All Features
Craig Cochran
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…
Jeffrey Eves
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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—…
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…
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,…
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…
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…
Patrick Runkel
Did you ever wonder why statistical analyses and concepts often have such weird, cryptic names? One conspiracy theory points to the workings of a secret committee called the International Committee for Sadistic Statistical Nomenclature and Numerophobia (ICSSNN), which was formed solely to befuddle…
ISO
A meaningful, systematic approach to environmental management has made IBM one of the world’s most environmentally conscious companies. The globally integrated IT company leverages ISO 14001 for a comprehensive corporate policy on environmental affairs.
In a recent interview for ISOfocus,…
Dawn Bailey
I heard the example that best helped me understand work systems and supply chains at a Baldrige training event right after the very sad 2011 earthquake and tsunami in Japan. A colleague was talking about automakers in the United States and elsewhere whose suppliers were located in the devastated…
Timothy Lozier
Compliance is a broad term. It can mean compliance to financial obligations, quality and safety, or general compliance to any regulation that is driving the organization. When you look at the current state of quality management and safety management with respect to compliance, most of the…
Craig Cochran
ISO 9001:2015 does a lot of things right, but using clear language isn’t one of them.
One of the most glaring examples is the transformation of the word “records” into “retained documented information.” That's right, the standard’s updaters took one word and turned it into three. And the three…
Harry Hertz
Business schools today have a renewed emphasis on teaching leadership. Dawn Bailey explored this topic in a recent Blogrige post. One of the principles behind this shift, she explained, is intended to cause a deep dive into values. And values-centered leadership is, in my opinion, a critical…
Sonal Sinha
In a recent poll, employees (22.9%) were identified as the top source of supply chain fraud risk, followed by vendors (17.4%) and other third parties (20.1%), including subcontractors and their vendors. In calling new attention to the old cliché of “an inside job,” the statistics may prove to be…
Fred Schenkelberg
Why do so many avoid confronting the reality of failure? In plant asset management, we are surrounded by people who steadfastly don’t want to know about nor talk about failures. Yet failure does happen; let’s not ignore this simple fact.
The blame game
Unlike a murder mystery, failure analysis (…
Randall D’Amico
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Relationships between an organization and its suppliers have traditionally been characterized by adversarial activities and posturing in which at least one, and often both, parties lose. Rather than working together to find ways to create a win-win outcome, buyers use their…
Donald J. Wheeler, Henry R. Neave
In theory, there is no difference between theory and practice. In practice, there is. During the past three months we have looked at three families of probability models and found that they share some remarkable properties. These properties provide a theoretical explanation of how and why process…
Christine Schaefer
In early 1989, Michael Whisman, MBA, MBB, was trained by his then-employer, Baxter Healthcare, to be an examiner within the company’s newly announced Baxter Quality Award. To determine award winners for the performance recognition program, the company was using the first edition of the Criteria…
Mike Micklewright
Finally... the new version of ISO 9001:2015 has been released. I can hear many of you screaming, “Hurray!” Or not. More realistically, I’m sure many of you living in the kaizen world are thinking, “Yeah, so what? This stuff has nothing to do with real kaizen, and in fact, it often creates…
Quality Digest
Born in Bulawayo, Zimbabwe, and raised in Cape Town, South Africa, Wayne Visser, Ph.D. is, as CSRWire USA says, “. . . one of the most prolific, creative, and original thought leaders on corporate social responsibility.” That begs a question, however—should we use the term “social” or “sustainable…
Chad Kymal
The outward focus of an organization comes from defining the context, mission, vision, policies, and interested-party expectations. A company’s goals and objectives provide the lens through which this outward focus can be seen (figure 1).
Setting the strategic direction
An organization uses its…
Akhilesh Gulati
The big data revolution is requiring a seismic shift inside organizations, both in the way we build relationships and the way we make decisions. Each is now driven by data rather than intuition.
In general, decision making is accomplished via a thought process of selecting a logical choice from…
Arun Hariharan
In my previous article, “Is Poor Quality ISO 9001’s Fault?” I shared the example of the chairman of a large company who ridiculed ISO 9001, saying, “Even the municipal office of this city is ISO 9001-certified. And we all know how bad the municipality is. I don’t believe ISO 9001 can do my…
Arun Hariharan
The chairman of a large company once ridiculed ISO 9001, saying, “Even the municipal office of this city is ISO 9001-certified, and we all know how bad the municipality is. I don’t believe ISO 9001 can do my business any good.”
The chairman had similar uncharitable things to say about other…
Tim Lozier
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We’ve all heard it before: Change is the only constant. This isn’t just cliché but a truth that all companies will come to recognize. Change is the driving force behind improvement. And all of the changes that take place within an organization, whether to products, processes, or…