Nondestructive testing (NDT) is used in engineering industries to test equipment, components, and materials without causing any damage. With a reliance on quality assurance and rating systems for tools to be used for the correct tasks, adhering to industrial safety norms is a large factor behind the NDT market.
When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.
A good day on the shop floor has everything running smoothly. No issues with machines, staff, or suppliers, and products are shipped on time and without defects.
NASA. Volkswagen. BP. It’s not hard to find examples of quality gone awry. The consequences of the Challenger disaster, VW’s Dieselgate, and the Deepwater Horizon were tragic and far-reaching. While these are some of the most well-known incidents, stories of quality failures are numerous and almost constant.
Hazard- and risk-based approaches to product design and manufacturing may be required by some standards, but they are also simply good practice. These approaches require a more holistic view of the product, intended use, skillset of users, materials, environment, and end-of-life.
During my courses preparing quality professionals to successfully take certification exams offered by American Society for Quality (ASQ), one topic that constantly comes up is the challenge of getting organizational management to support quality initiatives.