What is the purpose of CAPA in relation to updating SOPs?

• A. To escalate issues to external auditors only
• B. To document incidents without changing processes
• C. To conduct audits separate from SOPs
• D. To identify root causes and update SOPs to prevent recurrence

Answer: (D)

CAPA, which stands for Corrective and Preventive Actions, centers on finding out why something went wrong and preventing it from happening again. When a deviation or incident occurs, you dig into the root cause rather than just fixing the immediate symptom. After identifying the cause, you implement corrective actions to address the present problem and preventive actions to avert recurrence. A crucial part of the preventive step is updating Standard Operating Procedures so the documented processes reflect the new controls, revised steps, or checks that address the root cause. This ensures improvements are embedded in how work is actually done, reducing the chance of the same issue coming back. The other options miss this essential link: they either push issues outward to auditors, just record incidents without changing how things are done, or run audits separately from updating SOPs, which prevents the improvements from being integrated into standard practices.