Corrective Action and Preventive Action (CAPA) is the result of an US FDA requirement, FDA CFR 820.100. The CAPA requirement applies to all manufacturers of medical devices and compels them to include CAPA in their Quality Management System (QMS).
CAPA can be split into two distinct but related functions.
- Corrective Action (CA), which is also an extension of Root Cause Analysis (RCA). The goal of CA is to find the root cause, base event or error that preceded the problem. The second goal of CA is to take action directed at the root cause or error.
- Preventive Action (PA) is similar to Lessons Learned / Read Across. PA resembles the replication activity that is part of Design of Six Sigma (DFSS). Another relatable term for PA in the industry to Yokaten, a Japanese term used by Toyota, describing a sharing across organization. The primary goal of PA is to inform an organization and prevent the problem from returning in other facilities lines or products.
