All Features
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…
Shreya Dasgupta
Today’s businesses must innovate and evolve to stay ahead of the competition. However, despite the best efforts of business leaders, many organizations struggle to produce new, innovative ideas to keep up with the changing landscape. This is partially due to the limitations of the human brain.…
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…
Ken Voytek
It’s time for U.S. manufacturers to focus on productivity or they will lose their long-term advantage. Productivity is fundamentally about increasing output rather than decreasing costs and inputs while output remains static. We faced this challenge during the 1980s and 1990s but didn’t learn much…
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…
Mike Figliuolo
It’s a great time of year. Beautiful weather, flowers blooming, and 110 bags of mulch to be spread tell you it’s spring. Now is when we traditionally clean our homes and yards. It’s also a great time to clean up your work and professional life.
Face it: We’re creatures of habit and averse to…
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…
Mike Morini
Following the turmoil of the pandemic, many salaried employees have had the opportunity to work remotely and enjoy newfound flexibility in their day-to-day work lives. For many, the ability to be more in control over where and when they work has been life-changing, enabling them to find better work…
Taran March @ Quality Digest
As part of last year’s Masters Summit, hosted by the quality software specialists at MasterControl, Jeff Dewar, Quality Digest’s publisher, approached a few attendees for some candid comments. Since most people there were quality professionals of one sort or another, he cast a wide net and simply…
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…
Anders Rasmussen
Enterprise resource planning (ERP), product life cycle management (PLM), and customer relationship management (CRM) systems were transformative when they were first developed. They made it possible for businesses to establish centralized data repositories for customer, product, or financial…
Kate Zabriskie
‘They reduce our bonus if our calls go longer than three minutes. I’m not going to lie; I start talking faster at the 90-second mark.”
“She asked me to suggest ideas, so I did. I now have a whole bunch of extra work to do. It’s the last time I’m opening my mouth. I didn’t realize offering an idea…
Chengyi Lin
Although the days of fully remote work may be over, many employees have expressed a desire for flexible work arrangements. But with Covid-19 no longer a global health emergency, more organizations could demand that people return to the office—setting the scene for an inevitable tug-of-war.
Some…
Jake Mazulewicz
Wildland firefighters. Air traffic controllers. Flight deck crews of aircraft carriers. Operators of nuclear power plants and the national bulk electric grid. These are among the safest and most reliable work teams in the world. And they don’t try to eliminate all errors and surprises.
Decades of…
