Design and Development Outputs Approval, Verification and Validation

morteza

Trusted Information Resource
#1
Hi all,
I can not understand the difference between approval of design and development outputs (clause 7.3.3) and design and development verification (clause 7.3.5).
I think that one of the approval activities is the examination or assessment whether design and development outputs meet the input requirements of design and development or not. I think approval of design and development outputs includes checking of the satisfaction of sub-clauses 7.3.3 a to 7.3.3 d.
So, the approval of design and development outputs includes the verification activity.
In addition, ISO/TS in clause 7.3.3.1 requires design and development outputs validation.
Validation is the examination of product against the user needs (intended use). It is not the examination of design and development outputs against design and development inputs. Validation process is usually done by testing of prototypes in application conditions or bench tests.
In my view, ISO/TS should not use the term validation in clause 7.3.3.1
Thanks in advance for clarification.
 
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John Broomfield

Staff member
Super Moderator
#2
Re: Design and Development outputs approval,verification and validation

Hi all,
I can not understand the difference between approval of design and development outputs (clause 7.3.3) and design and development verification (clause 7.3.5).
I think that one of the approval activities is the examination or assessment whether design and development outputs meet the input requirements of design and development or not. I think approval of design and development outputs includes checking of the satisfaction of sub-clauses 7.3.3 a to 7.3.3 d.
So, the approval of design and development outputs includes the verification activity.
In addition, ISO/TS in clause 7.3.3.1 requires design and development outputs validation.
Validation is the examination of product against the user needs (intended use). It is not the examination of design and development outputs against design and development inputs. Validation process is usually done by testing of prototypes in application conditions or bench tests.
In my view, ISO/TS should not use the term validation in clause 7.3.3.1
Thanks in advance for clarification.
morteza,

Design output may be approved before verification, before validation and certainly before being issued for purchase or production.

The design output should be verified before its is validated so you know what you have validated. As an aside I understand the Wright Bros invented a plane that would fly because they verified before they validated. The successful design may then be approved for purchasing, delivering (in the case of a service) or producing.

Conflating approval with verification may suggest to some users that the validated design information does not need to be approved before issue for production (but it does).

Prototypes may be tested to validate the design but how would you do that with a bridge?

Designs may be validated with computer models, or by use of previously successful designs (for products operating in similar service conditions) or by partial prototypes testing (including freeze/thaw cycling, bake and shake or corrosion cycling perhaps) for novel features or by trial runs.

Approval of the design for production follows verification and validation but because validation is expensive approval of the verified design usually precedes validation as well (see 7.1c or 7.3.1).

Lastly 7.3.3.1 is not specifying validation requirements, but it is saying that product design output shall be expressed so it can be verified and validated.

The only problem with the list is differentiating what design output can be verified and what design output can be validated. The list does not include design prototypes but it is not meant to be exhaustive.

As with all minimum requirements you can decide to do more as necessary to run an effective design and development process (see 4.1f).

The verification team may report to the person who approves the design for validation on seeing evidence of verification.

For these reasons I recommend that you keep separate verification and approval.

John
 

sagai

Quite Involved in Discussions
#3
You have just selected one of the most controversy subject :)

My view is that ...
design verification and validation are not equivalent with testing.
Design verification runs throughout the whole design and development process, it manifested in design reviews, peer reviews, design meeting, even in the kitchen when people are talking to each other and trying to find out if they are about to develop the product according to specification. And yes, one of the verification activity is testing according to predefined protocol.
Validation also pervading the r&d, think about the traceability of the requirement engineering, validation of tools they use, etc and also, yes, one of the validation activity is user testing/validation.

The other thing is, this Design Output question.
You should find you way, I still believe, design output more or less all of the specification, test protocols, meaningful review remarks (not necessary documented), test and validation results, tool testing and validation, r&d process definition, all of the things are describing the design effort and the result of the design and development activities.
Okay, maybe it makes more confusion than less ...
Do not necessary think about one golden document and one golden revision. Design output evolves in terms of content and in terms of maturity of those content during the r&d activities, and when you say okay ... we have something we consider as ready to manufacture, that is the moment when you could claim, you have final design outputs.

These are just thoughts, neither ultimate truths, may help you to find your own way.

Cheers!
 

morteza

Trusted Information Resource
#4
Re: Design and Development outputs approval,verification and validation

Lastly 7.3.3.1 is not specifying validation requirements, but it is saying that product design output shall be expressed so it can be verified and validated.

The only problem with the list is differentiating what design output can be verified and what design output can be validated. The list does not include design prototypes but it is not meant to be exhaustive.
John
Thanks for your great answer.
I understand that the first paragraph of clause 7.3.3.1 is about the format of product design outputs. But, I think the writing format of the requirement is not correct. Because according to clauses 7.3.5 and 7.3.6:
verification is done by comparing product design outputs against design input requirements. And
validation is done by comparing product design outputs against specified intended use requirements, NOT against design input requirements.
So, it would be better that ISO/TS would write the requirement in this way:
The product design output shall be expressed in terms that can be verified and validated against product design input and specified intended use requirements.
I hope this clarifies my question.
Thanks again
 

John Broomfield

Staff member
Super Moderator
#5
Re: Design and Development outputs approval,verification and validation

John
Thanks for your great answer.
I understand that the first paragraph of clause 7.3.3.1 is about the format of product design outputs. But, I think the writing format of the requirement is not correct. Because according to clauses 7.3.5 and 7.3.6:
verification is done by comparing product design outputs against design input requirements. And
validation is done by comparing product design outputs against specified intended use requirements, NOT against design input requirements.
So, it would be better that ISO/TS would write the requirement in this way:
The product design output shall be expressed in terms that can be verified and validated against product design input and specified intended use requirements.
I hope this clarifies my question.
Thanks again
morteza,

Verification of design outputs against "design input and specified intended use requirements" is near enough the same as "product design input requirements".

In other words the standard is specifying does it look as if the design fulfills the brief?

Then, once we know the characteristics of the design output (through verification) we are ready to validate the design to see if it actually works. Indeed, validation may show deficiencies in the design brief (design inputs).

John
 
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