I am sure that there are probably two opposing trains of thought on this. Should you adjust first and check later.

I am sure that there are probably two opposing trains of thought on this.  Should you adjust first and check later.   Sometimes that is a choice dictated by procedure and regulations and other times it is dictated by the perception of what is best practice.   Far too many times calibrations are carried out and adjustments made because it is felt that it should be done.   In the world of Life Science and highly regulated industries this can be an extremely risky move not only for the product quality but also for the potential this could have to affect patient safety.   You may think well how can a simple adjustment have such a huge affect on product quality.   Okay well lets take an automated process plant as an example.   In this example the process has been validated and the product goes through the QA checks at the end of the production cycle.   You calibrate a flow meter and also make an adjustment, and then carefully put the instrument back in the process, happy that it is nicely back at Zero.  Was that really the right move well in my head an absolute No No.    As you found the instrument was how it was operating in the validated process and communicating to the control system.   The fact that this instrument is now feeding different information back to the control system effectively means that it has changed the process, could be feeding less or more ingredients into the mix.  Now to add to this mess only the "as left" after adjustment has been recorded during the calibration of the flow meter.  So your very expensive product gets tested at the end and something is off and you need to find out what.   So now that the adjustment has taken place the whole process is off and with no As Found data it is very likely that the full process will need to validated.   I am hoping that the potential costs of adjusting without checking are obvious.   So the next time you are thinking do I need a dedicated Calibration Management Software think of the cost of not having the right controls in place.   And to add to this is the cost of the stress that all of this causes on a lot of people.   Take the blinkers off and have a good look.

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