This spring have presented no shortage of hurdles. While many industries are facing new challenges, for those in manufacturing, this may mean continuing production despite supply chain disruptions, health and safety concerns, and economic impact.
The importance of auditing should not be overlooked. As longtime Quality columnist Jim Smith writes, “It’s rare that managers, or even most quality auditors, discuss how closely tied the findings of manufacturing audits are to the long-term ability of their companies to compete in this highly competitive market.”
A fundamental shift is taking place in the way companies are approaching regulatory compliance. A lack of structured data is proving to be a substantial liability—as ill-prepared companies are learning the hard way—which is leading more organizations to move away from conventional document-centric methodologies and toward a data-centered model of compliance.
Anyone involved in medical device manufacturing knows that their industry is highly regulated. Almost every medical device manufacturer or pharmaceutical supplier uses materials testing systems in their quality control and research laboratories or outsources their testing to approved third-party laboratories.
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.
Safety, prevention, and traceability are essential for compliance—and easier with modern quality management tools.
September 12, 2019
Regulatory demands in the food and beverage industry can be particularly challenging. Modernizing your quality management tools can simplify and streamline compliance by turning your efforts from reactive to proactive.