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Calibration Service: Understanding Quality, Speed, and Cost
Henry A. Zumbrun
Calibration, a critical aspect of maintaining equipment precision, involves more than routine checks. It’s a complex decision-making process in which quality, lead time, and price are weighed. The belief that you must compromise on one to excel in the others is a common misconception in the…
Integrating Risk Assessment and Continual Process Verification
Saurabh Joshi Shripad
Risk assessment and continual process verification (CPV) are fundamental regulatory requirements for pharmaceutical companies to ensure drug safety, efficacy, and quality. While risk assessment involves analyzing, mitigating, communicating, and monitoring risks that could ultimately affect patients…
Safely Navigating the Pay-for-Performance Minefield
Mike Figliuolo
Pay. It’s the topic we love to avoid. We don’t discuss it with friends or family. It’s verboten at cocktail parties. Heck, we discuss cancer, religion, and abortion at dinner parties more easily than we talk about our paychecks. We don’t even like to discuss compensation with the person whose pay…
To Discover Breakthrough Ideas, Look to the Outsiders
Lee Simmons
Investors and business leaders are always on the lookout for the next big thing, the paradigm shift that will upend industries and change the world. The hope is to get in early and ride the wave—or at least avoid getting flattened by it. But where should they be looking? “There’s a huge literature…
Dealing With Stress in Large-Scale Additive Manufacturing
Lawrence Bernard
Scientists at the U.S. Department of Energy’s Oak Ridge National Laboratory (ORNL) have determined how to avoid costly and potentially irreparable damage to large metallic parts fabricated through additive manufacturing (AM), also known as 3D printing, caused by residual stress in the material.…
How Leaders Can Avoid the Hubris Trap
Manfred Kets de Vries
Throughout history, leaders have been seduced by success, leading them down a path of hubris. This ancient Greek term, literally translating to “excess,” describes a state of exaggerated self-belief and arrogance. An extreme example is Xerxes, king of the Persian Empire. Feeling invincible from…
Building Fairness Into AI Is Crucial
Ferdinando Fioretto
Artificial intelligence’s capacity to process and analyze vast amounts of data has revolutionized decision-making processes, making operations in healthcare, finance, criminal justice, and other sectors of society more efficient and often more effective. However, with this transformative power…
Is Statistical Process Control Still Relevant?
Douglas C. Fair, Scott A. Hindle
In less than two months we will celebrate the 100th anniversary of the invention of the control chart, a tool most often associated with statistical process control (SPC). Considering SPC from our modern perspective made us ask, “Is SPC still relevant?” It’s a question asked within the purview of…
Cultivating Curiosity
Jones Loflin
This year I have committed to being a more curious gardener: to be willing to grow some things I haven’t grown before and see what happens. I decided to try growing one of my favorite fruits—papaya! I’ve heard that if I do certain things, give it the right soil conditions, and protect it from the…
Whose Chatbot Is It, Anyway?
Mark Hembree
Everyone knows customer service is increasingly automated and impersonal—that’s a “dog bites man” story. It’s not news because it happens all the time. When a man bites a dog, that’s news. But what if you’re bitten by a chatbot or AI? Aside from newsworthiness, is the owner responsible? Where does…
Real-Life Results from Implementing Compliance Management Systems
Stephanie Ojeda
Companies today implementing automated compliance management systems are motivated by a wide variety of factors. For many, it’s about reducing manual labor hours required to execute quality processes—and achieving greater efficiency and effectiveness in their operations. For others, the priority…
The Test to Use Before All Other Tests
Donald J. Wheeler
When presented with a collection of data from operations or production, many will start their analysis by computing descriptive statistics and fitting a probability model to the data. But before you do this, there’s an easy test that you need to perform. This test will quantify the chances that…
How to Build Flexibility Into Medical Equipment Inventories
Patrick Gale
Medical equipment is a necessary yet substantial investment for any health system. Making strategic decisions about these assets can be daunting in the face of shifting patient demand,  financial uncertainty, and fast-changing cybersecurity risks.  Because clinical assets account for an average of…
Dogs and Buns
Bruce Hamilton
In a humorous moment from Steve Martin’s comedy Father of the Bride, there’s a scene where George Banks (Martin) argues with a store clerk that the number of buns in a package is mismatched with the packaged number of hot dogs: “I wanna buy eight hot dogs and eight hot dog buns to go with them. But…
Researchers Help Robots Navigate Uncertain Environments
Adam Zewe
If a robot traveling to a destination has just two possible paths, it only needs to compare the routes’ travel time and probability of success. But if the robot is traversing a complex environment with many possible paths, choosing the best route amid so much uncertainty can quickly become an…
How Robots Are Transforming Manufacturing Processes
Evi Giourouki
Gone are the days of manual labor and repetitive tasks. Nowadays, robots are taking over these responsibilities, leaving human workers to focus on complex problem-solving and innovation. These robots are equipped with advanced sensors, artificial intelligence (AI), and machine learning capabilities…
Are You Telling Customers You Don’t Care If They Die?
Mike Figliuolo
  If you have kids, you know the nauseating feeling of one of them going down for the count and having to rush them to the emergency room. I had that grim experience recently. What I learned from that ER visit is businesses can make very strong statements about how little they care about their…
Turning the Tides on Tough Customers
Kate Zabriskie
‘She wanted to return a cake that was almost gone. How bad could it have been? Normally, if something is spoiled or not up to standards, it’s returned almost intact. This thing was a pile of crumbs. But it gets better: She demanded cash, yelled at me, and started causing a scene. I hope she never…
ISO 9001 Is Being Revised
Denise Robitaille
The buzz has begun. ISO 9001 is being revised. There hasn’t been a revision in about 10 years, so it’s due—if not overdue. Still, there are individuals who don’t understand the justification or the purpose of the revision. After all, it’s a perfectly good standard. So, what’s up? It’s worth…
From Inspections to Insights
Jennifer King
The cost of poor quality can be devastating to business: Failed quality control costs manufacturers anywhere between 15–20% of their total profits on average, and as much as 40% for some, the ASQ reveals. Businesses with successful quality programs, on the other hand, can benefit from increased…
How to Lose a War Before It Starts
William A. Levinson
What do quality and productivity have to do with World War III, which we all hope will never happen? The answer is everything. A massive loss of American manufacturing capability between 1945 and 2024 has conceded enormous advantages to aggressor nations that might be inclined to break the peace.…
Houston, We Have the Engine Remnants
Adam Creuziger
Like many people, as a child I had dreams of flying into space as an astronaut. That interest in aerospace and space exploration has continued throughout my life. So when my colleague Tim Foecke, who was working at the National Institute of Standards and Technology at the time, invited me to…
Optimize Work-Life Balance With Intentional Inflexibility
Jones Loflin
When we talk about a lack of work-life balance, stress, or burnout, one of the things we’re actually saying to ourselves is that we feel we have no control over the outcome or our future. It can feel like the line between work and life has blurred into one big, overwhelming blob. It’s time for a…
Medical Device Recalls Outpace All Industries
Alonso Diaz, Maria DiBari
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls. FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all product types. (See…
The Perversion of the ‘Stay Bonus’
Mike Figliuolo
Organizations that use “stay bonuses” as a retention tool could be making a huge mistake. Instead of letting poor performers go, they pay tons of money to keep them. It’s been a rough year in the market. Let’s hit rewind and explore some underlying axioms about business. Sure, many of these are…

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