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AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.
Inadequate corrective actions
An FDA investigation was conducted from January to February 2017 at…
Loic Sadoulet, Giovanni Tassini
Making the most of its position as an important seaport, Venice’s remarkable economic development during the Middle Ages relied on network effects, contractual innovation, and coordination among the players involved in long-distance trade. Companies today still exploit these mechanisms to succeed…
Katina Sawyer, Christian Thoroughgood
In times of organizational crisis, some companies are able to right the ship, while others sink under the pressure.
Recently, Uber has been under fire for a bad corporate culture, which promoted, among other things, sexism and other forms of toxic behavior. This led to a four-month investigation…
Pam Bethune
Every company is in business to take risks.
Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to identify opportunities and take them when beneficial, but the amount of risk must be understood. Whether it’s…
Mike Richman
The July 17, 2017, episode of QDL focused on some of the nitty-gritty of quality improvement, from the value of personal certifications to the opportunities of disruptive innovation, and to the fundamentals of risk management to the challenges of customer service. In case you missed it, here’s a…
Rick Barker
Operations and safety don’t always speak the same language, not because operations isn’t committed to keeping people safe at work or safety isn’t concerned with meeting operational goals, but rather because each area has its own methods, processes, and measures. This communication gap can increase…
Pat Toth
Recently a segment on my favorite morning news program stopped me in my tracks. The young and attractive hosts (why are they always so young and attractive?) were demonstrating new appliances, among them a smart refrigerator. The fridge was equipped with all kinds of high-tech features including…
Amie Whittington
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (dual status). The…
Tim Lozier
The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it.
The biggest question often asked is, “I’m aware my company needs to pay great attention to the detail of risk, but…
Erin Connelly
For a long time, medieval medicine has been dismissed as irrelevant. This time period is popularly referred to as the “Dark Ages,” which erroneously suggests that it was unenlightened by science or reason. However, some medievalists and scientists are now looking back to history for clues to…
Roger Lehman, Julius Koh
Lucy felt hollow and dissatisfied. She was a star performer and had just helped her team clinch a large government deal that they had been working on for months. At the celebration that evening, Lucy was forced to put on a smile and a dynamic front. She had good relationships with her team members…
William A. Levinson
‘We’ve always done it that way” explains why many suboptimal and even obsolete methods are taken for granted. The range chart for statistical process control (SPC) is, for example, somewhat inferior to the sample standard deviation chart, and it is almost certainly a holdover from when all…
Cassandra Burke Robertson, Irina Manta
Recent reports suggest that terrorists can now create bombs so thin that they cannot be detected by the current X-ray screening that our carry-on bags undergo.
In an effort to protect against such threats, the United States is considering banning laptops and other large electronic devices in the…
Wesley McGrew
Last month, the WannaCry ransomware attack hit more than150 countries and infected tens of thousands of systems worldwide. Among those victimized were England’s National Health Service, automobile manufacturers, and government systems. The worm’s ominous red ransom screen, informing the user that…
Iffet Turken
The world faces a new crisis situation more or less every day—be it political, economic, or humanitarian. Wherever a crisis is experienced, echoes are felt around the globe. In the digital age, social media conveys crises in real time, resulting in rich portfolios of pictures, videos, written…
Ryan E. Day
I remember my first trip to Michigan in 2012. I was covering the Ford Motor Co.’s annual Trend Conference and had the opportunity to meet Alan Mulally, who gave a compelling presentation explaining the vision, strategy, and implementation of the One Ford plan. I was impressed more with the man…
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…
