Distinguish between a Corrective Action (CAR) and a Preventive Action (PA) within a CAPA system.

• A. A corrective action addresses potential causes to prevent a possible nonconformity.
• B. A corrective action is used only after a failure is observed and is not preventive.
• C. A corrective action targets training programs; preventive action targets equipment maintenance.
• D. A corrective action addresses the root cause of an actual nonconformity to prevent recurrence; a preventive action addresses potential causes to prevent a possible nonconformity.

Answer: (D)

Understanding the distinction between corrective and preventive actions in CAPA hinges on timing and scope. A corrective action is about something that already happened: it uses root-cause analysis to identify why an actual nonconformity occurred and puts in place actions to remove that root cause so the problem doesn’t recur. It’s a reactive response aimed at stopping recurrence of a known issue.

A preventive action, on the other hand, is proactive. It looks for potential causes of a nonconformity before anything occurs and implements controls or changes to prevent that possible issue from arising. It’s about reducing risk and avoiding new problems by addressing what could go wrong.

So the correct description captures this clear split: a corrective action addresses the root cause of an actual nonconformity to prevent recurrence, while a preventive action addresses potential causes to prevent a possible nonconformity. In practice, you apply corrective actions after a failure is observed and preventive actions when a risk is identified ahead of time.