All Features
Mike Richman
In our latest episode of QDL from this past Fri., April 21, 2017, we examined the importance of the various steps in the plan-do-check-act (PDCA) cycle, considered what United Airlines could have done differently to avoid its latest public relations fiasco, and conversed with Mike McLean of ISO’s…
Ryan E. Day
I like my job in journalism. I get some interesting invitations from some interesting people. Last Friday my inbox greeted me with “The American Homebrewers Association (AHA) is throwing a rally in Chico! Let us know if you’d be interested in a press pass or an interview with an AHA representative…
Volodymyr Bilotkach
On April 9, 2017, a passenger was forcibly removed from a United Airlines flight from Chicago O’Hare to Louisville after the carrier was unable to find volunteers to accommodate four of its employees on standby. Many articles have reported that airlines routinely overbook their flights, and…
Knowledge at Wharton
The mismanagement of bet-the-company business crises has become pandemic. Consider just the most recent examples.
In December 2016, Yahoo disclosed that three years earlier hackers had stolen confidential information from more than 1 billion accounts, including users’ names, birthdates, phone…
Laurie Locascio
Like a lot of scientists, I am very goal-oriented, so after I got my Ph.D. in toxicology, I set out to become a leader in my field by the time I was 40. To get there, I knew I had to be acknowledged by the top researchers in my field, get invited to speak at important conferences, organize…
Fred Schenkelberg
A conversation the other day involved how or why someone would use the mean of a set of data described by a Weibull distribution.
The Weibull distribution is great at describing a dataset that has a decreasing or increasing hazard rate over time. Using the distribution we also do not need to…
Gleb Tsipursky
Let’s say you’re interviewing a new applicant for a job, and you feel something is off. You can’t quite put your finger on it, but you’re a bit uncomfortable with this person. She says all the right things, her resume is great, she’d be a perfect hire for this job—except your gut tells you…
Dirk Dusharme
In last week’s Quality Digest Live: Enterprise quality management vs. integrated quality management. Our deteriorating U.S. infrastructure. Stress testing composites. The Fowler Precision Mobile Tech Center.
“Save Costs When Implementing Enterprise Quality Systems”
An integrated quality management…
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been clear on what it expects on a granular level, the Common Vulnerability Scoring System can provide much-…
Taran March @ Quality Digest
As manufacturing becomes increasingly oblivious of where one country stops and another begins, the responsibilities of quality managers have extended beyond the safely measurable and into the loosely regulated wilds of global competition. Quality control now requires a sense of how different…
Chad Kymal
What is enterprise quality? Simply put, it is a system where there is one quality manual, and a core of common processes, work instructions, and forms and checklists for a multisite environment. Why is this a good idea? Because it saves money.
Figure 1 illustrates how enterprise quality takes…
Michael Jovanis
Sponsored Content
Particles of metal in children’s medicine. Adulterated baby formula. Spontaneously combusting smartphones. When scandal is only a tweet away, companies can’t hide from quality failures.
High-profile quality problems like these can not only harm consumers, but also lead to huge…
Ryan E. Day
Sponsored Content
My wife and I purchased a new car this year. The employee handling the closing paperwork gave a compelling presentation concerning the extended warranty, which we also purchased. His presentation included a litany of high-tech components and even higher-tech systems that could…
David Sefcik
Believe it or not, I love to grocery shop. Besides getting to pick all my favorite foods, I love the challenge of getting the best deals—and a challenge it can sometimes be. Without a doubt, I have found that the best tool available to enable price and value comparison is unit pricing—you know,…
Inderjit Arora
Risk-based thinking can be considered the fundamental change in ISO 9001:2015. Compared to ISO 9001:2008, where preventive action (PA) held a spot in the “act” phase of the plan, do, check, act (PDCA) cycle, risk now appears in the “plan” phase and at each stage thereafter. This change formalizes…
Mike Richman
The March 24 episode of QDL offered a potpourri of topics, including news and features from the realms of academia, corporate culture, and politics. Here’s a quick recap:
“Winners Selected for the 2017 InVenture Prize” Colloquially known as “American Idol for Nerds,” the InVenture Prize offered by…
Joseph Aldy
President Trump jettisoned more than 30 years of bipartisan regulatory policy on Jan. 30, 2017, when he issued an executive order on “Reducing Regulation and Controlling Regulatory Costs.” The order requires that whenever a new regulation is enacted by any federal agency, regulators must eliminate…
Timothy Lozier
Compliance is a common term that is very broad, and many companies interpret compliance as a host of different items. It can be related to quality, safety, or operations, but it encompasses a long list of areas within the organization, including financial, risk, governance, sustainability, and…
Greg Anderson
The most astute executives in health systems are rightfully concerned about compliance risks in physician contracting. Among these risks are that a transaction or an arrangement between a hospital and a physician are consistent with fair market value (FMV) and are commercially reasonable (CR) as…
DNV GL
“You should prioritize agility, but find ways to take risks without sacrificing sound execution that can jeopardize both customer satisfaction and, more importantly, safety.”
—PWC “2016 Auto Industry Trends”
Perhaps no sector is so thoroughly driven to balance innovation and safety as is the…
Mika Javanainen
The September 2018 certification deadline for ISO 9001:2015 is looming. The updated standard promises to further streamline mission-critical tasks and information flows as well as better align quality management with overall business management. But to earn certification, organizations must first…
Bert Coursey
Marie Curie is perhaps the most famous woman of 20th-century science. Major films and best-selling biographies have chronicled her discovery of the radioactive elements polonium and radium, for which she shared the Nobel Prize in physics in 1903 and then received a second Nobel Prize, this time in…
Tom Middleton
Just inside the entrance to Thomas Edison’s winter home in Naples, Florida, is a bronze bust of Edison himself. The base of the sculpture reads: “There is a way to do it better—find it.” As an accredited auditor of management systems and good manufacturing practices (GMPs), I have always seen…
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all…
Christine Schaefer
Last month, 2001 Baldrige Award-winning University of Wisconsin-Stout hosted a lively campus engagement session. (See for yourself via this video of the live-streamed event, which kicked off with dancing.) The university holds the “You Said... We Did” sessions each January to demonstrate its…