What is CAPA and how does it relate to SOPs?

• A. CAPA is a training program for new hires.
• B. CAPA stands for Corrective Action Audit and Review.
• C. Corrective Action and Preventive Action processes identify root causes of nonconformities, implement fixes, and update SOPs to prevent recurrence.
• D. CAPA is unrelated to SOPs.

Answer: (C)

CAPA is a systematic approach that tackles problems by finding their root causes and taking actions to fix them and prevent them from happening again. It combines Corrective Action (addressing the immediate nonconformity) with Preventive Action (putting safeguards in place to stop recurrence). In practice, CAPA involves investigating the issue, performing root-cause analysis, implementing and verifying effective fixes, and updating SOPs to reflect the new, proven way of working so the problem doesn’t repeat. This is why the relationship to SOPs is direct: CAPA drives changes to procedures, ensuring that the documented methods ongoingly reflect the best, repeatable process.

The other options don’t fit because CAPA is not simply a training program, nor is it correctly described as an audit and review. And it is not unrelated to SOPs—CAPA often leads to updated SOPs to prevent future issues.