As stated in Chapter 1 of the EU GMP guide ‘...the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk’. As such expectations of inspectors will be pragmatic regarding the degree of formality that is required, however appropriate evidence should be available of what has been done and as such a written output must be retained. Inspector’s pragmatism will be directly related to the nature of the risk with increasingly more formality and detail required for more significant risk (risk being the probability of occurrence of harm and the severity of that harm, often supplemented by the ability to detect the potential harm occurring).
