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Industry 4.0 and Your Total Cost of Quality
Stephen McCarthy
Cost of quality (CoQ) is certainly not a new topic. It was first described in 1956 by American quality control expert Armand V. Feigenbaum in a Harvard Business Review article. As you likely already know, CoQ consists of four categories: internal and external failures, and appraisal and prevention…
Responding to the Tide Pod Challenge
Knowledge at Wharton
When Tide and other detergent manufacturers developed colorful, convenient pods designed to be tossed into washing machines and dishwashers, they never expected teenagers would try to eat them. But what was dubbed the “Tide pod challenge” quickly went viral, with teens posting videos of themselves…
This Year’s Flu Exposes a Flaw in Our Medical System
Morten Wendelbo, Christine Crudo Blackburn
  Flu season in the United States typically peaks in February, but this year’s outbreak is already one of the worst on record. As of Jan. 6, 2018, 20 children have died from the flu, and overall mortality caused by the virus is already double that of last year’s. One reason the flu is so severe…
A Look at Risk Management in the World of Dating
George Hall
Every year, would-be suitors spend lots on cards, nice trinkets, flowers, and even chocolates, trying to win the attention of their sweetheart or crush. It can be a dangerous game of risk and chance, quite often resulting in disappointment for one or both parties. This is, I believe, most likely…
Five Things I Learned Writing a Novel That I Wished I Knew When I Was a CEO
John Bell
I have written more than a 100 blog posts about leadership, strategy, and culture. Within that portfolio are several accounts of business reinvention and transformation. Yet it was only a few months ago that I composed my first post on another type of reinvention: personal reinvention. My own. …
How to Leverage an EQMS for Managing Product Adulteration
AssurX
Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common violations in drug…
Nudging Your Staff to Healthier Habits
Wendy Wood
Employers have a stake in their staff’s health. It’s not just a matter of keeping health insurance premiums in check which is a consideration in countries without universal healthcare. It’s also about maximizing employee engagement and productivity, and even happiness. Promoting health habits is…
A Recipe for CX Success
Julia Russell
Retailers and brands convened in New York recently to experience the National Retail Federation’s Retail’s Big Show, and one of the biggest topics on attendees’ minds was technology. From automation to personalization to social marketing, the growing importance of technology in the shopping…
Just Because It’s Connected, Doesn’t Mean It’s Smart
Ryan E. Day
As a journalist in the quality improvement field, I try to keep an eye on emerging technology that can help us do things better, faster, and more efficiently. Naturally, the internet of things (IoT) is cropping up more often. IoT is all about connected devices, that is, connected to the internet,…
Is Your 10:30 Medical Appointment Really for 11:15?
Michael Armstrong, Kenneth Klassen
Patients often wait weeks or months for medical appointments. Canada’s Fraser Institute recently reported that Canadians typically wait 10 weeks to see specialists. Long wait times are one reason Canada ranks behind other developed countries in healthcare quality. In the United States, waits are…
New Steps to Facilitate Medical Device Innovation
Scott Gottlieb, Jeffrey Shuren
In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system. For instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance…
Drug Manufacturing That Is Out of This World
Rob Matheson
Liquid-liquid separation and chemical extraction are key processes in drug manufacturing and many other industries, including oil and gas, fragrances, food, wastewater filtration, and biotechnology. Three years ago, MIT spinout Zaiput Flow Technologies launched a novel continuous-flow liquid-…
Disrupting the Car Insurance Industry
Brian Rogers, Karel Cool, Christophe Angoulvant
Disruptive ventures arise from mobile device ubiquity, data-powered AI, and digital platforms that connect buyers and suppliers in new ways. They are reshaping industries such as transportation (e.g., Uber, Lyft, and Didi Chuxing), hospitality (e.g., Airbnb and FlipKey), payment services (e.g.,…
How the War on Tipping Harms Customers
Michael Lynn
Some journalists and other social commentators have in recent years called for the abolition of restaurant tipping, primarily because they argue that it hurts workers. Several restaurateurs have even replaced tipping at their restaurants with automatic service charges or inclusive pricing.…
How to Integrate Complaint Handling and Risk Management
Jon Speer
Complaint handling continues to be one of the biggest reasons medical device companies receive 438s and warning letters from the U.S. Food and Drug Administration (FDA). Companies have a lot going on once a medical device has reached the market, and it can be challenging to keep up with…
The Importance of Documenting Enterprise QMS Process Requirements
Eric Cooper
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house you end up with is going to be what you want? Documenting your requirements should be obvious, right…
Teaching Employees to Execute Customer Service Magic
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…
Inside Quality Digest Live for Jan. 19, 2018
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…
CVS Merger With Aetna: Healthcare Cure or Curse?
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…
Some of the FDA’s Major Policy Goals for 2018
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…
Think Like an Explorer
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…
DNA Has Gone Digital. What Could Possibly Go Wrong?
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…
Three Reasons Why Customers Are Not Always Right
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…
Quality Transformation: It’s the System!
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…
Grace: Honor Your Customer
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…

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