DMR (Device Master Record) Management and Index questions

N

NicoleinFlorida

#11
Thank you for the response. I agree with you that the document control system shall control the usage of those component documents.

So in this way, we will not update the revision of DMR when individual document updates. And we shall update the revision of DMR when new activities or requirements added to it. Is my understanding correct?
 
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Ronen E

Problem Solver
Staff member
Moderator
#13
MDR? I assume a typo.
Yes, sorry. I guess I was under the influence of another thread, where we were actually discussing MDR...

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.
That's interesting. I know of "DMR procedure", but I never thought of the actual DMR as a procedure. In my understanding it should be a record, perhaps the output of a procedure. Did you mean that the company was new so there was no DMR yet, and all that was inspected was the DMR procedure?

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.
I definitely don't take, or advocate taking, inspection results as the ultimate indication for regulatory alignment. I just thought that a competent FDA investigator* should have brought it up at some level. I wasn't aware that things are as you described them. Being located outside the USA I haven't witnessed too many FDA inspections lately. The investigators I did encounter were quite competent.

*) According to FDA terminology that I'm familiar with, FDA manufacturing facility inspections are held by "investigators". FDA "inspectors" are those FDA employees who inspect incoming goods at border check points etc.
 

Ronen E

Problem Solver
Staff member
Moderator
#14
Your document control system should also be robust enough to prevent obsolete documents from being used.
While this approach should work in theory, I think it's not a very good one in terms of DMR compliance.

I think I understand what you are saying - that the DMR actually points to the most current (effective) revision of any of its component, the one in effect at the time of manufacture. That means that to trace back which revisions should have been used - maybe years later - some lookup would be required. With a good, robust, configuration management system (or ERP with that capability), that might be possible; if the system is not that robust and user-friendly it might prove quite tricky. With a purely paper-based system it might become a nightmare and even down right impossible, especially if the device / production process is non-trivial (e.g. has many components / processes).

Plus, sometimes manufacturers make more than one revision of the same device, in parallel. If the DMR doesn't state the component revisions, how would different DMR versions point to different component combinations?
 
N

NicoleinFlorida

#15
Ronen E

In think you make a point that I am also concerned. Do you have any recommendations about how to address this issue?
 
Q

QA-Man

#17
That's interesting. I know of "DMR procedure", but I never thought of the actual DMR as a procedure. In my understanding it should be a record, perhaps the output of a procedure. Did you mean that the company was new so there was no DMR yet, and all that was inspected was the DMR procedure?
No stranger than a DHR procedure (a requirement).

The company was not new and DMR components were thoroughly sampled. The company was purchased a number of years ago by another company I work with. When I did due diligence and conducted a gap analysis I noted they had all the elements of a DMR in place but had nothing that said DMR. After purchase, I wrote a procedure that explicitly described how the existing document structure met requirements.
 
Q

QA-Man

#18
While this approach should work in theory, I think it's not a very good one in terms of DMR compliance.

I think I understand what you are saying - that the DMR actually points to the most current (effective) revision of any of its component, the one in effect at the time of manufacture. That means that to trace back which revisions should have been used - maybe years later - some lookup would be required. With a good, robust, configuration management system (or ERP with that capability), that might be possible; if the system is not that robust and user-friendly it might prove quite tricky. With a purely paper-based system it might become a nightmare and even down right impossible, especially if the device / production process is non-trivial (e.g. has many components / processes).

Plus, sometimes manufacturers make more than one revision of the same device, in parallel. If the DMR doesn't state the component revisions, how would different DMR versions point to different component combinations?
That's like saying airplanes will work in theory. I don't know why I ever respond to you, but here we go.

I understand that you have a limited point of view but there are many ways to achieve compliance. Often you must build upon a pre-existing system and make use of what's already there. You're one size fits all approach works in theory (emphasis added) but not everyone's got deep pockets. You have to think outside the box to achieve a high standard of quality while maintaining profitability.
 

Ronen E

Problem Solver
Staff member
Moderator
#19
That's like saying airplanes will work in theory. I don't know why I ever respond to you, but here we go.

I understand that you have a limited point of view but there are many ways to achieve compliance. Often you must build upon a pre-existing system and make use of what's already there. You're one size fits all approach works in theory (emphasis added) but not everyone's got deep pockets. You have to think outside the box to achieve a high standard of quality while maintaining profitability.
It's OK to disagree. Forums exist for exchange of different opinions. Let's please try to keep this discussion to the point, not to the person.

When I wrote that it should work in theory but it's not the best approach in my opinion, I also explained why. I pointed to some aspects that I thought could be problematic. I don't know your specific case to the last detail, so I hoped you would explain how it does work for you. Unfortunately you chose not to.

I did not state or hint that there's only one way to comply. I agree that there are many ways. I'm also quite sure that you will agree that some ways are better or easier than others. The goal was to try and highlight the pros and cons. If you feel that your way has no cons, fine. I definitely didn't suggest you were not in compliance.

The explanation about "working with what you find" and "not everyone has deep pockets" is also unnecessary. I've been in that situation more than once. I agree that sometimes you have to be creative, however such creative solutions are not always recommended as standard practice. I thought that this discussion was more general than a specific company / situation, and I responded from that perspective.
 
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