26 Dec 2013

Corrective Actions

A corrective action is a term that encompasses the process of reacting to product problems, customer complaints or other nonconformity's and fixing them. The process includes:
• Reviewing and defining the problem or nonconformity
• Finding the cause of the problem
• Developing an action plan to correct the problem and prevent a recurrence
• Implementing the plan
• Evaluating the effectiveness of the correction.

Inputs to the Corrective Action Request process (CAR) are the following
1. Customer complaints, including the return of defective products,
2. Quality system non conformances discovered during internal or external audits,
3. Evaluated reports of product or process nonconformity's, and
4. Reports of employee safety or material hazards.
The process for resolving problems includes:
1. Problem identification, evaluation and description,
2. Creating a Corrective Action Team and assigning responsibilities,
3. Selection of the Resolver, the person / department responsible for the corrective action,
4. Identification of the underlying (Root) cause,
5. Creation of a corrective action plan to eliminate the problem,
6. Implementation of the action plan,
7. Verification that the actions taken were effective,
8. Application of controls to prevent recurrence.
The output of the Corrective Action Request process include:
1. Analysis of the problem
2. Determination of the root cause of the problem
3. Action plan to resolve the problem and prevent recurrence,
4. Application of controls to determine the effectiveness of the solution,  
5. Verification that the problem has been resolved and that the controls are effective, and
6. Examination of other similar products / processes where similar problems may be prevented.
Returned Product Test / Analysis
Parts returned by a customer are analyzed to determine the mode of failure and detailed reports are made for each return involving failed parts.  Records of analysis are available to the customer upon request.  Corrective and preventive actions are initiated as appropriate.
Corrective Action Impact
Where appropriate, corrective actions are taken to eliminate the causes of nonconformity in similar products or processes.
The Quality Manager is responsible for the overall operation of the corrective and preventive action processes and for preparing and presenting corrective and preventive action reports at management review meetings.
The corrective action process follows these steps

Step
Action
Corrective Action
1
Identify the non conformance
Identify the non conformance from:
1.Faulty or missing procedures
2.Internal and external audit findings
3.Deviations from Environmental Policy
4.EMS requirements
5.Regulatory requirements
2
Investigate the Root Cause
Investigate the root cause of the non conformance relating to the activity, process, service, or environmental system.
3
Corrective Action
Determine the corrective action needed to eliminate the root cause of the non conformance.
4
Control
Apply controls to ensure the corrective action is implemented and effective.

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