the nelac institute accreditation body committee (abc) jeff flowers, ph.d., chair

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The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

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Mission  The mission of the TNI Accreditation Body Committee is to develop and support accreditation standards by engaging industry experts in a consensus-based standards development process.  To improve the quality and consistency of environmental data throughout the United States.  To foster the mutual recognition of laboratory accreditation by Accreditation Bodies.

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Page 1: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

The NELAC InstituteAccreditation Body Committee (ABC)

Jeff Flowers, Ph.D., Chair

Page 2: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Committee Members

Jeff Flowers, Flowers Chemical Laboratories,Chair

Sharon Mertens, Milwaukee Metro Sewerage Dist.

Stephen Arms, FL DOH Daniel Dickinson, NY DOH Linda Geddes MWH Laboratories Steve Stubbs TX TCEQ Lynn Bradley USEPA OEI Joe Aiello NJ DEP

Page 3: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Mission The mission of the TNI Accreditation Body Committee is to

develop and support accreditation standards by engaging industry experts in a consensus-based standards development process.

To improve the quality and consistency of environmental data throughout the United States.

To foster the mutual recognition of laboratory accreditation by Accreditation Bodies.

Page 4: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Strategies - ABC Assist TNI NELAP board and TNI

LASC as needed with review of existing NELAC policies

Develop policies and procedures to assist TNI NELAP board in implementing new standards

Page 5: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Accomplishment Volume 2, Module 1 was adopted by TNI members

Continued mutual recognition of AB’s

LASC Recommends Adoption

(once a guidance document has been produced, editorial changes made and a TIA has been used to change the standard.)

Page 6: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Current Assignment

Respond to LASC CommentsPrepared 2 TIAsObtained CSDB affirmative vote for TIA advancement

In Public Comment Period for TIA NowAddress to [email protected]

Page 7: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Current Assignment (cont.)

• Develop Affiliate/Associate TNI recognitions

• Progression Model of Attainment• Grant additional rights as

program matures

• Ask TNI Board to consider new membership category

Page 8: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

When to use a Tentative Interim

Amendment (TIA) The amendment appears to be of an

emergency nature requiring prompt action Will be used infrequently and only in cases

where the amendment is expected to be non-controversial.

Determination of an emergency nature shall include, but not be limited to, one or more of the following factors:

Page 9: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Why use a Tentative Interim Amendment

(TIA) The standard contains an error or an omission that was overlooked during the regular standard development or revision process;

The standard contains a conflict with other language;

The proposed amendment intends to respond to a new Federal regulation or other development; and/or

The proposed amendment intends to correct a circumstance that has resulted in an adverse impact that was overlooked during the regular standard development or revision process, or

Was without adequate technical justification for the action.

Page 10: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

How are Tentative Interim Amendments

(TIA) used Requires 15 day public

notice Effective 20 days after

vote of Expert Committee May remain in effect for

no more than two years

Page 11: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

TIA 1ABC TIA One

The section(s) of the standard that should be amended;

V2M1 4.3.5The rationale for the Tentative Interim Amendment:

Several states (both large and small; KN, NY, NH, FL…) will not be able to comply with the existing standard as written. Specifically; they in fact do not comply with the requirement to have “a person(s) or committee(s) different from those who carried out the assessment”. These existing NELAP states will need to lose their existing NELAP recognized status if the language remains as is.

The factor(s) that would determine whether the amendment qualifies as a Tentative Interim Amendment:

It has been determined by the ABC that it is of an emergency nature and that the committee missed the change originally.

The proposed change to the standard, including suggested wording.

The ABC proposes to add to the existing language to the end of the sentence;

“ unless the responsible government authority allows otherwise.”

Page 12: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

TIA 2ABC TIA Two

The section(s) of the standard that should be amended;

V2M1 5.7.3bThe rationale for the Tentative Interim Amendment:

Several states (both large and small; KN, NY, NH, FL…) will not be able to comply with the existing standard as written. Specifically; they in fact do not comply with the requirement to have “a person(s) or committee(s) different from those who carried out the assessment”. These existing NELAP states will need to lose their existing NELAP recognized status if the language remains as is.

The factor(s) that would determine whether the amendment qualifies as a Tentative Interim Amendment:

It has been determined by the ABC that it is of an emergency nature and that the committee missed the change originally.

The proposed change to the standard, including suggested wording.

The ABC proposes to add to the existing language to the end of the sentence;

“ unless the responsible government authority allows otherwise.”

Page 13: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

TIA Comments TIA allows AB assessor to be judge and Jury. Counter to ISO17011 theme Some ABs will need to drop TIN requirements if TIA is not

adopted Let states with problem use third party assessment committee,

to perform their statutory authority to approve/deny accreditation.

Can not change ISO language, need different phrasing. Labs are expected to change to comply with the standard, why

could we not require the same from an AB Let the standard be adopted as is, then let the ABs then tell us

that they will not or cannot meet the standard

Page 14: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

TIA Discussion New Language

Section 4.3.5NOTE: The decision may be made by person(s) or committee(s) not different from those who carried out the assessment if the responsible government authority allows it.

Section 5.7.3bNOTE: Internal audits may be conducted by personnel who perform the activity to be audited if the responsible government authority allows it.

Page 15: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Associate/Affiliate

Page 16: The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

Future Plans? Produce SOPs and Model Polices to allow

implementation by TNI Board and TNI LASC to:

Establish an effective system for the recognition of accreditation bodies.

Develop an effective system for having states participate in the program without having to become Accreditation Bodies

Monthly conference calls, 3rd Tuesday, 12 AM EST