Hi all, I am looking for information on violations and deviations in non-commercial organisations. The regulations are quite clear about the criteria for a serious breach and what is required to be reported to the MHRA, but does anyone have a more specific definition of violation or deviation in their procedures?

Is there a difference between a violation and a deviation? Is it necessary to quantify exactly what constitutes a violation or deviation in an SOP or protocol? E.g. if x number of tests are missed, does this constitute a deviation or violation? Is it necessary to quantify when a deviation / violation becomes a breach?