8.5.2 Corrective Action

Purpose

To document the corrective actions necessary to eliminate the causes of nonconformities, including complaints, in order to prevent their recurrence and drive continual improvement of the Quality Management System.

Corrective actions are implemented as appropriate, considering the effects of the nonconformities.

Procedure

[enter-your-company-name-here] has established procedures that record and review all reported nonconformities, including instances of customer complaint and detail the necessary corrective action.

Corrective Action Required

• When a non-conformance is identified a Corrective_Action_Required (CAR) form will be completed. All staff are trained and encouraged in the use of CAR forms.
• After completing the details, the CAR form is passed to the Quality Manager.  If appropriate, the CAR is discussed at staff meetings.
• The Quality Manager then processes the form promptly, identifying underlying or root causes and notes these on the form. 
• The Quality Manager will then proceed with appropriate corrective or preventive action, noting these on the form. 
• A Corrective_Action_Required_Log will be maintained by the Quality Manager, and the status of the CAR will be maintained.  CAR issues that are outstanding will be followed up regularly. 
• The CAR log will be presented at the regular quality management meetings.  The Quality Manager has the responsibility for making the appropriate changes to procedures, forms and management systems as required, from issues arising from the CAR forms.
• Top management will review and approve major CAR actions.

Evaluation

All instances of nonconformance are evaluated to determine the cause and the effect that they have on product realisation, safety, customer satisfaction etc.

As part of the evaluation process, any action to prevent a recurrence of the non-conformance is considered and evaluated. During this evaluation consideration is given to the potential for a recurrence, safety, customer satisfaction, legal and regulatory implications etc.    

Corrective action

Following the evaluation of the cause, potential for recurrence and the effects upon product realisation, consideration is given to determine the most appropriate method reducing or eliminating the risk of recurrence.

Communication and Documentation

All evaluation results and corrective actions taken to mitigate or eliminate the potential for further non-conformances are communicated to all relevant parties, recorded and stored in accordance with the procedure 4.2.4 – Control of records

Review

The effectiveness of corrective actions are reviewed on a regular basis, every three (3) months or as deemed necessary by top management. Where the non-conformance is considered to be serious, the frequency of review may be increased as deemed necessary by top management in order to ensure effective control. When a non-conformance is detected, additional work instructions, training and checklists may developed to prevent the recurrence.

Complaints

Major corrective action is necessary when the non-conformance includes complaints which have legal or financial impact or which might impact upon the reputation of the organisation.

Minor corrective action is necessary when the non-conformance includes complaints which are minimal or low impact and are easily resolved, with no long-term effects.