All Features
Scott Gottlieb
There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. At the U.S. Food and Drug Administration (FDA), we’re focused on propelling these innovations, collectively referred to as…
Mike Figliuolo
Legislative and regulatory changes can cause massive upheaval for your strategic plan. Elections happen all the time. New rules and regulations are proposed, implemented, or repealed on a daily basis. Court cases can change an entire industry landscape.
To stay on top of all these changes and to…
Dirk Dusharme
If asked whether you guard your company’s secrets, most of us would say, “Well, of course I do.” But I’m guessing that if you are a remote worker, or do any work while on the road, you are blithely handing out company secrets and don’t even know it. If nothing bad has happened yet, it’s only…
Thomas R. Cutler
Although automation has been successful in replacing repetitive, simple tasks, the human workforce still plays a critical role in manufacturing. Even the most sophisticated and automated manufacturing operations rely on human operators to configure, run, and properly maintain production equipment…
Aiman Sakr
Does your organization benefit from lessons learned? Does it learn from previous quality issues? A vast amount of learning takes place every day in every manufacturing facility. Do global manufacturing companies share experiences gained from resolving quality issues between overseas plants? And…
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…
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…
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
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
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…
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’…
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…
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…
Dirk Dusharme
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…
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,…
Mike Richman
During this past Friday’s episode of Quality Digest Live, our weekly web TV show, QD editor in chief Dirk Dusharme and I covered stories about the gig economy and the skills gap and workforce shortages within manufacturing, especially as it relates to metrology, which is the science of measurement…
Chad Kymal
ISO 45001 is the much-anticipated, first ISO-based international occupational health and safety (OH&S) standard. The International Organization for Standardization (ISO) has tried twice and failed in the past to create an international OH&S management system standard. Although there are a…
James Tehrani
People get overly tired. People get distracted; they get stressed and make poor decisions. People multitask when they shouldn’t. People lack training at times.
Our brains and bodies are machines, but they are imperfect ones. Even the most thorough and careful person will become an “err apparent”…
Laurel Thoennes @ QD
Employers can’t find people with the skills needed for the today’s workplace, because high schools and universities fail to teach students useful job skills. The skills gap is a decades-old and well-known problem that will remain unsolved unless we flip priorities not only in our school systems…
Wendy Wood
Employers have a stake in their staff’s health. It’s not just a matter of keeping health insurance premiums in check which is a consideration in countries without universal healthcare. It’s also about maximizing employee engagement and productivity, and even happiness.
Promoting health habits is…