This article explains how a Quality leader can establish external requirements by defining products in a specific region, using medical devices as an example based on FDA regulation Section 201(h) and the 513g Request process. Following this prevents wasting time, funds, and resources on incorrect regulatory assumptions.
New orders of metalworking machinery, measured by the U.S. Manufacturing Technology Orders Report published by AMT – The Association For Manufacturing Technology, totaled $392.7 million in May 2025.
The Association for Manufacturing Excellence (AME) supports continuous improvement and Lean thinking. As a Virginia/DC U.S. Senate Productivity and Quality Award board member and a Baldrige examiner, I’ll discuss how the Baldrige Framework and AME Lean Sensei address manufacturing challenges, especially in workforce development.
Quality sat down with the team from Sierra College−Amy Schulz, executive dean for Workforce and Strategic Initiatives, and Roy Ingram, department chair for Electronics, Automation, Robotics, and Industrial Systems, on a topic dear to the heart of the quality industry- the workforce, automation, and training.
Discover what your customers expect and consistently deliver. This remains a guiding principle for any quality system and should apply to product- and service-based environments.
AeroFlexx, a pioneer in sustainable liquid packaging, partnered with Factory Systems to enhance data visibility on its high-speed converter line. Renowned for disrupting traditional rigid packaging with a flexible yet rigid bottle design, AeroFlexx relies on a highly engineered converter system to shape and seal its innovative packages. As they refined this process, a key issue emerged.
Customers seem to have a greater understanding of metrology these days. This is good news for the industry, and for the Coordinate Metrology Society. We spoke with Justin Novak about the trends he’s seen in his 20 years in the field.