All Features
Laurie Locascio
Like a lot of scientists, I am very goal-oriented, so after I got my Ph.D. in toxicology, I set out to become a leader in my field by the time I was 40. To get there, I knew I had to be acknowledged by the top researchers in my field, get invited to speak at important conferences, organize…
Dirk Dusharme @ Quality Digest
In last week’s Quality Digest Live: Enterprise quality management vs. integrated quality management. Our deteriorating U.S. infrastructure. Stress testing composites. The Fowler Precision Mobile Tech Center.
“Save Costs When Implementing Enterprise Quality Systems”
An integrated quality management…
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…
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…
David Sefcik
Believe it or not, I love to grocery shop. Besides getting to pick all my favorite foods, I love the challenge of getting the best deals—and a challenge it can sometimes be. Without a doubt, I have found that the best tool available to enable price and value comparison is unit pricing—you know,…
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…
Mike Richman
The March 24 episode of QDL offered a potpourri of topics, including news and features from the realms of academia, corporate culture, and politics. Here’s a quick recap:
“Winners Selected for the 2017 InVenture Prize” Colloquially known as “American Idol for Nerds,” the InVenture Prize offered by…
Joseph Aldy
President Trump jettisoned more than 30 years of bipartisan regulatory policy on Jan. 30, 2017, when he issued an executive order on “Reducing Regulation and Controlling Regulatory Costs.” The order requires that whenever a new regulation is enacted by any federal agency, regulators must eliminate…
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…
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…
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…
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…
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…
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…
Joe Schlecht
According to the ISO/IEC Guide 99—“International vocabulary of metrology—Basic and general concepts and associated terms (VIM),” the traceability of a measurement result is demonstrated through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. This…
