ISOLove to Dance
I didn't see any existing thread this issue fits in, so here goes: On a recent surveillance audit, the Registrar was reviewing my listing of customer complaints that were actively being managed via my internal process (i.e. CAR had been created, root cause identified, actions being taken, and managed). The subject of a specific complaint caught his eye. Let's say for example, the complaint had to do with an issue that could have but did not cause any death or injuries to personnel. The Registrar wanted to write this up as a automatic MAJOR nonconformance because of the severe potential of the event (even though the worse case never happened). Now remember, the complaint was actively being worked through the QMS ... the Registrar did NOT uncover the issue for the first time. Can anyone explain to me WHY this should be a MAJOR nonconformance solely based on a potential outcome that never happened, for an already identified issue? What am I missing? BTW: the Registrar did confirm the MAJOR NC was being issued because of the potential "gravity" of the complaint.