Design History File - Looking for Examples of DHF's.

#1
Dear Forum,

I am studying clinical research management in my 5th semester. For my current term paper I am looking for design history files. I can't find an example anywhere to get an idea of this document. In this forum I have already read that it can be between 100 and 10000 pages. I also realize that no one will give me their original DHF. But is there somewhere the possibility to find examples at least for some sections?

For my term paper I need especially the verification, the design review and design changes. Theoretically I know from the FDA guidelines what belongs there, but it is hard to write about it without ever having seen a DHF.

Please help me.
Best regards Katrin
 
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#5
Do realize the DHF is more of a virtual file. It's the collection of all design history documents. Some of the things in the checklist in the thread @Jim Wynne directed you to aren't necessary for the DHF (e.g., kickoff meeting minutes, business analysis, etc.). 21 CFR 820 provides the framework for the DHF but there's a lot once you start peeling the onion. For example, the checklist shows a "Hazard Analysis" but risk analysis is (generally) driven by ISO 14971 and our normal set of risk analysis docs includes a Risk Management Plan, a System Hazard Analysis, Design FMEA, Use FMEA, a Software FMEA (if product includes software), and a Risk Management Report.

As you probably know, verification is confirmation that the design outputs meet the design inputs. Another way to think of it is "did we build the thing right" (contrast with validation, "did we build the right thing"). You'll have test protocols that drive the means to collect objective evidence that the requirements are satisfied. The executed protocols are records that identify who tested, when testing was done, what equipment was used, how many samples (statistically justified), etc. There's generally a test report summarizing testing and providing rationale for any issues found that are not to be corrected. The collection of design verification materials can often be well into the hundreds of pages, depending on complexity of the product (and the efficiency of the test developers!).

Design reviews are more formal reviews (not to be confused with a review of a particular document). The number of design reviews is established in the design and development plan. Generally, the only outputs are the minutes (listing the items reviewed and participants) and any action items arising.

Design changes authorize changes after you put something under design controls. These are just records that effectively authorize the change. There are particular requirements for assessing impact, e.g., to risk, to products in the field, to items in work, etc.
 
#6
Thank you for your detailed reply and effort. I am quite enthusiastic about this platform. I had doubts before that anyone would even take the time to read my post. Thank you.
 
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