Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking

J.Enger

Involved In Discussions
#1
We are being asked by one of our customers do do an IQ/OQ (Installation Qualification/Operational Qualification) for laser marking for medical implants/tools. I have done pretty much everything, except the Functional Tests for the OQ part. The only thing I can come up with is the Focus operation, but that is something that is done at every setup. I have sent an email to the company for help on that part as well,but any help from you guys on here would be appreciated.
 
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ScottK

Not out of the crisis
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#2
Re: Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Mark

We are being asked by one of our customers do do an IQ/OQ (Installation Qualification/Operational Qualification) for laser marking for medical implants/tools. I have done pretty much everything, except the Functional Tests for the OQ part. The only thing I can come up with is the Focus operation, but that is something that is done at every setup. I have sent an email to the company for help on that part as well,but any help from you guys on here would be appreciated.
I was with a company that did this for the same reason, same type of customer. I'm pulling this from memory as I am no longer with that company...

It kind of depends on your machine.
Definitely consider the focus. Can you adjust the power? If so that would be a consideration.
We also looked at the print range and did a worst case by printing something in the corners of the largest size piece the machine can handle.
And varying font sizes as well, we went to the smallest legible text size.
And material - we did several materials so we ran each test for each material.

Are you printing bar codes for these customers? If so that's a whole other level and you'll need some sort of calibrated bar code verifier/grader to check the bar codes you print... I would make that part of set-up QC check in normal operation too.
 

J.Enger

Involved In Discussions
#3
Re: Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Mark

Thanks for the info. I was able to generate the IQ/OQ to their acceptance.

If they do have us do the marking, I have several quotes for different Bar Code Verifier/Qualifiers to purchase, which we will split the costs over the different parts they want to have us mark.
 
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