Revision Reset for documents and components

Bev D

Heretical Statistician
Leader
Super Moderator
do you have a boss? Have you shared your concerns and the risks with them? Have you shared the risks with those in your company that will be affected? Have you tried to get input from those affected as to how you can deal with this together? Again I’m not really sure the IT people are being honest about the system.
 

Golfman25

Trusted Information Resource
Hi, Yes it is kind of deal breaker if i knew it. But this eQMS implemented when I started work here. So it is really making headache for me.
So google is your friend. Search for your issue and see what comes up. Or contact the software tech support directly. My guess is there is a misunderstanding somewhere.

For example, I have a customer using one of the biggest ERP/Management systems out there. They can't figure out how to to a foreign wire with a beneficiary bank (a very common occurrence). A google search brings up many solutions, built into the software. They are just stuck on "we can't do it."
 

Tidge

Trusted Information Resource
This is unbelievable.
Either your eQMS guy (internal IT or your sales/tech rep) is lying to you (out of ignorance or laziness) OR you just bought a really BAD eQMS. Revision control is one of the critical linchpins of a QMS let alone a business. For your eQMS to require a rest is a serious and disqualifying miss. If it really does require a reset then I have to question what else is it gong to do wrong putting your entire system and business at risk.
(+1) I supervised a project that migrated tens of thousands of inter-related items from one eQMS to another. Revisions control (including transfer) was a key feature, and ultimately was one of the least problematic issues with the migration.

If it is legitimately impossible, then a solution is to obsolete all the current documents and re-release them with new unique identifiers... and enjoy all the effort to remediate that.
 

Raisin picker

Quite Involved in Discussions
One solution might be to submit all documents in the original first revision and then add newer versions until you are at the current revision. This sounds like a fun thing to do for the next weeks or months, and completely without risk of errors ;-) Ask your boss if he wants to pay for this.
The benefit would be that you have all revisions in one system.
 

joezilla86

Starting to get Involved
(+1) I supervised a project that migrated tens of thousands of inter-related items from one eQMS to another. Revisions control (including transfer) was a key feature, and ultimately was one of the least problematic issues with the migration.

If it is legitimately impossible, then a solution is to obsolete all the current documents and re-release them with new unique identifiers... and enjoy all the effort to remediate that.
Yep, I refuse to believe that a company in 2024 (focused on serving a high-level compliance need, no less) is unable to do this. It would be such a glaring deficiency of working with them. They would effectively be limiting their customer base to brand new companies who haven't done anything yet and gullible rubes.
 

Sierra

Registered
We did this at my company when we moved all of our documents into a new eQMS. We wrote into the plan that all documents would start at revision 1. The catch, though, is that we were harmonizing across several sites so all of the documents received a new document ID (most contain a revision history table and we kept the legacy document ID in the header) and our prior system used a long (5-digit) revision ID so the new one was quite obvious. One of our other sites, however, was using 1, 2, 3 and switched to 1, 2, 3... They wrote this in the plan and as soon as the documents were revised for the first time, they created and identified a new revision history table in the document to clarify revisions after MON-YEAR. Can you leverage the version coupled with its implementation date somehow? Or maybe create a plan for high-risk documents like the drawings to push a revision number through somehow and let other documents go in as "1" due to less risk? Would create less work but still protect the most important things. (Curious about the eQMS company, too!)
 

Bev D

Heretical Statistician
Leader
Super Moderator
Nobody should have to do this stupid no value add waste of time confusing workaround. This is just slacker lazy less-than-mediocre product development - for a QUALITY Management System!?
 

ScottK

Not out of the crisis
Leader
Super Moderator
I've done this like 15 or so years ago. It was not a problem for our ISO 9001 and 13485 registrar/auditors or for the FDA when they inspected.... as long as you document what you did and where the prior revisions are stored.
Very similar to what Sierra says above.

of course, knowing what I know now, I would not buy a system that doesn't let me start with custom revisions.
 

Enternationalist

Involved In Discussions
Write up an estimate to your boss of the cost in hours of dealing with changing the numbers and revisions of every single document in your system. Then write them an estimate of the cost of getting a system that's not a piece of junk.

See what they say. If your boss really does make you reconfigure the whole thing after seeing the abysmal value proposition, make sure you get this eQMS provider on a tight-leash contract. Paper doesn't have this limitation, for god's sake.
 
Top Bottom