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More Common Cause Subtlety
Davis Balestracci
I was teaching a class and asked participants to create a control chart of an indicator that was important to them. A lab supervisor presented me with a chart on the number of procedures her department performed and told me that it wasn’t very useful. She wanted to use the chart for staffing…
Blind Wine, Part 1
Joel Smith
Already relaxed on his first day in Napa, Brutus and his wife, Suzy, decide to visit their favorite winery just before lunch to taste its new Cabernet Sauvignon. The owner recognizes them as they walk in the door and seats them on the patio overlooking the vineyard. Two glasses appear, and as the…
Lean Leadership Attributes, Part One
Mike Micklewright
Editor’s note: This article, as well as part two coming next week, discusses topics covered at greater length in a new streaming-video training series, “Enhancing and Sustaining Lean Improvements While Adding Spark to the Quality Management System” by the author and 360 Performance Circle, a…
Calibration and Metrology: Old School Ain’t All Bad
Mary McAtee
I started out my day with a quick chat with a colleague about a client project she is working on. It concerns calibration, and I could hear the tone of a righteous lecturer creeping into my voice. After a very long career in quality, I realize there are certain subjects that really get my blood…
On Lesser Gods and Devils
Matthew Barsalou
Bruce Hamilton recently wrote about his former colleague Manny S., whom he referred to as a “Lesser God.” The article reminded me of my former colleague Jose P., who trained me in my first quality job after college. By that time I had read W. Edwards Deming and Philip Crosby and had learned some…
Using SPC Software to Enhance Your Production Supply Chain
Danei Edelen
Manufacturers today report that their biggest challenge is satisfying customers who demand more detailed product information. For larger companies with many suppliers and remote locations, this is an important issue. To maintain profitability, manufacturers rely on production automation, and in …
Identify Your Employees by the Theory of 21
Chuck Reaves
“For every person who will say yes, there are 20 who will say no. For a positive response, you must find the 21st person.”—The Theory of 21 The CEO of an electronics company had an idea. He was a solid businessperson but was not as well-versed in electronics as some of his engineers. He came up…
Protecting the Global Drug Supply
Howard Sklamberg
Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of the statute. This section gave the FDA new authority to better protect the global drug supply chain,…
Second Annual Medical Device Product Development and Management Conference
Q1 Productions
(Q1 Productions: Chicago, IL) -- For the second consecutive year, Q1 Productions will be hosting the Medical Device Product Development and Management Conference, offering attendees an opportunity to obtain the up-to-date and valuable industry information and network with fellow healthcare…
Questioning Protocol
Christine Schaefer
In the Baldrige Health Care Criteria for Performance Excellence, category three, concerning customer focus, asks how your organization engages its patients and other customers for long-term market­place success. The related self-assessment questions cover how your organization listens to the voice…
What Is the Cost of Quality?
Paul Naysmith
Recently I walked headlong into a conversation on quality costs, or the cost of poor quality (COPQ), or the cost of quality, or some other term I’ve forgotten from that discussion. I realized that this area is very well-developed in the world of quality, but perhaps not fully understood by…
Integrating Post-Market Feedback With Quality Management
Alexandre Alain
Editor's note: Quality Digest will be hosting a webinar with EtQ on this subject on July 29th, 11 a.m. Pacific/2 p.m. Eastern. Click here to register. I went for a bike ride early one morning, one of those dawn rides when no one is typically around. My biggest issue was visibility. I was heading…
FDA Lets MDDS Off the Regulatory Hook
Michael Causey
The U.S. Food and Drug Administration (FDA) won’t enforce compliance with regulatory controls that apply to medical device data systems (MDDS) and medical image communications devices, recognizing the “low risk” they pose to patient safety and the importance they play in advancing digital health…
Leverage Advantages Through Complementarity
Henrich Greve
Quirky is actually the name of a company. It collects ideas on innovative products, allows “community members” on its list to vote and comment on them, and arranges to have some of them manufactured and sold. The idea is roughly similar to the wisdom of crowds, with many people being smarter than…
The Frank Principles of Business
Richard J. Bryan
Frank was ex-Special Forces with a fine arts degree—an unusual mix. He achieved a lot in his business career by following five simple principles that he was able to apply to any business, and many have achieved a lot by learning to do the same. If you can apply these same principles consistently…
Your Specification Is Highly General
Jim Benson
Years ago, William Rowden and I owned a business. In that business we wanted to build amazing software for our clients, and we adopted several practices to help us do this. One of the central practices we employed was test-driven development—a practice that essentially instructs you to write…
First Pharmaceutical Supplier Quality Assurance Conference
Q1 Productions
(Chicago, IL) -- Q1 Productions will be hosting the inaugural Pharmaceutical Supplier Quality Assurance Conference July 21-22, 2014, in Arlington, Virginia, fulfilling the demand for a tailor-made meeting for supplier quality assurance professionals within the pharmaceutical industry.…
Do You Know Your Supply Chain?
Andrew Savini
Global supply chains are growing significantly larger and more complex for many companies across the globe. At the same time, the regulatory environment is quickly evolving, requiring these companies to have more visibility into the behaviors and practices of their suppliers. As a result, elements…
TÜV Rheinland to Hold Open House at New Metallurgical Testing Lab
TÜV Rheinland of North America
(TÜV Rheinland ) -- TÜV Rheinland Industrial Solutions (TRIS), a full-service inspection, testing, and certification company, has expanded its metallurgical testing and engineering consulting services andrecently opened a new laboratory in Aliquippa, Pennsylvania. It is holding an open house and…
Social Media Wasn’t Social Enough for This Inc. 5000 Phenom
Ryan E. Day
What would you do if you were a young startup entrepreneur, and one day, out of the blue, you found a message on your phone from someone claiming to be a rep of the nation’s largest retail chain—which wanted to do business with you? If you were Yosef “Joe” Martin, founder and president of…
Higher Education, It’s Time to Refresh Your Understanding of Baldrige
Dawn Bailey
Much has been discussed about the value of tomorrow’s leaders learning about the Baldrige Criteria for Performance Excellence while still in school. As an example, I remember listening to a presentation by Bruce Kintz, president of Concordia Publishing House, a 2011 Baldrige Award recipient, about…
Heavy Equipment Manufacturer Improves Quality With NVision 3D Scanner
NVision Inc.
(NVision: Coppell, TX) A heavy equipment manufacturer with facilities throughout the world has improved the dimensional accuracy of its ground engagement tools by using an NVision HandHeld laser scanner to measure tooling and finished products with a higher degree of accuracy than was possible in…
Defining Your Ideal Work Environment
Michelle LaBrosse
With the summer in full swing, it’s easy to find yourself daydreaming about where you would rather be. Do you see yourself on a sunny beach, digging your toes into the sand? Or perhaps hosting a barbecue in the backyard? Most likely, these daydreams have nothing to do with your job, but are rather…
Companies That Train, Gain
Quality Transformation With David Schwinn
I recently noticed that Starbucks initiated a College Achievement Plan. Starbucks’ partners (employees) who pursue a college degree at Arizona State University (ASU) will receive some combination of tuition reimbursement, scholarships, and other financial aid from the company to help them graduate…
Unprecedented Energy Demand Overloads Aging Grid
Trey Kirkpatrick
The New York Independent System Operator (NYISO) held its 2014 energy conference in New York at the end of June. The topics this year included addressing the nation’s aging infrastructure, grid modernization, distributed resources, and fuel diversity. The panelists were a mix of industry experts…

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