Corrective and Preventive Action (CAPA)

Introduction: CAPA

Corrective and Preventive Action (CAPA) is a quality management process used to fix problems and prevent them from happening again. It is widely applied in Lean, Six Sigma, and regulated industries such as healthcare and manufacturing.

Background

CAPA has its roots in quality standards such as ISO 9001 and regulatory systems like the FDA’s requirements for medical devices. The idea is that fixing a problem once is not enough. Organisations need a structured way to remove root causes and prevent future issues.

Key Elements / Features

• Corrective Action – Steps taken to remove the cause of a detected problem.
• Preventive Action – Measures put in place to stop potential problems before they occur.
• Root Cause Focus – Use tools like the 5 Whys or Fishbone Diagram.
• Documentation – Clear records for audits, compliance, and learning.
• Follow-up – Check if the actions are effective and sustained.

Applications / Examples

In manufacturing, CAPA might involve redesigning a part that frequently fails. In healthcare, it may mean changing training and procedures after an incident to prevent repeat errors.

Relevance / Impact

CAPA ensures that organisations learn from mistakes and strengthen processes. It reduces risks, improves quality, and builds customer and regulatory trust.

See also

• Root Cause Analysis
• DMAIC
• 8D Method
• Team Problem Solving