All Features
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…
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…
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…
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…
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…
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…
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…
Anouschka Jansen
Global supply chains are going through steady disruption and reevaluation—some of it planned, much of it reactive. While political tensions and trade disputes often grab headlines, other important factors are reshaping how companies manage their suppliers.
Rising tariffs, challenges in sourcing…
Mike Figliuolo
During the 14 years I’ve run my firm, I’ve heard a polite “No, thank you” more times than I can count. That’s fine. Rejection, especially when it’s quick, enables me and my team to spend our time on more fruitful conversations.
It’s the silence that kills me. I know I’m not alone in this. I’ve…
Hexagon Manufacturing Intelligence
Did you know that shutdowns, turnarounds, and outages (STOs) can consume up to 50% of a plant’s annual maintenance budget? That’s according to a report by the Boston Consulting Group.
STOs are among the most complex and high-stakes events in industrial operations. They’re costly, especially when…
George Thuo
These are new times for manufacturers. Global pandemics. Worldwide supply-chain disruptions. Steep price increases for parts and materials. Increasingly competitive global markets.
Manufacturers are can-do people, but doing becomes harder in today’s “do more with less” manufacturing environment.…
Bryan Christiansen
Facility teams are constantly balancing urgent repairs, preventive tasks, asset tracking, and compliance, all while ensuring smooth day-to-day operations. But when processes are manual, fragmented, or unclear, even simple tasks can spiral into delays, miscommunication, and wasted time.
The…
Donald J. Wheeler
In statistics class we learn that we can reduce the uncertainty in our estimates by using more and more data. This effect has been called the “law of large numbers” and is one of the primary ideas behind the various big data techniques that are becoming popular today. Here we’ll look at how the law…
Michael McDowell
As artificial intelligence takes off, how do we efficiently integrate it into our lives and our work? Bridging the gap between promise and practice, Jann Spiess, an associate professor of operations, information, and technology at Stanford Graduate School of Business, explores how algorithms can be…
Etienne Nichols
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and the…
Mike Figliuolo
Most days we walk through life unaware of the conversations occurring around us. And then there are those times you overhear a conversation that stops you dead in your tracks. You have to hit rewind in your brain and ask, “Did they actually just say that?”
Ever have one of those moments? Clearly,…
Stephanie Ojeda
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and ultimately losing competitive ground.
In contrast…
Mike Figliuolo
I love passionate people—people who throw themselves into their work with every last bit of energy they have. To them, everything about their work is important. It’s serious business, and they drive hard to form the world in an image they’re proud of.
However, with passion comes peril. If…
Prasant Prusty, Arundhathy Shabu
A global food safety and quality certification, BRCGS (British Retail Consortium Global Standards) initially focused on food safety but now comprises various sectors such as packaging, consumer products, and retail. It aims to ensure that businesses maintain high standards of safety and quality…
Etienne Nichols
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF): • “AI-enabled device…
Mike Figliuolo
I heard an interesting twist on an old question the other day. People always ask the classic, “What keeps you up at night?” question. (By the way—don’t ever ask that of your interviewer during a job interview. It comes across as cheesy and stupid.) But while the question itself is a little corny,…
Cornelia C. Walther
On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.
One month later, the Amazon subsidiary issued a software recall on 270 autonomous vehicles and suspended operations while regulators investigated the…
MIT News
On Dec. 21, 2022, just as peak holiday season travel was getting underway, Southwest Airlines went through a cascading series of failures in its scheduling, initially triggered by severe winter weather in the Denver area.
But the problems spread through the airline’s network, and over the course…
Heidi Drafall
Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.
The…
Mike Figliuolo
For as many words as we use, we’re terrible communicators. Voicemails are jumbled streams of consciousness. Emails are “text bombs” with no rhyme or reason. Presentations are nothing but crippling piles of slides. But don’t worry—here are three rules of three to make your communications clearer,…