Change Order necessary to document FMEA Updates?

cubix rube

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We've been treating our PFMEA as a "living document", i.e., we update it fairly frequently, with no real documentation or tracking of revision level. In our last audit, it was pointed out that we should update the rev level whenever we make updates. For every other doc in our system, we initiate a Change Order to change a doc revision. If we are going to track each and every update to our PFMEA, do we need to document this with a change order, too? Curious how others handle this. Thanks!


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I don't know what standard you may be certified to, but the change order requirement is most likely from your own organization, not from the standard. I would ask what value you get from doing a change order for an FMEA update. If there is no value, then make sure that your procedures/work instructions allow you to make changes without a change order while still meeting the document control requirements of the standard.
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