Document: NUREG-0800
Document ID: 965060de-8238-4868-a4c8-9a07c3e8cf13
Document Type: srp
Title: Diversity and
Source: NUREG-0800
Source URL: https://www.nrc.gov/docs/ML1515/ML15159A199.pdf
Revision Date: 2023-06
Chapter: 7
Section ID: 7.9
CFR Part: 
CFR Title: 

Content:
0, Appendix B, quality assurance program or by dedicating the item for use in the safety system as defined in 10 CFR Part 21, “Reporting of Defects and Noncompliance.” Review topics for the former are described above. The review for the latter requires a determination that a suitable acceptance process has demonstrated reasonable assurance that the equipment will perform its intended safety function. 10 CFR Part 21 states that “this assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspections, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial-grade surveys; product inspections or witness at holdpoints at the manufacturer’s facility, and analysis of historical records for acceptable performance.” An acceptable set of fundamental requirements for this process is described in IEEE Std 7-4.3.2, Clause 5.4.2, as endorsed by RG 1.152. In this guidance, the qualification process is accomplished by comparing the commercial-grade item to the design criteria of the standard. This standard allows the use of engineering judgment for the acceptance of existing software, and the use of compensating factors to substitute for missing elements of the software development process. These provisions should not be interpreted to permit unsupported subjectivity in the acceptance of existing software. The guidance provided herein for the review of newly developed software provides the technical background pertinent to evaluating the use of the engineering judgment and compensating factors provisions. The standard requires the acceptance, and its basis, to be documented and maintained with the qualification documentation. To demonstrate reasonable assurance, the acceptance process for most PDS can be expected to comprise a variety of technical activities conducted in significant detail. Guidance on