Calibration of Processes

Mandy

Involved In Discussions
#1
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
 
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somashekar

Staff member
Super Moderator
#2
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
If the word calibrate is understood as validate in the process, and the word calibrate is understood as calibrate in measuring equipment, there may be no need to tackle the top management on the use of the word.
The more understanding is necessary at the executing and middle management.
 
#3
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
Why not use the international vocabulary document and other references, such as ISO 9000 etc and either make a presentation on the (correct) use of terminology, so that everyone is aligned. You are correct and, if the rest of the organization doesn't adopt this (universally) accepted use of terminology, they will get into problems of communication later - especially with external auditors!

Good idea to fix it now!
 
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