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Improving FDA Reviews of Combination Products
Russ King
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with…
Forget Winning; Think Improving
Dawn Bailey
I recently had the great experience of speaking as part of a panel on the value of the Baldrige Excellence Framework, but what meant the most to me was the chance, I hope, to dispel some common misconceptions about what the Baldrige is actually all about. And, no, it’s not just an “excellence…
How to Create a Culture of Continuous Improvement
John Hunter
I have discussed steps to take to build a culture of continuous improvement in numerous posts on my Curious Cat Management Improvement blog. What it boils down to is building a system that supports that culture. Your culture is the result, not your aim. David Heinemeier Hansson put it well…
Lazy Lean Guy
Bruce Hamilton
In 1987, shortly after I became a manufacturing manager, the shop foreman at the time warned me about a young assembler. “Watch out for Michael,” the foreman said. “He tends to bend the rules. You may need to talk to him.” In fact, I did watch Michael, and it did appear that he approached his…
So Why Is It Called ‘Regression,’ Anyway?
Patrick Runkel
Did you ever wonder why statistical analyses and concepts often have such weird, cryptic names? One conspiracy theory points to the workings of a secret committee called the International Committee for Sadistic Statistical Nomenclature and Numerophobia (ICSSNN), which was formed solely to befuddle…
The CEO’s Role in Knowledge Management
Arun Hariharan
I do not presume to preach to business leaders (CEOs and other senior managers). However, having helped a number of organizations and their leaders with knowledge management (KM), I’ve observed certain leaders who are able to achieve greater and more sustainable results from KM than others,…
Is Customer Experience Really Everyone’s Job?
Annette Franz
Pundits and experts alike say that ensuring a good customer experience (CX) is everyone’s job. In fact, if you Google “customer experience is everyone’s job” or “customer service is everyone’s job,” you’ll find endless articles, blogs, and webinars with that very title. It’s true. Technically, it…
FDA Eases Up a Bit on Enforcement Gas Pedal
Michael Causey
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical device-related warning letters dipped to 121 during calendar year (CY) 2014, compared to 144 during the…
Ten Mistakes Great Leaders Avoid in Building Work Culture
Shawn Murphy
Culture eats strategy for breakfast. It doesn’t matter how great your plans to introduce a new product to the market are if your culture weakens execution. Culture is how things get done around a company. Great leaders focus on the work culture their leadership helps create as much as they focus…
Fitness Test for Old Pipes
Artec 3D
Thames Water is the United Kingdom’s largest water and wastewater services provider with more than 15 million customers. As part of its business, Thames Water delivers an average of 2,600 million liters of drinking water every day. The company’s cast-iron water mains in many areas of London and…
How Many Episodes Does It Take to Get Hooked on a TV Show?
Michelle Paret
I have two young children, and I work full-time, so my adult TV time is about as rare as finding a Kardashian-free tabloid. So I can’t commit to just any TV show. It better be a good one. I was therefore extremely excited when Netflix analyzed viewer data to find out at what point watchers get…
How to Prepare Your Team for Customer Service Training
Jeff Toister
You’re ready to send your team to customer service training. The big question is whether your team is ready. Chances are, they’re not. A 2010 McKinsey & Co. survey revealed that approximately 75 percent of training programs failed to measurably improve business performance. A lack of…
Six Secrets for Productive Meetings
Davis Balestracci
“When I die, let it be in a meeting. The transition from life to death will be barely perceptible.” —Anonymous Today I’m going to share some ideas from an always-thoughtful newsletter written by Steve Harden of LifeWings—a company of pilots who use aviation ideas to create cultures of safety in…
On the Cowboy Trail: The 10-Percent Way to Get Buy-In
Lois Kelly
I’ve been fantasizing about going on a road trip next summer to Alberta to experience the majestic Canadian Rockies. While browsing possible itineraries, I keep noticing this advice: “Leave the beaten path and take the alternative route of....” If you’re trying to get new ideas considered at…
IBM Leverages ISO 14001 for Sustainable Business
ISO
A meaningful, systematic approach to environmental management has made IBM one of the world’s most environmentally conscious companies. The globally integrated IT company leverages ISO 14001 for a comprehensive corporate policy on environmental affairs. In a recent interview for ISOfocus,…
How Truly Great Companies Maintain Excellence
Mary McAtee
Businesses come and go. Even Fortune 500 companies get in trouble. There is at least one organization, however, that is setting a high bar for others. Do you know which one? Let me pose these questions: • What U.S. company is celebrating their centennial anniversary this year? • What company is…
Lean Accounting in a Nutshell
Brian Maskell
Companies that are seriously pursuing the lean journey soon find their accounting, control, and measurement systems need to change to support the new strategy. The principles and methods of lean thinking and practice are quite different from traditional business and therefore require different…
The Improvement Kata PDCA Cycles Record
Mark Rosenthal
Improvement kata describes a routine for continuous improvement through four major steps. Those steps provide a structured pattern to enable consistent practice of each kata routine until it becomes habit—until it’s a natural way of thinking and acting. This change in behavior makes it easier…
Optical 3D Metrology Supports Certification of Airbus A350
Capture 3D
To reduce weight and fuel consumption, the aerospace industry increasingly relies on lightweight materials and new material combinations. That’s why the entire fuselage of the Airbus A350 XWB consists of carbon fiber composite (CFC) materials. In total, the long-haul aircraft reaches a CFC portion…
Updates and Outlooks for CMSC 2016
Rina Molari-Korgel
What a busy year for the Coordinate Metrology Society (CMS). To get you updated, I will need to throw a lot of numbers and dates your way. Here we go! The 2015 Coordinate Metrology Society Conference (CMSC) in Hollywood, Florida, was a great success. Forty-five exhibitors and a newly expanded…
Integrated Composite Parts Thickness Measurements in Aerospace Manufacturing and Assembly
In aerospace vehicle manufacturing and assembly, including that at Northrop Grumman Aerospace Systems, measurements of composite part thickness are required for ensuring that underlying processes are within tolerance, and for achieving outer-mold line-control surface requirements. This article…
Field Trip: PrecisionPath Consortium Meets at Quality Show
Belinda Jones
This past summer, the Coordinate Metrology Society (CMS) and the University of North Carolina at Charlotte were awarded an Advanced Manufacturing Technology Consortia (AMTech) grant from the National Institute of Standards and Technology (NIST), an agency of the U.S. Commerce Department.…
Work Systems and Supply Chains: Are You Ready in Case of Disaster?
Dawn Bailey
I heard the example that best helped me understand work systems and supply chains at a Baldrige training event right after the very sad 2011 earthquake and tsunami in Japan. A colleague was talking about automakers in the United States and elsewhere whose suppliers were located in the devastated…
Benchmarking Risk and Compliance: How Do You Add Up?
Timothy Lozier
Compliance is a broad term. It can mean compliance to financial obligations, quality and safety, or general compliance to any regulation that is driving the organization. When you look at the current state of quality management and safety management with respect to compliance, most of the…
Best Practices in Creating a Layered Process Audit Program
Mark Whitworth
Layered Process Audits (LPAs) offer companies tremendous potential benefits, but they’re also more involved than other audits. They task all of a plant’s personnel - including multiple levels of management—and cover all key areas at varying intervals. Creating an LPA system that is truly effective…

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