I went thru this argument (discussion) some years ago so when I saw this I thought I'd post it.
-----snippo-----
Subject: Re: Design Validation -REQ: Clarification /Meron
Date: Thu, 22 Oct 1998 11:38:15 -0600
From: ISO Standards Discussion
From: Emanuel Meron
Subject: RE: Design Validation -REQ: Clarification /Meron
> From: Norm Ennis
> Subject: Q: Design Validation - Re: Clarification /Ennis
>
> I am seeking some clarification on a good defination of the term
> "Design Validation".
>
> I am working in the telecommunications field with a company that has an
> R+D dept. We are working on getting R+D ready for an ISO 9001 review in
> December and I am stumbling over this "Design Validation" section.
> The more I look at it, it seems to be a Marketing area. (ex. "Does the
> customer really want Pink Flamingos (sp) or would they prefer blue swans??)
>
> However, this would put the issue before Design Input / Output not after.
> Yet ISO indicates that Design Validation comes after Design Verification.
> Ref: "Design validation follows successfull design verification."
>
> Para. 4.4.7 states "..design verification shall be performed to ensure
> that design-stage output meets the design-stage input requirements."
>
> At our facility, Marketing determines customer need and feeds that info to
> R+D thru a specific document that defines specifications, delivery dates,
> etc. R+Ds only customer is Marketing. Once Marketing defines their
> requirements, R+D creates the device that meets those requirements. R+D
> verifies that the design functions to the design output specs.
>
> So where does that leave Validation?
>
> Any help would be appreciated.
>
> Yours,
>
> Norm Ennis, ECI Telecom, USA
>
These are FDA's (an agency notorious for their strict definitions...) of design verification and design validation:
Design verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
Design validation means establishing by objective evidence that device (product) specifications conform with user needs and intended use(s).
In other words:
You verify a design by checking drawings and specs, running simulations, checking that all design requirements have been addressed, that calculations are correct, etc. It's mainly a "paper" exercise and when you are through with it you should be quite confident that the design is complete and that a product that will eventually be built according to those drawings and specs stands a good chance of conforming to the requirements in the real world.
You validate a design by trying out actual products (an initial run or batch of products), built as above by real workers, installed and operated in the real environment of use by real operators, etc. It's the proverbial proof of the pudding where you can catch errors and other problems that escaped all former verification efforts ... and others bugs that might have crept in later on.
Hope this helps. Comments anyone?
Emanuel Meron
-----snippo-----
Subject: Re: Design Validation -REQ: Clarification /Meron
Date: Thu, 22 Oct 1998 11:38:15 -0600
From: ISO Standards Discussion
From: Emanuel Meron
Subject: RE: Design Validation -REQ: Clarification /Meron
> From: Norm Ennis
> Subject: Q: Design Validation - Re: Clarification /Ennis
>
> I am seeking some clarification on a good defination of the term
> "Design Validation".
>
> I am working in the telecommunications field with a company that has an
> R+D dept. We are working on getting R+D ready for an ISO 9001 review in
> December and I am stumbling over this "Design Validation" section.
> The more I look at it, it seems to be a Marketing area. (ex. "Does the
> customer really want Pink Flamingos (sp) or would they prefer blue swans??)
>
> However, this would put the issue before Design Input / Output not after.
> Yet ISO indicates that Design Validation comes after Design Verification.
> Ref: "Design validation follows successfull design verification."
>
> Para. 4.4.7 states "..design verification shall be performed to ensure
> that design-stage output meets the design-stage input requirements."
>
> At our facility, Marketing determines customer need and feeds that info to
> R+D thru a specific document that defines specifications, delivery dates,
> etc. R+Ds only customer is Marketing. Once Marketing defines their
> requirements, R+D creates the device that meets those requirements. R+D
> verifies that the design functions to the design output specs.
>
> So where does that leave Validation?
>
> Any help would be appreciated.
>
> Yours,
>
> Norm Ennis, ECI Telecom, USA
>
These are FDA's (an agency notorious for their strict definitions...) of design verification and design validation:
Design verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
Design validation means establishing by objective evidence that device (product) specifications conform with user needs and intended use(s).
In other words:
You verify a design by checking drawings and specs, running simulations, checking that all design requirements have been addressed, that calculations are correct, etc. It's mainly a "paper" exercise and when you are through with it you should be quite confident that the design is complete and that a product that will eventually be built according to those drawings and specs stands a good chance of conforming to the requirements in the real world.
You validate a design by trying out actual products (an initial run or batch of products), built as above by real workers, installed and operated in the real environment of use by real operators, etc. It's the proverbial proof of the pudding where you can catch errors and other problems that escaped all former verification efforts ... and others bugs that might have crept in later on.
Hope this helps. Comments anyone?
Emanuel Meron