1. THE ROLE OF PROFICIENCY TESTING - A PERSPECTIVE FROM AN ACCREDITATION BODY Randall Querry American Association for Laboratory Accreditation (A2LA) November 30, 2015 Washington, DC

2. Presentation Overview Laboratory Accreditation Proficiency Testing Requirements AB’s use and reliance on PT Results Laboratory’s use of proficiency testing

3. What is Accreditation? ‘ Independent evaluation of conformity assessment bodies against recognized standards to ensure their impartiality and competence to carry out specific activities, such as tests, calibrations, production of reference material, inspections and certifications.’

4. Who “accredits” the accreditors? Peer evaluations - 4 year cycle Evaluation team consists of experts from EA, APLAC, ILAC, IAAC Observed by US Government agencies AB operates in accordance with  ISO/IEC 17011  ILAC Requirements  ABs requirements

5. ILAC EA APLAC IAAC SADCA The International Picture ILACInternational Laboratory Accreditation Cooperation EAEuropean Cooperation for Accreditation APLACAsia Pacific Laboratory Accreditation Cooperation IAACInter-American Accreditation Cooperation AFRACAfrican Regional Accreditation Cooperation SADCASouthern African Development Community Accreditation ILAC EA APLAC IAAC AFRAC ARAC ARAC Arab Accreditation Cooperation

6. Accreditation Benefits... Applicants Provides a Credential Regular, objective “check-up” Increased productivity International recognition and acceptance Staying on “cutting edge” Improved performance

7. Accreditation Benefits... Users Confidence in accuracy of data/materials/products Accredited organizations listed on AB’s website Customers gain efficiency by deferring to assessments by accreditation body Reduced overhead with reliance on accredited third-party organizations

8. A2LA Goals Achieve customer satisfaction through meeting the needs of both laboratories and their users for competent testing Improve the quality of laboratories and the data they produce; and Increase acceptance of accredited laboratory data to facilitate trade.

9. How do we achieve these goals? Assessments leading to Accreditation Providing training courses Outreach Involvement in industry groups International activities

10. A2LA Today Providing accreditation for 38 years Approximately 180 technical assessors Over 2,800 organizations accredited Government, non profit, research and development, internal quality control and commercial testing/calibration laboratories

11. Accreditation Process Lab provides completed application AB staff reviews it for completeness Assessment team proposed/assigned On-site visit evaluates management system and technical aspects Report issued Corrective action response and AB review

12. Accreditation process continued Accreditation Council decision Acceptable proficiency testing results Accreditation granted!!! Accreditation is valid for two years New applicants receiving accreditation undergo surveillance visit in first year Renewal applicants-no onsite visit

13. Accreditation Cycle Accreditation is valid for two years New applicants receiving accreditation undergo surveillance assessment after one year Renewal applicants have no onsite assessment until 2 nd year renewal.

14. Ongoing Monitoring Annual Reviews  Updates on personnel/organization charts  Internal audit records  Management Review records Submittal of Proficiency Testing Results

15. Proficiency Testing Proficiency testing providers (PTP) Blind samples for testing or calibration Lab results reported to PT provider PT provider evaluates participants results PT provider reports the results to the participating labs and identifies outliers

16. Proficiency Testing Process of checking actual laboratory performance Indication of laboratories competence Tool used by ABs to verify a laboratory’s competency to perform specific tests or types of tests

17. Proficiency Testing Requirements ISO/IEC 17011:2004 ILAC P9 ISO/IEC 17025:2005 Accreditation Body Program Requirements

18. ISO/IEC 17011:2004 General requirements for accrediting bodies accrediting conformity assessment bodies 7.15.1 states “the AB shall establish procedures to take into account, during the assessment and the decision-making process, the lab’s participation in proficiency testing.”

19. 17011:2004 continued... 7.15.2 The AB may organize PT or other comparisons itself, or may involve another body judged to be competent. The AB shall maintain a list of appropriate PT programs.

20. 17011:2004 continued... 7.15.3 The AB shall ensure that its accredited labs participate in PT, where available and appropriate, and that corrective actions are carried out when necessary. The minimum number and frequency of participation shall be specified...

21. ILAC P9:2010 Policy document on Participation in national and international PT Activities Provides guidance on testing and calibration

22. ISO/IEC 17025:2005 ISO/IEC 17025 section 5.9 requires quality control procedures and a documented plan Maintain records of results Ability to detect trends

23. ISO/IEC 17025-What is not specified? frequency of participation statistical analysis tools to be used performance criteria

24. Interested Parties ISO/IEC 17011:2004 section 7.15.3 states that the minimum amount of PT and the frequency of participation shall be specified in cooperation with interested parties and shall be appropriate in relation to other surveillance activities.

25. Program Requirements Accreditation Bodies accommodate users of accredited lab data, specifiers, and regulatory agencies by implementing program requirements that go above and beyond ISO/IEC 17025 Requirements. AOAC, TNI, EPA-NLLAP, are a few examples that are currently offered.

26. AOAC PT Requirements If the PT program itself does not define frequency of testing or if a program is not suitable/feasible, the PT activities should cover a minimum of one activity per method/test/technology per year. The lab’s entire Scope should be covered over a 4 year period.

27. A2LA PT Requirements Document Requires documented plan No subcontracting / treat as “real” samples Instructions for providing results to A2LA Instructions on handling unacceptable results Corrective action responses

28. Accrediting Bodies’ use of PT Granting accreditation Ongoing monitoring Expansion of existing accredited lab scopes

29. Lab - PT Provider Relations A2LA encourages the use of accredited proficiency testing providers Accredited PT Providers are found to be competent, by meeting ISO/IEC 17043:2010

30. ISO/IEC 17025 4.6.4 Laboratory’s need to consider section 4.6.4 when enrolling in PT programs - “The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the quality of the testing and shall maintain records of these evaluations and list those approved.”

31. A2LA Guidance for Reviewing PT Reports A2LA Checklist Compliance to ISO/IEC 17043 Use of samples of the same type as routinely used Use of homogenous and stable samples Appropriate evaluation criteria

32. Clear Instructions and PT Reports Identity of PT scheme date type of sample tested characteristic method or calibration lab’s reported value details about method used the assigned value range of acceptable results evaluation of performance summary results from other labs

33. PTP Scheme Operations Date of shipments, response due and anticipated reports complete description of samples source of assigned value range of satisfactory results Procedures used to statistically analyze the data use of competent subcontractors evidence of functioning management system satisfactory service

34. More than just an accreditation hoop…PT provides labs: An external comparison An educational/ instructional tool Tool for continuous improvement

35. Summary AB can rely on PT to determine lab is technically competent between on site assessments Labs can rely and benefit from participating in PT for improvement, scope expansion and demonstrating competence Users are provided assurance of ongoing competence

36. Contact Info Randall Querry A2LA 5202 Presidents Court, Suite 220 Frederick, MD 21703 Direct line: 301 644 3221 Fax: 301 662 2974 rquerry@A2LA.org www.A2LA.org