As far as origin stories go, the technology behind helium leak detection is more glamorous than most. That is, when compared to the bubble test, a method many will remember experimenting with during childhood after a popped bicycle tire.
Walking the floor of the International Manufacturing Technology Show in Chicago—between the 100,000-plus attendees and the thousands of booths—it was impossible not to notice the ongoing trend towards speed and automation in every aspect of manufacturing. It’s no different in metrology, as more manufacturers look to automate their inspection processes.
New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version of ISO 13485.
Torque testing is an important quality-control step in nearly every manufacturing sector. Properly testing rotary parts for torque with handheld or automated gages can prevent everything from un-openable bottle caps to loose fasteners. Or, in a grave example, if GM properly acted on failed rotational torque tests of ignition switches in some of its mid-2000s models, 13 lives would have been saved.