What is the role of CAPA verification and effectiveness checks?

• A. Verify actions addressed root causes and prevented recurrence; may involve data reviews and re-audits.
• B. Actions are implemented without verification.
• C. CAPA only documents issues not verifying outcomes.
• D. Verification is optional for CBAs.

Answer: (A)

CAPA verification and effectiveness checks focus on proving that the actions taken actually fixed the underlying cause and prevented the issue from recurring. After implementing corrective or preventive actions, you gather evidence—such as data trends, performance metrics, re-testing, and any necessary re-audits—to confirm that the problem is resolved and that controls remain effective over time. This may include checking that the root cause was addressed, that processes are performing as intended, and that the improvements show sustained results rather than a temporary change. If the evidence doesn’t show improvement, the CAPA should be adjusted and rechecked, but the key idea is that verification demonstrates real, lasting impact rather than just completing tasks.