The date in the revision block is an internal statement within Engineering Services and is not a release date. (I assume you are talking about release because you are talking about PLM.) Some companies use automated functions within their PDM or PLM check-in system to update the revision block when the drawing is checked-in. But there is no requirement for that date to match the "PLM" date in any standards (or SOPs at your company, I'm guessing). In the old days, it used to be as a approval date. These days with paperless environments, approvals directly on drawings are not legally supported, so there is a reliance on the PDM and/or PLM. So, common practice is to use that date as a reference to revision inception by the change originator OR as the revision check-in date, but not as a release date within a PLM. (I know of only one company that uses it as a release date, and it is Quality Dept that updates the field directly, not the drafters or engineers.)
There is no true necessary correlation between the revision date and the PLM date. FDA will not look at this; and even if they did, your drafting practices SOP should already define that field as "revision initiation date" or other some-such none "release" type description. (All of your drawing fields (title block/rev block) should be defined in your drafting practices SOP already anyway.)
Additionally, knowing how to create and edit drawing content requires expertise and usually some sort of formal training within the Drafting or Engineering disciplines. Quality Dept associates are usually not qualified to assess drawing content (even if they think they are). Just because quality is employed by all associates, that doesn't mean that the Quality Dept is the first or final word in areas outside of their own dept.
That said, to make things clear for the FDA, an effectivity date (or release date) should appear on the drawing. This can be done with watermarks on the PDF or on the drawing itself. These watermarks can be added directly by some automated system, or added by Doc Control or a Quality Systems person who handles releases (for companies that run their ECO process through Quality Systems).
Matt Lorono
Lorono's SolidWorks Resources &
SolidWorks Legion
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