STANDARD OPERATING PROCEDURE CROSS FUNCTIONAL FAILURE INVESTIGATION

STANDARD OPERATING PROCEDURE

SUBJECT :                     CROSS FUNCTIONAL FAILURE INVESTIGATION

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines for carrying out investigation of product failures by multiple departments to assign a cause and /or conclusion, recommendation and implementation.

2.0       POLICY: 

To lay down a procedure for cross functional failure investigation.

SCOPE: This procedure applies to all product failure arising out of Market complaints and during manufacturing and packing operations.

3.0       Procedure:

3.1       Form a team consisting of QA, Production, and Ware House and nominate a team leader.

3.2       Prepare a schedule of meetings and distribute to concerned departments.

3.3       Prepare agenda before the schedule meeting.

3.4       Cross functional failure investigation will be conducted to investigate following types of failures.

3.4.1    Processing problem.

                       

3.4.2    Equipment / utility and systems malfunction.

3.4.3    Contamination or risk of contamination.

           

3.4.4    Packaging problem.

3.4.5    Stability failure.          

           

3.4.6    Yield out of limit.

3.4.7    Product complaints.

3.5       Record the minutes of meeting.

3.6       Based on the recommendations in the meeting, initiate time bound action plan. Investigation to be completed within 20 working days.

3.7       Monitor the progress of the action plan and document with proper sign offs of Cross Functional Failure Investigation team.

3.8       Prepare a summary report of the Cross Functional Failure Investigation as per pro forma and send copies to the following

3.8.1    Director

3.8.2    Concerned License

4.0       FREQUENCY:  As and when required

.

5.0       RESPONSIBILITY:  G.M (Q.A) and Team leader.

6.0       REVIEW GUIDE:  Investigation records.

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x