All Features
William A. Levinson
Among other requirements ISO 9001:2015, clause 4.4.1 requires an organization to identify the inputs and outputs of the processes of the quality management system; identify the sequence and interaction of these processes, noting that handoffs between processes often create risks; and identify the…
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…
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…
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…
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…
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…
Jeffrey Phillips
The attempt to eliminate noise from an operating system or a business process is an interesting and perhaps worthwhile challenge, until one considers the question: What is the real signal? What is creating the noise?
In many businesses today, there are several signals, what we might call noise…
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by…
Mark Whitworth
Layered process auditing (LPA) is a quality management approach increasingly used by manufacturing and service companies alike to address a gap in traditional product-oriented approaches. When properly implemented, layered auditing is the most effective way to ensure that processes consistently…
Stefan Geib
While the fallout of the United Kingdom’s decision to exit the European Union has sent shockwaves throughout the political and economic world, Brexit is merely a footnote in the global supply chain risk story. According to the latest risk index from the Chartered Institute of Procurement &…
Daniel Blake, Caterina Moschieri
Pulling out of a country is an expensive proposition for a multinational firm, but it is sometimes required for the corporate bottom line. If the host country changes laws or even expropriates a subsidiary, it is often time to leave or divest.
Divestiture—pulling out assets or closing down part…
Thomas R. Cutler
Two words no manufacturing organization wants to hear: product recalls. By their very nature, product recalls are unpredictable events.
The cost to a company transcends potentially expensive litigation and settlements. Product recalls and the effects that product failures have on companies that…
Katherine Watts
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling spending in the Medicare program. It’s a question we’ve wrestled with for almost 20 years and a challenge we…
Jessica Gabel Cino
Forensic science has become a mainstay of many a TV drama, and it’s just as important in real-life criminal trials. Drawing on biology, chemistry, genetics, medicine, and psychology, forensic evidence helps answer questions in the legal system. Often, forensics provides the “smoking gun” that…
Mike Richman
Before I dive into this column, a quick programming note: You may have noticed some formatting changes in today’s issue of Quality Digest. Starting today, on each Thursday we will present a special edition of our newsletter, with a pair of particularly thought-provoking articles from our library…
Fred Schenkelberg
If you have been a reliability engineer for a week or more, or worked with a reliability engineer for a day or more, someone has asked about testing planning. The questions often include, “How many samples?” and, “How long will the test take?” No doubt you’ve heard the sample-size question.
What…
Pat Toth
They say opposites attract. Although my husband and I have many important things in common, we are complete opposites in one area. He’s a “risk taker,” and I’m... well, not so much. Rather than being labeled as “risk averse,” I prefer the term “caution giver.”
I’m a federal employee. I come from…
