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Manufacturing Process Deviation linked to DMR (Discrepant Material Report)?

T

todayssunny

#1
Hi All,

Imagine I have a devation in the manufacturing process in place.
The deviation was requested and approved before the work order was started. a) It is applicable for a defined period of time only.
or
b) ... applicable for a certain number of lots/batches.

How is FDA expecting me to link such a deviation to the DMR?
Some consultants adviced us to get rid of the deviation process as for the time of the deviation in place, we do not manufacture according to the approved DMR.

Any reply is highly appreciated...

---------------------------------

just for clarification... by DMR I mean Device Master Record (Medical Devices) --> sorry for any confusion caused
 
Last edited by a moderator:
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yodon

Staff member
Super Moderator
#3
For right or wrong, I don't 'link' it to the DMR - I include the deviation as part of the DHR. (Note: the deviation is linked to a specific revision of the DMR.) This allows me to know that the device / lot / batch was built according to the DMR + the approved deviation(s).
 
I

isoalchemist

#4
The deviation itself should clearly state if it is a time period or a specific number of lots/batches so that you can maintain tracability of the materials that were produced under that deviation. I've used both approaches ( time or lot) depending on the reason for the deviation.

For the DMR I had a section for deviations that I added as a roadmap if questions came up we could go find them. It was rare I needed to deviate (thankfully), but we could trace it. I didn't put a copy of each deviation in the DMR, but pointed to where any deviations could be found. Make sure a copy of the deviation is in each DHF for the lots manufactured under that deviation regarless of the time/lot question.
 
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