All Features
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,…
William A. Levinson
According to the U.S. News & World Report article “FDA Warns Sanofi of Manufacturing Irregularities at Key Facility” (Jan. 23, 2025), the pharmaceutical company Sanofi received a U.S. Food and Drug Administration warning letter “stating that FDA inspectors found irregularities with the facility…
Bryan Christiansen
The cornerstone of efficient industrial and facility management, maintenance, repair, and operations (MRO) cover all activities related to equipment maintenance, procurement, upkeep, and inventory management. This includes spare parts, consumables, lubricants, cleaning supplies, safety equipment,…
Donald J. Wheeler
For many hundreds of years, “If it ain’t broke, don’t fix it” has summarized the predominant approach to process operation. From the physician’s admonition to do no harm, to the slightly more positive aphorism that the squeaky wheel gets the grease, there is a common theme of differentiating…
Mike Figliuolo
There’s an old army saying, “No plan survives first contact with the enemy.”
I’m sure some Navy or Marine guy out there will attribute this comment to their branch of service, but to be clear, it came from the Army.
Actually, the original of this paraphrased quote is widely attributed to Prussian…
Angie Basiouny
Chatbots are everywhere. A fast-growing communication channel for brands, AI-powered chatbots are being deployed by companies to handle everything from booking travel to refunding purchases to helping shoppers choose the right outfit.
When done right, they can drive sales and provide positive…
Akhilesh Gulati
In today’s competitive manufacturing landscape, resilience is the new quality. And one of the most powerful lessons in resilience doesn’t come from a factory—it comes from an art form.
In the Japanese tradition of kintsugi, a broken ceramic bowl is not discarded or disguised. It’s repaired—…
Satyajit Shinde
So here’s the deal: We’ve all been hearing about AI for a while now, but things have recently kicked up a notch. AI agents aren’t just some futuristic concept. They’re showing up everywhere—from your online shopping cart to hospital reception desks. And they’re not just answering questions or…
Mike Figliuolo
You can’t get big without thinking big right from the start. As an entrepreneur starting a business, it’s easy to see yourself as “the little guy.” If you do, you’ll forever stay the little guy.
Too many times I’ve seen entrepreneurs name their companies after themselves (e.g., Tom Jones, LLC).…
Chris Chuang
As a technology leader, I must admit that making the right investment in new innovations has its challenges. It’s easy to get caught up in the grandiose potential solutions offer, become overwhelmed by the setup, and struggle with employee adoption.
For the last decade, I’ve worked with human-…
Stephanie Ojeda
Every day, quality leaders face a variety of production and process issues. Although some problems are easy to fix, others require deeper investigation, such as using a 5 Whys analysis or fishbone diagram. But then there are the stubborn, recurring issues that can lead to quality issues, increased…
Akhilesh Gulati
When we step into a complex organization—whether in manufacturing, healthcare, or finance—we often find ourselves navigating a sea of competing truths. Everyone seems certain they see the problem clearly. Yet somehow, solving it feels harder than it should.
Why?
Often, it’s not the facts that…
ISO
Occupational health and safety (OHS) is often brushed aside as a checkbox exercise—something assigned to compliance officers or forgotten in day-to-day operations. But this mindset comes at a cost. Every year, millions of people suffer injuries, illnesses, or worse, simply because their workplace…
Simon Soloff
Boiler systems are a critical element of many manufacturing plants because they serve as a reliable source of heat and steam to power various processes. In today’s production environment, energy efficiency has become a crucial factor for manufacturing facilities aiming to reduce operational costs.…
Donald J. Wheeler
Define, measure, analyze, improve, control, goes the mantra used to carry out improvement projects in many companies. In various books, these steps get slightly different interpretations. But the overall outline is still characterized by DMAIC. This article will show a proven way to simplify and…
Harry Hertz
In an earlier blog, I introduced you to Arnie Weimerskirch, a former vice president of corporate quality at Honeywell and the former chair of the Baldrige Judges Panel. I recently had lunch with him and learned how he got involved with the Baldrige Program and how it influenced his career. I think…
Gleb Tsipursky
In a rapidly evolving technological landscape, generative artificial intelligence (gen AI) has emerged as a transformative force, reshaping industries and redefining operational paradigms. It offers unprecedented opportunities for organizations to enhance efficiency, innovation, and competitiveness…
Mike Figliuolo
Nobody likes change. I know if you do anything that changes my routine in the morning, my whole day is whacked. We all hate change. Heck, most of us hate getting change at the grocery store because of all those coins.
As a leader, though, your job is to get others to want to change.
Getting other…
CIH Equipment
Industrial hygiene equipment plays a critical role in ensuring workplace safety by monitoring airborne contaminants, noise levels, and other hazardous conditions. However, accurate readings depend on regular industrial hygiene equipment calibration to maintain precision and compliance with…
Cadrex
The semiconductor manufacturing industry is undergoing rapid transformation driven by technological advancements, increased demand for AI and electric vehicle (EV) chips, and geopolitical shifts. Needless to say, the semiconductor industry and the companies that fabricate the equipment used in the…
