Formal Way for Documenting Design Input Requirements

Aphel

Involved In Discussions
#1
Hello everybody,

At the moment I have really "nice" discussions with colleagues from the R&D department regarding the formal documenting of requirements.

I mentioned, that during documenting design input requirements it is always necessary to define acceptance criteria too - otherwise a developer would not know how he should design the product, respectivly it's components.

Perhaps you know the working-philiosophy in R&D areas - document as less as possible to get a maximum flexibility... My colleagues are asking me now - where in the quality standards (QSR, ISO 13485,...) is the requirement to document an design input requirement with acceptance criteria?
They are asking me - why isn't enough to document acceptance criteria directly before verification or validation acitivities start?

Do you have any suggestions - how can I demonstrate that I am right?

Thank you very much in advance for your support!

Best regards,
Aphel
 
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v9991

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#2
I agree that, not-all the inputs/requirements can be quantified at the beginning of development;

Hence the next step is to agree/identify the requirements/inputs relevant&required to be finalized at each stage of development. there is one clarity to be brought in; viz., we do not follow formal-change control to update/revise the requirements at developmetn phase. (this is more than adequate because, the spec.doc is maintained&used by just a small group of team ; and not intended for circulation! )(infact we do follow similar approach at our development stages, of course i am talking about pharma domain; and i guess its more feasible/relevant for devices)
+ ...not all requirements are met through design-controls; so as far as possible, its required to have clarity on inputs(quantified/acceptance criteria)
+ while we agree that validation data during transfer/manufacturing is relied for submission/finalization of process. but we need to acknowledge that the confidence/indicators are present right there at development/optimization stages.

Hope that helps. btw, here are some references &respective-interpretations on sub.matter
7.3 Design and development
7.3.1. Design and development planning
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification, validation and design transfer activities (see Note) that are appropriate at each design and development stage,

Unless we define certain acceptance criteria(relevant for a specific stage), how do we intend to ensure effectiveness of each stage of development!!!
7.3.2 Design and development inputs
These inputs shall be reviewed for adequacy and approved.
How can a requirement be adequately defined/verified without acceptance criteria?

7.3.4 Design and development review
a) to evaluate the ability of the results of design and development to meet requirements, and
Unless the inputs(where applicable/relevant) are quantified/qualified(wherever relevant/feasible); how can we move onto development w/o verifying the design; and same line for optimization or transfer stages.;
 
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