It is a short
FMEA-like work. The SOP for quality planning has a new chapter for process risk management. So, for each process, either during updates or during first implementation, competent people have to think of possible problems with the process (brainstorming part) and what our current controls are to cover these possible problems. Then we have a table at the end of each SOP (one SOP - one process) listing these results. As every employee is trained on "his/her" SOPs, everyone is aware (hopefully) of these obstacles, so that they cannot prevail. We got this idea from the SOP templates from the Medical Device Academy (Many thanks!).