All Features
Kostya Kimlat
A sale, like a great magic trick, occurs inside the customer’s mind. And it is there where it is replayed, remembered, and redefined continually afterward. Because magicians are masters of perception, they understand how to get into the heads of their prospects better than anyone else. That’s why…
Mike Richman
During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at work, and inspected some interesting stereo microscopes from Vision Engineering. Here’s a closer look…
Sharona Hoffman
CVS operates 9,700 pharmacies and 1,000 MinuteClinics. A decade ago, it also purchased Caremark and now operates CVS/Caremark, a pharmacy benefits manager (PBM), a type of business that administers drug-benefit programs for health plans. CVS/Caremark is one of the three largest PBMs in the United…
Scott Gottlieb
Twice a year the federal government publishes the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), which provides the American public with insight into regulations under development or review throughout the federal government. For the U.S. Food and Drug…
Carrie Van Daele, Ronee Franklin
The key to being an explorer lies in what you do with your creative thinking and attitude, which allow you to consider different points of view. Like the explorer, you look for probabilities and possibilities. This is what is known as creative thinking skills: having the ability to create…
Jenna Gallegos, Jean Peccoud
Biology is becoming increasingly digitized. Researchers use computers to analyze DNA, operate lab equipment and store genetic information. But new capabilities also mean new risks, and biologists remain largely unaware of the potential vulnerabilities that come with digitizing biotechnology.
The…
Debashis Sarkar
We all know the famous quote, “The customer is always right.” It was coined more than a century ago. In the United States, it was popularized by Marshall Field during the early 1900s. In the United Kingdom, it was popularized by Harry Gordon Selfridge of luxury retailer Selfridge’s fame. Since…
David Schwinn
I was recently reminded of a fundamental statement about continual improvement. In Out of the Crisis (Massachusetts Institute Center for Advanced Engineering, 1986), W. Edwards Deming stated, “I should estimate that in my experience, most troubles and most possibilities for improvement add up to…
Chip Bell
I do not at all understand the mystery of grace—only that it meets us where we are but does not leave us where it found us. —Anne Lamott
Howard Perdue was the owner, manager, and spiritual leader of the Ford tractor dealership in McRae, Georgia, during the 1950s and 1960s. In that era, about 185…
Lou Valdez, Dara Corrigan, Peter Stein
Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified…
Taran March @ Quality Digest
I loved my Honda. Is it OK to cling to that emotion, even after a car takes its final drive and lands in a dissection yard to be pulled to pieces so other old Hondas can stay on the road? Are there counselors out there specializing in car grief who might advise? ’Tis the Christmas season, so I can…
Trevor Blumenau
How does one define quality in the context of a warehouse? The perfect warehouse is clean, has everything in its place, and is easy to access. Your warehouse looks like the one below, right?
You have a perfectly accurate database table that tells you exactly where everything is, correct? And…
Patrick Horine
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly after being discharged; readmissions also hurt hospital bottom lines.
Readmissions cost hospitals $…
William A. Levinson
The recent revelation that a major steel maker falsified test data,1 and similar scandals at other companies,2 underscores the menace of counterfeit parts, or what a 1987 Senate hearing called COME UPS: COunterfeit MatErials and Unauthorized Product Substitutions. The history of COME UPS shows the…
Mike Richman
During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look:
“World Toilet Day” ISO truly has a standard (or at least a standard in development) for everything. World Toilet…
Jay Desai
The presidential symposium at this year’s annual meeting of the Child Neurology Society of America in early October in Kansas City raised many eyebrows: The first presentation focused on burnout rates among neurologists around the country.
Many of my colleagues felt that this was an inappropriate…
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key concepts presented is the idea of a risk-based QMS.
Historically, regulations have almost exclusively…
Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan. The intent was to establish one medical-device…
Annette Franz
When you think of the phrase “inside-out” relative to the customer experience, you probably cringe. This is not a phrase that customer experience professionals take lightly.
“Inside-out” means companies focus on processes that are designed and implemented based on internal thinking and intuition…
Dirk Dusharme
Our Nov. 17, 2017, episode of QDL looked at factories controlled by large-volume 3D metrology, the value (or not) of four-year degrees, and creepy Christmas.
“Developing the Light-Controlled Factory”
A UK development project directed by the University of Bath and supported by University College…
Davis Balestracci
During the early 1990s, I was president of the Twin Cities Deming Forum. I had a wonderful board to work with, one of whom was Doug Augustine, our self-appointed provocateur. Doug was a 71-year-old retired Lutheran minister, and we all loved him because he always pulled us right back to earth with…
Mike Richman
QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look:
“What Really Causes Workplace Stress” A multidisciplinary team of researchers at the University of Southern…
Chip Bell
Variation and defects. They are the bane of all manufacturing companies. They signal an absence of efficiency, a neglect of productivity, and a total disregard for cost effectiveness. Who is seen as the rescuing knight in shining armor? Sir Six Sigma!
Fundamentally, Six Sigma (always capitalized,…
Brandon McFadden
The food labeling craze coupled with banner headlines about the dangers of gluten, genetically modified organisms (GMOs), and hormones are leading to increasingly absurd results.
For example, you can now buy “premium” water that’s not only free of GMOs and gluten but certified kosher and organic…
The QA Pharm
If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.
When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure.
The…