ML22168A150
| ML22168A150 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/2022 |
| From: | Greg Galletti NRC/NRR/DRO/IQVB |
| To: | |
| GALLETI, G 301-415-1831 | |
| Shared Package | |
| ML22168A146 | List: |
| References | |
| Download: ML22168A150 (17) | |
Text
An Introduction to NRC Documents June 2022 NUPIC Vendor Conference Detroit, MI.
Greg Galletti Quality Assurance and Vendor Inspection Branch, Office of Nuclear Reactor Regulation
TOPICS
- Regulations
- Generic Communications
- Licensing Reviews
- Inspection-related Documents
- Enforcement
- Q&A Page 1 NUPIC Vendor Conference, June 2022 Detroit, MI.
NRC DOCUMENTS Figure 1. How the NRC Regulates Page 2 NUPIC Vendor Conference, June 2022 Detroit, MI.
REGULATIONS Requirements binding on all persons and organizations who receive a license from NRC to use nuclear materials or operate nuclear facilities 10 CFR 50.34 - Contents of Applications; Technical Information 10 CFR Part 52 - Licenses, certifications, and approvals for nuclear power plants 10 CFR 50.54 - Conditions of licenses 10 CFR Part 50 Appendix B - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants 10 CFR Part 21Reporting of defects and noncompliance Page 3 NUPIC Vendor Conference, June 2022 Detroit, MI.
REGULATORY GUIDES (RG)
The Regulatory Guide series provides guidance to licensees and applicants on implementing specific parts of the NRC's regulations, techniques used by the NRC staff in evaluating specific problems or postulated accidents, and data needed by the staff in its review of applications for permits or licenses RG 1.28, Quality Assurance Program Criteria (Design and Construction)
RG 1.33, Quality Assurance Program Requirements (Operation)
RG 1.234, Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21 RG 1.164, Dedication of Commercial-Grade Items for Use in Nuclear Power Plants RG 1.231, Acceptance of Commercial-Grade Design and Analysis Computer Programs Used in Safety-Related Applications for Nuclear Power Plants RG 1.26, Quality Group Classifications and Standards for Water-, Steam-, and Radioactive-Waste-Containing Components of Nuclear Power Plants Page 4 NUPIC Vendor Conference, June 2022 Detroit, MI.
GENERIC LETTERS (GL)
Transmittals to request an action, circulate technical or policy positions, or solicit participation in voluntary programs. Generic letters (1) request licensee actions and/or information to address issues regarding emergent or routine matters of safety, security, safeguards, or environmental significance, and (2) require a written response.
GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products GL 91-05, Licensee Commercial-Grade Procurement and Dedication Programs GL 93-02, NRC Public Workshop on Commercial Grade Procurement and Dedication Page 5 NUPIC Vendor Conference, June 2022 Detroit, MI.
INFORMATION NOTICES (IN)
Information notices communicate operating or analytical experience to the nuclear industry. Information notices may also communicate the results of recently completed research. The industry is expected to review the information for applicability and consider appropriate actions to avoid similar problems.
Vendor Inspection Related NRC Information Notices (IN) Issued Since 2010 IN 2011-01: Commercial-Grade Dedication Issues Identified During NRC Inspections IN 2014-11: Recent Issues Related to the Qualification and Commercial-Grade Dedication of Safety-Related Components IN 2015-12: Unaccounted for Error Terms Associated With the Irradiation Testing and Environmental Qualification of Important-To-Safety Components IN 2016-01: Recent Issues Related to the Commercial Grade Dedication of Allen Bradley 700-Rtc Relays IN 2016-09: Recent Issues Identified When Using Reverse Engineering Techniques in the Procurement of Safety-Related Components IN 2017-05: Potential Binding of Schneider Electric/Square-D Masterpact NT And NW 480-Vac Circuit Breaker Anti-Pump Feature IN 2018-11: Kobe Steel Quality Assurance Record Falsification Page 6 NUPIC Vendor Conference, June 2022 Detroit, MI.
SECY - COMMISSION PAPERS Written issue papers the NRC staff submits to the Commission to inform them about policy, rulemaking, and adjudicatory matters.
SECY-03-0117, Approaches for Adopting More Widely Accepted International Quality Standards The staff of the U.S. Nuclear Regulatory Commission (NRC) performed a review of international QA standards (ISO 9001-2000) against the existing framework of Appendix B to 10 CFR Part 50, and assessed approaches for adopting international quality standards for safety-related components in nuclear power plants into the existing regulatory framework.
Page 7 NUPIC Vendor Conference, June 2022 Detroit, MI.
REGULATORY INFORMATION SUMMARIES (RIS)
RIS are used to (1) communicate and clarify NRC technical or policy positions on regulatory matters that have not been communicated to or are not broadly understood by the nuclear industry, (2) inform the nuclear industry of opportunities for regulatory relief, (3) communicate previous NRC endorsement of industry guidance on technical or regulatory matters, (4) provide guidance to applicants and licensees on the scope and detail of information that should be provided in licensing applications to facilitate NRC review, and (5) request the voluntary participation of the nuclear industry in NRC-sponsored pilot programs or the voluntary submittal of information which will assist the NRC in the performance of its functions.
RIS 2018-05: Supplier Oversight Issues Identified During Recent NRC Vendor Inspections RIS 2016-01: Nuclear Energy Institute Guidance for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services RIS 2015-08: Oversight Of Counterfeit, Fraudulent, And Suspect Items in the Nuclear Industry Page 8 NUPIC Vendor Conference, June 2022 Detroit, MI.
BULLETINS (BL) AND CIRCULARS (CR)
Bulletins (1) request licensee actions and/or information to address significant issues regarding matters of safety, security, safeguards, or environmental significance that have great urgency, and (2) require a written response.
BL 79-01, Environmental Qualification of Class IE Equipment BL 79-05, Nuclear Incident at Three Mile Island BL 95-01: Quality Assurance Program For Transportation of Radioactive Material BL 2007-01, Security Officer Attentiveness Circulars transmit information to licensees or permit holders when (1) the information is of safety, safeguards, or environmental interest, (2) the NRC wishes to disseminate the information within 30 days, and (3) no reply is necessary in order for NRC to assess the significance of the matter.
CR 77-01, Malfunctions of Limitorque Valve Operators Description of Circumstances CR-78-08, Environmental Qualification of Safety-Related Electrical Equipment at Nuclear Power Plants Page 9 NUPIC Vendor Conference, June 2022 Detroit, MI.
NUREGS Reports or brochures on regulatory decisions, results of research, results of incident investigations, and other technical and administrative information.
NUREG-1055, Improving Quality and the Assurance of Quality in the Design and Construction of Nuclear Power Plants NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition Chapter 17 - Quality Assurance NUREG-0737, Clarification of TMI Action Plan Requirements NUREG-1358, Supplement No.1, Lessons Learned From the Special Inspection Program For Emergency Operating Procedures. Conducted October 1988 -
September 1991 Page 10 NUPIC Vendor Conference, June 2022 Detroit, MI.
SAFETY EVALUATION REPORTS (SER)
SERs are used to document the bases for staff approval for a variety of activities including (1) QA-related topical reports submittals by licensees, suppliers, and various applicants; (2) changes to approved or accepted QA Program Descriptions; (3) approval of license amendment requests such as changes to the plant design.
Final Safety Evaluation for Technical Report 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 Callaway Plant, Unit No. 1 - Operating Quality Assurance Manual Change Revision 34b (EPID L-2020-LLQ-0004 [COVID-19])
Columbia Generating Station - Reduction In Commitment To The Operational Quality Assurance Program Description (EPID L-2020-LLQ-0003)[Covid-19]
Waterford Steam Electric Station, Unit 3 - Issuance Of Amendment No. 260 Re: Digital Upgrade To The Core Protection And Control Element Assembly Calculator System (EPID L 2020 LLA 0164)
Page 11 NUPIC Vendor Conference, June 2022 Detroit, MI.
INSPECTION MANUAL CHAPTERS (IMC)
The IMCs provides guidance to NRC inspection staff on implementing the NRCs inspection program for licensed facilities, supplier organizations, and the various license and permit applicants.
Inspection Type Manual Chapters Inspection Responsible Organization(s)
Procedures Vendor IMC-2507 IP-35710 QA and Vendor Inspection IMC-0617 IP-36100 Technical Branches IP-43002 IP-43003 IP-43004 IP-43005 IP-43006 IP-81811 Construction (ITAAC) IMC-2503 IP-65001.22 IP-65001.23 Page 12 NUPIC Vendor Conference, June 2022 Detroit, MI.
INSPECTION PROCEDURES (IP)
IPs provides guidance to NRC inspection staff for the conduct of various NRC inspections.
Inspection Procedure Title IP35710 QUALITY ASSURANCE INSPECTION OF SOFTWARE USED IN NUCLEAR APPLICATIONS INSPECTION OF 10 CFR PART 21 AND PROGRAMS FOR REPORTING DEFECTS AND NONCOMPLIANCE IP36100 ROUTINE INSPECTIONS OF NUCLEAR VENDORS IP43002 REACTIVE INSPECTIONS OF NUCLEAR VENDORS IP43003 INSPECTION OF COMMERCIAL-GRADE DEDICATION PROGRAMS IP43004 NRC OVERSIGHT OF THIRD-PARTY ORGANIZATIONS IMPLEMENTING QUALITY ASSURANCE REQUIREMENTS IP43005 INSPECTION OF THE IMPLEMENTATION OF MITIGATION STRATEGIES REGULATION REGARDING THE USE IP 43006 OF NATIONAL SAFER RESPONSE CENTERS PROTECTION OF SAFEGUARDS INFORMATION BY DESIGN CERTIFICATION APPLICANTS AND VENDORS IP81811 INSPECTION OF DIGITAL INSTRUMENTATION AND CONTROL (DI&C) SYSTEM/SOFTWARE DESIGN IP65001.22 ACCEPTANCE CRITERIA (DAC) - RELATED TO ITAAC IP65001.23 INSPECTION OF HUMAN FACTORS ENGINEERING VERIFICATION AND VALIDATION ITAAC Page 13 NUPIC Vendor Conference, June 2022 Detroit, MI.
ENFORCEMENT POLICY AND MANUAL The Enforcement Policy and Manual provides guidance to the NRC staff. The Manual was first published in June 1990 as a tool to assist the NRC staff in implementing the Commission's enforcement program consistent with NRC's Enforcement Policy.
The Manual contains procedures, requirements, and background information used by the staff that develop or review enforcement actions.
NRC Enforcement Policy, sets forth the general principles governing the NRCs enforcement program and the Commissions expectations regarding the process to be used by the NRC to assess and disposition violations of NRC requirements.
Page 14 NUPIC Vendor Conference, June 2022 Detroit, MI.
NOTICES OF VIOLATION (NOV) AND NOTICES OF NONCONFORMANCE (NON)
NOVs - A Notice of Violation (NOV) (see 10 CFR 2.201, Notice of Violation) is a written notice setting forth one or more violations of a legally binding requirement and normally requires the recipient to provide a written response describing (1) the reasons for the violation or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken by the licensee or other person and the results achieved, (3) the corrective steps that will be taken, and (4) the date when full compliance will be achieved.
NONs - Notices of Nonconformance will be used for contractors who fail to meet commitments related to NRC activities but are not in violation of specific requirements.
Page 15 NUPIC Vendor Conference, June 2022 Detroit, MI.
QUESTIONS Page 16 NUPIC Vendor Conference, June 2022 Detroit, MI.