the 2016 tni standard and the national environmental laboratory accreditation program ·...
TRANSCRIPT
The 2016 TNI Standard and
the National Environmental
Laboratory Accreditation
ProgramVWEA/VAAWWA
GLP 07/26/16
Stacie MetzlerPlus resources to help
laboratories
Current Status of 2016 TNI
Standard
Volume 1: Laboratory Requirements
Module 1: Proficiency Testing - FINAL
Module 2: Quality Systems - FINAL
Module 3: Asbestos – No Changes
Module 4: Chemistry - FINAL
Module 5: Microbiology - FINAL
Module 6: Radiochemistry - FINAL
Module 7: Whole Effluent Toxicity – No Changes
Other 2016 TNI Standards
Volume 2: AB Requirements
Module 1: Accreditation Body – No Change
Module 2: Proficiency Testing - FINAL
Module 3: On-Site Assessment – No Change
Volume 3: PT Provider Requirements
Interim Standard published for vote on 3/21/16
Volume 4: PTPA Requirements Interim Standard published for vote on 3/21/16
2016 TNI Standards
See presentations made on Wednesday,
July 1, 2015 at the 2015 NEMC
http://nemc.us/meeting/2015/techprog.php
Click on the Wednesday tab!
Updated versions of these presentations
with more detail will be made on August 11
at the 2016 NEMC
Webinars likely this fall
2016 PT Standards
Volume 1
Reverse some decisions made in the 2009
standard
LOQ reporting
Analysis date
New sections for WET and Protozoa
Volumes 2, 3, and 4
Many changes affecting PT Providers
Clarification of role of AB in reviewing PT results
2016 Quality System
Standard Revised to include all of ISO/IEC 17025 verbatim
Removed Note from Section 5.6 on traceability
Added back language in Sections 5.4 on method
validation
Revised definition for Limit of Detection
Revise temperature calibration (5.5.13.1)
Allow single point verification at mandated condition
Other minor clarifications and revised definitions
Volume 1, Module 2
Clarifications and
Definitions “Parameter” was changed to “Analyte” Any Notes were either eliminated or had the
“NOTE” removed – this makes them requirements
Definitions
Analyte (revised)
Data Integrity (revised)
Lot (added)
Parameter (deleted)
Physical parameter (added)
Reference Method (revised)
Volume 1, Module 2
2016 Chemistry
Standard
Revised Calibration Section
Revised Section on LOD and LOQ
Clarified confusing language on method
validation in Section 1.5
Moved general language on method
selection and validation to Module 2
Volume 1, Module 4
Instrument Calibration
2009
1.7.1 Initial Calibration
1.7.1.1 Instrument
Calibration
10 subsections
1.7.1.2 Continuing
Calibration
5 subsections
2016
1.7.1 Calibration
1.7.1.1 Initial Calibration
13 subsections
1.7.1.2 Continuing
Calibration Verification
6 subsections
Volume 1, Module 4
Revised Calibration Section
Removal of calibration points
Number of standards required
Relative Error / Relative Standard Error
Corrective action for CCV
Many other minor changes
Volume 1, Module 4
1.7.1 Calibration
Clarifies that calibration of support
equipment is in Module 2
Continues to allow other options in
mandated methods or programs to
supersede these requirements
Clarifies that calibration may be performed
at the instrument or method level
Volume 1, Module 4
1.7.1.1 Initial Calibration Clarifies that results from most recent initial are
to be used
New section on removal and/or replacement of
calibration standards
Section on number of calibration standard
completely revised
New section on relative error
New sections on Arochlors, sensitivity checks
and upper reporting limits
Other minor clarifications
Volume 1, Module 4
Anscombe’s Quartet
1.7.1.2 Continuing
Calibration Verification
New section requires CCV to be < ½ high
point
Allows use a second source CCV
Allows LCS to be used as CCV in limited
cases
Allows a second CCV to be used with
justification
Volume 1, Module 4
Changes to LOD
New definition for the LOD (in Module 2)
Renamed TNI LOD as MDL
Added several new requirements
Samples used to determine MDL must be prepped and
analyzed over several days
Evaluation of routine method blanks must be included
Specifications for ongoing verification of MDL
Made consistent with revised 40 CFR Part 136 MDL
Volume 1, Module 4
Changes to LOQ
Minimum of 7 spikes at or below LOQ
Details requirements if multiple instruments will
have same LOQ
LOQ is the spiking level, unless < 3X MDL in
which case LOQ is 3X MDL
Allows determination of precision and bias at
the LOQ
Consistent with revised MDL, EPA MRL and
EPA LLOQ
Volume 1, Module 4
2016 Microbiology
Standard Significant Rewrite for Clarity
Clarified definition of source water
Revised Method Selection and Validation
Revised chlorine residual check
Additional guidance and options
Reinforce the concept of minimum requirements
Default to the use of the data
Reorganized QC section to “before” and “during”
analysis, for example:
Media Checks: Before
Blanks: During Volume 1, Module 5
Radiochemistry Standard
1.1 Introduction
1.2 Scope
1.3 Terms and Definitions
1.3.1 Additional Terms and Definitions
1.3.2 Exclusions and Exceptions
1.4 Method Selection
1.5 Method Validation1.5.1 Validation of Methods
1.5.2 Detection Capability
1.5.3 Evaluation of Precision and Bias
1.5.4 Measurement Uncertainty
1.5.5 Evaluation of Selectivity
1.6 Demonstration of Capability
1.6.1 General
1.6.2 Initial DOC
1.6.3 Ongoing DOC
1.7 Technical Requirements1.7.1 Instrument Set-up,
Calibration, Performance Checks,
and Background Measurements
1.7.2 Quality Control for
Radiochemistry
1.7.3 Data Evaluation and
Reporting
1.7.4 Sample Handling
Volume 1, Module 6
The 2016 TNI Standard
Changes to PT, Quality Systems, Chemistry,
Microbiology and Radiochemistry
Also changes to Volumes 2, 3, and 4
Expected to be adopted by CSDP by August 2016.
Will need review by LASEC for suitability
Will need adoption by NELAP for implementation
NELAP implementation will be for a specific date,
likely 2018
Implementation of 2016
TNI Standard
2-3 year process
Extensive training will be provided to labs
and lab assessors
New checklists and guidance will be
developed
Quality Manual template will likely be
revised
Full day session planned for August 11 in
conjunction with TNI’s summer meeting
TNI ResourcesCourse 2-1013: Implementing the 2009 TNI Standard
The objective of this course is to help laboratory management
understand the requirements of the 2009 TNI Standard. The
material will "demystify" terminology, provide assistance in
understanding the requirements, and provide guidance on how
to incorporate the requirements of the Standard into laboratory
operations without disrupting current practices.
Technical Assistance
Small Laboratory Handbook
Tips and Hints for implementing the standard
Quality Manual Template
Fill in the blank template
TNI Standard webcast
16- hour comprehensive training on the TNI
Standard
TNI Quality Systems webcast lectures
A series of 10 lectures on various topics (e.g.,
data integrity, corrective actions, LOD/LOQ)
Technical Assistance
Listing of consultants to help laboratories
How to get accredited flow chart
Quality Systems checklist
Standards Interpretations
Small Laboratory Advocacy Group bulletin board
Assessment Forum and Mentor Sessions
Fields of Proficiency Testing Tables
LAMS
Assessment Forum and
Mentor Sessions Making Internal Audits Effective
Internal Audits for Small Municipal Laboratories
Practicing Root Cause and Corrective Action
Microbiology QA/QC Requirements
Meeting TNI Standard Requirements for Microbiology
Writing Findings
What a QA Officer Really Does…
Following the Yellow Brick Road to Managing Quality
Top 10 Suggestions on Being a Better QA Officer
…and many more
http://www.nelac-institute.org/content/tnidocs.php
Laboratory Accreditation
Management System (LAMS)
Searchable database of accredited
laboratories
Method Table
4116 methods
Includes approvals in 136 and 141
Includes links to methods
Analyte Table
3219 analytes
Downloadable Webcasts
Corrective Action Process and Root Cause Analysis
Theoretical and Practical Consideration for Establishing
Sensitivity of Measurements
Internal Audits and Management Review
Ethics Training for the Environmental Professional
Establishing a Data Integrity Plan
Defining Organizational Responsibilities
Method Selection and Validation
Etc…
Webinars Planned for 2016
The TNI Radiochemistry Standard
2016 TNI Standard
How to Select Instrumentation
????
Send us your suggestions for training
Send us a proposal to provide training
Member Benefits
Access the TNI Methods Compendium, an
on-line portal to copies of over 3,000
environmental testing methods.
No charge to use the TNI Generic
Laboratory Application.
Access the Stationary Source Audit
Sample Statistics for no charge.
Free webcasts and webinars (Sponsor
and Patron)
Opportunities
We invite you to actively participate in our
activities
Join TNI
Join a TNI committee
Vote on our standards
Future Meetings
January 23-26, 2017
Houston, TX
Summer Meeting
Orange County, CA
August 8-12, 2016
Washington, DC
August 2017
Winter Meeting
Summer Meeting
In conjunction with National Environmental
Monitoring Conference
Orange County, CA
www.nemc.us
NEMC Sessions Academic Research Topics
Advances in Sample Preparation
and Clean-up
Air Methods & Monitoring
Applications of qPCR Methods for
Microbiological Contaminants
Best Practices for Reference
Materials
California Efforts in Revitalizing
the Environmental Laboratory
Accreditation Program
Changing the Paradigm for Water
Pollution Monitoring
Citizen Science
Collaborative Efforts to Improve
Environmental Monitoring
Contaminated Sediments
Current Trends in LIMS
Data Quality, Management and
Validation
Forensic Chemistry
HPLC in Environmental Monitoring
Metals and Metals Speciation
Non Targeted Compound
Screening
Operational and Advocacy Issues
Overcoming Legacy Obstacles
Review of Data for Chlorinated
Dioxins
Citizen Science and Innovation
Sensors and Field Analytical
Chemistry
Topics in Drinking Water
Topics in Shale Gas
Use of Continuous Monitoring
