All Features
Lou Valdez, Dara Corrigan, Peter Stein
Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified…
Taran March @ Quality Digest
I loved my Honda. Is it OK to cling to that emotion, even after a car takes its final drive and lands in a dissection yard to be pulled to pieces so other old Hondas can stay on the road? Are there counselors out there specializing in car grief who might advise? ’Tis the Christmas season, so I can…
Trevor Blumenau
How does one define quality in the context of a warehouse? The perfect warehouse is clean, has everything in its place, and is easy to access. Your warehouse looks like the one below, right?
You have a perfectly accurate database table that tells you exactly where everything is, correct? And…
Patrick Horine
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly after being discharged; readmissions also hurt hospital bottom lines.
Readmissions cost hospitals $…
William A. Levinson
The recent revelation that a major steel maker falsified test data,1 and similar scandals at other companies,2 underscores the menace of counterfeit parts, or what a 1987 Senate hearing called COME UPS: COunterfeit MatErials and Unauthorized Product Substitutions. The history of COME UPS shows the…
Mike Richman
During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look:
“World Toilet Day” ISO truly has a standard (or at least a standard in development) for everything. World Toilet…
Jay Desai
The presidential symposium at this year’s annual meeting of the Child Neurology Society of America in early October in Kansas City raised many eyebrows: The first presentation focused on burnout rates among neurologists around the country.
Many of my colleagues felt that this was an inappropriate…
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key concepts presented is the idea of a risk-based QMS.
Historically, regulations have almost exclusively…
Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan. The intent was to establish one medical-device…
Annette Franz
When you think of the phrase “inside-out” relative to the customer experience, you probably cringe. This is not a phrase that customer experience professionals take lightly.
“Inside-out” means companies focus on processes that are designed and implemented based on internal thinking and intuition…
Dirk Dusharme
Our Nov. 17, 2017, episode of QDL looked at factories controlled by large-volume 3D metrology, the value (or not) of four-year degrees, and creepy Christmas.
“Developing the Light-Controlled Factory”
A UK development project directed by the University of Bath and supported by University College…
Davis Balestracci
During the early 1990s, I was president of the Twin Cities Deming Forum. I had a wonderful board to work with, one of whom was Doug Augustine, our self-appointed provocateur. Doug was a 71-year-old retired Lutheran minister, and we all loved him because he always pulled us right back to earth with…
Mike Richman
QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look:
“What Really Causes Workplace Stress” A multidisciplinary team of researchers at the University of Southern…
Chip Bell
Variation and defects. They are the bane of all manufacturing companies. They signal an absence of efficiency, a neglect of productivity, and a total disregard for cost effectiveness. Who is seen as the rescuing knight in shining armor? Sir Six Sigma!
Fundamentally, Six Sigma (always capitalized,…
Brandon McFadden
The food labeling craze coupled with banner headlines about the dangers of gluten, genetically modified organisms (GMOs), and hormones are leading to increasingly absurd results.
For example, you can now buy “premium” water that’s not only free of GMOs and gluten but certified kosher and organic…
The QA Pharm
If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.
When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure.
The…
Dirk Dusharme
Our Oct. 27, 2017, episode of QDL looked at Ford, autonomous cars, and changes to FDA compassionate use rules.
“Ford Plans $14B in Cost Cuts as Part of New CEO’s Strategy”
Ford Motor Co’'s new CEO plans to cut $14 billion in costs, drop some car models, and focus the company’s resources on…
Christopher Martin
Nearly two decades ago, rising from the ashes of the once-giant video game hardware manufacturer Sega, Microsoft debuted the Xbox and entered into the video game market with the intent of competing directly with Sony’s PlayStation brand. By 2006, Microsoft’s launch of the second-generation of Xbox…
Scott Gottlieb
The FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide investigational…
Mike Richman
We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:
“Energy Harvested from Evaporation Could Power Much of U.S., Says Study” Renewal sources of energy like solar…
Ken Kingery
The first in-car measurements of exposure to pollutants that cause oxidative stress during rush-hour commutes has turned up potentially alarming results. The levels of some forms of harmful particulate matter inside car cabins was found to be twice as high as previously believed.
Most traffic…
Jon Speer
How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two can end up getting confused. When do you use one or the other?
There tends to be a lack of clarity out…
Dirk Dusharme
Our Oct. 13, 2017, episode of Quality Digest Live looked at edge computing for natural disasters, medical records, and zero defects.
“New Research May Improve Communications During Natural Disasters”
Could edge computing help communications during disasters?
“How Health Care Leaders Should…
Kristine Bammert
On July 5, 2017, I was on a canal boat in Amsterdam cruising to a dinner meeting when I received a call saying, “We need immediate access to your condo; water is rushing into the street from beneath your front door.” And my heart stopped beating for a moment.
Floods are serious. Even as water…
Bill Kalmar
If you were born prior to the 1950s, you may remember a sitcom filmed in black and white about two New York cops and their exploits in the city. As they pursued criminals and responded to various neighborhood incidents, there was always the prescribed call on their radio: “Car 54, where are you?”…