Challenges in document control, revisional control, and change control

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evaedge

Hello everyone :bigwave:
First of all, so glad that the Elsmar Cove is back! :D
I wonder if anyone can share their experience how BOMs, drawings, manufacturing instructions, and inspection procedures are linked and controlled in their company...?
My company makes active medical devices.
At our company, the BOM dictates what and how to make a device. The BOM itself has A revision, all components listed on it have revision (the revision of the drawing). It also includes the manufacturing instructions, final acceptance procedures, labels, etc. Everything is controlled and has revision. The problem is, every time any of those documents is changed, the BOM revision has to change, and this goes through a ECO review and approval process. Then Finance creates the new BOM and component revisions in our manufacturing control system (MiSys). The Finance and Operation departments have been complaining that it is very time consuming to go through this process, because we go through changes several times a year. If a Work Order is issued in the beginning of month, and then a change goes through, they have to do a deviation because they are not building to the latest BOM anymore - even if the change is just a document change and does not affect the actual component. I hope I'm explaining our challenges clearly... because frankly I'm confused too...:(
Thank you in advance for your help!! :thanx:
 

rob73

looking for answers
Sounds like you have a fairly robust system in place. Unfortunately there are no "easy" ways around this, IMHO document and revision control is one of the most difficult aspects of any QMS. If it works (albeit slowly) don't change it.
 

yodon

Leader
Super Moderator
Certainly agree with Rob. You *want* those controls in place to be sure everyone is on the same page (so to speak).

That said, there may be some opportunities to streamline. Are the changes for like parts (maybe the same part / different vendor)? If so, maybe you can ensure both parts are, truly alike (effectively interchangeable) then list both parts on the BOM as options.

However, if it's truly design changes, I think an introspective look is important to ensure nothing else gets broken.
 

Project Man

Involved In Discussions
We also manufacture medical devices and we chose to omit the rev level when referring to them in the higher level documents (i.e. Doc# 12345 instead of Doc#12345 Rev A). This allowed us to still follow our procedure of "reviewing all related documents" but we didn't actually have to revise the higher level documents for minor changes to lower level documents.
 
B

BoardGuy

It really sounds like it time to open a preventive action on this process and form a team to review the current method and to define a new method based on process owners input.

Of course you will need to meet the applicable QMS (ISO 9001 or ISO 13485) and/or regulatory body requirements but you definitely should take some action.
 

mihzago

Trusted Information Resource
In one of the companies I worked for, we had two types of changes (actually more, but two relevant to this discussion), namely 'Design', and 'Documentation".
Documentation type was reserved to minor changes to documents that do not affect the component or design. The amount of documentation and approvals required to process such change was much less than a full 'Design' change.

Also, not sure if you system supports it, but rather than referencing document revisions, we would have links to documents/records, and instead of updating each document to change the rev, we would just modify the link.

If you don't have the linking capability, then maybe you could create a table/matrix, which lists each document and version that you could manually update for each change. It's tedious and error prone, but may be better than updating each document just to change the rev.
 
E

evaedge

It really sounds like it time to open a preventive action on this process and form a team to review the current method and to define a new method based on process owners input.

Of course you will need to meet the applicable QMS (ISO 9001 or ISO 13485) and/or regulatory body requirements but you definitely should take some action.
Thank you BoardGuy! That's a great idea to open a Preventive Action to review this process. Our Management Review is coming up next week and this is one of the items that I'd like to include this in the discussion/recommendation.
 
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evaedge

Sounds like you have a fairly robust system in place. Unfortunately there are no "easy" ways around this, IMHO document and revision control is one of the most difficult aspects of any QMS. If it works (albeit slowly) don't change it.
Hi Rob - I agree with you. Document control and revision control is probably the most difficult part of the QMS. We definitely want to keep it in control but also try to find a way to streamline it like Yodon mentioned - I just don't know how.... so I would like to find out how other companies handle this process and hopefully find a way that suits us. :)
 

pbojsen

Involved In Discussions
Wow! Sounds painful. This is how we've done it at the last few companies I've worked for in medical devices.

1. The Device Master Record is the document that tells you how to make something. It lists manufacturing specs, quality specs, drawings, etc. It is numbered according to the finished goods number, i.e. product 12345 will have DMR-12345. The tricky part is manufacturing personnel having access to these specs on the floor.

2. The BOM is a document and listed in the DMR as a document.

3. For the components, we do not list those specs on the DMR, we say "see BOM" as all of the items on the BOM have a spec. Each spec (includes ALL specifications including electronic "documents" such as the BOM) is controlled separately.

4. We don't reference revs on the DMR (except maybe a drawing rev = design change), only on the specs themselves.

This cuts down on revisions.

Why is Finance doing BOM changes? Your document control people should be inputting this stuff into the ERP system, notifying Finance when ready for financials to be input. BOM change = engineering change.

I've done document control and doc control/change control systems for a number of years, and you need to keep it as simple as possible or you'll be buried in "no value added" work.
 
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