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Too Much Togetherness?
Knowledge at Wharton
The mere mention of keeping up with overflowing email, constant meetings, and time-sucking conference calls makes many of us groan and roll our eyes. How did we all get so busy? A major culprit is the sharp rise in cross-functional collaboration over the past several years.  Today, it’s often not…
The Lean Brain, Part 3: Flow
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…
What a Risk-Based QMS Means
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…
How to Make Your Point and Be Heard
Jesse Lyn Stoner
It’s quite frustrating to be not heard when you speak up, and unfortunately, it’s more common than you might think. Speaking up in a group setting is one of the biggest challenges many people face. You have some valuable information and opinions to share, but no one listens to you. It can be hard…
Conquering the 100% In-Line Inspection Challenge
Ryan E. Day
Sponsored Content Headquartered in Algona, Washington, Dynacraft is a diversified global manufacturer of PACCAR medium and heavy-duty truck parts sold under the Kenworth, Peterbilt, and DAF nameplates. For more than 40 years, Dynacraft has provided the company’s truck manufacturing divisions and…
Identify and Remove Bottlenecks in Your Business
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…
How About Weibull?
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…
When to Abandon an Unresolved Project
Kevin McCardle, Ilia Tsetlin, Robert Winkler
Academics and corporate innovators both spend their workdays pursuing breakthroughs that may never materialize. Venturing into unknown territory carries fairly high potential rewards, but also a fairly high risk of failure. When working on a research project, it can be difficult to decide when to…
Communication, Not Structure
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…
Three Stages of Quality Management System Implementation and Oversight
The QA Pharm
If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it. When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure. The…
Three Innovation Types: Evolution, Preventive, and Creative
Jeffrey Phillips
I was thinking over the weekend that for years we've positioned innovation incorrectly. Too often we position innovation as creating a new and valuable offering or solution, ready when customers demand new products and services. In other words, we've positioned innovation as something to do to…
Five Manufacturing Apps You Can Start Using Today to Cut Costs
Steven Brand
Manufacturing’s role is changing and evolving in ways that make the traditional methods of creating products and services outdated. As manufacturing enters a dynamic era, policymakers need new approaches and improved capabilities to save on costs while fulfilling the changing needs of consumers.…
Alloy Identification and Weld Inspections—Easy as 1-2-3
Olympus
Sponsored Content 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…
Three Ideas to Help Drive Change in Your Company
Jennifer V. Miller
According to a Deloitte Consulting study, 88 percent of executives state that to build an “organization of the future,” they must transform their business practices. Transformation requires extensive change, which is difficult. Or is it? In the Harvard Business Review article, “Stop Using the…
The Lean Brain Series, Part 2: Visualization Begets Alignment
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…
Six Signs Your Document Control System Is Effective
Timothy Lozier
Document control is probably one of the most sought-after applications within the quality management system (QMS). It allows an organization to manage the creation, approval, distribution, and archiving of all controlled documents and processes. It is an integral part of quality, environmental…
How to Ensure the Fourth Industrial Revolution Is ‘Made in the USA’
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…
Understanding New GM Layered Process Audit Requirements in IATF 16949
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-…
Epistemology at the Gemba
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…
Does ‘Think Outside the Box’ Help?
Scott Berkun
While researching my new book, The Dance of the Possible (Berkun Media, 2017), I studied the history of some of the most misleading ideas that have been popularized about creative thinking. Like the myth of epiphany and the other creative myths of innovation, these sayings are misleading despite…
Tools or Culture?
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…
Retranslating Lean From Its Origin
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…
Analyzing Quality Data with the Right SPC Tools
Douglas C. Fair
It’s not enough to collect the right data, ensure all your quality checks are done correctly and on time, and prioritize your quality improvement opportunities. You also need to be able to take advantage of those opportunities. In “What’s Your Priority? Use SPC to Maximize Your Impact on Quality…
A Proactive Approach to Cybersecurity
Dane Warren
Sponsored Content As businesses become increasingly dependent on an effective supplier network, more data must be shared with these suppliers to support business goals and delivery business value. This gives rise to the need for a more robust, next-generation approach to supplier assurance and…
Why IT Lobbied for Cloud QMS
Frank Defesche
Until recently, most quality departments were unable to select their own quality management system (QMS) software. Think about it. From hardware sizing to system requirements, database types to installation, only IT had the expertise to procure and maintain on-premise QMS software. At many…

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