Open a CAPA from a nonconforming product

Practice the sequence you already learned for “Open a CAPA from a nonconforming product” until the order feels automatic. Drill the ISO 13485 / 9001 nonconformance order. Product is identified and segregated first; disposition and CAPA close only after containment, evaluation, and recorded root-cause work.

1. Identify the nonconforming product.
2. Segregate it from conforming stock.
3. Record the NCR with lot, quantity, and requirement failed.
4. Contain further use or shipment.
5. Evaluate whether the issue is isolated or systemic.
6. Determine disposition: rework, use-as-is, or scrap.
7. Investigate root cause with the required method.
8. Open corrective action if escalation criteria are met.
9. Set effectiveness checks.
10. Close the NCR only after QA review.