All Features
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…
DNV GL
“You should prioritize agility, but find ways to take risks without sacrificing sound execution that can jeopardize both customer satisfaction and, more importantly, safety.”
—PWC “2016 Auto Industry Trends”
Perhaps no sector is so thoroughly driven to balance innovation and safety as is the…
Mika Javanainen
The September 2018 certification deadline for ISO 9001:2015 is looming. The updated standard promises to further streamline mission-critical tasks and information flows as well as better align quality management with overall business management. But to earn certification, organizations must first…
Bert Coursey
Marie Curie is perhaps the most famous woman of 20th-century science. Major films and best-selling biographies have chronicled her discovery of the radioactive elements polonium and radium, for which she shared the Nobel Prize in physics in 1903 and then received a second Nobel Prize, this time in…
Tom Middleton
Just inside the entrance to Thomas Edison’s winter home in Naples, Florida, is a bronze bust of Edison himself. The base of the sculpture reads: “There is a way to do it better—find it.” As an accredited auditor of management systems and good manufacturing practices (GMPs), I have always seen…
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all…
Christine Schaefer
Last month, 2001 Baldrige Award-winning University of Wisconsin-Stout hosted a lively campus engagement session. (See for yourself via this video of the live-streamed event, which kicked off with dancing.) The university holds the “You Said... We Did” sessions each January to demonstrate its…
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…
DNV GL
More than a million organizations around the world embrace the ISO 9001 quality management system (QMS) standard to guide their businesses and operate in the most efficient manner possible. The International Organization for Standardization (ISO) has recently updated ISO 9001 from its 2008 version…
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 &…
Pam Bethune
One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?
What the standard says
When making sense of Clause 4.1—“Understanding the organization and its context…
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…
Mary McAtee
Sponsored Content
Technical and commercial media sources are constantly discussing how design safety and security has not kept pace with quickly evolving technologies. Pundits are pointing to issues with everything from self-driving cars to new holiday toys that latch on to your home Wi-Fi and…
Tim Lozier
Sponsored Content
For quality management to be effective, a solid corrective action process is critical. ISO standards and general best-practice guides suggest—and even mandate—a set procedure and proper documentation for addressing and correcting issues.
In fact, 72 percent of quality…
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…
DNV GL
According the International Organization of Standardization (ISO), there are more than 300,000 certifications to ISO 14001 in 171 countries around the world, making it the most relied-upon symbol of environmental stewardship and sustainable business practice. True to its core tenant of continual…
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…
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from the…
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…