ML21014A438
| ML21014A438 | |
| Person / Time | |
|---|---|
| Issue date: | 01/27/2021 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | |
| Kavanagh K | |
| References | |
| Download: ML21014A438 (14) | |
Text
NRC Regulatory Update Nuclear Oversight Conference Meeting January 27, 2021 Kerri Kavanagh, Chief Quality Assurance and Vendor Inspection Branch, Office of Nuclear Reactor Regulation
Presentation Overview 2
COVID-19 Challenges Licensing Revision to Columbia Generating Stations Operational Quality Assurance Program (OQAP)
Revision to Callaways OQAP Public Meeting - Discuss Licensees Plans for Supplier Oversight Beyond Frequency Extension Limits Allowed During the Current Exigent Condition Electric Power Research Institutes (EPRI)
Use of Remote Assessment Techniques (Draft Guidance)
Inspections & Industry Outreach 2020 Vendor Oversight Workshop Update - ISO 17025:2017
Licensing 3
The current COVID-19 pandemic emergency limits on domestic and international travel, has resulted in licensees and their suppliers having significant challenges meeting their regulatory commitments.
The regulatory requirement for quality assurance program audits of suppliers is set forth in Criterion VII, Control of Purchased Material, Equipment, and Services, of Appendix B to 10 CFR Part 50.
NRC regulatory guidance and nuclear industry quality standards - a typical supplier audit or commercial-grade survey is conducted on a triennial basis with a 90-day grace period afforded for unforeseen administrative issues.
However, as a result of COVID-19 issues in the first quarter of 2020, licensees and suppliers became increasingly concerned that they might need to extend the grace period beyond the existing regulatory allowance in order to complete h i i h i ii i hi bl i f
Revision to Columbia Generating Stations OQAPD 4
Energy Northwests requested to implement guidance found in EPRIs Technical Report 3002019436, Remote Source Verification During a Pandemic or Similar State of Emergency: Screening Criteria and Process Guidance, for performing remote source verification.
The proposed change does not apply to vendor audits or commercial-grade surveys. (More on this later).
The NRC staff reviewed the alternative screening criteria developed in Technical Report 3002019436 and determined that it provides licensees and vendors with acceptable guidance for using remote communication and video capabilities to perform remote source verification in extreme circumstances where it is not possible to perform on-site source verification due to conditions ADAMS that threaten Accession the health No. ML20203K876 and safety of individuals performing the verification.
Revision to Callaways OQAPD 5
Union Electric Company, dba Ameren Missouri, proposed to adopt a 25 percent grace period (i.e., 9 months) for audits and commercial-grade surveys to address the current public health emergency situation, as well as any similar situation in the future.
Callaways existing 90-day grace period for completing triennial vendor audits and commercial-grade surveys where set to expire for some of its suppliers on August 2020. Without further extension, the affected suppliers would have to be removed from Callaways Qualified Suppliers List within 90-days of the triennial audit or commercial-grade survey expiration date, which would adversely impact their ability to procure safety-related items and services.
As the duration of the current national emergency is unknown, the NRC staff agreed that an overall extension of 25 percent to the triennial audit frequency for supplier audits and commercial-grade surveys may be implemented for extreme circumstances. Therefore, the NRC staff finds that the proposed changes continues to meet the requirements of Criterion VII of Appendix B to 10 CFR Part 50, and, therefore, is acceptable.
ADAMS Accession No. ML20216A681
Public Meeting 6
Purpose Discuss the licensees approach for performing supplier oversight when the 25 percent audit or commercial-grade survey frequency extension limit for the current exigent conditions allowance is exceeded.
Meeting was conducted virtually on November 2, 2020.
Public Meeting 7
Industry presented four alternatives for future NRC staff consideration:
Path A - develop guidance which allows audit Team Leader the flexibility to determine the team size required to conduct the audit or commercial-grade survey on-site while other members support the audit or commercial-grade survey remotely.
Path B -develop more comprehensive guidance to support a hybrid audit and commercial-grade survey approach and conducting audits and commercial-grade surveys fully remotely, should extensive travel and vendor restrictions not support any on-site presence. (Finishing touches been made to the draft document).
Path C - use decision tree to explore procurement alternatives to accomplish each licensees needs should a supplier approaches or goes beyond the 25 percent grace period.
Path D - use of the corrective action program (CAP) to document an evaluation for provisional authorization of the supplier, item, or service as the method of last resort.
Public Meeting 8
Meeting Results NRC provided feedback by stating the NRC staff has considered the industrys proposal and did not have any issues with the proposed approach and the use of the CAP as a last resort.
Licensees use of the CAP for conditions adverse to quality is within a licensees licensing basis and/or regulatory framework. The NRC staff understands that this approach is intended to be temporary while the NRC staff awaits a formal submittal from a licensee seeking approval for performing remote supplier audits and commercial-grade surveys.
Meeting Summary: ADAMS Accession No. ML20324A216
EPRI Guideline Use of Remote Assessment Techniques 9
The NRC staff continues to participate in the joint working group on the draft EPRI document for the conduct of hybrid and remote audits of suppliers.
The staffs goal of participating on the working group is to expedite the NRCs acceptance process, should the industry submit it for review.
The scope of the document would be limited to use during exigent conditions, such as the current pandemic or other such warranted conditions where licensees and vendors could not safely conduct audits of suppliers.
Inspections & Industry Outreach 10 IQVB conducted 14 vendor inspections during the fiscal year (FY) 2020:
Observed one NUPIC audit Observe one foreign Regulator vendor inspection as part of MDEP VICWG Majority of inspections were related to operating reactor suppliers The reduced number of vendor inspections performed in FY 2020 is largely due to the travel restrictions associated with COVID-19 IQVB participates in NQA-1 and ASME Section III standards development meetings - supports endorsement by NRC Issued yearly Vendor Times newsletter (ADAMS Accession No. ML20346A108)
Inspections & Industry Outreach 11 2020 Vendor Oversight Workshop NRC successfully hosted the first virtual NRC Workshop on Vendor Oversight.
The Seventh Workshop on Vendor Oversight was held over the course of three days, June 23 to June 25, 2020.
Workshop had an audience of about 500 attendees, representing companies and organizations from 15 countries including suppliers of basic components, industry groups, government regulatory agencies, and both foreign and domestic utilities.
Meeting Summary: ADAMS Accession No. ML20203M179
Provisional Recognition of ISO/IEC No.17025:2017 12 The Nuclear Energy Institute (NEI) submitted an update to Revision 1 of NEI 14-05A, which is been updated to recognize the 2017 edition of ISO/IEC 17025 as the basis for the International Laboratory Accreditation Cooperation (ILAC) accreditation process and to address other minor editorial changes, clarifications, and adjustments based on operating experience identified subsequent to the NRC's initial endorsement in February, 2015 (ADAMS Accession No. ML20259C391)
As result of the ongoing COVID-19 pandemic, ILAC extended the transition period to the 2017 edition of ISO/IEC 17025 from November 30, 2020, to June 1, 2021. In light of ILACs extension of the transition period, Revision 1 of NEI 14-05A also recognizes June 1, 2021, as an acceptable date for laboratories to transition to the 2017 edition of ISO/IEC 17025.
While the NRC finalizes its review and approval of the safety evaluation report endorsing Revision 1 of NEI 14-05A, the NRC extended its provisional recognition of the 2017 edition of ISO/IEC 17025 from November 30, 2020 to June 1, 2021 in a letter dated
For More Information 13 The Quality Assurance for New Reactors Website offers a variety of information including:
Vendor Inspection Program (VIP) Plan http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/vendor-insp-prog-plan.html Vendor Quality Assurance (QA) Inspection Reports for New Reactors http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/insp-reports.html Quality Assurance (QA) Inspections for New Reactor Licensing http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/qual-assure-license.html Vendor Quality Assurance (QA) Inspections https://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp.html
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