When must corrective actions be taken?

When must corrective actions be taken?

• A. During routine maintenance.
• B. Preventive controls are not properly implemented resulting in a deviation.
• C. During marketing campaigns.
• D. Only during external audits.

Answer: (B)

Corrective actions are triggered when a preventive control fails or isn’t implemented properly, causing a deviation that could impact product safety. If a control isn’t functioning as intended or isn’t followed, you must take corrective actions to fix the control, address any affected product, and prevent recurrence. This focuses on the real event of noncompliance, not routine maintenance, marketing campaigns, or actions taken only as a result of external audits. In practice, you identify the deviation, determine and implement the fix, verify its effectiveness, and document the entire CAPA process to ensure future protection of the product.

Corrective actions are triggered when a preventive control fails or isn’t implemented properly, causing a deviation that could impact product safety. If a control isn’t functioning as intended or isn’t followed, you must take corrective actions to fix the control, address any affected product, and prevent recurrence. This focuses on the real event of noncompliance, not routine maintenance, marketing campaigns, or actions taken only as a result of external audits. In practice, you identify the deviation, determine and implement the fix, verify its effectiveness, and document the entire CAPA process to ensure future protection of the product.