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Do Your Employees Believe in Your Company’s Core Values?
Annette Franz
Core values are the fundamental beliefs of an organization; they guide executives and employees in identifying which behaviors and actions are right and which are wrong. Everything you do must be aligned with your core values, and core values should be integrated into everything you do. When in…
New X-ray Measurement Approach Could Improve CT Scanners
NIST
A new measurement approach proposed by scientists at the National Institute of Standards and Technology (NIST) could lead to a better way to calibrate computed tomography (CT) scanners, potentially streamlining patient treatment by improving communication among doctors.  The approach, detailed in…
Why Customer Experience Is a Marathon Full of Sprints
Chanice Henry
According to CX Network’s latest “Annual Global State of CX Report,” showing return on investment (ROI) from customer experience (CX) projects is one of the top challenges troubling CX practitioners. The report saw nearly 270 responses from the CX community, with each participant providing insight…
Small Things
Bruce Hamilton
Last February I had the opportunity to observe healthcare providers up close and personal at one the world’s premier hospitals. “Who Cares for the Caregivers?” was written from the perspective of a patient in a cardiac step-down unit, sympathetically watching caregivers as they grappled with many…
The Higher the Quality, the Lower the Cost
Shobhendu Prabhakar
Historically, conventional wisdom among business managers was that the higher the quality, the higher the cost. This perception still holds true today among a few business managers. Common sense also tells us the same thing, i.e., to create higher quality products or services, organizations will…
Viewing Healthcare Through an Economics Lens
Hubert Gatignon
Health and economics are linked in more ways than just health insurance. When we look past the obvious, research shows us how brain scans, the gig economy, or even hospital queues are all part of the expanding domain of health economics. Recently, professors and researchers from the Sorbonne…
What to Expect During an FDA QSIT Inspection
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time. Because of…
On the Road to Big Medicine
Taran March @ Quality Digest
Life science companies are no strangers to data, so it would be easy to assume they are adept at making innovative use of huge amounts. Not necessarily. A tradition of rigorous scientific method and clinical trial hasn’t prepared them for the shifting inundation of big data or all its baffling…
Big Data: Your Health vs. Your Privacy
Dirk Dusharme
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
Nicole Radziwill, Graham Freeman
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
Kelly Kuchinski
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
Lee McIntyre
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
Rachel Plotnik
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?
Zach Y. Brown
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?
Annette Franz
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
Stephen McCarthy
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
Mike Richman
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
Quality Digest
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
Laurel Thoennes @ QD
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
Dirk Dusharme
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
Taran March @ Quality Digest
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
Graham Freeman
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
Teresa Purzner
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?
Chip Bell
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
Zac Cooper
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…

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