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Design Reviews

Discussion in 'Medical Devices (21 CFR Part 820)' started by QAengineer13, Dec 18, 2015.

  1. QAengineer13

    QAengineer13 Member

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    During the design and development phase, when we conduct design review ,does the documents being reviewed be approved? any thoughts ....
     
  2. MCW8888

    MCW8888 Well-Known Member

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    If you mean signed by the customer, not necessarily. We have stage gate meeting with the internal customer where we review the activities against the planned activities. Documented information of these reviewed are retained.
     
  3. Ronen E

    Ronen E Well-Known Member

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    No typically.
    Any agreements reached / expressed during design reviews should be captured in the meeting minutes, so they can later be acted upon, e.g. Signing-off on proposed drafts.
     
  4. Candi1024

    Candi1024 Well-Known Member

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    When have R&D, then we have design. R&D is it's own little world of experiments and innovation that run outside of our (as in the case of how we run our business) regulated realm.

    Then we have design in the sense of new product introduction. This is the bridge from R&D to production. These sets of documents are quality documents, are controlled, and are approved internally. We don't deal directly with outside customers.

    I don't know if that helps you at all.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maybe if you could narrow down what you mean by "the documents" it would help us give you a clearer answer. So far we've got one "yes" and one "no", so we need help...
     
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  6. Debra V

    Debra V New Member

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    If I understand the question correctly, yes. The design should be approved prior to development, otherwise how do you know you are developing the right product? This doesn't mean development can't influence the design, but if the design changes during development the changes should also be approved.
     
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  7. Ronen E

    Ronen E Well-Known Member

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    The question - as I understood it - wasn't whether the design should be approved. It was whether that should happen during (the formal) Design Reviews. In my opinion Design Reviews are for review, and nothing else. The review outputs should be acted upon (e.g. Signing off on design documents) after the review, not during it. Otherwise - in my experience - the reviews might become ineffective, lengthy or both.
     
  8. QAengineer13

    QAengineer13 Member

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    Thanks you folks for the input, I should have phrased my question properly, Apologies!

    Candi 1024 and Debra answered my question, I was referring to internal approval of documents ( Author , Reviewer & approver of DHFR ) not the customer and also my question was more focused on when the design is going through the iterative process, during appropriate stage gate do we need signed copy of Design description , dfmea etc reflecting the particular stage.
     
  9. Ronen E

    Ronen E Well-Known Member

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    Thanks or the extra info.

    I maintain my position. In my opinion there's no substantial difference between internal design gates and external / customer approval. Both need adequate documentation, review (could be at a formal design review meeting at defined stages, or by a single reviewer for interim deliverables) and formal approval. If you treat "internal" design progress more loosely you will very quickly have inadequate documentation, confusion in your design team, lots of arguments on what was actually agreed on and consequently, a poor design.

    The only exclusion I would make to the above is pre-project R&D feasibility studies (some companies refer to it as "research"), during which you want to explore many options quickly, with bare minimum necessary documentation. However, once a concept is adopted and a formal design project is launched, the "loose" style must give way to more formal processes.
     
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  10. Somashekar

    Somashekar Moderator Staff Member

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    A design review is to deliberate on an already approved draft of design outputs.
    So in that sense the design review feeds changes to the approved draft, so that a new release draft is made and approved.
    At the end of a design review, one of the output will be to fix the schedule of the next review in case of need.
    This next review would have the decisions of the previous review incorporated and approved in the new draft level.
    The purpose is to move towards the final approval to release.
     
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  11. MCW8888

    MCW8888 Well-Known Member

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    Glad you got your answer. Happy Holidays!
     

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