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Managing Compliance Through the Quality Hub
Tim Lozier
Quality management, if we’ve learned anything, is a central factor in any manufacturing organization. What’s most compelling is the evolution during the past decade of our perception of quality management. Once thought to be a compartmentalized system in an organization’s infrastructure, quality…
The Secrets of the System
MIT News
“Everyone, take your order slips and move the shipment to the left,” says Nelson Repenning, a professor of systems dynamics at the MIT Sloan School of Management. “Factories, brew beer.” With that, six groups of high-achieving managers from a major multinational firm, ensconced in MIT’s Building…
A Tale of Two Deviations
The QA Pharm
It stands to reason that pharmaceutical companies in compliance trouble also have problems with their deviation management and corrective and preventive action (CAPA) systems. After all, maintaining a good compliance profile as well as an efficient operation requires the ability to detect problems…
Feedback Is the Foundation of Effective Coaching
Timothy F. Bednarz
A manager who wishes to communicate effectively must receive and impart reliable and honest input by observing, questioning, and opening up productive two-way dialogue. Feedback is a major part of the total communication process that requires presenting ideas, thoughts, and messages clearly and…
Is There Any Value in Quality Process Training?
Ryan E. Day
Perhaps I am overendowed with self-confidence; or perhaps nothing more than plain old hubris. Then again, maybe some things are just as obvious as they seem to me. Take 5S, for instance. Really? There’s a place for everything and everything in its place. If you got it out, you put it back. Six…
FDA and EU Spar on Medical Device Regulation
Michael Causey
Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union. They apparently aren’t happy that the Food and Drug Administration (FDA) is writing…
The Quality of Your ISO 9001 Registrar Matters
Lisa Greenleaf
Located in Victor, New York, Surmotech is a full-service electronics contract manufacturer. For more than 20 years the company has provided a complete range of manufacturing, design, and engineering services to the military, medical, industrial, and telecommunications industries and consumer…
Organizational Targets—Enough Is Enough
Tripp Babbitt
Long ago, W. Edwards Deming warned us about the use of what he called “arbitrary numerical goals.” Targets are another name for these. They are so commonplace that governments, service, and manufacturing organizations all use them. Targets have become accepted in all organizations, but this…
When Do We Use Subgrouped Data?
Donald J. Wheeler
When the data come along one value at a time, we tend to put them on a chart for individual values (an XmR chart). Since virtually all business and managerial data occur one value at a time, the primary chart for service-sector data is the XmR chart. Yet the original process behavior chart was the…
Juran’s Teachings Live On
Jeff Dewar
Editor’s note: This is the third of a four-part video interview with Juran Institute’s CEO, Joseph DeFeo, and hosted by Quality Digest’s CEO, Jeff Dewar. View part one here, and part two here. Imagine this conversation.... Mary: “You still have to listen to the customer.” Bob: “But we’re certified…
Do Businesses Know What Their Customers Want?
Jaynie L. Smith
What customers value most changes constantly, and the pace of change has increased exponentially with the economic recession. One year ago people were looking at the financial stability of a company before purchasing its products, according to surveys conducted by my company, Smart Advantage. No…
Engineering a Safer World
MIT News
Innovations in software and technology are creating increasingly complex systems: cars that park themselves; medical devices that automatically deliver drugs; and smartphones with the computing power of desktop computers, to name a few. Such complex systems allow us to do things that seemed…
Variation Can Help: A Lean Muppet Lesson
Jim Benson
OK, so there’s nothing about this video that isn’t cute. And that’s fine. But what does it have to do with lean? One of the most important lessons that lean can teach us is how to appreciate variation and make the most of it. When Jim Henson and this little girl went on set, it was to create a…
Simplistic Ain’t Lean
Mark R. Hamel
Leonardo da Vinci’s comment, “Simplicity is the ultimate sophistication,” could easily serve as a lean tag line. Surely, lean tools, like standard work, visual controls, and mistake proofing devices, are only truly effective if they are easily explained, understood, deployed, maintained, and…
FDA Introduces Triage Pilot Program
Alberto Gutierrez
During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k), sooner than expected. This will be due to a six-month pilot program called Triage, launched…
To Better Protect Patients, Health Care Needs More ‘Lean Thinking’
Mark Graban
As the Supreme Court debates the fate of “Obama Care,” we should recall the formal name of the law: the Patient Protection and Affordable Care Act (PPACA). Most of the public debate has been about the cost of health care, losing sight of the urgent need to fix the ongoing crisis of quality and…
What Does 3P Stand For?
Bruce Hamilton
3P, or “Production Preparation Process,” is a method introduced to the United States during the mid-1980s by Chihiro Nakao, a contemporary of Taiichi Ohno, and a founder of the consulting firm Shingijutsu Ltd. I recall the method was called “New Production Preparation” (NPP) early along, but…
Assessing the Risks of Risk Analysis
Umberto Tunesi
Just a few reminders to start with: In the automotive supply chain, process failure mode and effects analysis (FMEA) must be based on—or at least must take into consideration—design FMEA. This is the case whether a given supplier is responsible for the design or not. During an FMEA, severity (S)…
What to Say When Things Are Going Badly
Andrew Sobel
Has this ever happened to you? You’re talking to a client, or perhaps your boss, and you realize the conversation has gotten off on absolutely the wrong foot. You may have learned new and unexpected information from the other person that renders everything you’ve said irrelevant. You may have…
Juran’s Teachings Live On
Jeff Dewar
Editor’s note: This is the second of a four-part video interview with Juran Institute’s CEO, Joseph DeFeo, and hosted by Quality Digest’s CEO, Jeff Dewar. View part one here. In this part of my video interview with Juran Institute president and executive coach, Joseph De Feo, we discussed where the…
Assessing Value in a Quality and EHS Management System
Tim Lozier
Everyone seeks out value. Whether you’re a coupon clipper, a sale shopper, or a garage-sale stalker, people look to get some sort of value out of their buying experience. And if the product is purchased at a retailer, you look for ways to get the most out of the product you purchased. The software…
Building a Talent Machine
Gallup
Companies that lead the world in growth have something in common: a relentless focus on talent. They are very intentional about this. The executives who lead these companies have created high-performing operating systems. From decades of work with companies to implement these systems, Gallup has…
Two Advanced Laboratories Open at NIST Boulder and JILA
NIST
Two new advanced laboratory buildings for high-precision science and measurements have officially opened in Boulder, Colorado, providing upgraded facilities to support technology innovation and economic growth as well as the training of future scientists. Federal, state, and local government…
Big Results from Small Data Analytics
Jay Arthur—The KnowWare Man
There’s a lot of buzz about “data analytics”—mining huge data sets to discover invisible patterns of customer behavior that can be leveraged to maximize sales. But I’ve found that few people know how to mine the hidden improvement projects from existing “small data” using Excel’s PivotTables. Over…
Medical Device CEO Laments ‘Anti-Industry’ FDA Culture
Michael Causey
While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on medical device classification is…

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