sop for failure investigation

 

1.0 OBJECTIVE

To lay down a procedure for investigation any failures in product, process or systems which may affect the quality of the finished product.

2.0 RESPONSIBILITY

Production Manager/Quality Assurance Manager.

3.0 ACCOUNTABILITY

Plant Head

4.0 Procedure

4.1 Failure investigation shall be carried out when a product does not meet the approved specification or any unusual observations are made during

the process of storage, handling, manufacturing or testing of the product(s).

4.2 Whenever a failure is identified in product or process or system the same shall be immediately brought to the notice of Quality Assurance Manager.

4.3 Failure investigation shall be initiated by Production Manger with the help of QA Manager. The documentation shall be done (Refer annexure-1).

4.4 QA Manager shall quarantine any component(s)/ intermediates/Finished product which might have been affected by the failure till

investigation is completed and a decision is made.

4.5 The investigation should establish the assignable cause for failure and its effect on the involved batch (s).

4.6 Investigation shall be extended to all the batches which could have possibly been affected by the failure.

4.7 The investigation may include additional testing of the involved batches or components.

4.8 The findings of the investigation shall be recorded in the failure investigation report
and reviewed by General Manager-Works.

4.9 QA Manager shall take final decision based on the investigation findings which shall be recorded in failure investigation report.

4.10 The failure investigation report shall be maintained in QA Dept. with all the supporting data.

A photocopy of investigation report shall be filed in Batch Production Record of affected batch(s).

4.11 Failure investigation shall be completed within 30 working days.

5.0 ABBREVIATIONS :

NIL