All Features
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…
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…
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…
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…
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…
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…
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…
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…