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Tonianne DeMaria
Lean says: Manage flow. Your brain says: My work isn’t linear. My day is filled with interruptions, and so I don’t have the “luxury” of flow. What’s at play here: functional fixedness.
If there is one area where there’s not an obvious transfer of lean principles from manufacturing to knowledge…
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…
Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan. The intent was to establish one medical-device…
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…
Jordan Kraemer
During the past year, I stopped responding to customer surveys, providing user feedback or, mostly, contributing product reviews. Sometimes I feel obligated—even eager—to provide this information. Who doesn’t like being asked his opinion? But, in researching media technologies as an anthropologist…
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…
Mike Richman
QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look:
“What Really Causes Workplace Stress” A multidisciplinary team of researchers at the University of Southern…
Chip Bell
Variation and defects. They are the bane of all manufacturing companies. They signal an absence of efficiency, a neglect of productivity, and a total disregard for cost effectiveness. Who is seen as the rescuing knight in shining armor? Sir Six Sigma!
Fundamentally, Six Sigma (always capitalized,…
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…
ICEE
Reflecting a greater focus on achieving organizational success through people, the first certification program for ISO 10018, “Quality management—Guidelines on people involvement and competence” is now available for organizations committed to quality people management. This standard was created in…
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…
Kevin Meyer
Changing an organization’s structure seems to be the common knee-jerk response to internal issues. My prior company embarked on a reorganization to eliminate arbitrary site- and function-based structures so that we could align around corporatewide value creation processes.
During the…
Gene Morrison
Never-before-seen growth has turned the aviation, space, and defense industries into lucrative markets. Demand for increased efficiency, security, quality, and durability has taken off in recent years, resulting in high margins and operating profits. With exponential growth potential and a long-…
Mike Richman
During the Nov. 3, 2017, episode of QDL, we (figuratively) traveled the globe to bring you quality information. Let’s take a closer look:
“‘Made in Japan’ Falls from Grace Amid Scandals, Systematic Flaws in Manufacturing Industry” Kobe Steel is the latest Japanese manufacturer to admit to…
Scott A. Hindle, Donald J. Wheeler
In theory, a production process is always predictable. In practice, however, predictable operation is an achievement that has to be sustained, which is easier said than done. Predictable operation means that the process is doing the best that it can currently do—that it is operating with maximum…
Olympus
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High-volume manufacturers need fast, nondestructive testing methods to help avoid material mix-ups and to meet customer quality requirements. Quality assurance (QA) inspectors are responsible for evaluating incoming raw materials by determining their elemental makeup and…
Tonianne DeMaria
Lean says: Map the value stream. Your brain says: I’ve been doing this so long, it’s become second nature to me. The steps are right here—in my head.
What’s at play here: • Illusion of transparency • Curse of knowledge/information imbalance • Status quo thinking • Groupthink/false consensus…
Kemper Lewis
President Trump has long talked about reinvigorating U.S. manufacturing, which has suffered heavy job losses as a result of automation, trade deals, and other factors. In July, the Trump administration even celebrated “made in America” week by showcasing things built in the United States and…
Eric Stoop
General Motors (GM) recently published updated customer-specific requirements for IATF 16949 compliance. The new requirements take effect Nov. 1, 2017, and cover layered process audit (LPA) requirements in greater depth than previous versions.
LPAs use a series of frequent audits to check high-…
Harish Jose
Today I will look at epistemology at the gemba. Epistemology is the part of philosophy that deals with the theory of knowledge. It tries to answer the questions, “How do we know things, and what are the limits of our knowledge?” I have been learning about epistemology for a while now, and I find…
Bruce Hamilton
The first two books I ever read about lean were Zero Inventories (McGraw-Hill, 1983) by Robert Hall, and Japanese Manufacturing Techniques (Free Press, 1982) by Richard Schonberger. In 1985, these definitive academic works were among just a few sources of information about what was then referred…
Christopher Martin
Nearly two decades ago, rising from the ashes of the once-giant video game hardware manufacturer Sega, Microsoft debuted the Xbox and entered into the video game market with the intent of competing directly with Sony’s PlayStation brand. By 2006, Microsoft’s launch of the second-generation of Xbox…
Lily Elefteriadou
What self-driving cars want, and what people want from them, varies widely. Often these desires are at odds with each other. For instance, carmakers—and the designers of the software that will run autonomous vehicles—know that it’s safest if cars stay far away from each other. But traffic…
Jun Nakamuro
The world first became aware of the Toyota Production System (TPS) when Taiichi Ohno published a book about his groundbreaking efforts at Toyota. It was published in Japan in 1978. The Japanese version of his book wasn’t translated into English until 1988. Because 10 years had passed, this…