All Features
Robert M. Califf, Nina L. Hunter
About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The report findings were derived from focus group studies with reviewers from the FDA’s different centers…
Dirk Dusharme
I’m pinch-hitting for my co-host Mike Richman in the wrap-up of this past Friday’s episode of Quality Digest Live. Mike was off on vacation last week, so I presented the show myself.
On Friday’s show, we covered:
The FDA Mutual Reliance Initiative In order to lower their inspection costs, avoid…
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from the…
AssurX
If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power system’s (BPS) eight regional entities (RE), even as NERC emerges with new risk management…
Dick Wooden
First of all, what does it mean to be orphaned by your customer relationship management (CRM) vendor? In short, it means that your CRM vendor sold you on a CRM product and for one reason or another forgot about you. Are you feeling left behind?
Of course, it’s no secret that choosing the right…
Annette Franz
This is part two of a two-part series on my discussion with Tangerine Bank CEO, Peter Aceto. I left off on part one of my conversation questioning why so many leaders still don’t get the importance of focusing on the customer and customer experience improvements. Here, I’ll share the rest of our…
Dick Wooden
There are various phases to consider when focusing on a business strategy for customer relationship management (CRM). An initial phase is creating a vision of a better future with a customer-centric strategy fully implemented and supported by CRM technology.
This phase establishes a shared vision…
Michael Causey
The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don’t bet on it.
In the most recent…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…