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Special Process Validation - ISO9001 Clause 7.5.2 - How do I go about it?

M

MsHeeler

#11
You could always ask for a certificate of compliance. That should work. It would depend on the welding shop and how critical the welds are. Would it be a safety issue? You see what I mean?

MsHeeler
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#12
You could always ask for a certificate of compliance. That should work. It would depend on the welding shop and how critical the welds are. Would it be a safety issue? You see what I mean?

MsHeeler
I agree to disagree here. The Certificate of Compliance is just a piece of paper that give the warm fuzzy feeling to the Customer. It would not hold water under a Court of Law, but again, I am not an Attorney.

The criticality of the welds should be the driving force on the validation of the process. Each circumstance is different. We weld parts and assemblies, but we do it under the AWS D17.1:2001 standard. We also have done some Navy work that required us to weld in accordance with NAVSEA. It really depends on the circumstances and the Customer's requirements.
 

Big Jim

Super Moderator
#13
Superchris, about it just being controlling a supplier.

OK, if you say so.

Sometimes controlling suppliers is more involved than other times.

I think that most of your problem is a lack of understanding of what special processes are, why they need to be validated, and how they can be validated. Let me try to explain.

Special processes are those that you cannot tell the quality or outcome from monitoring or measuring. Validation is performed to demonstrate the ability of the process to achieve planned results.

How can you determine if it has the ability to meet planned results if you cannot monitor or measure it?

Let's take the example of a fire sprinkler. You cannot tell if it will work without heating it and setting it off. Once you do that it cannot be sold as it has already been consumed.

Now you can validate it by determining exactly how to build it by building them over and over again and destructively testing them until you determine exactly how to do it so that the results are repeatable. By then you have determine the exact process or "recipe" that can provide repeatability.

Monitoring that process, (the recipe) the exact materials, exact quantities, exact times, exact temperatures, and so on can provide validation of that process.

Another example is welding, the one you are involved with.

Welding is usually validated by certifying the welder. The quality of a weld cannot be determined without destructive testing. The weld is pulled apart to determine if the break forms at the weld or from the parent material. If it pulls from the weld, it was not properly joined. Since you cannot use a weld that was destructively tested, the welder is trained and then he welds samples that are sent to a lab for various testing including destructive testing. If the welds pass, the welder is certified. This is a bit of an oversimplification as it does not cover the extensive training. Also, the certification is specific to the material, thickness, type of joint, and position of weld (gravity effects the weld puddle so overhead, side, and flat are all different).

To control a supplier for special processes can entail confirming that the welder is certified and his certification covers the type of welding you are having performed.

For plating it can be from the supplier certifying that he followed a specific MIL spec (the "recipe").

For either one you may want visit the supplier and confirm that they actually have the ability to perform what you are after.
 
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H

Hanr3

#14
Big Jim,
That is an excellent explanation of the Validation process. I prefer to use home brewing beer for an example. For some reason it gets peoples attention. :beerdive:

To the original poster, seems you have at least two members that have knowledge of welding. Might be a good source of information? :read:
 
M

MsHeeler

#16
I agree to disagree here. The Certificate of Compliance is just a piece of paper that give the warm fuzzy feeling to the Customer. It would not hold water under a Court of Law, but again, I am not an Attorney.

The criticality of the welds should be the driving force on the validation of the process. Each circumstance is different. We weld parts and assemblies, but we do it under the AWS D17.1:2001 standard. We also have done some Navy work that required us to weld in accordance with NAVSEA. It really depends on the circumstances and the Customer's requirements.
That sound a lot like what I said with a few flurishes dosen't it? :bonk:

MsHeeler
 
H

Hanr3

#17
Correct, however once tasted you cannot sell it. You can sample some of the product to ensure the process worked as expected. However you cannto sell what has been tested.
 

Stijloor

Staff member
Super Moderator
#19
But you can verify the quality of the beer. You can taste test it.
I agree with Big Jim!

Beer (samples) can be tasted, smelled, chemically analyzed, and will not render the product unsellable. Thus the provision for "Special Process Validation" does not apply.

Stijloor.
 
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