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Literally, everything that surrounds us has been measured—and I do mean literally. Look around you: Your desk, your chair, your pen, your pencil, the lead in the pencil, the paint on the pencil, the gas in your stove, the stove itself—it’s all been measured. The color of your orange juice, the…
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…
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…
Simply put, we live in a digital world—both in our personal lives and on the job. In manufacturing, challenges abound. Customization, fast-changing business and technology environments, and workforce and talent-pool concerns combine to present challenges for manufacturers of all types.
Among…
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…
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…
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…
Coming soon!
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.
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In this article I want to explore an observation on how we make distinctions and what this reveals about the structure of our thinking. I’m inspired by the ideas in George Spencer-Brown’s Laws of Form and broader themes in cybernetics about how observers construct meaning.
The starting point is…
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…
Coming soon!
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…
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…
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…
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…
When businesses talk about customer experience, the conversation almost always focuses on the end user. That’s understandable, but dangerously narrow. In modern service ecosystems, particularly those governed by service integration and management (SIAM), the customer experience depends just as much…
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…
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…
Digital calipers are one of the most common hand tools used on the shop floor. In a manufacturing plant, under a quality control system, these tools must be checked and calibrated regularly.
Past articles have discussed the pros and cons of doing gauge calibrations internally or by an external…
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…