Document: NUREG-0800
Document ID: f5fcd424-bea6-4f79-b002-f91d93dd4c9e
Document Type: srp
Title: QUALITY ASSURANCE PROGRAM DESCRIPTION - DESIGN CERTIFICATION,
Source: NUREG-0800
Source URL: https://www.nrc.gov/docs/ML0631/ML063190019.pdf
Revision Date: 2023-06
Chapter: 17
Section ID: 17.5
CFR Part: 
CFR Title: 

Content:
ted deviation. (NQA-1) P. CORRECTIVE ACTION (10 CFR Part 50, Appendix B, Criterion XVI) 1. A corrective action program is required to be established that includes prompt identification, documentation, classification, and correction of the conditions. The program is to include provisions that ensure that corrective actions are not inadvertently nullified by subsequent actions. (NQA-1) 2. For significant conditions adverse to quality, the cause of the condition shall be determined and corrective actions take to prevent recurrence. These shall be 17.5-27 March 2007 reported to appropriate levels of management and follow-up action taken to verify implementation of corrective actions. (NQA-1) 3. Specific responsibilities within the corrective action program may be delegated, but the applicant or holder maintains responsibility for the program’s effectiveness. (ANSI N18.7) 4. The program requires all personnel to identify conditions that are adverse to quality. (ANSI N18.7) 5. Reports of conditions that are adverse to quality are analyzed to identify trends in quality performance. Significant conditions and trends adverse to quality are reported to the appropriate level of management. (ANSI N18.7) Q. RECORDS (10 CFR Part 50, Appendix B, Criterion XVII) 1. Measures are required to be established that ensure that sufficient records of completed items and activities affecting quality are appropriately stored. (ANSI N18.7) 2. The records system(s) is (are) defined, implemented, and enforced in accordance with written procedures, instructions, or other documentation. Records may be hard copy records or electronic records. (NQA-1) 3. For QA records in electronic media, the program includes provisions for the generation, distribution, use, maintenance, storage, and disposition of electronic records. The plan provides for all acceptable media on which electronic records are created and stored. Also, the program should include provisions to verify that the media is appropriate,