Nonconformance

The report links an affected item and may link its source inspection, supplier, lot and quantity. Affected serial records can narrow the scope further. A defect citation refers to a catalog code and quantity. When citations change, severity follows the worst cited defect: critical before major before minor. Root cause work is required for critical or major severity.

Containment records state the action applied, the affected scope, the application date and the person who applied it. The action may represent segregation, a shipping stop, recall, production hold or release with certificate only. Release date stays with the containment record so the team can distinguish an active hold from a concluded one. Agree who can release the action before starting live work.

The report moves through open, containment, awaiting disposition and approved disposition states. A pending disposition is not an approval. The Quality Manager records the selected disposition and the approving user and time. For a major or critical report, routing creates a corrective CAPA once, with its owner and Quality Manager. The linked CAPA carries the longer investigation and verification work.

• Issue record. The report keeps source, affected item, severity and current state together.
• Immediate action. Containment records preserve what was held or released and when.
• Decision trail. The approved disposition identifies the deciding person and time.

Choose who can set affected quantity and serial scope, who applies containment and who records release. Quality Manager should document the local meaning of accept, return, rework, scrap, use as is and repair with deviation decisions. Supplier Quality Engineer should be included when the affected material came from a supplier.

Start with a failed incoming inspection citing a major defect. Open its nonconformance report and confirm that the source inspection, item and severity are present. Record a segregation action against the lot. Add an affected serial and a defect citation. Review the revised severity, enter a disposition, then have Quality Manager approve it. Check that the major issue has one linked corrective CAPA, even after the report is edited again.

• Open NC rs — Current issues by severity, source and state.
• NC rs Awaiting Disposition — Decisions waiting for Quality Manager.
• Active Containment — Applied actions without a release date.

Use inspection to nonconformance and nonconformance to CAPA.