nonconformances

Nonconformance refers to any deviation from specified requirements, standards, or customer expectations in products, services, processes, or systems. It encompasses defects, omissions, incorrect measurements, inadequate documentation, or failures to follow defined procedures. Nonconformances can arise at any stage of a lifecycle, from design and development to manufacturing, delivery, and after-sales service.

Organizations typically manage nonconformances through a formal process. A nonconformance report (NCR) or equivalent documentation records the issue, location, date, and parties involved. Immediate containment actions aim to prevent the problem from causing further impact, such as quarantining a batch or halting a process.

Nonconformances are commonly classified by severity, such as major and minor, or critical and noncritical. Major nonconformances indicate a significant risk to quality, safety, or regulatory compliance and often require prompt, documented corrective actions. Minor nonconformances are less severe and may be resolved through standard corrective steps.

Disposition decisions may include rework, repair, use-as-is with concession, scrap, return to supplier, or stopping production. Root cause analysis seeks to identify underlying causes and data-driven corrective actions to prevent recurrence. Preventive actions may address process controls, training, equipment maintenance, or supplier management.

Regulatory and industry contexts emphasize nonconformance management as part of quality systems. In manufacturing, healthcare, aviation, and pharmaceuticals, organizations document, investigate, and report nonconformances to maintain compliance and demonstrate continuous improvement. Metrics such as time to close, number of NCRs, and trend analysis support ongoing risk reduction.

Terminology varies by standard; for example ISO 9001 often uses nonconformity, while other frameworks may prefer nonconformance. Regardless of label, the goal is to identify deviations, resolve immediate issues, determine root causes, and prevent recurrence.