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DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record

#1
Dear all coves

Can some one explain by definition what is a difference between a DMR, DHF and DHR. Here is how FDA defines them

DHF :
§ 820.30(j) Design history file.
Each manufacturer shall establish and maintain a DHF for each type of device.
The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
II. DEFINITIONS
§ 820.3(e) Design history file (DHF) means a compilation of records which describes the design history of a finished device.

DMR :
DEVICE MASTER RECORD
Title 21 CFR 820.3(j) states a “Device master record means a compilation of records containing the procedures and specifications for a finished device.” A Device Master Record (DMR) is a comprehensive record of all of the procedures and instructions required to manufacture each type of glove. A DMR contains or refers to the location of documents for manufacturing and processing activities, such as procurement, processing, labeling, test and inspection, and packaging. The DMR also contains information on the design, formulation, specifications, complete manufacturing procedures, quality assurance requirements, acceptance criteria, packaging, and labeling of a finished glove.

DHR :
Sec. 820.184 Device history record.
Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any device identification(s) and control number(s) used.
 
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M

MIREGMGR

#2
Re: Dmr vs dhf vs dhr

DMR = all the documentation for design and manufacturing of your current product. Assumes all processes and decisions are fully documented.

DHF = past versions of all the records in your DMR. Assumes a fully change-controlled, systemic approach to documentation.

DHR = all your production batch records. Assumes that nothing happens in Manufacturing without appropriate work orders, and that all actions and decisions are documented.
 
A

arios

#3
Re: Dmr vs dhf vs dhr

I would had used the same definitions you posted to answer the question.

In few words:

DHF: are the records that describe the design process and its changes for a device over the time

DMR: could be considered the output of the DHF, is the set of specificatios developed for design and manufacturing

DHR: is the evidence that a lot, unit or batch was manufactured in accordance with the DMR. You just listed the specifics of what the DHR is meant to include.

Over the time, the performance of a device could result in improvements to the desigm, so, it can be said that the DHR could eventually become an input that will be reflected on the DHF
 
L

Laura Halper

#5
Oops, not exactly:
"So if your device remains original with no changes, then your Device Master Record would be considered your current Device History File."

In FDA nomenclature, there is no "Device History File". There is a Design History File, and there is a Device History Record, but there is no Device History File. The nomenclature is confusing.

Here's my simple definition for DHF, DMR, and DHR.

The Design History File explains how you developed the recipe for making your device.

The Device Master Record is the recipe itself (specifications, work instructions, inspection procedures, etc.) for making the device.

The Device History Record is the evidence that a particular unit, batch or lot of devices was made according to the recipe.
 
Q

QA compliance

#6
:applause: Excellent answer! That is what I would have said.
I just want to add the in your DHR, also include setup sheets per operation that were used for THAT PARTICULAR job.
 
G

geno27

#7
The DMR contains the documentation necessary to produce a device. The final design output from the design phase, which is maintained or
referenced in the DHF, will form the basis or starting point for the DMR. Thus, those outputs must be referred to or placed in the DMR.

The total finished design output includes the final device, its labeling and packaging, and the DMR that includes device specifications and drawings, as well as all instructions and procedures for production, installation, maintenance, and servicing.


The DHF, in contrast, contains or references all the records necessary to establish compliance with the design plan and the regulation, including the design control procedures. The DHF illustrates the history of the design, and is necessary so that manufacturers can exercise control over and be accountable for the design process, thereby maximizing the probability that the finished design conforms to the design specifications.

 
Last edited by a moderator:
A

andymo13

#8
Hi everyone,

I´m still confused about where to keep which document: do I put the Validation documentation into the DHF or DMR? Because these documents show (among other things) that the product complies with the regulations.
Or am I totally wrong? :confused:

Thank you in advance for your answers
 
M

MIREGMGR

#9
do I put the Validation documentation into the DHF or DMR?
At the company where I work, we don't worry about whether a particular file or storage location is called DHF or DMR. Our focus instead is on assuring that we retain everything that should be part of the DHF and DMR, and that we have a complete definition of where every retained record/document is located.

Our validation records, because they were very expensive to produce and have a uniquely broad importance to the legal marketability of our product range, live on a set of shelves in the Engineering Manager's office.

My take is that it's permissible to keep DMR and DHF records in intermixed form in a single file/storage location, as long as a potential user or auditor of those records is readily able to discern which are latest-dated or highest-version-numbered and therefore by definition "DMR", and which are prior and therefore by definition "DHF". We have records other than those pertaining to validation that are retained on that basis.
 
L

Laura Halper

#10
Validation documents should be part of the Design History File. The FDA defines two kinds of validation -- design validation and process validation. 21CFR 820.30(g) discusses design validation as part of the design control process (and therefore, part of the Design History File).

Although the FDA discusses process validation in 820.75, and not as part of the design control process, it should be one of the steps before you release the product to market. I would consider it to be part of the Design Transfer activities, and so part of the Design History File.

There is a linkage between the Design History File and the Device Master Record. Sometimes the design validation and/or process validation reveal issues that must be addressed before the product is introduced to the market. For example, if the design is modified as a result of the design validation to make it more user-friendly, then the new drawings etc. would be part of the Device Master Record. Or for example, if you find during process validation that the assembly steps must be modified in order to insure that acceptable products are consistently made, then the new assembly procedure would be part of the Device Master Record.

In a nutshell: The Device Master Record is the "recipe" for making the device. The Design History File explains how you developed the recipe.
The Device History Record demonstrates that a particular unit/batch/lot was made according to the recipe.
 
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