Corrective Action Procedure

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1.0 Purpose
2.0 Theory
3.0 Procedure: Internal Reports
4.0 Procedure: Investigation and Corrective Action Requests
5.0 Process Map

1.0    PURPOSE
This document provides details and procedures for the process governing the discovery, reporting, resolution and recording of actions taken to correct or prevent nonconformities.

2.0    THEORY
Corrective action is taken to correct nonconformities, which could be product defects found during production, errors found in documents, equipment problems or problems related to how the Company performs functions in its processes.  “Corrective action” is simply the “fix” that corrects the problem.

Whenever we take corrective action, we also attempt to prevent the problem from recurring. Sources for preventive action opportunities include risk management, error proofing, failure mode and effects analysis and reports of product problems by external sources. Having a formal system to record and resolve existing and potential problems ensures that these problems do not occur or reoccur, thereby improving our products, processes and work environment.

3.0    PROCEDURE: INTERNAL REPORTS
3.1     The Company utilizes a Request for Support (RFS) form to ...

3.2     ...employees are...

3.3     ... disciplinary action may be...

3.4     The Quality Manager has been assigned the role of RFS Administrator.

3.5     See Process Map for the processing and routing of RFS’s.

3.6     If the responsible manager determines they are...

3.7     Actions taken...

3.8     The Quality Manager shall...

3.9     In addition to corrective action efforts, management shall...

3.10     The management review process shall...

3.11     Where product is suspected of a nonconformance, the Company shall...

4.0    PROCEDURE: INVESTIGATION and CORRECTIVE ACTION REQUESTS (ICAR’s)
4.1     Any purchasing agent may submit an Investigation and Corrective Action Request (ICAR) to a Supplier that ...

4.2     ICAR’s are...

4.3     Failure of a Supplier to...

5.0    PROCESS MAP

...

6.0 REVISION HISTORY AND APPROVAL RECORD

Quality System Procedure
CORRECTIVE ACTION PROCEDURE
Rev: Orig (EO #??)

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