Update on the Activities of The NELAC Institute

(TNI)December 6, 2013

AGENDA Overview of TNI Recent Program Updates

Standards Development NELAP NEFAP Proficiency Testing

Training and Other Tools January Meeting in Louisville

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).

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.

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

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%

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

WHAT DO WE NOT DO?

Accredit laboratories Resolve disputes between

laboratories and their Accreditation Bodies

Interpret questions on methods

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

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

American National Standards

TNI laboratory standards now recognized by ANSI as American National Standards

Provides additional credibility

Changes to Standard Development Process

Another review step has been added Interim Standard

Standards Review Council being formed To ensure consistency between

standards

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

LAB Committee Third-party assessors

Listing Credentials

Generic Application

PT Committee Voting Draft Standard under

development Will contain new approach for LOQ

reporting Also changes to Volumes 3 and 4

Revised standard finalized Minor changes On hold until PT standard final

Current focus is Standards Interpretations

Quality System Committee

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

Radiochemistry Committees

Working Draft Standards under development

Would revise Modules 5 and 6 Changes may be incorporated into next

version of the standard

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.

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. 

 

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.

NATIONAL ENVIRONMENTAL

LABORATORY ACCREDITATION PROGRAM

Accredits over 1600 laboratories 49 states and territories 9 countries

The National Program Today

NELAP Accreditation BodyWorking on ApplicationAccept NELAPIncorporate NELAP elementsState program with significant differencesDrinking water only

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

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)

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

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)

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

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

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…

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:

Other Tools Small Laboratory Advocacy Group Small Laboratory Handbook Quality Manual Template SOP Templates Audit Process (in development) Accreditation Profiles

Small Laboratory Advocacy Group

(SLAG) Open to TNI members and non-

members http://www.nelac-institute.org/board/

Elizabeth Turner, NTMWD eturner@ntmwd.com

Seeks input from small laboratories and provides advice to TNI

Raises concerns of small laboratories to high visibility in TNI

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

MEETINGS TNI holds two conferences each year Winter Conference

Forum on Laboratory Accreditation Summer Conference

Environmental Measurement Symposium

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

Have fun!!!

Forum on Laboratory AccreditationJanuary 27-30, 2014Hyatt Regency LouisvilleLouisville, KY

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

Contact TNIJerry Parr, Executive Director

www.nelac-institute.org jerry.parr@nelac-institute.org 817-598-1624