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Why the FDA Presubmission Is an Underutilized Tool
Jon Speer
“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….” That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-device quality assurance and regulatory affiars…
Four Groups Will Make or Break Your Company’s Culture
Jake Herway
Every employer wants employees who feel like they belong at their organization, because those employees are able to give their best every day. They feel empowered to go all out, take risks, and be their best selves. That kind of deep belonging comes about when an organization fosters a culture that…
Ergonomics and the Remote Worker, Part 2
Ryan E. Day
So, the Quality Digest team is considering a transition to working remotely for the most part. I and two other associates already do. In part one of this series, I outlined my ad-hoc attempt at creating a computer work space at home. The result was not very pretty. As I said in part one, my home…
Where Is Consumer Research Going Next?
Hilke Plassmann
The rise of neuromarketing has already begun to provide companies and researchers with greater insight into consumer behavior than consumers themselves are capable of giving. Neuromarketing tools such as facial-affective recognition, eye tracking, and fMRI technology can illuminate the…
Mapping Layered Process Audits to Lean Manufacturing Principles
Eric Stoop
Roughly 7 in 10 manufacturers have implemented lean manufacturing principles in their organizations, with 5S, Six Sigma, and kaizen representing the most popular strategies today. One tool that supports these specific approaches and lean manufacturing principles more generally is a layered process…
Three Principles for Building a Great Post-Merger Culture
Larry Emond
The number of publicly listed U.S. companies traded on U.S. exchanges has been cut almost in half during the past 20 years—from about 7,300 to 3,700—which goes to show that mergers and acquisitions are still a primary growth strategy. In fact, 2018 looks to be another banner year for mergers and…
Why Tech Innovation Isn’t the Answer Everyone Thinks It Is
W. Chan Kim, Renée Mauborgne
The climb in the United States stock market during the last year has been greeted warmly by many, investors especially. This does not, however, take away the day-to-day challenges most businesses face. Think stiff competition, shrinking demand, and squeezed profits. The newspaper and magazine…
Do Leaders Really Care About Their Employees?
Annette Franz
I had another column in the hopper, but when this article came across my desk, followed by a phone conversation with Bob Chapman, I knew I needed to write something different, something that is top of mind for me now—and often—as I work with my clients. The article? “Beyond Nice,” which you can…
Check Your Policy Management System’s Health
Sal Lucido
Policies and procedures tell your employees, partners, vendors, and customers how your system operates. With changing regulations and expectations, a static library is not enough. Policies are dynamic and require a system to manage their creation, documentation, distribution, and management. Here’s…
Capturing Employee Tribal Knowledge
Steven Brand
By 2025, nearly 25 percent of the U.S. population is expected to be 60 years of age or older. With this demographic preparing to exit the workforce and enter retirement, what can be done to retain their knowledge and pass it down to the next generation of employees? After all, a good portion of the…
Accumold Starts With the Why
Bruce Bolger
Grace Swanson, vice president of human capital at Accumold, a leading micro-molding plastics injection company located just outside Des Moines, Iowa, knows the field of standards well. Her company has certifications in ISO 9001 for quality management, ISO 14001 for environmental management, and ISO…
Inside Quality Digest Live for April 13, 2018
Dirk Dusharme @ Quality Digest
In our April 13, 2018, episode of QDL, we talked about anti-hacker robots, data privacy, and new product introduction. “HoneyBot Lures in Digital Troublemakers” MIT nerds come up with a tasty target for IoT hackers. But this one fights back. “We Don’t Care About Data Privacy” Privacy, schmivacy.…
Organizational Culture Polarities Hold the Key to a Healthy Culture
Jesse Lyn Stoner
Too much of a good thing brings out its downside. Ever had too much team time? It makes you long for a solo vacation on a desert island. One of the best portrayals of “too much of a good thing” was in Black Mirror’s Nose Dive (Season 3). In what initially looks like a utopian culture where everyone…
Comprehensive Study Tackles Work-Life Balance for Medical Trainees
Marin Hedin
Limiting first-year medical residents to 16-hour work shifts, compared to “flexing” them to allow for some longer shifts, generally makes residents more satisfied with their training and work-life balance. It also makes their training directors more dissatisfied with curtailed educational…
Democratization of Laser Trackers
Ryan E. Day
Invented in 1987 and commercially available since 1991, laser trackers have long been a mainstay of the aerospace industry. Automotive manufacturers have also adopted laser trackers for quality control (QC) and design. The fact is, any industry dealing with large-scale measurements—from small…
Success Secret No. 4: Don’t Set Goals
Jack Dunigan
This is the next secret in our series, “The Secrets to Success You Don’t Know That You Already Know ” at The Practical Leader. Here we’re going to talk about Secret No. 4: Don’t Set Goals. You’ve probably heard of that famous Yale research study, the one in 1953 that said of the graduating class,…
Five Reasons Why Corrective Actions Can Miss the Mark
Shawn Faircloth
The cost of ineffective corrective action can be astronomical when you consider the monetary and reputational impact of delayed problem-solving. On a small scale, repeat problems—even minor errors—send a message to customers that you just don’t care to get it right. And when poor problem-solving…
We Don’t Care About Data Privacy
Dirk Dusharme @ Quality Digest
On April 10, 2018, Facebook co-founder and CEO Mark Zuckerberg testified before Congress regarding the unauthorized sharing of 87 million Facebook users’ personal data, vacuumed up by data research company Cambridge Analytica. There were pointed questions regarding Facebook’s lack of transparency…
Stop Being a Team Leader and Start Being a Team Member
Mike Figliuolo
A few years ago, I was very lucky to be reminded of what it’s like to be a team member instead of being a team leader. It was fun, refreshing, and insightful. Too many times as leaders, we forget what it’s like to be led instead of doing the leading. I tried to achieve some balance in my life by…
Taking Advantage of the Tattletale Effect
Martin J. Smith
If you want to make sure your new Whirlpool refrigerator really is meeting the efficiency standards of Energy Star compliance, as the manufacturer claims, is it better to test that claim by relying on regulators at the U.S. Department of Energy—or one of Whirlpool’s competitors? A new study co-…
Three Reasons Quality Professionals Must Be Part of Manufacturing’s Digital Transformation
Frank Defesche
Your company leadership team just issued a corporate goal (aka mandate) of reducing defects to fewer than five per million units made. This goal is coupled with a need to reduce manufacturing costs by 10 percent while meeting new good manufacturing practices (GMP) or ISO standards. Oh, and you have…
Inside Quality Digest Live for April 6, 2018
Mike Richman
During this past Friday’s episode of QDL, we presented two great interviews, both revolving around standards and certification, plus a piece about analytics, and a lively off-script about the responsibilities of media companies like Facebook when it comes to protecting user data. Here’s a closer…
The Six Core Questions
Gwendolyn Galsworth
The six core questions you see below are a window to help us understand why we struggle at work. Why? Because the answers to them are missing! The remedy is to first notice that—to notice the motion caused by those deficits. Then remove the motion by implementing visual answers. Imbed the answers…
Quality 4.0: What Defines Successful New Product Introduction?
Dan Jacob
Developing profitable, timely, high-quality products is more important today than ever before. Visibility of in-use product performance has never been higher, while competitive pressures continue to squeeze margins and time to market. Manufacturers devote considerable cost and effort to new…
Quality Transformation: It’s Still the System
Quality Transformation With David Schwinn
After my recent extended illness, I was surprisingly shocked to reemerge into organizational life in its broadest terms. Frequently, I engaged in the organizational lives of my students, my friends, my colleagues, and my own workplace. Everywhere I looked, I found: • Unhappy customers who, after…

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