Document: NRC Regulatory Guide
Document ID: a5ee4c78-1135-4bb6-8d54-e974a3402f87
Document Type: regulatory_guide
Title: An Approach for Plant-Specific, Risk-Informed Decisionmaking: Graded Quality Assurance
Source: NRC Regulatory Guide Division 1
Source URL: https://www.nrc.gov/docs/ML1221/ML12216A017.pdf
Revision Date: 2023-06
Chapter: 
Section ID: RG-1.176
CFR Part: 
CFR Title: 

Content:
he GQA effort is listed in Regulatory Position 4 of this regulatory guide. C. REGULATORY POSITION 1. ELEMENT 1: DEFINE THE PROPOSED CHANGE The first element in the process of evaluating a change to QA programs involves providing a full definition of the proposed change. The first step is to identify the overall scope of the GQA program in terms of the SSCs that are covered. Additionally, the 1.176-5 licensee's PRA would be evaluated with respect to its adequacy to support the GQA decisionmaking process. To accomplish this the licensee should: I. Identify, and consider during the GQA process, the set of regulatory requirements and commitments that are directly related to the proposed QA implementation changes as well as those that may be impacted. This information is used to demonstrate that the proposed QA changes do not violate existing regulatory requirements. The major regulatory requirements applicable to GQA programs are set forth in Appendices A and B to 10 CFR Part 50, 10 CFR 50.54(a), and 10 CFR 50.34. Changes to technical requirements are controlled under existing processes such as 10 CFR 50.59, license amendments, relief requests, and exemp- tion requests, which are outside of the scope of this document. Relevant quality commitments that are to be considered reside in a variety of licensing documents such as the QA program description, the Final Safety Analysis Report (FSAR), responses to generic communications, and responses to enforcement actions. 2. Identify the structures, systems, and components (SSCs) and associated activities that are candi- dates for assessment within the risk-informed application of GQA. The SSCs selected for the risk-informed application of GQA need not include all systems within the scope of this regulatory guide. A licensee may elect to only categorize and apply GQA controls to a limited number of SSCs. For those safety-related SSCs not categorized, the licensee's full Appendix B QA program controls will continue to apply. 3.