordered standard, contact your department supervisor to secure a copy.
8.4 Preparation
Standard and reagent solutions must be prepared using Class A volumetric glassware or internally calibrated
volumetrics and pipettes. Automatic pipettes and gas tight syringes used to prepare standards must be
checked for conformance to calibration specifications prior to use. Standards prepared in the laboratory
must be labeled with the contents (analyte and concentration), initials of the preparer, standard code, date of
preparation, date of expiration and potential hazard.
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8.5 Expiration Date
Expiration dates must be assigned and documented for all standard, reagent and quality control materials.
All standards and reagents must be labeled with expiration dates. Expiration dates can be figured or
assigned in different ways.
Manufacturer Set: Expiration dates set for stock materials are set by the manufacturer. Assigned expiration
dates for purchased materials must not exceed the manufacturer’s expiration dates. Assigned expiration
dates for laboratory-prepared stock and diluted standards must not exceed the most limiting expiration date
of a component stock solution or material.
Method Set: Standard and reagent expiration dates are set according to method references.
Laboratory Set: If the analytical method does not provide guidelines for standard material shelf life, the
expiration date must be assigned based on professional judgment, and in consideration of the stability and
concentration of the constituents and storage conditions. These expiration dates must be discussed in
method SOPs.
Prepare a standard orreagent from a stock
solution
Note the expirationdate of the analyte(s)of the stock solution
Does any analyte fromthe stock expire prior tothe expiration date set
by the method orlaboratory SOP?
Figure the expiration dateof the prepared standard
or reagent set by theref erenced method or thelaboratory . Ref er to the
method SOP.
The expiration date isdefaulted to the stock
expiration date.
The expiration date isset according to the
referenced method orlaboratory method
SOP.
Yes
No
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Prior to initial use, the quality and accuracy of standards must be accessed through comparison with
reference standard materials of known composition. Newly made standards must not exceed five (5) percent
difference from the reference standard.
8.6 Preservation and Storage
Preservation use and storage conditions must comply with manufacturer’s recommendations, method
protocols or with good laboratory practices as to maintain standard or reagent integrity. One must consider
storage container types, potential for cross contamination sources and temperature when storing reagents and
standards. Preservative use should take sample matrix matching situations into consideration. Please refer to
respective method SOPs for specific details.
8.7 Documentation
Laboratory logbooks must document the preparation of each standard and reagent from original stock
materials, including subsequent dilutions. A unique identifier must be assigned to each original stock
material and to each subsequent dilution. Logbook entries must include the prepared concentration and
unique identifier of the prepared material, the dates of preparation and expiration, the amount and the lot
numbers or unique identifiers of the materials and solvents used to prepare the material, and the identity of
the person who prepared the materials. The reference comparison check may also be included in the
standard log.
Organic Department personnel should refer to SOPs for details on the preparation and nomenclature of
standards and reagents. Inorganic standards and reagent preparation and nomenclature should be addressed
in individual method SOPs.
8.8 Disposal
When standards and/or reagents have expired, they must be pulled out of service. The remainder of the
standard/reagent must be disposed of properly through one of our waste streams. Please refer to the Waste
Disposal SOP or consult your department supervisor.
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9.1 Overview
The proper handling and use of laboratory glassware will assure the accuracy and validity of data to a
certain extent. For example, when we use proper glassware for standard preparation, we are assuring the
standard was made up with a prescribed tolerance or error. Our standard operating procedures include
specified glassware to be utilized because of the need to standardize operations and to allow our
analytical systems to reproduce results. We must also prescribe to diligently and properly clean
glassware to minimize the probability of introducing contamination and interfering artifacts. The
following section deals with good laboratory practices associated with glassware. Glassware includes
receptacles which are not only glass, but made of teflon or other materials.
9.2 Types
For our purposes we will define only two classes of volumetric glassware:
9.2.1 Class A glassware – Volumetric glassware that meets volume tolerance levels as
specified in ASTM E 288, E 542, and E 694. This glassware is exclusively used to
prepare standard materials and can be used for titration analyses.
9.2.2 Non-Class A – Any glassware that is not Class A. Used for general lab use such as
preparing reagents and can be used to prepare standards if proper calibration verification
studies deem volume deliveries or capacity meets Class A standards.
Class A Volumetric Flasks
Flask Capacity (mls) Tolerance (mls)
5 +0.02
10 +0.02
25 +0.03
50 +0.05
100 +0.08
200 +0.10
500 +0.20
1000 +0.30
2000 +0.50
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Class A Volumetric Pipettes
Capacity (mls) Accuracy (mls)
0.5 +0.006
1.0 +0.006
2.0 +0.006
4.0 +0.01
5.0 +0.01
10.0 +0.02
15.0 +0.03
20.0 +0.03
25.0 +0.03
50.0 +0.05
100.0 +0.08
9.2.3 Pipettes Types
9.2.3.1 Disposable Transfer pipette: Single unit with a built-in pipette bulb.
9.2.3.2 Pasteur Pipette: Pipettes with a long narrow tip, typically not graduated,
which require a bulb to receive liquid.
9.2.3.3 Serological and Mohr Pipettes: Long cylindrical graduated pipettes that
can be used to deliver various volumes.
9.2.3.4 Volumetric Pipettes: Used to deliver a specified volume. Has a
distinctive bulge in its design.
9.2.3.5 Repipette Dispensers: Adjustable delivery dispensers which are attached
to reagent containers.
9.2.3.6 Repeater Pipetters: A fixed volume delivery system that includes a pipette
head which connects to a flask. Volume is delivered by first filling the
pipette head by tilting the flask back then tilting the flask forward to empty
the contents.
9.2.3.7 Micro-pipettes: A plunger-type gadget with a disposable tip which is used
to deliver fixed volumes.
9.2.3.8 Syringe: A graduated opened end tube with plunger
9.2.4 Flask Types
9.2.4.1 Volumetric: Fixed volume flasks which are used to prepare or contain
samples, reagents or standards. This flask has a relatively long cylindrical
neck with a blown-out lower body. Designed to accept either teflon or
glass caps.
9.2.4.2 Erlenmeyer: All purpose graduated flask used for multiple purposes such
as reagent and sample preparation activities. This flask comes in many
sizes and is shaped like a rounded pyramid. The top can have a fitted cap
or can come with optional fittings or stems which allow for vacuum
processes.
9.2.4.3 Distillation: Rounded bottomed flask which was designed for efficient
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distillation through heat containment design or heating mantle fit and
continued sample dynamics by physical dispersion. A flask holder must be
used to house these flasks because they cannot stand on their own.
9.2.5 Funnels
9.2.5.1 Separatory: Rounded body receptacle equipped with a fitted top, long
stem and stopcock. Used to separate layers within solutions.
9.2.5.2 General Purpose Filtering: Wide angled funnel with long cylindrical stem.
Used to house filter paper used for gravity filtrations. Also used to
introduce materials into receptacles with narrow orifices.
9.2.5.3 Buchner: Funnels which are used when filtrates attack filter papers.
Designed for vacuum filtration.
9.2.5.4 Millipore: A four piece unit: (stem with a filter housing, cylindrical body,
clamp and filter screen), which fits onto a large Erlenmeyer flask. Used to
filter samples under vacuum.
9.2.6 Tubes
9.2.6.1 Test: Typically non-graduated, these receptacles are long and cylindrical
with a rounded end.
9.2.6.2 Centrifuge: Conical bottomed tubes which are designed to withstand the
rigors of a centrifuge. Usually graduated with screw top closure
capabilities.
9.2.6.3 Kuderna: Danish Concentrator: A graduated tube which is used in
conjunction with a flask with two orifices and a cooling column chamber
or condenser for the concentration of trace amounts of samples dissolved
in solvents.
9.2.7 Burets
Long, cylindrical, graduated open-ended tube equipped with a stopcock. Used to deliver and measure
liquid delivery for titrations.
9.2.8 Beakers
9.2.8.1 Griffin: Non-tapered cylindrical wide-mouthed container typically with
graduations that is used for preparing reagents and samples. The top
usually has a flared spout for easy pouring.
9.2.8.2 Berzelius: Taper cylindrical wide-mouthed container which is narrower
than a Griffin beaker. Use is generally the same as for the Griffin beaker.
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9.2.9 Watch Glasses
9.2.9.1 Non-ribbed: Beaker covers used to prevent excess splatter, control cross-
contamination and to speed up preparation processed which require a
heating step.
9.2.9.2 Ribbed: Beaker covers used to prevent excess splatter, control cross-
contamination and to speed up. Ribbed design permits reflux of digestate
and escape of excess vapor, thus preventing vapor build up. Ribs also
prevent watch glasses from sticking together when wet.
9.2.10 Graduated Cylinder
9.2.10.1Graduated Cylinder: Graduated tube with a flattened bottom which
allows it to stand upright. Used to prepare and measure samples and
reagents. Not highly accurate, thus use accordingly.
9.3 Glassware Colors
Glassware used in the laboratory typically comes in two colors, amber and flint. There are advantage
and disadvantages in housing samples or standard materials in amber or flint colored receptacles.
9.3.1 Amber: Brown colored receptacles used to slow the breakdown of light sensitive
components.
9.3.2 Flint: Clear colored receptacles which allow for clear viewing of sample or standard
material.
9.4 Cleaning
Because we report concentrations for many analytes at the part per billion level, it is important to wash
glassware thoroughly prior to use. Glassware cleaning should be thorough, appropriate, systematic and
consistent in order to maintain control of your process. Any artifacts left on glassware brought into
contact with a sample or standard material can cause adverse effects. Contamination is not the only
problem here; artifacts can interfere with certain tests thus causing compromised results. Certain tests
may require special cleaning and glassware preparation procedures, so always refer to the method SOP
for details.
As a general rule, if water drops adhere to the sides of containers and inside pipettes after rinsing, this
indicates that glassware is dirty.
9.5 Organics Testing
In the analysis of samples containing components in the parts per billion range, the preparation of
scrupulously clean glassware is mandatory. Failure to do so can lead to a myriad of problems in the
interpretation of the final chromatograms due to the presence of extraneous peaks resulting from
contamination. Particular care must be taken with glassware such as Soxhlet extractors, Kuderna-
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Danish evaporative concentrators or any other glassware coming in contact with an extract that will be
evaporated to a smaller volume. The process of concentrating the compounds of interest in this
operation may similarly concentrate the contaminating substance(s), which may seriously distort the
results.
The basic cleaning steps are:
1. Removal of surface residuals immediately after use;
2. Hot soak to loosen and float most particulate material;
3. Hot water rinse to flush away floated particulates;
4. Soak with an oxidizing agent to destroy traces of organic compounds;
5. Hot water rinse to flush away materials loosened by the deep penetrant soak;
6. Distilled water rinse to remove metallic deposits from the tap water;
7. Alcohol (e.g., isopropanol or methanol) rinse to flush out any final traces of organic
materials and remove the water; and
8. Flushing the item immediately before use with some of the same solvent that will be used
in the analysis.
Each of these eight fundamental steps will be discussed in the order in which they appear.
1. As soon as possible after glassware (i.e., beakers, pipettes, flasks, or bottles) has come in
contact with sample or standards, the glassware should be flushed with alcohol before
being placed in the hot detergent soak. If this is not done, the soak bath may serve to
contaminate all other glassware placed therein.
2. The hot soak consists of a bath of a suitable detergent in water of 50°C or higher. The
detergent, powder of liquid, should be entirely synthetic and not a fatty acid base. There
are very few areas of the country where the water hardness is sufficiently low to avoid the
formation of some hard-water scum resulting from the reaction between calcium and
magnesium salts with scum or curd would have an affinity particularly for many
chlorinated compounds, and being almost wholly water-insoluble, would deposit on all
glassware in the bath in a thin film.
There are many suitable detergents on the wholesale and retail market. Most of the
common liquid dishwashing detergents sold at retail are satisfactory but are more
expensive than other comparable products sold industrially.
3. No comment required.
4. The most common and highly effective oxidizing agent for removal of traces of organic
compounds is the traditional chromic acid solution made up of concentrated sulfuric acid
and potassium or sodium dichromate. For maximum efficiency, the soak solution should
be hot (40-50°C). Safety precautions must be rigidly observed in the handling of this
solution. Prescribed safety gear should include safety goggles, rubber gloves, and apron.
The bench area where this operation is conducted should be covered with fluorocarbon
sheeting because spattering will disintegrate any unprotected surfaces.
The potential hazards of using chromic sulfuric acid mixture are great and have been well
publicized. There are now commercially available substitutes that posses the advantage
of safety in handling. These are biodegradable concentrates with a claimed cleaning
strength equal to the chromic acid solution. They are alkaline, equivalent to ca. 0.1 N
NaOH upon dilution, and are claimed to remove dried blood, silicone greases, distillation
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residues, insoluble organic residues, etc. They are further claimed to remove radioactive
traces and will not attack glass or exert a corrosive effect on skin or clothing.
5. No comments required.
6. No comments required.
7. No comments required.
8. There is always a possibility that between the time of washing and the next use, the
glassware could pick up some contamination from either the air or direct contact. To
ensure against this, it is good practice to flush the item immediately before use with some
of the same solvent that will be used in the analysis.
The drying and storage of the cleaned glassware is of critical importance to prevent the beneficial effects
of the scrupulous cleaning from being nullified. Pegboard drying is not recommended. It is
recommended that laboratory glassware and equipment be dried at 100°C. Under no circumstances
should such small items be left in the open without protective covering. The dust cloud raised by the
daily sweeping of the laboratory floor can most effectively re-contaminate the clean glassware.
As an alternative to solvent rinsing, the glassware can be heated to no higher than 300°C to vaporize any
organics. Do not use this high temperature treatment on volumetric glassware, glassware with ground
glass joints, or sintered glassware.
9.6 High Concentrated Samples
Contamination of low-level samples may occur when prepared in the same laboratory with highly
concentrated samples. Ideally, if both type samples are being handled, glassware dedicated solely to the
preparation of highly concentrated samples would be available for this purpose. If this is not feasible, as
a minimum when preparing highly concentrated samples, disposable glassware should be used or, at
least, glassware dedicated entirely to the high concentration samples. Avoid cleaning glassware used for
both trace and high concentration samples in the same area.
9.7 Metals
Cleaning sample containers used for metals analyses involves a tap rinse, an addition of 1:1 HNO3, and
a final rinse with metal-free water. For quartz or glass containers housing samples or standard materials
for metals, use a concentrated solution using HNO3 and HCL, or aqua regia (3 parts conc HCL + 1 part
HNO3) for soaking. After soaking, thoroughly rinse with metal-free water. Chromic acid may be used
to remove organic deposits, however we suggest not to use chromic acid for plastic containers or if
chromium is to be determined.
9.8 Wet Chemistry
Thoroughly clean containers with a phosphate-free detergent, then rinse with copious amounts of Type II
water. Chromic acid may be used to remove organic deposits from glass containers, however do to
safety hazard, and use this reagent with care.
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9.9 How to Measure Containment
In order to properly measure liquids contained in glassware, you must fill until the liquids’ meniscus
touches the fill line or the desired graduation. The meniscus is the curved upper surface of a liquid.
9.10 Delivery and Containment Glassware Types
9.10.1 To contain: hold the exact volume of liquid specified.
9.10.2 To deliver/blow out: must be allowed to drain, then the drop that remains must be blown
out and added to the original delivery to equal the exact amount.
9.10.3 To deliver: must be held vertically with the tip against the side of the receiving vessel
and allowed to be drained completely. The stated volume is obtained when draining
stops.
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10.1 Weight
When weighing a component, one must consider the following variables:
Accuracy
Safety
Containment
10.2 Accuracy
Analytical balances are capable of accurately measuring the weight of a component to within 0.5 mg.
Instances where weighing using an analytical balance include:
Gravimetric testing requiring a high degree of accuracy
Weighing of standards and/or reagents
Micro-pipette calibration
Others
The analytical balance with the digital display is not as accurate as the other analytical balances, thus it is
highly recommended that you consider using an appropriate analytical balance dependant upon your
accuracy requirements.
Top-loading balances can accurately measure the weight of components to 0.1 to 0.001 g depending on
which model top-loader you use. Some top-load balances have two ranges, low and high. Be sure to set
the balance range, if applicable, to the most accurate setting possible for each measurement.
10.3 Safety
Some substances are highly toxic, thus you must take certain precautions when weighing because you
are in close contact. If the danger is from inhalation, you should weigh under a laboratory hood. Only
use top loading balances under hoods; analytical balances should not be moved. Please contact the QA
Officer and you department Supervisor when moving balances.
It is imperative that proper cleaning procedures are used at all times after using balances. All artifacts
and/or liquids must be removed from on top and around the balance before and after use. This will
minimize your exposure and will also reduce the possibility of cross-contamination. If you have any
questions regarding how to clean a balance in cases of unknown substances, contact the QA Officer.
10.4 Containment
The choice of the container or device you use to weigh substances into is extremely important. You
must consider cross-contamination potential, capacity, alignment and appropriateness.
10.5 Cross-Contamination
One must consider what testing is being conducted and what analytes are being reported per preparation
or analytical event. For example, it is not appropriate to weigh samples requiring metals into a metal
pan or using plastic containers to weigh samples for EPA 8270 tests because of potential phthalate
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contamination. Consult your Department Supervisor to discuss good practices regarding this issue.
10.6 Capacity
Each container has a maximum capacity that is dependant upon the matrix of the material being
weighed, and the container geometry. It is important that there is 100% containment of the material
being weighed because the weight may be accurate, but the amount of the material used for testing may
not be accurate of there is spillage and because of safety issues. Please note that you should not
necessarily fill the container to capacity or exceed capacity because of the same issues discussed earlier.
10.7 Alignment
All weighing should take place in the middle of balance pans. Ensure that the pan is properly placed or
affixed to the balance before each use. Keep all materials away from the top or within balances to
reduce the probability of inaccurate weighing.
10.8 Appropriateness
Other than container capacity, appropriateness deals with other common sense issues regarding
containment choice. For example, containers with narrow orifices should not be used for relatively high
particle size components unless an appropriate funnel is used. Also, the container the material is being
weighed into should fit onto the pan, or top of the balance without contact with any other surfaces.
There are too many other scenarios not mentioned here, so please use common sense in your decisions.
10.9 Liquids Measuring
One must first consider accuracy, appropriateness and safety when deciding measuring techniques and
apparatus for volume measurements. Please refer to the Glassware section of this document for accuracy
and appropriateness issues. Again, use common sense when deciding how, what, when and where you
measure liquids. It is especially critical to know what you are drawing or pouring because you can
increase you chance of exposure if you use inappropriate measuring tools and improper PPE and
environmental controls.
10.10 Important Safety Practices
1. Always use a bulb to draw liquids
2. Check the compatibility of the liquid with the container
3. Check the capacity of the container and verify the amount you are measuring
4. Add acid to water, never water to acid
5. Properly clean glassware before and after use, do not flick liquid from containers
Note: Section X was reviewed on 01/08/16(No Changes were made)
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11.1 Scope and Application
It is necessary to verify micro liter pipette calibration prior to laboratory use. Tolerances are
established to provide accuracy goals. Pipettes that do not meet specifications listed in section 11.4
will not be used until deemed acceptable and in good working order.
11.2 Summary of Method
Calibration of pipettes will be conducted through gravimetric testing. Testing will be done by
weighing a prescribed volume of di-ionized water on a sufficiently sensitive analytical balance.
11.3 Apparatus and Materials
11.3.1 Eppendorf Unipipettes 10 µl
20 µl
50 µl
100 µl
200 µl
500 µl
1000 µl
5000
11.3.2 ASTM Type II water
11.3.3 Analytical Balance
11.3.4 Digital Thermometer
11.4 Procedure
11.4.1 Test Room (Room # 15)
11.4.2 Use balance #8 in Room 15 weighing within 0.0001g
11.4.3 Use Digital Thermometer # 158 in Room 15
11.4.4 The test room should have a constant temperature between 15°C and 30°C at a constant
temperature of ±0.5C. (according to EN ISO 8655)
11.5 Temperature differences
11.5.1 Before the test, the device to be tested and test liquid must have stood in the test room for a
sufficient amount of time, at least 2 hours, in order to reach equilibrium with the storage
conditions
11.5.2 Take five separate weighing at each calibration volumes (see Form 2)
11.5.3 The color of the control button usually indicates the color of the appropriate pipette tip.
Volumes less than or equal to 10 µl should be rinsed from an unwetted pipette tip. If
volumes are > 10 µl, it is recommended that water be aspirated and dispensed two or three
times when a new pipette tip is used. Important: The Laboratory water, weighing vessel,
pipette tips, and pipette must have reached the same temperature prior to calibration.
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11.5.4 First secure the pipette to be calibrated. You will need a supply of ASTM Type II water, a
vessel, and an analytical balance. Weigh the vessel, preferably a two ounce plastic cup, on
the analytical balance. Record the weight of the vessel. Now attach a pipette tip tightly (pay
attention to the color code). Press control button down to first stop (measuring stroke).
Hold pipette vertically and immerse tip approximately 3 mm, release control button slowly.
Slide tip out of the water along the inside of the container. Wipe any droplets with lint-free
tissue. Ensure that no liquid is aspirated out of the tip. Hold the tip at an angle against the
inside of the weighed vessel. Press the control button slowly down to the first stop
(measuring stroke) and wait approximately 1-3 seconds.
11.5.5 Press down to the second stop to empty tip completely. Hold down control button and slide
tip up against the inside of the weighed vessel. Weigh and record new vessel weight.
Subtract initial weight from the final weight to measure uncorrected volume dispensed. Five
measurements are sufficient for accuracy control of initial use. To calculate volumes, divide
the weight of the water measurements by its density at 20°C: 0.9982. For daily use, conduct
1 measurement. Record micro liter calibration in a log along with the date of calibration.
11.6 Compliance Tolerance Limits
Eppendorf Series 2000 and Finnepipette Fixed Volume
Volume Inaccuracy Imprecision Inaccuracy(±µl) Imprecision
5 µl ±2% 1% 0.1 0.05
10 µl ±2% 1% 0.2 0.10
20 µl ±2% 1% 0.4 0.2
50 µl ±2% 1% 1.0 0.5
100 µl ±2% 1% 2.0 1.0
200 µL ±2% 1% 4.0 2.0
500 µl ±2% 1% 10.0 5.0
1000 µl ±2% 1% 20.0 10.0
2000 µl ±2% 1% 40.0 20.0
5000 µL ±2% 1% 100.0 50.0
Please refer to the following tables for recommended ranges. Weights consistently outside the
recommended range should initiate corrective procedures. If a micro-pipette is not in good
working order or not in calibration, please submit the pipette to the QA/QC Department. It is
imperative that incompliant pipettes are not in use.
11.7 Documentation
Gravimetric checks are to be documented on respective prep log and/or run logs. Accuracy
verified ± 2%
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11.8 References
Eppendorf Micro – pipette Series 2000 Reference Fixed – Volume and Finnepipette instruction manuals.
Eppendorf Series 2000 Reference Fixed – Volume pipette. Tests carried out in accordance with
Piston pipettes ISO 8655-2:2002.
Temp. °C-Water Temp 15°C and 30°C, constant to ± 0.5°C
Using ASTM Type II Water
Cal of Eppendorf Acceptance Criteria
Weight of Verified at ±2%
20 µL 0.0196 – 0.0204
50 µL 0.049-0.051
100 µL 0.098-0.102
200 µL 0.196-0.204
500 µL 0.490-0.510
1.0 mL 0.980-1.020
5 ml 4.900-5.100
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12.1 Scope and Application
The MDL for an analytical procedure may vary as a function of sample type. The procedure
requires a complete, specific, well-defined analytical method. It is essential that all sample-
processing steps of the analytical method be included in the determination of the method detection
limit. The MDL obtained by this procedure is used to judge the significance of a single
measurement of a future sample. The MDL procedure was designed for applicability to a broad
variety of physical and chemical methods. To accomplish this, the procedure was made device-or-
instrument independent.
12.2 Summary of Method
The Method Detection Limit is defined as the minimum concentration of a substance that can be
identified, measured and reported with 99% confidence that the analyte concentration is greater
than zero and determined from analysis of a sample in a given matrix containing analyte. Initially
the method utilizes a series of ways to estimate the detection limit; then using statistical
justification, the procedure verifies the reasonableness of the estimated MDL.
12.3 Required Apparatus and Materials
All instruments requiring MDL and IDL determinations and acceptable precision and accuracy
ranges. Calculators with statistical packages will be helpful. A table of student’s t values or a
table of normal values will be needed where applicable.
Instrument parameters - parameters will be set at routine analysis settings. MDLs may be
determined at practical concentrations thus not adhering to extreme constraints. Determinations
for pH and EC are examples of MDL=PQL.
12.4 Reagents and Standards
Reagents will be made up with high purity water and reagent grade chemicals. Standards will be
made up with high purity water and reagent grade chemicals with special emphasis on matching
matrices with samples used in the determination of MDLs of respective analyses.
Working standards – standards used will be made up with high purity water or treated water for
specific tests (i.e. Organic free water). Standard stock sources include manufactured and in-house
reagent grade standards. Matrix matching between samples and standards is essential for proper
determination of MDLs for each respective analysis. Special attention should be placed on the
linearity of the standard curve. The correlation of coefficient or (r) should be >=.995 but emphasis
should be placed on the lower end of the curve where MDL detections will be quantified. You
should check for a change in slope at the detection level.
Spikes – samples used for the determination of MDLs will be spiked at:
The concentration value that corresponds to an instrument signal/noise ration in the range
of 2.5 to 5. If the criteria for qualitative identification of the analyte is based upon pattern
recognition techniques, the least abundant signal necessary to achieve identification must
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be considered in making the estimate, or
The concentration value that corresponds to three times the standard deviation of replicate
instrumental measurements for the analyte in reagent water, or
The concentration value that corresponds to the region of the standard curve where there
is a significant change in sensitivity at low analyte concentrations (i.e. a break in the slope
of the standard curve), or
The concentration value that corresponds to known instrumental limitations.
It is recognized that the experience of the analyst is important to this process.
12.5 General MDL/PQL Procedure
12.5.1. Prepare reagent (blank) water that is free of analyte as possible. Reagent or interference
free water is defined as a water sample in which analyte and interferant concentrations are
not detected at the method detection limit of each analyte of interest. Interferences are
defined as systematic errors in the measured analytical signal of an established procedure
caused by the presence of interfering species (interferant). The interferant concentration is
presupposed to be normally distributed in representative samples of a given matrix.
12.5.2. If an MDL is to be determined in reagent water (blank), prepare a laboratory standard
(analyte in reagent water) at a concentration which is at least equal to or in the same
concentration range as the estimated MDL (recommended between 1 and 5 times the
estimated MDL). Proceed to step 12.5.6.
12.5.3. If the MDL is to be determined in another sample matrix, analyze the sample. If the
measured level of the analyte is in the recommended range of 1 to 5 times the MDL,
proceed to step 12.5.6.
12.5.4. If the measured concentration of analyte is less than the estimated MDL, add a known
amount of analyte to bring the concentration of analyte to between 1 and 5 times the MDL.
In the case where an interference is co-analyzed with the analyte.
12.5.5. If the measured level of analyte is greater than 5 times the estimated MDL, there are two
options:
12.5.5.1 Obtain another sample of lower level of analyte in the same matrix if
possible.
12.5.5.2 The sample may be used as is for determining the MDL if the analyte level
does not exceed 10 times the MDL of analyte in reagent water. The variance
of the analytical method changes as the analyte concentration increases from
the MDL, hence the MDL determined under these circumstances may not
truly reflect method variance at lower analyte concentrations.
12.5.6 Take a minimum of seven aliquots of the sample to be used to calculate the MDL and
process each through the entire analytical method. Make all computations according to the
defined method with final results in the method reporting units. If blank measurements are
required to calculate the measured level of analyte, obtain separate blank measurements for
each sample aliquot analyzed. The average blank measurement is subtracted from the
respective sample measurements.
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12.5.7 It may be economically desirable to evaluate the estimated MDL before proceeding. This
will: (1) prevent repeating this entire procedure when the costs of analyses are high and (2)
insure that the procedure is being conducted at the correct concentration. It is quite
possible that an incorrect MDL can be calculated from data obtained as many times the real
MDL even through the background concentration of analyte is less than 5 times the
calculated MDL. To insure that the estimate of the MDL is a good estimate, it is necessary
to determine that a lower concentration of analyte will not result in a significantly lower
MDL. Take two aliquots of the sample to be used to calculate the MDL and process each
through the entire method, including blank measurements as described above in 12.5.6.
Evaluate this data:
12.5.7.1 If these measurements indicate the sample is in the desirable range for
determining the MDL, take five additional aliquots and proceed. Use all
seven measurements to calculate the MDL.
12.5.7.2 If these measurements indicate the sample is not in the correct range, re-
estimate the MDL, obtain new sample as in 12.5.5 and repeat either 12.2.6
or 12.5.7.
12.5.8 Reporting - the analytical method used must be specifically identified by number or title
and the MDL for each analyte expressed in the appropriate method reporting units. If
the analytical method permits options which affect the method detection limit, these
conditions must be specified with the MDL value. The sample matrix used to determine
the MDL must also be identified with the MDL value. Report the mean analyte level
with the MDL. If a laboratory standard or a sample that contained a known amount of
analyte was used for this determination, report the mean recovery, and indicate if the
MDL determination was iterated.
12.5.9 If the level of the analyte in the sample matrix exceeds 10 times the MDL of the analyte
in reagent, do not report a value for the MDL. PQL values are calculated by multiplying
the standard deviation obtained through MDL studies by 5 – 10, then rounded up to a
number with 1’s, 2’s or 5’s.
12.6 Procedures by Test
ICP/AA/GFAA/Hydride/ICP-MS
Spike reagent water at levels outlined in Section 12.5.
Dissolved Metals: Analyze at least seven (7) low levels spikes (without digestion), on three non-
consecutive days.
Total Metals: Digest at least seven (7) low level spikes. Analyze the digested spikes.
Obtain standard deviation and mean of low level spikes. The mean should agree with the true value of
appropriate student’s t value to obtain the MDL. Multiply the standard deviation by ten (10) and round
up to the nearest 1, 2, or 5 to obtain the PQL.
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Hg by Cold Vapor
Spike reagent water at the current PQL level. In this case, spike at the established PQL level of 0.08
g/L for PQL determination. Analyze at least seven (7) low level spikes.
known value of the low level spike. Multiply the standard deviation by the appropriate student’s t
value to obtain the MDL. Multiply the standard deviation by ten (10) and round up to the nearest 1, 2,
or 5 to obtain the PQL.
The MDL can be determined by continuously spiking low level standards lower and lower until the
spike recovery is not discernable from the baseline or the method blank.
Autoanalyzer Analytes
If conducting a PQL/MDL study for the first time, spike reagent water at levels outline in Section
12.5.2. Otherwise, use the current respective method MDL=s as the spike levels. Analyze at least
seven low level spikes.
Obtain the standard deviation and mean of the low level spikes. The mean should be 10% of the
known value of the low level spike. Multiply the standard deviation by ten (10) and round up to the
nearest 1, 2, or 5 to obtain the PQL.
The MDL can be determined by continuously spiking low level standards lower and lower until the
spike recovery is not discernable from the baseline.
pH, EC
PQL=s and MDL=s for these individual tests will be defined the same. MDL=s are established by the
manufacturer.
Gravimetric Procedures
The MDL will be based on the sensitivity of the balance used for analysis. Generally, the spike level
should be such that the net weight is 1 mg otherwise spike reagent water at levels outlined in Section
12.5.2. If new PQL is to be established, analyze seven (7) reagent blanks, then compute the spike level
based on the three times the standard deviation of the reagent blank.
Obtain the standard deviation and mean of the low level spikes. The mean
known value of the low level spike. Multiply the standard deviation by ten (10) and round up to the
nearest 1, 2, or 5 to obtain the PQL.
Gas Chromatography and GC/MS
Spike reagent water at levels outlined in Section 12.5.2. Analyze at least seven (7) low level spikes.
Compute the standard deviation of the low level spikes. Multiply the standard deviation by the
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corresponding 99% Confidence Level Student=s t value for n-1 degrees of freedom to find the MDL.
Compute the mean recovery for the low level spikes. The mean must be 65-135% of the known value,
unless the department supervisor approves differently. Multiply the standard deviation five to ten
times and round to the nearest 1, 2, or 5 to find the PQL.
Digital Spectrometer Techniques
Spike reagent water at levels outlined in Section 12.5.2. Analyze at least (7) low level spikes.
Compute the standard deviation of the low level spikes. Multiply the standard deviation by the
corresponding 99% Confidence Level Student=s t value for n-1 degrees of freedom to find the MDL.
Compute the mean recovery for the low level spikes. The mean must be 80-120% of the known value.
Multiply the standard deviation five to ten times and round to the nearest 1, 2, or 5 to find the PQL.
12.7 Detection Limits for Soil Matrix
Follow procedures outlined in earlier sections except substitute sand or inert solid for reagent water.
12.8 PQL Deviations
In all cases PQLs can be arbitrarily set above official PQL findings. Reasons for this policy are: 1) to
accommodate routine reporting, 2) eliminate uncertainty in regards to matrix interferences and 3)
provide for reporting a PQL achievable based on true instrument limitations.
12.9 Documentation, Approval and Reporting
Record MDL studies on either or the forms on pages XII-8 or XII-9, or on a spreadsheet. If you choose
to use a spreadsheet, please include all data which is found on the following pages. Submit a copy of
your documentation and a copy of the raw data to your department supervisor for approval. The
department supervisor will review the data and the findings and then approve, if appropriate, by
signing report form or spreadsheet. The data will be submitted to the QA Officer. A copy of data will
be submitted to the laboratory coordinator to enter the MDL(s) and into the LIMS. The LIMS print out
is submitted to the QA Officer for review.
12.10 References
Gaser, J.I.; Forest, D.I.; Mckee, G.d.; Quave, S.a.; Budde, W.I. Environ. Sci. Technol. 1981, 15, 1426-
1435.
Long, G.I.; Winefordner, J.D. Anal. Chem. 1983, 55, 721a-724a. Anal. Chem., 55, 2210-2218.
40 CFR Part 136, Appendix B.
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PQL/MDL DETERMINATIONS
Analyst:
Analyte:
Method:
Run Date:
Instrument ID:
Matrix:
Units:
Prep Date:
MDL Study No:
__/__/__-___________-____-________
DATE INSTR ID SEQ MATRIX
NO (W,S)
Analyst:
Analyte:
Method:
Run Date:
Instrument ID:
Matrix:
Units:
Prep Date:
MDL Study No:
__/__/__-___________-____-________
DATE INSTR ID SEQ MATRIX
NO (W,S)
Analyst:
Analyte:
Method:
Run Date:
Instrument ID:
Matrix:
Units:
Prep Date:
MDL Study No:
__/__/__-___________-____-________
DATE INSTR ID SEQ MATRIX
NO (W,S)
MDL Std. ID
Conc.
Response
MDL Std. ID
Conc.
Response
MDL Std. ID
Conc.
Response
1
1
1
2
2
2
3
3
3
4
4
4
5
5
5
6
6
6
7
7
7
MDL Std Concentration:
_
x = s = 3.29(s) =
t(n-1, .99)s= MDL =
10s = PQL =
MDL Std Concentration:
_
x = s = 3.29(s) =
t(n-1, .99)s= MDL =
10s = PQL =
MDL Std Concentration:
_
x = s = 3.29(s) =
t(n-1, .99)s= MDL =
10s = PQL =
Standard Curve r= r2=
Standard Curve r= r2=
Standard Curve r= r2=
1st Order
2nd Order
3rd Order
1st Order
2nd Order
3rd Order
1st Order
2nd Order
3rd Order
Stand. ID
Conc.
Response
Stand. ID
Conc.
Response
Stand. ID
Conc.
Response
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BC LABORATORIES, INC.
MDL/PQL DETERMINATIONS
Analyte: Study No: Std Concentration Used:
_
x = s = 3.29(s) =
t(n-1, .99)s= t(n-1, .99)=
10s =
Dates: Run No. 1
Run No. 2
Run No. 3
Analyst: Blank Response Data:
_
x = s = 3.29(s) =
3s =
10s=
Instrument:
Method:
Matrix:
Units: STANDARD CURVE
Standard ID Conc. Response
Instrument Parameters:
Standard Calibration Setting:
Flowcell Length: 1st Order 2nd Order 3rd Order
Program Method ID: Correlation Coefficient:
Date of Preparation: PQL: MDL:
Run No. 1 Run No. 2
MDL STD. ID RESPONSE CONC. MDL STD. ID RESPONSE CONC.
1. 1.
2. 2.
3. 3.
4. 4.
5. 5.
6. 6.
7 7
8 8
Run No. 3 Blank Determination
MDL STD. ID RESPONSE CONC. BLANK ID RESPONSE CONC.
1. 1.
2. 2.
3. 3.
4. 4.
5. 5.
6 6
7 7
8 8
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Number of Degrees of
Replicates Freedom (n-1) t(n-1, 1- =.99)
7 6 3.143
8 7 2.998
9 8 2.896
10 9 2.821
12 10 2.764
16 15 2.602
21 20 2.528
26 25 2.485
31 30 2.457
60 60 2.390
2.326
Note: Section XII was reviewed on 01/08/16(No Changes were made)
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Reporting
It is extremely important to properly report data onto worksheets. Reported values must be technically
valid and accurate. The accuracy of the reported data will depend upon the analytical process and the
mathematical manipulations used to reduce data. The technical validity of the data depends on the
assessment of the QC parameters and thus will depend on the accuracy of the flagging or qualifying
process.
13.1 Reporting Procedures for Qualified Data
13.1.1 Holding time exceeded – If holding times are exceeded, qualify results as estimated. Add a
comment to the final report and/or other pertinent deliverables which explain the qualifier.
13.1.2 GC/MS Initial Calibration Incompliance – If %RSD is greater than 30.0% and the initial
calibration RRFs greater than or equal to 0.05, qualify positive results as estimated, and non-
detected target compounds using professional judgment. If any calibration RRF is less than
0.05, qualify positive results that have acceptable mass spectral identification as estimated
and non-detected analytes as unusable.
13.1.3 GC/MS Continuing Calibration Incompliance – If the %D is outside +20.0% criterion and
the continuing calibration RRF is greater than or equal to 0.05, qualify positive results as
estimated. If the %D is outside +20.0% criterion and the continuing calibration RRF is
greater than or equal to 0.05:
Qualify non-detect target compounds as estimated if –20%.
Do not qualify non-detect target compounds if +20%.
13.1.4 Blanks Incompliance – If a compounds is detected in the sample and in the blank, the sample
result is qualified if the sample concentration is less than ten (10) times the associated PQL.
Report method blank bias for associated sample concentrations >10 respective PQLs.
Results must not be corrected by subtracting any blank value, unless method references state
otherwise.
13.1.5 Surrogate Incompliance – If a surrogate has a recovery greater than the upper acceptance
limit, detected target compounds are qualified while results for non-detected target
compounds should not be qualified. If a surrogate has a recovery greater than or equal to
10% but less than the lower acceptance limit, detected target compounds are qualified while
non-detected compounds quantitation limits are qualified as approximate. If surrogate
recovery is less than 10% and less than the lower acceptance limit, detected compounds are
qualified and non-detected target compounds may be qualified as unusable.
13.1.6 Matrix Spike/Matrix Spike Duplicate Incompliance – No action is taken on MS/MSD data
alone unless informed professional judgment is used in conjunction with other QC criteria.
13.1.7 Laboratory Control Samples Incompliance – Action on the LCS recovery should be based on
both the number of compounds that are outside of the recovery and the magnitude of the
exceedance of the criteria. If the LCS recovery criteria are not met, then the LCS results
should be used to qualify samples data for the specific compounds that are in the LCS
solution. If the LCS recovery is greater than the UCL, then positive results for the particular
compounds should be qualified. If LCS compounds are below associated LCLs, then
affected results should be rated unusable. If more than half the compounds in the LCS are
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not within the required recovery criteria, then all of the associated detected target
compounds should be qualified unusable. Please note that the proximity of recoveries to
100% should be considered in assessment.
13.1.8 Internal Standard Incompliance – If an IS area count is outside –50% or +100% of the area
for associated standard, positive results for compounds quantitated using that IS should be
qualified, non-detected compounds quantitated using an IS area count greater than 100%
should not be qualified, non-detected compounds quantitated using an IS area count less than
50% are reported with an approximated quantitation limit.
13.1.9 Initial Calibration Incomplaince (GC) – If %RSD is greater than 20%, qualify all positive
results as estimated and use professional judgment is assessing non-detected target analytes.
13.1.10Continuing Calibration Incompliance – If % diff is greater than 15%, qualify positive results
as estimated. If % diff is less than –15%, qualify positive results as estimated and
approximate the non-detect target analytes quantitation limits.
13.1.11Initial Calibration Incompliance (Inorganics) – If the minimum number of standard were not
used for initial calibration, or if the instrument was not calibrated daily and each time the
instrument was set up, qualify the data as unusable. Please note that the Ion
Chromatography procedures mandate that an initial curve is validated by continuing
calibration checks. If the correlation coefficient is <0.995, qualify results as estimated.
13.1.12Continuing Calibration Incompliance (Inorganics) – If the CCV or ICV %R falls outside the
acceptance windows, use professional judgment to qualify all associated data.
13.1.13Interference Check Sample – For samples with concentration of Al, Fe, Ca, and Mg which
are comparable to or greater than their respective levels in the Interference Check Sample:
1. If the ICS recovery for an element is >120%, qualify detected results.
2. If the ICS recovery for an element falls between 50 and 79%, qualify detected and
non-detected results.
3. If ICS recovery results are <50%, qualify data as unusable.
13.1.14Duplicate Incompliance – If duplicate analysis results for a particular analyte fall outside the
appropriate control windows, qualify the results for that analyte in all associated samples of
the same matrix as estimated.
13.1.15Post Spike Incompliance – If sample absorbance is <50% of the post digestion spike
absorbance then:
1. If the post spike recovery is not within 85-125%, qualify results as estimated.
2. If method of standard additions is required but has not been done, qualify the sample
results as estimated.
3. If MSA spike levels are not appropriate, qualify data, and
4. If MSA correlation coefficient is <0.995, qualify data as estimated.
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13.2 Rounding Rules for Reporting Data
13.2.1 Significant figure and rounding rules for Inorganics analyses:
Values between Report to the nearest Example
0.00001 – 0.00099 0.00001 0.00075
0.001 – 0.00999… 0.0001 0.0010
0.01 – 0.0999… 0.001 0.053
0.1 – 0.999… 0.01 0.27
1.0 – 9.999… 0.1 7.3
10 – 99.9… 1 87
100 – 999.99… 1 562
1000 – 999.99… 10 6720
10000 – 99999.99… 100 15600
>100000 3 significant digits
All values are rounded to 2 significant digits until they get above 100 when they are rounded to 3
significant digits.
Rounding off numbers is the process of dropping digits that are not significant. In order to round off a
number to a particular place holder (for example, to the nearest 10) one looks at the next smallest place
holder (the 1’s place). If the next smallest place holder is a 6, 7, 8 or 9, then increase the preceding digit by
one and drop the digits to the right (if to the right of the decimal) or replace them with zeros (if to the left of
the decimal). If the next smallest place holder is a 1, 2, 3 or 4, then do not change the preceding digit and
drop the digits to the right or replace with zeros. If the next smallest place holder is a 5 and any number to
the right of the 5 is not zero, then treat it as 6, 7, 8 or 9 as above. If the next smallest place holder is a 5 and
all digits to the right of this digit are zero, then round the preceding digit to the nearest even number (0, 2,
4, 6, 8) and drop the digits to the right or replace with zeros. Thus, 2.250001 becomes 2.3 and 2.250000
becomes 2.2, and 6.750 becomes 6.8.
When rounding values, do not round off values that have been previously rounded. In other words, do not
round off during a preliminary calculation. Carry as many digits as possible until the final value has been
calculated and then round off as needed.
13.2.2 Significant figure and rounding rules for organics analyses:
Two significant figures are used as a rule for organics. Rounding rules are the same as for inorganics
testing.
13.3 Quality Control Parameter Evaluation
Before evaluating a number for being in control or out of control of a certain limit, the number evaluated
must be rounded using EPA rounding rules to the significance reported for that limit. For instance, the
control limit for an ICV is plus or minus 10% of the true value. A reported percent recovery value of 120.4
would be considered in control while a reported value of 120.6 would be considered out of control. In
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addition, a calculated value of 120.50 would be in control while a calculated value of 120.51 would be out
of control.
13.4 Low Level Reporting
“Reliable analytical measurements of environmental samples are an essential ingredient of sound decisions
involving many facets of society including safeguarding the public health, improving the quality of the
environment, and facilitating advances in technology”. Analytical objectives for environmental samples
typically require reliable measurements at part per billion levels. At these levels, it is important to properly
evaluate the significance and reliability of results at or near the detection and quantitation limits. In order to
properly assess the reliability of low level results, one must have a working knowledge of analytical
techniques, EPA method protocols and procedures, statistics and environmental regulations.
Our laboratory uses the terms MDL and PQL for reporting the sensitivity of particular methods or analyses.
Definitions
MDL: The minimum concentration of a substance that can be measured and reported with a 99%
confidence that the analyte concentration is greater than zero and is determined from analysis of a
sample in a given matrix containing the analyte. Operationally the same as the Limit of Detection
(LOD).
PQL: The lowest level that can be reliably achieved within specified limits of precision and accuracy
during routine laboratory operating conditions. Operationally the same as the Limit of Quantitation
(LOQ).
MDLs are determined using the procedures outlined in 40 CFR Part 136 Appendix B. PQLs are then
determined by the procedure listed in the “Principles of Environmental Analysis” and/or are determined
using the expertise of BC Laboratories, Inc’ analysts and chemists. When setting PQLs, analysts must
consider meeting precision and accuracy goals as set in referenced methods.
Excerpts from the “Principles of Environmental Analysis”, Analytical Chemistry, Volume 55, Pages
2210 - 2218, Dec. 1983
Table I. Guidelines for Reporting Data
Analyte Concn. in units of (S(t) - S(b)
<3 region of questionable detection(and therefore
unacceptable)
3 limit of detection(LOD)
3 to 10 region of less-certain quantitation
10 limit of quantitation(LOQ)
>10 region of quantitation
: Represents the standard deviation of replicate low level standards and blanks.
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±3 ±3
Region of HighUncertainty
Region of LessCertain
Quantitation
Region ofQuantitation
Total Signal
(S(t))
Zero PQL/LOQMDL/LOD
-3 -2 -1 0 1 2 3 4 5 6 7 8 10 11 12 13 14S(b)
9
(S(b) +3 ) (S(b) + 10)
“Signals below 3 should be reported as “not detected”(ND)” ....”Signals in the region of less-certain
quantitation (3 to 10) should be reported as detections with the limit of detection given in parenthesis.“
“... Data measured at or near the limit of detection have two problems. The uncertainty can approach and
even equal the reported value. Furthermore, confirmation of the species reported is virtually impossible;
hence the identification must depend solely on the selectivity of the methodology and knowledge of the
absence of possible interferents. These problems diminish when measurable amounts of analytes are
present. Accordingly, quantitative interpretation, decision-making, and regulatory actions should be
limited to data at or above the limit of quantitation. “.
Excerpt from Standard Methods for the Examination of Water and Wastewater 19th edition, 1995,
page 1-12.
The practical quantitation limit (PQL) has been proposed as the lowest level achievable among laboratories
within specified limits during routine laboratory operations. The PQL is significant because different
laboratories will produce different MDLs even though using the same analytical procedures,
instruments and sample matrices.
The curve labeled B is representative of the background or blank signal distribution. As Shown, the
distribution of the blank signals is nearly as broad as for the other distributions, that is (B) = (I) = (L).
As blank analyses continue, this curve will become narrower because of increased degrees of freedom. The
curve labeled I represents the IDL. Its average value is located k(B) units distant from the blank curve,
and k represents the value of t (from the one-sided t distribution) that corresponds to the confidence level
chosen to describe instrument performance. The overlap of the B and I curves indicates the probability of
not detecting a constituent when it is present (Type II error). The curve at the extreme right represents the
LLD. Because only a finite number of determinations are used for calculating the IDL and LLD, the curves
are broader than the blank, but are similar, so it is reasonable to choose (I) = (L). Therefore, the LLD is
k(I) + k(L) = 2k(l) from the blank curve.
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B I L
+kr(b) -kr(l) +kr(l)
Detection limit relationship
Comments
Please note in order for these statements to be considered valid, the variability of blank responses must
equal the variability of the low level standards used to compute MDLs. Since this is not always
determined, the MDL can be statistically computed low, thus widening the level of uncertainty between the
MDL and PQL.
In practice, an indication of whether an analyte is detected by an instrument is sometimes based on the
extent to which the analyte signal exceeds peak-to-peak noise. The question of a given analyte is often one
of the most important decisions in low-level analysis. The question which must be answered is whether a
measured value is significantly different from that found for the sample blank.
References
40 CFR Part 136 Appendix B
Long, G.L.; Winefordner, J.D. Anal. Chem. 1983, 55, 712A-724A
Revision to “Guidelines for Data Acquisition and Data Quality Evaluation in Environmental Chemistry”
Anal. chem. 1980, 52, 2242-2249, Reprinted from Anal. Chem, 1983 Vol. 55,
13.5 Manual Integration
Instrument software applications for chromatographic analyses allows for automated integration of analyte
peaks. Automated integration does not work 100% time due to many reasons, thus it is necessary to
conduct manual integrations. The following section deals with general integration practices.
13.6 Manual Integration Labeling
Manual integrations must be flagged, initialed and dated by analysts. Typically the instrument software will
automatically label manual integrations with an “m” or indicate change in quantitations by flagging
chromatograms “reprocessed”. A good laboratory practice is to be more descriptive in the labeling practice
of manual integrations. Analysts should use the following list of integration flags:
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M Manual integration due to irregular peak shape
MS Manual integration due to split peak
MR Manual integration due to retention time shift
MI Manual integration of correct isomer or peak
MT Manual integration due to peak tailing
MB Manual integration due to irregular baseline
1. All lone > or = to 90% baseline resolved peaks are to be integrated valley to valley
2. All peaks with adjacent peaks <90% resolved must be integrated baseline to
baseline; dropping a perpendicular at the minimum.
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3. All peaks with shoulders will be integrated in the beat manner possible.
Analysts' judgement. (Tangential skim or Perpendicular drop)
4. In a busy chromatogram, the analysts' judgement, subject to approval, as to
the best integration technique will supercede techniques 1 through 3.
5. All Manual re-integrations are printed and reviewed during the technical
review process. All controversial integrations (technique is not agreeable to both
the analyst and technical reviewer) must be approved by the department
supervisor.
6. Manual integrations are documented by the software being used. HP
Chemstation places an "m" by each peak that was manually integrated. The
Dionex software states that the run was reprocessed and the date upon which the
reprocessing occurred.
7. Be consistent between integrating standard peaks and like peaks in samples.
8. No peak shaving is to be observed or practiced.
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13.7 Manual Integration Discussion
When manual integrations are performed, raw data records include a quantitation report. A
quantitation report shows the results of manual integration labeled with “m” chromatograms of
manually integrated peaks. Each quantitation report is printed with date, time and initial of person
performing the manual integration. For Navy project, a case narrative will be provided with an
analytical report. A case narrative shall include all data qualifiers of flags. All samples and analytes
for which manual integration occurred, will be discussed in the case narrative under discussion, (i.e.
case narrative).
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QUALITY ASSURANCE PROTOCOLS MANUAL
REPORTING
SECTION XIII REVISION 4 EFFECTIVE DATE 01/08/16 Page XIII-10
Note: Section XII was reviewed on 01/08/16 (No Changes were made)
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AUDIT HANDLING PROCEDURES
SECTION XIV REVISION 6 EFFECTIVE DATE 01/08/16 Page XIV-1
14.1 Scope and Application
The purpose of this operating procedure is to document the steps taken to conduct, receive, and/or report
results regarding internal and external Performance Evaluation (PE) samples.
14.2 Summary of Method
Internal Audits (PE) samples– the QA/QC Department prepares audit samples purchased from Absolute
Standards and ERA. These samples are submitted to the Log-In Department. Chain-of-custody is prepared
to accompany batch of samples received.
Received Audits – the QA Officer examines the submitted audit for any irregularities regarding sample
containment or analysis requirements. The audit is then placed into the sample flow. Data review is
conducted by responsible supervisors before submitted to the QA Officer. The QA Officer reviews the data
and records the completed results onto Vendors Website.
14.3 Apparatus and Materials
Apparatus
Volumetric flasks (various volumes)
Volumetric pipettes (various deliveries)
Micro-pipettes (variable)
Sample containers (plastic and glass)
14.4 Reagents and Standard Solutions
Reagents – Name and Source
Organic free water – located in the AA room near the nanopure water system.
Nitric acid – located in the bottle preparation room. Use the acid for preserving metals.
Sulfuric acid – located in the bottle preparation room.
Hydrochloric acid – located in the bottle preparation room.
All preservatives are made from reagent acid stocks. A log is kept, by the Bottle Prep. Dept., that
includes information on preservative preparation.
14.5 Solution Preparation
The directions for standard audit (PE) samples preparations should be followed; however, if a
decision is made to alter sample dilution, this should be documented at the time of preparation.
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14.6 Working Standards
Internal audit standards proficiency testing are purchased from:
Absolute Standards ERA Sigma-Aldrich
P.O. Box 5585 6000 W. 54th
Street 2931 Soldier Springs Road
Hamden, CT 06518-0585 Arvada, CO 80002 Laramie, WY 82070
(800) 368-1231 (800) 372-0122 (800) 576-5690
www.Absolutestandards.com (303) 421-0159 Fax www.RT-Corp.com
www.eraqc.com
14.7 Sample Collection, Preservation and Handling
Audit samples should be prepared as soon as possible. If this is not practical, store samples or
ampuls according to specifications included in respective preparation method instructions.
Preserve audit solutions according to method preparation instructions, and/or laboratory guidelines.
Handle concentrated ampul solutions with care. Read associated MSDS sheets for more
information on safe handling of each material.
When analyses are completed, discard samples and remaining ampul contents according to
laboratory waste disposal protocols.
14.8 Procedure
14.8.1 Internal Audits (conducted by the QA/QC Dept.)
Purchase audit samples from ERA and Absolute Standards of an as needed basis. When the
audits samples arrive, prepare and process them immediately. If this cannot be done, store
the samples inside the walk-in refrigerator. Follow preparation procedures and fill out
chain-of-custody forms under fictitious client identifications. Document these sample
identifications and notify the billing department of the audit samples so they are not billed.
The most anonymous method of submitting samples is to pack the sample batch into an ice
chest or box. Then leave it overnight in the walk-in refrigerator. The samples will be
logged in the following morning. When analyses are completed, retrieve data and report on
vendor website. Process the results in report form as part of the quarterly report to upper
management. Process an unacceptable results open SIF section that includes: sample IDs,
methods, analytes, reasons or cause for discrepancies, and corrective action.
14.8.2 External Audits
Examine all aspects of sample condition when the audit arrives. If any discrepancies are
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found, contact the responsible parties for further instruction or action. After examination of
samples and instructions, initiate the analytical process. Review all pertinent raw data after
respective supervisor validations. If any discrepancies are found, allow the responsible
supervisor to correct the problem. When all data is acceptable and complete, hand in the
data package to the Data Control Department. Review of data transferal is conducted by the
Data Control Supervisor.
14.9 Forms
Preparation Forms
Sample Constituency Forms
Analyte Concentrations Reports
Chain-of-Custody
14.10 Safety
Follow any precautions listed in the MSDS associated for each sample. Always wear a lab coat,
gloves and safety glasses.
Note: Section XIV was reviewed on 01/08/16(No Changes were made)
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TECHNICAL REVIEWS
SECTION XV REVISION 4 EFFECTIVE DATE 01/08/16 Page XV-1
15.1 Scope and Application
This section describes the process by which the technical review of analytical data is carried out
throughout the lab.
15.2 Summary of Method
Upon completion of a test method, each individual analyst reviews all parameters governing the
acceptability and correctness of the data generated. (Quality control, calculations, method protocols,
holding time, and reasonableness of data.) A second level 100% technical review is carried out by a
qualified peer which is a repeat of the first level of review plus the review of the raw data. A third
level of review, typically by department supervisor, is carried out to ensure completeness, QC
control, protocols, and reasonableness of data.
When a peer is either absent of extremely busy, the back-up reviewer will be assigned review duties.
15.3 Materials
Indelible ink pen
All raw data and worksheets associated with a given run
Quality control criteria
Technical review sheet
15.4 Procedure
Preparation task reviews – all extraction and preparation tasks must be reviewed and approved.
Technical reviews should be conducted by qualified personnel. Reviewed parameters should
include:
Sample numbering
Reagents
Standards
Proper documentation
Data entry into the LIMS
Review completion is verified in the LIMS and via initials on either preparation logs or review
sheets. Refer to the appropriate processing SOP for more details.
Upon completion of testing, the first level of review takes place. The first level of review entails
checking all quality control parameters, calibration, blanks accuracy and precision. All calculations,
identifications, method protocols and holding times are also checked at this time. The analyst who
performed the analyses conducts this first level of review. All sample preparation reviews are
conducted by person(s) not directly associated with the task of concern.
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A second level 100% technical review must take place within 24 hours following the first review or
before the data is submitted to our clients. All raw data as well as a technical review sheet are given
to the assigned reviewer. The reviewer is a qualified peer who has conducted the analyses he/she is
reviewing.
The second level of review contains all the elements of the first review plus a review of the raw
data. Review sheets for specific tests have been constructed in order to guide and maintain a record
of all such 100% technical reviews.
If upon review a problem/mistake is found, the analyst who performed the testing is approached to
correct the matter. The problem is noted on the review sheet and the analyst signs and dates the
review sheet as to his acceptance of any changes or problems.
The raw data and worksheets are returned to the analyst who files the raw data according to protocol
and turns in the worksheets as well as review sheets for final review by his/her supervisor.
Each department supervisor conducts the third level of review. This review entails checking QC
controls and protocols and reasonableness of the data. All comments and qualifying flags are also
reviewed and corrected as required.
A fourth level of review is completed by the Quality Assurance Department if QC reporting is
required. The QC review includes quality control acceptance, deliverables and possibly historical
trending.
15.5 Quality Control
Only indelible ink pen must be used to complete QC forms, data sheets, and technical review sheets.
If an error is made, a single line is drawn through it and the correction made. The correction must
be initialed and dated as to when the correction was made. There will be no obliterations.
In the event of an assigned reviewer being absent or extremely busy, a backup reviewer who is also
a qualified peer may be assigned review duties during their absence.
A qualified peer is:
1. An analyst/tech who has conducted the analysis and has passed the respective IDC,
2. A senior analyst who was responsible for the method at one time,
3. A team leader within his/her responsibility scope, or
4. A department supervisor within his/her responsibility scope.
Reviews will be monitored periodically by respective department supervisors and QA/QC
department personnel.
Note: Section XV was reviewed on 01/08/16(No Changes were made)
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CONTROL CHARTING
SECTION XVI REVISION 4 EFFECTIVE DATE 03/15/16 Page XVI-1
16.1 Introduction
A tool that is commonly used to monitor and control process variations on an ongoing basis is
control chart. Control charts are used to ensure that the process is in control and capable of
repeatedly meeting requirements. Control charts are based on the statistical theories of the normal
curve. By turning the normal curve 90°, the relationship between the normal curve and control
charts become more evident. The upper control limit represents +3 standard deviations from the
mean. The central line represents the mean and the lower control limit represents –3 standard
deviations from the mean. These lines representing +2 standard deviations from the means are
commonly called warning limits.
A process is in control when the following conditions are met:
All points on a control chart are within the control limits.
No patterns are formed by the points on the control chart. Patterns may be runs, cycles, trends and
so on.
When a process is out of control when any one of the following conditions exist.
Points exceed the upper or lower control limits.
Points within the control limits form a pattern.
One common pattern is a run. A run is a series of consecutive points that fall on one side of the
central line. Runs can be defined by any one of the following conditions:
Seven (7) consecutive points fall on one side of the central line.
Ten (10) of eleven (12) consecutive points fall on one side of the central line.
Twelve (12) of fourteen (14) consecutive points fall on one side of the central line.
A run indicates that the process mean has shifted or a change has occurred in the process. When
this occurs, the process should be investigated to identify and remove the cause of the changes.
Another common pattern is a trend. A trend is a steady progression of points in one direction. If a
trend continues, a point will eventually exceed control limits. Trends usually indicate equipment
wear, or standard/reagent degradation.
When patterns exist and/or points exceed control limits, a special or assignable cause of variation is
usually present.
16.2 Monitoring of LCSW
The Laboratory Control Sample Water is the QC spiked parameter of choice to be monitored
through control charting.
Charting of Multi-Analyte Methods – In cases where charting organic multi-analyte methods is not
feasible, a select subset of analytes should be identified and charted. Those analytes chosen should
represent the entire retention time range and must represent normal analytical activity or
performance (i.e., do not chart abnormally stable or unstable analytes).
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16.3 Development of Control Charts
A minimum of 30 data points is required in order to administer statistical manipulations to a
particular QC parameter. Once at least thirty data points are obtained, the standard deviation and
mean of the data set can be calculated. The mean plus or minus two sigma will define warning
limits while the mean plus or minus three sigma will represent LCS control limits. Please contact
the QA Officer for guidance or for additional charting options.
16.4 Maintenance of Control Charts
16.4.1 Electronic Charting
Instrument data which is processed via Element, control limits are calculated by analyst
using QA admin in Element then select control charts. Recalculations of control limits shall
be monitored on an on-going basis (at least quarterly) for shifts in mean recovery, changes in
standard deviation, and development of trends. The recalculated limits should be submitted
to the QA/QC Department for LIMS updating.
16.5 Calculation Controls
It is important that control limits are properly calculated to correctly assessed control of the system
and to validate presence of interferences and bias.
General Rules
Include all recoveries unless outliers are validated.
If significant changes are made, reestablish control limits by initiating a new data set.
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CORRECTIVE ACTION/SYSTEM IMPROVEMENT
SECTION XVII REVISION 4 EFFECTIVE DATE 01/08/16 Page XVII-1
17.1 Introduction
It is inevitable that problems will be encountered. When these problems occur, it is imperative that
we prevent future similar mistakes by incorporating a corrective action program. Corrective action
is a process by which errors are corrected in such a way to prevent future errors of the same nature
or type. Corrective action should be systematic, documented and monitored.
System improvement is used to describe preemptive positive actions or process modifications that
increase the level of quality and customer satisfaction. This differs from corrective action.
Corrective action is reactive while system improvement is proactive.
17.2 When to Initiate
Corrective action should be initiated when:
1. A client requests
2. An out of control situation is detected on a control chart
3. An unacceptable result is found on a PE study
4. QC anomalies arise (see flow charts)
5. Significant process/procedural problems occur
6. Communication problems occur
7. Instruments fail
8. Persistent “minor” problems exist
9. Project specific anomalies occur
10. Reagent/equipment problems are detected
11. Problems are found associated with the LIMS
12. Procurement anomalies occur
13. Subcontractors do not perform to our standards
14. Policies conflict
System Improvement Forms can be initiated anytime you have a good idea. Please document
system improvement and corrective actions on SIFs.
17.3 DEFINITIONS
17.3.1 Corrective Action (CA)
A process by which a critical error is corrected in such a way as to prevent future errors of the same
nature or type.
Some examples of when to initiate corrective action:
S Calculation errors.
S Client Request.
S Out of control trend
S Significant QA/QC anomalies
S Unacceptable PE results.
S Poor curve linearity.
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S Dilution error (if sample is diluted).
S Equipment malfunction.
S Improper methodology for sample matrix.
S Contamination.
S Incorrect report formatting.
S Clerical discrepancies.
S Invoicing problems.
S Field service problems.
S Inherent or chronic problems with methodology.
17.3.2 Corrective Action Process
Corrective action steps for reporting and correcting problems for non conformance
measurement or instruments
1. Identify the problem: A problem must be identified in a clear and concise term.
2. Evaluation (Root Cause): A root cause of the problem must be determined to see whether the
problem is local or systematic.
3. Extent of Problem: Extent of the problem must be specific to the area of the problem; so that
it can be addressed appropriately.
4. Develop Action: Develop a through action plan to address the problem in question
5. Implementation of Corrective Action: A plan needs to be designed that reflect how this plan
was implemented that demonstrates the outcome of implementation.
6. Expected Completion Date: A problem expected completion date ought to be assigned
7. Evaluation of Effectiveness of Corrective Action: Develop a plan (test) to evaluate the
effectiveness of the corrective action
8. Criteria for Verification: A criteria needs to be set up in order to verify whether your action
was effective
9. Documentation: All Corrective Action must be documented for future reference
PROCESS
Please refer to Appendix D for background on initiation of analytically based corrective action.
Implement
Corrective
Action(s)
Demonstrate
correction of
the problem
Close the
corrective action
process
(documentation)
END
Identify what
went wrong
Identify the
root cause
Extent of
problem
Develop Action
Expected
Completion Date
Evaluate the
effectiveness of
Corrective Action
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SECTION XVII REVISION 5 EFFECTIVE DATE 01/08/16 Page XVII-3
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BC Laboratories Inc.
Customer Complain Form
Date: Filled out by:
Company Name: Contact Name:
Complain via: Affected Lab#/Invoice #:
Complaint:
TAT Courier Service Web Service/IT Other
Quality of Data Invoicing Issues Missed holding times Clerical
Customer Service Incorrect Tests/Methods Bottle Orders D.L’s
QC Issues (Flagging) Reporting Issues
Explanation of Customer Complaint:
Action Taken:
Reviewed by: Date::
(Management)
Reviewed by: Date::
(Authorized Signature)
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17.4 Determining the Root Cause
Quality problems can be the result of complex causes. Once a problem has been identified on a
process, the potential causes need to be determined before any corrective actions are taken.
The cause and effect diagram is one of the tools that can be used to identify all of the potential
causes. The cause and effect diagram is also used to describe the relationship between the various
causes and the effect (problem) on the process. The left side of the diagram lists the primary causes
the variation. This half of the diagram is the cause side. The right side of the diagram lists the
problem or quality characteristic to be improved. This half is the effect side. The major purpose of
the cause and effect diagram is to identify the relationships that exist between each of the various
causes and to determine their overall effect on the problem.
All things vary. That is, each result or item differs to some degree from the others produced by the
process. These differences are the result of various causes in the process. Causes of variation can be
categorized as common or assignable.
Common causes of variation result from normal events operating within the process. Common
causes cannot be eliminated entirely, but their effect on the quality of items can be controlled.
Assignable causes, on the other hand, are the result of abnormal or unnatural events in the process.
Assignable causes can be detected, corrected, and eliminated.
Common causes of variation are usually grouped into five major categories; people, machinery,
methods, materials, and environment.
People: Since every person is unique, individual performance and perceptions vary from one
person to the next. Even when established procedures are used to perform a specific task, no two
people perform tasks in the exact same manner. Given this, variation occurs as a result of the
people involved in the process.
Machinery (instrumentation): The performance of instrumentation and equipment used in
processes changes daily. These changes are due to mechanical functions, wear, calibration, and so
on. Variation naturally occurs as a result of equipment, instrumentation and so on.
Methods: On the surface, method of operation appears to be fairly consistent, yet differences exist.
These differences may occur between shifts, supervisors, pressures, location and so on. The
methods used in a process are based on interpretation. Various interpretations of methods affect the
variation of the process.
Materials: The basic composition and measurements of raw materials vary. In addition, the
materials delivered by various suppliers also vary. Therefore, the materials used in any process vary
to some degree.
Environment: The events that naturally make up the environment, such as organizational culture,
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management, humidity, temperature pollution and so on, all affect the variation in the process.
When these factors are combined in a process a certain level of variation will occur in the process.
These causes of variation are referred to as common cause variation, which cannot be entirely
eliminated.
In addition to common cause variation in the process, assignable causes may also be present.
Assignable causes of variation are the result of abnormal or unnatural events. Any factor outside the
realm of a common cause can be defined as an assignable cause.
Examples of assignable causes:
Environmental factors such as air conditioner breakdowns, power outages, or abnormally high
levels of pollution.
Measurement devices or gauge malfunctions.
Equipment malfunctions.
Whenever an attempt is made to condense or reduce the amount of time normally required to do a
job or perform a given task, variation in the process increases.
For the most part, both common and assignable causes of variation are present in all processes.
These combined levels of variation directly affect the quality of the items produced by the process.
The higher the level of variation, the poorer the quality. To improve quality, the variation of the
process must be monitored and controlled. Any assignable cause of variation should be eliminated
and common cause variation can be reduced by improving the process continuously.
The cause and effect diagram can be used to identify the causes of variation in the process. This
information allows you to identity the major causes of variation that can be controlled or eliminated.
The net effect of these efforts will enable you to reduce variation in the process and improve
quality.
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17.5 Constructing a Basic Cause-and-Effect Diagram
Step 1: Identify a problem or quality characteristic
Once a specific problem has been identified, draw a box on the right side of the paper and write the
problem in the box.
Step 2: Draw a line pointing to the problem identified
After one problem has been identified, draw a perpendicular horizontal line pointing to the problem.
Step 3: Determine the major causes of the problem
Identify the major causes of the problem that have been identified and list each major cause in a box
around the main line. Then draw an arrow pointing toward the main line.
Step 4: Determine the minor causes of the problem
Minor causes are the causes associated with the major cause. Isolate each major cause and
determine all the factors that contribute to each major cause. Then list each minor cause around the
major cause and draw an arrow pointing to the major cause.
Step 5: Identify the sub-causes for each minor cause
The primary purpose of the cause and effect diagram is to illustrate the interactions among various
causes of variation in a given process. Therefore, it is necessary to break cause down, in a step-by-
step fashion, from the most major to the most minor aspects of each cause. For example, if
equipment is listed as the major cause, a specific piece of equipment could be listed a minor cause;
the condition of the equipment could be a sub-cause; and the measurements or characteristics or
calibration could be another sub-cause. List all of the sub-causes around the minor cause and draw
an arrow from the sub-cause to the minor cause to illustrate their relationship.
Step 6: Review the cause-and-effect diagram
When you review the diagram, be sure that all of the items contributing to the problem have been
identified.
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PREVENTIVE MAINTENANCE
SECTION XVIII REVISION 4 EFFECTIVE DATE 01/08/16 Page XVIII- 1
18.1 Overview
Preventive maintenance is an orderly program of positive actions (equipment cleaning, lubricating,
reconditioning, adjustment and/or testing, etc.) done to prevent the failure of measurement systems
or support equipment. The goal is to ensure that analytical systems are in control and to prevent any
nonconformance due to instrument malfunction from occurring before or during any procedure. In
order for preventive maintenance to function properly, analysts and technicians need to maintain and
reference maintenance documentation. Documentation should be in the form of Preventive
Maintenance Schedules or Preventive Maintenance Logs. Use of preventive maintenance logs for
each analytical measurement system and support apparatus aids in the foretelling of possible
problems while preventive maintenance schedules are used to prevent problems from occurring.
Periodic preventive maintenance (PM) routines by outside services are contracted to extend
instrument/apparatus life and to verify current and future working status. Many instruments are
maintained under service contracts, thus PM calls should be made on a regular basis.
18.2 Part Maintenance
Every instrument has parts which are routinely exhausted, refurbished or cleaned. These parts
should have replacement parts readily available. Replacement inventory should be maintained
according to replacement part use and life. Information on part life can be obtained from Preventive
Maintenance Logs. Since some of the personnel have multiple responsibilities, including running
different instruments, it is important to maintain a centralized area for replacement parts and a
working inventory. A minimum number of each replacement part should be designated to act as a
reordering point. Refer to section XIX for details on supply ordering.
18.3 Preventive Maintenance Schedules
It is important to maintain instrumentation in good working order to limit down time. Following a
preventive maintenance schedule can prevent down time and also can prevent QC anomalies. In
order to produce a Preventive Maintenance Schedule, one needs to be extremely familiar with the
instrumentation or apparatus. Please follow the steps below:
1. Record specific instrument maintenance routines.
2. Figure a frequency for maintenance routines based on experience and information on
Preventive Maintenance Logs.
3. Construct a Table that has the maintenance tasks as rows and times (in days) in columns.
4. Have this table or schedule sheet approved by your department supervisor. Please make sure
“BC Laboratories, Inc.” is written on the top of the draft sheet.
5. Submit the table to the Word Processor (WP).
6. Review the WP’s work and approve the sheet when all corrections, if necessary, are
completed.
7. Tell the WP the number of sheets needed for your log. The WP will bind the log.
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2
Preventive Maintenance Logs
A Preventive Maintenance Log is used to document preventive measures conducted on a day-to-day
basis. These logs can be paginated composition books or any paginated bound notebook. Maintenance
logs should be instrument specific. Entries into these logs should be periodically checked by
respective department supervisors.
18.5 Service Contracts
Service contracts are maintained for various instruments. These contracts entitle us to unlimited corrective
labor and parts. Preventive maintenance is also covered on each service contract, thus it is imperative to
schedule a PM for insured instruments on an annual basis.
18.6 Service Calls
All service calls are subject to approval by department supervisors. Once approved, analysts should contact
service personnel as soon as possible to schedule corrective work or preventive maintenance. When a firm
date has been set, analysts should relay the date information to the department supervisor.
18.7 Tagging Out
In cases when instrumentation or equipment is not operational, they must be labeled “out of service, do not
use”. A label with the aforementioned quote should be affixed to all non-operational instruments or
equipment. The same labeling convention should be used in cases of temporarily out of service situations.
Labels are available from the QA/QC Department.
Non-operational status should be documented on either a Preventive Maintenance Log or a Preventive
Maintenance Schedule.
18.8 Verification of Working Status
When an instrument or apparatus is placed back into service after being tagged out, analysts must verify
working condition prior to use. Condition verification can be an acceptable calibration, an acceptable
performance check, service technician performance check documentation, or any other record that verifies
the instrument or apparatus is functioning properly. Entries in Preventive Maintenance logs or schedules
should allude to the performance verification records. Analysts or technicians should always document
working status after tag out on either a Preventive Maintenance Log or a Preventive Maintenance Schedule.
Note: Section XVIII was reviewed on 01/08/16(No Changes were made)
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PREVENTIVE MAINTENANCE
SECTION XVIII REVISION 4 EFFECTIVE DATE 01/08/16 Page XVIII- 3
Maintenance Request Form
General Manager Use Only
Request No.:
Priority Rating:
Employee:
Date of request:
Requested date of maintenance completion:
ASAP
1 week
At earl iest convenience
Specific Date: ____________
Maintenance Request:
Problem(s) if not corrected:
Maintenance Dept. use only
Estimated Cost: $_____________
Supplies:
Department: Supervisor Approval:
Date:
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PROCUREMENT
SECTION XIX REVISION 3 EFFECTIVE DATE 01/08/16 Page XIX- 1
19.1 Overview
An important aspect of the overall quality of a system is its interaction with outside services. The
quality of supplies has a direct relation with the quality of finished work. Our goal is to conduct
business with reputable, reliable vendors and to have an ordering system of high quality and
efficiency. Every order or service provided by a subcontracted vendor must be accounted for by
some form of documentation (requisition forms) which will be used for cost analysis and quality
control purposed. Utilizing, archiving and scrutinizing requisition forms will prove for many by-
products such as analytical consistency, cost analysis, theft tracking, vendor quality measurement,
workload monitoring, and test pricing.
19.2 Responsibilities
19.2.1 Technicians/Analysts
19.2.1.1 Complete a requisition form
19.2.1.2 Submit a completed requisition form to the appropriate department supervisor
19.2.1.3 Receive the orders (communicate to the purchasing agent)
19.2.1.4 Submit orders on a timely basis
19.2.1.5 Monitor inventory
19.2.1.6 Ensure the quality of products meets quality goals
19.2.2 Purchasing Agent
19.2.2.1 Place orders
19.2.2.2 Track orders
19.2.2.3 Ensure the quality of products meet quality goals
19.2.2.4 Mitigate procurement anomalies
19.2.2.5 Receive the orders
19.2.2.6 Cost analysis
19.2.3 President
19.2.3.1 Order approval
19.2.3.2 Purchases are in-line with company mission
19.2.3.3 Reasonableness of purchases
19.2.3.4 Budgeting
19.2.4 Department Supervisors
19.2.4.1 Interpreting the Requisition Forms
19.2.4.2 Approve orders
19.2.4.3 Monitor orders (number, cost)
19.2.4.4 Ensure the quality of products meet quality goals
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19.2.5 QA Officer
19.2.5.1 Monitor the quality of the ordering system
19.2.5.2 System audit
19.2.5.3 Calibration of new measuring products
19.3 Requisition Forms
Requisition forms are used to place orders. These forms, which are department dependant, are
available from department supervisors.
19.3.1 Obtain a requisition form from your department supervisor.
19.3.2 Place your name and the date in the appropriate fields.
19.3.3 Fill in the “date needed by” field. Please do not use terms such as “ASAP” or
“normal”. Please keep rush orders to a minimum.
19.3.4 Fill in the total number of units required under the Quantity field.
19.3.5 Enter the part number (if available) into the proper field.
19.3.6 Enter the product description under the proper field. Be descriptive. If information
cannot fit into appropriate boxes, use the back of the form or the next row under the
appropriate column.
19.3.7 Enter the vendor under the appropriate field.
19.3.8 Fill in the “Use” field. Be descriptive. Method number should be entered here also
(if appropriate).
19.3.9 Figure the frequency of use to the best of your knowledge.
19.3.10 Enter the PO# if applicable. Typically this field will be left blank.
19.3.11 Write in the number from the legend which represents the reason for purchase. If
none of the choices represent the reason for purchase adequately, use “8” for other
and describe accordingly.
19.3.12 If a service is required, rather than a product, enter the required information in the
fields located near the bottom of the requisition form.
19.3.13 When the form has been completed, submit to your department supervisor. If you
like, you can keep a copy for tracking and for a reference for future ordering.
19.3.14 Some of the orders are submitted by the Technical director, either under his name or
supervisor’s name.
19.4 Supply Receiving
Please follow the steps for receiving ordered products:
19.4.1 Sample custodian will receive the orders and the Technical Director will approve them.
19.4.2 Pick up your order in the sample receiving area. A page will be placed by the sample
custodian or receptionist for order pickups.
19.4.3 All containers are received by the Technical Director, this means he has accounted for
receiving the product, and thus it is available for use without any further communication.
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19.4.4 Open the packaging and inspect the product.
19.4.5 Verify the product is what you ordered in type and number.
19.4.6 Sign/initial and date the shipping paperwork to accept custody of items.
19.4.7 If a discrepancy was found, please contact your department supervisor.
19.5 Standard Receiving
Follow the receiving steps noted above. Locate the Certificate of Analysis and store according to
supervisor specifications. Label the standard (if possible) or standard paperwork with your initials
and the date received. Also record the date the standard was put into use.
19.6 Reagent Receiving
Follow the receiving steps outlined in the section labeled “Supply Receiving.” Write the date
received and your initials on the container label. Write the date the reagent is opened on the label.
19.7 Receiving Products Which Can Be Calibrated
Any device used for measuring can qualify as a product which can be calibrated. Follow the
receiving steps outlined in the section labeled “Supply Receiving.” Submit the device or glassware
to the QA/QC Department or supervisor for fitness of use approval.
Please note that if any supplies, standards, reagents, etc., received are not the usual products or
product brands you usually use, you need to scrutinize your work very closely to tie in possible
improved or degraded quality. If you have time, pre-qualify the new products through investigative
testing. Contact your department supervisor or the QA Officer for guidance.
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20.1 Introduction
All methods utilized by BCL must be tested, documented and approved. We must have stringent
control on our approved methods and on our modification process. Communication, approval and
capability must be assured. If an employee makes changes to a method and does not effectively
communicate these changes, significant mistakes can occur during their absence. Also if the
changes are not approved, gross errors may occur because the chemistry or instrument is not
functioning properly. The capability of methods after modification must be checked to verify
compliance with referenced methods and internal controls. It is extremely important that all
employees follow the following method modification process to keep our system in control.
20.2 Modification Process
The method modification process includes the following steps:
1. Method modification petition
2. Petition approval
3. SOP revision and approval
4. Method modification capability study
5. Capability study approval
6. Method modification approval
20.2.1 Method Modification Petition
A request for a method modification must be placed in writing and submitted to a
department supervisor or to the President. This petition should have the following elements:
1. Method Identification
2. Instrument/Equipment IDs
3. Statement of the Problem
4. Proposed modification
5. Effects of the modification
6. Explanatory comments
20.2.2 Petition Approval
The department supervisor, Technical Director or can approve petitions by signature.
Additional requests or requirements can be added to the petition at any time during the
modification process. The original petition should be kept by the department supervisor and
a copy o the petition should be made and kept by the person responsible for carrying out the
modification.
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20.2.3 SOP Revision and Approval
Refer to section 5.3.
20.2.4 Method Modification Capability Study
The capability of a method must be verified after every method modification. Method
capability includes sensitivity, accuracy, precision and efficiency.
Sensitivity
An MDL study must be conducted.
Accuracy
4 replicates of a laboratory control sample must be analyzed and accessed.
Precision
The RPD/Standard Deviation of the 4 replicates of a laboratory control sample must be
accessed.
Efficiency
A logical metric must be used to express efficiency. Examples include, but are not restricted
to, samples/hour, samples per day, dollars per run/day. A comparison must be made
between the efficiency of the method prior to and after the modification.
20.2.5 Capability Study Approval
The capability study must be place in writing to the department supervisor for approval. The
department supervisor and the President should both sign the capability study. If not
approved, a subset of the capability study may require re-work.
20.2.6 Method Modification Approval
Once the capability study has been approved, the method is ready for use. Please note that it
is important to train all personnel responsible for the modified method.
20.2.7 New Methods
The State of California requires all laboratories requesting the use of methods off of their
respective certification lists to submit formalized data packages. Please refer to the
following sections for details.
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ENVIRONMENTAL LABORATORY ACCREDITATION PROGRAM (ELAP)
CALIFORNIA DEPARTMENT OF HEALTH SERVICES
850 Marina Bay Park Way 500 North Central Avenue Ste. 50
Building P 1st Floor M0512 Glendale, CA 91203
Richmond, CA 94804, (818) 551-2047
(510) 620-3155
______________________________________________________________________________________
DATA PACKAGE GUIDELINES
INTRODUCTION
The following guidelines are to be used by laboratories when submitting a Data Package if requested by
ELAP as a demonstration of laboratory competency
This format is to be used when submitting packets for the following instrumental methods: Gas
Chromatography (GC), Gas Chromatography/Mass Spectrometry (GC/MS), High Pressure Liquid
Chromatography (ICP/MS), Ion Chromatography (IC), Flame Atomic Absorption Spectrometry (FAA), and
Graphite Furnace Atomic Absorption Spectrometry (GFAA) and related instrumental techniques.
The laboratory must demonstrate that requirements for instrumentation, quality control, performance
criteria, procedures and reagents as specified in the method are complied with. Modification is allowed
only where permitted in the method.
As a document necessary for the verification of your laboratory’s competency for certification, a Data
Package must provide clear evidence of compliance with method standards and practices. To assist in our
determination or your competency, please be sure that all information is legible (preferably typewritten), all
pages of the document are numbered and that the Data Package is bound. Each method applied for must be
presented in a separate package.
A Data Package consists of a concise tabular summary of the key elements necessary to demonstrate
method proficiency. The basic format described in this document must be followed. Variations in the
presentation style and combining of tabular results are permitted, but the package must include complete
documentation of all required elements and the package must be well-organized. All raw data, including
chromatograms and instrument printouts, that support Data Package results should also be included for
ELAP review.
Incomplete, unsigned or disorganized packages will be returned to the laboratory unprocessed.
Data Packages are just one portion of the certification process and other factors such as an application, PE
samples and fees may be involved. Written approval from ELAP is necessary before the method applied
for can be employed for regulatory analysis.
Refer to the ELAP Guidelines and the Appendices for specific details, tips and/or additional details for the
particular method(s) you are preparing the data package(s) for.
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IF YOU HAVE ANY QUESTION REGARDING PREPARATION OF A DATA PACKAGE FOR
ANY METHOD, CONTACT YOUR ELAP CONSULTANT FOR FURTHER INFORMATION.
DATA PACKAGE FORMAT
Data packages submitted to ELAP should be presented in the following sections:
1. Cover Page
2. Table of Contents
3. Instrument Operating Conditions/Parameters
4. Standard and Sample Preparation Summary
5. Quality Control Limits
6. Summary of Data:
a. Calibration
b. Method Blank
c. Sample Analysis
d. Matrix Spike/Matrix Spike Duplicate
e. Method Detection Limit/Reporting Limit
f. External Reference Sample Analysis
7. Information/Comments
8. Raw Data
1. Cover Page
The Cover Page should include the following:
A. Full laboratory name and ELAP certificate/application number
B. Method Reference Number and Title of Method
C. Printed name and dated signature of Laboratory Director
D. Printed name and dated signature of analyst(s) who prepared data package
NOTE: All data packages must be reviewed for content and accuracy by the Laboratory
Director prior to submission. The director must sign and date the data package and
attest to the following statement (please print statement on cover page):
“I have reviewed this data package and found it to be accurate and complete.
All work was completed at our facility by the analyst and instrument as listed
in this document.”
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2. Table of Contents
The Table of Contents must list all items in the data package with page reference.
3. Instrument Operating Conditions/Parameters
A complete listing of all instruments operating condition should be described.
Chromatographic Methods – Instrument manufacturer and model number, detector(s), columns,
flow rates, carrier, temperature conditions and run times.
Atomic Absorption/Emission Methods – Instrument manufacturer and model number,
wavelength(s), gases, matrix modifiers, and temperatures for drying, ashing and atomization (if
appropriate).
Variances are allowed only if demonstrated as equivalent to the original method practice and as
allowed for in the method. Data packages with improperly modified procedures are not in
compliance with the method and certification will be denied.
4. Standard and Sample Preparation Summary
Procedures involved in the preparation of Standards and Samples should be summarized in tables
for the Data Package.
Standard Preparation should cover all steps involved in the preparation of the working calibration
standards, and include the following information:
Source of standard, lot number, dilutions, final concentrations preparer and date prepared.
Sample Preparation should cover all steps involved in the preparation of the sample for analysis
and include the following information:
Sample ID number, matrix sample preparer, date, initial weight or volume for sample, pretreatment
(sitting, milling), preparation (extraction, digestions, clean-up) and final volume for analysis.
The method of sample introduction into the analytical instruments should be described.
5. Quality Control Limits
Acceptance ranges for calibration linearity, response factors, recoveries, replicates and reference
standard. Analyses must be presented in the Data Package.
For Hazardous Waste instrumental methods acceptance limits for both solid and liquid matrices are
required.
Please present acceptance limits by analyte in a table form. Quality control limits may be combined
with analytical results which are evaluated against the acceptance criteria in the Data Package.
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In addition, control charts may be included in the quality control section.
NOTE: Quality control acceptance limits should be established by the following criteria:
Limits as described in the method.
Limits as described in the Code of Federal Registers
Limits derived by statistical procedures in the “Handbook for Analytical
Quality Control in Water and Wastewater Laboratories” EPA-600/4-79-019.
6. Summary of Data
A. Calibration
The calibration data for the method must be included in the Data Package.
Calibration curves must be presented for all compounds of interest. For the specific calibration
procedure requirements, refer to the individual method. In general, a calibration blank and three (3)
to five (5) calibration points as specified in the method must be presented in a summary form along
with peak areas/heights and appropriate statistical evaluation of linearity including response factors
and % relative standard deviations. If linearity is evaluated by graphic methods, the graph must be
included. All internal and surrogate standards should be identified.
NOTE: If one point calibration is used as the daily calibration check for the method, please
include the results of the daily RF and % difference from the RF derived form the
calibration curve.
Calibration information must be presented for all compounds being evaluated. All results must be
referenced to the chromatograms, printouts, etc. in the Raw Data section of the Data Package.
NOTE: Compounds To Be Analyzed For Multiple Analyte Methods
For initial certification, at a minimum all regulated analytes and/or analytes to be reported by the
method must be analyzed. Any common compounds that may coelute or interfere with target
analytes must also be tested for.
If no analytes to be evaluated by a method are regulated (i.e., certain 600 and 8000 series methods),
analyze at a minimum:
1. All analytes if the method list has ten (10) compounds or less.
2. If the method list has eleven (12) to thirty nine (39) analytes, evaluate at least ten (10)
analytes representative of early, mid-range and late elutors.
3. If the method list has more than forty (40) analytes, evaluate at least 25% of the analytes
representative of early, mid-range and late elutors.
B. Method Blank
The result of a Method Blank must be included in the Data Package.
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List any compound(s) and/or contaminant(s) identified in the method blank. Results may be
combined in the summary with calibration and sample results. Contamination above reporting
limits should be noted.
NOTE: A method blank is processed through the entire method and includes all surrogate
and internal standards, if used.
C. Sample Analysis
The results of a sample analysis must be included in the Data Package.
List the sample results in appropriate reporting units in a table. Results may be combined with the
Method Blank, Calibration and Matrix Spike results. All results must be referenced to the
chromatograms, printouts, etc. in the Raw Data section of the Data Package.
A local soil sample is recommended for hazardous waste methods and a tap water sample is
recommended for drinking water and wastewater methods. The sample does not necessarily have to
contain the analytes of interest. Inert sand or reagent water should not be used.
D. Matrix Spike/Matrix Spike Duplicate
The result of a Matrix Spike/Matrix Spike Duplicate must be included in the Data Package.
List the results of the matrix spike/matrix spike duplicate in a table. The spike is to be added to the
sample prior to any preparation steps necessary for analysis. Source of spiking solution, amount and
concentration of stock added, final concentration in sample, percent recovery, relative percent
difference and acceptance limits should be included.
NOTE: For multi-analyte methods, spike all analytes as specified in the method. If not
specified in the method, analyze at a minimum of three compounds or 10% of
analytes listed in the method, whichever is greater.
E. Method Detection Limit (MDL)/Reporting Limit (RL)
The results of the Method Detection Limit determination and Reporting Limits to be used when
employing the method must be included in the Data Package.
List the MDL’s and summarize all determination procedures in a table. Reference the results to
chromatograms and printouts.
For details on how to determine the MDL, consult the ELAP Information Appendices Guidelines or
refer to Glaser, J.A., Forest, D.L., McKee, G.D., Quave, S.A. and Budde, W.L., “Trace Analysis For
Waste Waters,” Environmental Science and Technology, 15, 1426, 1981.
The Reporting Limit (RL) is considered to be the minimum quantifiable level that the laboratory can
detect and is to be used when reporting results. The RL should be greater than or equal to the MDL.
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Reporting limits must conform to Regulatory Agency requirements.
Reporting limits must be verified. The RL is verified by spiking a matrix free of target analytes at
the reporting level. The spike is taken through all steps of the analytical process and is then
analyzed as a sample. Spiked values and actual recoveries should be indicated.
For Hazardous Materials methods, RLs should be defined for both soils and aqueous matrices.
F. External Reference Sample Analysis
The results of an External Reference Sample must be included in the Data Package.
Summarize the results of External Reference Sample analysis. Include the source (vendor and lot
number), a description of the matrix (if applicable), true values, concentration found, percent
recovery and acceptance limits.
If your laboratory has recently participated in any sort of Performance Evaluation (PE) study either
through EPA or another organization, please submit a copy of the results along with the acceptance
limits (if available).
For Hazardous Materials instrumental methods, a Laboratory Control Sample (LCS) is also required
in the Data Package. An LCS is a reference sample made from a matrix representative of the
samples being analyzed, and spiked with the analytes of interest.
7. Additional Information/Comments
Other information such as examples of calculations or Standard Operating Procedures may be
included in the package. Please feel free to submit any other information that will help us to
evaluate your proficiency in performing the method.
Comments (or footnotes) on various items in the data package may be included in this section.
8. Raw Data: Chromatograms, Printouts, Quantitation Reports
Submit copies of all relevant chromatograms, printouts, quantitation reports, etc., that support
results summarized in the previous sections. Chromatograms may be reduced in size by
photocopying to accommodate binding. Do not obscure any of the information printed on the raw
data. Paginate all raw data for easy reference.
All chromatograms and printouts must be clearly identified and referenced. All compounds must be
clearly identified. Integrator printouts must list relative retention times, peak areas, response factors
and concentrations. All surrogate and/or internal standard compounds should be identified.
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Appendix
DATA PACKAGE ELEMENTS
The following items are required for a complete data package.
Inorganic Analysis
EPA 200 Series Methods – Metals in drinking water and wastewater
1. Calibration
2. Method blank
3. Tap water sample analysis
4. Duplicate matrix spike of sample
5. MDL determination
6. DLR verification
7. External Reference Sample
NOTE: Primary standards for drinking water: use Office of Drinking Water (ODW)
reporting limits.
EPA 7000 Series Methods – Metals in Hazardous Wastes
1. Calibration
2. Method blank
3. Soil sample analysis
4. Duplicate matrix spike of sample
5. MDL determination must be presented for both soil and liquid matrices
6. RL verification must be presented for both soil and liquid matrices
7. External Reference Sample
8. Laboratory Control Sample
EPA 6010 Inductively Coupled Plasma (ICP)
1. Calibration
2. Method blank
3. Soil sample analysis
4. Duplicate matrix spike of sample
5. MDL determination must be presented for both soil and liquid matrices
6. RL verification must be presented for both soil and liquid matrices
7. External Reference Sample
8. Laboratory Control Sample
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9. Analysis of an interference check standard. The interference check standard used must be as
specified in the method or made according to the following:
Analytes (mg/L) Interferant (mg/L)
Ag 1.0 Al 500
Ba 0.5 Ca 500
Be 0.5 Fe 200
Cd 1.0 Mg 500
Co 0.5
Cr 1.0
Cu 0.5
Mn 0.5
Ni 1.0
Pb 5.0
Ti 1.0
V 0.5
Zn 1.0
EPA 200.8, 6020 Inductively Coupled Plasma/Mass Spectrophotometry (ICP/MS)
1. Calibration
2. Method blank
3. Tap water (200.8) or soil (6020) sample analysis
4. Duplicate matrix spike or sample
5. MDL determination
6. RL/DLR verification
7. External Reference Sample
8. Laboratory Control Sample
9. Analysis of a tuning solution for evaluating isotopic resolution in the 20 – 200 AMU range
(Be, Mg, Co, In, Pb).
ORGANIC ANALYSES
EPA 500/600 GC Methods
1. Calibration
2. Mid-range check standard for daily run
3. Method blank
4. Tap water sample analysis
5. Duplicate Matrix spike of sample
NOTE: For Purge and Trap methods, a Duplicate Laboratory Fortified Blank (Section 3.7 –
500 Series Methods) may be substituted for a matrix spike.
6. MDL determination
7. External Reference Sample
8. Mass spectra and relative ion abundance as specified in the method turning criteria using
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BFB (Purge and Trap) or DFTPP (Extractions) must be generated for GC/MS procedures.
EPA 524, 525, 624, 625 GC/MS Methods
1. Calibration
2. Mid-range check standard for daily run
3. Method blank
4. Tap water sample analysis
5. Duplicate matrix spike of sample
6. MDL determination
7. DLR verification
8. External Reference Sample
9. Mass spectra and relative ion abundance as specified in the method turning criteria using
BFB (Purge and Trap) or DFTPP (Extractions) must be generated for GC/MS procedures.
EPA 8000 GC Methods
1. Calibration
2. Mid-range check standard for daily run
3. Method blank
4. Soil sample analysis
5. Duplicate matrix spike of sample
6. MDL determination must be presented for both soil and liquid matrices
7. RL verification must be presented for both soil and liquid matrices
8. External Reference Sample
9. Laboratory Control Sample
For PCBs (EPA 8080)
Complete demonstration of proficiency is required for PCBs 1016 and 1260. A mid-range check standard
for PCBs 1221, 1232, 1242, 1298, and 1254 is required.
Please summarize quantitation procedures for PCBs in the Instrument Operating Conditions Section.
For Total Petroleum Hydrocarbons (TPH)
Analysis of both Gasoline and Diesel Fuels is required.
For Gasoline Fuel Analysis by FID, a PID profile of BTEX in gasoline is also required (EPA 8020).
Please summarize quantitation procedures for all fuels analyzed in the Instrument Operating Conditions
Sections.
EPA 8240, 8260, 8270 GC/MS
1. Calibration
2. Mid-range check standard for daily run
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3. Method blank
4. Soil sample analysis
5. Duplicate matrix spike of sample
6. MDL determination must be presented for both soil and liquid matrices
7. RL verification must be presented for both soil and liquid matrices
8. External Reference Sample
9. Laboratory Control Sample
10. Mass spectra and relative ion abundance as specified in the method turning criteria using
BFB (Purge and Trap) or DFTPP (Extractions) must be generated for GC/MS procedures.
NOTE: For calibration of GC/MS methods, Calibration Check Compounds (CCC) RSDs
and System Performance Check Compounds (SPCC) RFs must be evaluated.
Results and acceptance criteria should be included in the calibration table and
should be highlighted or in bold.
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21.1 Security System
Our security system is maintained through Kern Securities, Inc. Kern Securities is responsible for the
maintenance of the hardware, monitoring of activated system, and initiating fire and/or police response. In
order to activate and deactivate the security system, employees need to obtain an access number and a
clearance password.
21.2 How to Obtain an Access Code
Access codes are available through Human Resources. Contact your Department Supervisor for approval
prior to obtaining an access code from the Human Resources. Temporary employees and employees under
probation are not qualified to obtain access codes.
21.3 How to Obtain a Password
When obtaining an access code, you must have a password in mind that you will use as a clearance or abort
code. The password can be any length, but please note that you must remember this password when Kern
Securities representatives call for clearance. Be discrete with your password and access code. Other than
you and Human Resources, only Kern Securities should be privy to this information.
21.4 How to Activate/Deactivate the Security System
21.4.1 Deactivation
When opening the laboratory, the system should initially be armed, thus you need to deactivate the alarm
system. Upon entering the building, find an alarm keypad within 45 seconds and enter your access code
number. This should deactivate the alarm. If the access code is not acceptable or there was a discrepant
keypad entry, the alarm will go off after 45 seconds. If the alarm goes off, enter your six digit access code,
then call Kern Securities to explain the situation.
21.4.2 Activation
In order to activate the alarm, first verify all exits are locked and secure, then verify no other employees are
in the laboratory by using the intercom system or by conducting a search of the entire premises. If all exits
are secure and you are the only employee on the laboratory grounds, activate the alarm by entering your six
digit access code. Please wait until the digital display on the keypad reads “Ready to Arm” before you enter
your access code. If this prompt does not appear, a door may not be locked or secured. When you
successfully activate the alarm system, the prompt “All secure, please exit” will appear in the keypad
display. You must exit within 45 seconds.
Kern Securities must be contacted whenever the alarm goes off. Representatives from Kern Securities call
for police response, thus you must contact Kern Securities whenever the alarm goes off.
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21.5 How to Use the Intercom
Locate a phone that is connected to the phone network. Pick up the receiver, enter “810”, wait for the
acknowledgement tone, then speak into the receiver.
21.6 What to do When Working Odd Hours
Whenever working on weekends or late hours, please contact Kern Securities to communicate how long
you expect to work. If you leave prior to another employee also working odd hours, please tell him/her the
expected exit time you gave to Kern Securities, so he/she can correct the expected exit time.
21.7 How to Contact Kern Securities
When contacting Kern Securities, you must be ready to give them you access code number and password.
Contact Kern Securities at 588-HELP or 588-4357.
21.8 How to Answer Phone Calls
When the night service function is activated on the phone system, all incoming calls are acknowledged
through the intercom system. If you hear the intercom phone call acknowledgement, pick up the receiver of
the nearest phone and enter “73290”. An appropriate greeting would be “BC Laboratories. How can I help
you?” It is extremely important to answer the phone because Kern Securities calls numerous times to verify
system status. If calls from Kern Securities are not answered, the police or management will be called.
21.9 Responsibility
It is the responsibility of all employees to do their best in following proper procedures listed here regarding
the security system. The last person entering their code into the security system is responsible for security
of the laboratory. In order to transfer responsibility, the responsible employee must secure a written
verification of the transfer of responsibility from another employee. Transfer of responsibility
documentation must be submitted to the President by the following work shift.
An example of a Transfer of Responsibility Form is attached.
21.10 Keys
You must request the use of a laboratory key through your Department Supervisor. If the Department
Supervisor is not available, contact either Human Resources or the Team Leader within your department. If
you require a copy of a laboratory key, please contact Human Resources. Laboratory keys may not be
copies unless prior approval is granted by the President. Sharing of keys is not acceptable. You are subject
to disciplinary procedures if you are found to share your key.
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BC LABORATORIES, INC.
QUALITY ASSURANCE PROTOCOLS MANUAL
SECURITY
SECTION XXI REVISION 3 EFFECTIVE DATE 01/08/16 Page XXI-3
Transfer of Responsibility Form
Relinquished by: Date/Time:
Assumed by: Date/Time:
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Relinquished by: Date/Time:
Assumed by: Date/Time:
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Relinquished by: Date/Time:
Assumed by: Date/Time:
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Relinquished by: Date/Time:
Assumed by: Date/Time:
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Relinquished by: Date/Time:
Assumed by: Date/Time:
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Comments:
Note: Section XXI was reviewed on 01/08/16 (No Changes were made)
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