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Myth: Your Management System Documentation Must Resemble the ISO Standard
Inderjit Arora
Every company uses a system to understand the requirements and inputs of its customers, and then plans to deliver outputs meeting those requirements as a conforming product or service. The International Organization for Standardization (ISO) publishes management system standards that, when…
What Climbing Expeditions Tell Us About Teamwork
Dylan Walsh
In principle, the mountaineer’s work is simple: “To win the game he has first to reach the mountain’s summit,” said George Mallory, who took part in Britain’s first three attempts on Everest during the 1920s. “But, further, he has to descend in safety.” The tension between these two goals—…
Worker-Protection Laws Aren’t Ready for an Automated Future
Jeffrey Hirsch
Science fiction has long imagined a future in which humans constantly interact with robots and intelligent machines. This future is already happening in warehouses and manufacturing businesses. Other workers use virtual or augmented reality as part of their employment training, to assist them in…
Functional Safety, Automotive SPICE, and Cybersecurity in New-Product Development
Chad Kymal
Organizations in the automotive and related industries such as steel, plastics, and semiconductors have been heavily influenced by automotive industry standards and practices like IATF 16949, advanced product quality planning (APQP), failure mode and effects analysis (FMEA), and production parts…
Getting It Ripe
Rachel Ehrenberg, Knowable Magazine
This story was originally published by Knowable Magazine. If you’re lucky, you’ve tasted a perfectly ripe fruit—a sublime peach, perhaps, or a buttery avocado. But odds are most of the fruit you’ve eaten tastes more like wet cardboard. Although plant breeders have mastered growing large, perfect-…
How Do Hospitals Know What to Do When Hurricanes Approach?
Daniel Hess
We all expect hospitals to be open and operating when we need them, but extreme weather events like hurricanes are a strain on resources and pose significant challenges for hospitals. Closing a hospital is an extreme action, but several hospitals in Florida, Georgia, and South Carolina did just…
Are you Prepared for an Active Shooter Situation?
DNV GL
Workplace safety is a complex issue, addressing everything from rules for operating heavy machinery to guidelines for respecting your fellow employees. For many of these issues we, as a business community, have developed and applied a variety of best practices and global standards—such as ISO 45001…
How to Use Gamification Principles to Boost Audit Participation
Paul Foster
When Deloitte wanted to get people excited about employee training, the company decided to adopt a gamification strategy for its online training portal. Using elements like achievement badges, missions, and leaderboards, they achieved a 37-percent increase in participation. And when Ford Canada…
Quality Control in the Tariff-Challenged Supply Chain
Sébastien Breteau
Whether it be a move forced by the U.S.-China tariff turmoil, or a sourcing strategy long in the works, the exodus from China is a reality for a host of businesses, from small to medium-sized enterprises to multinationals. While the departure is widespread, it isn’t universal—some major players,…
New Packaging Technologies Promote Sustainability and Food Safety
Krystle Morrison
From carrying food in from the field, to shipping processed products, to assembling a supermarket display, packaging matters. As a follow-up to our exploration of emerging trends in food packaging, we’re taking a look at several innovative technologies that could change the future of packaging.…
When Standardized Data Can Help Save Lives
Britta Voss
When you email friends, you don’t have to worry about whether they use Gmail, Outlook, Yahoo, or some other email provider. You just enter their email address, write your message, and hit send. The reason this works is because there are layers of standardized protocols that all the email clients…
Physician Burnout: Why Legal and Regulatory Systems May Need to Step In
Sharona Hoffman
A career as a physician has traditionally been considered to be among the best vocations that talented students can pursue. That may no longer be the case. All too many doctors report that they are unhappy, frustrated, and even prepared to leave the profession. That should worry all of us. The…
Implementing ISO 13485
Jon Speer
Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International Organization for Standardization (ISO), standard 13485 outlines the guidelines for medical device quality…
Under a Watchful Eye
Jill Barshay, Sasha Aslanian
When Keenan Robinson started college in 2017, he knew the career he wanted. He’d gone to high school in a small town outside Atlanta. His parents had never finished college, and they always encouraged Robinson and his two older siblings to earn degrees. Robinson’s older brother was the first in the…
How To Transport Delicate Goods Safely With Fleet Management Systems
Ekim Saribardak
Transporting cargo over long distances has always been a logistical nightmare, but when the goods are of a delicate nature, the whole operation becomes significantly more challenging. Perishable foods, chemicals, pharmaceutical products, and other delicate goods all need special treatment during…
Wake-Up Call: Class I Manufacturers, Get an Early Start on EU MDR Compliance
Peter Rose
On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and…
Why Future Jobs Will Require Data Analytics Skills
Knowledge at Wharton
From a lone statistician toiling over narrowly defined problems for the marketing department, to a C-level executive overseeing a mission-critical area impacting every function of the company, the meaning of “data and analytics professional” has changed a lot in recent years. A. Charles Thomas’s…
A Middle Path to Sustainable Farming
Natasha Gilbert, Knowable Magazine
This story was originally published by Knowable Magazine. Alfalfa, oats, and red clover are soaking up the sunlight in long narrow plots, breaking up the sea of maize and soybeans that dominates this landscape in the heart of the U.S. farm belt. The 18 by 85 meter sections are part of an…
Never Fear ‘Hold My Beer’
The Un-Comfort Zone With Robert Wilson
When I was 7 years old, I went into the woods behind my house, built a fire, then fried an egg over it in an old pie tin. When the egg was done, I ate it. I didn’t even like eggs, but because I had cooked it on my own, it was delicious. I was so proud of my achievement that I ran inside and told…
The Transformative Impact of Standardization
Eric Weisbrod
In manufacturing, standardization in production and process control leads to increased profitability and cuts down on many siloed problems that can plague even the most quality-focused organization. But when you have multiple, disparate plants around the country or the globe, standardization can…
Voices From an Age of Uncertain Work
David Blustein
On the surface, the well-being of the American worker seems rosy. Unemployment in the United States hovers near a 50-year low, and employers describe growing shortages of workers in a wide array of fields. But looking beyond the numbers tells a different story. My new book, The Importance of Work…
Why Companies Should Seek Higher Damages for Counterfeiting
Ziv Carmon
Counterfeiting is widespread and rapidly expanding. In 2015, the value of fake and pirated products globally was estimated at $1.7 trillion, equivalent to the GDP of Canada. The scope of this phenomenon is vast. In both developing and developed countries, counterfeiting affects many sectors,…
Transforming Quality Operational Data Into Business Insights
Stephen McCarthy
In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes. This challenge is particularly evident in the…
Filters of Responsibility
Jim Benson
Responsibility. It’s a hard word to come to grips with. What is the responsible thing to do right now? What is my personal responsibility? What is my responsibility as a team, family, company, state, or country member? What do I expect from others? The world now is in transition, from being…
IATF 16949 Adds Value to ISO 9001:2015
William A. Levinson
The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance, but it is only that—a first step. It covers only by implication many of the risks and opportunities…

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