kgott

Quite Involved in Discussions
#12
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..
As welding is considered as special process..so it needs validation such as:

4) we have done xyz numbers of these welds to this specification and they are still in service and we have had no negative feedback from customers.
5) in addition to destructive testing we have carried out NDT on a representative number of samples and our acceptance criteria for both destructive and non destructive testing has been met x out of y times. Therefore, the weld specification, the welding procedure specification, welding operator qualification testing and welding machine calibration have demonstrated the welds performed using these specifications are are proven and valid for application the welding is performed for.
 
E

ewemily

#13
I think, validation plan of welding process may include equipment used for welding, temperature and other technical concerns.
 
#15
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.
As a medical device supplier, maybe you need to refer GHTF-process validation guidance (maybe you didnot heard of it, please google it)which recommended by the FDA,
 
#16
Hi Jason !
I´m solving very similar topic ...
Did you solved validation of welding?
I´m preparing validatioon for capacitive discharge welding (basically this is the easiest welding method for validation), TIG, MIG, MAG and spot resistance welding...
 

Miner

Forum Moderator
Staff member
Admin
#17
Hi Jason !
I´m solving very similar topic ...
Did you solved validation of welding?
I´m preparing validatioon for capacitive discharge welding (basically this is the easiest welding method for validation), TIG, MIG, MAG and spot resistance welding...
Jason is no longer active on this forum. Hopefully, someone else will respond to your question.
 
#20
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.
Yeah, I think this should be more on the client's side. Are they auditing you? Did they just throw out: ISO 13485 ? You should be providing at a minimum what would be required for commissioning, but if they're requiring you to do process validation they should be setting up shop inside your facility to help you out. Especially with all the design planning, tracking, and requirements.
 

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