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Jason S

#1
Our company is trying to earn ISO 13485 certification. Along with that we have been introduced to process validation. Our company is a contract manufacturing shop specializing in welding. We do a lot of work for medical device manufacturers as a second or third tier vendor. We frequently get work from machine shops who require welding, mainly laser welding.

We keep running into problems when trying to create a validation plan specifically process performance and qualification. We have installation qualifications and operational qualifications in place. 100% of our work is on customer supplied parts. So getting parts to qualify our process performance is like trying to squeeze water from a rock. The other problem is that we have little to no defined tolerance or quantitative acceptance criteria. Inspections are typically only visual. A few customers require a tensile test or cross sectioning, but this is only about 5% or less. If they do require this, it's only when we initially weld parts. It's not done with any frequency. There are next to zero specs for the weld itself. Rarely is there a penetration requirement or weld size. Rare being <1% of our orders.

Has anyone else had similar issues? What was your explanation regarding process validation to an ISO auditor? What did you do to qualify your processes with no quantitative criteria?

Thanks for the help.
 

shamhaider

Starting to get Involved
#3
As welding is considered as special process..so it needs validation such as
1) Welding parameters... temperature, pressure, colling water temp etc.. must be as per defined standards..
2) The operators must be trained and skilled to do the job..
3) The destructive testing must be carried out as per defined frequency/customer rqmnt..
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Good day Jason S,

Weld process verification, like other processes is done to ensure you and the customer can depend on outcomes.

As always, it starts with control. So the customer doesn't give requirements, but we can be sure the industry does. Welding-advisers.com has put out a web page titled Welding-validation, Definitive Approval Stamp to explain it. I am not affiliated with welding-advisors.com. That page has links to ANSI and AWS welding standards too.

The standards' criteria for welder qualification processes, destructive and nondestructive testing are generally based on the industry the welds serve. I doubt you will be held to nuclear industry weld standards, so look for differentiation. Your ISO auditor isn't looking for a full blown-out program like the nukes would have, but we do expect to see that you recognize the requirements from the industry, have met them and keep up-to-date with them.

I hope this helps!
 
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Darrell B

#5
Your final responsibility is to meet your customers expectations. If they don't give you parameters, then it can be a safe assumption that if the reject/ failure rate is low that the customer is happy.

For ISO sake, you could develop your own parameters. Red line the drawing for weld sizes, develop a WPS for weld machine settings, etc. Get rid of the "tribal knowledge" and document what you do.
 
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cosmobenz

#6
Hello, did you ever get anywhere on this? I need to get this done asap. Any help would be appreciated.
 

John Broomfield

Fully retired...
Trusted
#7
Jason S and cosmobenz,

Is it reasonable for a customer to expect a contract manufacturing shop specializing in welding to be the expert in helping the customer to establish acceptance criteria (welding specifications) for their welds?

Providing your customer with a welding service and doing nothing to specify and validate the welds for yourselves exposes your firm to liability.

You could choose to manage this risk by offering the customer a choice of recommended (and validated) weld specifications.

You could also provide the customer with the option to pay for validation (destructive) testing if the joined metals belong to the customer or are specified by the customer. You would then test the coupon made strictly in accordance with the selected specification and provide the customer with the test results.

You would also revalidate the welding specification in the event of any change to the joined metals, weld materials, welders or methodology. Of course, if this is the case, your contract must oblige the customer to inform your firm of any change to the joined metals.

John
 

kgott

Quite Involved in Discussions
#8
Our company is trying to earn ISO 13485 certification. Along with that we have been introduced to process validation. Our company is a contract manufacturing shop specializing in welding. We do a lot of work for medical device manufacturers as a second or third tier vendor. We frequently get work from machine shops who require welding, mainly laser welding.

We keep running into problems when trying to create a validation plan specifically process performance and qualification. We have installation qualifications and operational qualifications in place. 100% of our work is on customer supplied parts. So getting parts to qualify our process performance is like trying to squeeze water from a rock. The other problem is that we have little to no defined tolerance or quantitative acceptance criteria. Inspections are typically only visual. A few customers require a tensile test or cross sectioning, but this is only about 5% or less. If they do require this, it's only when we initially weld parts. It's not done with any frequency. There are next to zero specs for the weld itself. Rarely is there a penetration requirement or weld size. Rare being <1% of our orders.

Has anyone else had similar issues? What was your explanation regarding process validation to an ISO auditor? What did you do to qualify your processes with no quantitative criteria?

Thanks for the help.
Just in case this helps;

perhaps your validation plan might consist of records of returns, failures, complaints, NCs and incident investigation reports and your own statistics about the number of parts supplied vs the number of the above you have received from customers, industry and CB auditors, end users and regulators.

I.e ratio of the above to the number of parts supplied.

Do you do radiography, ultrasound etc and any other testing on components you weld? These are also records
 
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cosmobenz

#9
If i had a template i could look at and follow then it would be much simpler. I do not have deep pockets like the large corps. It's hard to beleive no one has a template that has names removed etc they can share.

Thanks for your help.

Cosmo
 

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