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Corrective and Preventive Action (CAPA)

The CAPA system is one of the most scrutinised elements of KGMP during MFDS inspections (ISO 13485:2016 Section 8.5.2 and 8.5.3).

Corrective action​

Taken to eliminate the cause of a detected nonconformity to prevent recurrence:

  1. Review and document the nonconformity
  2. Determine the cause (root cause analysis)
  3. Evaluate the need for action to prevent recurrence
  4. Implement corrective actions
  5. Verify effectiveness of corrective actions

Preventive action​

Taken to eliminate the cause of a potential nonconformity to prevent occurrence.

Common MFDS inspection findings in CAPA​

  • CAPAs that address symptoms rather than root causes
  • No effectiveness verification step
  • CAPAs left open for extended periods without justification
  • Adverse events or complaints not triggering CAPA investigation