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