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Big Data: Your Health vs. Your Privacy
For centuries, medical procedures, prescriptions, and other medical interventions have been based largely on experience—what is known about a set of symptoms. The doctor looks at those symptoms, tests you in various ways (blood tests, X-rays, MRIs), and interprets the results based on experience…
Ensuring Food Safety With Quality Management Software
In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths. Although a burger is only required by law in that region to contain 47-percent…
Ensuring Food Safety With Quality Management Software
In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths. Although a burger is only required by law in that region to contain 47-percent…
Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to unravel…
Three Philosophers Set Up a Booth on a Street Corner
The life choices that had led me to be sitting in a booth underneath a banner that read “Ask a Philosopher” at the entrance to the New York subway at 57th and 8th were perhaps random but inevitable. I’d been a “public philosopher” for 15 years, so I readily agreed to join my colleague Ian Olasov…
I Studied Buttons for Seven Years
All day every day, throughout the United States, people push buttons—on coffee makers, TV remote controls, and even social media posts they “like.” For more than seven years, I’ve been trying to understand why, looking into where buttons came from, why people love them—and why people loathe them.…
What Would Happen If Hospitals Openly Shared Their Prices?
Imagine there was a store where there were no prices on items, and you never knew what you’d pay until you’d picked out your purchases and were leaving the shop. You might be skeptical that the store would have any incentive to offer reasonable prices. This exact situation has become the norm in U…
Have You Digitized Your Journey Map?
In the past, I’ve written about some of the myths of journey mapping. One of those myths is: Without a digital mapping platform, I can’t even begin to map. Let me explain my position. You probably know by now that I’m an advocate of digitizing your maps, for a variety of reasons, not the least of…
Welcome to a Special Report on Life Sciences
I am thrilled to introduce Quality Digest’s special report, “Unlocking the Future of Life Sciences.” This series explores the last several decades of quality management within the life sciences industry. It begins with the genesis of early regulations, shows us how that led to the current state of…
Power Moves: Turning Compliance Into True Quality
Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality?…
Life Science Regulations, Compliance, and the Move Toward QMS Software
Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science…
FDA Milestones
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business? 1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Taking a Risk-Based Approach to Drug Inspections
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests. The goal of any honest pharmaceutical company is to make…
To Unlock Life Science’s Future, Use a Quality Key
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well. At J&J, he…
Proactive Processes in High-Reliability Organizations
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
Drug Development Is No Longer Just for Big Pharma
Developmental biologist Matthew Scott and I went from purely basic biological research in our lab at Stanford University, to discovering a target for drug development, to identifying a drug for a pediatric brain cancer called medulloblastoma, to a clinical trial—all within five years and for just $…
Are You a Disrupter?
Visioning beyond the customer is the responsibility of every person interested in a competitive advantage. What do Bill Marriott, Ray Kroc, and Al Hopkins have in common? No, they are not all people of wealth and fame. In fact, Hopkins is a small-town accountant and part-time preacher. They all…
Visual Configure-Price-Quote Systems Reduce Cost of Poor-Quality Job Specs
The role of quality starts with product design and moves rapidly across the supply chain to the selling and buying experience, which includes the bidding process. When operating a formal continuous process improvement program, nearly all manufacturing engineers are tasked with some level of quality…
Inside Quality Digest Live for Jan. 25, 2019
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based…
Trust: The Real Corporate Wellness Initiative
The global wellness industry is doing superbly, thank you very much. In recent years, it grew a healthy 12.8 percent, becoming a $4.2 trillion market. Whether the lives of wellness consumers are improving at a comparable rate is another matter altogether. Wellness products and services run the…
Trust: The Real Corporate Wellness Initiative
The global wellness industry is doing superbly, thank you very much. In recent years, it grew a healthy 12.8 percent, becoming a $4.2 trillion market. Whether the lives of wellness consumers are improving at a comparable rate is another matter altogether. Wellness products and services run the…
Positive Work Cultures Are More Productive
“Although there’s an assumption that stress and pressure push employees to perform more, better, and faster, what cutthroat organizations fail to recognize is the hidden costs incurred.” —“Proof that Positive Cultures are More Productive,” Harvard Business Review The timeworn industry standard is…
What’s in Your Library?
I still love to hold and read physical books (as opposed to audible or Kindle). I don’t know how many books I added to my library this year, but it was a lot. I thought I’d share some good ones that I’d recommend you add to your reading list for 2019. These books are not customer experience books…
Inside Quality Digest Live for Dec. 7, 2018
In this episode we look at bioethics, next-gen manufacturing employees, and the death of Le Grand K. What happens if customers want designer babies? We discuss the latest news about a Chinese researcher who claims to have edited the genes of two babies. Should society draw a line in the sand? “…
Inside Quality Digest Live for November 30, 2018
One of our favorite things on our show is to welcome guests, either via Skype or live in the studio. And this week, we were joined by three of our great partners. Here’s a closer look: Interview: Nicole Radziwill of Intelex Radziwill is quality manager and data scientist along with the presenter of…

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