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The New Standard for Medtech QMS
Elizabeth Weddle
The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed. And while the regulations themselves aren’t going anywhere, the world they…
Teaching Robots to Map Large Environments
Adam Zewe
A robot searching for workers trapped in a partially collapsed mine shaft must rapidly generate a map of the scene and identify its location within that scene as it navigates the treacherous terrain. Researchers have recently started building powerful machine-learning models to perform this…
The Hidden Cost of a Fragmented QMS in Life Sciences
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…
The Quality Profession: A Noble Calling
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…
How to Stop Your Boss From Sabotaging Your Career
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…
How to Shorten Time to Market and Lower Development Costs
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…
Stop Bleeding $260,000 per Hour
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…
Real-World Lessons on Laser Marking
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…
The Real Meaning Behind Return to Office
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%…
The ABCs of Modern Manufacturing
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…
Cracking the Code of Resistance to Gen AI Learning
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.…
Rethinking Meritocracy
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…
The Quality Digest Roadshow
Jeff Dewar
I’m thrilled to announce something we’ve been working on for a year and a half—a project that took us 30,000 miles across America and into the heart of industries that most people never see. On Nov. 12, 2025, Quality Digest will premiere the first episode of The Quality Digest Roadshow, a 12-…
The Power of Fun at Work
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…
The Evolution of Maintenance
Chris Kuntz
What once seemed like the future of work is fast becoming present-time reality on factory floors worldwide as artificial intelligence (AI) evolves from experimental technology to practical tools that directly affect daily operations. While algorithms can predict when a bearing will fail or when a…
3D Scanners Keep WTR Race-Ready and Drivers in Control
Creaform
In motorsport, performance isn’t defined by a single factor. It’s the sum of countless details, each playing a decisive role when pushing speeds up to 200 mph (320 km/h). From how a driver sits in the car to how the bodywork complies with strict regulations, accuracy can mean the difference between…
Building a Strong EQMS Foundation
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…
The Importance of Diversifying Your Business
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…
Giving Manufacturing Intelligence a Sense of Space With Physical AI
Alex de Vigan
D uring the past decade, manufacturers have wired their plants with sensors, robots, and software. Yet many “AI-driven” systems still miss the mark. They analyze numbers but fail to understand the physical reality behind them: the parts, spaces, and movements that make up production itself. “…
A Guide to 21 CFR Part 11 and Annex 11 Compliant Signatures
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…
How NIST Helps American Manufacturing Grow
Cassondra Blasioli
Growing up in Pittsfield, Massachusetts, I witnessed firsthand the heartbeat of American manufacturing. I remember the hum of machines, the rhythm of assembly lines, and the pride of workers crafting products that powered industries across the nation. I can still smell the oil and hear the machines…
Strengthening the US Steel Industry Through Science
Andrew Iams
I grew up outside Pittsburgh, widely known as “Steel City.” Although the city is no longer the center of steel or heavy manufacturing in America, its past remains a proud part of its identity. Like many Pittsburghers, my family’s story is tied to this industrial legacy. My relatives immigrated…
Buying a Quality Management System
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…
How to Conduct a Root Cause Analysis
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…
Palladium Filters Could Help Generate Cheaper, More Efficient Hydrogen Fuel
Jennifer Chu
Palladium is a key to jumpstarting a hydrogen-based energy economy. The silvery metal acts as a natural gatekeeper against every gas except hydrogen, which it readily allows through. For its exceptional selectivity, palladium is considered one of the most effective materials for filtering gas…

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