All Features
Jeffrey Eves
Sponsored Content
In 1996, the International Organization for Standardization (ISO) first released the ISO 14000 family of standards, which provided tools for organizations wanting to manage their environmental responsibilities. In the years since, ISO 14001—“Environmental management systems—…
Leo Sadovy
Having a mentor is the No. 1 factor in increasing the steepness of your personal learning curve. So says my oldest, Garik, a Park Scholar at North Carolina State University (class of 2012), during a discussion he recently had with the incoming Park Scholar class of 2019.
To accept the value of…
Arun Hariharan
During my years of experience helping companies with quality, I’ve observed that in some, any conversation and initiatives related to quality seem to revolve around operations. In manufacturing companies, this tends to be the actual production plant or factory; in service companies, it’s their…
Mary Ann Pacelli
As a manufacturer, you don’t want workers; you want company ambassadors. Workers are individuals who show up and get their tasks done. Company ambassadors are a team of employees who are enthusiastic about their careers, and they are inspired and empowered to proactively help your business grow.…
Giles Hutchins
Much of today’s organizational management mindset—whether corporate, nonprofit, government institution, or startup—is rooted in a flawed logic about how the world works.
“We have been, and still are, in the grips of a flawed view of reality—a flawed paradigm, a flawed worldview—and it…
The QA Pharm
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the…
Ryan E. Day
The words “plastic,” “polymers,” and “environmental responsibility” rarely bump consonants in the same sentence, but public sentiment and keen competition can nudge a company into exploring all kinds of plastic substitutes. Of course, a $160 price tag on a barrel of oil is also rather compelling.…
Jack Dunigan
Delegation. If you’ve been in leadership for very long, you’ve undoubtedly had a class or two on the subject, read a couple of books about it, and encountered effective delegators as well as ineffective ones.
I have as well. Your experience might be different, but most of the classes and books I…
John Bell
Leadership doesn’t begin when you step up on the first rung of the management ladder. One direct report doesn’t make you a leader; nor does 10. Yet, the moment you have direct reports, you are expected to lead. When you fail to demonstrate traits critical to successful leadership, the expectations…
TÜV SÜD America
As we near the end of 2015, the pilot phase of the International Medical Device Regulators Forum’s (IMDRF) Medical Device Single Audit Program (MDSAP) is approaching its third and final year. In this article, we’ll provide a review of the pilot study’s progress since its inception two years ago,…
Ken Miller
Your employees are your greatest asset—and your greatest cybersecurity risk. That statement may sound harsh, but hackers often prey on unwary employees because employees can provide easy access to otherwise secure systems.
Remember the Anthem breach earlier this year? Hackers gained access to…
Howard Sklamberg, Jeffrey Shuren, Melinda Plaisier
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review…
Mika Javanainen
With more than one million certifications issued, ISO 9001 is the world’s most widely adopted framework for quality management systems, helping companies achieve conformity of products and services to meet customer expectations and regulatory compliance. The ISO 9001 standard has become synonymous…
NIST
The National Institute of Standards and Technology (NIST) is about to open the world’s most accurate facility for calibrating infrared (IR) detectors. What makes this possible is an extremely precise reference scale based on NIST’s newly developed standard detectors with sensitivities two orders…
Michelle LaBrosse
Project managers, and especially certified project managers, know firsthand the value of quality training for their own professional development and effectiveness. Being a project management professional (PMP), after all, requires project managers to pursue ongoing education to maintain their…
Donald J. Wheeler
When industrial classes in statistical techniques began to be taught by those without degrees in statistics it was inevitable that misunderstandings would abound and mythologies would proliferate. One of the things lost along the way was the secret foundation of statistical inference. This article…
NIST
In a world of incessant change, some things have to stay the same. One is the set of values for the fundamental physical constants—such as the speed of light or the charge of the electron—that underlie precision measurements in industry, science, and medicine worldwide.
Yet even the constants…
Gallup
As technology advances, it’s tempting for companies to believe that gathering more data and crunching more numbers will consistently lead to better customer insights. But Gallup finds that’s not always the case, particularly in the business-to-business (B2B) arena.
Here’s why: For B2B companies,…
Mark Rosenthal
It's a typical staff meeting. The function heads sit around the table with the boss. One of them describes a hiccup or problem he's encountering that's outside of his control because it originates in another department. An action item is assigned, and we move on to the next topic. Good to go,…
William A. Levinson
The Shewhart control chart is relatively insensitive to non-normal distributions, and the worst foreseeable consequences of a wrong decision involve searching for an assignable or special cause when none is present. The economic consequences depend on the time wasted, and whether unnecessary…
The Un-Comfort Zone With Robert Wilson
During the late 1970s when I was a college psychology student, I worked in two different psychiatric hospitals. I was enthralled with my studies and loved learning what made people tick. Especially what motivated them. At the same time I was disturbed by the therapy I was witnessing. Depressed…
Quality Transformation With David Schwinn
This month’s column results from my wife, Carole, asking me to “watch this.” This was a short video on her computer showing two young children brilliantly and inspirationally singing, “You Raise Me Up.” I was dumbstruck. Their song immediately took me to many places. I was reminded of the wisdom…
Harry Hertz
I feel like I should start this article with something like: “An innovator and a boss walk into a bar....” But I don’t have a punch line to follow it, so I’ll stick to the facts.
I recently read a blog post titled, “Think Like an Author, Not an Owner.” I felt the story should be more accurately…
Russ King
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with…
Dawn Bailey
I recently had the great experience of speaking as part of a panel on the value of the Baldrige Excellence Framework, but what meant the most to me was the chance, I hope, to dispel some common misconceptions about what the Baldrige is actually all about. And, no, it’s not just an “excellence…
