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All Features

Auditing Career Pathway Survey
Peter Holtmann
The auditing profession is changing. Auditors are getting older. Technology is changing the way auditors work. Companies now work 24/7 around the globe, speaking different languages and integrating different cultures, forcing auditors to adapt to a new work reality. How is all this affecting the…
Less Than Six Sigma
David Schwinn
I teach management and leadership. Recently, the topic in one of my classes was change and stress. I asked my students, who are nearly all employed and range in age from 19 to 55, what caused them the greatest stress in the workplace. Among the various responses were several related to how they…
Five Costly Mistakes to Avoid When Applying SPC
Steve Daum
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 9001:2015—An Introduction
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…
Start Your ISO 14001:2015 Transition Now
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—…
Management Responsibility for GMP Oversight and Control
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…
The Medical Device Single Audit Program: A Progress Report
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,…
Are You Wearing ISO 9001’s Risk-Based Thinking Cap?
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…
The Secret Foundation of Statistical Inference
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…
Fundamental Constants: The Latest—and the Last?
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…
Know Your Distribution
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…
We’re Not Alone, Children Remind Us
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…
How to Create a Culture of Continuous Improvement
John Hunter
I have discussed steps to take to build a culture of continuous improvement in numerous posts on my Curious Cat Management Improvement blog. What it boils down to is building a system that supports that culture. Your culture is the result, not your aim. David Heinemeier Hansson put it well…
Lazy Lean Guy
Bruce Hamilton
In 1987, shortly after I became a manufacturing manager, the shop foreman at the time warned me about a young assembler. “Watch out for Michael,” the foreman said. “He tends to bend the rules. You may need to talk to him.” In fact, I did watch Michael, and it did appear that he approached his…
So Why Is It Called ‘Regression,’ Anyway?
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…
IBM Leverages ISO 14001 for Sustainable Business
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,…
Lean Accounting in a Nutshell
Brian Maskell
Companies that are seriously pursuing the lean journey soon find their accounting, control, and measurement systems need to change to support the new strategy. The principles and methods of lean thinking and practice are quite different from traditional business and therefore require different…
Work Systems and Supply Chains: Are You Ready in Case of Disaster?
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…
Benchmarking Risk and Compliance: How Do You Add Up?
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…
Discovering the Inner Merton
Kevin Meyer
“If you are too obsessed with success, you will forget to live. If you have learned only how to be a success, your life has probably been wasted.” —Thomas Merton, Love and Living Sometimes there are dots just waiting to be connected.... I was rather surprised when Pope Francis mentioned Thomas…
‘Retained Document Information’ in ISO 9001:2015
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…
What Comes After Teaching Leadership?
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…
Your Employees: A Principal Factor in the Supply-Chain Risk Equation
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…
Failure Analysis
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 (…
Using ISO Management Systems Standards to Develop Effective Supplier Partnerships
Randall D’Amico
Sponsored Content 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…

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