M
micmart3000 QC RI
I have conducted hundreds of medical device investigations for NCR's. As with any other conclusion, I would only used operator error if I had a demonstrable path to point to. I try to avoid at all costs using such a root cause code without exhausting all other avenues first (5 M's). In my experience, I have seen too often that Operator Error is used as a cruch for an incomplete investigation that is lacking of cohesive details. This is probably why your customer demanded more information, perhaps they did not feel such a RC was waranted without sufficient documented analysis of the processes and procedures.