All Features
Sharona Hoffman
On June 12, 2018, the American Medical Association announced that drug shortages pose an urgent public health crisis. This crisis should be of concern to all Americans.
The Food and Drug Administration (FDA) defines a drug shortage as a “period of time when the demand or projected demand for a…
Matthew M. Lowe
The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-induced nausea to epilepsy and neuropathic pain. If you’re a startup in the industry, what does this mean…
Steven Brand
Many consider 2017 the “worst year ever” for data breaches and cyber attacks, largely due to the rise in ransomware, and IT experts predict it’s only going to get worse. According to the Online Trust Alliance (OTA), a nonprofit that works to develop tools and best practices that enhance internet…
Dirk Dusharme @ Quality Digest
In our June 15, 2018, episode of QDL, we get a field report from the HxGN LIVE user conference, examine the “story of quality,” and consider the importance of experience.
HxGN Live recap
Mike Richman went to HxGN LIVE... but I didn’t. I relive it vicariously through Mike’s field report.
“A…
Tim Lozier
Quality management systems (QMS) have become strategic components that touch more and more of the business today. With new versions of QMS standards, and the enrollment of all people in the quality management effort, the need for cohesion from one system to the next is becoming critical.
Let’s…
NIST
Augmenting its efforts to protect the nation’s critical assets from cybersecurity threats as well as protect individuals’ privacy, the National Institute of Standards and Technology (NIST) has issued a draft update to its Risk Management Framework (RMF) to help organizations more easily meet these…
Ryan E. Day
With the threat of a trade war between China and the United States looming, business relations between Asia and the West have not been this hot a topic since the Japanese Economic Miracle that was birthed shortly after WW II. Today, it is China’s turn on center stage as its soaring economic growth…
Dirk Dusharme @ Quality Digest
In part one we saw that China has made great strides in terms of product quality, notably in the tech sector. But it still has a long way to go in other products. Driven by the growing middle class, who like all middle class buyers want value for their money, and by the Chinese government’s desire…
Dirk Dusharme @ Quality Digest
Back in the 1950s and 1960s, Japanese products were synonymous with cheaply made. Anyone over the age of 50 probably remembers cheap Japanese transistor radios when they were a kid. We all believed, in the day, that the more transistors a radio had, the better. That wasn’t necessarily true, but try…
William A. Levinson
A job safety analysis (JSA) worksheet is almost identical in organization to a job breakdown sheet and standard work, all of which assess a job (or process) on a step-by-step basis. This suggests combining standard work with job safety analysis to support ISO 45001.
The concept can be carried even…
Mohammad Jalali
Like any large company, a modern hospital has hundreds, even thousands, of workers using countless computers, smartphones, and other electronic devices that are vulnerable to security breaches, data thefts, and ransomware attacks. But hospitals are unlike other companies in two important ways. They…
Matthew E. May
Process improvers the world over rally around root cause analysis as if it were the holy grail of all things organizational. But is it?
Understanding the root cause of a problem certainly makes sense in the context of a present day situation carrying the potential for a correct answer or solution…
Ryan E. Day
Unily is a leading digital workplace platform designed by BrightStarr to improve engagement, productivity, and efficiency for global enterprises. Unily is also a SaaS solution. That is, it’s served up via the cloud. Meaning that—with more than a million users, including the likes of Shell, Hershey’…
Terry Onica
The new automotive quality management system (QMS), IATF 16949:2016, was released in October 2016, and it officially went into effect on Jan. 1, 2017, along with revisions to IATF Rules for Achieving and Maintaining IATF Recognition, Fifth Edition. Starting Oct. 1, 2017, all automotive QMS audits…
Fred Schenkelberg
Mean time between failures (MTBF) is a symptom of a bigger problem. It’s possibly a lack of interest in reliability (which I doubt is the case). Or it’s a bit of fear of reliability.
Many shy away from the statistics involved. Some simply don’t want to know the currently unknown. It could be the…
BSI
Organizations worldwide recognize the need to provide a safe and healthy working environment, reduce the likelihood of accidents, and demonstrate they are actively managing risks. ISO 45001 will provide an internationally accepted framework that will help protect employees as well as protect the…
Ryan E. Day
So, the Quality Digest team is considering a transition to working remotely for the most part. I and two other associates already do. In part one of this series, I outlined my ad-hoc attempt at creating a computer work space at home. The result was not very pretty.
As I said in part one, my home…
Jay Zagorsky
The world is an uncertain and risky place. The news constantly bombards us with scary situations from school shootings to gruesome murders.
Risk is everywhere and associated with everything. For example, the Centers for Disease Control and Prevention a decade ago estimated 234,000 people a year…
Larry Emond
The number of publicly listed U.S. companies traded on U.S. exchanges has been cut almost in half during the past 20 years—from about 7,300 to 3,700—which goes to show that mergers and acquisitions are still a primary growth strategy.
In fact, 2018 looks to be another banner year for mergers and…
Sal Lucido
Policies and procedures tell your employees, partners, vendors, and customers how your system operates. With changing regulations and expectations, a static library is not enough. Policies are dynamic and require a system to manage their creation, documentation, distribution, and management. Here’s…
Marin Hedin
Limiting first-year medical residents to 16-hour work shifts, compared to “flexing” them to allow for some longer shifts, generally makes residents more satisfied with their training and work-life balance. It also makes their training directors more dissatisfied with curtailed educational…
Knowledge at Wharton
America’s healthcare system has been on the examining table lately: from the tortuous battle over the Affordable Care Act, to Senator Bernie Sanders’ bill to allow low-cost prescription drugs in from Canada, to the intriguing announcement in January that Amazon, Berkshire Hathaway, and JPMorgan…
Dirk Dusharme @ Quality Digest
On April 10, 2018, Facebook co-founder and CEO Mark Zuckerberg testified before Congress regarding the unauthorized sharing of 87 million Facebook users’ personal data, vacuumed up by data research company Cambridge Analytica. There were pointed questions regarding Facebook’s lack of transparency…
Martin Gordon
On March 15, 2018, a 950-ton partially assembled pedestrian bridge at Florida International University (FIU) in Miami suddenly collapsed onto the busy highway below, killing six people and seriously injuring nine. Forensic engineers are taking center stage in the ongoing investigation to find out…
Richard Harpster
The AIAG-VDA FMEA Handbook committee and everyone who responded to the request for comment on the proposed AIAG-VDA failure mode and effects analysis (FMEA) manual must be applauded for their efforts. Harmonizing the VDA and AIAG FMEA methods is not an easy task. According to industry sources,…
