Marek D. why did non-conformities jump from 9 to 29
overnight
FSM The findings are real. The jump is not. The model
the QMS names for non-conformity evaluation was decommissioned
yesterday, so last night’s run fell back to the default one,
which is stronger and catches more. Those twenty were always
there.
Two things follow, and the order matters. The QMS
still names a model that no longer exists, so that entry has to be
corrected before last night’s run counts as evidence. Then
the twenty stand on their own and go to CAPA.
Marek D. oh wow I didn’t even realize that was a thing.
this is terrible, what do we do now
FSM I understand, and it looks worse than it is. Most of
them are easy to fix. Twenty-three are records and traceability
gaps, which close by supplying what is missing, and I can prepare
all of those. Six need your judgement, not mine. I have started.
- QMS model entry correcteddone
- Minor findings, drafting corrections14 of 23
- Major findings, routing to CAPAqueued
FSM is working