Calibration is a procedure which gives the assurance of respective Instrument/ Equipment are accurate and working perfect for intended use in given condition.
By calibration we measure the working performance of Instrumental, Equipment, Accessories by covering the entire usage range and got assurance on performance of respective Instrument, Equipment, Accessories.
In simple words we can say "Calibration is a process by which we measure and compare the accuracy of Instrument/ Equipment/ Accessories by known and proven standard".
Now we are going to discuss in which circumstances calibration need to perform. The followings are the most important reason to perform calibration:-
(In below paragraph, Instrument word is used however, it may be read as Instrument/ Equipment/ Accessories as per applicability)
1- After installation of new Instrument:- When any new Instrument procured and Installed. The qualification/ validation activities used to performed for same. At time of qualifications, calibration also need to perform to check the performance and accuracy of respective Instrument.
2- When any Instrument has been repaired or modified:- When any Instrument does malfunctioning and some parts need to replace with new one in that case calibration required related to respective new part to check the proper functioning and accuracy of Instrument.
3- When any Instrument moving from one location to another location:- If required to move the Instrument from one location to another location then before moving the Instrument, calibration need to perform to check the accuracy of Instrument and also for assurance of measurements was performed on this Instrument at till time are valid.
4- When a specific time period has elapsed:- Based on critically of any Instrument a time schedule should be fixed for calibration of that Instrument. Before due date calibration should be completed. After completion of due date for calibration if any measurements was performed, that will be non authentic.
5- After specific operating hours of usage has elapsed:- Some of Instruments are too sensitive and critical for performance hence based on operating hours Performance check need to finalise. After completion of specific operating hours, these Instruments shows malfunctioning and gives inaccurate results. Hence before elapsed usage operating hours, calibration need to perform.
6- Before and/or after a critical measurements:- If any specific product or analysis which is more sensitive and critical as it may impact on some parts of Instrument hence before and after analysis of respective product calibration to be performed to assure respective measurements was completed error free and now Instrument working perfectly.
7- After an event:- Let's assume if any Instrument has been exposed to electric shock, or its electronic parts got damaged, Instrument affected with vibration or physical damage which might be potentially compromised with integrity of Instrument's accuracy. In this condition after resolved the issue calibration need to perform.
8- When suddenly changed in weather:- If weather was suddenly changed and due to this controlled environment got affected then based on criticality of impact of weather on Instrument, calibration need to perform.
9- As per specification requirements:- If any changes in testing procedures and need to extend the working range of Instrument parameters, in that scenario to cover the entire working range calibration need to perform.
10- If any addition or modification of calibration parameters by regulatory authority:- If regulatory authority updated the guidelines in calibration parameters for specific Instrument, calibration need to perform as per updated parameters.
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.