When an employee determines that a situation requires corrective action, that employee should fill out the Manufacturing Corrective Action Request Template and submit this to the Quality Manager. The Quality Manager should assign a number to the request and enter it in the Corrective Action Log (or database), then forward a copy of the MFG111-1 CORRECTIVE ACTION REQUEST to the affected Department’s manager. The Department manager – or an individual designated by the Department manager – should investigate the problem and, if necessary, take the necessary action(s) to correct the problem and prevent its recurrence.
The individual charged with taking corrective action should take action to correct the problem and prevent recurrence, record the action(s) taken and result(s) on the MFG111-1, and submit the MFG111-1 to the Department manager. The Department manager should verify the results, sign off on the request, and forward it to the Quality Manager. The Quality Manager should review the corrective actions taken and determine the appropriate follow-up or verification required. If the actions taken did not eliminate the problem and it’s root cause, a new Corrective Action Request should be generated.
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