Continuing Assessment Audit - Recommended for continued registration 13485:2003

Doug Tropf

Quite Involved in Discussions
#1
We completed our assessment audit yesterday and were recommended for continued registration (13485:2003 & EN 550). We did have three minor nonconformances relating to using an obsolete form, using a monometer that was not calibrated, and failing to follow a defined procedure in that a pallet of non-conforming product was labeled as such on only one side as opposed to two sides, as required by our procedure.
 
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#2
Re: Continuing assessment audit

We completed our assessment audit yesterday and were recommended for continued registration (13485:2003 & EN 550). We did have three minor nonconformances relating to using an obsolete form, using a monometer that was not calibrated, and failing to follow a defined procedure in that a pallet of non-conforming product was labeled as such on only one side as opposed to two sides, as required by our procedure.
Good for you, Doug! I bet with findings like that, you were relieved they didn't find the big stuff, eh?;):notme::rolleyes::mg:

Well done!:applause:
 
S

SilverHawk

#4
Congratulations! Great that there is no finding related to sterilization EN550. U have done an excellent job.
 

Doug Tropf

Quite Involved in Discussions
#5
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.
 
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