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

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MyronW

#72
#72
I have pored over this entire thread, along with every other thread on the subject that I can find, and I am more than intrigued. Applying the wiki concept to a QMS was a stroke of genius!
I work for a medical device manufacturer (class 2 devices), and one topic that I have not seen discussed is Part 11 compliance. Sharepoint has many controls in place that will bring the system into compliance, but what about the other wiki engines that are driving QMS systems? I don't want to merely migrate our entire PDFs-in-folders system over to a wiki and end up with a PDFs-in-wiki system; I think that would be a waste of time. The collaboration that a wiki brings will make our system much, much better, and I want to do it right from the beginning.
Oh yeah- I am a total noob with the wiki stuff. Maybe that's for the better...
 
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Brizilla

Brizilla

Quite Involved in Discussions
#73
#73
So, how would you generate Corrective actions from a WIKI? Most CA at my company are customer driven. They request an 8D. We currently use an Access db to do that. Is it integratable?
 
Pancho

Pancho

wikineer
Super Moderator
#74
#74
Brizilla said:
So, how would you generate Corrective actions from a WIKI? Most CA at my company are customer driven. They request an 8D. We currently use an Access db to do that. Is it integratable?
Click to expand...

Databases and wikis indeed complement each other. Structured data, like CARs and CAs are better handled in a database. We use Bugzilla, an open-source issue-tracking system accessible through a browser. Browser accessibility is nice because you can link back and forth between the database and the wiki.
 
C

cmeby

Involved In Discussions
#76
#76
I find this idea VERY intriguing, since I maintain a QMS for a software development company and the employees use wikis more than other traditional document systems.

In the past we have 'incubated' the necessary information in the wiki and then exported it to the Doc Mgmt SYstem. This was because we could not get the wiki functionality to do what we needed to be compliant. I would like to know more about how you did this!!!

A question:
How do you show Approval or Effective status in the Wiki? Can you share a screenshot?

Thank you:bigwave:
 
Pancho

Pancho

wikineer
Super Moderator
#77
#77
Hi Cmeby,

I've seen three ways to handle drafts/reviews/approvals.

  1. Have "draft" document pages. When a draft document passes the review/approval, the doc controller updates the links and makes the draft current.
  2. Changes go live immediately. Empower users to approve their changes, and ask for a parallel review by process owners (this is the method we use).
  3. Use a workflow plugin such as Comalatech's Ad-Hoc Workflows.
The first two are described in a bit more detail in the discussion Wiki vs. Controlled Documents - Eliminating Conflicts.

Here is the screenshot of the approval/effective status note in our QMS:



​
 
Le Chiffre

Le Chiffre

Quite Involved in Discussions
#78
#78
Here's the simple technique I use that satisfied our auditors and isn't too cumbersome or restrictive on normal wiki expectations.

A new wiki article that will one day become controlled is tagged with a banner like this to warn readers that it hasn't been reviewed and to remind the author(s) to get it reviewed and controlled.



A new wiki article that is never intended to become controlled is tagged with this banner



Once an article has been reviewed, the review evidence is written into the article's discussion tab and the article is tagged with


The wiki's "permanent link" feature is used to label the most recent controlled revision so it can be recalled as required. The banners are inserted via the wiki's templates (macros) that also add them to the corresponding wiki category - Draft, Controlled, or Uncontrolled.
 
Le Chiffre

Le Chiffre

Quite Involved in Discussions
#80
#80
If you're interested in the wiki markup that the banner templates use I'd be glad to share. The dates use wiki magic words to be fully automated. The article's history captures the auditing trail including the approval date(s), authors/editors, etc.
 
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