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  • Fady Khalla replied to the topic Discussion Topic: Is the DHF a living document? in the forum The Design History File 8 years, 8 months ago

    I am one of the people that believe that DHF is a living document. Any changes to the Device Must be included in the DHF. I also believe that any changes have to go through a design transfer especially changes to the SOPs and work instructions. This in fact is to ensure that knowledge affected by this change have been transferred to the people systemically. The other reason behind my decision is that the change have to evaluated in the context of the whole design. The DHF have to be evaluated to determine the impact of the change on other aspects of the design and add an impact statement of the change with regulatory rationale behind why no additional verification or validation processes are needed after implementing this change.
    Finally, The idea of capturing all changes in the DHF will allow the organization to maintain a whole design history in one place without the need to inspect multiple location to determine the change impact or change details.