Which documents must be updated upon product validation?

#1
Since all my QMS experience is working with startups that had not yet gotten to the point of releasing a product for Manufacturing, I’m unsure about what happens after the product is validated.

Imagine the QMS is structured with revision numbers using Alphabetical identifiers for pre-validation engineering documents, i.e. Rev A, B or C. Then, after product validation, the engineering documents are supposed to move to a numerical revision, i.e. Rev 0, then 1.

When the product achieves validation, and you have several dozen or hundred engineering documents that are in Alpha versions, are you supposed to update them all to “Rev 0” with no actual changes, just to show the product was validated? That would be a great deal of time and work.

And if this is what is supposed to happen, then which engineering documents are updated?
  • Only the parts and procedures listed in the BOMs, or
  • All the documents in the DMR, or
  • All the documents in the DMF?
Thank you for your assistance.

Scott
 
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Randy

Super Moderator
#2
There are no rules so do what you want when you want, make sure it's understood by people that really need to know (which isn't the entire world), make sure everything lines up, and be consistent in the process...In the end it isn't anyone else's business how or when and there's no right or wrong.
 
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