Definition Verification vs. Validation - What are the differences?

Helmut Jilling

Auditor / Consultant
#41
What is "checks/verifies"? Doesn't it involve any physical measurements just looking at papers/data? To verify that the "thing" actually works is to me design verification, and more often than not, involves a prototype too.
Validation is to check beyond the basic functionality that the "thing" performs as specified over its entire range of operational (use ) conditions .
This argument is never going to end as long as it remains theoretical. There is no definition that fits every type of product.
Your prerogative to view it as you wish. I simply explained the common view in automotive.

Design Verification happens on paper, long before you have shaped metal, plastic etc. into a product. It makes sure the design inputs were accounted for. Does the design have the right dimensions? Did you design in all the holes and features that were specified in the design plan? Did you evaluate the feautes from a manufacturability point of view? It is generally a discussion "checking" things on paper or onscreen. Some CAD software even has certain verification routines (error checking) built into the software.

It would be silly to build the prototype before you verified and checked repeatedly that all the items (inputs) were addressed. That is why most companies have ongoing regular design review meetings, as the design progresses.

Then, when you have verified that you got everything covered, you commence to making the thing, typically in prototype.
Then you test and evaluate that physical thing, to "validate" that it actually works as planned and that the customer's needs will actually be satisfied. A design engineer spends an inordinate amount of time and energy verifying all the details are covered before we go to the cost of tooling and materials and all that stuff.

Yes, it will vary for different products, but only in scale. The general principles apply pretty universally.
 
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Helmut Jilling

Auditor / Consultant
#42
Alll of the confusion stems from the fact that validation is a type of verification, and vice versa and that validation isn't necessarily a standalone activity--it's comprised of a series of verifications.

Think in terms of efficacy--the property of being able to perform as intended. In our business, "validation" is confirmation of the efficacy of a design--that design intent has been met. Validation comes about through various types of verification--dimensional, cosmetic, performance, etc. After we're satisfied through verification that design intent has been met, the product/process/whatever has been validated.

Sure, but when you design a product, don't you make sure that the drawing meets all the specified inputs, before you submit the drawing for tooling or fabricating a prototype. That is essentially the Design Verification. Then, when you have a part or prototype, you verify again, all the things you mentioned. You also test or do whatever else you are goin to run it through. That is Design Validation. Yes both are verifying the design as it progresses through the different phases.
 

Paul Simpson

Trusted Information Resource
#43
Alll of the confusion stems from the fact that validation is a type of verification, and vice versa and that validation isn't necessarily a standalone activity--it's comprised of a series of verifications.
Coming in from left field! :notme:

As a system implementer do you need to know the difference?

Think in terms of efficacy--the property of being able to perform as intended. In our business, "validation" is confirmation of the efficacy of a design--that design intent has been met. Validation comes about through various types of verification--dimensional, cosmetic, performance, etc. After we're satisfied through verification that design intent has been met, the product/process/whatever has been validated.
My recommendation is to document what you do. It is down to the assessor to evaluate what you put in front of him / her and decide if you have satisfied the requirement. So if you have a new product introduction process and it satisfies your needs it should meet ISO 9001 and it is the CB's job to tick off all the boxes in their report.
 

Jim Wynne

Staff member
Admin
#44
Coming in from left field! :notme:

As a system implementer do you need to know the difference?



My recommendation is to document what you do. It is down to the assessor to evaluate what you put in front of him / her and decide if you have satisfied the requirement. So if you have a new product introduction process and it satisfies your needs it should meet ISO 9001 and it is the CB's job to tick off all the boxes in their report.
What you're saying is more or less what I was driving at, but poorly apparently. :D
 
P

potdar

#48
Our company just recently aquired a manufacturing division. This required me to remov our 7.3 exclusion(much to my dismay). I created a controlled form that requires all of the measurements to be checked and recorded after the product has been made. Can this be my validation? If so, how do I show verification?

Thanks in advance!
Susan
A lot has been discussed in a lot of detail. I do not wish to clarify (confuse?) any further.

Just expressing my dismay over the situation - same as yours. You say you purchased a manufacturing division and acquired their drawings and designs. This by itself does not require you to include 7.3.

Are going to design new products? Or are you in automotive with a TS? Only then 7.3 would come into the picture. If not, ignore verification and validation even if you have understood it. Its only academic.

Else, hopefully you have your answer by now.
 

Stijloor

Staff member
Super Moderator
#49
Our company just recently aquired a manufacturing division. This required me to remov our 7.3 exclusion(much to my dismay). I created a controlled form that requires all of the measurements to be checked and recorded after the product has been made. Can this be my validation? If so, how do I show verification?

Thanks in advance!
Susan

Hi Susan,

After 47 posts, did you get your question answered?

Stijloor.
 

Helmut Jilling

Auditor / Consultant
#50
A lot has been discussed in a lot of detail. I do not wish to clarify (confuse?) any further.

Just expressing my dismay over the situation - same as yours. You say you purchased a manufacturing division and acquired their drawings and designs. This by itself does not require you to include 7.3.

Are going to design new products? Or are you in automotive with a TS? Only then 7.3 would come into the picture. If not, ignore verification and validation even if you have understood it. Its only academic.

Else, hopefully you have your answer by now.
I would not ignore it. Whether you designed it originally, or now inherited the designs, they will have to be managed going forward. These skills matter and do not have to be complicated.
 
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