For the type of continuing instruction that matters most to hands-on implementation of new technologies with optimal Sigma Six impacts, nothing surpasses the detailed (and usually no charge) course offerings from those who pioneer new technologies.
Originally published in European Medical Device Technology, October 2011:
Although the medical device industry have been using dry air leak testing methods since Uson first developing this technology for the USA’s space exploration efforts in 1963, I still regularly bump into manufacturing engineers and other support staff throughout Europe who run compromised assembly lines because the basic principles ofleak detection remain misunderstood. For example, last week I encountered a test station using a leak test system that was ideal for leak testing a single lumen catheter but a very inefficient way of testing multi-lumen catheters. What was needed for this 4 lumen application was a 4 channel concurrent tester, capable of switching between occlusion and leak testing on all four channels at once. The test process is much safer as each and every assembly is tested to the same pre-programmed rigorous test regime without the risk of a channel being missed, plus the bonus of a much faster test.
Choosing the right leak detection equipment is only the beginning—but a very necessary beginning of successful application of best-match leak detectors. Other examples of the basic knowledgebase that ANY manager responsible for medical device or component assembly lines that require leak testing would include: understanding how to create a reliable test program, and relate leak detector results to fitness for purpose of their devices being tested. Armed with a clear understanding of the test process the manager can then determine what level of test reports are required to provide traceability, and how to, and how often to verify system integrity, and protect leak detector from contamination and the complete test station from the effects fixture creep and ambient temperature changes to ensure good Gage R&R capability.
Technology does not stand still. For example, the leak detector options of 5 years ago are no longer the best-match technology for many medical applications such as endoscopic instruments where multiple tests at different pressures need to be performed and where state-of-the art multi-channel leak and flow testers would now make for better fits. In addition, modern manufacturing and quality control processes require traceability of test results involving remote data logging and methods of attaching tests results to the product being tested. Like many reputable manufacturers Uson recognized this need and now offers free 1-3 day courses in leak testing with data management (Applications to attend can be made to [email protected] for the USA and [email protected] for Europe).
Yes, you should definitely attend conference events such as the upcoming MedTec Ireland, which I will report on in my next fortnightly blog. But for the type of continuing instruction that matters most to hands-on implementation of new technologies with optimal Sigma Six impacts, nothing surpasses the detailed (and usually no charge) course offerings from those who pioneer new technologies.