All Features
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…
Aman Pandey
In the dynamic landscape of the life sciences industry, ensuring compliance with good manufacturing practices (GMP) is imperative to guarantee the safety, efficacy, and quality of pharmaceutical products.
One critical aspect of GMP is the analytical product quality review (APQR), an essential…
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…
Del Williams
In the food industry, it’s common for processors to test—and even retest—their products on the conveyor systems they are considering purchasing. After all, every food product or raw ingredient has distinct characteristics that will determine how it behaves under the stresses and pressures of…
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…
Antonio Possolo
If a traveler from Germany goes to Vietnam and falls ill, the results of their blood test there should be as meaningful as if the test were taken at home. If a Japanese airliner lands in Argentina and needs a part, that part needs to be installed using properly calibrated tools.
Commerce, science…
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.…
Morehouse Instrument Co.
In the healthcare sector, precision isn’t just a requirement. It’s a necessity where the margins for error are perilously thin, and the consequences of inaccuracy can be grave. At the heart of this precision lies the unassuming yet critical load cell, a device whose reliability is foundational to…
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…
Laurie Locascio
Growing up as a scientist, I didn’t see role models who looked like me. I grew up in a small town where my father was a physicist—and my role model. He nurtured me to be a scientist, just like him. I’m so grateful he didn’t have different expectations for my brothers and me. He always told me that…
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…
Gleb Tsipursky
Generative AI, when harnessed correctly, has the potential to revolutionize the way companies operate, innovate, and compete. But the question that arises is how businesses can effectively tap into this potential. The answer lies in setting up an AI center of excellence that combines IT with…
ISO
Trust makes the world go ’round. Without it, democracies crumble and relationships suffer. The same goes for organizations and businesses: Without the trust of their customer base, they simply can’t succeed.
Trust, however, is never a given. Like respect, it must be won. In an ever-evolving…
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…
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…
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.…
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…
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…
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…