1. Forum FM308: Policy Changes Tuesday June 5 10:00 a.m. AIHA Laboratory Accreditation Policy Changes—ISO 17025 “How Do Changes Affect My Laboratory?” “What Happens with the Site Assessment?” James H. Nelson, Ph.D., CIH

2. AIHA Policies—2001 Fundamental Changes—Why? ISO 17025 Continued: Adaptation Improvement How do changes affect my laboratory?

3. AIHA 2001 Policies The Program What’s new?

4. The Site Assessment What new elements will the Site Assessor consider and evaluate?

5. The New Policies: What to Do? Organize in accordance with requirements Sometimes no written policy document is required

6. Language “Shall”—You must do it “Should”—You do not have to do it Compare: “Shall include” “Shall ensure” Include—Look for an item Ensure—Look for performance

7. Language Consider these phrases: “when feasible” (2.7.10) “where appropriate” (2.7.5) “where needed” (2.7.16.3) “if appropriate” (2.7.14) “where applicable” (B.4.4.1) “when necessary for interpretation” (2.7.9.4) How does one interpret these?

8. Two Essential Considerations Practices:Establish systems of execution and record keeping Policy:If required--write brief, new Standard Operating Procedures or Directives

9. New Primary Issues of Concern Communication with Clients Candidates for Modified or New SOPs Expanded Lists of Specific Requirements Uncertainty Associated with Test Results

10. Client Communication General (2.7.12.1, 2.7.12.3) Analytical Methodology (2.6.2) Problems (2.7.6.4) Subcontracting (2.7.6.7) Notification of Corrective Action (2.7.11.2) SOP

11. SOPs Do I need a new SOP? Do I need a modified SOP?

12. SOPs (Candidates to Consider) Equipment or Materials Used at a Location Other than the Primary Facility (2.4.6, 2.4.9, 2.4.10, 2.7.7.4)

13. SOPs (Candidates to Consider) Protection of Data— Accuracy/Integrity/Confidentiality (2.4.11)

14. SOPs (Candidates to Consider) Use of Non-Standard Methods (2.6.4) Deviations from: Methodology (2.6) SOPs Sampling Plans (where relevant) (2.7.5)

15. SOPs (Candidates to Consider) Procurement General (2.7.8) Reagents and Standards (2.7.7, 2.7.7.1) Use of Subcontractors (2.3, 2.7.9.4)

16. SOPs (Candidates to Consider) Management Review and Preventive Action (2.7.11.3, 2.7.11.4, 2.7.14)

17. Uncertainty in Test Results Uncertainty Policy and Procedures for Estimation of Uncertainty of Measurement (2.7.10) Identification and Estimation of Components of Uncertainty (2.7.10.7) Factors of Influence (2.7.9.2) Reporting (2.7.9.4)

18. Resources (Uncertainty) EURACHEM/CITAC Guide NIST Technical Note 1297 Environmental Testing & Analysis November/December 2000 Thomas Georgian

19. Program Modifications Additional elements have been added to previous requirements

20. Expanded Requirements Equipment descriptions and logs (2.4.4) Name and unique identifier Manufacturer name Model number Serial number Location

21. Expanded Requirements Records of Validation of Computer Programs (2.4.11)

22. Expanded Requirements Quality Assurance Manual (2.7.1) Three Specific Additions Procurement Preventive Action (Management Review) Client Communications

23. Expanded Requirements Review of test data (2.7.9.1) Correlation of results for more than one parameter (same sample)

24. Expanded Requirements Final Report of Results (2.7.9.4) Unique identification of report on each page Clear identification of the end of the report Documentation of condition of test samples Statement that results relate only to the items tested (where relevant) Note (as applicable) that results are not relevant to AIHA Accreditation Subcontractor results clearly identified

25. Expanded Requirements Policy pertinent to amended reports (2.7.9.5) Quality Control Data Records (2.7.10.6) Monitor Trends Policy Charts

26. Expanded Requirements Internal Audits (2.7.11.1, 2.7.11.2) Policy and Procedures Schedule Verification of Adherence to SOPs and Other Directives (AIHA; ISO 17025) Documentation of Results Documentation of Resolution

27. Corrective Action (2.7.13) A core element of success Policy and Forms (Documentation) Resolution and Closure Follow-up

28. Corrective Action --Preventive Action What is the difference?

29. IHLAP and ELLAP Dates of authorization to perform specific tasks (B.3.2.1 and C.3.2.1)

30. IHLAP Reporting Limits (B.4.3.3) Verified annually or with modification of method or procedures Matrix specific MDL study or processing of a media- spiked sample through the entire analytical scheme (preparation and instrumental analysis)

31. IHLAP Instrument Performance at the Reporting Limit (B.4.3.4) A calibration standard processed at the reporting limit Each analytical batch

32. ELLAP Reporting Limits (RLs) (C.4.1) RL (greater than or equal to: 2MDL For paint and soil: RL must be less than 20% of the relevant regulatory limit For dust wipe samples: RL must be less than 50% of the relevant regulatory limit

33. ELLAP Wipe sampling media— ASTM E 1792 Specifications MDL Studies (C.4.3) Recognition of Results (C.4.4)

34. ELLAP Reporting Limit Verification (C.4.10, C.5.6) Matrix spike at the reporting limit Each day of analysis Results must be +/-20% of target

35. ELLAP Assessment of Accuracy and Precision for Wipe Samples and for Filter Samples (Air) (C.5.3) MS/MSD—Spiked Blank Medium Solid material must be used for spiking Material must be traceable to NIST or similar organization (CRM)

36. ELLAP Laboratory Control Samples (C.5.5) Matrix-matched to samples Source is independent of calibration standards and traceable to NIST materials or other similar reference material Liquid spikes are not permitted except for filter (air) samples Frequency: 5% of workload

37. Goals of the Laboratory Meet the Requirements of the Client Meet the Requirements of the Laboratory Accreditation Organization (AIHA) Provide a Stimulating Work Environment