All Features
Mike Figliuolo
Sometimes you fire someone who doesn’t deserve it. Your job as a leader is to admit the mistake and do your best to rectify it properly as soon as possible.
Many of you (likely about 80%) have fired someone at some point. The odds are that some of you made a mistake in doing so along the way. A…
Chandrakant Isi
Additive manufacturing (AM) and AI are two of the most exciting fields in technology today. 3D printing has revolutionized manufacturing and design, allowing for the creation of complex objects with ease. Meanwhile, AI tools such as ChatGPT, MidJourney, Stable Diffusion, and Resemble have shown…
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).
A QMS contains everything that…
FABTECH
Manufacturers understand that their businesses won’t grow if their workforces don’t grow along with them. That’s why the talent shortage in the metal fabrication industry continues to be a pressing concern—and three-quarters of respondents in the National Association of Manufacturers’ 2023 First…
Hank C. Andersen
Not many years ago, there was a CEO so exceedingly fond of finding the right strategy that he spent all of his money on consultants to tell him what the strategy should be. One day there came two consultants, and they said they could craft the most magnificent strategy imaginable. Not only would it…
Megan Wallin-Kerth
Business owners and employees alike have long debated over how best to achieve quality standards and what those standards ought to be. However, as much as linear thinking may help when measuring degrees of improvement, increases in profit, or low turnover rates, it can’t tell you that your company…
Jennifer V. Miller
What are the stories we tell ourselves? It’s a simple question, yet one rich with possibility. In my years of creating leadership development programs, one of the “stories” that continually surfaces with leaders is “I need to do X for my direct reports because they are not yet ready/willing/able to…
Mike Figliuolo
You folks know I love asking questions. From this post about forgoing answers in favor of asking questions, to my quote, “Asking the right question about the future is more powerful than having the right answer about the past,” I’ve found questions to be a more powerful leadership tool than many…
Mark Mortensen
The end of Covid-19 workplace disruptions has ushered in a fresh set of challenges for organizations. Chief among them has been establishing new office policies for a workforce that has largely embraced flexible work and has expressed a desire for this to become a permanent fixture.
But…
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.
FDA guidance also makes an explicit link between…
ISO
Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic, social, and health advantages. Failing to act swiftly and decisively risks catastrophic climate change,…
Mark Hembree
Pick a problem—any problem. As soon as you have one without an immediate answer, we can begin.
Perhaps you’re a quality professional, an auditor, a systems analyst, or just the person your boss sent to find out what the heck is going on around here. Whether you have a problem on your plant floor…
Ethan Mollick
Nano Tools for Leaders—a collaboration between Wharton Executive Education and Wharton’s Center for Leadership and Change Management—are fast, effective tools that you can learn and start using in less than 15 minutes, with the potential to significantly affect your success.
The goal
Adopt a seven…
Gleb Tsipursky
The unemployment rate is surprisingly low, at 3.7%, shocking economists who expected a slowdown in hiring and rising unemployment rate. Frontline work, such as healthcare, led job growth. Frontline workers are in high demand, and the competition for their services is fierce. Yet wage growth cooled…
Bruce Hamilton
Last May marked the 35th anniversary of the Shingo Prize, an award bestowed each year to recognize organizations that demonstrate the principles and methods espoused by its namesake, Shigeo Shingo. Although I haven’t made it to every celebration and award ceremony, it turns out that I was the only…
Kevin Cool
You probably won’t find it in a book on business leadership, but Faiz Shakir has a dictum for executives of major corporations who really want to understand what their employees’ jobs are like: “Know the coffee.”
The reference was in the context of unionization efforts by Starbucks employees, and…
Etienne Nichols
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications.
But achieving that goal is easier said than done, and it depends heavily on whether you take a risk-based approach to…
Jon Finerty
In today’s highly competitive business environment, a trusted supply chain that functions seamlessly is essential. Even small errors can affect the entire supply chain, resulting in lost revenue, unsatisfied customers, and irreparable damage to your brand.
Now more than ever, companies need the…
Stephanie Ojeda
Effective complaint handling is fundamental to life-sciences quality management, with implications for operations, product design, risk management, and more.
It’s also critical to ISO 9001, FDA Quality System Regulation (QSR), and EU Medical Device Regulation (MDR) compliance.
Manufacturers that…
Selena Rezvani
Have you ever had one of those career moments where you felt like you’d made it? A moment of proof that you’d finally earned a spot at the cool or important table?
I remember mine vividly.
I was invited to a leadership awards event to accept an honor alongside many strong businesswomen I admired…
Wayne Schaefer
Industrial machine-vision systems use high-resolution cameras, image-processing algorithms, and artificial intelligence to enhance quality control, automate inspections, and optimize production processes with precision and efficiency.
Implementing vision systems spans applications such as 2D…
Mike Figliuolo
Twice in the last week I’ve heard about “idiot bosses.” Being the inquisitive guy I am, I probed for the root cause of such comments. Rather than simply asking what the cause is, I decided to address the symptoms first.
Q: “Tell me more about this idiot boss.”
A: “I’m so fed up with him. He’s…
Evan Milberg
The year is 2033: The owner of a planned high-rise in a big city is looking to build prefabricated modules with recyclable, low-carbon materials. Work is expected to begin as soon as possible, so the contractor can’t afford to spend a great deal of time figuring out how much of each material will…
William A. Levinson
Time value of money calculations, including net present value analysis, is important when selecting projects and investments. The calculations are part of the body of knowledge for some of ASQ’s certification exams. They also go a long way toward explaining exactly what happened to Silicon Valley…
Etienne Nichols
Medical device companies must have established risk management processes that comply with ISO 14971. It doesn’t matter whether you’re developing medical devices in the U.S., EU, Canada, or elsewhere. Every international regulatory agency you’ve ever heard of accepts ISO 14971.
ISO 14971 is a good…
