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CAPA — Corrective and Preventive Action

CAPA under MO 169​

Corrective and preventive action (CAPA) is a core QMS element. MO 169 requires the organisation to take action to eliminate the causes of nonconformities and to prevent their recurrence (corrective action) and to prevent the occurrence of potential nonconformities (preventive action).

CAPA process requirements​

An effective CAPA system under MO 169 must:

  1. Identify sources of CAPA inputs — complaints, adverse event reports, internal audits, process monitoring data, management review outputs, nonconforming product reports
  2. Investigate root cause — determining the actual root cause, not just the symptom
  3. Define the corrective/preventive action — actions address root cause, not just the immediate occurrence
  4. Implement the action — with defined timelines and responsible parties
  5. Verify effectiveness — confirming the action has resolved the root cause and has not introduced new risks
  6. Document the process — CAPA records must be maintained and retrievable for PMDA inspection

Nonconformance handling​

Nonconforming products must be identified, documented, and segregated to prevent unintended use. Disposition (rework, rejection, acceptance under deviation) must be authorised. Where a nonconformance affects devices already shipped, a market action assessment must be performed — this may trigger an adverse event report or FSCA.

PMDA's CAPA expectations at inspection​

PMDA reviewers consistently scrutinise CAPA records at QMS inspections. Common findings:

  • CAPA inputs not systematically captured (complaints not linked to CAPA)
  • Root cause analysis superficial (symptom-focused rather than root cause)
  • Effectiveness verification not completed or documented
  • CAPAs from previous inspections still open without adequate justification