The NELAC Institute Consensus Standards Development Program

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The NELAC Institute Consensus Standards
Development Program

• Kenneth W. Jackson
• NY State Dept. of Health
• Wadsworth Center, Albany NY

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Programs of TNI

• Core Programs
• Consensus Standards Development
• Laboratory Accreditation System
• National Environmental Laboratory Accreditation
• Proficiency Testing
• Program Support
• Policy Development
• Advocacy
• Administration
• Technical Assistance

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TNI Bylaws, Section 1
(D) Consensus Standards Development Program The
purpose of the Consensus Standards Development
Program (CSDP) is to develop standards for the
accreditation of environmental laboratories. The
Consensus Standards Development Program Board is
responsible for managing this program. The CSDP
Board consists of the Chair of each Expert
Committee plus additional at-large members
representing other stakeholder interests. This
core program has a support role in assisting the
LASP Committee in developing the laboratory
accreditation system.
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Consensus Standards Development Program Board

• JoAnn Boyd (member-at-large)
• Bob DiRienzo (Quality Systems Committee Chair)
• Jeff Flowers (Accreditation Body Committee Chair)
• Ken Jackson (Board Chair)
• Anand Mudambi (Proficiency Testing Committee
  Chair)
• Denise Rice (On-Site Assessment Committee Chair)
• Dave Speis (Field Activities Committee Chair
  pro tem)
• TNI staff Jane Wilson

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Consensus Standards Development Program

• The CSDP Board has oversight of the following
  committees
• Proficiency Testing Expert Committee
• On-Site Assessment Expert Committee
• Quality Systems Expert Committee
• Accreditation Body Expert Committee
• Field Activities Expert Committee
• Uniformity of Standards Committee

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Expert Committee Membership

• Committee Members
• 5-15 on each committee
• Appointed to maintain balance
• Votes are tallied for passage or failure of a
  voting item
• Votes with comments must be brought to resolution
  for passage of a voting item
• Associate Committee Members
• All TNI members and affiliates can be Associate
  Committee Members on any/all committees
• Votes with comments must be brought to resolution
  for passage of a voting item

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Goal of the Consensus Standards Development
Program

• To develop standards for accreditation of
  laboratories by accreditation bodies
• Standards for
• laboratories (includes sampling and field
  measurement organizations)
• accreditation bodies
• PT providers
• PT provider oversight bodies
• Standards based on ISO 17011 and ISO 17025 where
  applicable
• Standards are developed through an open consensus
  process, involving all stakeholders

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Application for ANSI Accreditation as a
Consensus Standards Development Body

• TNI had to demonstrate
• Openness
• Balance of interest
• Consensus
• Due Process
• Appeals Process

• This was achieved through submission to ANSI of
• Policies Governing Standards Development
• Procedures for Expert Committee Operations
• TNI Bylaws

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ANSI Requirements of a Consensus Standards
Development Body

• Openness
• Committee membership open to all
• All meetings open to all members
• Minutes of all meetings are posted
• The public may provide input
• Balance of interest
• Consensus
• Due Process
• Appeals Process

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ANSI Requirements of a Consensus Standards
Development Body

• Openness
• Balance of interest
• No single interest category can constitute a
  majority of committee members on any
  committee.Interest categories are a)
  accreditation bodies b) accredited laboratories
  and c) others (consultants, PT providers,
  non-accredited labs, state and fed agencies that
  do not run accreditation programs, etc.)
• Consensus
• Due Process
• Appeals Process

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ANSI Requirements of a Consensus Standards
Development Body

• Openness
• Balance of interest
• Consensus
• General, but not necessarily universal agreement
• Due Process
• Appeals Process

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ANSI Requirements of a Consensus Standards
Development Body

• Openness
• Balance of interest
• Consensus
• Due Process
• Any person with a direct and material interest
  has a right to participate by a) expressing a
  position and its basis b) having that position
  considered and c) having the right to appeal
• Appeals Process

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Application for ANSI Accreditation as a
Consensus Standards Development Body

• Having met all requirements, the TNI Consensus
  Standards Development Program was approved by
  ANSI, effective December 18, 2007.

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Standards Development Process

1. Expert Committees submit Working Draft Standard
   (WDS) for public comment.
2. WDS is modified to become Draft Interim Standard
   (DIS).
3. All TNI members may vote on DIS.
4. DIS modified as a result of persuasive comments
   received.
5. If modified DIS passes, it becomes Interim
   Standard (IS).
6. All TNI members may vote on IS.
7. If IS passes, it becomes the Final Standard (FS).

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Status of the TNI Standards
Environmental Sector (Red Interim Black
Final Standard) Volume 1 Laboratory
Requirements Module 1 Proficiency
testing Module 2 Quality Systems General
Requirements Modules 3 7 are QS requirements
for Asbestos Testing (3) Chemical Testing (4)
Microbiological Testing (5) Radiochemical
Testing (6) and Toxicity Testing (7) Volume 2
Accreditation Body requirements Module 1
General Requirements Module 2 Proficiency
Testing Module 3 On-Site Assessment Volume 3
Proficiency Testing Provider Requirements Volume
4 Proficiency Testing Oversight
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Status of the TNI Standards
Field Sampling and Measurement Organization
Sector (Final Standard) Volume 1 General
Requirements for Field Sampling and Measurement
Organizations Volume 2 General Requirements for
Accreditation Bodies Accrediting Field Sampling
and Measurement Organizations
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Modified Standards Development Process

• ANSI objected to the Final Standard vote
• Vote by entire membership is not a consensus
  vote, since balance is not achieved, and it is
  just a yes/no vote.
• This would open the door for any special interest
  group to dominate the voting process.(Only 79
  members voted on the previous Final Standard)

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Modified Standards Development Process

1. Expert Committees submit Working Draft Standard
   (WDS) for public comment.
2. WDS is modified to become Draft Interim Standard
   (DIS).
3. All TNI members may vote on DIS.
4. DIS modified as a result of persuasive comments
   received.
5. If modified DIS passes, it becomes Interim Final
   Standard.
6. All TNI members may vote on IS.
7. If IS passes, it becomes the Final Standard (FS).

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TNI Accreditation StandardsAvailability

• Environmental Sector A complete set of
  standards is now available

• Field Sampling and Measurement Organization
  Sector General Requirements Standards are now
  available

• The Final Standards will be offered to
  interested organizations, including the TNI NELAP
  Board

• The Final Standards with ISO 17011 (V2M1V2M3)
  and ISO 17025 (V1M2 and FSMO volumes) included
  are available for purchase from TNI. Non-ISO
  versions can be downloaded at no cost.

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Summary

• The TNI Consensus Standards Development
  Program develops standards though an open
  consensus process.
• The standards are based on relevant ISO
  standards where applicable.
• These standards are then offered to the TNI
  NELAP, and are available to any other interested
  organization.
• This week The PT and QS committees will
  present their standards and responses to comments
  received during the recent vote.
• The CSDB will continue to develop new and
  improved standards as requested.