DMR and DHR - Two requirements, One Document

[QA-Man]

I am working on creating DMR's & DHR's for a repacker/relabeler (very basic stuff).

The plane is to make the the DMR & DHR the same document two-sided single page document. Is there anyone out there who's done the same? Maybe you have some thoughts/examples you can share?

I would love to see some creative unorthodox approaches!

 

[MIREGMGR]

A DMR has no relationship to a DHR. One is design documentation and manufacturing directions, the other is manufacturing batch/lot/unit records. Not the same thing.

How would a DHR, even for a single step process, fit on one side of a single sheet...unless perhaps the product is only to be made once...?

 

[QA-Man]

A DMR has no relationship to a DHR. One is design documentation and manufacturing directions, the other is manufacturing batch/lot/unit records. Not the same thing.

How would a DHR, even for a single step process, fit on one side of a single sheet...unless perhaps the product is only to be made once...?

DMR is recipe on how to make the device. The DHR is the record of these activities. How can you say they have no relationship?

 

[somashekar]

DMR is recipe on how to make the device. The DHR is the record of these activities. How can you say they have no relationship?

DMR can have many components, one of which can be the recipe as you state.
In our case one such the recipe is the assembly flow. An other is the bill of material (BoM).
We have the BoM (copy of the BoM from the DMR) on one side of the paper of the DHR with additional field that captures the traceability details of the materials used in a lot. The back side has the assembly flow (copy of the assembly flow from the DMR), with additional field to capture quantity started and quantity pass at each stage and the signatures of the process inspector at several in-process stage.
When any changes happen with the assembly flow or the BoM, the engineering issues a new revision of the DHR format.
This can easily be done. But then our DMR has much more info than just the BoM and the assembly flow sequence.
If i am understanding you correctly, your plan is good...

 

[QA-Man]

Thanks Somashekar.

I imagine most DMR's would have more than just the recipe. However this site is only repackaging/relabeling finished products. No inspection/testing other than checking that the component's match the BOM and a visual examination. After that, its just a matter of putting the product in a box and slapping a label on. This is the only thing they do at this site and I want the number of their documents and forms to be minimal.

 

[somashekar]

Thanks Somashekar.

I imagine most DMR's would have more than just the recipe. However this site is only repackaging/relabeling finished products. No inspection/testing other than checking that the component's match the BOM and a visual examination. After that, its just a matter of putting the product in a box and slapping a label on. This is the only thing they do at this site and I want the number of their documents and forms to be minimal.

Good thinking ... Who controls that DMR must also control the DHR form. Pretty much I see it similar to our approach.

 

[MIREGMGR]

DMR is recipe on how to make the device. The DHR is the record of these activities. How can you say they have no relationship?

I didn't say that.

It sounds as if maybe you think the DHR is a form for recording the production activities for a given production batch. That would be incorrect.

The DHR is the records themselves of every production batch, within the time window for which you retain such records.

FDA requires you to have a controlled DHR, i.e. complete set of production records. Whether you have a particular form for recording your DHR information is your call. FDA cares about the result, not the method.

So if you make fifty batches of a device per year and retain records for five years on a rolling basis, eventually your DHR would contain 250 batch records...or some number between 250 and 300 if you only discard obsolete records once a year, say after your fiscal year rollover.