All Features
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…
Mike Figliuolo
Meetings give me a rash. A really bad one. One that not even calamine lotion can soothe. The only things worse than meetings are reports. Standard daily reports, weekly reports, hourly reports. Reports on the status of reports. If I wasn’t already insane, these things would drive me insane.
Take a…
Etienne Nichols
Supply chain management is crucial to any medtech company’s ability to deliver safe, effective, and high-quality devices to their customers.
But as anyone in the industry can tell you, consistently getting the products and services you need to manufacture your devices is harder than it sounds. In…
Gleb Tsipursky
Many employees are asking, “Do we really need to go to the office?” as the leadership at major companies like Amazon, Apple, Disney, Starbucks, and JP Morgan mandate three or more days a week of office-based work. Employees are adamant that they are doing their jobs effectively at home, and data…
William A. Levinson
Inflation is a serious national issue. Credit agency Fitch Ratings just downgraded the U.S. credit rating—as in the “full faith and credit of the United States”—from AAA to AA+.1 This doubtlessly reflects the fact that our national debt exceeds $31 trillion, or almost $100,000 for every American,…
Chandrakant Isi
Apple’s Vision Pro announcement has sparked a renewed interest in the world of augmented reality (AR) and virtual reality (VR). Looking through the lens of industrial environments, these technologies have already made significant contributions in manufacturing, maintenance, and training processes.…
Gleb Tsipursky
Have you wondered how to foster remote and hybrid diversity, equity, and inclusion (DEI) in the workplace? Many companies have consulted with me about developing and implementing their strategies for returning to the office and establishing permanent work arrangements. During my interviews with…
Stephanie Ojeda
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Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on their employer’s approach to safety.
There are also huge risks to companies themselves, which face…
Mark Graban
I can’t count how many times during the past 20 years I’ve heard executives complain that their people aren’t enthusiastically participating in their lean program. Leaders lament that while the company has spent a small fortune to put everybody through continuous improvement training, hardly…
Michael Platt, Elizabeth Z. Johnson
Most leaders would attest that true collaboration—the pooling of knowledge, perspectives, and brainpower of talented people—is a desired yet often elusive outcome. To change that, and boost the likelihood of generating breakthrough results, draw on parallels with improvisational jazz during your…
Mike Figliuolo
Do you find yourself muttering, “I hate my job” every day when you wake up? Have you been saying that for more than a month straight? Are people starting to avoid you because you’re a downer to be around?
Then it’s probably time to shut your mouth and quit your job.
Yep. Time for another…
Kobi Leins, ISO
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In everyday life, the most common conversation about artificial intelligence (AI) goes along the lines of, “I used ChatGPT, and it did x.” Corporate leaders, governments, and international organizations, however, are having a very different conversation. Theirs is about how the…
Andrey Koptelov
In this age of rapid technological innovation, the introduction of sophisticated technologies in various industries has raised complex ethical dilemmas. As businesses strive to achieve financial goals and keep stakeholders happy, they also have to mitigate the adverse effects of technology…
Jones Loflin
During my 29 years of working with leaders and managers, I’ve rarely heard any of them say, “I’m so excited about doing the performance reviews for my team.” They see it as another “elephant” in their schedule.
But performance reviews are important. Some of the benefits include:
I also believe…
Mike Figliuolo
Life goals. Bucket lists. “One day I’ll ....”
We all have dreams and goals. The biggest difference between people who achieve them and those who don’t is the act of actually doing. Do you have goals and things you want to achieve? Professional aspirations? Personal bucket list items?
Let me ask…
William A. Levinson
Starbucks’ implementation of artificial intelligence coffee makers1 offers a simple and ideal case study that can illustrate the synergy between efficiency, wages, profits, and inflation. Even if we don’t know the actual cost figures, we can use some hypothetical numbers to demonstrate how higher…
