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Thursday, September 25, 2008

HANDLING OF OUT OF CALIBRATION ANALYTICAL INSTRUMENTS

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

2.0. SCOPE:
Applicable to all the QC instruments

3.0. RESPONSIBILITY:

3.1. Quality Control Chemist

3.2. Maintenance Engineer

4.0. ACCOUNTABILITY:
Manager-Quality Control

5.0. DEFINITION:

6.0. PROCEDURE:
Following actions should be taken in the event of out of calibration status of instruments.

6.1. Inform the head of the QC department and affix a status label 'OUT OF CALIBRATION'

6.2. Inform the Maintenance department to carry out in house rectification of the instrument.

6.3. If the in-house maintenance department can rectify the defect, then use the instrument after proper calibration.

6.4. In case in-house maintenance department is unable to rectify the defect, call the supplier / manufacturer of the instrument.

6.5. Once the said instrument is repaired then carry out calibration and ensure that it is working satisfactorily.

6.6. If the external expert performs the servicing satisfactorily, use the instrument after calibration for routine analysis.

6.7. If the external expert fails to rectify the instrument, Affix a status label ' OUT OF ORDER'

6.8. Arrange to replace the instrument
In case an instrument is found out of calibration then the results of previous calibration are reviewed.

7.0. REFERENCES:
SOP:QCGN:xxx

8.0. ENCLOSURES:
Flow chart for handling OUT OF CALIBRATION INSTRUMENTS

9.0. ABBREVIATION:
Nil

1 comment:

DEEPAN said...

Do we have to perform Impact analysis for the instrument which is out of calibration and how to handle the same.