Could you give me a risk based approach example. For example, we have a number of equipment that was just calibrated, I would assign a low risk to these because they were just calibrated and are in working order. For larger pieces equipment, such as a 3D printer that is used for the main production, it has not been validated but we do have 100% inspection on the final product through QC, what type of risk assessment do you assign to this and what is the rationale?
Thank you
Thank you