Which statement best describes CAPA in the AMQS framework?

• A. CAPA is a one-dimensional corrective action to fix symptoms.
• B. CAPA stands for Corrective and Preventive Action; identifies root cause, implements actions, and verifies effectiveness.
• C. CAPA is purely for compliance audits.
• D. CAPA relates only to external suppliers.

Answer: (B)

CAPA involves a structured approach to quality issues that goes beyond fixing the symptom. It starts with identifying the root cause of a nonconformity, then implementing actions to correct that root cause (corrective action), and adding preventive actions to reduce the likelihood of similar issues in other parts of the system. Finally, it includes verifying the effectiveness of those actions to ensure the problem won’t recur before closing the CAPA. This combination—Corrective and Preventive Action with root-cause identification and verification—best describes how CAPA is used in AMQS. It isn’t limited to a single fix, nor is it just for compliance audits or solely about external suppliers.