Tuesday, April 06, 2010

Corrective Actions

Corrective Action
a) Corrective action is one of some key elements in a Quality Management System (QMS) that is focused on continual improvement and customer satisfaction.

b) Corrective actions are systematic actions as a problem solving process that will be taken to remove the causes of an existing nonconformity or undesirable situation and prevent recurrence of nonconformities.

c) Corrective Action is based on a nonconformity event that has happened in the past.

d) Normally corrective actions are implemented in response to a customer complaint, abnormal levels of internal nonconformity, nonconformities identified during an internal audit or adverse or unstable trends in product and process monitoring.

The Procedure shall ensure that corrective actions have been effective in preventing the reasons for nonconformity.

Definition
i) “Use as is” is a disposition taken for the deviation of product that it can be accepted and the responsible organization shall develop as built drawings and/or revise documents. The Customer shall approve on it.

ii) “Repair” is a disposition taken for the deviation of product that it can be accepted and the responsible organization shall develop the repair procedure. The repair procedure shall be reviewed by QA/QC Manager and approved by Project Manager, prior to start of the works.

iii) “Reject” is a disposition taken for the deviation of product that it can not be repaired cause of out of design, standard and/or specification so the product can not be used. The product shall be removed or scrapped; and the new one in accordance with specification shall be made.

Responsibilities
i) QA manager has responsibility to make coordination with related function, and archives it.

ii) Related function manager has responsibility to implementing required execution as corrective actions decision and record it.

iii) Management representative or Project Manager shall prescient.

Coordination
i) QA Manager shall review and collect required data related to the Non conformity report and/or customer complaint.

ii) QA Manager, Engineering Manager and related function shall discuss to specify measurable terms.

iii) QA Manager shall describe the decision of discussion on corrective action request include required procedure, work instruction; and distribute it to related function for implementation.

iv) Related function Manager responsible for required corrective action to close the NCR or Customer complaint; and document it.

Systematic steps to develop corrective actions
A corrective action is not reworking or remaking an item to bring it back into specification. Patching up a mistake doesn't address what made it happen in the first place and it won't prevent a recurrence.
A corrective action can be documented using either a paper or electronic system. Either way, the process is basically the same:

Step-1 Team Approach
Establish a small group of people with the knowledge, item, authority and skill to solve the problem and implement corrective actions. The group must select a team leader.

Step-2 Describe the problem
- Compare between documents that was specified versus one that was found.
- Check the functional specifications and any other requirements against the actual result.
- Describes the problem in measurable terms, specify the internal or external customer problem.

Step-3 Implement and Verify Short Term Corrective Actions
- Define and implement those intermediate actions that will protect the customer from the problem until permanent corrective action is implemented. Verify with data the effectiveness of these actions.
- Determine how much time should be allowed for a corrective action.
- Decide who will investigate the problem, find a solution and perform the corrective action.

Step-4 Define and Verify Root Causes
- Identify all potential causes which could explain why the problem occurred.
- Test each potential cause against the problem description and data.
- Identify alternative corrective actions to eliminate root cause.
- Describe the corrective action plan to keep the problem from recurring.

Step-5 Verify Corrective Actions
Confirm that the selected corrective actions will resolve the problem of the NCR or customer and will not cause undesirable side effects. Define other actions, if necessary, based on potential severity of problem.

Step-6 Implement Corrective Actions
- Define and implement the required corrective actions; communicate the corrective action procedure to everyone involved, at each appropriate level.
- Choose on going controls to insure the root cause is eliminated.
- Monitor the long term effects by periodically check to ensure the problem is solved and the corrective action procedure was effective; and implement additional controls if necessary.

Step-7 Prevent Recurrence
Modify the internal procedures, up date training, review work flow, improves practices and procedures.

Attachments
- Corrective Action Request Form
- Corrective Action Log Form







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