Whew! :confused:

For those of you that eat and sleep quality regulations, this may seem to be real novice group of questions.

1.) DMR.... like an index showing where specific files are?
2.) DHF.... a file containing all the pertinent information about how you got to the point of producing the product?
3.) DHR.... individual records of each manufactured product or group of products (batch)?
4.) Master Batch Record.... Same as a DHF?
5.) Batch Record.... Same as a DHR?


It seems that these terms cause a lot of disagreement in my group. The argument centers around the differences between a record of plans (DMR, DHF, MBR) and in-process records (DHR, BR). :argue:


Can anyone make the definitions simpler? Thanks. :bonk:

Whew! :confused:

For those of you that eat and sleep quality regulations, this may seem to be real novice group of questions.

1.) DMR.... like an index showing where specific files are?
2.) DHF.... a file containing all the pertinent information about how you got to the point of producing the product?
3.) DHR.... individual records of each manufactured product or group of products (batch)?
4.) Master Batch Record.... Same as a DHF?
5.) Batch Record.... Same as a DHR?


It seems that these terms cause a lot of disagreement in my group. The argument centers around the differences between a record of plans (DMR, DHF, MBR) and in-process records (DHR, BR). :argue:


Can anyone make the definitions simpler? Thanks. :bonk:

Take a breath, Ted, it will be ok, I promise! :)
1) DMR - Device Master Record. This can be a matrix or index that identifies the pertinent documents/procedures/records/specs, etc. and their location.
2) DHF - Design History File. This is all the documentation that results from the design history - all the activities of the design team (planning, input, review, output, review, changes, transfer, etc.). This should all be included in the DHF.
3) DHR - Device History Records. These are all the records generated during the production, testing, review, inspection, etc. of the device(s). These can include production schedules, specs, inspection reports/records, NCRs, CARs, MRBs, deviations, etc. - anything relevant to the production of that lot/batch of device(s).
4) Master Batch Record. This is not a term we (current company) use, but it could be similar to the DHF or DMR. I'm not certain.
5) Batch Record. This is what I would consider to be the same as the DHR.

I hope this helps. :)

Whew! :confused:

For those of you that eat and sleep quality regulations, this may seem to be real novice group of questions.

1.) DMR.... like an index showing where specific files are?
2.) DHF.... a file containing all the pertinent information about how you got to the point of producing the product?
3.) DHR.... individual records of each manufactured product or group of products (batch)?
4.) Master Batch Record.... Same as a DHF?
5.) Batch Record.... Same as a DHR?


It seems that these terms cause a lot of disagreement in my group. The argument centers around the differences between a record of plans (DMR, DHF, MBR) and in-process records (DHR, BR). :argue:


Can anyone make the definitions simpler? Thanks. :bonk:

My thoughts

Prob start at beginning

DHF - Design History File, this is the documents that were compiled during the design of the product, Customer requirements, System requirements, User Requruirements, prototyping, design reviews, risk analysis, verification etc etc
This document is for the design of a device and the inspectors use it to verify that input (requirements) match output (design effort). Updates to this are required if you amend the design of the device (and features, change specs etc)

DMR - Device Master Record, this is a compilation or listing of all the materials, drawings, labels, BOM's, SOP's, WI's that are needed to manufacture the device (think of a recipe card, a listing of all that is required to bake a cake)

DHR - Device History Record, this is a compilation of the records, charts, routing cards, etc etc that were used to during the manufacture of the device (if you had to complete a record for every stage of baking the cake, packing and shipping the cake, this would be your DHR)

Batch Record, this is a document that records what happened during a particular part of the process (you would have lots of these when baking your cake, oven prep, oven temp, lot number of flour used, name of hen who layed eggs you used...he he, guess you get the idea). These records are refenced in the DMR, completed ones are part of the DHR.

Master Batch Record, probably refers (I say prob cause not a term I am familiar with) to the controlled copy of a batch record held in an area that copies are made from for use when you manufacture, when there is an update to the batch record in question the current master becomes superseded and is replaced with this new master. These days master records are mostly held electronically and printed when required.

I hope this helps

Nigel :rolleyes:

Thank you folks. I think. :cfingers:

Your answers confirmed my definitions. I think. :cfingers:

So, this should settle the arguments. I think. :cfingers:

I think, so therefor, I am. :cool:

"I am whats I am" quoth the Popeye. :lol:

I appreciate your help. :agree1: