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Corrective & Preventive Action (CAPA)

What is CAPA?​

CAPA (Corrective and Preventive Action) is a systematic process for:

  • Corrective action — eliminating the cause of a detected nonconformity to prevent recurrence
  • Preventive action — eliminating the cause of a potential nonconformity to prevent its occurrence

Under 21 CFR § 820.100 (QMSR), manufacturers must establish and maintain procedures for implementing CAPA.

CAPA data sources​

FDA expects CAPA to be driven by analysis of quality data from:

  • Nonconforming product records
  • Customer complaints
  • MDR data and adverse events
  • Audit results (internal and external)
  • Service and maintenance records
  • Post-market surveillance findings
  • Process, work operations, and quality records

The CAPA process​

A robust CAPA process includes:

  1. Identification — detect and document the problem or potential problem
  2. Investigation — root cause analysis (RCA) using appropriate tools (5 Why, fishbone, FMEA)
  3. Corrective/preventive action plan — specific actions to eliminate root cause
  4. Implementation — execute the plan with defined timelines and responsibilities
  5. Effectiveness check — verify that the CAPA was effective
  6. Documentation — complete CAPA record in the quality system

CAPA as the #1 FDA 483 observation area​

CAPA deficiencies are consistently the most cited 483 observation in FDA device inspections. Common deficiencies:

  • CAPA opened but root cause not adequately determined
  • CAPA actions do not address root cause
  • No effectiveness check performed
  • CAPAs not closed in timely manner

Official resources​

Common CAPA Deficiency Examples from FDA 483 Observations

  • Incomplete root cause analysis: Identifying symptoms (e.g., "operator error") without investigating why the error occurred or what systemic gaps enabled it
  • Actions that don't address root cause: If root cause is inadequate training, providing updated instructions alone without retraining and competency verification
  • Vague or unverifiable effectiveness checks: "Process improved" without measurable metrics; no verification that the corrective action actually prevented recurrence
  • Untimely CAPA closure: CAPAs remaining open >90 days without documented justification or interim measures
  • Failure to link trending to CAPA: Ignoring patterns of similar complaints or nonconformances that indicate systemic issues requiring preventive action