What are the two primary CAPA categories and how do they differ?

• A. Corrective actions (address root cause to prevent recurrence) and preventive actions (address potential issues before they occur)
• B. Corrective actions and compliance actions
• C. Preventive actions and enhancement actions
• D. Audit actions

Answer: (A)

The main idea here is understanding how CAPA works in practice: one part fixes what already happened, and the other helps prevent what could happen.

Corrective actions are reactive—they come after a problem is detected and aim to identify the root cause and fix it so the same issue doesn’t recur. This involves digging into why the failure happened, implementing a fix that eliminates the underlying cause, and then verifying that the fix works.

Preventive actions are proactive. They address potential issues before they occur by identifying risks or weak points in processes and putting controls in place to stop problems from arising. This could involve updating procedures, adding monitoring or control limits, providing training, or making design or process changes based on risk assessments or trend data.

So, the best answer captures both ideas: corrective actions address the root cause to prevent recurrence, while preventive actions address potential issues before they occur.