In CAPA terms, how do preventive action and corrective action differ?

• A. Corrective action addresses root causes of existing nonconformities; preventive action aims to prevent potential issues.
• B. Preventive action addresses root causes; corrective actions prevent potential issues.
• C. They are the same.
• D. Only preventive actions exist.

Answer: (A)

CAPA distinguishes between actions taken after something goes wrong and actions taken to stop problems before they occur. Corrective actions address the root causes of nonconformities that already exist, with the goal of eliminating the reason the issue happened so it doesn’t recur. Preventive actions, on the other hand, are proactive measures aimed at preventing potential issues from arising in the first place, often by identifying risks and putting safeguards in place before they cause trouble.

In practice, if a batch fails quality testing because of a worn tool, a corrective action would fix or replace the tool and modify the process so that failure doesn’t happen again. A preventive action would involve scheduling regular maintenance, monitoring the tool’s condition, and perhaps adding early warning checks to catch wear before a failure could occur.

This distinction—reactive treatment of an existing problem versus proactive steps to avert a potential one—is what sets corrective actions apart from preventive actions.