Document Revision Numbers and Control of Documents

D

dlipdlip

#1
We have a document management system that handles all revisioning of documents for us. We have established in our quality manual that documents are only considered to be controlled if: 1) Viewing directly from our intranet on which we store a read-only copy; 2) If viewing directly from our document management system; 3) For a period of 12 hours after printing (from either of these locations) when a hard copy is required.

With this system we have not been putting revision numbers on documents since the revision number and change history is maintained by our doc. management system and this would be a reduntant step that we would have to make sure was performed. It has been suggested to us by an auditor that we have to have the revision number on the document itself. I think that we are meeting section 4.2.3 with our current system.

Any thoughts?
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Are you using document control software or just putting documents in a 'Read Only' directory?

Personally I'd be wary about no document revision / version identification on documents.
 

Jim Wynne

Staff member
Admin
#3
Re: Document revision numbers and control of docs

We have a document management system that handles all revisioning of documents for us. We have established in our quality manual that documents are only considered to be controlled if: 1) Viewing directly from our intranet on which we store a read-only copy; 2) If viewing directly from our document management system; 3) For a period of 12 hours after printing (from either of these locations) when a hard copy is required.

With this system we have not been putting revision numbers on documents since the revision number and change history is maintained by our doc. management system and this would be a reduntant step that we would have to make sure was performed. It has been suggested to us by an auditor that we have to have the revision number on the document itself. I think that we are meeting section 4.2.3 with our current system.

Any thoughts?
I think you're in the clear. The questions that any document control system must answer are, "How can you be sure you're using the current version?" and "How do you make sure that obsolete versions are not used?" Your system addresses both questions. The standard requires you to "...ensure that...the current revision status of documents [is] identified." This does not say that the identification must be on the document itself.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Re: Document revision numbers and control of docs

Don't forget the revision history aspect. While revision history is more important in some cases than others, revision history should not be totally ignored.
 
D

dlipdlip

#5
Are you using document control software or just putting documents in a 'Read Only' directory?
We're using document control software that handles approvals, revision history, archiving previous revisions and etc.
 
Last edited by a moderator:

Jim Wynne

Staff member
Admin
#6
Re: Document revision numbers and control of docs

Don't forget the revision history aspect. While revision history is more important in some cases than others, revision history should not be totally ignored.
I agree. I ellipsed-out the language about changes in the snip I quoted because it wasn't directly relevant to the question. Old versions can be archived in such a way as to satisfy the requirement to identify changes. Again, there's nothing that requires either changes or revision levels to be identified on each document (although I would do it that way).
 

Helmut Jilling

Auditor / Consultant
#7
We have a document management system that handles all revisioning of documents for us. We have established in our quality manual that documents are only considered to be controlled if: 1) Viewing directly from our intranet on which we store a read-only copy; 2) If viewing directly from our document management system; 3) For a period of 12 hours after printing (from either of these locations) when a hard copy is required.

With this system we have not been putting revision numbers on documents since the revision number and change history is maintained by our doc. management system and this would be a reduntant step that we would have to make sure was performed. It has been suggested to us by an auditor that we have to have the revision number on the document itself. I think that we are meeting section 4.2.3 with our current system.

Any thoughts?
As an auditor, I can't be certain without seeing how it works, but what you described certainly can be approrpiate. Many of my clients use something similar. Thekey is simply if your system can ensure that only current, accurate, approved docs are being used. If you can demonstrate your system does that, it should work. Sounds like a simple, sweet solution.
 

Wes Bucey

Quite Involved in Discussions
#8
FWIW:
I have faith in electronic doc management/control (EDM) systems.

The primary reason for the anal retentive systems for revision numbering and control systems [of who could read/make copies/change/delete/etc. a document] was to offset the problems inherent in trying to keep track of hard paper documents once they left the file cabinet. If a person picked up a paper document that had dropped from the chain of custody, the only way to identify it as valid or obsolete was by the revision number. With EDM (especially as described by dlipdlip), the document is NEVER out of the chain of custody. Ergo, the auditor cannot justify demanding additional marking of a document any more than he could demand the client use a particular brand of file cabinet for paper copies. The essence of configuration management is to assure no obsolete documents are used to the detriment of the organization or its customers. The description given by dlipdlip seems to provide that assurance.
 

Helmut Jilling

Auditor / Consultant
#9
FWIW:
I have faith in electronic doc management/control (EDM) systems.

The primary reason for the anal retentive systems for revision numbering and control systems [of who could read/make copies/change/delete/etc. a document] was to offset the problems inherent in trying to keep track of hard paper documents once they left the file cabinet. If a person picked up a paper document that had dropped from the chain of custody, the only way to identify it as valid or obsolete was by the revision number. With EDM (especially as described by dlipdlip), the document is NEVER out of the chain of custody. Ergo, the auditor cannot justify demanding additional marking of a document any more than he could demand the client use a particular brand of file cabinet for paper copies. The essence of configuration management is to assure no obsolete documents are used to the detriment of the organization or its customers. The description given by dlipdlip seems to provide that assurance.

I fully agree with Wes' premise.
 
D

dlipdlip

#10
FWIW:
I have faith in electronic doc management/control (EDM) systems.

The primary reason for the anal retentive systems for revision numbering and control systems [of who could read/make copies/change/delete/etc. a document] was to offset the problems inherent in trying to keep track of hard paper documents once they left the file cabinet. If a person picked up a paper document that had dropped from the chain of custody, the only way to identify it as valid or obsolete was by the revision number. With EDM (especially as described by dlipdlip), the document is NEVER out of the chain of custody. Ergo, the auditor cannot justify demanding additional marking of a document any more than he could demand the client use a particular brand of file cabinet for paper copies. The essence of configuration management is to assure no obsolete documents are used to the detriment of the organization or its customers. The description given by dlipdlip seems to provide that assurance.
This is really how I felt about it also. The only time I can see it as a problem would be for documents that are used externally (such as a print given to a supplier, or a quality directive provided to a supplier, etc.) but with these we would always insure a revision number was present.
 
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