ML22054A102
| ML22054A102 | |
| Person / Time | |
|---|---|
| Issue date: | 02/23/2022 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | |
| Kavanagh K | |
| References | |
| Download: ML22054A102 (13) | |
Text
Regulatory Update Nuclear Oversight Committee February 23, 2022 Clearwater, FL Kerri Kavanagh Quality Assurance & Vendor Inspection Branch / Office of Nuclear Reactor Regulation
Topics 2
NRC Vendor Inspections during COVID-19 NRC review of EPRI Technical Report 3002020796 Commercial-Grade Dedication Inspections at Licensees NRC Meeting with NEI on ISO 9001 Regulatory Guide 1.28 Update Industry Outreach - NRC Town Hall on Vendor Oversight and 8th NRC Workshop on Vendor Oversight Questions
NRC Vendor Inspections During COVID-19 3
In 2020 - Vendor Inspection Program goal of 20 vendor inspections per fiscal year (Oct - Sept)
FY 2020 - 14 vendor inspections completed FY 2021 - Vendor Inspection Program goal revised to include licensing audits and observations (i.e., NUPIC or other regulators) - 20 per fiscal year FY 2021 - 21 inspections/audits/observations: 10 vendor inspections, 4 observations of NUPIC audits, 1 observation of an ASN inspection, 1 parallel vendor inspection with ASN, 1 multinational vendor inspection, 3 licensing audits, and 1 Region 2 assist.
FY 2022 - 9 inspections/audits/observations completed to date
Vendor Inspection Program Changes 4
due to COVID 19 Pandemic Revised inspection strategy Established exigent inspection criteria to prioritize the safety of our inspectors and the vendor employees Criteria includes safe mode of transportation, mandatory travel restrictions (state/county), available accommodations (hotels/restaurants etc)
Lead inspector tracks COVID transmission and positivity rates at vendor locations prior to final decision to travel and conduct onsite inspections Remote and hybrid vendor inspections to supplement onsite inspections
NRC review of EPRI Technical Report 3002020796 5
EPRIs Technical Report 3002020796 Remote Assessment Techniques Planning and Conducting Audits and Surveys Using Remote Techniques During Exigent Conditions May 7, 2021, and May 26, 2021, Southern Nuclear Operating Company (SNC) requested approval of a proposed change to the SNC Quality Assurance Topical Report (QATR)(ADAMS Accession No. ML21127A184 and ML21147A077)
NRC Safety Evaluation completed on June 22, 2021 (ML21161A201) - 46 days from submittal
Commercial-Grade Dedication Inspections at Licensees 6
Commercial-grade dedication chosen to replace POV design engineering inspection, part of inspection procedure (IP) 71111.21 Update to IP expected to be completed in the Spring of 2022 Public meetings planned for the Fall of 2022 to discuss preparation and implementation
NEI proposal to utilize ISO 9001 7
The Nuclear Energy Institute (NEI) requested a public meeting with the NRC to discuss proposal.
Meeting held on Nov. 30, 2021 NEI presentation slides - ADAMS Accession Number ML21327A263.
Observation meeting summery - ML21348A313 Purpose - to discuss alternative approach to use suppliers with a commercial quality program (ISO 9001)
Addresses necessary growth of the AR supplier community Drives innovation for emergent AR technologies Reduces economic challenges to small suppliers posed by development of Appendix B Program
Meeting with NEI on ISO 9001 8
Discuss planned proposal to use ISO 9001 to satisfy Appendix B to 10 CFR Part 50 requirements to support 10 CFR Part 53 and the operating fleet NRC staffs perspective:
Scope of safety-related components for advance reactors needs to be defined and understood Beneficial to focus on advance reactors and not on operating reactors NEI to submit a white paper with a more detailed proposal sometime in 2022
NEI proposal to utilize ISO 9001 9
Observation meeting conclusions The staff stated that SECY-03-0117 already provides options on approaches for adopting more widely accepted international quality standards such as ISO-9001.
Approach 1: Acceptance of ISO 9001 as an Alternative to Appendix B Approach 2: Nuclear Sector-Specific ISO Program Approach 3: Licensee-Specific Controls for ISO 9001 Certified Suppliers Approach 4: ISO 9001 Certified Suppliers for Commercial-Grade Item Procurement NEI proposed:
To address gaps between the requirements of ISO-9001 and the requirements of Appendix B, such as special processes like welding, the licensee procuring the safety-related item or service and the ISO-9001 supplier supplying the item or service would have to address these gaps through procurement specifications and contractual agreements.
10 CFR Part 21 requirements would be contractually passed down from the licensee procuring an item to the ISO-9001 supplier supplying the item through the procurement specifications.
To provide oversight of an ISO-9001 supplier, the licensee would extend their Appendix B QA program requirements to the ISO-9001 supplier.
NRC SECY Paper, SECY-03-0117, Approaches for Adopting More Widely Accepted International Quality Standards (ML031490421-SECY Paper; ML031490463 - Attachment)
Regulatory Guide (RG) 1.28 Update 10 Draft RG currently in development Revision 6 of RG 1.28 will endorse NQA-1 2017 and 2019 editions with conditions Draft RG to be issued for public comment in 2022
NRC Town Hall on Vendor Oversight 11 1st Town Hall Meeting on Vendor Oversight held on June 24, 2021, virtually Approximately 220 attendees representing companies and organizations from 10 countries including vendors, industry groups, and government regulatory agencies.
Importance of Adhering to Procurement Specifications Regulatory Alternatives for Supplier Oversight During Exigent Conditions NRCs recognition of the ILAC accreditation process Plan to continue town halls in during non-NRC workshop years https://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/town-hall-meetings/past/2021.html
8th NRC Workshop on Vendor Oversight 12 Workshop will be held virtually - date TBD Proposed topics:
Implementation of 50.69 Inspecting During a Pandemic - Lessons Learned Commercial-Grade Dedication Inspections at Licensees NRCs Position on the Use of ISO 9001 (SECY-03-0117)
Counterfeit, Suspect & Fraudulent Items Implementation of EPRI Guidance on Hybrid & Remote Assessments Licensee and/or Vendors Perspective on Implementing the EPRI Guidance Registration will open in the Spring of 2022
Questions 13