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How to Structure Your Medical Device Technical File
Jon Speer
The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must…
Applied Root Cause Analysis, Part 1
Bryan Christiansen
Root cause analysis (RCA) is the process of finding the basic underlying cause for an effect we observe or experience. In the context of failure analysis, RCA is used for finding the root cause of frequent machine malfunctions or a big machine breakdown. But what exactly is RCA, and how is it done…
Who Is Shaping the Future of Autos: Tech Firms or Automakers?
Knowledge at Wharton
Technology firms are the drivers of disruption across industries, but things will play out differently for automobiles, according to John Paul MacDuffie, Wharton management professor and director of the school’s Program on Vehicle and Mobility Innovation. Tomorrow’s vehicles will be built with…
PDSA As a Lean Agile Lens
Jim Benson
We want to grow as professionals. We want our products to be better, our know-how to be deeper, our impact to be known and recognized. This is impossible without continuous improvement. I have met many mediocre professionals who are mediocre only for one reason: They feel like they are done…
WD-40 CEO: What It Takes to Lead
John Baldoni
Leadership is not about the leader. On the other hand, leadership is all about the leader. Garry Ridge, CEO of the WD-40 Co., knows this lesson firsthand. In 2008, at the start of the Great Recession, when Ridge would travel from office to office and country to country, people would ask him how he…
How to Choose the Right Smart Handheld Gauge
George Schuetz
Inspection is often subject to the management team’s efforts at cost control or cost containment, as is the case with most other areas in modern manufacturing operations. Although it’s sound business judgement to maximize the value of every dollar, it also means that hard choices must be made when…
A Seven-Step Choreography for Thriving Teams
Vincent Dominé
Remember the last time you tried to change your habits in a big way? Perhaps you made a vow to eat healthier, or to listen more actively during meetings. Whatever it was, whether you ultimately succeeded or succumbed to the force of old habits, you almost certainly struggled. You may have done well…
100% Inspection Using Camera-Based Cap Control With Artificial Intelligence
Sabine Terrasi
Strong price pressure combined with high-quality requirements—the beverage and bottle industry faces the classic dilemma of many industries. This is also the case in the quality control department of SOLOCAP, a French manufacturer of plastic caps. SOLOCAP is a subsidiary of La Maison Mélan Moutet…
The Business SEO Battle: Ranking by Numbers or Intelligence?
Nate Burke
Search engine optimization (SEO) has come a long way, with continued developments, advancements, and algorithm tweaks giving business owners, brand agencies, and marketing gurus more than just a digital headache. But traditionally, SEO has been a numbers game, with ranking positions the all-…
Using Drones to Disrupt the Status Quo
Austin Choi-Fitzpatrick
The civil rights movement and Moore’s Law are colliding to transform politics. On the street, smartphone technology is being used to document social life as never before, putting power into the hands of the public and making eyewitnesses of us all. This same technology, bolted onto cheap and easy-…
When to Use Tightened Specifications
Donald J. Wheeler
In my article, “Tightened 100% Inspection” (Quality Digest, March 29, 2021), we found that the excess costs associated with tightened specification limits are generally prohibitive. Here we consider the question: “Under what conditions can we use tightened specifications without incurring undue…
How Does Analytical Testing Improve Food Quality?
Emily Newton
Food manufacturers must carry out numerous specific processes to check that the foods they produce and distribute are safe for consumers. Analytical testing plays a vital role in meeting that goal. Here’s a look at how such examinations raise food quality and purchaser trust. Checking foods for…
Can Managers Who Wear Many Hats Be Trusted?
Henrich Greve
In March 2001, publishing executive Ann Godoff—then in her third year as president, publisher, and editor-in-chief of Random House Trade Publishing Group (RHTPG)—was the subject of a gushing profile in New York Magazine. Laced with tributes from authors and peers (“She’s the real deal,” rhapsodized…
FDA’s Ongoing Use of Inspectional Tools During the Covid-19 Pandemic
Janet Woodcock, Judy McMeekin
During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19 pandemic required us to rework our business operations so that we could carry out our public health…
How One Person Can Change the Reliability Culture
Fred Schenkelberg
In 2019, Nicholas W. Eyrich, Robert E. Quinn, and David P. Fessell published an article in the Harvard Business Review titled, “How One Person Can Change the Conscience of an Organization.” In it, they discuss how corporate transformations, although assumed to occur from the top-down, are actually…
How Do You Get the CEO to Care About Customers?
Chip Bell
Iam often asked by customer service leaders how to get the CEO to care about customers. They are convinced there is a missed tactic that, if implemented, would have the C-suite camping out in the contact center and inviting customers to board meetings. When I outline a number of possible approaches…
PULSEROLLER Pallet-Handling Motor Rollers Move Pallets Up to 70-in. Wide, Reduce Energy Consumption
Dirk Dusharme @ Quality Digest
Motorized drive rollers (MDR) are an efficient and safe way to move large or heavy products down a conveyor line. They are also a key part of zero pressure accumulation, which allows conveyor systems to accumulate product without collision. In traditional conveyor systems, products can back up…
Flow As a Lean Agile Lens
Jim Benson
In lean there is mura, the waste of unevenness. It’s probably the most important, but also most overlooked, in the waste theater. For knowledge work, unevenness primarily interrupts flow. It’s when you have work that you should do easily but you don’t. There is this mura lying around that makes…
Reshoring Must Be Our Top Priority
William A. Levinson
The current national controversy over the need for a mandatory high minimum wage is but a symptom of a much larger underlying problem: the offshoring of American manufacturing capability. Offshoring ruined Spain and Portugal during the 16th century, and it is similarly a clear and present danger…
Small Manufacturers Seek New Ways to Find Quality Personnel
Thomas R. Cutler
The demand for quality assurance and quality control managers in the manufacturing sector has never been stronger, according to Patrick O’Rahilly, founder of FactoryFix. This online platform matches vetted manufacturing workers with companies seeking specific skill sets. They set a new quality…
Observing With Your Hands
Harish Jose
Today I’m looking at the ideas inspired by mirror neurons. Mirror neurons are a class of neurons that activate when someone engages in an activity, or when they observe the same activity being performed by someone else. The phenomenon was first identified by a group of Italian neurophysiologists…
The Staggering Costs of Health Insurance ‘Sludge’
Edmund Andrews
Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process. It’s no secret that healthcare in the United States is…
Counting Queries: Extracting Key Business Metrics From Datasets
David Darais, Joseph Near
How many people drink pumpkin spice lattes in October, and how would you calculate this without learning specifically who is drinking them, and who is not? Although they seem simple or trivial, counting queries are used extremely often. Counting queries such as histograms can express many useful…
Businesses Need to Get Serious About Reaching Their Online Customers
Nate Burke
Unfortunately, a website is no longer enough for a significant or successful digital presence. Essentially, a presence is nonexistent without some consideration of search engine optimization (SEO). But this, too, has become one of the basics of “going digital”—a must, rather than a “nice to have…
Exact Metrology Helps Pattern Maker Ensure Greater Accuracy
Quality Digest
Located in Butler, Wisconsin, Accurate Pattern has specialized in wood, metal, and plastic patterns, tools, fixtures, gauges, prototypes, and models since 1985. Technologies and services include CAD design, manual and CNC machining, wood and metalworking, painting and welding, plastic fabrication,…

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