What should a CAPA plan include in AMQS?

• A. Scope, root cause, actions, responsibilities, timelines, verification of effectiveness, and evidence of closure.
• B. Only root cause analysis.
• C. Only actions and timelines.
• D. Only verification of effectiveness.

Answer: (A)

A CAPA plan in AMQS must cover the full lifecycle of a nonconformance: define the scope of the issue, determine the root cause, specify corrective actions to fix the immediate problem and preventive actions to stop recurrence, assign responsibilities to specific individuals or teams, set realistic timelines, plan how you will verify the effectiveness of the actions, and gather evidence that the issue is closed and the system updated. This comprehensive approach ensures problems are not only corrected but also prevented from happening again, with clear accountability and traceability. Focusing only on root cause misses the necessary steps to implement fixes, assign ownership, and verify that the changes truly work; leaning only on actions and timelines neglects whether those actions address the underlying cause; and emphasizing verification alone doesn't ensure that proper corrections and preventive measures were put in place.