All Features
Manfred Kets de Vries
A young manager told me about the day she nearly quit her job. A major restructuring had left her team reeling. As targets shifted overnight, colleagues departed and rumors spread faster than facts. “I felt like I was living in a storm without a compass,” she said.
What changed her mind wasn’t a…
Adam Zewe
What can we learn about human intelligence by studying how machines “think?” Can we better understand ourselves if we better understand the artificial intelligence systems that are becoming a more significant part of our everyday lives?
These questions may be deeply philosophical, but for Phillip…
Stephanie Ojeda
Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden. Entrenched legacy systems compound the problem as organizational inertia and complacency lead companies to make do…
David Schwinn
I’ve been in and around the quality profession for decades. When I first started, we were most concerned about products failing in our customers’ hands... too often and too soon. I worked at General Motors in those days, in the Frigidaire division when Frigidaire was part of General Motors. We made…
Mike Figliuolo
Have you ever been in line for a promotion or a transfer to a new role only to find out your boss was quashing your efforts to make that leap? Here are some tips on how to deal with a boss sabotaging your career.
Many of us have been there—you hear about a cool new role somewhere else in the…
Creaform
Your company works hard to bring quality products to market, but your current inefficient development process slows you down. Your engineers rely on traditional tools like measuring tapes, calipers, verniers, or photos to gather dimensions and document how to shorten time to market and lower…
James Glover
Your facility has detailed standard operating procedures (SOPs), ISO certifications, and quality management systems that would impress any auditor. But operators still skip calibration checks when production is behind, modify machine settings without authorization during shift changes, and forget…
Nimax
The global coding- and marking-equipment market is on a clear growth path. As shown in a recent Grand View Research report, the market was worth $17,528 million worldwide by the end of 2024.
Furthermore, GVR’s projections estimate the market value will reach $24,927 million by 2030, with a…
David Matalon
The term return to office (RTO) has dominated headlines for the past year. But despite the noise, data tell a different story: Full-time office life isn’t coming back—at least not in the same way.
According to 2025 research, 85% of organizations now stipulate an attendance policy, but only 37%…
Adam Grabowski
To stay profitable as a manufacturer, you have to run a tight ship. I’ve been lucky enough to visit with owners and key people at thousands of manufacturers all over the world. My main goal during these visits is to listen and learn what makes them so good at what they do.
It turns out that the…
Gleb Tsipursky
Reshaping industries, automating routine tasks, and unlocking new realms of creativity—welcome to the world of generative artificial intelligence (gen AI).
However, the technology’s potential can only be fully realized when employees actively engage in learning how to use it effectively.…
Akhilesh Gulati
Meritocracy—the idea that individuals should advance based on their talent and hard work—appeals to our sense of fairness. However, despite its noble intentions, meritocracy often fails in practice.
Emilio J. Castilla’s The Meritocracy Paradox (Columbia University Press, 2025) highlights how…
Chip Bell
One hour after takeoff from London’s Heathrow Airport on an intercontinental flight to the U.S., the pilot announced the aircraft was returning, “because my windshield just shattered.” After gasps from passengers, he calmly announced there was no danger, but there would be a long delay to secure…
Kate Zabriskie
When most people think about work, fun probably isn’t the first word that comes to mind. Deadlines, meetings, and spreadsheets? Sure. But laughter, camaraderie, and a little silliness? That often feels like a luxury, not a priority.
Here’s the truth: Fun at work isn’t just about blowing off steam…
Mike King
Change is inevitable in manufacturing. Controlling change effectively distinguishes industry leaders from quality-deficient, recall-plagued, and regulatory-troubled companies. As organizations are increasingly pressured to reduce costs while maintaining high levels of product quality, the drive to…
Stephanie Ojeda
When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality. While these functions are critical, starting there can be a misstep. Without the right…
William A. Levinson
My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason for warning letters, and also introduces the role of failure mode effects analysis (FMEA) in preventing trouble in the first place. The U.S. Food and Drug…
Mike Figliuolo
I had a great conversation with a friend of mine. He was bemoaning the fact that his company was almost completely dependent on one huge customer. He saw the inherent risks in that relationship but confessed that his organization had a bad habit it couldn’t kick. It had succumbed to the addiction…
Lexi Sharkov
We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe. That makes collecting physical, “wet ink” signatures nearly impossible and turns digital approvals into a daily…
James J. Kline
The use of artificial intelligence (AI) models, specifically generative AI, is growing. This has raised concerns about the effects on jobs in various professions. The quality profession is among them.
Like it or not, the quality profession has been disrupted. This occurred before AI became widely…
MasterControl Inc.
Ninety days to implementation vs. 12 to 18 months with traditional systems: That’s not just an incremental improvement—it’s a complete reimagining of what’s possible in life sciences quality management.
In the highly regulated life sciences industry, quality management system (QMS) implementations…
Harikrishna Kundariya
AI has amazing capabilities, and it’s one of the best technologies for the future. It’s helping to change the world and bringing productivity enhancements across industries with its exceptional use cases. Quality assurance isn’t left out, either. AI is highly useful in any product development…
Robin F. Goldsmith
Many organizations have decided to automate their quality management system (QMS) or upgrade their currently automated QMS. Quality management tends to involve significant numbers of documents, which automated systems are especially efficient at creating, accessing, tracking, updating, and…
Knowledge at Wharton
The case for in-office work has never been stronger. This may seem surprising, given that many businesses have operated remotely or in hybrid models for more than five years. The initial excitement about remote work stemmed largely from its immediate conveniences and the individual flexibility it…
Lexi Sharkov
When an issue arises, it’s important to take quick action. Whether that means launching a software patch, pulling a batch, or halting the use of a reagent, it’s critical to tackle the immediate problem.
But just as critical as “How do we fix this?” is “How do we make sure this doesn’t happen again…