Medical Device Design History File
After much kicking and screaming, I spent a couple days this week making sure the Design History File (DHF) was adequate and up to date. The QSR (820.30) is pretty open ended regarding the requirements:
Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
Some more details are available here. Thankfully, it says "or reference" so we can throw in the Engineering Change Notices (ECN - sometimes called change control records or orders), which contain a reason and description of changes, and not worry too much about the all of the actual product requirements (design input) and specifications (design output) going in there. Obviously, testing protocols and reports including V&V, biocompatibility, sterilization, etc., go in there. Our company SOP also has design meeting notes listed, which has been interpreted as pretty much every meeting that I attend is a design meeting. I think the strategy is to err on the side of completeness instead of usability. We also have some goofy things required to be in there like marketing and competitor information.
As an engineer its hard for me to efficiently maintain the DHF since I do not see every finalized ECN. I did badger the QA to run everything going into the master file by me before filing for the time being. This way the DHF shouldn't get out of date, but hopefully I can turn it over to the DHF quality department soon as they can maintain it more efficiently because they have final sign off. However, right now no one in the company outside of engineering is able to make the distinction of which documents are necessary to show "that the design was developed in accordance with the approved design plan."
Other than that we are going to miss another filing deadline, part of it due to some consultants falling behind, part of it due to management doing some things that caused a bit of a delay, but it also crushed morale, it was so bad that they tried to make amends on Friday by offering lunch and not a single person outside of management took them up on their offer of free lunch. Ouch.
5 comments:
You have some great ideas about keeping DHFs. I'd like to offer one key suggestion: the DHF should only contain (or make reference to) design control documentation. All the other stuff (e.g. marketing, competitor info) is not part of the DHF. I recommend keeping two files: the DHF (design controls)and a project file (which has everything else). The DHF is a subset of the project file. I also recommend treating the DHF as a living file. It should have a strong association with the DMR and risk management file.
Yeah, that other stuff needs to go, the SOP has those goofy things in there because I whoever wrote it thought it sounded like a good idea, but in practice its not so hot.
Most believe that "design control" is synonymous with "product development".
This is a really good insight into practical DHF management. Did you retain an index of all entries?
DHF is really a pain to maintain. This process is something we target with Vuuch. Checkout this link to see how we maintain DHF http://vuuch.me/collaboration/fileRepNW4/discussions/227. What we do is create a Private WEB Page for each part of your design and everything you are tracking for each part is tracked on this page. For instanace all the parts issues, discussions, notes, tasks, part status and all people involved and how they are involved is recorded. OH and people wrk through the tools they already use, like CAD and Outlook.
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