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MDSAP Reaches for a 2019 Deadline in Canada
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member countries: the…
Desired Outcomes Matter
What happens when we really understand our customers’ desired outcomes or the jobs they are trying to do? Something pretty incredible. A few weeks ago I wrote about “Faster Horses... and Customer Outcomes” and the importance of asking the right questions to understand desired outcomes in order to…
Will You Be Ready for a FSMA Audit?
Although the FDA’s Food Safety Modernization Act (FSMA) was passed in 2011, the reality is that the rules that went along with the law—and that truly define how it will be executed and regulated—are just now being finalized. Enforcement of these rules should really ramp up in 2016 and 2017. Will…
Cold Hard Facts of Metrology
Flu season typically peaks between December and February, but by the time the winter holidays roll around, many of us will have already waited in line at area clinics, grocery stores, and pharmacies to get our annual flu shot. The Centers for Disease Control reports that U.S. vaccination efforts…
How to Manage a New World of Risk
These days, even a cursory scan of the headlines brings fresh reminders of risk, from the ramifications of climate change to shocking terror events such as the recent attacks on Paris by the Islamic State. Now more than ever, companies need risk managers. Paradoxically, however, the new ubiquity…
The Levey-Jennings Chart
The Levey-Jennings chart was created in the 1950s to answer questions about the quality and consistency of measurement systems in the chemical and process industries. This column will illustrate the fatal flaw in this technique and show a better way to track the consistency of your measurement…
Who Have the Skills to Drive Innovation?
Hackers and hipsters may be behind the innovative success of today’s startups, but established companies require different skill sets. It’s becoming obvious to the startup world that entrepreneurial teams based on the corporation’s typical structure work poorly. The idea that a team should be…
David Bowie: Look Back in Quality
Unless you live under a rock, you’ve no doubt heard that the world recently lost David Bowie, one of the greatest artists of our time. My memories of the Thin White Duke go all the way back to my formative years. I recall his music echoing through the halls of our house as I crooned along while…
Develop Your Team: the Truth About Bell Curves
When applied to people’s intelligence, the theory behind the bell curve says that most people will be average, with a small percent being top performers and a small percent being losers. But when it comes to performance, the truth is the bell curve only exists if you believe it does. Robert…
NIST Launches National Competition to Make Robots More Agile
Manufacturers, robot suppliers, and researchers, here’s your chance to get in on the ground floor of an upcoming national competition intended to help make robots more handy and nimble on the factory floor. The National Institute of Standards and Technology (NIST) is launching the Agile Robotics…
Process Excellence Makes Sales Problems Solvable
This month Quality Digest Daily welcomes Michael Webb, a noted author and consultant who writes about how the quality and productivity sciences improve sales and marketing departments. How well does your company benefit from quality improvement and productivity? For instance, how well do you…
Building Comprehensive Quality Capabilities
While contemplating the teachings of Edwards Deming, who is widely known for being vocal on the topics of quality and statistical analysis, I thought I’d delve into a few areas where he was a little less known, but just as passionate and to a certain extent influential: leadership and innovation…
Workforce Tips for Manufacturers, Part 2
In part one of this series, we discussed the importance of providing formal skills training and having open communication. Without further ado, here are two more workforce tips, one about cross-training, and the other about employee engagement. Implement cross-training initiatives Cross-training…
Resolution for 2016: Simplify
As I was preparing this column, one of my resources referred to chapter 48 of the 2,500-year-old Tao te Ching (quoted below), which, as some of you know, is one of my favorite sources of wisdom. It really tied today’s message together, and I hope you can apply its wisdom to your improvement…
Lighting the Way Toward Better Measurements
As a physicist who explores ways to measure light more accurately, it should come as no surprise that I’m fascinated by even common optical phenomena that we see all around us (e.g., rainbows or oil slicks on butterfly wings). Rainbows occur because light travels through water and air at…
Don’t Let Resources Sit Idle
Before 2015, many of us rode one of the largest waves of success in the history of the oil and gas industry. Everything was booming—companies, salaries, bonuses, cities, services, etc. Then 2015 came and crashed the party, leaving us all a bit uncertain. Now, entering 2016, you may have some your…
Fair Isn’t Always Fair
T he negotiation phase of my client’s merger with a larger organization was drawing to a close. This consolidation was going to be big news, and everyone was looking forward to getting it done. I sat with my client through a long week of agreeing to terms, and then it happened: The other CEO’s…
Lessons From Software Development Can Help Create Dynamic Clinical Practices
It amazes me how seemingly disparate ideas, when considered together, can create new ways of seeing the world. Bear with me for a minute, and I’ll share an insight I’ve received lately based on two seemingly unrelated ideas. Here’s the first idea: New York Times bestselling author Bruce Feiler…
Process Improvement on Process Improvement
As process improvement practitioners, we get hired to drive waste and variation out of our clients’ businesses. But what if we hired ourselves, provided frank advice, and then listened to it to drive waste out of our own business or process? Could we then drive down the cost of organizational …
Are Your Goals Right for You?
For many people, January is the time of the year to set and pursue new goals. As the years go on, this yearly goal-setting becomes routine. Even though you have new goals you’re passionate about pursuing each year, your faith in your ability to accomplish them or your awareness about why you’re…
Salt River Project’s Integrated Calibration Odyssey
For more than a century, Salt River Project (SRP) has produced power and delivered water to meet the needs of its customers in the greater Phoenix metropolitan area. Today, as one of the nation’s largest public power utilities, SRP provides reliable electricity and water to more than 1 million…
It’s Not About You
The baseball thudded into the dirt at the batter’s feet causing a dusty orange cloud as the dry powdery clay splashed over home plate. “Ball four!” cried the umpire, and the batter took off for first base. The coach signaled a timeout to the ump and walked toward the pitcher’s mound. When he…
Five Reasons Most Companies Fail at Strategy Execution
I t’s no longer a secret that most companies struggle with strategy execution. McKinsey research tells us, for example, that 70 percent of change efforts fall short of desired results. The financial losses implied by statistics like these are massive, and corporate leaders have taken notice.…
Baldrige Fans Share Their Criteria-Based Resolutions
A question for devotees of the Baldrige Excellence Framework: Do people who passionately promote continuous improvement within organizations also tend to make New Year’s resolutions to improve their own well-being? Seriously, I’m wondering if those who fully appreciate the framework’s value in…
Purposeful Problem Solving
We all have problems in life, in business, everywhere. Many of us have “solving problems” as the key component of our daily roles. Management and any form of supervision only exist in order to help solve problems. If problems disappeared, a great many of the structures within our businesses and…

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