Interesting Discussion Using a Wiki to implement a Quality Management System (QMS)

eboelen

Registered
How do your company, with Confluence, handle ISO "documented information" requisites, like copy control, approvals, etc, etc?
Actually, that was the easiest part, as "Document Control" (4.2.4 and 4.2.5 in ISO13485) is almost an out-of-the-box feature. Page history (who wrote what when) is included. For Approval you need to use a plugin called Comala Document Management.
 

rogerpenna

Quite Involved in Discussions
It's free up to 10 users, so ideal for startups. Unless you want permissions (which you don't need initially, but at some point you do), you have to upgrade to the paid version. Indeed you pay per user and you want all employees to be users, but also that is affordable imho, especially if you compare it to the pricing model of dedicated eQMS platforms. Plus it eliminates the use of paper notebooks for meeting notes ;)
Still, the greatest value comes from being your central knowledge-base, so your team saves a lot of time searching for internal information.
We have 300 employees and paying R$15 thousand per month is prohibitive just for the knowledge base system. For R$1500 a month (10 times less) I can get an awesome system that is both a Document System and a Business Process Management System which would allow me to created Automated Business Processes for all QMS needs, and have 25 users being able to log in simultaneously (and 300 users in total)
Which is why an Open Source solution like XWiki is very cool for me.



What about control of copies? I mean... if someone prints a copy, how do you garantee the old copy won´t stay with the person even when the document is updated? I suppose every print is considered uncontrolled (only documents IN THE WIKI, online, are considered controlled) and then there is good training that copies/prints should not be used for more than a couple of days.
 
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eboelen

Registered
We have 300 employees and paying R$15 thousand per month is prohibitive just for the knowledge base system. For R$1500 a month (10 times less) I can get an awesome system that is both a Document System and a Business Process Management System which would allow me to created Automated Business Processes for all QMS needs, and have 25 users being able to log in simultaneously (and 300 users in total)
Which is why an Open Source solution like XWiki is very cool for me.



What about control of copies? I mean... if someone prints a copy, how do you garantee the old copy won´t stay with the person even when the document is updated? I suppose every print is considered uncontrolled (only documents IN THE WIKI, online, are considered controlled) and then there is good training that copies/prints should not be used for more than a couple of days.
The choice is yours! I can't really remember why XWiki didn't work for us, I think we found Confluence easier and prettier?! Maybe at that time the GUI wasn't that good? And we had ~10 users, so we thought 5,75$/user/month is worth it.

Regarding copies; we don't print hardcopies, we do everything digitally. I do think paper is impossible to control; as you say, the printed copy can't tell you there's an updated version available. Although perhaps you could put a timestamp whenever you print and define the expiry date as the printed date + X days?! But maybe that is a separate discussion...
 

rogerpenna

Quite Involved in Discussions
It's possible. I have added plenty of extensions AND a nicer skin with colors I liked to XWiki.

Here is how my XWiki test site looks
Using a Wiki to implement a Quality Management System (QMS)


If I went for looks, Bookstack looks simple, clean and great, though it lacks many features
 

FRA 2 FDA

Involved In Discussions
What about control of copies? I mean... if someone prints a copy, how do you garantee the old copy won´t stay with the person even when the document is updated? I suppose every print is considered uncontrolled (only documents IN THE WIKI, online, are considered controlled) and then there is good training that copies/prints should not be used for more than a couple of days.
This isn't unique to Wikis. Not matter what system you use, you either must have a very strict system to control paper copies, much of it training (dos and don'ts based) or you can't control at all.
 
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