Transcript TNI Update
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).
Mission
The 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
Accredited organizations
Recognized accreditation bodies
States that are not recognized accreditation bodies
Federal agencies that operate accreditation programs
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
Other: 4%
PT Providers: 4%
Vendors: 7%
EPA: 3%
Other Federal Agencies: 3%
Commercial laboratories: 39%
State agencies: 15%
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
Quality System Committee
Revised standard finalized
Minor changes
On hold until PT standard final
Current focus is Standards Interpretations
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 Body
Working on Application
Accept NELAP
Incorporate NELAP elements
State program with significant differences
Drinking 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:
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
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
Elizabeth Turner, NTMWD
http://www.nelac-institute.org/board/
[email protected]
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
Profiles for all 50 states
Summary information
http://www.nelac-institute.org/abdb.php
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
Forum on
Laboratory
Accreditation
January 27-30,
2014
Hyatt Regency
Louisville
Louisville, 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 TNI
Jerry Parr, Executive Director
www.nelac-institute.org
[email protected]
817-598-1624