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Jason S
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.
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.