Nonconformance to CAPA

Step by step

1. Scope the issue Inspector / QC Operator

   Inspector / QC Operator records affected lot, quantity, serials and cited defects.

   • Identify material and defects
   • Updates Non conformance reports, NCR defects, NCR affected serials

2. Apply containment Inspector / QC Operator

   Record the action and application time; keep the affected scope visible until release.

   • Preserve immediate action
   • Updates Containment, Non conformance reports

3. Review severity Quality Manager

   The worst cited defect sets the report severity and root cause requirement.

   • Prioritize issue
   • Updates Defects, NCR defects, Non conformance reports

4. Approve disposition Quality Manager

   Quality Manager decides the disposition and records approving user and time.

   • Record decision
   • Updates Non conformance reports
   ApprovalA person approves before the work moves on.

5. Open corrective work Quality Manager

   For a major or critical issue, the linked CAPA identifies owner, Quality Manager and due date.

   • Assign investigation
   • Updates CAP as, Non conformance reports

6. Begin investigation Quality Engineer

   Moving the CAPA into progress creates root cause analysis and an investigation task if none exists.

   • Start cause work
   • Updates Root cause analysis, Five whys steps, CAPA tasks

Inspector / QC Operator

Gathers issue detail; Supplier Quality Engineer handles supplier cases; Quality Engineer facilitates cause work; Quality Manager approves disposition and owns CAPA closure.