Laser Weld Operational Qualification

[DLud88]

I work for a small job shop which manufactures surgical instruments and other medical devices for OEM's. We have recently received our ISO13485 certification and as part of our process validation plan I have been tasked with performing an Operational Qualification for our Laser Welder. It's a Nd:YAG laser with computer control. We typically use it for seam welding stainless steel materials. If anyone has an example of a protocol plan for OQ of laser welding it would be greatly appreciated.

Thanks - DLud88

 

[BenBB]

I suggest the following:
1. Have operator instruction.
2. Have a startup checking that includes a peel test since your welding foil.
2a. Depending on the requirements of the weld strength, the peel test can be as simple as manually peeling with plyers to see if rips at the seam. This would signify the weld is as strong as the foil yield.
2b. If design is a weld that is not as strong as the yield of the foil, you will need peel test equipment with a load sell and have the operator log the results.

If you need to close an audit finding quick you will need to to the peal test for a population quick. You can generate the Cpk and back interpulate UCL and LCL and establish your peal strenth limits.

If you are going to use the case a 2a, the limit is the yield stength of the material thickness.

3. If for an ISO audit they usually like to see it spelled out somewhere the frequency of the peal test and data showing it is being done as well as what happens when a failure is detected.


BenBB

 

[DLud88]

I suggest the following:
1. Have operator instruction.
2. Have a startup checking that includes a peel test since your welding foil.
2a. Depending on the requirements of the weld strength, the peel test can be as simple as manually peeling with plyers to see if rips at the seam. This would signify the weld is as strong as the foil yield.
2b. If design is a weld that is not as strong as the yield of the foil, you will need peel test equipment with a load sell and have the operator log the results.

If you need to close an audit finding quick you will need to to the peal test for a population quick. You can generate the Cpk and back interpulate UCL and LCL and establish your peal strenth limits.

If you are going to use the case a 2a, the limit is the yield stength of the material thickness.

3. If for an ISO audit they usually like to see it spelled out somewhere the frequency of the peal test and data showing it is being done as well as what happens when a failure is detected.


BenBB

BenBB,
Thank you for the quick reply. Your suggestions are right on the mark. Some of the information I am hoping to acquire includes what the critical system parameters might be that I should include as variables in order to establish worse case conditions. I would like to obtain a document format that has worked well for others.

Thanks again for your input!
DLud88

 

[BenBB]

Until you do a DOE you should consider all factors/variables that go into the material and machine settings as important.

You can do a screening DOE Taguchi to determine what variables have the most effect on the process.