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

[eboelen]

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]

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.

 

[eboelen]

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]

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

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

 

[FRA 2 FDA]

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.

 

[rogerpenna]

So, we are finally releasing our Wiki Knowledge Base.

I think the coolest thing I was able to do with XWiki is that I created pages for all departments. And each document has a responsible department that is selected with a dropdown menu when creating the doc.
The department pages then show in tables, by type of document, all documents that department is responsible for, no matter WHERE the doc is located in the Wiki.
Another cool thing is integration with iDraw diagrams. So I can create process diagrams (which have version as any page) where each task can be LINKED to a procedure OR department or person.
So you are reading a diagram and one task is, let's say "Access Probability and Impact of Risk". But how the hell do I do that? I click on that task and it takes me to the procedure, work instruction, whatever, of that task explaining it.

I can also attach Risks to each task, etc.
As people WILL want to print copies of some documents, as seriously, many times it's impossible to do everything on screen, I was able to add PDF Printing Templates where there is a footer with information, and a header with logo, DATE OF PRINTING and a warning that the document is only valid for 7 days after printing.
Still in doubt if after 7 days printed documents should be discarded (or be marked and have their blank verse used for drawing stick figures while on a meeting) or thrown in the trash bin.
Another doubt is how to inform users of the new document that's important for them.
XWiki allows users to "watch" documents... that THEY decide to watch. So they get screen notifications and emails.
It's also possible for someone to make comments MENTIONING other users... so I can for example make a comment "@JohnDove Check this new WI so you won´t die again!"
But I can´t do it for groups.
Maybe should just be training... and checking at audits if users are watching all required pages. Maybe have a procedure what pages users should watch.
It would be awesome if XWiki had a Group Watch feature... where I could just push a page, by mentioning it to an entire group of users. (groups of users already exist for permissions, etc)

edit: I could swear I could take screenshots and post directly at the forum, like I did two posts above. Can´t do it anymore apparently. Only insert media through links?

 

[Randy]

Wow, I've seen large (1000+) companies get by with MS Office just fine. Got a couple using Google Doc's as well, no problem. Y'all seem to create headaches that aren't necessary.

 

[rogerpenna]

Wow, I've seen large (1000+) companies get by with MS Office just fine. Got a couple using Google Doc's as well, no problem. Y'all seem to create headaches that aren't necessary.

Hi Randy, thanks for your input.

Well, the same companies, if old enough, also got by with typewriters and real paper spreadsheets in the 70s, right? I am a young 1979 man, so I remember electronic typewriters in my dad's office, but I have no idea how they managed to work without computers back then

I am not sure what headaches you are talking about Randy... if my questions of how do to this or that are the headaches you mention.

If those questions I made are what you mean with it, I think the headaches are not being created. They already existed. When the documents were created in word and controlled through a Excel Spreadsheet (until around 2010 in my company).

Document Control problems already existed here for a loooong time. Many were sweapt under the rug. And it was stagnant, there just to conform to the audits, but useless to the company. Not used in reality. I am trying exactly to make it more dynamic and have employees USE it instead of keeping the files they need in the hard drive, UNCONTROLLED, and just fix and check stuff before external audits.

One common problem was a department or job to be mentioned in a task of another process/procedure that was, by face value, not related to that department/job. So they would never read that document. The old personnel maybe knew they had to do it. But when changes ocurred, the new personnel would just read the documentation they KNEW was theirs and not that other department's that needed them to complete a task.
The Wiki changes that because of backlinks.

 

[Randy]

Well whatever, you probably get around and have been around more than me. I just know from 1st hand experience that (not surmised conjecture) that the vast majority of document control problems start with people and not process, or control tool. The easiest, low hanging fruit for a 3rd party auditor is, has been and will always be document control and it doesn't matter what fancy database that costs tons of $$$$$ there is.........I myself love the "We will review every document every year and twice on Sunday's" statement........My 1st move is capturing their definition of "YEAR" and it can go down the toilet from there.

Have fun.

 

[rogerpenna]

vast majority of document control problems start with people and not process, or control tool.
I agree, and I guess you are talking about training? I would say it's not only training, but auditors never agree when Root Causes found are people... you are almost always supposed to find the root cause of a non conformity is the process...

doesn't matter what fancy database that costs tons of $$$$$
fortunatelly, except for human time, XWiki cost us $0, as it's open source and we already had the servers.

I myself love the "We will review every document every year and twice on Sunday's" statement........My 1st move is capturing their definition of "YEAR" and it can go down the toilet from there.
i hate time definitions to review documents. Better to just review them in internal audits. And make it part of the process for internal audits, which happen a once, twice or thrice a year, to find the outdated documents that don´t match reality. And the Non Conformity shouldn´t be seen as really a non conformity, just a warning to update the document. I think it works better than periodic reviews that don´t really happen the way they should.

Like our Bidding Department relies on Bidding Law 8.666, which has remained unchanged for 27 years. The bureaucratic procedure required the department head to review the document annually to confirm it was up-to-date... in case the law had changed.

It's her job. The Bidding Law would NEVER change without her knowing. She knows the law, which is 126 pages long, by heart.

So is it really necessary to have her go through the bureaucratic process every 12 months to confirm the law hasn't changed?



ps: I asked ChatGPT to answer my question in the last sentence

Regarding Document Control procedures in accordance with ISO requirements, particularly ISO 9001, the scenario described raises several considerations:

1. Regular Reviews: ISO standards typically require regular reviews of documents to ensure they remain current and applicable. This helps maintain the integrity of the quality management system. Even if a law hasn't changed in many years, regular reviews ensure that the organization is vigilant and prepared for any changes.
2. Efficiency vs. Compliance: While it may seem redundant to review a document annually when the responsible person is well aware of any changes, this practice ensures compliance with ISO requirements. It also provides a formal record that the document has been reviewed and deemed current, which is crucial for audits.
3. Risk of Over-Reliance on Individual Knowledge: Relying solely on an individual’s knowledge, even if they are highly knowledgeable, can be risky. Formal reviews ensure that there is no oversight and that the information is cross-checked and verified.
4. Documentation of Changes: ISO standards emphasize the importance of documenting changes. Even if no changes have occurred, the act of formally recording a review can serve as evidence of compliance during audits.
5. Potential for Streamlining: While compliance is essential, there may be opportunities to streamline the process. For instance, if a particular document is unlikely to change, the review frequency could potentially be extended, or the review process could be simplified, provided that this is justified and documented in the quality management system.

In conclusion, while the described procedure may seem bureaucratic, it aligns with the principles of ISO document control by ensuring regular reviews, maintaining records of compliance, and mitigating risks associated with over-reliance on individual knowledge. However, exploring ways to streamline the process without compromising compliance could enhance efficiency.

gosh, go to that place ChatGPT.