ML21252A494
| ML21252A494 | |
| Person / Time | |
|---|---|
| Issue date: | 09/15/2021 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | Christopher Regan NRC/NRR/DRO |
| Park D | |
| References | |
| Download: ML21252A494 (6) | |
Text
September 15, 2021 MEMORANDUM TO: Christopher M. Regan, Acting Director Division of Reactor Oversight Office of Nuclear Reactor Regulation FROM: Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
SUBJECT:
TRIP REPORT BY THE NUCLEAR REGULATORY COMMISSION STAFF OF THE REMOTE NUPIC EVALUATION OF APAC AND IAACS JOINT ASSESSMENT OF ANAB On March 8 - 12, 26, 31, and April 1, and July 8, 2021, Yamir Diaz-Castillo and Dong Park of the Office of Nuclear Reactor Regulation, Division of Reactor Oversight, Quality Assurance and Vendor Inspection Branch, observed the performance of a Nuclear Procurement Issues Corporations remote evaluation of the joint assessment by the Inter-American Accreditation Cooperation (IAAC) and the Asia Pacific Accreditation Cooperation (APAC) of the ANSI National Accreditation Board (ANAB) to the requirements of the International Standard Organization (ISO)/International Electrotechnical Commission (IEC) standard No. 17011, Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies, 2017 edition, and ISO/IEC No. 17025, General requirements for the competence of testing and calibration laboratories, 2017 edition.
The purpose of the NRC staffs observation was to evaluate the industrys oversight of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) accreditation process. This was the second NRCs observation of a NUPIC evaluation of the ILAC MRC accreditation process using the 2017 editions of ISO/IEC 17011 and ISO/IEC 17025.
CONTACTS: Yamir Diaz-Castillo, NRR/DRO/IQVB (301) 415-2228 Dong Park, NRR/DRO/IQVB (301) 415-0001 Signed by Kavanagh, Kerri on 09/15/21
ML21252A494 NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB
NAME DPark YDiaz-Castillo KKavanagh
DATE 09/13/2021 09/14/2021 9/15/2021 NUCLEAR PROCUREMENT ISSUES CORPORATION OBSERVATION TRIP REPORT
Accrediting Body Observed: ANSI National Accreditation Board (ANAB)
Laboratory Observed: Cummins Corporate Standards Laboratory (CSL) 500 Central Ave. & 1900 McKinley Ave.
Columbus, IN 47201
Scope of Supply: ANAB is a private organization that offers third-party accreditation services for calibration and testing laboratories. CSL is a commercial laboratory that offers calibration services for electrical, length, mass, thermodynamic, and time and frequency equipment.
Lead Licensee: Ameren Missouri (Union Electric Company)
Contact:
Earl Mayhorn Nuclear Procurement Issues Corporation Lead Auditor (314) 605-9701 emayhorn@ameren.com
Observation Dates: March 8 - 12, 26, and 31, 2021 April 1, 2021 July 8, 2021
Observers: Yamir Diaz-Castillo, NRR/DRO/IQVB Dong Park, NRR/DRO/IQVB
Approved by: Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
Enclosure Subject
This trip report documents observations made by members of the U.S. Nuclear Regulatory Commission (NRC), Office Nuclear Reactor Regulation, Division of Reactor Oversight, Quality Assurance and Vendor Inspection Branch, during a Nuclear Procurement Issues Corporations (NUPIC) remote evaluation of the ANSI National Accreditation Boards (ANAB) joint assessment by the Asia Pacific Accreditation Cooperation (APAC) and the Inter-American Accreditation Cooperation (IAAC) to the requirements of International Standard Organization (ISO)/International Electrotechnical Commission (IEC) standard No. 17011, Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies, 2017 edition, and ISO/IEC No. 17025, General requirements for the competence of testing and calibration laboratories, 2017 edition.
Background/Purpose
The NRC currently recognizes the International Laboratory Accreditation Cooperations (ILAC) accreditation process as an acceptable alternative to a licensees or suppliers commercial-grade survey as part of the commercial-grade dedication process for domestic and international laboratories that provide calibration and testing services for U.S nuclear power plants. In a safety evaluation dated November 23, 2020 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML20322A019), the NRC staff found that Revision 1 of the Nuclear Energy Institute (NEI) Technical Report 14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, (ADAMS Accession No. ML20259B731) provides an acceptable approach for licensees and suppliers of basic components for using the ILAC accreditation process in lieu of performing commercial-grade surveys as part of the commercial-grade dedication process.
This approach addresses procurement of calibration and testing services performed by domestic and international laboratories that are accredited to ISO/IEC 17025.
As described in Revision 1 of NEI 14-05A, NEI formed an industry team, consisting of licensees (including NUPIC members) and suppliers, to monitor ILAC activities as they relate to the nuclear industrys use of the ILAC accreditation process as part of the commercial-grade dedication process. NEI is a stakeholder member of ILAC as a liaison for the nuclear industry and provides to its licensee and supplier members access to ILACs information and activities.
NUPIC plays a central role in the continued oversight activities as a NUPIC member leads the observations of assessments of calibration and testing laboratories to the requirements of ISO/IEC 17025.
The purpose of the NRC staffs observation was to evaluate the industrys oversight of the ILAC accreditation process. This was the second NRCs observation of a NUPIC evaluation of the ILAC accreditation process using the 2017 editions of both ISO/IEC 17011 and ISO/IEC 17025.
The NRC staff independently observed how NUPIC performed its oversight of the joint evaluation of ANAB by IAAC and APAC as well as how ANAB performed a renewal accreditation assessment of a calibration laboratory.
Observation Activities
ANAB is a private organization that offers third-party accreditation services for calibration and testing laboratories. ANAB is a fully recognized accrediting body (AB) by APAC and IAAC to provide calibration and testing accreditation services. Due to the travel and workplace restrictions associated with the pandemic caused by the Coronavirus Disease 2019 (COVID-
2 19), ANABs assessment was performed remotely, including the assessment of the calibration laboratory.
The evaluation of an AB involves a team of peers (generally senior staff of experienced ABs) to establish its qualification to be a member of ILAC. APACs and IAACs evaluation of ANAB involved a team of peers from New Zealand, Chile, Japan, Sri Lanka, India, Malaysia, Indonesia, Canada, Brazil, Thailand, China, Colombia, and the United States. APAC and IAAC performs re-evaluations of its ABs every four years. These type of re-evaluations are typically one weeklong, however, due to the COVID-19 pandemic, this re-evaluation started in March and ended in June. The evaluation consisted of a review of ANABs compliance with the requirements of ISO/IEC 17011, as well as a renewal accreditation assessment of a calibration laboratory performed by ANAB to verify compliance with the requirements of ISO/IEC 17025.
The objective of an evaluation of the AB is to establish confidence in the endorsed reports and certificates (i.e. reports and certificates containing the ABs accreditation symbol) issued by its accredited laboratories. The evaluation focuses on how the AB ensures the technical competence of its accredited laboratories. The re-evaluation concentrated on examining changes at the AB and in its documentation, on compliance with the current issues of the relevant ISO/IEC standards (especially since a new edition of the standard has been issued since the previous evaluation) and any other new supplementary requirements adopted by APAC and IAAC, and on obtaining evidence that accredited laboratories continue to operate in compliance with the relevant ISO/IEC standards.
In turn, ANAB conducts a full renewal assessment of all accredited laboratories at least every two years. According to ANABs procedure PR 2303, Administrative Process Rule:
Assessment Activities, regarding remote virtual assessments, ANAB may use various technological platforms to perform assessment activities using remote virtual assessment techniques. These techniques may include teleconference, video conferencing, and computer-screen-sharing technology platforms. The objective of the assessment is to determine the laboratorys compliance with ANAB requirements for accreditation and observe competent performance of tests or calibrations covered in the laboratorys scope of accreditation. Although accreditation is granted for two years, after the initial year of accreditation each laboratory must undergo an annual surveillance assessment each year prior to the full renewal assessment.
The objective of the surveillance assessments is to confirm that the laboratory's management system and technical capabilities remain in compliance with the accreditation requirements.
Assessments are performed by assessors who are selected based on their testing or calibration expertise. Prior to the assessment, ANAB performed a review of the required documentation.
The document review is typically performed by the lead assessor. After the lead assessor reviews the management system documentation and determines that the documentation meets the requirements of the accreditation standard, the laboratory will be able to demonstrate technical competence identified on the proposed scope of accreditation and certification.
Assessors are given an assessors guide and a checklist from the AB based on ISO/IEC 17025 to follow when performing the assessment. During the assessment, any findings are identified as deficiencies which are nonconformities to the accreditation requirements as described in ISO/IEC 17025. At the conclusion of the assessment, the assessor prepares a report of findings in which any deficiencies are identified and must be corrected by the assessed laboratory before accreditation is granted. If there are any deficiencies identified, the laboratory is requested to respond, in writing, within 30 days after the date of the exit briefing detailing either its corrective action or why it does not believe that a deficiency exists. The corrective action response must include the laboratorys root cause analysis and a copy of any objective evidence to indicate that the corrective actions have been completed.
3 The renewal accreditation assessment of the calibration laboratory started with ANABs assessor performing a thorough review of CSLs scope of accreditation. The ANAB assessor witnessed the demonstration of measurement capabilities for instruments calibrated within the scope to accreditation. During the renewal assessment, the NRC staff observed how the ANAB assessor reviewed records associated with internal audits, management review, corrective action, complaints, purchasing, equipment calibration, proficiency testing, and the training records of those performing the calibrations. The NRC staff noted that the ANAB assessor was continuously asking for objective evidence throughout the assessment to verify full compliance by the laboratory to the requirements of ISO/IEC 17025:2017 listed in the checklist, as applicable. The ANAB assessor concluded the renewal assessment with the review of the draft assessment report which included five nonconformities.
Discussion
The NRC staff verified that both the NUPIC evaluation, ANABs assessment by IAAC and APAC, and ANABs renewal accreditation assessment of Cummins Corporate Standards Laboratory (CSL) adequately considered ANAB and CSLs scope of accreditation and remotely observed in-process work practices to verify activities were in accordance with applicable procedures. WebEx was the technology platform chosen to conduct the remote assessments.
While being onsite is always the preferred method for performing an assessment, advances in technology that provide sufficient resolution allowed for adequate viewing of live demonstrations using remote virtual assessment techniques. While technology tools are available, these resources need to be better managed to have an efficient remote virtual experience. During a remote virtual assessment, the activities naturally take longer because only one activity can be performed on the screen. Use of the WebEx chat box and file sharing feature could have improved the online experience of the assessment.
The NRC staff found that the NUPIC lead evaluator, IAAC and APACs per reviewers, and ANABs assessor were thorough in their review, were very knowledgeable, and possessed the technical experience necessary to perform the assessments.
Conclusion
For the NUPIC evaluation of ANAB and ANABs renewal assessment of CSL, the NRC staff determined that both were adequately performed by observing specific activities to a sufficient level to be able to conclude whether the renewal assessment was performed consistent with the requirements of 2017 editions of ISO/IEC 17011and ISO/IEC 17025, and ANABs and CLS procedures, as applicable. The NRC staff concluded that the renewal assessment covered sufficient program and technical areas highlighted in the ANAB assessment plans to provide assurance that the laboratory is adequately implementing the management, program, and technical requirements of the 2017 edition of ISO/IEC 17025 and ANABs policies and procedures, as applicable.
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