Design and Process - Validation vs. Verification - What is the difference?

Kevin Mader

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Dbzman,

Say that you can’t verify hardness of the part because the hardness test is a destructive test method (it will leave a dimple where you don’t want one). How will you ensure that the heat treat process produces the right results?

You must validate the process by knowing what the process is capable of producing through various validation and verification techniques. Perhaps the only way to ensure shipping the right hardness is by knowing the process intimately, through a prior validation process, where you can offer reasonable assurance that the outcome will meet specifications (process control monitoring, sample bar of material with similar composition, etc).

If I run a process in statistical control, my outcomes are predictable. By performing SPC, I monitor the process and know that the outcomes are what they should be, without having to perform any verification activities (beyond initial process validation, of course).

Regards,

Kevin
 
O

olddog

Re: Reply to Answers

dbzman said:

Thanks for all of the input!

One more question:

we are a Heat Treating company. All we do is take the customer part, heat treat it to harden it, and then send it back to the customer. We test for hardness to make sure that it is correct. Verification

How does verification and validation fit into this?

Thanks!:bonk:

When you setup the line to process the next batch of parts for this customer and take a first piece sample to assure that hardness is within the requirements you are validating. (You do this by testing a part -verification)
 
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T

tattva

Speaking of diferences

Can anybody tell me now the diference about efficiency and effectiveness?:confused:
 

howste

Thaumaturge
Trusted Information Resource
Re: Speaking of diferences

tattva said:

Can anybody tell me now the diference about efficiency and effectiveness?:confused:
Why don't we start with the ISO 9000:2000 definitions:
effectiveness
extent to which planned activities are realized and planned results achieved

efficiency
relationship between the result achieved and the resources used
Effectiveness is about how well something works. Efficiency seems to be about how much it costs to do it (in terms of $$, people, or other resources).
 
L

Link Xue

Re: Validation & Verification - Dif??

Originally posted by dbzman
Could someone help me better understand the differance between "Validation" and Verification"?

Thanks!

:bonk:

I think in TS 7.5.2 Validation of processes for production and service provision has clear definition, it said:

The organization shall VALIDATE any processes for production and service provision where the resulting output cannot be VERIFIED by subsequent mornitoring or measurement..............

SO, VALIDATE IS A PROCESS
VERIFY IS AN ACTION
 

howste

Thaumaturge
Trusted Information Resource
According to the ISO definitions, verification is confirmation that a requirement has been met. Validation is confirmation that a requirement has been met related to the intended use of the product (or process).
 
N

noboxwine

Re: Validation & Verification - Dif??

Originally posted by dbzman
Could someone help me better understand the differance between "Validation" and Verification"?

Thanks!

:bonk:

Verification: Paper
Validation: Product

:)
 
T

tattva

Originally posted by tomvehoski
Verification will be to do a hardness check to make sure you hardened it to the correct specification. Validation will most likely be up to your customer - unless you have the ability to run the part in a real world type test.

In your situation I normally state something to the effect that verification is the act of inspection. Validation is the responsibility of the customer. As long as the customer does not complain, and pays the invoice, the part is considered validated and the design process can be considered closed.

Tom

I´m in the foam seat industry and we do perform hardness test to seats, and recently one of our customers in Plymouth found out one headrests was not in SPC, they said it had 14.5 N for I.L.D., the SPC is 30.6 to 39.5, they sent it back to us, made us to present a contianment program, hand & visual verification, and many other things, president of this company even said: how in God´s Name we were QS certified and worse trying for TS.

The issue here is that the piece was returned to us and try another shot for the piece´s hardness " IT WAS 31.6 N". So is it a good thing to leave validation to the customer?

Any ideas about another way to perform validation? Thanks im advance :truce:
 

howste

Thaumaturge
Trusted Information Resource
It sounds like you need to do a correlation of measurement methods with your customer, and educate them on the proper method. More than likely your method is right, since (I assume) you're the experts...
 
S

Sam

From TS2;
Verification - "...ensure that the design and development outputs have met the design and development input requirements".
Outputs are design records, BOM, test requirements, process studies,etc.,etc. that are required to meet the input requirements.

Validation - "... ensure that the resulting product is capable of meeting the requirements ...".
This is perfromance testing of the product.
 
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