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I must confess up front that the title of this column is misleading. Similar to the Spoon Boy in the movie, The Matrix, I will say, “There is no lean problem or a Six Sigma problem. All these problems are our mental constructs of a perceived phenomenon.”
A problem statement is a model of the…
Recently, I’ve had a sad, increasing sense of déjà vu. Twitter has become even more vacuous, and LinkedIn has quickly devolved into a business version of Facebook. Literally right after I finished this draft, I read a newspaper headline: “Twitter Use Eroding Intelligence. Now there’s data to prove…
‘Any customer can have a car painted any color that he wants,” said Henry Ford in 1909, “so long as it’s black.” Ford’s strategy of standardization and efficiency made a runaway success of the Model T car and built Ford Motor Co. into one of the world’s biggest automakers. But 110 years on,…
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized standard for medical device quality management systems (QMS).
Well before these risk-based processes became a quality…
One of my hobbies is building and flying radio-controlled model aircraft. Not the small foam ones from Kmart but larger 2-m wingspan craft. It is a lot of fun and usually very relaxing.
My birthday was a few months ago, and for the first time I was given a plane. Somehow my family read my mind,…
Even tedious jobs like cleaning out archives can sometimes lead to great insights. Sifting through my old files recently, I was pleasantly surprised to find a treasure trove of old memories and forgotten facts. Among these papers were notebooks from my engineering studies; I realized that I no…
When you think about Domino’s, you think about getting pizza quickly—30 minutes or less. Domino’s has also become known for technology, including flashy and fun concepts such as the Associated Talent Development (ATD) conference in Washington, D.C. There, attendees heard from Domino’s training and…
MIT researchers have developed a computer interface that can transcribe words that the user verbalizes internally but does not actually speak aloud.
The system consists of a wearable device and an associated computing system. Electrodes in the device pick up neuromuscular signals in the jaw and…
Many people are writing about innovation. Yet, the more I read, the more confusing the term becomes.
Some have said an innovation is an idea. Others have said an idea isn’t an innovation until it has been applied or implemented into a new product, service, or method. Hm, from my experience the…
Whether we like it or not, manufacturing is becoming digitized and connected. Industry increasingly connects production machinery with internet of things (IoT) devices, gathers multiple real-time sensor information into large datasets, and harnesses machine learning to make data-driven decisions.…
In Parts One and Two we defined the equivalence of instruments in terms of bias and measurement error based on studies using a single standard. Here we look at comparing instruments for differences in bias or differences in measurement error while using multiple standards.
When we use multiple…
In Parts One and Two we defined the equivalence of instruments in terms of bias and measurement error based on studies using a single standard. Here we look at comparing instruments for differences in bias or differences in measurement error while using multiple standards.
When we use multiple…
I was told there would be robots.
We are living in a world in which we are surrounded by technology tailored to our needs. Our clothes are treated with nanoparticles to resist wrinkles and stains. We have sent probes beyond the farthest reaches of our solar system, and we have selfie-taking…
Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new sustainable treatment plants. The International Organization for Standardization (ISO) and the Gates …
Many years ago, I worked for the president of a bank famous for aggressive bank acquisitions and rapid growth in the financial services space. The bank ultimately became the Bank of America, and the president became its CEO. Hugh McColl was famous for his swashbuckling leadership style, his…
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace external cloud networks. Merely a decade ago, in fact, an International Data Corp. survey showed that…
As some of you already know, I was in Ford Motor Co.’s corporate quality office during the early 1980s when, just after “If Japan Can, Why Can’t We” aired on NBC, we pleaded with W. Edwards Deming to help us out of a very bad place. One of the things I most remember about those times was that he…
Faced with a growing range of tech solutions in marketing, from AI to big data to blockchain, business-to-business (B2B) companies too often choose the status quo. Recent evidence suggests the divide between success and failure is not about how much companies spend, but how well they integrate…
My favorite part of a recent podcast with James Clear, author of Atomic Habits (Avery, 2018), was the last five minutes, when he talked about a potential downside of good habits. When we decide to improve and create a new practice with the right cues and rewards, we form a new habit. But habits can…
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
If your…
When I first learned quality improvement back in 1989 at Florida Power and Light, the consultants who trained us taught a very specific way to draw a Pareto chart. They’d been trained in Japan, the place where quality improvement first took root during the 1950s, so I took it for granted that the…
A leader’s job is to keep the team on track. You focus on hitting deadlines and executing projects without losing focus or getting lost in the weeds of decisions, communications, and logistics. The ability to execute in this way is critical for every leader.
In fact, Jack Zenger and Joseph Folkman…
The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard. Although numerous articles and several books have…
As early as 2015, McKinsey’s “Digital America” report projected that adoption of Industry 4.0 technologies in manufacturing alone was expected to increase domestic GDP by more than $2 trillion by 2025. This estimate, developed from expectations surrounding productivity enhancements, waste reduction…
In manufacturing today, data analysis tools can give management the information it needs to make better decisions in areas such as maintenance and labor. Unfortunately, however, many data analytics systems require large sets of historical data to generate accurate and useful results.
According to…