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Collaborative Kaizen Workshop Strengthens OEM and Supply Chain
Kyle Pheland, Belinda Jones
Change is inevitable in every organization. Planned or not, forces inside and outside the enterprise can sometimes encumber a workforce and lead to nonvalue-added processes. Growing spurts, major technology implementations, or even small supply-chain organizational projects can present more issues…
‘Unknown or Unknowable’... Yet Shocking!
Davis Balestracci
Those of you familiar with W. Edwards Deming know that his Funnel Experiment ultimately shows that a process in control delivers the best results if left alone. Funnel Rule No. 4, also known as a “random walk”—i.e., making, doing, or building your next iteration based on the previous one—has been…
Color Your Service Purple
Chip Bell
It started out as a lackluster taxi ride from the airport to the hotel. But it turned regal and elegant the second I hailed the next taxi as I exited Charlotte Douglas Airport. The Crown Cab that pulled up was shiny and spotless. When the taxi driver raised the trunk to deposit my roller bag, I…
Lessons Learned From Using 3D-Printed Models to Improve Surgical Planning
Vijay Iyer
As the director of the structural heart team at Kaleida Health’s Gates Vascular Institute in Buffalo, New York, I perform minimally invasive, endovascular surgeries to repair structural defects of the heart. I specialize in valve replacements, clip procedures, and other structural heart treatments…
How to Scale a Startup
Kara Baskin
Care.com co-founder Donna Levin played a key part in that company’s growth, and the passion was personal. Levin’s work plans were curtailed when her son was 11 weeks old and had a seizure following a difficult pregnancy. Tests were inconclusive. Her daycare situation evaporated; she and her…
ACSI Report on Customer Satisfaction With Banks Shows Rebound
American Customer Satisfaction Index ACSI
(ACSI: Colorado Springs, CO) -- Customer satisfaction with banks is up, according to the American Customer Satisfaction Index (ACSI). Its recent report covers the finance and insurance sector, which includes retail banks, credit unions, health insurance, property and casualty insurance, life…
FDA Warning Letters Target Weak CAPA Programs Globally
AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the…
Thanks!
Mike Richman
My colleague and buddy, Christopher Martin, is an unsung hero here at Quality Digest. Few of our readers know him, but all our advertisers do, because he’s the guy who keeps them happy. In addition to being a great salesperson, Christopher handles ad materials, tracking, reportage, traffic…
Creating a Safety Net for Medical Devices
Suzanne Schwartz
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of…
Four Ways Third-Party Logistics Providers Improve Customer Experience
Dan Silva
In today’s global supply chain, shipping a product across the world isn’t as simple as loading it onto a truck, train, or boat and signing a few papers. International shipments often involve coordination between counterparts in the countries of origin and destination, complete and accurate…
Weology, Part 1
Annette Franz
Weology. What is it? If you guessed that it sounds like “the study of we,” you’re pretty close. The name of the concept stems from a Muhammad Ali poem, which simply goes like this: “Me... we.” Three unique letters rearranged into two powerful little words.  The concept itself, which is also the…
Put a Surprise Inside: the Cracker Jack Principle
Chip Bell
We bought a new house in a real nice neighborhood. The house was perfect except for one important feature—it came with a yard! I do not like yard work, and my wife does not like yard work. I travel all the time, and she works long hours. One Saturday morning, I got a big idea. “Why don’t we just…
Lean Project Helps Colorado Dept. of Transportation Improve Permit Process
ASQ
Sponsored Content When flood waters ravaged portions of Colorado in September 2013—killing crops, inundating homes, and buckling many miles of roadways—countless federal, state, and municipal government workers sprang into action helping citizens. State and federal government agencies spent…
Lean Healthcare Improves Quality and Safety
Joel Bradbury
Healthcare professionals have a long history of caring for their patients and improving the quality of their services. During the Crimean War (1853–1856), British nurse Florence Nightingale realized that the mortality rate of soldiers was far too high. A visionary statistician as well as a…
How Strong Is Your QMS Program?
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be…
Shitsu vs. Shitsu
Harish Jose
I had a conversation recently with a quality professional from another organization. The topic somehow drifted to the strict quality standards in Japan. The person talked about how his product is rejected by his Japanese counterparts for “defects” such as small blemishes and debris. The defects…
Manage Your Risk When Choosing Healthcare Payment Models
Brooke Pierce
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at risk” and “risk-based” are used more and more, but what do they really mean? And why should healthcare…
Trend Prediction: Connections With Customers Matter
Barbara A. Cleary
Among the “10 top business trends that will drive success in 2016,” reported in an end-of-2015 Forbes article by author and consultant Ian Altman, was the point that “Top performing companies will focus on connecting customers.” Citing examples that include Uber, AirBnB, Kickstarter, and others,…
Industrial Sector Remaking Sales Models and Value Chains in Face of Slow Growth
Industrial companies are facing critical challenges rooted in slow growth, globalization, the effect of disruptive technologies, and unforeseen competitive threats. A new report from global management consulting firm, L.E.K. Consulting, reveals how those companies are responding—and what the…
RAPS Review: FDA CDRH Director Shuren Talks Priorities
Michael Causey
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San…
The Patient’s Voice Enhances FDA’s Approach to Drug Review and Development
Since the launch of the Patient-Focused Drug Development (PFDD) program as part of the fifth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) has worked intensively to explore ways to enhance the patient’s voice in drug development. Recently the FDA…
The Evolving Regulatory Landscape of 3D-Printed Medical Products
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming…
Five Benefits of Sustainability and Green Manufacturing
Brian Lagas
Embracing sustainable and green principles is more than simply “a good thing to do.” Manufacturers are realizing the many practical short- and long-term financial benefits to implementing environmentally conscious improvements. Such practices helps organizations become more efficient, competitive…
Quality Is Critical in the Age of Digital Transformation
Dave Page
Digital technologies have reached a tipping point. Enterprises are moving from a focus on process automation to entire business models built on and driven by digital technologies. The development and convergence of myriad digital technologies such as the internet, cloud, mobile, big data,…
Implementing the Converged Healthcare Revenue Recognition Standard
Kade Moody
Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your organization, but I think for many healthcare systems, the answer is false. If you have already started…

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