SDWA “Laboratory Quality Assurance Plans” & NELAP/TNI “Laboratory Quality Manuals”

1. SDWA “Laboratory Quality Assurance Plans” & NELAP/TNI “Laboratory Quality Manuals” Joseph Slayton USEPA, OASQA ESC, Ft. Meade, MD 410-305-2653 Slayton.joe@epa.gov

2. Outline: • Purpose. • Definitions. • Background. • Components of a Laboratory Quality Assurance Plan (SDWA Certification Manual). • Comparison to Components of a Laboratory Quality Manual (NELAP/TNI). • Other Key QA/QC Items. • Summary.

3. Purpose Emphasizing Drinking Water but Applicable to All Programs • To Provide Managers & Analysts Information for Development of Useful, Accurate and Complete Focal Document/s for their “Formal Laboratory Quality Control Program”.

4. Definitions • Quality Assurance:an integrated system of management activities [Policies] involving planning, quality control, quality assessment, reporting and quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence, (CLADW Appendix C). Plan Do Check Act

5. Definitions • Quality Control: the overall system of technical activities whose purpose is to measure and control the quality of a product or service so that it meets the needs of users, (NELAC Glossary).

6. Definitions • Manual for the Certification of Laboratories Analyzing Drinking Water, Criteria and Procedures Quality Assurance (CLADW), 5th edition, EPA 815-R-05-004, January 2005: = Adopted as Requirements for Laboratories by State Certification Authorities. = Laboratory Quality Assurance Plan: A Written Description of a Lab’s Quality Assurance Policies and QC Activities (Formal QC Program).

7. Background • Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006, June 2008: http://www.epa.gov/ogwdw/methods/pdfs/ manual_labcertification_supplement_5th-ed.pdf = Requirementfor a “Formal Quality Control Program”.

8. Region 3 SDWA Certification Programs Bottom Line: Region 3 Lab Cert. Programs are to Require a Written QAP/QM: = to Document a Lab’s “Formal QC Program”. = Content Should be as per CLADW or NELAP.

9. Background: NELAP “Option” • National Environmental Laboratory Accreditation Conference (NELAC) Standards, June 5, 2003 (Effective July 1, 2005). = An EPA Publication Listing the Requirements for Laboratory Accreditation for the Analyses of Drinking Water (DW), Non-Potable Water, Air and Emissions, etc. = 10/20/97 & 10/1/02 & 2009? Director EPA’s OGWDW Supports Use of NELAC Standards for DW Lab Certifications. Appendix F of the CLADW.

10. Background: NELAP “Option” • The NELAC Standards will be Replaced by the NELAC Institute (TNI) Standards when Adopted by the National Environmental Laboratory Accreditation Program (NELAP), State Authority Programs in 2010. http://www.nelac-institute.org/ • Laboratory Quality Manual: Document Stating Management Policies, Objectives, and Principles to Ensure the Quality of its Product and the Utility of its Product to its Users.

11. LAB QA Plan (LAB QAP) or Quality Manual (QM)Fundamentals: • Written. • Include Lab’s Policies & Do WHAT YOU SAY. • Maintain the Document: State Frequency of Review and Revision. • Have a “Keeper” e.g., QAO/QA Manager. = Responsibility Clearly Defined.

12. LAB QAP/ QMFundamentals: • Contents Known by All Lab Personnel: = Should have Signed Statements, e.g., “I have read and understand the laboratory’s QA Plan/Quality Manual”. = Clear, Brief, Concise. = Useful, Helpful Tool.

13. LAB QAP/ QMFundamentals: • Table of Contents = Hyper Text is COOL! • .DOC not .PDf to Allow Searches“Edit /Find”. • Readily Available” = Official Hardcopy & Electronic Locations.

14. LAB QAP/ QMFundamentals: • Content: Focus on Policies (Global/LAB-WIDE Decisions) Include a Quality Policy Statement, e.g., “…provide data of known & doc. quality that meets the needs of our customers…”. Consider having Detailed Procedures of QC Program in : = Attachments . = Reference Other Documents (e.g., “Administrative SOPs”).

15. LAB QAP/ QMCLADW& NELAC Topics • Organization (11.1): =Lines of Responsibility/Authority. =Highlight Data Quality Activities. • Customer Request Review, Data Review, Internal Audits. • Signatory Authority (QAP/QM, SOPs, DOCs, Data Reports, etc.). • Reference Job Descriptions.

16. LAB QAP/ QMCLADW& NELAC Topics • Process to Review Customer Requests(11.2) = Emphasis Compliance with Mandatory Program Methods & CFR & CLADW Requirements: • QC. • Analytical Procedures. • Detection (MDL<QL<MCL). • Proficiency Testing (PTs). • DOC/IDP (Already Completed). • HT/Preservatives/Containers, etc. • Needed Work Force.

17. LAB QAP/ QMCLADW& NELAC Topics • SOPs (11.3): = Set a format/s (e.g., Administrative/Technical). = Set a Review Frequency. = Reference a List/s of SOPs (e.g., In Prep., Current, In-Revision, Archived w/ Dates Recorded). = Commit to Revisionw/ Significant Change (e.g., method and/or equipment and/or personnel that impacts detection, or accuracy or precision).

18. LAB QAP/ QMCLADW& NELAC Topics SOPs (11.3): • Detailed Procedures on Lab’s Formal QC Program: = Administrative SOPs (EPA G-6 Format), e.g., Preparation of SOPs, Manual Integration, PT Program, Support Equipment (Ovens, Thermometers, Analytical Balances, etc.), www.epa.gov/quality/qa_doc.html • Technical SOPs (NELAC 5.5.4.1.2, 23 topics including P2, Hz Waste & Safety).

19. LAB QAP/ QMCLADW& NELAC Topics • Field Sampling Procedures (11.4): = Specify Need for Written Sampling Procedures: • Documentation (Sampler ID, Station Location). • Preservation & Holding Time. • Shipping Procedures.

20. LAB QAP/ QMCLADW& NELAC Topics • Sample Receipt & Handling Procedures (11.5): = Documentation of Receipt (e.g., Bound Book/Data Base). = Unique Sample IDs. = Listing of Required HTs / Preservations. = Procedures for Checking Preservation &When & by Whom. = Procedures for Storage(e.g., Security, Isolation, Temperature Monitoring, etc.). = Sample Rejection Policy & Customer Input. = Chain-of-Custody (i.e., “when Enforcement Likely”).

21. LAB QAP/ QMCLADW& NELAC Topics • Instrument Calibration (11.6): • State the Frequency & Global QC Criteria for Calibration: = Acceptance Criteria for Initial (e.g., R, R2, RSD, Special for Quadratic—More Calibration “Points”, Tighter Fit). = Second Source Verification of Initial Calibration. = Continuing Calibration Verification (RPD). • Calibration/Verification of Performance of Support Equipment(e.g., Ovens, Thermometers, Balances, Ref. Wts., etc.). • Cal. Std. Shelf-Life Use Policy/ies (e.g., Method Listed, Manufacturer Listed, Use of Expired Materials).

22. LAB QAP/ QMCLADW& NELAC Topics • Analytical Procedures (11.7): = Reference SOP Collection /”Methods Manual”. = Emphasis Adherence to Mandated Methods.

23. LAB QAP/ QMCLADW& NELAC Topics • Data Procedures (11.8): = Reduction/Production (e.g., Reference Technical SOPs). = Verification/Procedures to Check Accurate Reporting (e.g., Checks on Software, Peer/QAO Data Review, Qualitative Identification). = Validation/Procedures to Check Customers DQOs (e.g., Check Final Data Report vs. Customer Request).

24. LAB QAP/ QMCLADW& NELAC Topics • Data Procedures (11.8): = Procedures for Data Corrections ** Line Thru/Initials/Date (Footnote?). ** Supplemental Reports). = Manual Integration(i.e., Manual Overriding of Instrument Software).

25. LAB QAP/ QMCLADW& NELAC Topics • QC Checks (11.9) What, Frequency, Acceptance Limits and Corrective Actions Set an Essential Set for All Analyses: = Accuracy(e.g., Blanks/Sterility Checks. QC Samples (2nd Source), Laboratory Control Samples/Lab Fortified Blank/Positive & Negative Controls, PTs, Matrix Spikes/Fortified Samples, DOCs/IDOC/IDP, etc.).

26. LAB QAP/ QMCLADW& NELAC Topics • QC Checks (11.9) What, Frequency, Acceptance Limits and Corrective Actions Set an Essential Set for All Analyses: = Precision (e.g., Laboratory Duplicates, MSDs…RPDs ). = Detection (e.g., QL Verifications, MDLs, Listing of MCLs).

27. LAB QAP/ QMCLADW& NELAC Topics • QC Checks (11.9) Acceptance Limitsof QC Checks Specify Source/s: = QC Charts. = Fixed from Mandatory Methods. = Fixed from Historical Data.

28. LAB QAP/ QMCLADW & NELAC Topics • Audits (11.10) • Reference Procedures & Schedules: = Internal Audits & Schedule (e.g., Managerial Review, QAO QS Review, Technical System Audits). = External Audits & Schedule (e.g., Corporate, State Certification On-site Inspections/Accreditation Body Assessments).

29. LAB QAP/ QMCLADW & NELAC Topics • Preventive Maintenance (11.11): = Procedures and Schedule/Frequency. = Location of Instrument Manuals (IMs). = Maintenance Contracts. = Records (e.g., Maintenance Logs ...should List IMs & Reference Run Logs).

30. LAB QAP/ QMCLADW & NELAC Topics • Corrective Actions Contingencies (11.12): • Unacceptable QC Checks (Including PTs): = Description of Procedures, Documentation & Responsibilities and Timelines. • “Root Cause Analysis”: Identification of Fundamental QC Program or Technical Reason.

31. LAB QAP/ QMCLADW& NELAC Topics • Corrective Actions Contingencies (11.12): • Corrective Action Plans to Avoid Reoccurrence in the Future. Adding Qualifier Codes on Data for Routinely Failed Sample Matrix Independent QC Checks is NOT a CA (Blanks, LCS, CCV…)! • Verification & Documentation of Implementation & Effectiveness (who, what, where, when).

32. LAB QAP/ QMCLADW& NELAC Topics • Records Management (11.13): • General Description of Policies & Reference to Administrative SOP if Complex Record System (e.g., R3-QA342 / 343). • Policies on: • Record Types. • Storage Length. • Storage Location/s & Labeling of Records. • Responsibility. • Access & Security & Procedures for Retrieval. • Hardcopy & Electronic Records. Bottom Line—Can You Locate the Document!

33. LAB QAP/ QMAdditional NELACTopics • Structure of QS Documentation (i.e., QM is core document), 5.4.2.3. • Additional Cover Page Details (e.g., List of Major Organizational Units Covered by QM), 5.4.2.3.

34. LAB QAP/ QMAdditional NELACTopics • Format for QM (e.g., Table of Contents, References, Glossary, Appendices), 5.4.2.3.v. • Verification of Detection Limits (C.3.1, LOD). • “Adequate” Technical Training e.g., successful DOCs/MDLs(5.4.2.3.t).

35. LAB QAP/ QMAdditional NELACTopics • Traceability of Measurements (5.4.2.3.g). • Listing of Major Equipment (Inventory) (5.4.2.3.l). • Lab Procedures to Check Capabilities/Capacities Prior to Accepting Work (5.4.2.3.i).

36. LAB QAP/ QMAdditional NELACTopics • Procedures for Customer Complaints (5.4.2.3.q). • Procedures for Customer Confidentiality (5.4.2.3.r). • Procedures to Assure Lab Personnel Receiving Needed Training—MUST Have Training Records.

37. LAB QAP/ QMAdditional NELACTopics • Data Integrity Procedures (5.4.2.6) More Details (BUT NOW IN CLADW Supplement 1): = Data Integrity Training & Documentation. = Signed Data Integrity Adherence Statements. = Monitoring of Data Integrity (e.g., Peer Review). = Yearly Review of Policies/Procedures. = Confidential Reporting Procedures.

38. Additional Differences NELAC/CLADW • Record/Doc. Control More Detailed: = Effective Date. = Signatory Authority. = Document Control Number. = Notebook Tracking System.

39. Additional Difference NELAC/CLADW • Fixed Technical SOP Content(i.e., 23 Topics via NELAC Including P2, Hz Waste and Safety). • Emphasis that SOPs are to be at where the Work is Performed. • More Details/Emphasis on Notebook & SOP Tracking and Assuring Older Versions Archived.

40. CLADW & NELAC Both Need • More Details on Electronic Data: = Instrument Data. = LIMS Data. = Good Automated Laboratory Practices (GALP). www.epa.gov/irmpoli8/ciopolicy/2185.pdf

41. Summary Laboratory, QA Managers & Analysts Be Proactive ! Maintain & Work to Continuously Improve Your Lab’s Formal QC Plan !

42. Definitions • Quality System: a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work preformed by the organization and for carrying out required QA and QC, (NELAC Glossary)