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Two Valued Stealth Mentors
In my last column, I reflected back on my career to date and issued a challenge. Based on the relatively lukewarm response, let’s see whether I can engage a few more of you to join me on my quixotic journey. “Trying to manage your career or your organization in a world changing as rapidly as ours…
Why IT Lobbied for Cloud QMS
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…
Rush Hour Pollution May Be More Dangerous Than You Think
The first in-car measurements of exposure to pollutants that cause oxidative stress during rush-hour commutes has turned up potentially alarming results. The levels of some forms of harmful particulate matter inside car cabins was found to be twice as high as previously believed. Most traffic…
Juran Announces New Online Lean Six Sigma Workshops
(Juran: Southington, CT) -- Juran is now enrolling for online lean Six Sigma training. The training varies from Yellow Belt, Green Belt, and Black Belt workshops. The workshops utilize Juran’s self-paced, online platform, and includes live online group webinar instruction sessions. These…
Ensuring the Cybersecurity of Manufacturing Systems
Cybersecurity, at this point in the technological age, has become a household word. Every week, almost like clockwork, it seems there is a story in the news about a newly discovered hack or data breach, often made possible by poor cybersecurity practices. Many of these incidents are focused around…
Design Validation vs. Clinical Evaluation
How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two can end up getting confused. When do you use one or the other? There tends to be a lack of clarity out…
Optimize SPC Data Collection
Want to improve something? You’ve got to measure it first. If you’re motivated to improve product quality and reduce manufacturing costs, the first step in establishing a successful statistical process control (SPC) solution is getting some data. And if you want to make good decisions from those…
Inside Quality Digest Live for Oct. 13, 2017
Our Oct. 13, 2017, episode of Quality Digest Live looked at edge computing for natural disasters, medical records, and zero defects. “New Research May Improve Communications During Natural Disasters” Could edge computing help communications during disasters? “How Health Care Leaders Should…
From Percent Rejects to Parts Per Billion: Moving Toward Zero Defects
When Philip Crosby announced zero defects as a philosophy during the 1970s, it was met with incredulity. There were already many articles written on the fallacy of such a strategy and the enormous costs of moving toward zero defects. Fast forward 40+ years, and zero defects has become a reality.…
Jay Leno’s Garage
Sponsored Content By any measure, a $50 million car collection is a whopper. When your collection includes fully restored muscle-car icons, ultra-rare vintage originals, one-off factory concept cars, and... oh yes, a 2017 Ford GT super-car—it is a spectacular whopper. At a car show, you would win…
How to Use ISO 14971 and Project Risk Management Effectively
Medical device companies use ISO 14971 to identify and manage user risks with their devices. However, we often find these same companies do not manage their project risks well. What is project risk management? The Guide to the Project Management Body of Knowledge (Project Management Institute,…
The Consequences of Carelessness
On July 5, 2017, I was on a canal boat in Amsterdam cruising to a dinner meeting when I received a call saying, “We need immediate access to your condo; water is rushing into the street from beneath your front door.” And my heart stopped beating for a moment. Floods are serious. Even as water…
The Nine Major Ways of Doing Business in the World
There is a simple truth in international business: All else being equal, the more similar the host country abroad to the home country of a firm, the more likely is success. It is a lot easier, for instance, for a Spanish firm to do well in Portugal than in Switzerland. For firms and…
Pirates of the Caribbean
To save his own life, Joseph Dombey had an idea. As two pirate ships surrounded the ship he was on in the Caribbean Sea in 1794, Dombey scrambled below deck, disrobing as he went. He appropriated the outfit of one of the ship’s many Spanish sailors and prayed that he had picked up enough of their…
An Introduction to Technical Cleanliness Inspection
The cleanliness of components and parts is at the center of most industrial manufacturing processes, as these components must be free of contaminants to ensure a high-quality finished product. Technical cleanliness inspection involves quality control, process management, and manufacturing…
Some of the Best Parts of Autonomous Vehicles Are Already Here
Fully automated cars are still many years away. Amid the government activity and potential for social benefits, it’s important not to lose sight of smaller improvements that could more immediately save lives and reduce the injuries and economic costs of highway crashes. Our research found that…
Some of the Best Parts of Autonomous Vehicles Are Already Here
Fully automated cars are still many years away. Amid the government activity and potential for social benefits, it’s important not to lose sight of smaller improvements that could more immediately save lives and reduce the injuries and economic costs of highway crashes. Our research found that…
Visuality: A System of Systems Hidden in Plain Sight
When James Womack and Daniel Jones published Lean Thinking in 1996, they offered the world a book that collected the core principles of a key operational model. Though not stated directly, they created a profile for the Toyota Production System (TPS) that was revelatory and highly useful, adding a…
The Future’s Looking Technological
“Alexa, what does the future of leadership look like?” Whether at home, on the road, or in the office, fascinating technology is altering our world every day. And it isn’t just simplifying our daily tasks or making our cars safer; it’s changing the future of our company leaders. Those working…
Credentials, Competencies, Careers
Certificates, certifications, badges, and licenses: What are they worth to the workforce? The last decade has seen huge growth in the number and variety of credentials, and this explosion has fueled a great deal of confusion among students, workers, job seekers, employers, and others. Job seekers…
Handheld X-ray Fluorescence (XRF) Analyzers
Sponsored Content Restriction of hazardous substances (RoHS) regulations help protect the public from dangerous or toxic materials in consumer products and electronics. Beyond public health and safety concerns, noncompliance represents significant potential costs, including fines, product recalls…
When Should We Use Extra Detection Rules?
How do extra detection rules work to increase the sensitivity of a process behavior chart? What types of signals do they detect? Which detection rules should be used, and when should they be used in practice? For the answers read on. In 1931, Walter A. Shewhart gave us the primary detection rule…
When Should We Use Extra Detection Rules?
How do extra detection rules work to increase the sensitivity of a process behavior chart? What types of signals do they detect? Which detection rules should be used, and when should they be used in practice? For the answers read on. In 1931, Walter A. Shewhart gave us the primary detection rule…
New Research May Improve Communications During Natural Disasters
Storms like Hurricanes Irma and Maria as well as other natural disasters bring with them lots of uncertainty: Where will they go? How much damage will they cause? What is certain is that no matter where they strike, natural disasters knock out power. And no power means no internet for thousands…
Car 54, Where Are You?
If you were born prior to the 1950s, you may remember a sitcom filmed in black and white about two New York cops and their exploits in the city. As they pursued criminals and responded to various neighborhood incidents, there was always the prescribed call on their radio: “Car 54, where are you?”…

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