DMR (Device Master Record) Management and Index questions

#1
We're a fast growing Medical Device company that markets different types of kits in multiple configurations. Haven't seen recent info on Device Master Record management so I have several questions:
What is the most effective way to set up the DMR index to properly maintain? Should there be individual DMRs for each kit?
Should there be one DMR for each type of kit and let the BOMs be the vehicle for explaining the different configs?
Should the revision level and DCO of the items be included on the index?
Should the DMR index itself be revision controlled?

Thanks in advance!
SquirrellyGirly
 
Last edited:
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Ronen E

Problem Solver
Staff member
Moderator
#2
We're a fast growing Medical Device company that markets different types of kits in multiple configurations. Haven't seen recent info on Device Master Record management so I have several questions:
What is the most effective way to set up the DMR index to properly maintain? Should there be individual DMRs for each kit?
Should there be one DMR for each type of kit and let the BOMs be the vehicle for explaining the different configs?
Should the revision level and DCO of the items be included on the index?
Should the DMR index itself be revision controlled?

Thanks in advance!
SquirrellyGirly
Hi,

If you have a large number of different kit configurations / sub-variants (and are fast growing, as indicated), I recommend managing your configurations / BOMs / DMR index electronically, using some config management / PDM software package / ERP module. You could then integrate all your DMR revision aspects into that system, since most such packages manage all BOM revisions anyway. Make sure to reflect the control rationale and mechanics in you quality SOPs, and you're good to go.

Please feel free to contact me in a PM if you need a closer assistance.

Cheers,
Ronen.
 
Last edited:

Ajit Basrur

Staff member
Admin
#3
We're a fast growing Medical Device company that markets different types of kits in multiple configurations. Haven't seen recent info on Device Master Record management so I have several questions:
What is the most effective way to set up the DMR index to properly maintain? Should there be individual DMRs for each kit?
Should there be one DMR for each type of kit and let the BOMs be the vehicle for explaining the different configs?
Should the revision level and DCO of the items be included on the index?
Should the DMR index itself be revision controlled?

Thanks in advance!
SquirrellyGirly
The 21 CFR Part 820.181 would be a great start for Device master record

Regarding your questions,

What is the most effective way to set up the DMR index to properly maintain? Should there be individual DMRs for each kit?

DMRs need not be for each device but could be for each type of device

Should there be one DMR for each type of kit and let the BOMs be the vehicle for explaining the different configs?

See earlier response

Should the revision level and DCO of the items be included on the index?

Prefered not; just mention the title and document number without the Revision number.

Should the DMR index itself be revision controlled?

Yes
 
J

jouana

#5
I have a follow-up to the original question. Is it necessary to include SKU configurations and accessories of a device for other countries on the DMR? What about for a RMA version of the same device? Does the modified configuration need to be within the same DMR or would it need a separate one?

"J"
 

QA-Man

Involved In Discussions
#6
I have a follow-up to the original question. Is it necessary to include SKU configurations and accessories of a device for other countries on the DMR? What about for a RMA version of the same device? Does the modified configuration need to be within the same DMR or would it need a separate one?

"J"
I believe it is best to have the DMR be nothing more than a list of referenced documents (without revisions indicated) and then have one DMR for each SKU. The DMR's can reference the shared documents (e.g., work instructions) but also list specific documents (e.g., labels)

The RMA version sounds like a repair...yes? Specific servicing work instructions that are routinely used should be in there and should meet the same acceptance criteria as in the DMR.

I agree with Ronen that it should be electronic. If you can incorporate it into the ERP/MRP as he said, even better. Talk with Operations/IT. If you can get work instructions and other documents added to the BOM as non-inventoried items the BOM can be the DMR.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
I believe it is best to have the DMR be nothing more than a list of referenced documents (without revisions indicated)...
Has that practice successfully gone through an FDA inspection? I feel that an MDR without the revisions indicated misses the point of an MDR, and necessitates other means for unambiguously identifying the effective design and production process.

I second the approach that the MDR can be no more than a set of pointers, though.
 
Last edited:

QA-Man

Involved In Discussions
#8
Has that practice successfully gone through an FDA inspection? I feel that an MDR without the revisions indicated misses the point of an MDR, and necessitates other means for unambiguously identifying the effective design and production process.

I second the approach that the MDR can be no more than a set of pointers, though.
MDR? I assume a typo.

The answer is yes but only once. In this instance, the DMR was nothing more than a procedure that described what types of documents make up a DMR for a given item number. Not even a reference list.

I caution you against using inspection-worthiness as criteria. You have to remember that inspections are not like ISO audits, they're very subjective and often have irrational results. Also, inspectors also have very different core competencies. It is not unusual for a device company can be inspected by someone who primarily deals with food. The bias is often obvious. Further, companies in the US "fix" things in response to observations even when they feel they are compliant just to move on.
 

NicoleinFlorida

Inactive Registered Visitor
#9
Hello cove,

I have a similar question. So based on the discussion, the DMR is not suggested to include revision of each individual document. Then my question is how to control the revision of DMR.

According to the DHR (Device History Record), the record shall show that the manufacturing process completes all activities in the DMR. If we don't know the revision, how could we make sure that the most updated version of procedures or instructions are used?

Thank you.
 

QA-Man

Involved In Discussions
#10
It's a good question.

The components (work instructions, labels, etc.) themselves have revision levels. Your document control system should have a provision for considering the effect on other documents. Your document control system should also be robust enough to prevent obsolete documents from being used.
 
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