Using Agile for Quality System Documentation Control

[Shawn97701 - 2009]

The company that I work for uses Agile for the drawing approval system and they want me to place the Quality docs into this same system. The one thing that concerns me in the ability of pulling older revisions in Agile. What is your opinion? If you know Agile, do you know how to prevent this?

[howste]

In Reply to Parent Post by Shawn97701

The company that I work for uses Agile for the drawing approval system and they want me to place the Quality docs into this same system. The one thing that concerns me in the ability of pulling older revisions in Agile. What is your opinion? If you know Agile, do you know how to prevent this?

A company that I used to work for used Agile for QMS document control. I don't recall old versions being a major issue. If I recall correctly, the latest version is obvious, and you would have to take extra steps to find an obsolete version. I think they added an OBSOLETE watermark or footer to them in case someone printed an old copy of something.

As an internal auditor, I liked the document history logs tracking who opened the documents. During audit prep you could easily tell which documents were used (and which were not) and by whom. In one area I found that the only people who ever looked at the documents were the internal auditors. During the audit we discussed how we could make the documentation more useful for them.

[E Wall]

First let me be clear I do not know anything about 'Agile' software.

What I wanted to share is that (by description) we use something close to the same in controls. We use a portal format intranet, where the files are actually part of a db. Each document posting has two identifiers one for the content and another for the version (if your using hyperlinks to access be very careful which you are linking to). For documents, there is a 'tree' folder format and any folder main listing shows only the latest version but one can choose to see the details and access previous verions (posted by date).

In our system, the electronic posting is the 'controlled version'. All of our documents have a footer indicating only the electronic version is controlled and printed version are the user's responsibility to verify they are current prior to use. However, once posted you cannot change the posted file, so as a newer revision is posted there is no way to update the obsolete version with a 'watermark' or anything else (hence the additional benefit of the responsibility caveat).

For efficiency we use hyperlinks in logs/TOC and if you delete a document and then post the update this doesn't work well as then the link ID would change. As I update a document, I then print out the TOC list (electronic file) and update the html index. This is much simpler for my users to navigate then digging through folders (though that options still exists as that is where the file resides). I use the TOC format because the rule of thumb I was provided was 3-clicks; it should only take someone 3 clicks to access the information they are looking for.

There are numerous times when accessing an older version for comparision is needed. For my experience, most people don't go so far in depth to know there is even an option to get to the older versions. So far this has not been an issue for us.

[Watchwait]

Sounds like a very good system! Just curious - has your system been audited to Part 11 requirements?

[Juan Dude]

In Reply to Parent Post by howste

A company that I used to work for used Agile for QMS document control. I don't recall old versions being a major issue.

Same here, as a matter of fact Agile is great for Doc ctrl.