Hi All,

My best understanding is that the Design History File (DHF) contains all information about the development of the the product, as the design is created. It contains all inputs, outputs, and protocols. The Device History Record (DHR) is contains everything that was done to manufacture the device. This includes, when it was manufactured, how many were made, and any identifying numbers associated with the device.

This site really helps to break it down nicely as well: http://blog.greenlight.guru/design-history-file-dhf-device-master-record-dmr-device-history-record-dhr

Hope this helps,
-Andrew Nashed

From my experience, your product will almost always require both a DHR and a DHF. The reason being is that one is for the design phase (DHF) and one is for the production phase (DHR). A DHR shows how to produce the device to meet the specification (drawn up by the company.) A DHF ensures that during development, the proper protocol was followed for testing and release, which leads to a specification being written. For example, a DHR may have manufacture dates (since they are specific to each lot) while a DHF may have a tensile test performed on the final (or up to the final) design. A product can have multiple DHR’s but only one DHF.

This website explains it well:
http://blog.greenlight.guru/design-history-file-dhf-device-master-record-dmr-device-history-record-dhr

Hi all,
A DHR is a key deliverable from design controls and it is a checklist that is used during manufacturing of the device. The DHR, is created during design controls but it is not used until manufacturing of the device. Therefore, during manufacturing the DHR defines how a device or a lot of devices should be produced to meet specs. For instance, a DHR gives tolerances, how many turns you must apply to a nut, it verifies quantities of an ingredient, show releases for sterilization and after the product is finalized, this DHR must be signed by the QA person in charge. If the DHR is not signed by QA, the product cannot be released.
A DHF, is created during design phase and contains all the development of the device that lead up to its release. It shows the history of the device, everything that has been done from the beginning to end. Every step of Design Control creates info to be recorded and contains the project proposal, the DDP, DID, DSD, all documentation of design outputs, results of verification and validation, documentation of design reviews, references, meeting minutes notes, risk analysis documents, basic research used to start design controls and the design transfer information to manufacturing.

To answer your question of when do you need to generate a DHF vs. DHR is that the DHF is created during the first planning session of the developing the device. This includes every document from the inception of the device to the design transfer phase of the device. The DHF is more in depth of what document it contains, whereas the DHR contains a checklist that the device has been properly made, inspected, and passed its quality check. The DHR is used after design transfer and during the manufacturing phase of the device. Also, as you asked what are major differences in these documents, for one the DHF is not a document it is essentially an electronic container for all types of information from Risk Reviews, Meeting Minutes, Design Reviews, Design Change Processes, Design Specifications, etc. The DHR is a record maintained for each device or batch manufactured.

I have gone through the same process a while back when I first started working with design controls. It was always confusing what is the difference between a DHR and a DHF. Reading definitions may not be very helpful until you see actual documents to realize the difference. I will do my best to explain it in an easy way.

- DHF is simply a Historical view of all the design effort, from concept phase up to design transfer (i.e. production). If you look through the DHF (which is usually consists of multiple huge binders), you will find a detailed description of the device and the reasoning behind why everything was designed that way. You will also find the risk analysis documentation which is used to prove that the device is safe for its intended use. DHF will also include manufacturing processes, shipping studies, Verification and Validation protocols and reports. All of these documents are relevant to ALL the manufactured devices of the same model.

- DHR is simply a compilation record of all the components (including serial numbers), processes, work orders, QC records, Sterilization records and all supporting documents to prove that this specific device is made to the specifications defined in the DHF. Usually the DHR is a specific document for each device, or it is called a Batch Record if multiple devices are manufactured at once.

A simple scenario I have always used to give people a clearer picture of the difference is the cell phone example. If you want to know how the cell phone is designed and find out the circuitry layout, you will have to look into that model's DHF. If you are looking for the serial/lot number of the signal transmitter chip inside YOUR phone, then you will have to locate the DHR that has your phone serial number and inside that DHR you will find the serial/lot number of that signal transmitter chip.

Hope that helps,
Fady Khalla

I think it depends on your department. I work in development so we only deal with DHF and if you were in manufacturing or production it would be a DHR. Also an easy way to differentiate DHF is all encompassing and you can build a device from that but a DHR just tells you the steps it's been through.

As many have already commented on both DHF and DHR, the FDA actually has some form of DHR database with the new GUDID and UDI initiative. This maintains manufacturing, sterilization, QC as well as produced quantities of any specific lot number of 1 time use medical devices or the complete traceability of implants and multi-use medical devices.

This link definitely provides a great representation of the difference between the two. Some key aspects of the DHF that are mentioned are that all the activities during the design and development process should be properly collected and should be compiled as you go. Also, how is it important to have the design outputs along with design verification and validation protocols and reports. This helps to have all the necessary items for when bringing the device into the manufacturing team.
The DMR, as described by link, assist in having the device specifications, production process specification, Quality assurance procedures, packaging and labeling, installation maintenance and servicing procedures. And a key aspect provided is if your team was really meticulous in organizing the DHF portion, it will be very easy to reference the location in the DMR.
Lastly, the difference within the DHF vs the DMR is in the first letter: design vs. device. With that detail, it can help to identify the hint to know the difference.

The essential differences are is that DMR contains all documentation for the design and manufacturing of the current product and all process are fully documented, while DHR contains all production/process records of the device.

Chris

DHF contains all the design records from inception to launch and changes over time.DMR is one of the outputs from the DHFas It contains the specification that were developed during design process.Their difference resides in the phase of product life cycle ,DhFcovers the design phase and DMR is used during production phase .DMR contains information on design formulation,specification,complete manufacturing procedure,quality assurance requirement,acceptance criteria,packaging and labeling of a finished device.If the device remains original with no changes ,then DMR would be considered current DHF.

There is a vast difference between the Design History File (DHF) and the Device History Record (DHR). Once the timeline during which these are created is understood, the difference is apparent. The Design History File is created during the product development stage of the device. This is the main deliverable of the Design Input phase containing the records involved in the design of the device. There is one DHF for the device project as a whole, and this is written before the manufacturing process of the device even begins. This is different from the DHR because the DHR is one per individual device manufactured. This details all of the processes that occur when that device was made, down to the operator responsible for each stage in production. This follows the individual device through the entire process and is later filed away but is still accessible to see how that individual device was made.

As @julienneviuya described Design History File (DHF) is created during the Design Phase during the product development stage of the device and is written before the production. Whereas the Design History Record (DHR)is produced during the Production Phase and is a record of everything done to a single device or a single lot/batch of devices, which ensures traceability. It defines how the lot should be produced to meet the spec, gives tolerances, tells you what to do if things go wrong, verifies the quantities of ingredients, shows the release for sterilization, has a section for documenting QC, and a section doe QA review of the documentation and the product cannot be released unless DHR is signed off. The Device History Record is the evidence that a particular unit, batch or lot of devices was made according to the specifications laid out in the DMR.

Dr.Simon mentioned (in Week 3) about DHF, Design History File is required by law in 21CRF820.3(e) – “a compilation of records which describes the design history of a device”. Also, the DHF should contain some basic documents:
PDF, DDP, DID
– Business plan, market research
– Risk Analysis
– Research protocols: clinical and pre-clin
– Regulatory pathway
The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.Your DHF must be accurate and should be a “living” document, meaning it should be consistently updated even beyond the development phase. When you archive your DHF after manufacturing, it defeats the purpose. It should always be an accurate representation of the product you are delivering.Design History File (DHF)--> Inputs to --> Device Master Record (DMR) --> Inputs to Device History Record (DHR)