Re: Continuing assessment audit
Good for you, Doug! I bet with findings like that, you were relieved they didn't find the big stuff, eh?
Thanks! It is always a relief to get through these assessments, especially when you are dealing with an auditor you are unfamiliar with. I thought we were in good shape, as we are audited by our customers on a regular basis and have not had any major findings from those audits.
The unauthorized document being used was an isolated incident, however the finding did alert us to a problem in our document control practices.
The manometer cited is used to document air flow direction as part of our efforts to minimize employee exposures to ethylene oxide. We argued that it was not actually used as a measuring device and also was not part of the sterilization process. What got us was that our procedures state that any such devices will be calibrated. Our response is going to be to quit using the manometer in this instance and instead use smoke to determine air flow patterns.
The missing non-conforming label was really not defensible on our part. We are going to add verbage to the labels to remind operators that two labels are required on each pallet.
As often is the case, you learn from these audits and take steps to get better.