Update on the Activities of The NELAC Institute (TNI)
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Transcript of Update on the Activities of The NELAC Institute (TNI)
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Update on the Activities of The NELAC Institute
(TNI)December 6, 2013
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AGENDA Overview of TNI Recent Program Updates
Standards Development NELAP NEFAP Proficiency Testing
Training and Other Tools January Meeting in Louisville
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WHO IS TNI? A 501(c)3 non-profit organization.
A member organization managed by a Board of Directors.
A voluntary consensus standards development organization accredited by the American National Standards Institute (ANSI).
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MissionThe purpose of the organization is to foster the generation of environmental data of known and documented quality through an open, inclusive and transparent process that is responsive to the needs of the community.
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Who Are Our Members? Organizations that accredit
laboratories Recognized accreditation bodies States that are not recognized accreditation
bodies Federal agencies that operate accreditation
programs Accredited organizations
Laboratories Field Sampling and Measurement Organizations
Others State and federal agencies that do not operate
accreditation programs Data users, consultants, PT Providers, vendors,
etc. Anyone interested in laboratory accreditation
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Member Demographics
Commercial laboratories: 39%
State agencies: 15%
EPA: 3%
Other Federal Agencies: 3%
Vendors: 7%
PT Providers: 4%Other: 4%
Regulated industry: 3%Municipalities: 22%
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WHAT DO WE PROVIDE? Infrastructure for stakeholders Consensus building for establishing
requirements for: Organizations that accredit Organizations that are accredited Proficiency testing programs
Recognition of organizations that operate accreditation programs
Assistance to members and others
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WHAT DO WE NOT DO?
Accredit laboratories Resolve disputes between
laboratories and their Accreditation Bodies
Interpret questions on methods
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TNI PROGRAMS Consensus Standards Development Program National Environmental Laboratory Accreditation Program (NELAP) National Environmental Field Activities Program (NEFAP) Proficiency Testing Program Stationary Source Audit Sample Program (SSAS) Administration and Support
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Consensus Standards
Development Program Expert committees develop standards
consistent with TNI’s mission, using a consensus process
Expert Committees Chemistry Field Activities Laboratory Accreditation Body Microbiology Proficiency Testing Radiochemistry Quality Systems Stationary Source Audit Sample
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American National Standards
TNI laboratory standards now recognized by ANSI as American National Standards
Provides additional credibility
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Changes to Standard Development Process
Another review step has been added Interim Standard
Standards Review Council being formed To ensure consistency between
standards
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Chemistry Committee Voting Draft Standard on instrument
calibration Significant changes to current standard
Minimum number of points based on degrees of freedom
Relative error used for verification Many other changes
Working Draft Standard on detection and quantitation under development Proposed changes to MDL Procedure
published for comment
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LAB Committee Third-party assessors
Listing Credentials
Generic Application
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PT Committee Voting Draft Standard under
development Will contain new approach for LOQ
reporting Also changes to Volumes 3 and 4
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Revised standard finalized Minor changes On hold until PT standard final
Current focus is Standards Interpretations
Quality System Committee
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Microbiology Committee Working Draft Standards under
development Changes may be incorporated into next
version of the standard Committee has been working with EPA to
determine whether NELAP ABs might implement accreditations for cryptosporidium in their programs. No change to the standard would be needed Checklist and other tools may need to be
developed More discussions at the winter meeting in
Louisville
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Radiochemistry Committees
Working Draft Standards under development
Would revise Modules 5 and 6 Changes may be incorporated into next
version of the standard
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New Standard? Consensus Standards Development
Executive Committee (CSDEC) has set a target date of 2015 for the next published version of the Environmental Sector Standard.
Replaces the 2009 standard.
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What will be affected? Volume 1, (labs)
Module 1, Proficiency Testing; Module 2, Quality Systems General
Requirements (the already approved 2012 version);
Module 4, Chemical Testing (Calibration section);
Module 5, Biological Testing; Module 6, Radiochemical Testing.
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And for ABs… Volume 2 (ABs):
Module 2, Proficiency Testing. Volume 3, General Requirements for
Environmental Proficiency Test Providers.
Volume 4, General Requirements for an Accreditor of Environmental Proficiency Test Providers.
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NATIONAL ENVIRONMENTAL
LABORATORY ACCREDITATION PROGRAM
Accredits over 1600 laboratories 49 states and territories 9 countries
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The National Program Today
NELAP Accreditation BodyWorking on ApplicationAccept NELAPIncorporate NELAP elementsState program with significant differencesDrinking water only
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Non-Governmental ABs
NGABs would be recognized to grant NELAP accreditations
NELAP ABs may or may not accept these accreditations
Primary focus is on out-of-state labs Policies and SOPs in development Draft program was presented in August
with implementation expected in 2014
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NEFAP Consensus standards that are
voluntarily adopted by state agencies or third parties approved as Accreditation Bodies (ABs)
AB grants accreditation, which is unconditionally recognized by other participating ABs
Program applies to Field Sampling and Measurement Organizations (FSMOs)
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PT Program Recognize organizations to be PT
Provider Accreditors Establish Fields of Proficiency Testing
Drinking Water Non-potable water Solid & Chemical Materials Whole effluent toxicity
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PT Program News & Plans
Recently expanded to include Stationary source audit samples Field lead testing
Update the WET table Plan to implement a Protozoa FoPT table
(Cryptosporidium)
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Training and Other Tools
Comprehensive Training Curriculum being developed Technical training QA Manager training Assessor training
Goal is to move most training on-line Will begin awarding CEUs Other tools to assist labs
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Educational Delivery System
New EDS/training pages on TNI website Educational opportunities Application to provide training Needs survey
Training developed by TNI and others “Live” training courses Webinars Webcasts
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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…
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On-Demand Training: Title Presented By
Brown Bag 1: Corrective Action Process and Root Cause Analysis
Jack Farrell
Brown Bag 10: Records and Record Keeping Jack Farrell
Brown Bag 2: Theoretical and Practical Consideration for Establishing Sensitivity of Measurements
Jack Farrell and Jerry Parr
Brown Bag 3: Internal Audits and Management Review Jack Farrell
Brown Bag 4: Ethics Training for the Environmental Professional
Jack Farrell
Brown Bag 5: Establishing a Data Integrity Plan Jack Farrell
Brown Bag 6: Defining Organizational Responsibilities Jack Farrell
Brown Bag 7: Method Selection and Validation Jack Farrell and Jerry Parr
Brown Bag 8: Developing the Quality Manual as a Useful Management Tool
Jack Farrell and Ilona Taunton
Brown Bag 9: Document and Document Control Jack Farrell
NEFAP as seen through the FOG - Quality for Field Operations
Marlene Moore
NEFAP Assessor Training TNI FSMO Standard Volume 1 Marlene Moore
The 2012 EPA Method Update Rule Jerry Parr
On-Demand Training:
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Other Tools Small Laboratory Advocacy Group Small Laboratory Handbook Quality Manual Template SOP Templates Audit Process (in development) Accreditation Profiles
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Small Laboratory Advocacy Group
(SLAG) Open to TNI members and non-
members http://www.nelac-institute.org/board/
Elizabeth Turner, NTMWD [email protected]
Seeks input from small laboratories and provides advice to TNI
Raises concerns of small laboratories to high visibility in TNI
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Accreditation / Certification Profiles
New web site area http://www.nelac-institute.org/abdb.php
Profiles for all 50 states Summary information
Scope of program Summary of fees
Contact information Links
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MEETINGS TNI holds two conferences each year Winter Conference
Forum on Laboratory Accreditation Summer Conference
Environmental Measurement Symposium
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Why go to a TNI Conference?
Opportunity to contribute to development of standards.
Participate on TNI Committees. Annual mentor sessions and
technical assistance for labs and lab accreditors (how do others do this?)
“Talk to the other side” Learn new things; and
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Have fun!!!
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Forum on Laboratory AccreditationJanuary 27-30, 2014Hyatt Regency LouisvilleLouisville, KY
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2014 and Beyond Implement the adopted NELAP standards Implement the FSMO accreditation
program Implement a Stationary Source Audit
Sample Program Develop and refine a comprehensive
training program Implement a national database of
accredited laboratories Continue to develop consensus standards
that meet the needs of the community