NCR (nonconformance record)

An NCR is the record of a nonconformance: a product, process or quality-system failure to meet a specified requirement.

ISO 13485 clause 8.3 requires you to identify and control nonconforming product so it is not used or delivered by mistake, and to act when you discover the problem after delivery. The NCR is the form that captures what failed, where it is, who owns the disposition, and what you decided: use as-is with concession, rework, scrap, or return to supplier.

An NCR is not automatically a CAPA. You evaluate whether the cause needs a systemic action. Recording that evaluation matters as much as recording the scrap quantity. If the same NCR repeats, the evaluation should change.

HAVGATE logs nonconformances from audits and from day-to-day quality work, classifies severity, and can continue into CAPA. Supplier-related NCRs should also appear on the supplier record so re-evaluation is based on history.