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Ah... Baseball
Davis Balestracci
Welcome to baseball season! I always do a baseball-themed article around this time, and I found my topic after stumbling on this article recently: How accurate are umpires when calling balls and strikes? From what I understand, since 2008, home plate umpires have been electronically monitored…
FDA Plays Catch-Up
Michael Causey
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool, which promises faster,…
Perspective, Pounce, Propel
Patricia Walsh
We all face adversity in our lives. The difference is in how you approach it. If you’re willing to look past the challenge and have the determination to overcome it, you can achieve more than you ever dreamed was possible. In 1986 I lost my vision due to a pediatric brain tumor. I lost my vision…
Improving Manufacturing Processes Through Lean Implementation
Chip Johns
Reducing waste, implementing efficiency-promoting practices, and continuously improving operations are the main goals of lean manufacturing ideology. These tasks may seem daunting for a manufacturer at the start of an improvement program, but there are many concrete steps that can be taken to…
The ‘Rites of Passage’ Into the Five Project Phases
Michelle LaBrosse
As a project manager, you’re most likely familiar with the five project phases outlined in the Project Management Body of Knowledge (PMI, 2013): initiating, planning, executing, monitoring and controlling, and closing. However, do you know the 47 project management “processes” that these five…
Unreasonableness
Bruce Hamilton
Sometimes we receive unreasonable and confusing directions, and sometimes we give them. As in the short video clip below, even if the systems behind this confusion are sound and the motivations reasonable, when you put them together they can create a frustrating no-win situation: Here are a few…
Our Five Estimate Pathologies
Jim Benson
Business runs on estimates. “How long do you think that might take?” we naively ask. Then when someone tells us how long they think something might take, we write that down and hold them to it. Merriam-Webster’s says the very word “estimate” means to roughly calculate or judge the value, number,…
Political Correctness Comes To Lean
Bob Emiliani
Regular readers of my column, as well as my Twitter and LinkedIn feeds, will know that in recent months I have posted many critiques on various aspects related to the products, promotion, and practice of lean management. Why now? The reason is that 20 years of engagement in lean offers the unique…
RIP, Quality Manual
Strahinja Stojanovic
A quality manual will not be a mandatory document for a quality management system (QMS), according to the available version of the ISO/DIS 9001:2015 standard. How did that happen? The quality manual was one of the first documents that a certification body asked for before the certification audit.…
Benefits of Certification
Calin Moldovean
Management systems programs such as ISO 9001 and ISO 14001 were originally implemented to help organizations gain market access, satisfy mandatory customer requirements, streamline processes, manage growth, drive continual improvement, and generally keep up with the competition. In today’s…
Wave a Magic Wand Over Your DOE Analyses
Michelle Shemo
As a member of Minitab’s technical support team, I get the opportunity to work with many people using design of experiments (DOE). People often will call after they’ve already chosen their design, run the experiment, and identified the important factors in their process. But now what? They have…
Three Reasons Hospitals Resist Investing in Quality
Alexandra Brown
Why is it easier for many hospitals to justify investing in capital equipment, new buildings, and service lines rather than in quality improvement? There are three major reasons. Many hospital systems don’t know their real costs It’s been said that the first step in fixing a problem is realizing…
Women in Manufacturing Leadership
Thomas R. Cutler
Magline is a leading manufacturer of route distribution solutions. Back in 1947, the company was founded to “make things out of magnesium” because such products offered unrivaled strength and lightness. Magline’s first product was a modular magnesium hand truck that caught on rapidly. That was a…
Automation Cuts a Wide Swath From Industrial Waste
Ryan E. Day
Have you heard the one about the robot that hops a train down to the brewery? It may not seem likely that robots, beer, and high-speed trains have much in common, but the industrial quest to coax more output from no more input (translate that to efficiency) can make for some unlikely bunkmates.…
Nine Questions You Can’t Answer if You Don’t Visualize Your Work
Jim Benson
There are many techniques to visualize your work. Obviously, our most popular is Personal Kanban. The way the human brain is constructed, we’re very sensitive to the content of visual information, and we quickly assimilate it. Just walking down the street, we’re exposed to different buildings with…
Who Will Survive the Great Mall Shakeout?
Knowledge at Wharton
The future of retailing is in upheaval, and the country’s malls top the list of potential collateral damage. Tenants are pulling out as chains scale back and retailers continue to struggle with how to adapt to the rise of e-commerce and other changes in shopping behavior, and to better target a…
A More Robust ‘P’ for Any PDSA Cycle
Davis Balestracci
Good data collection requires eight questions to be addressed. The first four involve designing the collection. Most of these issues were discussed in my last column. To summarize:1. Why collect the data? • Is there a clear objective for this collection? 2. What method(s) will be used for the…
Swat Your SWOT... Forever
Matthew E. May
The more strategy development work I do with organizations, the more I’m becoming aware of a prevalent pattern, one that I find counterproductive, even detrimental. It concerns the starting point for their strategy work: In nearly every case, they begin with convergent thinking, the polar opposite…
Three FDA Initiatives That Affect Life Sciences
Larry Spears
If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to…
Leading From Behind
Jack Dunigan
The concept of leading from behind appears in the news fairly often. The term has found expression via academia, in an idea put forth by Linda Hill of the Harvard Business School. She claims it originated from a reading of Nelson Mandela’s autobiography, in which he likened leaders to shepherds…
A Simplified Management Model
Matthew Barsalou
I see a weakness in management models. It’s not the models themselves that are the problem, but rather their application in smaller organizations. Those of us with either business experience or a business-related degree can be expected to have an understanding of at least a few management models,…
What’s the Meaning of All of This Employee Lingo?
Annette Franz
A couple weeks ago, I participated in a webinar with Kyle Antcliff of Intradiem. We talked about the employee experience, employee journey mapping, and solutions that drive or affect workforce efficiency. During the presentation, a lot of employee experience terms were used, and I attempted to…
Wishful Thinking and Risk Management in Real Time
Alan Nicol
There are a great many risk management tools available, in a variety of forms. Most of us are familiar with failure mode and effects analysis (FMEA) for design risk management, or some other form of risk matrix for project risk planning. But what do we use for real-time decision making? Our…
Tips to Ensure Your Software Vendor Delivers As Promised
Rob Harrison
  Organizations face multiple challenges when selecting a vendor and planning the implementation of enterprise quality management system (EQMS) software. The potential for failure (assuming that all the functional and nonfunctional, usability, deployment model, and support requirements are…
College Productivity
Bob Emiliani
In a recent article in the Dec. 28, 2014, issue of The Wall Street Journal, “Colleges Need a Business Productivity Audit,” authors Frank Mussano and Robert Iosue argue that colleges should be audited, as business are, “to identify unprofitable practices.” Audits are the answer to structural…

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