How to answer ISO9001:2015 audit finding of old revisions of documents being used?

#1
We have a Master Document List, but when people re-save the forms on their desktop or personal computer, we then lose control when the form changes, although notified of the change, they don't always re-save the most up to date revision to their local computer. Here document control is not effective. How do you handle this issue?
 
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JimS

Involved In Discussions
#2
One source of truth! There can only be one location to released documents, whether it's in a DMS system, SharePoint, even a controlled share folder. But it sounds like you need some good training to change the culture. Users should not be saving controlled documents to their own computer. Ever.

The reality is that you'll probably never eliminate it completely. But if you make the controlled location easy for everyone to access and push out the message that uncontrolled copies can really cause problems, you might minimize it. Get some managers involved. This really is a company culture thing. If it's seen as acceptable and no big deal, then no one will make an effort to find the right revision. If they're printing their own copies, there are various versions of "Uncontrolled When Printed", even with a time stamp and "invalid 30 minutes after printing" that can be in footers to help remind folks.

But it's a culture issue. You have to turn local copies into a bad thing. The Quality Manager should be able to help (unless that's you...?)
 

blackholequasar

The Cheerful Diabetic
#3
I have had the same issue working at a paper based company. The end resolution was to create digital "binders" for each area that contained all the forms and documentation that they needed with hyperlinks to the controlled location. They could only access documents from this hub - and were trained NOT to save documents to their desktops. Unfortunately, there is no possible way to make absolutely sure this is being done outside of doing a desktop audit. So the training served as record and those who had repeated offenses for not following the process were written up and dealt with by their management.

It's actually much more difficult to create a controlled document setting than one would think. If there is a way for folks to take shortcuts, they usually will
 

Ron Rompen

Trusted Information Resource
#5
Hyperlinks to a master document directory is a possible solution, and fairly easy to implement. You will still, however, have the problem of users saving documents on their desktop because it's 'easier'. You need to (somehow) change the mindset of people, so that they STOP seeing it as being easier, and just see it as being wrong
 

Jim Wynne

Staff member
Admin
#6
What type of audit?

If important requirements are not fulfilled, and there are no uncomfortable consequences for offenders, the behavior won't change. The question here is not about discipline, per se, because if the door is left open people will continue to pass through it. How you prevent the problem from happening is the question. The hyperlinks idea is okay as far as it goes and should probably be implemented, but it won't prevent.

I gave up on trying to control forms a long time ago, using the simple expedient of controlling the information that must be recorded, and providing a "convenient format" for doing so. Create documented requirements that tell what must be recorded, and control that document.
 

Scanton

Wearer of many hats
#7
I work for a small manufacturing company and I have a single document on our server that acts as a portal to all things related to our QMS, using hyperlinks to all of our forms, procedures, reports etc. These are password protected to prevent change, and there is a shortcut on every PC (using the same tree icon) so that everyone has access to it.

When I started here 10 years ago it took much effort and badgering to get everyone to use this instead of keeping digital and hard copies locally. Making an example (and plenty of noise) when errors occurred because or using the wrong issue document also helped everyone understand that keeping local copies was a bad practice.

The main reason people kept stuff locally was so it was easy to find, so make whatever you are directing them too just as easy to navigate. We have not had any issues with this in over 8 years, and if you would like me to share my basic (word based) system with you, just PM me.
 
#9
It's true that you can only do so much. Awareness is key followed by making access to the needed forms, documents, etc as simple as possible. I just started at a med dev start up a few months ago and among my hats is document controller/ QA manager. My first project was to take a very messy, very mismanaged QMS and basically start anew. No one here had much, if any, concept of document control so awareness training was the next big step. Fortunately both because we are very small (only 9 of us!) and because no one had any pre-existing bad habits it seems to have taken root pretty well. But because I can't control everyone (apparently document controller isn't as all-powerful as it sounds :p) only time will tell how lucky I've been.
 
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