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Laboratory Name and contact

information

Title: Internal Audit Standard Operating Procedure and Simplified

Quality System Checklist

Doc. No. 2 Rev. No. 2

Date: 01/24/13 Page: 1 of 30

Approved by:

Technical Director

______________________________ (Name) ______________________________ (Signature)

_______________ (Initials) _________________ (Date)

Quality Assurance Officer

______________________________ (Name) ______________________________ (Signature)

_______________ (Initials) _________________ (Date)


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Revision History

Rev Date Description of Change

1 9/5/07 Name Initial Release

2 01/13/13 Name Updated all sections. Reformatted

Appendix A.

Distribution List / Location

This SOP is to be distributed to those individuals involved in the internal audit process of

the lab.


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Annual Review(The review is to be documented if the document has not been revised in

the past 12 months)

_______________________ ____________________ _______

Signature Title Date

______________________ ____________________ _______


___________________ ____________________ _______


______________________ ____________________ _______


___________________ ____________________ _______


Training RecordThe following laboratory staff have read and agree to follow the latest version of the SOP.

_____________________ ______________________ _______ _______

Signature Name Initials Date

_____________________ ______________________ _______ _______


_____________________ ______________________ _______ _______


_____________________ ______________________ _______ _______



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Table of Contents

1. Purpose ........................................................................................................................... 52. Scope............................................................................................................................... 5

3. Responsibilities................................................................................................................ 54. Procedure ....................................................................................................................... 65. Related Documentation and References ...................................................................... 86. Definitions ....................................................................................................................... 8

APPENDIX A ..................................................................................................................... 9


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1. Purpose

To ensure that the procedures in the quality manual, related to quality systems, andthe labs method manual, related to testing activities, are being followed.

To determine the effectiveness of the labs procedures in controlling the quality ofdata reported

To identify, correct, and implement any changes needed in any of the quality systemand testing activities procedures found to be deficient

To ensure all deficiencies in the labs quality system and testing activities aredocumented though its corrective action process

2. Scope

The internal audit SOP and associated checklist is used to audit, on an annual basis, the

labs quality system, policies and procedures, work instructions, analytical records, and

reports. In addition, the lab audits its testing activities (each method-technology) on an

annual basis.

3. Responsibilities

Quality Assurance (QA) Manager or QA Officer (QAO):

is knowledgeable and trained in quality system requirements, including internalaudits

initiates all internal audits and ensures they are conducted in an efficient and


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has completed auditor training has sufficient experience in performing audits performs audits in an efficient and timely manner reports all findings to the QAO

4. Procedure

4.1 The Audit Team

The Quality Assurance Manager or QA Officer (QAO) selects trained staff, if applicable,to perform the audits defined in this procedure. If trained staff is limited, the QAO and/or

technical director may perform the audits. If trained staff is not limited, the QAO will

designate one of the trained staff to serve as the lead auditor. When ever possible,

auditors are selected from a function not directly involved in the audit.

4.2 Training

Auditors are trained in auditing techniques. Training consists of reading andunderstanding this procedure and reference material related to internal auditing, and

where possible, shadowing a trained auditor or completing a formal, external training

course. The auditors are also provided with the applicable auditing guidelines and

checklists. Both quality system and method-specific checklists are to be provided to the

auditor.

Evidence of the training includes a signature that the auditor has read and understands

this procedure (see page 3). It may also include documentation of any external seminars

or course work related to quality system auditing. All training records are to be kept for a

minimum of five years.

4.3 Audit Plan


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4.4 Performing the Audit

The QAO notifies the supervisors of the areas to be audited at least a month in advance.

The QAO briefs the auditors on the audit procedures and the areas to be audited. The

auditors are to prepare prior to the audit by familiarizing themselves with the audit

procedures.

During the audit, auditors use applicable checklists. They record all findings on the

checklists. The findings are discussed with the staff responsible for performing the

function that was found to be deficient.

4.5 Deficiency Report and Corrective Action Response

A deficiency report is generated by the auditor for each legitimate finding. The QAO

makes the final decision as to whether the finding is legitimate if it can not be resolved

between the auditor and the staff audited. The QAO presents the final report to the

audited staff, as well as, laboratory management, including the technical director.

The audited staff responds to the deficiency report in a manner prescribed by the labs

corrective action procedures, which are included in the Quality Manual. The corrective

action must be completed within 90 days of the date of the finding.

When deficiencies cast doubt on the correctness or validity of the calibration or test

results reported, the lab needs to immediately notify its clients of the situation. A record

of the client notification must be maintained.

4.6 Closing an Audit

Audit findings are closed upon completion of an effective corrective action for each of

the findings. All documents related to the audit, including checklists, deficiency reports,

i i i i d b h QAO


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technical director, as part of the labs annual management review.

5. Related Documentation and References

Audit Plan

Audit Checklists, including method-specific checklists

Deficiency (Audit) Report

Corrective Action Response (CAR)

Corrective Action Procedures as noted in Quality Manual

National Environmental Laboratory Accreditation Conference (NELAC), 2003 NELAC Standard,

Approved June 5, 2003, Effective July 1, 2003, 324 pp (EPA/600/R-04/003).

National Environmental Laboratory Accreditation Conference (NELAC), 2009 NELAC Standard,

Approved August 24, 2009, Effective July 1, 2011.

New York State Department of Health (NYS DOH) Environmental Laboratory Approval Program

(ELAP), method-specific checklists,http://www.wadsworth.org/labcert/elapcert/appforms.htm

New York State Department of Health (NYS DOH), NYCRR Subpart 55-2, Approval of

Laboratories Performing Environmental Analysis, Sections 55-2.1 through 55-2.12 effective

November 17, 2004, and Section 55-2.13 effective October 6, 2004.

6. Definitions

Audit Finding - A conclusion of importance based on observation(s). An undesirable

deviation or nonconformity.

Corrective Action - Action taken to eliminate the root cause(s) and the symptom(s) of an


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APPENDIX A

TOPIC Y N N/A Comments

Organization & Management

1.) Does the laboratory have a policy to ensure its personnel are

free from any commercial, financial and other undue pressures,

which might adversely affect the quality of the work?

2.) Does the laboratory specify and document the responsibility,

authority, and interrelation of all personnel who manage, perform

or verify work affecting the quality of calibrations and tests in job

descriptions for all positions.

3.) Does the laboratory have documented certifications thatpersonnel performing all tests for which the laboratory is

accredited have the appropriate educational and/or technical

backgrounds?

4.) Does the laboratory nominate deputies in the case of absence

of the technical director or QA officer?

5.) Does the laboratory have documented policies and procedures

to ensure the protection of clients' confidential information andproprietary rights?

Quality System

1.) Is the quality documentation available to, understood by, and

implemented by all laboratory personnel?

2.) Does the quality manual and related quality documentation


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include the objectives and commitments by top management?


include the organization and management structure of the

laboratory, its place in any parent organization, and relevant

organizational charts?


include procedures to ensure that all records required under

NELAC are retained?


include procedures for control and maintenance of

documentation through a document control system which ensures

that all standard operating procedures, manuals, or documents

clearly indicate the time period during which the procedure ordocument was in force?


include procedures for achieving traceability of measurements?


include a list of all methods under which the laboratory performs

its accredited testing?


include mechanisms for ensuring that the laboratory reviews all

new work to ensure that it has the appropriate facilities and

resources before commencing such work?


include reference to the calibration and/or verification test

procedures used?


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include procedures for handling submitted samples?


include reference to the major equipment and reference

measurement standards used as well as the facilities and services

used by the laboratory in conducting tests?


include reference to procedures for calibration, verification and

maintenance of equipment?


include reference to verification practices including inter-

laboratory comparisons, proficiency testing programs, use of

reference materials, and internal quality control schemes?14.) Does the quality manual and related quality documentation

include procedures to be followed for feedback and corrective

action for failed quality control samples, or when departures from

documented policies, procedures, or NELAC standards occur?


include procedures for dealing with complaints?


include processes/procedures for establishing that personnel are

adequately experienced in the duties they are expected to carry out

and/or receive any needed training?


include processes and procedures for educating and training


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personnel in their ethical and legal responsibilities including the

potential punishments and penalties for improper, unethical, or

illegal actions?


include reference to procedures for reporting analytical results?

19.) Does the quality manual and related quality documentationinclude a Table of Contents, and applicable lists of references and

glossaries, and appendices?

20.) Does the QA officer keep the quality manual current?

21.) Does the QA officer arrange for or conduct internal audits on

the entire technical operation annually and notify laboratory

management of deficiencies in the quality system and monitor

corrective action22.) Where a complaint, or any other circumstance, raises doubt

concerning the laboratory's compliance with the laboratory's

policies or procedures, or with the requirements of this Standard

or otherwise concerning the quality of the laboratory's calibrations

or tests, does the laboratory ensure that those areas of activity and

responsibility involved are promptly audited?

23.) Does the laboratory have a procedure for the annual

management review of the quality system?

24.) Is an annual review of the quality system completed by

management to evaluate its continuing suitability and

effectiveness and make any necessary changes or improvements?

25.) Does the annual review take into account reports from


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managerial and supervisory personnel, the outcome of recent

internal audits, assessments by external bodies, the results of

interlaboratory comparisons or proficiency tests, any changes in

in the volume and type of work undertaken, feedback from

clients, corrective actions and other relevant factors?

26.) Are all audits and review findings and any corrective actionsthat arise from them documented?

27.) Does the laboratory management ensure that corrective

actions are discharged within the agreed time frame?

28.) Does the laboratory implement checks to monitor the quality

of laboratory results using:

_a__ Internal quality control procedures (using statistical

techniques whenever possible);_b__ Participation in PT or other interlaboratory comparisons;

_c__ Reference material and/or in-house quality control using

secondary reference materials;

_d__ Replicate testing;

_e__ Re-testing of retained samples; and/or

_f__ Correlation of results for different parameters of a sample.

29.) Does the laboratory have general procedures to be followed

when there are departures from documented policies, procedures,and QC have occurred?

30.) Do the procedures to be followed when there is a departure

from documented policies, procedures, and QC include but not

limited to:

a___ Identify the individuals responsible for assessing each QC


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data type;

b___ Identify the individuals responsible for initiating and/or

recommending corrective actions;

c___ Define how the analyst should treat the data set if the

associated QC measurements are unacceptable;

d___ Specify how out-of-control situations and subsequentcorrective actions are to be documented; and

e___ Specify procedures for management (including the QA

officer) to review corrective action reports.

31.) Is a corrective action log maintained, up-to-date?

32.) If a QC measure is out of control and the data is to be

reported, are data qualifiers reported with samples associated with

failed QC measures?33.) Are all quality control measures assessed and evaluated on an

on-going basis, and quality control acceptance limits used to

determine the usability of the data?

34.) Does the laboratory have procedures for the development of

acceptance/rejection criteria where no method or regulatory

criteria exist?

35.) Are the quality control protocols specified by the laboratorys

method manual followed?

Training

1.) Are training records available for all technical staff that

include:

a___ Evidence that the employee has read, understands, and is


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using the latest version of the labs in-house quality

documentation;

b___ Training courses or workshops on specific equipment,

analytical techniques, or lab procedures;

c___ Training courses in ethical and legal responsibilities

including the potential punishments & penalties for violations.d___ Evidence that the employee has read; acknowledges, and

understands their personal & legal responsibilities including

potential punishments & penalties for violations; and

e___ Documentation certifying that the employee has read,

understands, and agrees to use the latest version of a test method

used; and

2.0 Are initial demonstrations, continuing demonstrations and

method certification documented through the use of the forms in

the latest approved NELAC document in Appendix C?

3.) Does the laboratory use another approach, documented in its

Quality Manual, to demonstrate capability for analytes for which

spiking is not an option and for which quality control samples are

not readily available?

4.) Does the laboratory retain all associated supporting data

necessary to reproduce the analytical results summarized in theIDC certification statement?

5.) Is a copy of the initial demonstration of Capability Certificate

(IDC) in the personnel records for each employee performing a

test method?

6.) Do the training records of each of the technical staff include


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documentation of continuing proficiency by at least one of the

following:

___ Acceptable performance of a blind sample;

___ Another demonstration of capability;

___ Successful analysis of a blind performance sample on a

similar test method using the same technology; a___ Analysis of at least 4 consecutive lab control samples with

acceptable levels of precision and accuracy; or

___ If one of the above can be performed, the analysis of

authentic samples that have been analyzed by another trained

analyst with statistically indistinguishable results.

7.) Does the laboratory complete a new demonstration of

capability whenever there is a significant change in instrument

type, personnel, or test method?

8.) Has the laboratory management developed a proactive

program for the detection of improper, unethical, or illegal

actions?

Equipment

1.) Are maintenance procedures documented?

2.) Is each item of equipment including reference materials

labeled, marked or otherwise identified to indicate its calibration

status, when appropriate?

3.) Are maintenance records available?

Support Equipment Calibration and Traceability

1.) Does the laboratory have an established program for the

calibration and verification of its measuring and test equipment


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including balances, thermometers and control standards?

2.) Are measurements made by the labs traceable to national

standards of measurement where available?

3.) Does the laboratory maintain records of all certificates that

indicate traceability to national standards of measurement and/or

statements of compliance with an identified metrologicalspecification?

4.) Is all support equipment calibrated annually, using NIST

traceable references when available, over the entire range in

which the equipment is used?

5.) Are the results of support equipment calibration within the

specifications required of the application for which it is used?

6.) Is support equipment removed from service until repaired oris a deviation curve prepared and all measurements corrected for

the deviation when the calibration is not within acceptance limits?

7.) Does the laboratory maintain records of established correction

factors to correct measurements?

8.) Are all raw data records retained to document equipment

performance?9.) Prior to use on each working day, are balances, ovens,

refrigerators, freezers, incubators and water baths checked with

NIST traceable references (where possible) in the expected use

range?

10.) Are mechanical volumetric devices checked for accuracy on


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on a quarterly basis?

11.) Demonstration of sterilization for biological tests provided by

use of a continuous temperature recording or with the frequent

use of spore strips?

SOPS and Test Methods

1.) Does the laboratory have SOPs for all test methods?

2.) Are all instructions, standards, manuals and reference data

relevant to the work of the laboratory maintained up-to-date and

readily available to the staff?

3.) Are copies of SOPs assessable to all personnel?

4.) Does each SOP clearly indicate:

a___ Effective date of the SOP

b___ Revision numberc___ Signature(s) of approving authority

5.) Does the laboratory have an in-house method manual for each

accredited analyte or test method that clearly describes the labs

method?

6.) In cases where modifications are made to published methods

or where the reference test method is ambiguous or provides

insufficient detail, are any modifications, changes, orclarifications clearly indicated?

7.) Are the practices specified by the laboratorys method manual

followed by all analysts?

8.) Are all essential quality control measures incorporated in the

labs method manual?


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9.) Are all quality control measures assessed and evaluated on an

on-going basis?

10.) Does the laboratory have procedures for developing

acceptance/rejection criteria for each test method?

11.) Do the SOPs or the test method SOP reference the details of

the initial calibration procedures, including calculationsintegrations, and acceptance criteria associated statistics?

12.) Is the criteria for the acceptance of an initial calibration

established (correlation coefficient or relative percent difference)?

13.) Are the details of the continuing instrument calibration

procedure, calculations, and associated statistics included or

referenced in the test method SOP?14.) Does the laboratory establish Standard Operating Procedures

to ensure that the reported data is free from transcription and

calculation errors?

15.) Does the laboratory establish Standard Operating Procedures

to ensure that all quality control measures are reviewed, and

evaluated before data is reported?

16.) Are calculations and data transfers subject to checks as

established in the laboratorys SOP?

17.) Do documented procedures exist for the purchase, reception

and storage of consumable materials used for the technical

operations of the laboratory?

18.) Does the laboratory retain records for all standards, including


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including manufacturer/vendor, the manufacturers Certificate of

of Analysis or purity (if supplied), date of receipt, recommended

recommended storage conditions, and an expiration date after

which the material shall not be used unless verified by the

laboratory?

19.) Are original reagent containers labeled with the expirationdate?

20.) Are detailed records maintained on reagent and standard

preparation?

21.) Do the records of reagent and standard preparation indicate

traceability to purchased stocks or neat compounds, and include

the date of preparation and preparer's initials?

22.) Are containers of prepared reagents and standards uniquelyidentified and include an expiration date and can it be linked to

the documentation of its preparation?

Sample Handling

1.) Does the laboratory have a documented system for uniquely

identifying the items to be tested, to ensure that there can be no

confusion regarding the identity of such items at any time?

2.) Does the laboratory assign a unique identification (ID) code to

each sample container received in the laboratory?

3.) Is the laboratory ID code placed on the sample container as a

durable label?

4.) Is the laboratory ID code entered into the laboratory records

(see 5.11.3.d) and does the link that associate the sample with


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related laboratory activities such as sample preparation or

calibration?

5.) Does the laboratory have a written sample acceptance policy

that clearly outlines the circumstances under which samples will

be accepted?

6.) Is data from any sample which does not meet the policycriteria flagged in an unambiguous manner clearly defining the

nature and substance of the variation?

7.) Is the sample acceptance policy made available to sample

collecting personnel and does it include at a minimum all the

policy criteria?

8.) Upon receipt, is the condition of the sample, including any

abnormalities or departures from standard condition as prescribedin the relevant test method, recorded?

9.) Are all items specified in sample acceptance policy criteria

checked?

10.) Are all samples, which require thermal preservation,

considered acceptable if the arrival temperature is either within

+/-2C of the required temperature or in the method specified

range?

11.) For samples with a specified temperature of 4C, are samples

maintained within a temperature of just above freezing to 6C?

12.) In cases where samples are hand delivered to the laboratory

laboratory immediately after collection and do not meet the


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temperature criteria considered acceptable, is there evidence that

that the chilling process has begun such as arrival on ice?

13.) Does the laboratory have procedures for checking chemical

preservation using readily available techniques, such as pH, free

chlorine or temperature, prior to or during sample preparation or

analysis?14.) Does the laboratory implement procedures for checking

chemical preservation using readily available techniques, such as

pH, free chlorine or temperature, prior to or during sample

preparation or analysis?

15.) Are the results of all checks recorded?

16.) If the sample does not meet the sample receipt acceptance

criteria does the laboratory do any of the following:___ Retain correspondence and/or records of conversations

concerning the final disposition of rejected

___ Fully document any decision to proceed with the analysis of

samples not meeting acceptance criteria

___ Is the condition of these samples, at a minimum, noted on

the chain of custody or transmittal form and laboratory receipt

documents?

___ Is the analysis data of these samples appropriately "qualified"on the final report?

17.) Does the laboratory utilize a permanent, sequential log, such

as a logbook or electronic record, to document receipt of all

sample containers?

18.) Is the following information recorded in the laboratory


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chronological log?

a___ Client/Project Name

b___ Date and time of laboratory receipt of sample

c___ Unique laboratory ID code (see 5.11.1)

d___ Signature or initials of the person making the entries

19.) Are samples stored away from all standards, reagents, foodand other potentially contaminating sourcesin such a manner as

to prevent cross contamination?

20.) Are samples, sample fractions, extracts, leachates or other

sample preparation fractions stored according to the conditions

specified by preservation protocols or according to the test

method?

21.) Does the laboratory have standard operating procedures forthe disposal of samples, digestates, leachates and extracts or other

sample preparation products?

Records

1.) Does the laboratory retain on record all original observations,

calculations and derived data, calibration records and a copy of

the test report for five years?

2.) Does the record keeping system allow historical reconstruction

of all laboratory activities that produced the resultant sample

analytical data?

3.) Is the history of the sample readily understood through the

documentation including inter-laboratory transfers of samples

and/or extracts?

4.) Do the records include the identity of personnel involved in


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sampling, preparation, calibration or testing?

5.) Are all documentation entries signed or initialed by

responsible staff with the reason for the signature or initial clearly

indicated in the records? (Ex. sampled by, prepared by,

reviewed by)

6.) Are all generated data, except those that are generated byautomated data collection systems, recorded directly, promptly

and legibly in permanent ink?

7.) Are entries in records not obliterated by methods such as

erasures, overwritten files or markings?

8.) Are all corrections to record-keeping errors made by one line

marked through the error and the individual making the

correction signing (or initialing) and dating the correction?9.) Do records that are stored or generated by computers or

personal computers (PCS) have hard copy or write-protected

backup copies?

10.) Does the laboratory have a record management system for

control of laboratory notebooks; instrument logbooks; standards

logbooks; and records for data reduction, validation storage and

reporting?

11.) Is access to archived information documented with an access

log?

12.) Is archived information protected against fire, theft, loss,

environmental deterioration, and vermin and, in the case of

electronic records, electronic or magnetic sources?


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Reports

1.) Does the test report contain all information necessary for the

interpretation of the test results and all information required by

the method used?

2.) Does the facility management ensure that the appropriate

report items are in the report to the regulatory authority if thereport is prepared by another individual within the organization.

3.) Where the certificate or report contains results of tests

performed by sub-contractors, are these results clearly identified

by subcontractor name or applicable accreditation number?

4.) Does the laboratory certify that the test results meet all

requirements of NELAC or provide reasons and/or justification ifthey do not?

Chemistry Quality Control(To be used with the method checklist)

1.) Is a method blank performed 1 per batch, per matrix type per

sample extraction or preparation method?

2.) Is the analysis stopped, corrected and the problem eliminated

if the blank contamination is greater than 1/10th of the measured

sample contamination or 1/10th of the regulatory limit; or are the

results reported with appropriate data qualifying codes?

3.) Is an LCS (a sample matrix free of analytes of interest spiked

spiked with a verified known amount of analyte) analyzed at a


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minimum of 1 per batch of 20 or less samples per matrix, per

sample extraction or preparation method except for analytes for

which spiking solutions are not available?

4.) Is a matrix spike (sample prepared by adding a known mass

of target analyte to a specific amount of matrix sample)

performed at a frequency of 1 in 20 samples per matrix, persample extraction or preparation method?

5.) Is a matrix spike duplicate (MSD) or laboratory duplicate

performed at a frequency of 1 in 20 samples per matrix, per

sample extraction or preparation method?

6.) Is the initial instrument calibration used directly for

quantitation?

7.) Is the continuing instrument calibration verification used toconfirm the continued validity of the initial calibration?

8.) Are all initial calibrations verified with a standard obtained

from a second source?

9.) If the results of samples are not bracketed by the initial

calibration, are the results reported as having less certainty

(defined qualifiers, flags, or explanation in the case narrative)?

10.) Is the lowest calibration standard of the initial calibration

above the detection limit?

11.) When an initial calibration is not performed on the day of

analysis, does the laboratory verify the validity of the initial

calibration prior to the analysis of samples by analyzing a

continuing instrument calibration verification sample?


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12.) Is continuing instrument calibration verification repeated at

the beginning and end of each analytical batch? (If an internal

standard is used, only one continuing calibration verification must

be analyzed per analytical batch)

13.) Are the concentrations of the continuing calibration standard

varied within the established calibration range?14.) Are sufficient raw data records retained to permit

reconstruction of the initial calibration including:

a___ Calibration date

b___ Test method

c___ Instrument

d___ Analysis date

e___ Each analyte name

f___ Concentration

g___ Response

h___ Calibration curve or response factor

15.) Does the laboratory use detection limits that are determined

by the protocol in the mandated test method or applicable

regulation?

16.) Is the quality of water sources monitored and documented to

meet method specified requirements?Quality Control for Bacteriology(To be used with the method checklist)

1.) Are temperatures of incubators and water baths recorded twice

daily (morning & afternoon) as required by the methods as

indicated below:


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a. ____ Total Coliform bacteria incubation at 35.0 +/- 0.5

degrees Celsius (SM9221B, SM9221D, SM9222B

& EPA-600/8-78-017)

b. ____ Fecal Coliform bacteria incubation at 44.5 +/- 0.2

degrees Celsius (SM9221E, SM9222D, & EPA-600/8-78-017)

c. ____ Total Coliform & Escherichia coli (E. coli)

incubation at 35.0 +/- 0.5 degrees Celsius (SM9223

+ UV; Colilert, Idexx-18, & Colisure)

d. ____ E. coli incubation at 44.5 +/- 0.2 degrees Celsius

(EC with MUG or Nutrient Agar with MUG)

2.) Is the following support equipment associated with

microbiological testing checked with NIST traceable materials(where possible)

a. ____ pH meter

b. ____ Balance(s)

c. ____ Conductivity meter

d. ____ Refrigerator(s) for sample storage and/or media

storage

e. ____ Incubators

f. ____ Water baths

3.) Is a minimum of one uninoculated control prepared and

analyzed?

4.) When the same equipment is used to prepare multiple samples

samples does the laboratory prepare at least one blank at the


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beginning, one at the end, with additional blanks inserted after

every 10 samples?

5.) Is a known negative culture analyzed with each set of samples.

6.) Is each lot of media tested on a monthly basis with at least one

pure culture of a known positive reaction (positive control)? (Notrequired if the laboratory has at least one known positive result of

the appropriate organism during the month).

7.) Is the positive control test tested with a sample test batch?

8.) Are at least 5% of the suspected positive samples analyzed in

duplicate?

9.) In laboratories with more than one analyst performs the testing

does each analyst make parallel analyses on at least one positivesample per month?

10.) Are the calculations, data reduction and statistical

interpretations specified by each method followed?

11.) Where the method specifies colony counts, such as

membrane filter or colony counting, is the ability of individual

analysts to count colonies verified at least once per month, by

having two or more analysts count colonies from the same plate?

12.) In order to demonstrate traceability and selectivity, does the

laboratory use reference cultures of microorganisms obtained

from a recognized national collection or an organization

recognized by the assessor body?


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Date: 01/24/13 Page: 30 of 30

Controlled Document

13.) Are the graduations of the temperature measuring devices

appropriate for the required accuracy of measurement?

14.) Are records maintained on all laboratory reagent water

monitoring activities as below when dilution water and/or media

are prepared in house:

a_ Residual Chlorine < 1.0 mg/L.b_ Conductivity < 2.0 umho/cm at 25 degrees Celsius

c_ Heterotrophic Plate Count < 1000 cfu per mL.

d_ Bacteriological ratio 0.8 3.0.

e_ Cd, Cr, Cu, Ni, Pb, Zn each < 0.05 mg/L, collectively

internal audits op

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