E
evaedge
Hello everyone
First of all, so glad that the Elsmar Cove is back!
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!!
First of all, so glad that the Elsmar Cove is back!
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!!