All Features
Stephanie Ojeda
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management. With…
Harry Hertz
I enjoy solving puzzles! I start each morning by doing at least two New York Times puzzles, Wordle, and Connections. My wife and sons and their spouses do the same, although not necessarily as part of their early-morning routine (except on weekends). We have a texting thread where we each report…
Mike Figliuolo
Have you ever met someone who was fired from their job? I’ll bet you $50 they said, “Yeah, I never saw it coming.” For some reason, getting canned always comes as a shock to people. They’re clueless as to how bad they’re doing and how close to the door they are.
Makes you wonder: Are you close to…
Ron Soonieus
Driven by geopolitical uncertainty, trade risks, and new technologies such as generative AI, the most profound business transformation in 50 years is underway. Alongside these factors, pressures from regulators and stakeholders are mounting around the reporting, transparency, and accountability of…
Tim Heston
At Metalworks Inc.’s main plant in Lincoln, Nebraska, co-founders Rob Ernesti and Doug Swanson walked past a new punch/laser system being tested, complete with part removal and stacking automation. It’s one piece of a value stream dedicated to a family of parts. They next walked by a row of small…
ISO
Healthcare administrators find themselves at the fore of a demanding and transformative field, where the pursuit of excellence in patient care is nonnegotiable. In a health industry landscape facing evolving regulations, escalating costs, and an increasing emphasis on patient outcomes, the need for…
Matt Fieldman
When I first started at MAGNET (part of the Ohio MEP) in 2015, I walked into my new office and saw a white paper sitting on my desk. In it, our former board chair Felix Brueck outlined how we could adapt the German apprenticeship model of workforce development to Northeast Ohio and reap real…
John Davis
Over the past decade, one of the biggest advances in enterprise resource planning (ERP) has been the ability to communicate and integrate with machines and external software programs to lower costs and increase efficiency. For example, BOM Compare software can reduce engineering costs and get jobs…
Mike Figliuolo
I’m going to take over the world! It’s really fun to say that. It’s even more fun to take action toward that goal.
Our world has gotten smaller. Way smaller. Globalization is an unstoppable trend. But as they say, the trend is your friend, so why not take advantage of it? I don’t care how big or…
Mark Rosenthal
This all happened nearly three decades ago. Since then, the company has been through a series of mergers and acquisitions. Thus, the only thing I can be certain of is that things are different today—at least I hope so.
It was Tuesday afternoon of a traditional five-day kaizen event. Monday morning…
Melissa Stewart
Companies are always looking for ways to bring in fresh ideas and new perspectives. And in an ever-evolving digital world, you can’t blame them. Young talents possess the latest technological skills and insights, which can be incredibly useful in adapting to the times. However, there’s one thing…
Gleb Tsipursky
Atlassian, one of the world’s most successful remote-first companies, has unlocked the secrets to mastering distributed work. I recently spoke with Atlassian’s Annie Dean, head of its aptly named “Team Anywhere” program, to get her insider’s perspective on the keys to thriving in the distributed…
Wael William Diab
Artificial intelligence (AI) is everywhere—and that’s something to marvel at. AI is powering everything from advanced web searches to social media recommendations and video game design. But it could do infinitely more.
AI has the potential to revolutionize our societies and economies. Discussions…
William A. Levinson
Valuable American manufacturing jobs were sent offshore under the dysfunctional belief that low-wage labor would result in lower product costs and higher profits. Although it may seem counterintuitive, manufacturers do better with high-wage workers who will acquire skills, follow work standards,…
Mike Figliuolo
Some people advocate giving good feedback before and after bad feedback. Doing so is actually harmful. Instead, good leaders deliver tough feedback directly.
Every once in a while history repeats itself—and those who fail to learn from it are doomed to repeat it. This post is in the spirit of that…
Stephanie Hinton
If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.
The European Union Medical Device Regulation (EU MDR) lists this as one of…
Tobias Dennerlein
A majority of American workers right now aren’t feeling very motivated on the job, a new survey suggests. Management experts often encourage business leaders to motivate employees by empowering them. The idea is that when workers are free to make decisions and manage their workday, they become more…
Bruce Hamilton
I’ll admit it: After five decades watching U.S. companies turning to simplistic accounting tricks to remain profitable, I’m discouraged.
I was a kid when I first discovered the Toyota Production System (TPS). My eyes were opened to the immense amount of waste in our production and business…
Ekin Ilseven
An organization’s resilience can’t be measured in advance. Crises, by definition, emerge not only from unfamiliar, disruptive, and unexpected events, but also when the immediate consequences of such events get entangled and intertwined with the complex dynamics of the organization.
Organizations…
Stephanie Ojeda
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021, according to the ISO Survey.
This occupational health and safety standard is especially prevalent in manufacturing, where managing safety incidents is a core concern from the perspective of protecting workers,…
Mike Figliuolo
Stupid stuff is going to happen. Expect it. It’s part of our complex and highly interdependent world. People will make mistakes. A lot of them. Layer on top of that some incredibly politically charged cultures (for more on that subject see “Hot Heads and Karma”), and there’s an abundance of…
Jones Loflin
I’ve been dabbling in AI (or ChatGPT as some of you may call it) for about eight months. I’ve used it to strengthen blog titles, make content “punchier,” and help me get some creative juices flowing.
However, by far my favorite thing to do with it is to ask it to explain a complex topic to a 5-…
Elizabeth Z. Johnson, Michael Platt, Vartika Parasramka, Victoria Villacorta, Emily Foy, Natalie Richardson
Countless management and HR blogs, articles, and books are packed with advice about best practices for improving workplace culture, making teamwork more effective, ways to stay on task, and methods to get the most out of meetings. In parallel, organizations often query employees with self- and peer…
NIST
Manufacturing Day, or MFG Day, has grown to mean many things since it was officially proclaimed in 2012. Some celebrate on the first Friday in October with an event at a manufacturing facility or a school. Others participate in a regional celebration at an events center. Some areas have a…
William A. Levinson
The difference between common (or random) cause and special (or assignable) cause variation is the foundation of statistical process control (SPC). An SPC chart prevents tampering or overadjustment by assuming that the process is in control, i.e., special or assignable causes are absent unless a…
