Activity

  • sjm39 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls 8 years, 5 months ago

    AS sdl3 said, the Design Dossier or Tech File can be beneficial for audits as they only have to look back at the material that was updated since the last audit because of the new ‘snapshots’. I think this method can also be helpful if a product starts to fail after a change in design. One can easily compare the different snapshots and see where the design failed. I believe the DHF is better in certain apects. It contains everything from start to finish and is continuously updated leaving nothing out. Essentially the DHF would contain everything a Design Dossier or Tech File would but with more information and in more detail. This could help the company if they want to change the product in anyway, cut down on costs, change supplier, etc.