ML20259C391
| ML20259C391 | |
| Person / Time | |
|---|---|
| Site: | Nuclear Energy Institute |
| Issue date: | 09/11/2020 |
| From: | Richter M Nuclear Energy Institute |
| To: | Leslie Fields Licensing Processes Branch |
| Fields L | |
| Shared Package | |
| ML20135H200 | List: |
| References | |
| NEI 14-05A, Rev. 1 | |
| Download: ML20259C391 (7) | |
Text
MARK A. RICHTER, PH.D.
Senior Project Manager, Used Fuel and Decommissioning 1201 F Street, NW, Suite 1100 Washington, DC 20004 P: 202.739.8106 mar@nei.org nei.org September 11, 2020 Ms. Leslie Fields Senior Project Manager U.S. Nuclear Regulatory Commission Office of Nuclear Reactor Regulation Washington, DC 20555-0001
Subject:
Submittal of Response to Request for Additional Information (RAI) for NEI 14-05A, Revision 1, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services" Project Number: 689
Dear Ms. Fields:
On July 6, 2020, 1 the U.S. Nuclear Regulatory Commission (NRC) issued a second round of Requests for Additional Information (RAIs) in order to continue portions of its review of NEI 14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1. 2 This revised guidance provides an approach to utilize accreditation by signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) as part of a purchasers commercial grade dedication of laboratory services.
On behalf of the nuclear energy industry, the Nuclear Energy Institute (NEI) 3 submits the attached responses to the NRCs RAIs and a mark-up of NEI 14-05A Revision 1 that reflect updates in response to the RAI's. We believe that these responses will allow the NRC to complete its review and endorse the revised 1
Email from Leslie Fields (NRC) to Mark Richter (NEI), Request for Additional Information for NEI 14-05A Revision 1, July 6, 2020, ADAMS ML20184A288.
2 M. A. Richter (NEI) letter to K. A. Kavanagh (NRC), Submittal of NEI 14-05A, Revision 1, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, February 20, 2020 (ADAMS ML20054C066.)
3 The Nuclear Energy Institute (NEI) is responsible for establishing unified policy on behalf of its members relating to matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect and engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations involved in the nuclear energy industry.
Ms. Leslie Fields September 11, 2020 Page 2 guidance as an acceptable method for continuing the use of accreditation by ILAC MRA signatories in lieu of commercial grade surveys. All changes are described in the attached response.
We appreciate the NRCs consideration of the guidance and look forward to a timely endorsement. If you have any questions or require additional information, please contact me.
Sincerely, Mark A. Richter Attachments c: Ms. Kerri Kavanagh, Chief, NRC/NRR/MVIB Mr. Yamir Diaz-Castillo, NRC /NRR/MVIB Mr. Dong Park, NRC/NRR/MVIB Mr. Dennis Morey, NRC Mr. Earl Mayhorn, NUPIC/Ameren NRC Document Control Desk
NEI Response to NRC RAI #2 and #3 September 11, 2020 Page 1 NEIs response to the questions contained in the July 6, 2020 letter titled "2nd Round - Request for Additional Information Associated with NEI 14-05A, Revision 1, "Guidelines for the use of Accreditation In Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services." The changes indicated in the response are included in the update to Revision 1 of NEI 14-05A.
NRC RAI NEI 14-05A - Section 1.3, Acceptance of Accreditation by ILAC Signatories in Lieu of Commercial Grade Surveys Section 1.3 states, in part, that ISO/IEC 17025:2017 was released on November 30, 2017. During the three-year transition period, both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 are valid. After November 30, 2020, ISO/IEC 17025:2005 will become invalid and only accreditation to ISO/IEC 17025:2017 can be achieved and recognized under the ILAC MRA process. Therefore, this document recognizes accreditation to ISO/IEC 17025:2005 through November 30, 2020.
As result of the ongoing Coronavirus Disease 2019 (COVID-19) pandemic, ILAC extended the transition period for ISO/IEC 17025:2017 from November 30, 2020 to June 1, 2021.
In light of ILACs extension of the transition period, please clarify if Revision 1 of NEI 14-05 A also recognizes June 1, 2021 as an acceptable date for laboratories to transition to ISO/IEC 17025:2017.
NEI Response At the time of the original submittal of Revision 1 of NEI 14-05A, the current global COVID-19 pandemic had not been declared. In June 2020, ILAC decided to extend the end of the ISO/IEC 17025:2017 transition period from November 30, 2020 to June 1, 2020 to ensure all laboratories can be transitioned following the restrictions imposed as a result of the global COVID-19 outbreak. Likewise, Section 1.3 of NEI 14-05A has been updated to recognize both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 through June 1, 2021. After June 1, 2021, ISO/IEC 17025:2005 will no longer be valid and only accreditation to ISO/IEC 17025:2017 will be achievable and recognized by ILAC. The NRC has previously provisionally endorsed ISO/IEC 17025:2017. In addition, due to the extension of the transition period, the new limitations for the use of the ILAC Process regarding subcontracting calibrations/testing and Non-Destructive Examination (NDE) services will not go into effect until June 2, 2021.
NEI Response to NRC RAI #2 and #3 September 11, 2020 Page 2 NEI RAI 03 - NEI 14-05A - Section 5.2, Verification That the ILAC Process Continues to be Consistent with NRC Accepted Practices Section 5.2 states, in part, that The assessments and conclusions of the rigor of the ILAC process documented herein are based in large part on the evaluation of the ILAC requirements and procedures.
The comparison of ILAC requirements and procedures, in particular standard ISO/IEC 17025:2017, to NRC requirements, NRC endorsed guidance, and NUPIC checklists, which conform to these requirements and guidance, is the primary basis for the approach documented within to use the ILAC process in lieu of a commercial grade survey. As part of the continued oversight, the nuclear industry (NEI, NUPIC members, and other industry representatives) will monitor the ILAC requirements and procedures to verify that they continue to be consistent with NRC accepted practices.
Due to the ongoing COVID-19 pandemic, the NRC staff recently learned that accrediting bodies are currently performing renewal assessments remotely. This is not a position the NRC staff has had the opportunity to evaluate and determine to be an acceptable approach for performing renewal assessments. The NRCs recognition of the ILAC accreditation process allows licensees and vendors to take credit for the ILAC accreditation process in lieu of performing an on-site commercial-grade survey as part of the commercial-grade dedication process of calibration and testing services. In its initial recognition of the ILAC accreditation process, the NRC staff determined that as part of the on-site renewal assessments performed by the accrediting bodies, the critical characteristics for calibration and testing services would be verified as part of the on-site renewal assessment. Given that these renewal assessments are now being done remotely:
- a. Please clarify if NEI has considered how these remote assessments still provide the same degree of confidence to determine that the laboratories are adequately implementing the requirements of ISO/IEC 17025.
- b. As part of its continued oversight, please explain how the nuclear industry (NEI, NUPIC members, and other industry representatives) will effectively monitor the implementation of the ILAC accreditation process to verify that it continues to be consistent with NRCs accepted practices.
NEI Response to Part A While ISO/IEC 17025 outlines the requirements that accredited calibration and testing laboratories must meet, ISO/IEC 17011-2017, " Conformity assessment Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies," includes the requirement that Accreditation Bodies (ABs) must meet for accrediting laboratories. Section 7.9.3 of ISO/IEC 17011:2017 indicates, in part, that the time between consecutive on-site assessments shall not exceed two years. However, if the accreditation body determines that an on-site assessment is not applicable, it shall use another assessment technique to achieve the same objective as the on-site assessment being replaced and justify the use of techniques such as a remote assessment. The term remote assessment was not included in previous versions of ISO/IEC 17011 and was added to the ISO/IEC 17011:2017. Remote assessment is defined in ISO/IEC 17011 as assessment of the physical location or virtual site of a conformity assessment body using
NEI Response to NRC RAI #2 and #3 September 11, 2020 Page 3 electronic means. Due to travel restrictions caused by the current COVID-19 pandemic, ABs are now exercising the option of performing remote accreditation assessments to maintain laboratories' accreditations. This practice was not identified by the industry during our 2017 observation of the Peer Evaluation of ATS- Serbia nor earlier observations such as the 2014 observation of the American Association for Laboratory Accreditation (A2LA) or the 2013 observation of the Japanese Accreditation Board (JAB). The industrys conclusion that accreditation assessments performed by ABs are essentially equivalent to NUPIC style commercial grade surveys was based on the accreditation assessments being performed on-site at the laboratory undergoing accreditation. Currently, NUPIC commercial grade surveys are required to be performed at the supplier's facility.
After receipt of this RAI, the industry researched this issue by contacting both ABs and laboratories to understand how remote assessments are being applied and to verify the integrity of the accreditation process is maintained which is strictly required by ISO/IEC 17011 regardless of the assessment technique employed. Due to the COVID-19 Pandemic, ABs are exercising the option of performing remote assessments to varying degrees including reaccreditation assessments, mid-term surveillances, and to a lesser extent, initial accreditation assessments. There have been no examples identified for which an initial accreditation assessment was performed for a laboratory performing testing/calibration for nuclear customers.
Based on information provided by US based ABs, currently is no there is no ILAC guidance or procedure for performing remote assessments. However, these ABs have controls in place which include the development of remote assessment guidelines; performance of risk assessments on a case by case basis to determine if a laboratory can be assessed remotely; management approval on a case by case basis; a requirement to document the justification for a remote assessment; and training of assessors prior to performing the assessment. In addition, we were informed that ILAC regional bodies such as APAC, IAAC, and EA are working to develop guidance for their regional ABs which should be available in Fall 2020.
While all ABs and laboratories contacted generally agreed that remote accreditation assessments have been an effective and useful tool to maintain accreditations during COVID-19 and during mid-term surveillance assessments, on-site assessment are preferred and there are no plans to replace on-site assessments going forward. These remote assessments are being employed to maintain the accreditation of laboratories and protect the health of laboratory and AB personnel with plans to resume on-site assessments as soon health conditions allow. In addition, ABs are motivated to maintain the integrity of the accreditation process. This is evident by the extension of the ISO/IEC 17025:2017 transition period to June 1, 2021 rather than relying on remote assessments alone. However, from an economic standpoint, the industry recognizes there will be some that will attempt to broaden the use of remote assessments after the global pandemic is over.
Next, the industry compared the practices of ABs during the pandemic with what is being done by the nuclear industry during the pandemic to maintain the qualification of suppliers. When NUPIC surveys are used to assess a commercial calibration or testing laboratory control over the identified critical
NEI Response to NRC RAI #2 and #3 September 11, 2020 Page 4 characteristics, these assessments are required to be performed on a 36-month cycle. The NRC recently endorsed a nine-month grace period for completion of these surveys during extenuating circumstances such as the current COVID-19 pandemic. This represents a maximum time between onsite surveys of 45 months. By comparison, ISO/IEC 17025 accreditations are typically performed on a 24-month cycle and two accreditation cycles represent 48 months. This 48-month period is quite comparable to the maximum period of 45 months for nuclear industry on-site surveys during periods of extenuating circumstances.
Based on all of the above, the industry still maintains a high degree of confidence that ABs world-wide are appropriately maintaining the integrity of the ISO/IEC 17025:2017 accreditation process during the pandemic in accordance with the ILAC MRA, ISO/IEC 17025:2017, and ISO/IEC 17011:2017 requirements. There are enough checks and balances in the process and robustness of the standards to conclude based on reasonable assurance that in the short term, there has been no loss of effectiveness of the accreditation process.
NEI Response to Part B While the industry maintains our confidence in the ILAC Process for ABs that are signatory to the ILAC MRA, our position is going forward, additional controls are needed to ensure that remote accreditations are not overused and not substituted for on-site assessments. Therefore, revision 1 to NEI 14-05A, Sections 1.3, 4.2, 6, and Appendix A have been updated to recognize the use of remote accreditation assessments and to place a limitation on use of laboratories accredited based on a remote accreditation assessment. The update stipulates that users of the ILAC process per NEI 14-05A will be required to verify the laboratories being contracted to perform ISO/IEC 17025 accredited calibration or testing services have undergone an on-site accreditation assessment within the past 48 months or two accreditation cycles. This prevents a laboratory that performs calibration or testing for licensees and suppliers of basic components from receiving consecutive remote assessments. While it is believed the reliance on remote assessments will subside after the current pandemic is over, this new measure will assure that the spirit of ISO/IEC 17011 Section 7.9.3 is met by requiring verification of on-site accreditation assessments for laboratories performing work for licensees and suppliers of basic components.
In addition to requiring users of the NEI 14-05A to verify on-site assessments are utilized, a new procurement clause has been added to NEI 14-05A (Sections 1.3, 4.2, and Appendix A) which will be invoked in procurement documents to accredited laboratories. This procurement requirement will stipulate that as a condition for acceptance of the purchase order, the laboratory has achieved their accreditation to ISO/IEC 17025 based on an on-site assessment within the past 48 months. This will ensure that laboratories that achieved accreditation based on a remote accreditation assessment during COVID-19 pandemic cannot maintain their accreditation based on consecutive remote accreditation assessments. An on-site accreditation assessment will be required within 24 months following a remote assessment. Laboratories will still be required to certify to meeting the customer's purchase order
NEI Response to NRC RAI #2 and #3 September 11, 2020 Page 5 requirements. This was discussed with ABs and a selection of laboratories, all of which agreed to this approach. The imposition of this new procurement clause will be required effective June 2, 2021.
As mentioned above, the concept of remote assessment is something that was added to the 2017 version of ISO/IEC 17011 and ABs implementation of this assessment technique will certainly be evaluated during the mandatory periodic peer reviews. NUPIC/NEI is scheduled to observe the 2020 peer evaluation of ANSI National Accreditation Board (ANAB). The NRC has been invited to observe this peer evaluation as well. The observation team will pay close attention to this area and these observations will be documented in a written report which will be available to the NRC. Any concerns will be evaluated for impact on our confidence on relying on the ILAC process to approve suppliers of calibration and testing services based on accreditation to ISO/IEC 17025:2017 in lieu of commercial grade surveys.