CAPA Template — Corrective & Preventive Action

Corrective Action and Preventive Action (CAPA) is a systematic process used in pharmaceutical quality management to identify the root cause of quality failures, implement corrections, and prevent recurrence. CAPA systems are required under 21 CFR 820 (US medical devices), ISO 13485, EU GMP Chapter 1, and ICH Q10 Pharmaceutical Quality System.

Corrective action addresses an existing, confirmed problem — it is reactive, responding to something that has already occurred. Preventive action addresses potential problems identified proactively through risk assessment, trend analysis, or audit findings, before a failure actually occurs. Both require root cause analysis and verification of effectiveness.

Industry standard expectations: Critical and High priority CAPAs should be closed within 30 days; Medium priority within 60 days; Low priority within 90 days. Timeframes should be defined in the organization's quality SOP. CAPAs that cannot meet target dates require approved extensions with documented justification. Overdue CAPAs are a common FDA inspection observation.

CAPAs are typically triggered by: deviations from SOPs or specifications, OOS (Out-of-Specification) or OOT (Out-of-Trend) analytical results, internal or external audit findings, customer complaints, product recalls or field safety corrective actions, regulatory observations (Form 483, Warning Letter), risk assessment outputs, adverse trend analysis, or change control review.