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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…
Mark Whitworth
For 17 years, ISO/TS 16949 was the leading standard for quality system requirements in the automotive industry. The technical specification was jointly developed by the International Automotive Task Force (IATF) and the International Organization for Standardization (ISO) in 1999. In October 2016…
Timothy Woodcome
Sponsored Content
If your organization has yet to make the transition from ISO 9001:2008 to ISO 9001:2015, you’re not alone. It’s estimated that less than 20 percent of the more than one million organizations certified globally have made the transition to the latest version of the standard (as of…
American Customer Satisfaction Index ACSI
(ACSI: Colorado Springs, CO) -- Customer satisfaction with banks is up, according to the American Customer Satisfaction Index (ACSI). Its recent report covers the finance and insurance sector, which includes retail banks, credit unions, health insurance, property and casualty insurance, life…
The new revision of AS9100D is now out, and clause 10.2—“Nonconformity and corrective action” will require us to “evaluate the need for action based on human factors to ensure nonconformities do not recur.” In addition, clause 7.1.4 of both ISO 9001:2015 and AS9100D require us to consider human…
Suzanne Schwartz
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of…
William A. Levinson
Sept. 22, 2018, is the deadline for registration to ISO 9001:2015, and this seems to allow organizations plenty of time to make the transition to the new standard. The good news is that, despite the radical changes to the standard’s structure, the underlying requirements are not particularly…
NIST
The U.S. Commerce Secretary, Penny Pritzker, has named four organizations as the 2016 recipients of the Malcolm Baldrige National Quality Award, the nation’s highest presidential honor for sustainable excellence through visionary leadership, organizational alignment, systemic improvement and…
Mike Richman
Hard as it may be to believe, a close analysis of our extensive trove of behavioral data on the Quality Digest user group indicates that more than a handful of you don’t regularly watch our regular weekly web TV show, Quality Digest Live, which broadcasts from our studio in Northern California…
Cole Cooper
A production part approval process (PPAP) is used by companies to establish confidence and rules in a production process. In a sense, it gives customers a view into their suppliers’ manufacturing capabilities.
A PPAP is required when there is a new part, engineering changes, tooling changes,…
The United State Occupational Safety and Health Administration (OSHA) estimates that $60 billion is lost annually from workplace injuries and illness. Using the administration’s $afety Pays Program calculator, 20 carpal tunnel syndrome injuries will cost a company $1,260,000 in direct and indirect…
NIST
Until recently, if a company wanted the best measurements in the world for the physical dimensions of one of its dimensional standards, it had to book time on the NIST Physical Measurement Laboratory’s (PML) Moore M48 coordinate measuring machine (CMM). Operating at NIST since 2000, this CMM—…
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be…
Paula Oddy
Changes to the global economy during the last two decades have dramatically altered the landscape of business and industry. Globalization has enabled an ever-lengthening supply chain, which confers greater complexity and risk to every step of the process, whether for material goods or for services…
Dawn Bailey
Should an organization embrace risk or spend millions of dollars a year to avoid it? How do you know when a particular strategy is best?
Considerations for such thinking are covered in the Baldrige Excellence Framework, and the topic was recently explored by Brennan McEachran in an Innovation…
