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In daily conversations, I field questions from plant managers, quality managers, engineers, supervisors, and plant production workers about the challenges of applying statistical process control (SPC) methods. Following are the five most prevalent and costly mistakes I witness in the application…
ISO 9001 might be the most confusing document in business history. I first became aware of the standard in the late 1980s when my manager handed it to me and said, “See if you can figure this thing out. Our plant has to get certified.”
I took the document back to my desk and attempted to read it…
The first industrial revolution may have been the most dramatic we will ever have. This is an unpopular notion because we suffer from what Tom Standage called “chronocentrism,” which is the belief that the present is the most amazing time ever in history, and our inventions will transform the…
A recent article in The Wall Street Journal reported that quarterly profits and revenue at big U.S. companies are poised to decline for the first time since the 2008 recession, as some industrial firms warn of a pullback in spending.
The authors point out that industrial companies are being…
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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—…
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…
(Exemplar Global: Sydney, Australia) -- Exemplar Global Inc., a global provider of professional credentialing and training certification, has acquired The Auditor Online from Paton Professional, a publisher of quality, standards, and regulatory compliance books, training, and other media.
The…
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…
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.…
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…
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…
