Which activities define a CAPA process?

Which activities define a CAPA process?

• A. Root cause analysis, implement corrective actions, verify effectiveness, and document results.
• B. Implement actions without verification.
• C. Perform only data collection.
• D. Ignore documentation.

Answer: (A)

CAPA is a structured approach to address problems by identifying the root cause, taking action to fix the issue, confirming that the fix works, and documenting what was done and what happened. The best option captures all these steps: you start with root cause analysis to understand why the problem occurred, implement corrective actions to prevent recurrence, verify that those actions actually resolved the issue, and document the process and results for traceability and accountability. Other options miss essential elements: acting without verification means you can’t be sure the problem is solved or that it won’t recur; doing only data collection doesn’t address causes or corrective actions; skipping documentation eliminates the audit trail and makes it hard to demonstrate improvement or compliance.

CAPA is a structured approach to address problems by identifying the root cause, taking action to fix the issue, confirming that the fix works, and documenting what was done and what happened. The best option captures all these steps: you start with root cause analysis to understand why the problem occurred, implement corrective actions to prevent recurrence, verify that those actions actually resolved the issue, and document the process and results for traceability and accountability.

Other options miss essential elements: acting without verification means you can’t be sure the problem is solved or that it won’t recur; doing only data collection doesn’t address causes or corrective actions; skipping documentation eliminates the audit trail and makes it hard to demonstrate improvement or compliance.