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Hello! We just completed Stage I of our ISO13485 registration audit. We had one finding & I do not agree with it but want input. The short of it - we cannot have hair nets in our main mfg. area w/o beard covers. We have no cleanliness requirements. We do not have a clean room. Based on our experience, however, we find an improvement in particulate reduction with some minimal protection, including hair nets. I understand the path of least resistance is to just do what he asked, however I hate doing something just because an auditor said so. Although the write-up seems to give some options, he clearly told us, "you do both or none." If we can find perhaps a white paper & show our own justification (in addition to the documented procedures we have), I want to consider challenging this.
It was written up under Infrastructure section 6.3 which he quoted verbatim.
His 'details:' Documentation for controls over the equipment maintenance and the work environment incomplete or conflicting."
-"The posted procedure for personnel gowning shows a requirement for hair covers, but not any similar requirement for beard covers."
Thanks!!
It was written up under Infrastructure section 6.3 which he quoted verbatim.
His 'details:' Documentation for controls over the equipment maintenance and the work environment incomplete or conflicting."
-"The posted procedure for personnel gowning shows a requirement for hair covers, but not any similar requirement for beard covers."
Thanks!!