Revision Reset for documents and components

evan_kim90

Involved In Discussions
Hi, all

I have quick question regarding for revision.
So our company started implementing to use eQMS from our original QMS.
The problem is all revision has to be reset.
The SOP or other documents I created revision history and explained revision is going to 1 because of transition to eQMS.
But I do not know how can we do for components or design parts revision.
Is it okay to reset revision for components or design drawing or parts?
If we reset, there is any issue will be from standards (ISO13485. MDSAP, FDA, and MDR)
 

Bev D

Heretical Statistician
Leader
Super Moderator
Why do you have to reset? Any software system worth anything should allow you to simply continue. Reset has many risks.

Here’s a thought: ask your IT person to reset their salary to their first job
 

mattador78

Quite Involved in Discussions
Is the issue with the items being dragged over to your new system from your old? If thats the case it would be just as easy up rev them all once they are added to the required revision? If Part and drawing numbers are the same surely the obvious solution would be the easiest. As Bev has stated your IT should be able to sort this or your new EQMS provider. If not its the easiest option i can think of if not you are basically submitting "old parts"
 

evan_kim90

Involved In Discussions
Is the issue with the items being dragged over to your new system from your old? If thats the case it would be just as easy up rev them all once they are added to the required revision? If Part and drawing numbers are the same surely the obvious solution would be the easiest. As Bev has stated your IT should be able to sort this or your new EQMS provider. If not its the easiest option i can think of if not you are basically submitting "old parts"
Hi, I discussed with eQMS provider but they said we cannot edit revision in system so we have to reset our revision. I know it is risky for parts drawing so I am consider I have to keep old revision in note in eQMS and keep update manually. And just double checking any standards issue.
 

evan_kim90

Involved In Discussions
Why do you have to reset? Any software system worth anything should allow you to simply continue. Reset has many risks.

Here’s a thought: ask your IT person to reset their salary to their first job
I do know why but eQMS provider said it is not possible to change because it is automatic system...
 

jmech

Trusted Information Resource
Hi, I discussed with eQMS provider but they said we cannot edit revision in system so we have to reset our revision. I know it is risky for parts drawing so I am consider I have to keep old revision in note in eQMS and keep update manually. And just double checking any standards issue.
This is risky for all your QMS documents, not just the drawings. It is more than a standards issue - it is an issue for ensuring that you order, manufacture, inspect/verify, and sell products that meet the correct revisions.

A note in the eQMS will not solve this problem - it would also have to be referenced in your purchase orders, manufacturing plans, inspection instructions, sales documents, and more. Doing this manually will inevitably lead to (potentially costly and/or dangerous) errors.

One possible work around that reduces (and possibly eliminates) these risks is to switch to a different revision counter or add a prefix to your revision counter. For example, if you currently use 0, 1, 2, 3, ... for revisions, switch to A, B, C, D, ... or to e1, e2, e3, e4, ...- this would ensure that the revision numbers are unique and not duplicates. However, this could still require a significant effort for you to revise all your document revisions, and there is a chance of making mistakes in the process.
 

evan_kim90

Involved In Discussions
This is risky for all your QMS documents, not just the drawings. It is more than a standards issue - it is an issue for ensuring that you order, manufacture, inspect/verify, and sell products that meet the correct revisions.

A note in the eQMS will not solve this problem - it would also have to be referenced in your purchase orders, manufacturing plans, inspection instructions, sales documents, and more. Doing this manually will inevitably lead to (potentially costly and/or dangerous) errors.

One possible work around that reduces (and possibly eliminates) these risks is to switch to a different revision counter or add a prefix to your revision counter. For example, if you currently use 0, 1, 2, 3, ... for revisions, switch to A, B, C, D, ... or to e1, e2, e3, e4, ...- this would ensure that the revision numbers are unique and not duplicates. However, this could still require a significant effort for you to revise all your document revisions, and there is a chance of making mistakes in the process.
That is exactly what I am worrying about. Unfortunately, we are using numbers but eQMS also using numbers. I really do not know how I can figure it out.
 

Bev D

Heretical Statistician
Leader
Super Moderator
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.
 

joezilla86

Starting to get Involved
This is unbelievable.
Wither 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.
Agreed, this is insane. If the system is so automated, then how can they accept even the existing document numbers? They have to be doing an import of some kind and it makes no sense that revs can't be imported as well. This alone would be a deal breaker for me with that eQMS vendor.
 

evan_kim90

Involved In Discussions
Agreed, this is insane. If the system is so automated, then how can they accept even the existing document numbers? They have to be doing an import of some kind and it makes no sense that revs can't be imported as well. This alone would be a deal breaker for me with that eQMS vendor.
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.
 
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