Currently, I work with the Process Validation aspect of our Cardio Surgery devices where I validate test methods. Deviations from protocol do occur every now and then but it is best to avoid them at all cost. One deviation I am facing right now is the incorrect revision of the test method instruction in protocol. This occurred because a change was made to the procedure while my protocol was being approved. Another deviation that I also had to report was the incorrect documentation of calibration for one of the fixtures that I plan to use in my validation. Quality was not happy with the way the calibration was reported in the report so I had to fill out a deviation form stating the two deviations that occurred from the procedure.

Finding deviations before executing a validation is always better than finding it during the validation as it can hinder or halt the validation until a solution is reached.