"Calibration is a process by which we measure and compare the accuracy of Instrument/ Equipment/ Accessories by known and proven standard".
If calibration failure occurred then all the activities which were performed on that Instrument or Equipment between previous calibration to current calibration is suspected. Based on the Instrument/ Equipment category frequency of calibration may varies. Here we are going to discuss for next step in case of calibration failure of Instrument and Equipment.
1- Immediately Stop the activities for identified calibration failures Instrument/ Equipment and intimate to you superior.
2- Affixed the label calibration failure and under investigation.
3- Document the failure results and logged the incidence for investigation.
4- Start the investigation to find out the cause of reported failure. If cause identified related to human error (analytical errors/ handling error) then repeat the particular or impacted calibration parameter.
5- If cause identified as Instrument/ Equipment malfunctioning then resolve the same. If identified malfunctioning can not be resolved at our end then call to expert and authorised service engineer for further investigation and to resolve the problem.
6- If any part need to replace with new one and after replacing the part verify the working condition of Instrument/ Equipment. Take detailed investigation report by service engineer which contains reported issue, finding of root cause, action taken and confirmation for currently working condition of Instrument/ Equipment.
7- Perform partial or full calibration or start from repeat calibration for impacted calibration parameters as applicable.
Impact evaluation of calibration failure:-
If root cause for calibration failure identified as Instrument/Equipment error then need to evaluate impact on earlier activities between previous calibration to current calibration. Bases on failure of Instrument/ Equipment part, depths of Impact assessment to be finalized.
Below is some examples in case of calibration failure of Instrument in Quality control laboratory.
1- Failure of lamp intensity in HPLC calibration:- If lamp intensity failure observed in HPLC calibration then need to verify the area response in previous analysis. Lamp with low intensity will also impact on detection levels.
2- Failure of MCGV in HPLC calibration:-
Failure MCGV will impact on retention time, relative retention time, Baseline pattern in binary or Gradient composition analytical method analysis. Hence need to verify above mentioned points in earlier analysis.
3- Failure of accuracy test in analytical balance calibration:-
Accuracy test failure will impact on weight accuracy hence all the weight which were taken on respective balance will be suspected hence need to verify the generated results.
4- Failure of micropipette calibration:- Micropipette failure will impact on pipetting accuracy hence need to compare the generated response by using respective micropipette and by using other passes calibration micropipette.
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.