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HIPAA Audits Are Coming! HIPAA Audits Are Coming!
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits. Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
Take Down Your Corporate Ladder
Jesse Lyn Stoner
Traditionally, career paths have been based on the idea of “moving up the ladder.” Success is measured by how high you get. A lateral move is usually not seen as a smart career move. Even when changing jobs to increase your skills, the expectation is the new position will be a step higher up the…
Five Questions to Ask When Budgeting for a CMM
April Lemois
Whether it’s budgeting season, or you’re preparing for the future, you need to make strategic decisions about where your allocations will go. As planning commences to replace your current coordinate measuring machine (CMM) or to add a new one, important business considerations such as prior-year…
What Really Is a ‘Stretch’ Objective?
Ken Levine
One poorly understood concept in lean Six Sigma is how much to “stretch” when setting S.M.A.R.T. goals. These letters are defined as S—specific; M—measureable; A—assignable, attainable, or achievable; R—realistic, reasonable, or relevant; and T—time-based or time-bound. Regardless of the different…
It’s Always Better to Perform a Design of Experiments
Bruno Scibilia
Sponsored Content Suppose that on your way to a summer holiday resort (a very distant place), your car breaks down. You might just call roadside assistance and wait for your car to be towed to a repair shop. But suppose that you think you’re smarter than that, and you would like to solve the issue…
Lean Six Sigma Applications in Healthcare
Kimberly Watson-Hemphill, Kristine Nissen Bradley
Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley. Like every company, healthcare businesses do their work through processes, and any process can be studied and improved using basic lean Six Sigma methods. Figure…
Nation Should Implement a Medical Device Evaluation System
Duke University
Evidence on the safety and effectiveness of medical devices is difficult to coordinate and assess, despite the critical role medical devices play in diagnosing and treating patients. A new report from the planning board for a national medical device evaluation system (NMDES) describes how the…
Researchers Develop First Widely Useful Standard for Breast MRI
NIST
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer. The NIST instrument—a “phantom”—will help standardize MRIs of breast…
Outwitting Imposter Syndrome
Manfred Kets de Vries
T wenty-five years ago, corporations and business schools were preoccupied with models of the rational economic man, not realizing that executives are anything but rational decision makers. The emotional aspects of leadership and the importance of corporate culture were all but ignored. At that…
Four Steps to Build a Quality Network Through Improved Supplier Management
Joby George
Driven by market expansion, financial pressures, and the need to accelerate innovation, today’s manufacturers have expanded their global operations and supply partners. This evolution has only amplified the manufacturer and supply-chain relationship, which is often characterized by a delicate…
Continuous Improvement Accelerates (and Eases) Growth at Hub Pen
GBMP
Hub Pen Co., located in Braintree, Massachusetts, imports specialty writing instruments and imprints them with company logos and other customized inscriptions. In 2013, the company received a grant for training in lean and continuous improvement, which was delivered by the Greater Boston…
Addressing Human Factors Relating to Combination Products
Jill Hartzler Warner, Thinh Nguyen
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
Data Torturing in the Baseball World, Part 2
Davis Balestracci
In part one yesterday, we looked at stats of the Boston Red Sox bullpen, a typical example of baseball’s tendency to find special cause in just about anything. The Boston Globe article on which these two columns are based has been a gold mine for teaching many useful, basic concepts about…
Data Torturing in the Baseball World, Part 1
Davis Balestracci
In honor of baseball season, I’m going to apply some simple statistical thinking to my favorite sport in a two-part series today and tomorrow. I want anyone to be able to enjoy this, so I’ll mark any technical statistics as optional reading. For those of you interested only in the interpretations…
The Necessary Shift Required of Leaders
Giles Hutchins
Globalization, disruptive technologies, pressure on finite resources, increasing social disparity, and demand for business transparency: Enter the age of uncertainty. These transformative times are reshaping the workplace in profound ways, demanding the crossing of thresholds at myriad levels. …
Five Lessons I Learned From a Successful ISO 9001:2015 Audit
Lillian Erickson
The updated version of ISO 9001, published in September 2015, generated much anxiety among companies fearing a bumpy transition to the updated and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries. Despite having quality experts…
Border Crossings
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States‎, many loaded full with fresh produce…
Clarity > Coffee
Tonianne DeMaria
I recognize that the title of this column might stir up some controversy, especially among fellow coffee enthusiasts. Not to mention it puts me at risk of getting exiled from my beloved adopted home, Seattle. And yes, perhaps “Clarity > Coffee” even seems a tad hypocritical, considering that I’…
Plotting the Complex Path of Products
MIT News
In March 2011, Leonardo Bonanni was preparing to defend his Ph.D. thesis about Sourcemap, software that lets consumers map every connection of a product supply chain on a digital map, when tragedy struck in Japan. Although the deadly earthquake and tsunami occurred half a world away, the events…
The American Statistical Association Speaks Out on P-Values
Jim Frost
P -values have been around for nearly a century, and they’ve been the subject of criticism since their origin. In recent years, the debate over p-values has risen to a fever pitch. In particular, there are serious fears that p-values are misused to such an extent that it has actually damaged…
Speed, Reuse, and Sustainability in Process Improvement Projects
Niranjan Deodhar
Previously in this series, we looked at applying the principles of process improvement (PI) to itself. We identified metrics that help define effective and efficient PI, and then analyzed some work practices that help drive these metrics. Here, we move on to analyze more work practices, this time…
The Art of Managing Dispersed Teams
Knowledge at Wharton
A trained mechanical engineer, Mark Chang found himself “totally uncertain and unprepared” the first time he was called on to hire someone else. “I didn’t even know why I was hired in the first place—what did they like about me?” Chang recalls. “So, how do I go out and look for the next person?”…
Amping Antimicrobial Discovery With Automation
NIST
I n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics…
How ISO 9001:2015 Helps Improve Customer Relationships
John Nolan
The ultimate aim of ISO 9001:2015 is to enable businesses to satisfy their customers effectively. You could say that all the standard’s clauses help to provide your customer with a consistent and rewarding experience from your goods or services, but ISO 9001:2015 actually deals with “customer…
Confidence Intervals for Proportions and Poisson Means
William A. Levinson
Experiments that might require a handful of real-number measurements (variables data) could need hundreds or more attribute data for comparable power, i.e., the ability to determine whether an experiment improves performance over that of a control. Sample sizes needed for ANSI/ASQ Z1.4 (for…

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