AMA on ASQ Certification

  • 27 May 2022
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This week we’ve invited Shawn Findlater from the VirtualQE for an exclusive AMA (ask me anything) session on ASQ Certification.

If you have run into problems, send a message directly to @Etienne and let us know!


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How would you approach implementing Out of Specification testing for medical device testing? 

 

Background: batches are small quantities (between 5 and 50). In the past a sampling plan was used to destructively test the routine QC samples and if one of these failed, the batch would be failed. 

In app 90% of batches we are unable to find the exact source of the problem due to an extremely labour intensive assembly process where microns of millimeters matter and where just a little too much heat in the wrong place cause rejects. There are systems in place to ensure consistent repeatability but where the human element is involved, it is always tricky.

The expectancy is to find a system to be able to pass the batch even if one of the devices failed

Great question! This is actually a business question and I will tell you why it is during the call and how it informs your decisions from a quality perspective. 

 

Excellent, I look forward to the discussion. Thank you for your willingness to discuss this issue tomorrow.

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