Definition Verification vs. Validation - What are the differences?

R

reaganmom

#1
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
 
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Marcelo

Inactive Registered Visitor
#2
Re: Verification vs. Validation

One of the best ways, in my opinion, to understand the differences between verification and validation is the waterfall model. That a look at this link, for example: http://www.fda.gov/cdrh/comp/designgd.html (it´s the first figure).

Returning to your question..i think you´re really misunderstanding concepts.

Verification has to be done between phases of the development to guarantee that the output from each phase met the input requirements from that phase.

Validation has to be done to guarantee that the final product meets the custumer needs (for example, you might have misunderstood some "brute" requirements when you translated the costumer requirements to design requirements and this might have affected the final product and made it unfit for some of the custumers needs). Just remember that "custumer" in this case means all the stakeholders.

I don´t see how a "form that requires all of the measurements to be checked and recorded after the product has been made" can ensure any of those.
 
Last edited:

BradM

Staff member
Admin
#3
Re: Verification vs. Validation-what are the differences?

:modcop: I added some detail to the title. Let me or another moderator know if it does not suit you.:)

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
Susan, what do you mean when you say verification in the last sentence?
 

Stijloor

Staff member
Super Moderator
#4
Re: Verification vs. Validation

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
With Design and Development Verification you check that the output meets the input requirements. It basically verifies that all design documents adequately address the inputs. (Document focus).

With Design and Development Validation you check that the product (i.e. a prototype) meets the design requirements. (Product focus).

Checking all measurements is simply inspection, which may not demonstrate that the product will perform in accordance with the customer's wishes.

You can have a product that is dimensionally correct, and still may not work.

Hope this makes sense.

Stijloor.
 
M

madannc

#5
Re: Verification vs. Validation

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
I would say this is process control, and verification that parameters meet the specification. Validation is to ensure that the product as a whole performs as intended from design inputs. This means simulating use of the product in the customers hands in a customer environment.

Design inputs include performance and functional requirements according to the intended use, not just tolerence measurements.

7.3.6 states that you have a plan for validation to ensure the product is capable of meeting the requirements for specified use, this will not be achieved by just measurements.

Verification 7.3.5

Also requires a plan this is intended to show that the requirements (design inputs) have been met.

There is an old adage that goes

Verification - Did we make the thing right?

Validation - Did we make the right thing?

records for both verification and validation need to be kept
 

Randy

Super Moderator
#6
Always use you References..

ISO 9000:2005 defines the answer to your question as.......

3.8.4
verification
confirmation, through the provision of objective evidence (3.8.1), that specified requirements (3.1.2) have been fulfilled

NOTE 1 The term “verified” is used to designate the corresponding status.

NOTE 2 Confirmation can comprise activities such as
— performing alternative calculations,
— comparing a new design specification (3.7.3) with a similar proven design specification,
— undertaking tests (3.8.3) and demonstrations, and
— reviewing documents prior to issue.


3.8.5
validation
confirmation, through the provision of objective evidence (3.8.1), that the requirements (3.1.2) for a specific intended use or application have been fulfilled

NOTE 1 The term “validated” is used to designate the corresponding status.

NOTE 2 The use conditions for validation can be real or simulated.

3.8.1
objective evidence
data supporting the existence or verity of something

NOTE Objective evidence may be obtained through observation, measurement, test (3.8.3), or other means.


Here's how I like to put it.............

Verification checks whether the design meets the original specifications (design input).

Validation checks whether the new product works (does it do what it's supposed to as it is supposed to do it).

Both are important, but different ways of looking at a new product.

The input to for example would be NASCAR regs, but also would include and the owner/engineer/driver input. One of those inputs might have to do with the speed the vehicle needs to be capable of. That speed requirement is translated into an engine design in terms of displacement, horse power, torque, etc.

When the engine is designed and built we 'verify' that it is the displacement specified, supplies the specified torque, produces x amount of horsepower. This is design verification.

We then take it to the track to determine if it can meet the speed requirement, which is the 'end user' requirement. Does it perform? This is design validation. Now, in theory, we should do the validation under use conditions, which would imply running it in a race. In fact, the validation probably is performed in a more 'sterile' condition with just that vehicle on the track.


In retrospect, every flight of every Space Shuttle has been a "Validation" flight to test the new design under actual conditions. No 2 shuttles have ever flown in the same configuration and many systems cannot be validated except under actual conditions.
 
R

reaganmom

#7
Re: Verification vs. Validation-what are the differences?

Susan, what do you mean when you say verification in the last sentence?
Hmmm....to be perfectly honest...I'm not really sure!:biglaugh:
I guess I"m just struggling with the entire design concept. When we took the manufacturing company in as a division of our company, we took their designs and drawings and made them our own. But, since we're manufacturing, I was told that we do need to include 7.3 in our QMS. I hope this makes sense...I'm starting to confuse myself!
 
J

Jeff Frost

#8
Randy,

It’s a shame that most people do not use ISO 9000:2005 even though ISO 9001, ISO/TS 16949 and AS9100 all state that this Standard is a normative reference and that the terms and definitions given in ISO 9000 apply (Clause 2 & 3).
 

Randy

Super Moderator
#10
Randy,

It’s a shame that most people do not use ISO 9000:2005 even though ISO 9001, ISO/TS 16949 and AS9100 all state that this Standard is a normative reference and that the terms and definitions given in ISO 9000 apply (Clause 2 & 3).

It isn't reinforced as it should be and most of those same folks do not look upon the definitions and other material as applicable.........shame. In my case I don't interpret, I use the Standard.
 
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