Nonconformance management covers the identification, documentation, segregation, evaluation, and disposition of items or activities that do not conform to specified requirements. NQA-1 Requirement 15 and 10 CFR 50 Appendix B Criterion XV establish the requirements. The program has two equally important objectives: preventing nonconforming items from being installed or used inadvertently, and generating the data needed to identify systemic quality problems before they become recurring findings. An organisation that identifies more nonconformances is not necessarily performing worse than one that finds fewer, the latter may simply have weaker detection.
Identification and documentation
A nonconformance is identified when an item or activity is found not to meet a specified requirement. The requirement may come from a drawing, specification, procedure, code, or contract. When a nonconformance is identified, it must be documented immediately, before any disposition decision is made. The non-conformance report (NCR) must describe the nonconformance objectively: what was found, what the requirement is, the item identifier and work order, and who identified it.
NCRs must not be held pending rework. The NCR documents the condition as found; any subsequent rework is a separate activity that must itself be documented and re-inspected. Initiating an NCR after rework has already been performed, to create a paper record of a condition that was informally resolved, is a records integrity violation and a significant quality concern. The sequence must be: identify, document, segregate, then disposition.
Segregation and control
Nonconforming items must be physically controlled to prevent inadvertent use before disposition. This typically means tagging, marking, or physically segregating the item. Tags must be durable, unambiguous, and attached securely, "Hold, Do Not Use" or equivalent wording, with the NCR number and date. In some cases, nonconforming items must be moved to a designated segregation area with controlled access. Physical segregation removes the risk that an item in the normal production flow will be used while its status is under evaluation.
The segregation requirement remains in force until the disposition is approved and implemented. An item with an approved "use-as-is" disposition must be formally released from hold status through a documented process, not simply by removing the hold tag without authorisation.
Suspect counterfeit items: The segregation requirements are particularly critical when counterfeit, fraudulent, or suspect items (CFSI) are suspected. Once CFSI is suspected, items must be quarantined immediately, the supply chain traced to identify other potentially affected items, and, for items subject to NRC jurisdiction, evaluation for potential 10 CFR 21 reportability initiated.
Disposition options and authority
Four standard dispositions are available for nonconforming items. Use-as-is: the item is accepted in its nonconforming condition based on documented engineering justification demonstrating that requirements are still met. Repair: the item is restored to functional condition but may not fully meet original requirements, requires engineering evaluation and re-inspection. Rework: the item is returned to full conformance with original requirements through additional work and must be re-inspected. Reject/scrap: the item cannot be used and must be removed from the quality program.
Disposition authority must be defined in the QA program. Use-as-is dispositions for safety-related items typically require engineering sign-off and may require review by the original designer or the Authorized Nuclear Inspector. Dispositions made without adequate authority or technical justification are themselves nonconformances, they must be corrected, which may require reversal of the original disposition decision.
NCR trending and programme health
The nonconformance program's real value is in the patterns it reveals over time. NCR trending should examine: which suppliers or processes generate the most nonconformances, whether the same types of nonconformance recur, whether disposition patterns suggest that requirements are unrealistic or that design margins are being consumed, and whether corrective actions from prior NCRs have been effective. High rates of repeat nonconformances for a single supplier are a signal that source oversight needs to increase and that continued use of that supplier should be evaluated.
Trending data should feed directly into the corrective action program and the audit schedule. An organisation that tracks NCRs individually but never analyses the aggregate data is operating a compliance program, not a quality program. The point of the data is to drive systemic improvement, not just to document individual events.
Forged Operations manages the full NCR lifecycle, initiation, segregation tracking, disposition routing, re-inspection sign-off, and closure. AI identifies repeat nonconformance patterns across suppliers and work areas, and surfaces use-as-is disposition rates that may indicate systemic quality issues.
References
- American Society of Mechanical Engineers. ASME NQA-1-2022: Quality Assurance Requirements for Nuclear Facility Applications, Requirement 15 — Control of Nonconforming Items. New York: ASME, 2022.
- U.S. Nuclear Regulatory Commission. "Criterion XV — Nonconforming Materials, Parts, or Components." Code of Federal Regulations, 10 CFR 50 Appendix B. Washington, D.C.: NRC.
- CSA Group. CSA N286:12(R2018): Management System Requirements for Nuclear Facilities, Clause 8.7 — Control of Nonconforming Outputs. Toronto: CSA Group, 2018.