DMR - Device Master Records - What is the best way to structure the DMR

[leonorhelena]

In my experience as OEM and contract manufacturer, when we became a contract manufacturer we had a Quality Agreement with the OEMs that we would have a "distributed" DMR. That means we had a DMR for our portion of the work, e.g. as a manufacturer we had manufacturing instructions, quality inspections, product release, etc. in our DMR. In the DMR we had the customer's name, which we also put as a part of the document number so it was easy to find (pre-EDMS). The DMR, for us, was an approved, controlled document that referenced all of the other docs that were required to make a device. For the components, we referenced the Bill of Material in the ERP system so we wouldn't be revising the DMR for that. Each document in the DMR was required to be approved and released before the DMR could be released. This was our control that everything was in order before the product was released. This was for Class II and III devices. If you have lower risk devices you could probably get away with a family DMR that has common manufacturing instructions for the device, and refer to the BOM for specifics on components. Each component should also have their own specification (not referenced in the DMR). The DMR was more of a high level document that we didn't want to revise unless we had to, so we referenced other systems where we could. Still, all drawings and specs were released, and we made sure of that during the BOM review.

Hello,
can you clarify again what would a distributed DMR would have? we do have some of the technical drawings and material specifications for some of our OEM products but some of the companies we buy from are not very responsive and asking for more documents is a hassle.

thank you in advance.

 

[pbojsen]

Hello,
can you clarify again what would a distributed DMR would have? we do have some of the technical drawings and material specifications for some of our OEM products but some of the companies we buy from are not very responsive and asking for more documents is a hassle.

thank you in advance.

First, you are not responsible for the activities that you don't do. Those would be with the OEM because a) you don't have them/do that activity, and b) they're not your responsibility. You really should have something in a Quality Agreement that addresses this, plus an NDA between you. For your DMR you would not, for example, have a manufacturing spec number if you don't manufacture, or likely even a drawing of the device. If you package, you would likely have an incoming inspection document, definitely your packaging doc numbers, release procedures, etc. For the BOM, I would just reference the BOM in the ERP system. Without actually seeing what you have, that's the best advice I can give you.

I know as the OEM we had all of the information, but when we went to being a contract manufacturer for the exact same product, we took the Tech File info off, for example, because it wasn't under our control and we had no copy. We did put the drawings, manufacturing specs, packaging specs, labeling, inspections, release, etc. but we actually had those controlled documents and used them.

 

[leonorhelena]

First, you are not responsible for the activities that you don't do. Those would be with the OEM because a) you don't have them/do that activity, and b) they're not your responsibility. You really should have something in a Quality Agreement that addresses this, plus an NDA between you. For your DMR you would not, for example, have a manufacturing spec number if you don't manufacture, or likely even a drawing of the device. If you package, you would likely have an incoming inspection document, definitely your packaging doc numbers, release procedures, etc. For the BOM, I would just reference the BOM in the ERP system. Without actually seeing what you have, that's the best advice I can give you.

I know as the OEM we had all of the information, but when we went to being a contract manufacturer for the exact same product, we took the Tech File info off, for example, because it wasn't under our control and we had no copy. We did put the drawings, manufacturing specs, packaging specs, labeling, inspections, release, etc. but we actually had those controlled documents and used them.

Agree, as an OEM you don't manufacture anything, and at some points like you mentioned you do have some of the technical files but are not necessary to use since we don't manufacture them. As per your advice, we should only show the steps and procedures we are involved in and show for the rest, the NDA and the quality agreement between the two parties.

Thank you for all your help I am a beginner trying to figure out how to do all of this.