DMR (Device Master Record) For Contract Manufacturers

I work for a company in the US. We have a sister company in Ireland we are using as a contract manufacturer for some of our Class II devices. We own the design in the USA (i.e., we designed the device and maintain the DHF, DMR, 510(f), etc.), and the sister company in Ireland is ISO 13485 certified, but they took an exemption for Design Controls due to the fact that they do Not design devices, they only manufacture on a contract basis.

My question/concern is: They are maintaining a DMR in Ireland for all the devices they are manufacturing, is this necessary?

I’m thinking the “M” stands for “Master” for a reason. There can not be 2 DMR’s for the same device in 2 different factories.

Has anyone had a similar issue? How did you handle it?

If you look at the requirements for the DMR, you will see that it contains all the information used to manufacture the part. So the DMR will specific to the part and to the manufacturing location. Your Ireland plant needs prints, work instructions, inspection sheets, etc to make the part. Because they need documents to make the part, they need their own DMR.

Thanks Dave,

My concern is that the DMR is being maitained in 2 locations which seems like a problem waiting to happen. I'm not sure what the solution is, but I would like to reduce our exposure to documentation errors, and unnecessary paperwork.

Bill

I don't think it is as big of a problem as you might think. All of the product information (such as prints, bill of material, etc) need to be identical of course, but there could easily be process documents that vary from location to location. Differences could be due to various equipment type and ages, as well as local requirements for inspections, material certs, etc.

I kind of agree with Dave B but have a somewhat different take. The DMR doesn't need to contain the items maintained at either site; only needs to reference / identify them. Some sort of cooperative effort, though does need to be established. Maybe divide up the DMR into parts that the design center keeps / is responsible for and the parts that the manufacturing center keeps / is responsible for. At some point they need to come together to establish *THE* DMR for a particular build.

What I do is just have the DMR as an index. I also version the DMR so if build x uses one set of revisions of drawings / manufacturing instructions and build y uses a different set, I can always tell the difference.

Like Dave B does say, it's not (shouldn't be) a big problem as long as the lines of responsibility are clear and an overarching management approach is established.

Cautiom: ensure the labeing and packaging specs are respected in case the distributed product are identical in design. One possibility to ensure consistency is both sites utilize shared IT configuration management system. Good luck!

bkabitz said:

There can not be 2 DMR’s for the same device in 2 different factories.
They are maintaining a DMR in Ireland for all the devices they are manufacturing, is this necessary?

Click to expand...

There is only one DMR, for which the specification provider (not the contract manufacturer) is responsible. However, it's permissible for the DMR to be distributed. Master records and documents can be kept at two or more locations, as long as appropriate controls are maintained. If particular required information is kept at both locations for operational convenience, you must establish and maintain clarity via the applicable controls as to which is the master version of a particular required item of information, and which is a dependent copy.

In your case, since the contract manufacturing site in theory is not participating in design, it might be hard to justify to FDA why their version of an item of DMR information was the master and yours was dependent.

They on the other hand might maintain the master version of the DHR, i.e. the production records.

Hello Everyone,

I am a Design Engineer in a startup medical device company, i have been assigned the responsibility of creating a Device Master Record. In most of the articles i see a complete set of DMR documents to be referred.

But our problem is, we only design and develop the device and we have our contract manufaturers for manufacturing after design freez. The DMR index i have created is attached herewith. The confusion is that i dont have any controlled document for the manufacturing what they use for them like equipment maintainance procedures, blank work forms , etc. So should i have to include them too in our DMR??
Thank you in advance!!

The DMR can be distributed, i.e. you would have some of the DMR info, and the contract manufacturer would also have some of the info.

You = Design History File, Drawings, BOM, component/subassy specs, labeling, IFUs, shelf life, sterilization, etc. Do you inspect the devices? If so, you would have those inspection document numbers listed if you have an "index" type of DMR.

Contract Mfg = Manufacturing procedures, some sort of reference to the design documents they received from your company, Inspection procedures, testing procedures, etc.

You, as the designer, would do "design transfer" of many of the documents to the CM, and the CM would take those documents and (in most companies) keep that information in a product file, and transfer that information into their documentation system, i.e. their own drawing numbers, part numbers, etc. As a contract manufacturer, sometimes we dictated the manufacturing procedures, and sometimes they were dictated to us and we had to provide the manufacturing specs to the Spec Developer (design house). If those docs changed, then the Spec Developer also had to sign off on the change order.

You need design control.
You need supplier change control, i.e. the changes that your supplier wants to make should be approved by your company before they make any changes to your product.

Things like equipment maintenance should be covered in your audit or inspection of their site in your supplier approval SOPs. Your supplier "should" have a QMS as well that addresses design transfer, change control, etc.

This is not a comprehensive answer, but should get you further down the road.