STANDARD OPERATING PROCEDURE LABORATORY FAILURE INVESTIGATION

 STANDARD OPERATING PROCEDURE

SUBJECT :                     LABORATORY FAILURE INVESTIGATION

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

1.0       OBJECTIVE:

To provide guidelines for Laboratory failure investigation.

2.0       POLICY:

To ensure establish a procedure for laboratory failure of investigation.

SCOPE: This procedure applies to Raw materials and finished products of all Parties.

3.0       Procedure:

Any Laboratory errors determined through a failure investigation to identify the assignable cause of out of  specification results are as follows.

3.1       If any result in the analysis of Raw material or finished product sample is out of Specification, the concerned Executive informs the Manager.

3.2         Executive along with the concerned Manager reviews all the relevant data of the out of specification results.

3.3       The sample integrity considering the aspects such as storage condition unusual appearance, sample weight and dilutions made in sample solution are checked.

3.4       If standard is used in the analysis, the integrity of standard is checked.

3.5       All the reagents, solutions used in the test are checked for purity and strength against Standards. Alternately fresh solutions are prepared and standardized.

3.6       If instrument is used in the analysis, check whether condition of the instrument is appropriate to the analysis. Consider the possible contamination of the instrument with the sample previously analyzed.

3.7       Check the calibration of the instrument and recalibrate, if necessary.

3.8       All the analytical data such as calculations, spectra, and chromatograms are checked against the analytical method to confirm that they are in line with approved method of analysis

                                                                                               

3.9       If the assignable cause of error in out of Specification result is identified, it is documented in the laboratory work book .Two officers will retest the same sample in triplicate and record values for quantitative estimation .Supervisor and officers initial the record with date .If assignable cause of the out of specification results is not found the matter will be referred to the cross functional investigating team for the possible process related cause of the discrepant result.

3.10     If the retesting results are also out of specification, G.M (Q.A) is informed and rejection report of the sample will be made.

3.11     In case of multiple out of specification results same procedure is followed as described in step 1 to

Documentation: All the investigation data is recorded in Laboratory work books. Failure Investigation report proforma.  

 4.0      FREQUENCY:  As and when required.

5.0       RESPONSIBILITY: General Manager QA.

6.0       REVIEW GUIDE: Laboratory Review Guide.

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