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.