Industry reference
Nuclear quality requirements depend on the licensed activity and safety function of the supplied item or service. Design control, procurement, verification and defect evaluation need to follow the applicable regulatory and contractual baseline through the supply chain.
A product-specific review
Establish the licensed activity, safety function and procurement classification of the item or service. Identify regulatory requirements and the actual contract baseline. A commercial component can require additional evaluation before it supports a safety-related function.
Connect design, procurement, special processes, inspection and testing with the relevant quality assurance criteria. Keep lower-tier evidence and as-built configuration records traceable. A quality manual or certificate does not demonstrate that every required control has been implemented for the supplied item.
Maintain a route for deviation evaluation, corrective action and potential reporting. Review changes against the licensed and contractual baseline. Package approval for radioactive transport is a separate question from facility equipment quality assurance and must be assessed in its own scope.
3 source profiles
Review the references relevant to your product and activity. This selected federal collection does not replace a separate review of applicable state, local or contractual requirements.
Federal regulationNRC
10 CFR Part 50, Appendix B
Appendix B establishes quality assurance criteria for applicable nuclear power plant and fuel reprocessing plant activities. Its importance extends through design, procurement, manufacture, installation, testing and operation. A supplier needs to understand the safety function and procurement commitments attached to its work before selecting the controls and records that will demonstrate acceptable performance.
Federal regulationNRC
10 CFR Part 71
Part 71 addresses packaging and transportation of radioactive material, including package approval, design and quality assurance. The approved package configuration and authorized contents are central to its use. A package certificate does not authorize an arbitrary material, loading arrangement or operating procedure; these must be assessed against the applicable approval and transport requirements.
Federal regulationNRC
10 CFR Part 21
Part 21 links nuclear supply quality to the identification, evaluation and reporting of defects and failures to comply. Its application turns on the regulated activity, basic component and potential safety significance. Supplier controls should preserve the information needed to evaluate a deviation, communicate with the purchaser and identify the responsible reporting organization.
Identify the product configuration, the controlling provision and edition, the evidence required and the person authorized to make the decision. Keep a reason for exclusions and unresolved questions alongside confirmed requirements.
Revisit the record when design, materials, suppliers, software, claims or the applicable source changes. An earlier report remains useful only to the extent that it supports the current configuration and requirement.
Practice guide
A disciplined route from product identity and intended use to a documented federal requirement register.
Read the guidePractice guide
A practical examination of identity, method, scope, results and the meaning of a conformity claim.
Read the guide