How to separate Product Design Review, Verification, and Validation Activities

Peters

Quite Involved in Discussions
#1
Product design
1.Review,
2.Verification,
3.Validation
how to separate these operations?
which activities to include in review, verification, validation?
 
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harry

Super Moderator
#3
Product design
1.Review,
2.Verification,
3.Validation
how to separate these operations?
which activities to include in review, verification, validation?
The separation is very distinct in certain industries but can be confusing in others. Take the example of designs for structures or infrastructures, they are usually major and take a lot of time and so you can see the distinct steps from input -> design -> output -> verification and then back to input again. The cycle repeats for a few round till the parties involved are satisfied before the design is validated, finalized and then ready for release. Sometimes, the cycle is repeated again if some parties are not happy during the validation stage. Also note that review is ongoing and at every of the steps.

For others like design of artworks, you may find that all these steps including verification and validation are carried out almost simultaneously - but they can still be identified.

One of the best document for a better understanding is from the APG - Auditing the Design and Development Process. The attached figure gives a good illustration.
 

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somashekar

Staff member
Super Moderator
#4
Product design
1.Review,
2.Verification,
3.Validation
how to separate these operations?
which activities to include in review, verification, validation?
It pains when you use the word separate.
Design and development which is a planned activity almost happens (or has to happen) with a very smooth overlap of all your said design steps. That is what the design plan needs to capture.
The various subsystems of a product can be at several stages of the respective designs and may come together to a place around a determined time for validation when combined to make the product.
If you have records at each stage that demonstrates that the activity has happened and approved by the responsible managers, you should be happy and progressing well.
The stages of design has been clearly stated in the standard and it has never asked for any separation. Design and develop your product in a systematic and logical way (The ISO9001 gives you this) as you have planned and also feel free to amend the plan as the design activity progresses.
 

Peters

Quite Involved in Discussions
#5
I really do not have to divide the review, verification and validation, but ISO 9001 requires records of review, verification and validation, so I'm looking for the answer - what to record in the review, what to record in the verification and what to record in the validation? Recorded information should be consistent with the activity - hence my question about the activity.
 

sagai

Quite Involved in Discussions
#6
I think there is no such segregation between the ones you have mentioned.
I also do not think that any regulatory mandates a kind of sequence between activities, it is only a kind of recognition of it.
I would suggest to take a bit more holistic view on this subject and first try to set the way you consider these principles, than put into this picture the activities your company carries out during the design and development. And also season with a loads of common sense.
In my personal universe review is a subset of verification and the superset of these is the validation. Companies are carrying out activities in a very different timely manner, that is the case when common sense should be applied to make a judgement if the practice and the sequence of these practices are still sensible things.
Cheers.
 

qusys

Trusted Information Resource
#7
I really do not have to devide the review, verification and validation, but ISO 9001 requires records of review, verification and validation, so I'm looking for the answer - what to record in the review, what to record in the verification and what to record in the validation? Recorded information should be consistent with the activity - hence my question about the activity.
Usually you can rely on meeting minute in multidisciplinary approach as record, or mathemical tools or other methods for validation and verification
 

Mikishots

Trusted Information Resource
#8
I really do not have to devide the review, verification and validation, but ISO 9001 requires records of review, verification and validation, so I'm looking for the answer - what to record in the review, what to record in the verification and what to record in the validation? Recorded information should be consistent with the activity - hence my question about the activity.
OK, I'll bite:

Subclause 7.3.4 implies that there should be more than one review conducted during the design process. It's expected that you would evaluate the success of the design to be able to meet the design input requirements, ID problems and choose thactions to resolve them. These reviews need to be shown as a systematic activity rather than a random event.

Verification activities can be as simple as a comparison/review of inputs vs. outputs or through the use of calculations or simulations. Design verification should occur at each stage to make sure that the design outputs are satisfying the design inpouts all the way through the design process. There is also a requirement to maintain a record of any actions needed that arise from performing design verification activities, in addition to the design verification results themselves.

Design validation is where you'll determine if the output actually works. If the design plan was solid, then at this point you would expect to show successful validation results, with perhaps some minor adjustment activities. A lot of companies let their customers perform the bulk of the validation phase, an activity not for the faint of heart. The subclause asks that this validation be performed before delivery of the product. Records might be in the form of test or trial results, or test and trial reports.
 

sagai

Quite Involved in Discussions
#9
My apology for the rebellious thoughts, but validation for me far not equivalent with a kind of end user testing at the end of the development activities.
Is it part of it? Yes, definitely, but the criteria set for validation can not be covered with any kind of, any depth what so ever testing activities.
For me validation is a set of activities or even more, the organizational attitude (I would not go that far at this time ... :eek: ) in the reality, but let me go back, so a set of activities performed to ensure the intended use of the product fulfills it in the intended environment.
Some examples in order to go down to the basement of every day reality. ;)

Configuration management activities, defect management activities, acceptance activities of supplied materials or interim products during the R&D phase also targeting the fact that we want to make sure the product at the end of R&D fulfills its intended use. Are these all of the activities we carry out to do effective validation? Far not. Verification is also a kind of activities we are doing to ensure the end product is the one and only according to our best understanding at that time.
Is verification equivalent with testing? Very much not. Review, discussion, investigation of scientific literature, etc. also part of it.

Is there any predefined sequential order in the standard?
Faaar not. Read it, it is about principles, not about the sequences.
Each company has to find its own way and awareness how to manage and organize validation.

I guess ... :rolleyes:

Cheers!
 

Peters

Quite Involved in Discussions
#10
What do you think - Is review of the design and development focused more on the design process or more on the design documentation/specification?
 
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