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Getting Your Foot in the Door When Switching Industries
Claire Harbour, Antoine Tirard
Born to a Dalit family, Megha was raised in Southwest India and learned English at her convent school. As a child, she aspired to be a fashion designer or a cardiologist, but her parents insisted that she become an IT engineer. After four years of higher education, Megha found a job in the booming…
On the Road to Big Medicine
Taran March @ Quality Digest
Life science companies are no strangers to data, so it would be easy to assume they are adept at making innovative use of huge amounts. Not necessarily. A tradition of rigorous scientific method and clinical trial hasn’t prepared them for the shifting inundation of big data or all its baffling…
The Power of Thought: How Critical Thinking Can Help Your Business
Knowledge at Wharton
Many people work on their goals by engaging in positive actions—hitting the gym, planning a trip, or taking guitar lessons. But they may be overlooking one of the most important tools for effecting change: the power of thought. Harvard Business School professor emeritus Gerald Zaltman recommends…
ANSI’s Role in the Wide World of Standards
Ryan E. Day
I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up. You just benefited from at least seven U.…
Ensuring Food Safety With Quality Management Software
Nicole Radziwill, Graham Freeman
In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths. Although a burger is only required by law in that region to contain 47-percent…
Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
Kelly Kuchinski
Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to unravel…
NIST: Blockchain Provides Security, Traceability for Smart Manufacturing
NIST
Engineers at the National Institute of Standards and Technology (NIST) needed a way to secure smart manufacturing systems using the digital thread, so they turned to the new kid on the block... blockchain, that is. According to a new NIST report, the security system better known for underpinning…
Here Today, Gone Tomorrow
Knowledge at Wharton
In the 1999 film Office Space, a dark comedy about the mundane conventionality of work, disgruntled software engineer Peter Gibbons tells his new love interest, Joanna, that he hates his job and doesn’t want to go anymore. When Joanna, played by actress Jennifer Aniston, asks Peter whether he is…
Design Robust Processes to Avoid ISO 9001:2015 Nonconformances
William A. Levinson
The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001 users can avoid most nonconformances by focusing on the clauses that are the most frequent trouble…
Power Moves: Turning Compliance Into True Quality
Mike Richman
Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality?…
Life Science Regulations, Compliance, and the Move Toward QMS Software
Quality Digest
Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science…
FDA Milestones
Laurel Thoennes @ QD
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business? 1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Taking a Risk-Based Approach to Drug Inspections
Dirk Dusharme @ Quality Digest
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests. The goal of any honest pharmaceutical company is to make…
To Unlock Life Science’s Future, Use a Quality Key
Taran March @ Quality Digest
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well. At J&J, he…
Proactive Processes in High-Reliability Organizations
Graham Freeman
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
Are You a Disrupter?
Chip Bell
Visioning beyond the customer is the responsibility of every person interested in a competitive advantage. What do Bill Marriott, Ray Kroc, and Al Hopkins have in common? No, they are not all people of wealth and fame. In fact, Hopkins is a small-town accountant and part-time preacher. They all…
Visual Configure-Price-Quote Systems Reduce Cost of Poor-Quality Job Specs
Zac Cooper
The role of quality starts with product design and moves rapidly across the supply chain to the selling and buying experience, which includes the bidding process. When operating a formal continuous process improvement program, nearly all manufacturing engineers are tasked with some level of quality…
Inside Quality Digest Live for Jan. 25, 2019
Dirk Dusharme @ Quality Digest
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based…
Amelia Earhart Would Have a Hard Time Disappearing in 2019
Brian Strzempkowski, Shawn Pruchnicki
When Amelia Earhart took off in 1937 to fly around the world, people had been flying airplanes for only about 35 years. When she tried to fly across the Pacific, she—and the world—knew it was risky. She didn’t make it and was declared dead in January 1939. In the 80 years since then, many other…
Turn Free Services Into Paid Opportunities
Wolfgang Ulaga
Offering free services may seem like a good way to keep customers happy, but how much money is your business leaving on the table? By redefining freebies as paid opportunities, B2B firms can generate new sources of income and secure long-term growth. This not to say that companies should stop…
Make Some Tweaks in Your China Business Strategy
Stanley Chao
This past year has created havoc for Western companies purchasing raw materials, furniture, high-tech components, auto parts, and power tools from China. And the rocky relationship continues into 2019 as both countries continue to negotiate while kicking the can down the road toward a new March 1,…
Averting a Plane Crash
Stephen Fankhauser, Matt Ebbatson
The world is running out of experienced pilots. Supply is not keeping up with the growing demand for air travel. In Australia, the effects are already starting to bite. Even flagship carrier Qantas is having problems. In recent months it has had to perform a very nimble tap dance to crew its vast…
Opinion: Should the AIAG Be in the FMEA Software Business?
Richard Harpster
On Oct. 13, 2018, the Automotive Industry Action Group (AIAG) sponsored a webinar on the status of the AIAG Core Tools Software (AIAG CTS). John Cachat, AIAG project manager for the AIAG CTS project, was the presenter for the webinar. The presentation provided information on why the AIAG was…
Inside Quality Digest Live for December 21, 2018
Dirk Dusharme @ Quality Digest
We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context. “The Gift of Being Small” This article by Quality Digest’s Taran March wonderfully illustrates how we…
ISO 14001, ISO 50001 Benefit the Environment and the Bottom Line
William A. Levinson
The U.S. government’s Fourth National Climate Assessment warns that climate change “creates new risks and exacerbates existing vulnerabilities in communities across the United States, presenting growing challenges to human health and safety, quality of life, and the rate of economic growth.” The…

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