DHF, DMR, DHR Part 1, Overview
Design History File, Device History Records, Device Master Record, Device Tips, DHF, DHR, DMR
This is the 1st of the 4-part series around tips for leveraging the interrelationship between the Design History File (DHF), Device Master Record (DMR) and Device History Records (DHR’s). At minimum I hope these tips will help you understand the interrelationships, and allow you to leverage those interrelationships in your own situation.
First a few definitions. The FDA Quality System Regulation (QSR) defines the following terms:
Design History File (DHF): The compilation of records that describe the design history for a finished device. [FDA QSR (21CFR820)]
Device Master Record (DMR): A compilation of records containing the procedures and specifications for a finished device. [FDA QSR (21CFR820)]
Device History Record (DHR): A a compilation of records containing the production history of a finished device. [FDA QSR (21CFR820)]
The records of the design and development of a Medical Device are kept in a Design History File (DHF) during development prior to commercial release. I like to think of the DHF as the records of the Design Control process.
At the completion of development, only a portion of the Design History File is transferred to formal Document Control and becomes the Device Master Record (DMR) to be used by manufacturing to produce devices for commercial distribution. I like to think of the DMR as the “recipe” for the device. So here’s the tip:
Create a matrix that links elements of the DHF, DMR and DHR.
Such a matrix will define which elements of the DHF will go into the DMR, and which elements of the DMR will be recorded on the DHR.
Typically the DHF contains at least the following elements:
- Design and Development Planning – design and development plans
- *Design Input – requirements and specifications
- *Design Output – electronic, mechanical, software, packaging and labeling designs
- Design Review – design review records
- Design Verification – design verification protocols and reports
- Design Validation – design validation protocols and reports
- *Design Transfer – design output translated into production documents
- Design Changes – identification** or design changes
**NOTE: the other elements of design changes are captured in the other sections of the DHF.
The items indicated with an asterisk (*) are the only elements of the DHF that typically become part of the DMR.
The DMR typically contains the following elements:
- Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
- Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
- Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
- Packaging and labeling specifications, including methods and processes used; and
- Installation, maintenance, and servicing procedures and methods.
Of these, only Device specifications and Packaging and labeling specifications typically come from the DHF. Production process specifications are typically developed by manufacturing engineering staff, and Quality assurance procedures and specifications are typically developed by quality engineering staff. Installation, maintenance, and servicing procedures and methods are typically developed by the installation and service staff.
Details on how elements of the DHF end up in the DMR will be discussed in a future Device Tip in this series.
The QSR specifies that the minimum information to be recorded in the DHR is:
- The dates of manufacture;
- The quantity manufactured;
- The quantity released for distribution;
- The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
- The primary identification label and labeling used for each production unit; and
- Any device identification(s) and control number(s) used
Details on how elements of the DHR are generated will be discussed in a future Device Tip in this series.