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FDA Compliance
Is the Pharmaceutical Industry Missing Out on FMEA?
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 Administration’s keyword-searchable warning letter database, however, shows only five entries for…
Management
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 of predictability and comfort.

Is your business overly reliant on one key customer…

Metrology
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.

“Physical AI” changes that. It’s a form of artificial intelligence built on detailed 3D…

Innovation
The Persistent Unmarked Space
Harish Jose

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 simple. When we make a distinction, we create a boundary that separates what’s inside…

Featured Video

Hexagon’s Revolutionary Handheld 3D Scanners can Reduce Inspection Times by 50%

Videos

What the %@$# Is Metrology?
Features
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,…
AI and How It Affects the Quality Profession
James J. Kline
The use of artificial intelligence (AI) models, specifically generative AI, is growing. This has…
How NIST Helps American Manufacturing Grow
Cassondra Blasioli
Growing up in Pittsfield, Massachusetts, I witnessed firsthand the heartbeat of American…
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…
QMS Implementation in 90 Days
MasterControl Inc.
Ninety days to implementation vs. 12 to 18 months with traditional systems: That’s not just an…
Business Needs to Remember the Forgotten Stakeholders
Dolf van der Haven
When businesses talk about customer experience, the conversation almost always focuses on the end…
How AI Is Reshaping Quality Assurance Across Industries
Harikrishna Kundariya
AI has amazing capabilities, and it’s one of the best technologies for the future. It’s helping to…
More Features
News
AMETEK MOCON Launches Small-Volume Modules for Dansensor CheckMate 4
(AMETEK MOCON: Ringsted, Denmark) -- AMETEK MOCON, a global leader in gas measurement solutions,…
FexaAI Launch Marks New Era
(Fexa: Jersey City, NJ) -- Fexa, a flexible and AI-forward facilities and HVAC/R management…
Leading Foundry Selects Nova ELIPSON for GAA Processes
(Nova: Rehovot, Israel) -- Nova announced that its ELIPSON materials metrology solution has been…
ZEISS Report Reveals Link Between Quality and US Manufacturing Success
(ZEISS: Maple Grove, MN) -- A 2025 report from ZEISS Industrial Quality Solutions USA reveals that…
Optimize MyProgramming Makes Higher-Quality Products With More-Efficient Production
(Siemens: Munich) -- At EMO 2025 last September, Siemens introduced Optimize MyProgramming /3D…
Platinum Tooling Offers Custom and Special Tooling Engineered by Heimatec
(Platinum Tooling: Prospect Heights, IL) -- Platinum Tooling, the exclusive importer of Heimatec…
Shimadzu Introduces ALTRACE Energy Dispersive X-Ray Fluorescence Spectrometer
(Shimadzu Scientific Instruments Inc.: Columbia, MD) -- Shimadzu Scientific Instruments announces…
Hexagon Makes Professional Grade 3D Scanning Accessible
(Hexagon Manufacturing Intelligence: Cobham, England) -- Hexagon’s Manufacturing Intelligence…
More News

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