All Features
Michael Causey
After years of decline, medical device approvals by the FDA have finally begun to hit the gas pedal, according to an interesting report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).
In hindsight, it appears the FDA hit bottom in 2010 when approval times…
Bob Marshall
When, nearly 20 years ago, I started Familiar it was with a very clear and declared purpose: To allow people to come together and discover what “fulfillment” means for each of them as individuals.
At the time, few working with us understood the importance of that purpose, and for those observing…
Mike Micklewright
Editor’s note: This article discusses topics covered at greater length in episodes 19–23 of a new streaming video training series, Creating and Sustaining Lean Improvements—Integrating Principles, Culture, and Tools by the author and 360 Performance Circle, a sister company to Quality Digest.…
NIST
Penny Pritzker, the U.S. commerce secretary, has announced that four U.S. organizations are recipients of the 2014 Malcolm Baldrige National Quality Award, the nation’s highest presidential honor for performance excellence through innovation, improvement, and visionary leadership.
The 2014…
Quality Digest
Judging by articles from The Wall Street Journal, CNN, and Forbes, it seems the lion's share of coverage of the 2014 midterm election results concerned how the results will affect Wall Street, the Fed, and Fortune 500 companies. There's nothing wrong with that, but there is another story. A…
Ron Rode
Several years back, I was asked this question: Does measurement software have the ability to determine scale without the use of scale bars? On numerous occasions in a variety of ambient conditions, I have tested and compared the results of initially setting up a system using temperature/material…
Hubert Meagher
Most manufacturing facilities have to manage the seemingly never-ending cycle of having to keep costs down while increasing production levels and maintaining high quality standards. Often, this ongoing struggle includes a reduction in staff and resources, and a lower-than-ever budget for…
The reconstruction of scenes from multiple images or video streams has become an essential component in many modern applications. Many fields, including robotics, surveillance, and virtual reality, employ systems to reconstruct a 3D representation of an environment in order to accomplish specific…
Eston Martz
Here’s a shocking finding from the most recent “ASQ Global State of Quality” report: The higher you rise in your organization’s leadership, the less often you receive reports about quality metrics. Only 2 percent of senior executives get daily quality reports, compared to 33 percent of frontline…
Gorur N. Sridhar
You might think that the medical and engineering professions would operate quite differently from each other. Yet, as we will see, not only are they similar, but there is a lot that the engineering profession could and should borrow from the medical profession.
So what is it that they have in…
Publically announced breaches of secured information are so common today that they almost seem routine. Last year, in the United States alone, financial companies like JPMorgan Chase and retailers such as Target and Home Depot were victimized by information system hackers that allegedly gained…
Rob Harrison
Managing risk in a quality management system (QMS) is considered a clear maturity indicator and a way to determine that an organization has shifted from a reactive and less controlled state toward an agile, proactive and anticipatory approach to quality management.
In this post we are going to…
The QA Pharm
Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation.
Here, I’ll share my views on getting the work done to fulfill…
James Soto
Imagine: You find someone you’d like to connect with on LinkedIn. You email the person to ask if you can pick his or her brain. A coffee date is set. You’ve just become part of the phenomenon that’s taking over industrial sales: zombie coffee. This no-frills networking strategy, fueled by a lethal…
Jesse Lyn Stoner
Story update 11/10/2014: We clarified the meaning of the 16% response in the Bamboo HR report.
Mark was upbeat at the end of his first day at his new job as a programmer for a small tech company. He was shown around, introduced to his co-workers, and given a desk and a computer. He had spent most…
Dan Nelson
ISO 9001 certification is like a driver’s license test. To prepare for a driver’s license test, a new, unlicensed driver requests a booklet from the state. This booklet explains the laws and conventions of driving in that state. From ISO, a new, unregistered company receives two booklets…
Michael Causey
After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks.
FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a maker of Class III medical device life vests, with a…
Dave Cranmer
Some things are just meant to be, apparently. Sept. 23, 2014, marked an interesting waypoint in the career of someone concerned about standards of measurement, because on that day, I became a standard reference human.
Having started working for the (then) National Bureau of Standards (NBS) almost…
Christine Schaefer
The following tips have been compiled from interviews with representatives of Baldrige Award-winning organizations during the 2014 Quest for Excellence conference.
How to get started using the Baldrige framework
Communicate. Make sure you have the support of senior leadership and employees.…
Johns Hopkins University
A weekend design challenge to develop new protective gear for health workers fighting Ebola drew students, faculty, and clinicians from across Johns Hopkins University and beyond, along with $25,000 in state seed grants to support further development of the best ideas.
Jhpiego, a nonprofit global…
Mike Figliuolo
One of the biggest barriers to creating new ideas is the raw inertia of organizations. Personally, I’m not satisfied with the “way we’ve always done it.”
Whenever I’m given an explanation of how the organization does something, I ask, “Why?” five times. That’s my maxim for generating new insights…
The QA Pharm
This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations to the Federal Food, Drug, and Cosmetic Act. We’ll look at how to assess the work needed to address…
Jack Dunigan
His was a politically unpopular act. The tension between Britain and the American colonies had heightened. The resentment against the crown had grown, and the mere presence of British troops only made feelings more bitter.
A small platoon of British soldiers stood sentry on King Street in Boston…
Gary Phillips
Every manufacturing company that gets audited, anywhere in the world, is required to do gauge repeatability and reproducibility (R&R) studies. In some cases, this one study is the only chance to find unknown problems with measurement quality. (When problems do occur, it is often downstream…
Bruce Hamilton
There was a time when it was unfashionable for managers to associate with front-line employees. Alluding to an old adage, I used to joke that you could not even lead the horse (i.e., the manager) to water, let alone make him drink. Division of labor at that time was a great divide. In my early…
