Definition Verification vs. Validation - What are the differences?

Randy

Super Moderator
#31
To the best of my knowledge I did not post anything "against" other posters. I did argue some of others opinions, isn't this forum excatly for that?
To a certain degree it is, we just need to ba careful how passionate that agument is.

The 700 pages airfraft spec was a joke- there is really no need to comment on jokes.
You'll find that some folks have no sense of humor, so one has to be careful. (Most of them don't go to the bathroom either:lol:)

You provided pretty good comment, just hang in there and stay involved.
 
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Kevin Mader

One of THE Original Covers!
Staff member
Admin
#32
More for the mix…

Customer need: chocolate cake

How will this be specified? Milk chocolate, dark or perhaps a blend? If I gather the ingredients, develop a recipe, mix the ingredients and bake the cake, will the customer be happy?

Through verification activities, I can confirm that my inputs are correct, the proportions correctly measured, and blending and bake times correct. There’s still no guarantee that the customer will like my chocolate cake, but I did create a chocolate cake.

Through validation, I need to confirm that I’ve met the consumer’s expectations (requirements). Did I use enough chocolate or too much? Was the cake moist and fluffy? All the bench testing (verification) in the world can’t confirm that I’ve met expectations. I must have the consumer’s (user’s) confirmation. It's the one that counts!!

Marketing specifications, which are usually vague, establish the general customer requirements. These must be refined into more detailed requirements (which can take the shape of product requirements) for engineering. Here, the engineering team establishes design requirements on how they plan to fulfill the customer needs. These might be thought of as to how the engineering team plans to mechanically and electronically establish the product the customer wants. These initial design requirements will undergo an iterative design process until final input requirements can be established. Often times, engineering test is performed during this development phase (sniff testing), but this is not yet design verification. Customer preference testing might also be done at this time to further dial in the product requirements. Design verification will occur later after the final design inputs have been established, generally in the form of a design requirements specification. Design Verification activities trace directly to the Design Inputs. Design Validation is performed to confirm that the customer/end user requirements (intended uses) have been met. As noted in Randy’s post, both activities are important, but separate.

Potential document/activity hierarchy:

· Marketing Specification (top level user needs sometimes called a User Needs Document)
· Product Specification (engineering translation of user needs)
· Design Requirements (initial design inputs, perhaps broken down into subordinate requirements documents for recognized disciplines such as mechanical, electrical, software, etc.)
· Design Requirements Specifications (final design inputs)
· Design Verification (confirmation of final design inputs)
· Design Validation (confirmation of user needs)

It has been my experience that mastery of these two concepts is difficult. I suspect that this is why there is disagreement amongst us Covers, especially for those folks who seldom engage in validation activities. The thing of it is that through continued discussion and debate, we continue to refine our theory of what verification and validation are. For me, I’m always in a curious mode to refine my own theory, so I enjoy these types of exchanges.

Enough for now, so back to the group…

Kevin
 

Helmut Jilling

Auditor / Consultant
#35
Simple but true>
Verification: Did we make the thing right?
Validation: Did we make the right thing?

That is very elegant and simple, but I think it misses the point.

Verification is checks (verifies) whether all the details have been addressed in the design.
Validation checks whether the "thing" actually works. There is a product or prototype at the validation stgae.

That is the fundamental difference.
 
M

madannc

#37
That is very elegant and simple, but I think it misses the point.
In what way?

Verification is checks (verifies) whether all the details have been addressed in the design.
In other words did we make the thing right - against requirements, design inputs. A prototype would be used here for testing usually in a QA controlled environment.

Validation checks whether the "thing" actually works. There is a product or prototype at the validation stage.
In other words did we make the right thing - The functionality that we have verified: meets customer requirements, can be used by the customer in customer environment, does it intergrate with configurations as expected, etc etc

This would not be a prototype unless it was manufacturing representive, as the result of the validation would be part of the data used to determine if it can be released as a product/"thing"
 

Helmut Jilling

Auditor / Consultant
#38
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
Out of curiousity, Susan, with all the opinions and replies this simple question attracted...have you gotten an answer to your original question? Or, is it still not clear?
 
W

w_grunfeld

#39
That is very elegant and simple, but I think it misses the point.

Verification is checks (verifies) whether all the details have been addressed in the design.
Validation checks whether the "thing" actually works. There is a product or prototype at the validation stgae.

That is the fundamental difference.
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.
 

Jim Wynne

Staff member
Admin
#40
That is very elegant and simple, but I think it misses the point.

Verification is checks (verifies) whether all the details have been addressed in the design.
Validation checks whether the "thing" actually works. There is a product or prototype at the validation stgae.

That is the fundamental difference.
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.
 
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