All Features
Fred Schenkelberg
MTBF use and thinking is still rampant. It affects how our peers and colleagues approach solving problems, and there is a full range of problems that come from using the “mean time between failure” (MTBF) metric.
So, how do you spot the signs of MTBF thinking even when MTBF is not mentioned? Let’…

Richard Harpster
Richard Harpster's op-ed is in response to a recent Quality Digest article and webinar discussing the benefits of the draft AIAG-VDA FMEA Handbook. As he points out at the end of this article, the AIAG has provided a means to solicit comments, pro or con, on the handbook. We encourage interested…

Michael Lynn
Some journalists and other social commentators have in recent years called for the abolition of restaurant tipping, primarily because they argue that it hurts workers. Several restaurateurs have even replaced tipping at their restaurants with automatic service charges or inclusive pricing.…

Annet Aris
After an initial phase of euphoria about how the digital world improves our daily life with virtual assistants, among other gadgets and services, slowly but surely, we're coming firmly back to earth. Post-honeymoon, the breakneck speed of digital development has created an increasing number of…

Jack Barkenbus
Every day about 100 people die in car crashes on U.S. roads. That death toll is a major reason why both Congress and the Trump administration are backing automotive efforts to develop and deploy self-driving cars as quickly as possible.
However, officials’ eagerness far exceeds the degree to…

Stanislav Shekshnia, Veronika Zagieva, Alexey Ulanovsky
During the last decade, we studied CEOs of companies that thrive within some of the most challenging business environments on the planet. Though very different in many respects, these CEOs share leadership behaviors and attitudes that strongly parallel those of top athletes. We further theorize…

Dirk Dusharme @ Quality Digest
Our Jan. 12, 2018, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs.
“Impatient With Colleges, Employers Design Their Own Courses”
Microsoft, Amazon, and others are teaming up with third-party online courseware providers to…

Abdesalam Soudi
Recently, while on my way to the University of Pittsburgh’s campus, I made a quick “Pittsburgh left”—taking a left turn just as the light turns green—while facing a driverless car.
Instead of jolting forward or honking as some human drivers would be tempted to do, the car allowed me to go. In…

Jenna Gallegos, Jean Peccoud
Biology is becoming increasingly digitized. Researchers use computers to analyze DNA, operate lab equipment and store genetic information. But new capabilities also mean new risks, and biologists remain largely unaware of the potential vulnerabilities that come with digitizing biotechnology.
The…

Richard Harpster
The concept of risk-based thinking has been implicit in previous editions of ISO 9001 through requirements planning, review, and improvement. But ISO 9001:2015 requires companies to use risk-based thinking to manage their business.
If you want to implement an ISO 9001:2015-compliant quality…

Bhargav Mitra, Robert McCausland
Google might be in trouble for collecting the personal data of its users, but many companies have a growing incentive to rid their hands of the data that users entrust them with. This is because of growing costs of holding onto it.
A major cause is the rising number of cyber attacks where hackers…

Scott Berkun
On Tuesdays I write about the top-voted question on “Ask Berkun.” This week’s question came from J.R., who wrote: “What is a favorite theory that you wish more people understood?”
A favorite theory that I wish was more well-known is the Satir Change Model. It’s popular in some circles, but often…

William A. Levinson
ISO 9001:2015, Clause 6.1—“Actions to address risks and opportunities,” relates to Clause 4.1—“Understanding the organization and its context.” The external context includes the social environment, which in turn includes social networking, a potentially devastating vehicle for the delivery of “…
Peter J. Strauss
The recent spate of natural disasters that devastated parts of North America included a violent variety of events. There were three major hurricanes—Harvey, Irma, and Maria—wildfires in California, an earthquake in Mexico, and tornadoes in Oklahoma.
One thing these calamities have in common: They…

Rob Magee
I have a friend who owns a hardware store. One morning during the 1980s, he strolled into his back-room office to start his day. He was shocked to discover his safe was missing—along with a lot of cash inside.
The thing is, when he’d arrived a few moments earlier, all the doors had been locked,…

Tab Wilkins
There’s no question the digital manufacturing revolution is racing at us. As a small or medium-sized manufacturer, how close are you to already being “smart?” Here are five steps in the journey to becoming a smarter digital enterprise.
First and foremost, be cybersecure. Cybersecurity is an…

Dirk Dusharme @ Quality Digest
Our Dec. 8, 2017, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs.
“Smart Manufacturing Trends in 2017”
The digital manufacturing environment, or smart manufacturing, is growing by leaps and bounds, and is spurred on by…

William A. Levinson
The recent revelation that a major steel maker falsified test data,1 and similar scandals at other companies,2 underscores the menace of counterfeit parts, or what a 1987 Senate hearing called COME UPS: COunterfeit MatErials and Unauthorized Product Substitutions. The history of COME UPS shows the…
Jay Desai
The presidential symposium at this year’s annual meeting of the Child Neurology Society of America in early October in Kansas City raised many eyebrows: The first presentation focused on burnout rates among neurologists around the country.
Many of my colleagues felt that this was an inappropriate…

ISO
A new version of ISO 31000:2009—“Risk management” is due to be unveiled early next year. As the threat of risks grows for governments, organizations, and the public alike, how can the new, streamlined standard help to make our future more secure?
Ten years ago, the boardrooms of banks and…

Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key concepts presented is the idea of a risk-based QMS.
Historically, regulations have almost exclusively…

Scott Shackelford
Hackers around the world are attacking targets as diverse as North Dakota’s state government, the Ukrainian postal service, and a hospital in Jakarta, Indonesia. Unfortunately, many governments—in the developing world, and even cash-strapped states and local communities in the United States—lack…

Jason Furness
You have defined what you want as an outcome of the change program; you have looked at how to understand your financial statements and how to use them to assess options. You have looked at the obstacles that lay in your path. Now we are going to start to look at your business, specifically.
Why…

Fred Schenkelberg
The term “Weibull” in some ways has become a synonym for reliability. Weibull analysis = life data (or reliability) analysis. The Weibull distribution has the capability to describe a changing failure rate, which is lacking when using just mean time between failures (MTBF). Yet, is it suitable to…

Jeremy Straub
Some people are afraid that heavily armed artificially intelligent robots might take over the world, enslaving humanity—or perhaps exterminating us. These people, including tech-industry billionaire Elon Musk and eminent physicist Stephen Hawking, say artificial intelligence technology needs to be…