DMR (Device Master Record) Revision Requirements? FDA GMP Manual

[Watchwait]

In reviewing the current FDA GMP manual, I see no specific requirement that a DMR, as an item, be revision controlled. Clearly, the individual records comprising the DMR need revision control, but I was somewhat surprised to see that the DMR ITSELF does not, per the requirement, need to be revision controlled. I find this interesting as most organizations (except my current one) do revision-control the DMR. Consequently, the DMR always needs updating when one of it's components is revised. Again, given no requirement to do so, why do organizations typically create this additional burden for themselves? Conversely, if someone can identify a procedural requirement to control the DMR as an item, I'd appreciate their input!

[GStough]

Originally Posted by Watchwait

In reviewing the current FDA GMP manual, I see no specific requirement that a DMR, as an item, be revision controlled. Clearly, the individual records comprising the DMR need revision control, but I was somewhat surprised to see that the DMR ITSELF does not, per the requirement, need to be revision controlled. I find this interesting as most organizations (except my current one) do revision-control the DMR. Consequently, the DMR always needs updating when one of it's components is revised. Again, given no requirement to do so, why do organizations typically create this additional burden for themselves? Conversely, if someone can identify a procedural requirement to control the DMR as an item, I'd appreciate their input!

We have our DMR (Device Master Record) in our QMS as a controlled document, but none of the elements listed in it have a revision level tied to them, so I don't think we'll have to revise it very much at all. The one device we manufacture has not changed since its development (several years ago).

[Phil Fields]

For a good explanation of the DMR and reference to 21 CFR Part 820 obtain a copy of "The Quality System Compendium, GMP Requirements & Industry Requirements." This is available through the Association for the Advancement of Medical Instrumentation (AAMI). I received a copy of this through a FDA seminar, it gives both the FDA interpretation and Industry practice.

[yodon]

Originally Posted by Watchwait

In reviewing the current FDA GMP manual, I see no specific requirement that a DMR, as an item, be revision controlled. Clearly, the individual records comprising the DMR need revision control, but I was somewhat surprised to see that the DMR ITSELF does not, per the requirement, need to be revision controlled. I find this interesting as most organizations (except my current one) do revision-control the DMR. Consequently, the DMR always needs updating when one of it's components is revised. Again, given no requirement to do so, why do organizations typically create this additional burden for themselves? Conversely, if someone can identify a procedural requirement to control the DMR as an item, I'd appreciate their input!

The reg says the DMR must be prepared and approved IAW 820.40, Document controls. I am not sure how you would have (true) document control without revision control. I also think it makes good business sense to revision control it.

Originally Posted by GStough

We have our DMR (Device Master Record) in our QMS as a controlled document, but none of the elements listed in it have a revision level tied to them, so I don't think we'll have to revise it very much at all. The one device we manufacture has not changed since its development (several years ago).

I would think it would be necessary to explicitly state the revision of each item just to know a particular configuration. If you do make a change to a component, how do you know you're building to the correct configuration? If you get a device back from the field, you can trace its lineage through the DHR up to the DMR. However, at that point, you wouldn't know if component x were revision A or B.

[Watchwait]

All interesting comments but still no (clear) answer to my original question: "Does the DMR as an item need to be revision controlled, if every item comprising the DMR is revision controlled?"

Admittedly, I'm looking for a direct procedural reference if one indeed exists. Lacking the procedural requirement I believe if we can provide revision control of the elements comprising the DMR we will be in compliance.

[Ajit Basrur]

If you are refrrring to revision control on the template of the DMR, Yes, I would.

Was that what you meant ?

[Watchwait]

Not the template of the DMR, the actual DMR as an item. Imagine, if you will an indented bill of material listing all the required components of the DMR (physical components, documents, etc.) to include the revision levels of each item listed. Further imagine this document as a Word document entitled "Widget ABC Device Master Record Index", without a part number of it's own. When any item on the Index changes, the Index is updated to reflect the change. But still, the Index itself has no part number or revision level. Unusual, I realize, but FDA compliant or not?

[Ajit Basrur]

This is really interesting and havent seen any one putting the DMR itself under revision control.

Any takers ?