All Features
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.
The CDRH continues to put a premium on quality when it assesses a…
Ryan E. Day
Sponsored Content
Founded in 1927 to produce aluminum splints—cutting edge at the time—Zimmer Biomet is a medical device company commanding second place in the entire world’s overall orthopedic market share. The organization’s stated purpose is to “Restore mobility, alleviate pain, and improve the…
UC Davis
Three transportation revolutions are in sight, and together they could help reduce traffic, improve livability, eventually save trillions of dollars each year, and reduce urban transportation carbon dioxide (CO2) emissions by 80 percent or more worldwide by 2050. That’s according to a report…
Winnie Ip
You may have heard that it takes 21 days to form a new habit. Well, it turns out that’s just a myth. Researchers found that, on average, it takes people more than two months before a new behavior becomes automatic. So what does that have to do with your office ergonomics process? A lot, especially…
AssurX
A common pitfall in quality management system (QMS) process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streamline the entire eQMS process in one giant undertaking. However, real-world experience…
DNV GL
The internet of things (IoT), robotics, augmented reality, 3D printing... look at megatrends, and despite their unique attributes and myriad differences, you’ll find that they all have one thing in common: time—or more precisely, the fact that there’s always less of it.
No matter how long your…
Mark Bartholomew
Ethics lawyers and historians have argued that Donald Trump has blurred the line between his public office and private business interests in an unprecedented fashion. In another sense, it’s part of a much larger social trend.
Commercial entreaties, whether in the form of magazine ads, radio…
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 &…
