Design - Simple System - ISO 9001 Clause 7.3 - Review vs. Verification vs. Validation

D

David Hartman

#11
dbzman said:
Hi everyone!

I'm a little confused on this Verification Validation thing.

I work for a Heat Treating company (Heat Treat metal parts), and I'm trying to get this right.

Verification: Testing to Specification, Paperwork.

Validation: Testing to customer performance req.

When we develop a new process to heat treat a part we look at the customer input (specifications, metal parts, etc) and determine the output (work order, procedures, etc).

When we perform a test run to see if the process works we test the parts to spec (Verification). When we develop the heat treating process we may look a similier jobs to determine the right process (Validation).

When are we actually performing Verification and Validation. I was under the assumption that Validation came before Verification.

Where am I missing the boat.

If Verification is paperwork then where does the testing of the part come in?

If Validation is testing why compare to other jobs?

As you can see I'm having a little trouble fitting the two in. Everytime I think I have an understanding I read something else that confuses me.

Thanks for any help given!


Mike W

:bonk:
Verification: Comparing your new process against the customer's requirements to ensure that you have not overlooked any of the requirements, and that it appears that your process should provide a product that will meet those requirements.

Validation: Testing the actual product to prove that the customer's requirements are in-fact being met.
 
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howste

Thaumaturge
Super Moderator
#12
From ISO 9000:2000
verification - confirmation, through the provision of objective evidence, that specified requirements 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 with a similar proven design specification,
— undertaking tests and demonstrations, and
— reviewing documents prior to issue.

validation - confirmation, through the provision of objective evidence , that the requirements for a specific intended use or application have been fulfilled
NOTE 1 The term “validated” is used to designate the corresponding status.
Example for a basketball system:
Verification: Measure dimensions of parts, tensile test & chemical analysis of materials
Validation: Durability testing on the hoop, simulating 10,000 slam dunks.

Example for paint:
Verification: compare color samples, check visual appearance, measure thickness
Validation: salt-spray testing
 

Paul Simpson

Trusted Information Resource
#13
V and V

There is still this confusion with Verification and Validation. Here is my two pennyworth.

Verification - a theoretical study that a product meets the requirements. Design reviews come into this category as it is people sitting round a drawing (or a tube) and discussing the design (with the requirements in mind). CAD simulations similarly. Interesting that component testing also comes into the verification because it isn't on the complete product.

Validation - The finished product is tested against customer or company requirements. The emphasis here is on real life conditions.
 
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