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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 or distribution. Disposition (rework, rejection, acceptance under deviation, or scrap) must be documented and authorised by a designated individual with appropriate authority (typically Quality function). Records must clearly identify the nonconformance, root cause determination (if conducted), and justification for the disposition. 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 — for example, complaints documented in the complaint register are not reviewed for potential CAPA triggers, or trending analysis is not performed to identify systemic issues
  • 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