Suggestions on how to control a Design Dossier?

B

BostonQP

#1
I am recently back in the medical device industry after a 10 year hiatus in drugs/biotech!! Upon reviewing audit findings from an ISO13485 surveillance audit in January that pre-dates my time, our ISO registrar cited us for not "controlling" our design dossier binder. The CAPA was to issue it a document number and revision level however I am not thinking that is sufficient. Should I write a procedure, specific for the Design Dossier defining its contents, its periodic review, how and when to add or delete from it etc and reference the actual binder as an attachment to the SOP or should I merely include the Design Dossier in the scope of my general doc control SOP? Pros/cons...other suggestions?As you can imagine the DD is hunderds of pages including outside laboratory reports and other documents from a variety of sources with a variety of dates but the pages are not uniquely numbered. How should I correct that issue as well? Thanks for any help.
 
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yodon

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#3
An approach I've taken in the past is to have an Index listing the contents. The index is version controlled. So when a Design Dossier is submitted for review, you can identify what was reviewed through the Index. (The index lists revisions of documents referenced.)

I've had similar discussions regarding other compilations such as the DHF, DMR, etc. and this approach has worked for those as well.
 
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