NonConformanceReports

Nonconformance reports are formal records used in quality management to document deviations from specified requirements, standards, or procedures in products, processes, or services. They provide a traceable account of nonconformities identified during inspections, tests, manufacturing, logistics, or field use, and they initiate containment, investigation, and corrective actions. NCRs support accountability, compliance, and continual improvement by capturing the nature of the nonconformance, its potential impact, and the disposition.

Typical content of a nonconformance report includes: a unique identification number, date of detection, reference to the related requirement or specification, a clear description of the nonconformance, location or batch/lot information, associated risks or severity, containment actions already taken, proposed disposition (such as rework, repair, scrap, or acceptance with concession), root cause analysis findings, requested corrective and preventive actions, responsibilities, due dates, and verification of effectiveness after implementation.

Process and lifecycle: when a nonconformance is detected, the item is isolated or quarantined as appropriate, and an NCR is created and reviewed. Investigations often use root cause analysis methods, followed by corrective actions to prevent recurrence and preventive actions to address potential related issues. The efficacy of actions is verified, and the NCR is closed in the documentation system once closure criteria are met. NCRs are typically managed within a quality management system and linked to other records such as corrective action reports and deviation logs.

Standards and usage: NCRs are common in manufacturing, construction, aerospace, automotive, medical devices, and software, in line with standards such as ISO 9001, ISO 13485, IATF 16949, and AS9100. They support compliance, supplier management, and process improvement by providing data on nonconformities and corrective outcomes.