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?

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.

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 identified." This does [I]not say that the identification must be on the document itself.

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.

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.

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).

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.

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.

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.

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.

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.


A revision DATE would also be acceptable. Anything that is traceable or can make the revision link.

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 use a similar system. But I always ensure that revision numbers are updated in line with the electronic system. That way, as many of you have said, if it get's pulled from the system it can be at least referenced to the system to ensure it is current.

However, I have issues with rules 1) & 2).

1) Is your read only copy on the intranet instantly updated the moment a document is updated in your controlled system?

2) If the 12 hour rule applies, do printed copies contain the date and time that the document has been printed? Otherwise this rule is useless because who knows when it was last printed.

Obviously I don't know your system so I cannot comment completely on it's effectiveness, I would just be happier to see references on "Non COntrolled" copies so we know at what level these are at!!!!!

Of couse I have dreamed of a document control system that does the revision number updating automatically onto the document LIVE!

1) Is your read only copy on the intranet instantly updated the moment a document is updated in your controlled system?

This question made me think about a possibility I hadn't thought of before. It might be possible, through the phenomenon of browser disk-caching (and the user settings for same) for an intranet-based system to produce an obsolete (i.e., cached) version of a document without the user's being aware of what is happening.

Short explanation: Browser (Internet Explorer, Firefox, whatever) performance is enhanced by caching of web pages (or portions of them) on the local hard disk. This means that after the first time a page is downloaded, the browser, before downloading the same page again, will look in the local cache for the information and load it from there, which is much faster. There are user settings (under Internet Options in IE, for example) that control how this happens: Always download from the server, regardless of cache content; check the server version first to see if it's different from the cached version, etc.

It's conceivable that if the browser cache settings aren't controlled, a user could load an old version from the cache while thinking he's looking at the most recent version on the server.

Just some food for thought, speaking of which, it's lunch time:bigwave:

It's conceivable that if the browser cache settings aren't controlled, a user could load an old version from the cache while thinking he's looking at the most recent version on the server.

Just some food for thought, speaking of which, it's lunch time:bigwave:

I like to include a rev number or rev date just because it is possible to get a cached version from the browser, or for people to select text and copy and paste it even if you do have read only. I love electronic document control, but there is always somebody out there that can figure out how to mess you up, sometimes without really meaning to.

Let me mess with your heads just a little.

Even if you have rigid, never-screwed-up systems for ensuring only the most recent version of a hard paper copy or electronic copy is issued from the central storage place (file drawer or server farm), you probably need a "push/pull system" to ensure the folks using that copy do NOT continue to use it once a new version is issued. This probably means keeping a hard copy or electronic record of everyone who had access to the previous versions and alerting them a new version has been issued and getting acknowledgement from each to the effect they have destroyed or deleted previous versions (even cleaning out local computer caches)

The intensity of doing this varies with both the effect using an obsolete version may have on finished product, service, inspection, etc. and the frequency with which changes may occur.

The consideration of steps necessary to integrate a new version throughout a system is all part of the process we call "Configuration Management."

Let me mess with your heads just a little.

Even if you have rigid, never-screwed-up systems for ensuring only the most recent version of a hard paper copy or electronic copy is issued from the central storage place (file drawer or server farm), you probably need a "push/pull system" to ensure the folks using that copy do NOT continue to use it once a new version is issued. This probably means keeping a hard copy or electronic record of everyone who had access to the previous versions and alerting them a new version has been issued and getting acknowledgement from each to the effect they have destroyed or deleted previous versions (even cleaning out local computer caches)

The intensity of doing this varies with both the effect using an obsolete version may have on finished product, service, inspection, etc. and the frequency with which changes may occur.

The consideration of steps necessary to integrate a new version throughout a system is all part of the process we call "Configuration Management."


While this might be possible, I think we are trying to hard. All we are trying to do is ensure that people have and are using current, accurate, approved info. Any method, or combination of methods can achieve this, without expending too much effort.

Electronic read-only is a good step forward. Reduce the number of unneeded paper copies. And do a little training to help people understand the basic steps.

Wouldn't that handle almost all of it?

While this might be possible, I think we are trying to hard. All we are trying to do is ensure that people have and are using current, accurate, approved info. Any method, or combination of methods can achieve this, without expending too much effort.

Electronic read-only is a good step forward. Reduce the number of unneeded paper copies. And do a little training to help people understand the basic steps.

Wouldn't that handle almost all of it?It might. Each case is different. The cardinal rule is "each system is tailored to fit the organization's needs."

I can envision (and have witnessed) oganizations where very few controls are needed because the culture is efficient and professional. Other situations are just downright scary. We write here for a generic world usually and only deal with "outliers" when they are specifically identified.

Its a nicely designed system and should work well inhouse. However, as already discussed, documents do get printed and go out for reference. They are meant to remain updated. A system for ensuring that these remain upadated will still need to be defined.

E.g. engineering specs given to a supplier. Does purchase send a drawing / document with every purchase order or only when there is a change? How do they come to know that there is a change?..

Same will be true for documents of external origin. The standards, customer specific requirements..

I think I am adding questions. Not solutions.

I use a similar system. But I always ensure that revision numbers are updated in line with the electronic system. That way, as many of you have said, if it get's pulled from the system it can be at least referenced to the system to ensure it is current.

However, I have issues with rules 1) & 2).

1) Is your read only copy on the intranet instantly updated the moment a document is updated in your controlled system?

2) If the 12 hour rule applies, do printed copies contain the date and time that the document has been printed? Otherwise this rule is useless because who knows when it was last printed.

Obviously I don't know your system so I cannot comment completely on it's effectiveness, I would just be happier to see references on "Non COntrolled" copies so we know at what level these are at!!!!!

Of couse I have dreamed of a document control system that does the revision number updating automatically onto the document LIVE!


Concerning 1) people can obtain the most current version from the intranet (for people without access to and training on usage of the doc. management system) or from the doc. management system. It's the quality managers responsibility to immediately update the intranet once a new doc. revision is approved. The QM is notified through routings defined by the Doc management system. Pretty simple process really compared to trying to find hardcopy controlled versions.

Concering 2), documents must either be printed with a time and date stamp or immediately signed with a time and date stamp, if not they are just uncontrolled documents.