This procedure outlines the requirements of taking appropriate Corrective and Preventive Actions against non-conformance or the potential non conformance in order to avoid or prevent the reoccurrence of non-conformity.
This procedure is applicable to all functions in the company who can suggest and implement corrective and preventive actions for continual improvement in the quality management system.
◊ The Management Representative has responsibility for directing the activities of this procedure.
◊ All company personnel are encouraged to identify and bring into the notice of their supervisor an area for improvement in the quality management system.
◊ The section in-charge or departmental head can initiate the corrective and preventive action by filling in the Corrective / Preventive Action Request (CPAR) describing the unsatisfactory condition or the improvement suggestion.
All company personnel are encouraged to identify opportunities for improvement in the quality management system related to his work function. The improvements may be identified in the following manner:
a) Progressive up-grading the quality objectives on routine basis
b) Performance improvements
c) Initiating corrective actions on recurrent problems
d) Initiating preventive actions on potential non-conformities
e) Giving suggestions for improvement
f) Quality Circles
4.2 Initiating Corrective Actions
Corrective actions are taken to eliminate the causes of non-conformities to prevent their recurrence. Corrective Actions may be initiated in the following cases:
: Identification of major product non-conformity or recurrent problems
: Any non-compliance identified during follow up internal quality audit
: Customer feedback including customer complaints
: Non-conforming deliveries from suppliers
4.3 Requesting and Processing CAR’s
Corrective actions can be initiated by any person in the company by reporting it to his section in-charge or departmental head. The concerned section in-charge or departmental head fills in the Corrective / Preventive Action Request (CPAR). The request contains a description of the unsatisfactory condition that needs to be corrected and are addressed to the manager who is responsible for the area where condition occurred.
The CPAR is sent to MR, who reviews the corrective action with concerned departmental head. After approval by departmental head, the responsible person and target date for implementing the corrective actions are assigned then the corrective action listed into Corrective Action Log.
The responsible person investigates the causes of the problem that initiated the request. The investigation process includes:
: Interviewing the concerned persons and gathering their views about the possible causes of non-conformities.
: Observing and examining the concerned processes and related records.
: Examining the supplier and his supplies, where required.
: If appropriate, make use of statistical techniques (cause and effect diagram) to determine root causes.
He then proposes a corrective action to be taken and indicates the date by which the corrective action will be fully implemented.
4.4 Implementation of Corrective Action
When a corrective and preventive action is decided upon, it is implemented on trial basis and the results are closely monitored. Further measures or changes in the measures may have to be made during the trial period until satisfactory results are attained. The magnitude of corrective action depends on the nature of non-conformity and its effect on the quality of product.
4.5 Verification of Corrective Action
On, or immediately after, the due date of implementation of a corrective action, concern person follows up to determine if the corrective action has been implemented and if it is effective. When there is objective evidence that the corrective action is effective, the CAR can be closed out. If more work is needed to fully implement the action, a new follow up date is agreed upon.
When the corrective and preventive measures are found to be effective, they are incorporated in the quality system by making suitable changes in the relevant documents such as drawings, specifications, operating procedures, work instructions and quality system procedures.
4.6 Preventive Actions
Preventive actions are taken to eliminate any potential causes of non-conformity. The objective is to provide a mean for detecting any deterioration in processes, work standards and systems and thus to prevent the occurrence of a non-conformity.
The need for preventive action is brought out by analysis of the following information:
: Data on product and process trends
: Customer feedback
: Inspection and test records
: Performance reviews of suppliers
A preventive action can also be initiated by any person by reporting it to his/her (Employee) section in-charge or departmental head who fills in the CPAR and sends it to MR. The procedure for processing, implementation and follow-up of preventive actions is the same as described in subsections 4.3, 4.4, and 4.5 above.
4.7 Management Review meetings
Status of corrective and preventive actions is presented in management review meetings as input. MR compiles the status of corrective and preventive actions and submits it in the management review.
5.0 Records Related to Improvement Procedure
Corrective / Preventive Action Request (MR/3/07)
Corrective & Preventive Action Log (MR/3/08)