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AS9100 Transition
Eric Stoop
If you had your AS9100 transition audit tomorrow, could you say right now whether you would pass? More important, do you know where the gaps are in your processes that could trigger nonconformities? AS9100 is the leading standard for aerospace management systems, required by original equipment…
Primetime for Integrated Management Systems
Violet Masoud
Imagine going to work, motivated to meet all your goals and deadlines, only to find you need a different computer for each of the applications you use: Microsoft Word on the laptop in your office; the customer database solution on the tower PC in the conference room; and email on the desktop in…
Human Capital Is Critical to ISO 9001:2015 Success
Bruce Bolger
Many quality professionals remain unaware that a systematic approach to human resources is now a requirement in ISO 9001:2015. These new requirements are based on the principles considered by the International Organization for Standardization (ISO) to be essential to quality management success.…
On Innovation, Intelligent Risks, and Leaking Sinks
Harry Hertz
The Baldrige Excellence Framework encourages organizations to create an environment for innovation by pursuing intelligent risks. How do you know whether a new idea is an intelligent risk, and therefore worth pursuing? How do you know if the resulting change is an innovation? An experience from my…
One in Five Materials Chemistry Papers May Be Wrong
John Toon
Can companies rely on the results of one or two scientific studies to design a new industrial process or launch a new product? In at least one area of materials chemistry, the answer may be yes—but only 80 percent of the time. The replicability of results from scientific studies has become a…
Responding to the Tide Pod Challenge
Knowledge at Wharton
When Tide and other detergent manufacturers developed colorful, convenient pods designed to be tossed into washing machines and dishwashers, they never expected teenagers would try to eat them. But what was dubbed the “Tide pod challenge” quickly went viral, with teens posting videos of themselves…
How to Leverage an EQMS for Managing Product Adulteration
AssurX
Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common violations in drug…
Inside Quality Digest Live for Feb. 9, 2018
Dirk Dusharme
Our Feb. 9, 2018, episode of QDL looked at electronic notes, electronic privacy, smart electronic device, and... wow... have we taken technology too far? “Study Shows Doctors Record Better Notes After Using Best-Practices Program” Shortcuts to electronic note taking, such as autofill and copy…
Nudging Your Staff to Healthier Habits
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…
Three Ways to Expose MTBF Problems
Fred Schenkelberg
MTBF use and thinking is still rampant. It affects how our peers and colleagues approach solving problems, and there is a full range of problems that come from using the “mean time between failure” (MTBF) metric. So, how do you spot the signs of MTBF thinking even when MTBF is not mentioned? Let’…
Are You Ready for the EU’s General Data Protection Regulation?
Martin R. Voelk
In just a few short months, the European Union’s General Data Protection Regulation (GDPR) will take effect. The regulation, which replaces the EU’s 20-year-old Data Protection Directive, imposes new and more rigorous requirements on any entity that collects or maintains personal consumer data,…
The Case Against the AIAG-VDA DFMEA
Richard Harpster
Richard Harpster's op-ed is in response to a recent Quality Digest article and webinar discussing the benefits of the draft AIAG-VDA FMEA Handbook. As he points out at the end of this article, the AIAG has provided a means to solicit comments, pro or con, on the handbook. We encourage interested…
How the War on Tipping Harms Customers
Michael Lynn
Some journalists and other social commentators have in recent years called for the abolition of restaurant tipping, primarily because they argue that it hurts workers. Several restaurateurs have even replaced tipping at their restaurants with automatic service charges or inclusive pricing.…
The Three Dilemmas of Data Gathering
Annet Aris
After an initial phase of euphoria about how the digital world improves our daily life with virtual assistants, among other gadgets and services, slowly but surely, we're coming firmly back to earth. Post-honeymoon, the breakneck speed of digital development has created an increasing number of…
Fresh Changes in the Pipeline
ISO
Ageing wastewater systems are under threat from growing populations, urbanization, pollution. and climate change, not to mention human behavior. However, despite these challenges and fears for health and safety, the new ISO 24516 series is playing a key role in turning what many consider a burden…
The Importance of Documenting Enterprise QMS Process Requirements
Eric Cooper
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house you end up with is going to be what you want? Documenting your requirements should be obvious, right…
ISO 9001:2015 and ISO 10018: Developing People Engagement In a QMS
Bruce Bolger
HighlightsThe New Focus on People Overview of ISO 9001:2015 Standards and the ISO 10018 Certification How This Microsite Helps Quality Management, Auditors, and Solution Providers Articles ResourcesOther Articles In This Series This Month's Featured ArticleAccumold Starts With the Why  Can the…
To Get the Most Out of Self-Driving Cars, Tap the Brakes on Their Rollout
Jack Barkenbus
Every day about 100 people die in car crashes on U.S. roads. That death toll is a major reason why both Congress and the Trump administration are backing automotive efforts to develop and deploy self-driving cars as quickly as possible. However, officials’ eagerness far exceeds the degree to…
Inside Quality Digest Live for Jan. 19, 2018
Mike Richman
During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at work, and inspected some interesting stereo microscopes from Vision Engineering. Here’s a closer look…
Five Key Standards Trends to Watch in 2018
Miriam Boudreaux
If you are a manufacturing company or a service provider, there is a good chance that you have heard about standards such as ISO 9001. In fact, you may already be certified. But whether you are certified or not, read on for some of the expected trends in the world of standards and certification…
Turbulent Times Call for Athletic Leaders
Stanislav Shekshnia, Veronika Zagieva, Alexey Ulanovsky
During the last decade, we studied CEOs of companies that thrive within some of the most challenging business environments on the planet. Though very different in many respects, these CEOs share leadership behaviors and attitudes that strongly parallel those of top athletes. We further theorize…
Transitioning to ISO 45001
Ismael Belmarez
Workplace safety is a vital concern for every organization. According to the U.S. Bureau of Labor Statistics, 2.9 million nonfatal workplace injuries and illnesses were reported by private industry employers in 2016, costing employers tens of billions of dollars. In March of this year, the leading…
Inside Quality Digest Live for Jan. 12, 2018
Dirk Dusharme
Our Jan. 12, 2018, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs. “Impatient With Colleges, Employers Design Their Own Courses” Microsoft, Amazon, and others are teaming up with third-party online courseware providers to…
The Test of Time: NIST’s Wall of Many Stones
Jason Stoughton
Frequented by more deer than people, the NIST stone test wall lives a fairly isolated existence. Out among the trees and the grass on the south end of the Gaithersburg, Maryland, campus, it cuts an imposing and visually bizarre figure. Set in the mortar of its technicolor face are more than 2,000…
How Will Autonomous Vehicles Interpret Hand Signals?
Abdesalam Soudi
Recently, while on my way to the University of Pittsburgh’s campus, I made a quick “Pittsburgh left”—taking a left turn just as the light turns green—while facing a driverless car. Instead of jolting forward or honking as some human drivers would be tempted to do, the car allowed me to go. In…

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