All Features
Anat Amit-Eyal
Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum. Eric believed the attention he devoted to his family was adequate, and that he had fully harmonized his work as CEO and life as a family man…
Michael Millenson
In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 Americans were being killed each year by preventable errors in hospitals, and another 1 million were being injured. Could that be true? Based on my research, I replied, the estimate seemed low.
The “To…
The QA Pharm
Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!
This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups. Also, each quiz will have one…
Heather Thompson
Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.
Medical device…
The company Grace Science was born through an inversion of the normal business sequence. Typically, if an entrepreneur launches a startup and it succeeds, the founders will create a nonprofit, declaring, “We want to give back.” In this case, the nonprofit spawned the startup.
The company’s…
Dileep Thatte
According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12…
William A. Levinson
How will the United States’ withdrawal from the Paris Agreement affect greenhouse gas emissions? Quality Digest editor in chief Dirk Dusharme and Mike Richman, principal at Richman Business Media Consulting, point out that most manufacturers already recognize that waste, including waste of energy…
Emily Safrin
When Scarlett hung up the phone, she was close to tears. Even more unexpectedly, so was the customer service representative on the other end. How did a seemingly simple inquiry end in two people so frustrated they were on the verge of a breakdown?
Scarlett had called to resolve a mistaken charge…
Boris Liedtke
In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages. This was the third and largest verdict against Monsanto, now owned by German…
Lola Butcher, Knowable Magazine
Any patient scheduled for surgery hopes, and maybe assumes, that his surgeon will do a high-quality job. Surgeons know better. Nearly three decades of research have made clear that some hospitals and surgeons have significantly better outcomes than others.
Exactly how to measure the quality of a…
Mark Rosenthal
I was sitting in on a conversation between a continuous improvement manager and the operations manager the other day.
The operations manager was asking for help developing good leader standard work.
The C.I. manager was responding that she had already developed it for the value stream manager and…
David Moser
Technology companies are frequently driven by their engineering processes. Of course product quality is regarded as most important, and that quality can be tested and measured with numbers and data. Such companies also frequently align their core identity with the engineering that belies their…
Paul Laughlin
What tools should data analysts have in their toolbox? It’s a broad question and one with diverging views. So, I am delighted to welcome back a guest blogger who doesn’t shy away from controversy.
Martin Squires is a very experienced znalytics leader, whom I’ve previously interviewed in our audio…
Jon Speer
When it comes to making medical devices, quality is key. That’s a concept that nearly every medical device professional agrees with, but what does it mean? Why is quality so important, and how should it be pursued? These are the questions that medtech executives and company stakeholders should be…
Samantha Maragh
I didn’t understand what people were asking me when I was a kid. The question would come in several different forms. Sometimes it was, “What are you?” Other times it was, “Where are you from?” I would answer with things I knew to be true, like, “I’m a girl,” or, “I’m a person,” or, “I’m from…
Pavel Kireyev
Good salespersonship is a species of street smarts. It’s about quickly sizing up your customers and pitching your wares in terms that reverberate with their unspoken needs and desires. As artificial intelligence (AI) and machine learning increasingly intersect with e-commerce, these priceless human…
Steven Brand
The food industry is evolving rapidly, with consumers demanding quality, authenticity, and transparency from food manufacturers. And they’re not just demanding it; they’re “voting with their dollars,” supporting companies that align with their personal beliefs. To keep up with consumer demand—and…
Jim Benson
Editor’s note: Read episode two in the Respect for People series here.
I was standing in a back room of the Honolulu Museum of Art that was off limits to the public. In this one room, protected from bugs, humidity, and light, was the world’s largest collection of Japanese woodblock prints. (My…
Annette Franz
I write about organizational culture and core values quite often. One of my most recent articles on this topic was about whether employees believe in their companies’ core values. I shared this statistic from Gallup: Only 23 percent of U.S. employees believe that they can apply the core values to…
Daniel Hess
We all expect hospitals to be open and operating when we need them, but extreme weather events like hurricanes are a strain on resources and pose significant challenges for hospitals.
Closing a hospital is an extreme action, but several hospitals in Florida, Georgia, and South Carolina did just…
Sharona Hoffman
A career as a physician has traditionally been considered to be among the best vocations that talented students can pursue. That may no longer be the case. All too many doctors report that they are unhappy, frustrated, and even prepared to leave the profession.
That should worry all of us. The…
Søren Block Olsen
Manufacturers face constant challenges of rising expectations as customers and regulators demand better quality and greater traceability throughout the supply chain. Exacerbating matters are unpredictable tariffs, which necessitate faster responses to changing trade barriers and regulatory…
Peter Rose
On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and…
Annette Franz
Being a customer experience (CX) professional is hard enough; misinformation just makes our work more challenging. Misinformation or confusing information by a person with a ton of followers and a ton of influence makes our work even more challenging.
Recently, Seth Godin published a post on his…
Stephen McCarthy
In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes. This challenge is particularly evident in the…