Which statement best describes CAPA?

Which statement best describes CAPA?

• A. CAPA stands for Corrective and Preventive Action; it investigates nonconformities, identifies root causes, implements actions, and verifies effectiveness to prevent recurrence.
• B. CAPA is a regulatory filing for clinical data.
• C. CAPA is a method of post-market surveillance only.
• D. CAPA stands for Corrective and Preventive Action; it focuses only on cost reductions.

Answer: (D)

CAPA stands for Corrective and Preventive Action, and the goal is to systematically tackle problems so they don’t recur. This means first recognizing a nonconformity, then digging to find its root cause, implementing actions that correct the immediate issue, and also introducing preventive measures to prevent future occurrences. Finally, you verify that those actions actually worked. The statement that CAPA focuses only on cost reductions isn’t accurate. While reducing waste or costs can be a beneficial outcome, CAPA’s core purpose is quality improvement and risk mitigation through addressing root causes and sustaining effective fixes. It isn’t a regulatory filing for clinical data, nor is it limited to post-market surveillance; CAPA is a broader quality-management activity used to prevent problems across the product lifecycle.

CAPA stands for Corrective and Preventive Action, and the goal is to systematically tackle problems so they don’t recur. This means first recognizing a nonconformity, then digging to find its root cause, implementing actions that correct the immediate issue, and also introducing preventive measures to prevent future occurrences. Finally, you verify that those actions actually worked.

The statement that CAPA focuses only on cost reductions isn’t accurate. While reducing waste or costs can be a beneficial outcome, CAPA’s core purpose is quality improvement and risk mitigation through addressing root causes and sustaining effective fixes. It isn’t a regulatory filing for clinical data, nor is it limited to post-market surveillance; CAPA is a broader quality-management activity used to prevent problems across the product lifecycle.