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Manage Change
William A. Levinson
A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of…
Analytic Hierarchy Process: The Art of Choosing Projects Wisely
Akhilesh Gulati
Organizations often face a familiar dilemma: It’s not a shortage of good ideas, but a struggle to decide which one to pursue first. During project prioritization meetings, leaders are likely to present a wide range of perspectives. The finance team pushes for hard savings, while operations advocate…
Safety First, Rewards Next
Cindy Mielke
Over the years, there have been many developments in systems and technologies that have helped industries redefine how businesses are structured. These changes, especially in sectors like manufacturing and distribution, have led to new roles and responsibilities for employees. However, often with…
The Recalibration Secret
Donald J. Wheeler
Everybody wants to have good measurements. To this end, many recommend a regular schedule of recalibration. While this sounds reasonable, it can actually degrade the quality of the measurements. The key to getting the most out of a measurement process is to know when to recalibrate and when to…
What Is an FDA Auditor Looking For?
Jake Walton
Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam. Better still, you can also find a posted list of common…
Stop the Bleed: Reduce Costs, Not Capacity
Global Shop Solutions
Cutting costs is nothing new in manufacturing. What’s new is having to do it while juggling labor shortages, supplier delays, and tighter customer demands. Lean principles such as reducing waste and optimizing workflows still matter, but they’re no longer enough on their own. Staying competitive…
Tips on Adopting 3D Scanning and Automation
Creaform
C hallenges abound for today’s manufacturers. Labor shortages and rising labor costs require innovative solutions to maintain productivity with fewer staff. Inflation continues to exert pressure on raw material costs, squeezing margins. Manufacturers are also racing against tight production…
3 Business Lessons From a Cracked Tooth
Mike Figliuolo
After a couple of heart attacks, I’ve learned to eat much healthier. But finding snacks can be challenging once you remove Doritos and Cheetos from the equation. A good substitute for me is now Harvest Snaps, which are baked lentil pods. I highly recommend the tomato-basil version. Anyway, I was…
Configuration Management
ISO
Security configuration management (SCM) is a critical concern for organizations and a fundamental part of many cybersecurity frameworks. Consider this scenario: A team member tweaks a hardware setting on their personal laptop to boost software performance. However, this change causes unforeseen…
Karbonius Composites Masters 3D Scanning
Creaform
Karbonius Composites specializes in manufacturing precision molds and composite components across various sectors, including automotive restoration and high-performance customization. Founded in 2008 and based in La Coruña, Spain, the company’s production capabilities cover every step needed to…
Resetting, Not Retreating
Stephen Graham
Uncertainty often pushes manufacturers to slow down. Orders fluctuate, budgets tighten, and “wait and see” becomes the default strategy. But a growing number of companies are taking the opposite approach, using slowdowns as windows to invest in digitalization and automation.   Hexagon’s 2025 “…
Break Down Silos to Create a Culture of Continuous Improvement
CANEA
In several articles about challenges for tomorrow’s quality leaders, we’ve addressed how to plug the knowledge drain and effectively manage your company’s know-how. Your organizational structure and processes can be your worst enemy—or best asset. Organizational silos and roadblocks can impede…
How to Write an SOP
Lexi Sharkov
They may seem simple, but SOPs (standard operating procedures) are surprisingly tricky. On the surface, they describe how a specific process is carried out at your organization. Pretty straightforward, right? In reality, there are a lot of requirements for writing a good SOP, and auditors have a…
The Juicy Truth About Leading People Well
Jones Loflin
As a keynote speaker and author dedicated to helping leaders make the best choices with their time, I’ve found that some of my greatest leadership insights come from the backyard. Gardening has taught me so much—not just about cultivating fruit but about cultivating people. One of the clearest…
Celebrating Our Frontline Scapegoats
Bruce Hamilton
With Labor Day coming around, here’s an article to celebrate the folks who usually get blamed for the quality problems. Not surprisingly, when people first learn about lean’s seven wastes, the one they find most relatable is defects. They might not immediately grasp the concept of overproduction…
Becoming a Net Exporter of Talent
Mike Figliuolo
Want to build your team? Get rid of the people who are on it. I don’t mean go about firing people in a flurry. Become what I call a “net exporter of talent.” You need to develop your people to the point that they’re ready for new challenges. Build their skills. Make them more valuable to the…
5K Kaizen
Bruce Hamilton
I took a walk-jog this morning, something I’ve been doing pretty regularly since early June. Some days are better than others, and today started out sluggish. But as I turned the corner of my street, my neighbor drove by, rolled down his window, and gave me a friendly wave. Almost like getting a…
Pharmaceutical Serialization
Nimax
Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices had…
Different Answers to a Common Question
Donald J. Wheeler
The engineer came into the statistician’s office and asked, “How can I compare a couple of averages? I have 50 values from each machine and want to compare the machines.” The statistician answered, “That’s easy. We can use a two-sample t-test.” “How would that work?” asked the engineer. “We…
Carrying Out a Supplier Audit
Etienne Nichols
Good supplier management is one of the most important methods of building a safe and effective medical device. A single device may be made up of dozens of parts and components coming from several different suppliers, and many medical device companies outsource the manufacturing of their device to a…
CNC Machine Tool Calibration
Automated Precision Inc.
CNC machine tool calibration is essential for machining precision and process reliability. Even a well-built CNC machine will gradually drift out of alignment due to everyday wear and environmental factors, leading to deviations in accuracy. Without regular calibration, these small errors can…
Reclaiming Quality in the Age of AI, Drift, and Customer Distrust
Akhilesh Gulati
Complacency won’t show up on a control chart. But its damage is real. Can AI and systems thinking help us detect it and respond before trust is lost? As customer expectations evolve, one question remains: Are customers still at the core of your company’s operations? Back in 1999, a simple but…
Stop Isolating Your Business
Mike Figliuolo
This article is dedicated to all the paranoid businesspeople out there who are terrified of their competitors. You know, the people who run businesses centered around “consulting” who view any other “consulting” firm as a competitor. You can insert whatever industry you like in the quotes, and this…
How Leaders Can Move From Chaos to Clarity
Alexander Gelfand
A lecturer at Stanford Graduate School of Business for more than two decades, Robert Siegel says, “I’ve taught almost 20% of the people who graduated from the GSB.” He has also served as an executive at Intel and General Electric, founded and led startups, and worked as a consultant and venture…
All Over the Dial
George Schuetz
There are endless variations in the dials used on mechanical dial indicators. In most cases, though, they can be broken down into two distinct styles: balanced and continuous. Let’s look at both. With a balanced dial, the graduations around the dial represent the smallest value, or resolution, as…

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