1. Most Common Deficiencies Cheryl O. Morton Managing Director, AIHA Laboratory Accreditation Programs, LLC

2. AIHA Laboratory Accreditation Programs, LLC AIHA starting accrediting industrial hygiene laboratories in 1974. Accreditation now done by AIHA Laboratory Accreditation Programs, LLC which was formed in 2009 AIHA-LAP accredits all testing labs to the ISO/IEC 17025:2005 Standard.

3. International Recognition Formally recognized by two regional bodies of the International Laboratory Accreditation Cooperation (ILAC) –Inter American Accreditation Cooperation –Asia Pacific Laboratory Accreditation Cooperation (APLAC)

4. AIHA-LAP Programs The Industrial Hygiene Laboratory Accreditation Program (IHLAP) for labs involved in testing to evaluate workplace exposures. 70% of all accredited labs are in IHLAP. The Environmental Lead Laboratory Accreditation Program (ELLAP) for labs testing lead in environmental samples. Recognized by the U.S. Environmental Protection Agency. The Environmental Microbiology Laboratory Accreditation Program (EMLAP) for labs identifying microorganisms detected in air, fluids, and bulk samples. Unique Scopes Accreditation Covers consumer product testing and other testing not typically part of legacy programs.

5. AIHA-LAP Programs (continued) Food Laboratory Accreditation Program (FoodLAP) for labs testing food products (including raw agricultural commodities), finished food products, and food ingredients. –Labs can also be accredited to AOAC Requirements

6. AIHA-LAP Site Assessments About 300 labs assessed every two years to: –ISO/IEC 17025:2005 –Additional AIHA-LAP requirements Mainly developed to clarify AIHA-LAP’s interpretation of the Standard Initial laboratories undergo surveillance assessments after first year. Follow-up and surveillance assessments can be recommended based on the number and/or scope of findings or if deficiencies are repeated in a lab.

7. AIHA-LAP Site Assessors 19 individuals who work independently and conduct 140-170 assessments a year. Team assessments conducted on a limited basis. Monitored by peers/staff and receive annual performance evaluations. Meet as a group 3 times annually including one face-to-face meeting to create consistency around writing deficiencies.

8. Deficiencies Deficiencies are documented failures around specific requirements of ISO/IEC 17025 and/or AIHA-LAP policies. Assessors must cite specific Policies. Laboratories given time to address. Staff and technical experts routinely review assessor findings and the acceptance of laboratories’ responses.

9. Review of AIHA-LAP Deficiencies Quality Manager and Technical Manager just started in-depth review of deficiencies. New data management system will make this data more readily available so trend data can be generated. For now, presentation of data for the last 18 months reviewed covering initial, reaccreditation and surveillance assessments. “Common” means cited more than 9 times (in different laboratories) over the past 18 months.

10. Most Common AIHA-LAP Deficiencies – Number 10 ISO/IEC 17025, Clause 4.6 Purchasing Services & Supplies (Specifically 4.6.4) Examples Laboratory fails to evaluate suppliers of critical supplies or services that affect the quality of testing. Laboratory does not maintain list of approved critical suppliers.

11. Most Common AIHA-LAP Deficiencies – Number 9 AIHA-LAP, LLC Policy 2A.4.2.1, Management Systems Examples SOPs are out of date or incomplete. Policies or procedures do not reflect current practice.

12. Most Common AIHA-LAP Deficiencies – Number 8 ISO/IEC 17025, Clause 4.9.1, Control of non- conforming work Examples Procedure does not state responsibility for reauthorization of work

13. Most Common AIHA-LAP Deficiencies – Number 7 Appendix H, Section 5.8 – Internal Verification and Calibration on equipment Examples Lab does not provide enough information to ensure they are using acceptably calibrated equipment. Lab fails to provide supporting documentation from equipment or service provider. Calibration and verification procedures are not fully documented. Calibration and verification intervals have not been established with justification for the intervals.

14. Most Common AIHA-LAP Deficiencies – Number 6 ISO/IEC 17025, Clause 5.10.2 Test Reports Examples Test reports do not include applicable information –Condition of items tested –Description of items tested –Unique identification –Lack of page identification

15. Most Common AIHA-LAP Deficiencies – Number 5 ISO/IEC 17025, Clause 4.13.2.1Technical Records Examples Records do not include identification of specific equipment used to conduct the testing or identification of who conducted the testing. Records discovered in the lab that were illegible, unsigned and/or altered. Lab does not maintain sufficient data to establish an audit trail.

16. Most Common AIHA-LAP Deficiencies – Number 4 ISO/IEC 17025, Clause 4.14.1 – Internal Audits Examples Lab’s internal audit did not verify compliance to all requirements (including AIHA-LAP policies.) Lab unable to provide objective evidence that the internal auditor was trained and qualified. Lab failed to conduct internal audit or address finding according to stated procedure.

17. Top Three Deficiencies – Number 3 ISO/IEC 17025, Clause 5.4.1 – Test Methods and Validation Examples Deviation from test methods not documented, technically justified, authorized and/or accepted by the customer. Lab’s procedures or test methods do not contain specific instructions on use of equipment thereby jeopardizing the test results.

18. Top Three Deficiencies – Number 2 ISO/IEC 17025, Clause 4.3.2.1 – Document Approval and Issue: Examples Master list not maintained according to procedure. Lab personnel witnessed using obsolete procedures. Documents maintained by the lab not uniquely identified. Documents not approved by authorized personnel.

19. Top Three Deficiencies – Number 1 ISO/IEC 17025, Clause 5.4.7.2 – Control of Data: Examples Computer software developed by the user no suitably validated as being adequate for use. Procedures not implemented for protection of data.

20. Distribution of Top Deficiencies

21. Distribution of Top 3 Deficiencies

22. Observations Assessors generally agree on the common deficiencies. Laboratories can dispute deficiencies and sometimes assessors rescind them…but those challenged not among the most commonly-cited. Trends in deficiencies can help AIHA-LAP with training programs.

23. Observations Most common deficiencies split between technical requirements of ISO/IEC 17025:2005 that pertain to the competence of a laboratory to carry out tests and management system requirements -- processes focused on achieving quality policy objectives.

24. Questions? For more information, contact Cheryl O. Morton at cmorton@aiha.orgcmorton@aiha.org or call (703) 846-0789.