Forum FM308: Policy Changes Tuesday June 5 10:00 a.m.

1. Forum FM308: Policy ChangesTuesday 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