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.