Accreditation Body Application and Evaluation Adapted from Daniel Hickman’s 2008 version to include the 2009 TNI standard 1
Overview ¨ ¨ ¨ ¨ 2 NELAP Accreditation Council (AC) Accreditation Body Application Evaluation Team Onsite Evaluation Observation of Laboratory Assessment Reports and Responses Final Recommendation Vote by NELAP AC 2
NELAP Accreditation Council Mission Statement: To implement a national program for the uniform and consistent accreditation of environmental laboratories 3 3
NELAP Accreditation Council The purpose of the National Environmental Laboratory Accreditation Program (NELAP) is to establish and implement a program for the accreditation of environmental laboratories. The primary components of this program are: Ø Ø Ø 4 The recognition of accreditation bodies, The adoption of acceptance limits for proficiency testing developed in the Proficiency Testing (PT) Program, and The adoption of the laboratory accreditation system developed in the Laboratory Accreditation System (LAS Executive Committee). 4
NELAP Accreditation Council ¨ ¨ ¨ 5 One representative and one alternate from each NELAP-recognized Accreditation Body (AB) Each representative and alternate is officially appointed by AB to represent their state program A chairperson is selected by the members of the NELAP AC Program administrator to help with administrative functions Meets on 1 st and 3 rd Mondays at 1: 30 pm eastern 5
NELAP Accreditation Council ¨ Member ABs Ø Ø 6 Agree to grant accreditation to any laboratory with NELAP primary accreditation from another NELAPrecognized Accreditation Body ª Laboratory must apply for secondary accreditation to additional ABs ª Secondary AB must grant all Fields of Accreditation from primary certificate applied for and included in the secondary AB’s recognition ª Secondary AB may not ask for additional documentation or require laboratories to meet additional standards Provide representative for AB evaluation process 6
NELAP Accreditation Council ¨ Discussion topics include: Ø Ø Ø 7 Consistency of assessment Implementation issues Evaluation process and SOP Vote on recognition recommendation Self-sufficiency and fees 7
Process Overview ¨ ¨ ¨ ¨ 8 Submit Application Package Completeness Review Technical Review Onsite Evaluation Onsite Report and Recommendation Lab assessment observation (delayed) Final Report Evaluation Team recommendation to AC 8
AB Application ¨ Download documents located on NELAP Accreditation Council page of TNI website Ø Ø Ø 9 TNI Accreditation Body Application TNI Fields of Accreditation Spreadsheet Recognition Flowchart TNI SOP for the Evaluation of Accreditation Bodies TNI Application Completeness Checklist TNI Checklist to Determine Accreditation Body Compliance (Technical Review) 9
Completing the AB Application ¨ ¨ ¨ ¨ 10 Check the appropriate application type. Enter the Accreditation Body name as you want it displayed on the recognition certificate. Enter the Accreditation Body mailing address. Enter Accreditation Body Phone, FAX and general Email. Identify the Accreditation Body program manager and provide contact information. Identify the Accreditation Body Quality Assurance Officer and provide contact information. List the Accreditation Body staff, their area of responsibility, education, experience, and most recent NELAP assessor training. 10
Completing the AB Application, cont’d ¨ ¨ ¨ 11 Provide names and contact information for contractors to be used by the program The list of Laboratories is only used for renewal applications. You can skip this page Identify all individuals authorized to sign Laboratory Accreditation Certificates List normal business hours Be sure that the person responsible for laboratory accreditation signs document Attach spreadsheet denoting requested areas of NELAP recognition. (Technology/Matrix table) 11
Fields of Recognition Technology Description Amperometric Titration Alpha Spectrometry Alpha Scintillation Cell Counter Anodic Stripping Voltammetry Auto Analyzer Beta Spectrometery Beta/Gamma Coincidence Scintillation Counter Toxicity Testing Chromofluorogenic-Qualitative Chromofluorogenic-Quantitative Conductance Coulometric Titration Chromogenic/MPN-Quantitative Chromogenic/Quantitray Atomic Absorption-Cold Vapor Spectrometry Atomic Fluorescence - Cold Vapor Spectrometry Atomic Emission - Direct Current Plasma Spectrometry Differential Pulse Polarography Atomic Absorption - Flame Spectrometry Atomic Emission - Flame Spectrometry Fermentation Broth(A-1)-Quantitative Fermentation Broth+Fluorogenic-Qualitative 12 Drinking Water X X X X X X Non-Potable Water X X X X X X Solids and Chemical X X X Air X X X Tissue X X X X X 12
Completing the AB Application, cont’d ¨ ¨ ¨ 13 Copies of the statutes and regulations establishing and governing the accreditation body’s environmental laboratory accreditation program. Copies of the policies, guidance documents, and SOPs governing the operation of the accreditation body’s environmental laboratory accreditation program. Provide documentation on how the AB restricts the use of its accreditation by accredited laboratories. Copy of the Quality Systems Manual The procedures for selecting, training, contracting and appointing assessors. A description of the AB’s conflict of interest disclosure program. 13
Completing the AB Application, cont’d ¨ Complete Checklist to Determine Accreditation Body Compliance. Ø Answer all 403 questions on 36 pages by checking Y, N, or N/A. ª ª Ø Ø ¨ 14 There should be very few N/A Every “N” will likely be identified as a deficiency during the technical review. For every “Y” indicate the document supporting your answer and identify exact location in the document. List multiple documents if necessary Send this completed checklist as part of the Application Package. 14
AB Application ¨ Send application with receipt confirmation to: Jerry Parr, Executive Director The NELAC Institute P. O. Box 2439 Weatherford, TX 76086 ¨ ¨ ¨ 15 Letter acknowledging receipt sent to AB Application forwarded to Evaluation Coordinator Any questions about process should be sent to Lynn Bradley, NELAP Program Administrator and Evaluation Coordinator: [Lynn. Bradley@nelac-institute. org] 15
Evaluation Coordinator (EC) ¨ ¨ 16 Assists the evaluation team by assuring all communications between the evaluation team and the AB, and between the evaluation team and the NELAP AC occurs in a timely manner. Tracks and documents that all aspects of AB evaluations are performed in a timely manner in conformance with the SOP for Evaluation of Accreditation Bodies. Reviews the AB application for completeness, with concurrence of Lead Evaluator (LE). Reviews the evaluation reports for completeness and consistency according to the Evaluation SOP and 2009 TNI Standard. 16
Evaluation Team State Accreditation Body representative (generally serves as the lead evaluator) ¨ Quality Assurance Officer (accompanies Team for on-site visit) ¨ One EPA member, probably from the EPA region in which the AB is located, or a third party evaluator contracted by TNI ¨ Possibly additional evaluator if large AB ¨ All members work under the direction of the Lead Evaluator Evaluation Coordinator monitors progress but is not part of the evaluation team ¨ 17 17
Evaluation Team ¨ ¨ 18 All evaluation team members must meet minimum requirements for training and professional qualifications (see the SOP. ) The lead evaluator (and preferably all team members) must successfully complete the NELAP accreditation body evaluator training course. All members of the evaluation team must sign the conflict of interest certification. All evaluation team members must comply with the policies of the TNI NELAP AC and the SOP For Evaluation of Accreditation Bodies. 18
Lead Evaluator (LE) ¨ Generally responsible for planning activities Ø Ø ¨ ¨ ¨ 19 Team coordination Scheduling Provides direction to the evaluation team throughout the evaluation process The LE is responsible for obtaining consensus of the evaluation team for the final recommendation of AB recognition status to the NELAP AC. The LE reviews and approves all reports sent to the AB. 19
Quality Assurance Officer (QAO) ¨ ¨ The QAO assures all AB evaluations are performed in a consistent manner in conformance with the Standard Operating Procedure for the Evaluation of Accreditation Bodies. Reviews the following aspects of the AB evaluation process: Ø Ø Ø ¨ ¨ 20 technical review of the AB application; on-site evaluation of the AB; review of the AB’s corrective action plans; Informs NELAP AC of any unresolved consistency problems as they occur and provides report to NELAP AC at completion of each AB evaluation. Submits Standard Interpretation Request (if needed) 20
Completeness Review ¨ ¨ Upon receipt, application is transferred to the Evaluation Coordinator, who then has 30 days to complete the Checklist for Application Completeness. If the EC identifies missing information, an Application Completeness Deficiency report is sent to the AB. The AB has 30 days to submit missing documentation, though they can request a 30 day extension. The Lead Evaluator is notified of the application completeness status. Ø Ø 21 If additional material is needed to complete application, LE notifies the AB applicant If application is complete, LE notifies AB and initiates Technical Review 21
Technical Review ¨ ¨ ¨ 22 The Evaluation Team must complete a technical review of the application package and issue technical review report within 30 days. The AB must respond with a corrective action plan addressing all deficiencies within 30 days of receipt. The Evaluation Team must complete review of the corrective action plan and issue review report within 30 days of receipt. If deficiencies remain, the AB has 30 days to address these remaining deficiencies. The Evaluation Team must review the 2 nd corrective action plan and send report within 30 days of receipt. 22
Technical Review ¨ ¨ 23 If no deficiencies were identified during the technical review or if all the deficiencies have been appropriately addressed in corrective action plan(s), the LE will schedule the onsite evaluation. If application deficiencies remain after the 2 nd corrective action plan, the Evaluation Team will recommend to the NELAP AC that the application for recognition be denied. 23
Onsite Evaluation ¨ ¨ ¨ 24 An onsite management review (ISO 17011) is required initially and every three years. Once the evaluation team determines that the documentation is satisfactory and the application is accepted, the AB will be notified within 30 calendar days to schedule the on-site evaluation. An on-site evaluation will be conducted within 60 days of completion of the application technical review, at the mutual convenience of the evaluation team and the AB. 24
Onsite Evaluation ¨ The LE sends written confirmation to the AB of the logistics required to conduct the evaluation including: Ø Ø 25 onsite evaluation date and agenda or schedule of activities, copies of the standardized evaluation checklists, the names, titles, affiliations, and on-site responsibilities of the NELAP evaluation team members, and the names and titles of AB staff that need to be available during the on-site evaluation. 25
Onsite Evaluation ¨ 26 The evaluation team conducts a comprehensive evaluation of the AB’s accreditation program to determine the accuracy of information contained in the AB application and the AB’s conformance to the TNI Standard. The evaluation team will do this by: Ø interviewing management and technical staff (AB lab assessors) and reviewing documentation to determine if corrective actions were taken to address deficiencies noted in the technical review. Ø reviewing the training records and conducting interviews of AB staff designated as qualified assessors to evaluate their training. 26
Onsite Evaluation ¨ The evaluation team has 30 days to prepare and send findings of the on-site evaluation to the AB. Ø ¨ ¨ ¨ 27 (Note – The AB evaluation is not considered complete until the on -site evaluation and laboratory assessment observation are complete. ) The AB must respond to the onsite report with a plan of corrective action within 30 days. The Evaluation Team must review and respond to the corrective action report within 30 days. The AB must respond to that corrective action review report with another plan of corrective action within 30 days. 27
Onsite Evaluation ¨ ¨ 28 If the AB addresses all the deficiencies, the LE will recommend to the NELAP AC that the AB be granted NELAP recognition. The NELAP AC then reviews the evaluation report and associated documentation and votes on recognition status. NELAP AC issues the Certificate of Recognition, including fields of recognition, valid for three years. The AB or Evaluation Team has the right to appeal the final decision. 28
Onsite Evaluation Need current image 29 29
BECOMING A NELAP-RECOGNIZED ACCREDITATION BODY What do you need to do? Adapted from presentation by Kenneth W. Jackson, 2008 30
Today’s Discussion 1. The management and quality systems the potential Accreditation Body (AB) must have in place 2. Will discuss the “what”, not the “how” 3. Will refer to: § § 31 The Application Completeness Checklist (ACC) The Checklist to Determine AB Compliance (CABC)
Essential Requirements 1. Statute and enabling regulations (ACC 2) § § Must have regulations to comply with the TNI/NELAP standards and enforce them § 32 The AB must have statutory authority to grant, deny, suspend and revoke accreditation Regulations must authorize the AB to grant secondary accreditation based on the primary accreditation granted by any other NELAP AB
Essential Requirements, cont’d 2. Fully documented management and quality systems (ACC 3, 10, 16, 17) § § Quality Systems Manual (ACC 10). (include: policy statement; document control; organizational chart; etc. ) § Policies and Procedures for maintaining well documented and orderly lab files (ACC 16) § 33 All SOPs and guidance documents for program operation (ACC 3). Internal audit reports and corrective actions (ACC 17)
Essential Requirements, cont’d 3. Personnel (ACC 7, 8, 12) § Program manager § Quality Systems Officer § 34 Trained assessors (assessor files must have quals, internal and external training; Note: recent NELAP ruling that basic and technical training requirements must be met within one year)
Assuring all Requirements are in Place The TNI Standard Volume 2, Modules 1 and 2, includes requirements for ABs. The AB requirements (403 of them!) are also reflected in the “Checklist to Determine Accreditation Body Compliance” (Compliance/Technical Review Checklist) The TNI Standard Volume 1 includes requirements for Laboratories The TNI Standard Volume 3 includes requirements for PT providers The TNI Standard Volume 4 includes requirements for PT provider accrediting bodies 35
The AB Requirements The 403 items in the Compliance Checklist are grouped as follows: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 36 Accreditation Body: Legal Responsibility and Structure (1 -15) Impartiality and Confidentiality (16 -21) Liability and Financing (32 -33) Accreditation Activity (34 -36) Management – General (37 -38) Management System (39 -46) Document Control and Records (47 -56) Non-Conformities, Corrective Actions, and Preventive Actions (57 -70) Internal Audits and Management Reviews (71 -98) Complaints (99 -104) Human Resources – Personnel Associated with the Accreditation Body (105 -109)
The AB Requirements, cont’d 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 37 Personnel involved in the Accreditation Process (110 -118) Monitoring and Personnel Records (119 -131) Accreditation Process – Accreditation Criteria and Information (132 -143) Application for Accreditation, and Resource Review (144 -152) Subcontracting the Assessment (153 -160) Decision-Making and Granting the Accreditation (161 -182) Appeals (183 -188) Reassessment and Surveillance (189 -195) Extending, Suspending, Withdrawing, or Reducing Accreditation (196 -207) Proficiency Testing and Other Comparisons of CABs (208 -210) Obligations of the CAB (accredited environmental testing laboratory) (211 -224)
The AB Requirements, cont’d 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 38 Obligations of the Accreditation Body (225 -232) Reference to Accreditation and Use of Symbols (233 -241) Proficiency Testing – Accreditation Body Requirements (242 -252) Proficiency Testing – Requirements for Accreditation (253 -262) Requirements for Assessment of PT Sample Analysis (263 -272) Requirements for Assessment of Final PT Evaluation Reports (273 -278) Requirements for Assessment of Corrective Action (from Failed PT Attempts) (279 -283) Requirements for Complaint Resolution (284 -285) Suspension or Revocation of Accreditation (287 -292) On-Site Assessment Human Resources – General Provisions (293 -297) Education and Training Requirements for Assessors (298 -310)
The AB Requirements, cont’d 34. 35. 36. 37. 38. 39. Records on Assessors (311 -321) Standards of Professional Conduct for Assessors (322 -333) Frequency of On-Site Assessments (334 -335) On-Site Assessment Process Resource Review (336 -339) Preparation for Assessment (340 -360) Assessment Activities (361 -370) NOTE: items 353 and 360 -370 are answered during the evaluator’s observation of an assessor performing a laboratory assessment. 40. Reporting Procedures (371 -389) 41. Reassessment and Surveillance (390 -397) 42. Changes in CAB (Environmental Laboratory) Capabilities (398 -403) 39
Summary The AB must have a Quality Manual, Policies and Procedures addressing the following: 1. § § § Document control Organizational Structure Records control Contracting Complaints Lab Application Review Assessor Training and Oversight On-Site Assessment Deficiency Review On-Site Assessment Corrective Action Review On-Site Assessment Follow-up and Administrative Action Internal Quality Audit - and more! If you do it, it must be documented 40
Summary, cont’d The AB must have a fully documented file (electronic and/or hardcopy) on each accredited laboratory 2. § § § § 41 Application forms Documentation that Technical Director qualifications have been verified (primary accreditation) PT data On-site assessment checklists Corrective action reports Correspondence Copies of certificates of accreditation etc.
Summary, cont’d 3. 4. The Technical Review: “Tell me”. Does the AB have all essential documentation in place? The On-Site Evaluation “Show me”. Is the AB doing in practice what its documentation says it must do? (It is recognized that many functions will not be implemented until the AB starts accrediting labs) Note: the AB will be held to following its SOPs even if they exceed the requirements of the TNI Standard. 42
Next Steps This presentation describes WHAT the AB must do. NELAP can make available mentoring, i. e. , HOW to do it If you are considering becoming a NELAP AB, contact either: the NELAP Accreditation Council Chair, Aaren Alger, <aaalger@state. pa. us> the NELAP AC Program Administrator, Lynn Bradley, <lynn. bradley@nelac-institute. org> TNI’s Executive Director, Jerry Parr, <jerry. parr@nelac-institute. org> 43
NELAP wants YOU as an AB, and we are here to help. The ABs collectively have about 8 -9 decades experience in running NELAP accreditation programs, and most have gone through the application process 4 times. They can help and share experiences (mistakes and successes). 44
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