CAPA (Corrective and Preventive Action)

Corrective and Preventive Action (CAPA) is a systematic process used in the medical device, pharmaceutical, and food industries to address and prevent recurring non-conformances, deviations, or adverse product quality or safety events. CAPA is mandated by the FDA under 21 CFR 820.100 for medical devices, as well as other regulatory frameworks.

  • Corrective Action addresses the root cause of existing non-conformances. For example, if a batch of products has already failed quality testing, a corrective action seeks to rectify the immediate issue, such as a faulty manufacturing step.
  • Preventive Action aims to prevent the recurrence of potential issues before they occur based on risk assessments, audits, or trend analyses.

A CAPA system typically follows these steps:

  1. Identification of a problem or non-conformance.
  2. Investigation and determination of the root cause.
  3. Development of corrective and/or preventive actions.
  4. Implementation of actions and effectiveness checks.
  5. Documentation and closure.

Effectiveness checks are a key component of CAPAs and are frequently targets of inspections of the CAPA system in inspections. Instead of assuming a CAPA was effective, documented proof of effectiveness is good business practice and is expected by health authorities.

CAPA is a key part of a company’s overall Quality Management System (QMS) and helps ensure continuous product quality and regulatory compliance improvement.