Handling of Out of Calibration Instruments and Equipment

Procedure for Instruments / Equipment other than Quality Control Laboratory

1. Stop usage of instrument/ equipment if it fails in calibration test or if there is a sudden malfunction in the instrument.
2. Affix “UNDER MAINTENANCE” label to the instrument/ equipment.
3. Fill an “Incident Report” and inform engineering department.
4. Engineering department shall carry out the investigation to find the reason for failure. The effect of failure on the quality of the product since the last calibration shall be evaluated.
5. Hand over the instrument/ equipment for repairs to the engineering department
6. Refer the instrument to outside agencies, if the instrument cannot be repaired in-house.
7. Calibrate the instrument/ equipment as per respective SOP after completion of repairs.
8. Replace the instrument/ equipment with identical instrument/ equipment if the same is beyond repairs. The replaced instrument/ equipment ideally should be of the same make, model, size, range, least count. If instrument/ equipment of same make, model, size, range, and least count are not available, the change should be done through change control procedure.

Procedure for Instruments/ Equipment in Quality Control Laboratory

1. Stop usage of instrument/ equipment if it fails in calibration test.
2. Affix “UNDER MAINTENANCE” label to the instrument/ equipment.
3. If any sudden malfunctions / or Out of calibration results are obtained from instruments in regular use. Contact the manufacturer/ supplier and call the Service Engineer.
4. The service engineer shall investigate and rectify the problem.
5. After the repairing/ maintenance of the instrument/ equipment, partial or complete calibration shall be performed.
6. The service report detailing the cause of failure, an action is taken and remarks if any shall be filed into the respective calibration/ maintenance file along with the partial/ complete calibration report.
7. The reason for failure and the effect of failure on the quality of the product since the last calibration shall be covered during the investigation.
8. Head QA shall evaluate the necessity to re-analyze the previous sample/ samples for the correctness of results to ensure that there is no product failure due to out of calibration.
Also see: Cleaning Validation of Manufacturing Equipments