Corrective and Preventive action SOP

1.0. PURPOSE:
To establish a procedure for corrective and preventive action on non-conformation relating to product.
2.0. SCOPE:
To process and Quality system to prevent recurrence / occurrence of actual and potential non-conformation.
3.0. RESPONSIBILITY:
Quality Control & Quality Assurance Personnel.
4.0. ACCOUNTABILITY:
Quality Control & Quality Assurance Personnel.
5.0. DEFINITION:
6.0. PROCEDURE:
6.1. The production, Q.C, Q.A managers shall investigate the root cause of non conformance by receiving the batch records, test reports, in process checks and reports of disposed materials, audit reports and customer’s complaints.
6.2. On identification of the root cause of nonconformance, necessary corrective/preventive measures such as correct adherence to work instructions and procedure shall be initiated and developed. New procedures/instruction shall be incorporated if required.
6.3. In case, if the root cause is due to process related problem, develop suitable modification, validate and record the changes to avoid recurrence.
6.4. Necessary preventive steps shall be taken, for the removal of causes due to potential non-conformation and case study, training will be initiated.
6.5. Ensure effectiveness of the corrective and preventive action through audits.
6.6. Records of corrective / preventive action and implementation shall be maintained.
6.7. The preventive action reports and their effectiveness shall form a part of management review.