Regulatory Open Forum

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  • 1.  Design control and user needs

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jul-2019 09:51
    This message was posted by a user wishing to remain anonymous

    Seeking insights:
    Does your design control process dictate that user needs are documented separately and distinctly from design inputs? Looking for some best practices to learn from for how this could be managed.
    Thanks!


  • 2.  RE: Design control and user needs

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jul-2019 12:35
    This message was posted by a user wishing to remain anonymous

    Hi, 

    We have separated user needs from design inputs historically. User needs are the starting point for design inputs; they are the abstract stories that need to be translated into design inputs. Design inputs have their acceptance criteria. I am sure others have different approaches.  I'd be interested in hearing what others in this forum have to say.


  • 3.  RE: Design control and user needs

    Posted 10-Jul-2019 06:13
    Edited by Richard Vincins 10-Jul-2019 06:15
    User needs may be viewed differently from user requirements.  From my perspective user needs would be a higher level document such as marketing requirements, user needs, user expectations - sort of like a wish list of what a product would look like, function, perform, etc.  These user needs are then transposed into user requirements which are part of design inputs; these would be define user requirements transposed from those needs.  As an example, Marketing goes out doing a market survey for the product that determine the finished device needs to be light and portable.  A user requirement transposed from user needs for light and portable could be <6 kg.  Then an actual product specifications would be a targeted specification of 5.4 +/- 0.5 kg.  User needs would be that top level perspective what is viewed from a user perspective such as needs, expectations, wants, or wishes.

    Whether it needs to be documented separately really up to your design control system.  I have worked in design control processes with Marketing Requirements -> Product (User) Requirements -> Product Specifications or you could have Marketing/User/Product Requirements together -> Product Specifications.  Often times depending on the product the User Requirements would have an idea of the user needs or expectations.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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