Wednesday, December 1, 2010

Handling of Out of Calibration of Analytical Instrument

1.0  Purpose      : To provide a procedure for the action to be taken in the event of out of Calibration of instruments.

2.0  Objective  : To provide a documented procedure for the action to be taken in the event of out of Calibration of instruments.

3.0               Scope     :   Applicable to QC/QA Department.

4.0     Responsibility  :
·       Primary        :     QC Chemist / QC Officer
·       Secondary    :      Manager QC/ Manager QA
5.0       Procedure   :
·       Following actions should be taken in the event of out of calibration status of instruments.
Ø      Inform the head of the QC department and affix a status label 'OUT OF CALIBRATION'.
Ø      Inform the Maintenance department to carry out in-house rectification of the instrument.
Ø      If the in-house maintenance department can rectify the defect, then use the instrument after proper calibration.
Ø      In case in-house maintenance department is unable to rectify the defect, call the supplier / manufacturer of the instrument.
Ø      Once the said instrument is repaired then carry out calibration and ensure that it is working satisfactorily.
Ø      If the external expert performs the servicing satisfactorily, use the instrument after calibration for routine analysis.
Ø      If the external expert fails to rectify the instrument, affix a status label ' OUT OF ORDER'.
Ø      Arrange to replace the instrument.
Ø      In case an instrument is found out of calibration then the results of previous calibration are reviewed.

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