2010 PNCWA Conference Bend, OR

Transcription

1 2010 PNCWA Conference Bend, OR

2 Built in 1964,1971,1988, 1999, 2007, 2010

3 EPA Proposed Method Update Rule New Approved Methods and new versions of Old Approved Methods Revised Table of Holding Times and Preservatives (Table II takes precedence over all other methods, etc.) Change to Most Recent Standard Methods Edition New requirements for QA/QC

4 Standard Methods Citations: EPA has approved more than one version of a Standard Method leading to inconsistencies in quality assurance/quality control (QA/QC) practices. EPA is proposing to approve only the most recent version of a method by listing only one version of the method with the year of publication designated by the last four digits in the method number

5 Holding Times and Preservation Coliforms, Total, Fecal and E. coli PA, G Cool, <10 C, 0.008% Na2S2O3 8 hours (see note 22) Sample analysis should begin as soon as possible after receipt; sample incubation must be started no later than 8 hours (2 + 6) from time of collection.

6 Required QA and QC I. Proposed New Quality Assurance and Quality Control Language at 40 CFR EPA is proposing to specify essential quality control at Part for use in conducting an analysis with an approved method and when insufficient instructions are contained in an approved method

7 Required QA and QC In addition to and regardless of the source of the laboratory s QA and QC instructions, EPA is proposing at to specify twelve essential quality control checks that must be in the laboratory s documented quality system unless a written rationale is provided to explain why these controls are inappropriate for a specific analytical method or application.

8 Required QA and QC This written rationale will be included in the laboratory s Standard Operating Procedure (SOP) for each method to which specific controls do not apply.. as well as being included with the monitoring data produced using each method. These twelve essential quality control checks must be clearly documented in the written SOP (or method) along with a performance specification or description for each of the twelve checks.

9 Essential QA/QC Elements (1) Demonstration of Capability (DOC); (2) Method Detection Limit (MDL); (3) Laboratory reagent blank (LRB), also referred to as method blank; (4) Laboratory fortified blank (LFB), also referred to as a spiked blank, or laboratory control sample (LCS); (5) Matrix spike, matrix spike duplicate, or laboratory fortified blank duplicate (LFBD) for suspected difficult matrices; (6) Internal standards, surrogate standards (for organic analysis) or tracers (for radiochemistry);

10 Essential QA/QC Elements (7) Calibration (initial and continuing), initial and continuing performance (ICP) solution also referred to as initial calibration verification (ICV) and continuing calibration verification (CCV) (8) Control charts (or other trend analyses of quality control results); (9) Corrective action (root cause analyses); (10) QC acceptance criteria; (11) Definitions of a batch (preparation and analytical); and (12) Specify a minimum frequency for conducting these QC checks.

11 Essential QA/QC Elements Quality Control is not the same as Quality Assurance. QA is the larger system designed to see that QC is maintained. (QC is only one part of QA) QA asks if we are doing the right things. (QA is related to laboratory operation.) QC asks if we are doing things right. (QC is directly related to a sample s data.)

12 Effect on PNCWA Members? Washington DOE accreditation program Idaho No WW lab accreditation Lab analysts can be licensed Oregon No WW lab accreditation mandatory

13 Newest Development in Lab Management: The NELAC Institute s 2009 Laboratory Standard Based on ISO Standard 17025: General Requirements for the Competence of Testing and Calibration Laboratories

14 WHO IS TNI? A 501(c)3 non profit organization. A member organization managed by a Board of Directors. A voluntary consensus standards development organization accredited by the American National Standards Institute (ANSI).

15 TNI History SDWA Certification Program CLP De-facto National Program NELAC Restructure Explore Self Sufficiency s State Programs expand into other media 2003 NELAC Standard The NELAC Institute

16 WHAT DOES TNI PROVIDE? Infrastructure for stakeholders Consensus building for establishing requirements for: Organizations that accredit Organizations that are accredited Proficiency testing programs Recognition of organizations that operate accreditation programs Assistance to members and others

17 CONSENSUS Federal Agencies must use voluntary consensus standards except where inconsistent with law or otherwise impractical Policy applies to all Federal government, including test procedures

18 TECHNICAL ASSISTANCE Quality Manual Template Small Laboratory Advocacy Group Consultant Listing Accreditation Roadmap Training Courses Assessment Forum Mentoring Sessions

19 WHAT DOES TNI NOT DO? Accredit laboratories Resolve disputes between laboratories and their Accreditation Bodies Interpret questions on methods

20 TNI CORE PROGRAMS Consensus Standards Development Program National Environmental Laboratory Accreditation Program (NELAP) National Environmental Field Activities Program (NEFAP) Proficiency Testing Program

21 FUNDAMENTAL CONCEPTS TNI develops consensus standards that are voluntarily adopted by states agencies designated as accreditation bodies (ABs). State ABs grant accreditation, which is unconditionally recognized, by other participating ABs. Laboratories can voluntarily apply to any approved NELAP AB, if their home state does not participate.

22 NELAP ABs NELAP Accreditation Body Application Being Processed Working on Program/Application Require Program Recognize Program Incorporated Program Components

23 2003 STANDARD One Big Document = One Standard Constitution and Bylaws Chapter 1: Program Policy & Structure Chapter 2: Proficiency Testing Chapter 3: On Site Assessment Chapter 4: Accreditation Process Chapter 5: Quality Systems Chapter 6: Accrediting Authority

24 The 2003 STANDARD STRENGTHS: Requires conformance to EPA mandated methods, but otherwise allows flexibility in meeting requirements, Allows for multiple Accreditation Bodies to implement consistently, Appropriate level of proficiency testing, and Includes data integrity component missing from

25 The 2003 STANDARD WEAKNESSES: Refers to an organization that no longer exists, Hard to find all the laboratory requirements, Written by chemists for chemists, Some language could be improved, Not a true consensus standard. Only Government agencies had a vote, not laboratories.

26 THE NEW NELAP STANDARDS Four Small Volumes = Four Standards Volume 1: Requirements for Laboratories 7 Modules Volume 2: Requirements for Accreditation Bodies 3 Modules Volume 3: Requirements for PT Providers Volume 4: Requirements for a PT Provider Accreditor

27 VOLUME 1 Everything a lab needs to know (in 60 pages) Proficiency testing (Module 1) Personnel requirements (Module 2) Quality systems (Module 2) Technical requirements (Modules 3 7) Chemistry Microbiology Toxicity Radiochemical Asbestos

28 PROGRAM IMPLEMENTATION 2010 Training and outreach 2010 Guidance, checklists, etc New Quality Manual template July 1, 2011 Replace NELAC 2003.

29 THE NEW STANDARDS

30 DISCUSSION BOARD

31 QUALITY SYSTEM

32 Quality System The means by which a laboratory ensures the quality of its services: Policies and Objectives Procedures and Practices Organization Responsibilities Performance Measures V1M2

33 QUALITY MANUAL New TNI Template available early Not ready quite yet? Small Laboratory Handbook (Summer 2011)

34 Quality System: Module 2 Section 3.0 has definitions for 10 of the 12 Essential QC elements Control charts and Frequency not defined. Section 5.9 explains essential quality control V1M2

35 Module 4: Chemistry

36 TECHNICAL MODULE KEY ELEMENTS 1.4 Method Selection 1.5 Method Validation LOD and LOQ explained 1.6 Demonstration of Capability 1.7 Technical Requirements Calibration (ICV,CCV, etc.) Quality Control (Blanks, Controls, Spikes.etc.) Data Acceptance/Rejection Sample Handling

37 1.6.1 DOC: GENERAL Initial DOC is required for all methods and analysts, except for methods in place for one year before applying for accreditation. Initial DOC required if change in instrument, method or personnel Ongoing DOC is required. Records maintained V1M3 M7

38 1.7 CALIBRATION Initial Calibration Comparable to NELAC Low standard must be at or below LOQ Minimum number of points changed to 3 Continuing Calibration Virtually identical to NELAC V1M4

39 1.7 QUALITY CONTROL No change from NELAC Appendix D.1 Reorganized with evaluation criteria as a separate section Method Blank LCS MS/MSD MD Surrogates For failed surrogates, must qualify data (was a should ) V1M4

40 Module 5: Microbiology

41 M5 Microbiology 1.4 Method Selection 1.5 Method Validation Defines Accuracy, Precision and Selectivity 1.6 Demonstration of Capability Use of 4 aliquots plus other techniques 1.7 Technical Requirements Microbiology specific QC explained Positive & Negative controls Sterility Checks V1M5

42 1.6 INITIAL DOC Much more detail One acceptable approach described Other approaches acceptable Acceptable approach 4 aliquots; calculate recovery and SD, or For P/A tests, assess against criteria For qualitative tests, blind study with blank, negative and positive V1M5

43 1.6 ON GOING DOC Acceptable approaches One spike sample, or One duplicate set of analyses, or One PT sample, or Analyst review of QC samples

44 SUMMARY New TNI Standard is the most comprehensive set of requirements for environmental lab operation. Covers all 12 of EPA s essential QC elements See Standard Methods for Control Charting Consult specific methods for Acceptance Criteria and QC Frequency Other TNI resources: QM Template Small Lab Handbook Website

45 SUMMARY Standard Methods still good source for methodspecific information, but Will be necessary to subscribe to Online Version to get latest approved versions. QC information not as clearly explained as in TNI Standard.

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47 SLAG: Small Lab Advocate Group Keith Chapman TNI Small Laboratory Advocate 5915 Windsor Island Rd. N., Salem, OR

48 Contact TNI Jerry Parr The NELAC Institute PO Box 2439 Weatherford, TX institute.org institute.org

49 Small Laboratory Handbook

50 Small Laboratory Handbook

51 Questions?