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How QA Consulting Saved a Software Project
Boris Shiklo
About 10 years ago, software testing was perceived as the only possible quality assurance (QA) measure for software, according to the World Quality Report 2018–2019. However, QA has since outstepped these boundaries. The QA process now implies that all stakeholders have a direct interest in…
The Drive to Digital for MMOG/LE v. 5: What to Expect
Terry Onica
Since the Automotive Industry Action Group (AIAG) and Odette International introduced the Materials Management Operations Guideline/Logistics Evaluation (MMOG/LE) more than 16 years ago, it has become the de facto standard for evaluating supply chain processes in the global automotive industry.…
Teach Kids to Think As They Read, and Revise What They Write
Tara García Mathewson
Once students learn how to sound out words, reading is easy. They can speak the words they see. But whether they understand them is a different question entirely. Reading comprehension is complicated. Teachers, though, can help students learn concrete skills to become better readers. One way is by…
An Industrialized, Global Food Supply Chain Threatens Human Health
Robyn Metcalf
In an outbreak that has now run for more than 28 months, at least 279 people across 41 states have fallen ill with multidrug-resistant Salmonella infections linked to raw turkey products. Federal investigators are still trying to determine the cause. In response to food company recalls, more than …
Eliminating the Digital Divide in Life Sciences, Part 1: Compliance Concerns
Matthew M. Lowe
It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing…
Seven LPA Mistakes to Fix Before Your Next Customer Audit Checklist
Richard Ruiz
When a customer asks to see your layered process audit (LPA) documentation, will you be ready? For many manufacturers, the answer is no. Instead of having proof of an effective audit process, many companies are left scrambling for data that show low audit compliance and few actual results.…
The Rising Need for Quality Control Within the Cannabis Industry
Rachel Mann
With medical cannabis being legal in Canada since 2002, and recreational use becoming legal in 2018, Prime Minister Justin Trudeau’s promise to his country has caused a storm. This legal framework has given Canadian companies the leverage to lead the cannabis industry to new heights. Not only…
The Dating Game: When Food Goes Bad
Alla Katsnelson, Knowable Magazine
In August 2011, a can of Great Value peas joined the nonperishables in my pantry, one of several panic purchases as Hurricane Irene barreled toward my home on the northeast U.S. coast. But the emergency passed, and the can, with its unassuming blue-on-white outline font, remains on my shelf seven…
The Perils of Outsourcing: A Case Study
Tom Taormina
Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case…
The Higher the Quality, the Lower the Cost
Shobhendu Prabhakar
Historically, conventional wisdom among business managers was that the higher the quality, the higher the cost. This perception still holds true today among a few business managers. Common sense also tells us the same thing, i.e., to create higher quality products or services, organizations will…
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…
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…
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
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…
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
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…
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,…
Signals, Not Predictions, About Innovation in 2019
Jeffrey Phillips
I recently wrote an article about innovation during 2018, and in it I made some disparaging remarks about Apple, which may or may not have caused it to lose a tremendous amount of market capitalization. Or perhaps the stock was overvalued, and Apple has become more interested in margin than in…
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
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…
Quality Control Concerns Grow as Students Flock to Credentials Instead of Degrees
Matt Krupnick
When graduate student Atis Degro got an email about a George Mason University course in resilience last year, he had to look up what that meant. He was also curious about the credential being offered for successfully completing the course: not a conventional degree or a certificate, but a “badge…
An Airplane With No Moving Parts and a Blue Ionic Glow
Steven Barrett
Since their invention more than 100 years ago, airplanes have been moved through the air by the spinning surfaces of propellers or turbines. But watching science fiction movies like the Star Wars, Star Trek, and the Back to the Future series, I imagined that the propulsion systems of the future…
Thinking About Manufacturing and Its Future
Mark Schmit, Ken Voytek
Manufacturers throughout the United States are facing a new set of challenges and exciting growth opportunities. Given the manufacturing industry’s important role in providing both direct and indirect jobs, how firms react to these changing conditions is critical not only to the companies…

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