Control of Obsolete Documents

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insect warfare

QA=Question Authority
Trusted Information Resource
#2
At a minimum you must have these controls in place for obsolete documents...

1) Dispose of them in such a manner that they cannot be re-used, or
2) If you intend to retain copies for whatever purpose, segregate them from relevant versions of the same document to prevent unintended use by others.

The main point is to keep outdated information from being applied in the workplace. Other than that, you need not do much else other than following your document and record control procedures.

Brian :rolleyes:
 
R

Randy Lefferts

#3
Is it necessary to rev a document when obsoleting it?
Short answer is no. Insect warfare already provided you with what you must do when obsoleting but assigning a new rev level to a document when obsoleting it is not necessary, required or even realistic. It already has a rev level, that is now obsolete.
 
#4
If you were to feel the need to stamp "obsolete" across the face of the document I suppose that some very anal auditor may claim that is a revision to the document and would need to be shown with new revision identification. That would be one very sick auditor.

In other words, forgetaboutit.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#5
It depends on your system. Is it a system of paper documents? If so, a stamp and segregation might work.

If it's in an electronic system that stores documents with the most recent revision available, they might be moved but it might be safer and easier to identify their revision as "OBS" or the like, because the standards ask us to make the documents' status available/identifiable to the user.

Should it go through the review process when obsoleting? Again, that depends on your system. Do your documents have related documents that would need updating? Do certain people need to be informed that a document is being obsoleted? If so, putting them on a review and approval loop might get the job done.

Remember the method to achieve this required identification is more about what your organization would benefit from, and less about what would satisfy an auditor.
 

wooden nickle

Involved In Discussions
#6
I believe ISO 13485 is telling us differently in clause 4.2.3 Control of Documents;
"The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions".
I believe that to obsolete a document without the originators approval is contrary to the standard. Obsoleting a document is definitely changing it, there may be ramifications the Quality System Coordinator is not aware of. All original reviewers should be in agreement that the document needs to be obsoleted.
 

Jim Wynne

Leader
Admin
#7
I believe ISO 13485 is telling us differently in clause 4.2.3 Control of Documents;
"The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions".
I believe that to obsolete a document without the originators approval is contrary to the standard. Obsoleting a document is definitely changing it, there may be ramifications the Quality System Coordinator is not aware of. All original reviewers should be in agreement that the document needs to be obsoleted.
I moved this into the 13485 forum for better exposure. I'm not an expert in this area, but I think you're asking a different question than the original one, which was whether you have to "rev" a document when it becomes obsolete. I take this to mean that you would, in rendering a revision "A" document obsolete, change the revision to "B." That wouldn't make much sense to me, but it does make sense that obsolescence would be a matter of consensus of the responsible parties rather than a unilateral action.
 

wooden nickle

Involved In Discussions
#8
Thank you Jim, but isn't it true that the only way you can document the approval to obsolete the document of all the signers of the document is through rev control.
 
G

Geoff Withnell

#10
It is not a requirement, but I have found it very useful, when obsoleting a document, to issue a new revision. A one page document which says Document No. xxxxxxxx "yyy yyy yyy" has been obsoleted as of month day year, without replacement, or is replaced by Document No. zzzzzzzzz. That way, if someone unfamiliar runs across a reference to the document, they get the story.
 
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