Corrective and Preventive Action

Identify the time window, lots, locations and conditions that may be affected. Hold the product and use supported evidence to decide release, rework, diversion or disposal rather than relying on appearance.

Corrective action addresses why the failure occurred through equipment repair, process change, supplier control, training or another verified intervention. Repeating the original instruction is not enough when the system allowed the failure.

Preventive action applies the learning to comparable products, lines or sites before the same mechanism creates another event. Its scope should follow the risk and evidence rather than an automatic facility-wide response.

Assign an owner, due date, approval and required records. Changes to formulations, limits, equipment or procedures should be controlled so the corrective action does not create a new unassessed hazard.

Close the action only after evidence shows the cause is controlled. Trend recurrence, review monitoring and verify the changed process; completion of a form or one acceptable batch is not always sufficient.