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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…
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.…
(The W. Edwards Deming Institute: Ketchum, ID) -- On June 24, 1980, Americans widely viewed a NBC documentary called “If Japan Can… Why Can’t We.” The program, part of NBC’s white paper series, prominently featured W. Edwards Deming. Produced by Clare Crawford-Mason and narrated by Lloyd Dobyns,…
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…
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…
(BSI: London) -- A new report released Nov. 30, 2015, by The Economist Intelligence Unit (EIU) on behalf of BSI identifies a worrying gap in the capability of firms to maintain long-term growth. The global study of 411 business leaders drawn from Europe, North America, and the Asia-Pacific region…
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,…
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…
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…
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…
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…
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…
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…
(ANSI) -- The Food and Drug Administration (FDA) is requesting feedback on the use of the term “natural” in food labeling. The action is a response to consumers who have requested that the administration explore the use of this term on food labels, considering the changing landscape of food…
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…
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…
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…
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,…
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,…
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…
(CMSC: Weatherford, TX) -- The Coordinate Metrology Society (CMS), in collaboration with UNC Charlotte, has completion of the first working meeting of the PrecisionPath Consortium for Large-Scale Manufacturing. The new project is funded by an Advanced Manufacturing Technology Consortia (AMTech)…
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…
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…
(API Services: Newport News, VA) -- The Lake George Steamboat Co., located in New York, boasts the title of the “world’s oldest transportation company.” The steamboat company recently had API Services laser scan the hull of the 107-year-old Mohican, the oldest boat in its fleet.
The original…
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…
