All Features
Etienne Nichols
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
The FDA classifies medical devices by risk into three categories: Class I, Class II, and Class…
Stephanie Ojeda
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management software. The…
Kelly Nault, Ko Kuwabara, Yejin Park
Giving and receiving help are essential aspects of organizational life, whether that’s providing career advice or soliciting a colleague’s input on a tricky technical problem that you just can’t solve. Through help exchange, individuals gain access to ideas, resources, and relationships that help…
Mike Figliuolo
This article is an excerpt from the cutting room floor. It was in an early draft of my book One Piece of Paper: The Simple Approach to Powerful, Personal Leadership (Jossey-Bass, 2011; order your copy here). It covers how to lead through guidelines rather than leading through rules.
We need…
Bruce Hamilton
I was asked to lead a workshop in the sales order department of a manufacturer that we had helped with process improvement on the factory floor. Those efforts had positively reverberated across the company in the form of fewer late and expedited orders. Still, sales order employees were wondering…
Pawel Korzynski
Amid seemingly never-ending layoffs and a laser focus on efficiency, companies expect their employees to make productive and focused use of their time on the clock. Yet, research has shown that they often spend a significant amount of time cyberloafing—using the internet for personal purposes…
Mike Figliuolo
Sometimes the key to getting a lot done is to actually do nothing at all.
I’ve been dreading writing this post. Massive writer’s block. “I have nothing to say,” says the tired little voice in my head (no comments from the peanut gallery).
Normally, I write on Sundays. Writing is relaxing for me.…
Dawn Bailey
The Center for Organ Recovery & Education (CORE), a 2019 Baldrige Award recipient, is a nonprofit organ procurement organization (OPO) in Pittsburgh with a federally designated service area encompassing a population of 5.5 million in western Pennsylvania, West Virginia, and one county in New…
James Chan
Management of change (MOC) is a defined process that organizations establish and follow to ensure health, safety, and reduction of risk during periods of change. MOC systems and policies are essential for companies that undergo significant updates to their facilities, personnel, equipment, or…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Alissa Greenberg
Calls for cultural transformation have become ubiquitous in the past few years, encompassing everything from advancing racial justice and questioning gender roles to rethinking the American workplace. Hazel Rose Markus recalls the summer of 2020 as a watershed for those conversations. “Everybody…
Mark Graban
I’ve learned so much from Timothy R. Clark of the firm LeaderFactor, and author of the excellent book, The 4 Stages of Psychological Safety (Berrett-Koehler, 2020). I can’t recommend his work enough—including his free podcasts, webinars, and more. I was fortunate to go through a formal…
Graham Ward
Just as there’s no yin without yang, there’s no leadership without followership. The two interdependent and complementary roles can’t exist without each other.
Followership is the symbiotic interchange between a leader and those they seek to influence. However, the word has long carried…
