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Modernizing the Pharmaceutical Manufacturing Base
Lawrence Yu
If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant, it might be surprising to learn that he would already be familiar with most of the processes and production techniques being used. That’s because not much has changed in…
Four Steps to An Audit-Proof Measurement System
Eric Gasper
An upcoming audit can be one of the more stressful times of the year for a quality team. Whether you are pursuing a new certification or retaining your current one, audit preparation can be a daunting challenge to even the most diligent organization. Although standards such as ISO/IEC 17025, ISO/…
How Layoffs Hurt Companies
Knowledge at Wharton
Time was, layoffs were seen as an emergency strategy, the last resort in a downturn or crisis. Today, however, layoffs are a standard tool for doing business. As the economy continues to heal and job indicators improve, a number of firms have announced a fresh wave of layoffs—Nordstrom, Sprint,…
An Alternative Test for Randomness of Error Terms in a Regression Model
Donald S. Holmes, A. Erhan Mergen
Regression analysis is used in a variety of manufacturing applications. An example of such an application would be to learn the effect of process variables on output quality variables. This allows the process control people to monitor those key variables and keep the output variables at the…
The Quiet After the Storm
Ryan E. Day
Ihave never been accused of being an early adopter of cutting-edge technology. On the other hand, I don’t dance the Luddite jig, either. True to my own type, I hung on to my old M-1A tank, aka a Motorola flip phone, for as long as I could, but was pleased as punch when circumstances led me to…
The Rise and Fall of Theranos
Norman A. Paradis
The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the news that federal regulators may ban Theranos founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal…
A Break to Reflect and Unlearn
Kevin Meyer
During  the past few years I’ve been working hard on cultivating positive habits. New habits can be powerful. But habits can also create barriers that limit our perspective, which can hinder kaizen, creativity, and even our knowledge of ourselves. We’ve all found ourselves in the proverbial “rut”…
A Make-Believe World of Random Failure Rates
Fred Schenkelberg
What if all failures occurred truly randomly? Well, for one thing the math would be easier. The exponential distribution would be the only time to failure distribution—we wouldn’t need Weibull or other complex multi-parameter models. Knowing the failure rate for an hour would be all we would need…
Use Virtual Conferencing to Eliminate Waste
William A. Levinson
All process activities can be broken down into one of five categories: waiting, handling and setup, inspection, transportation, and transformation. Of these, only transformation of the product adds value. A figure in Frederick Winslow Taylor’s 1911 book, Shop Management makes it clear that, while…
Bigger Picture, Better Data
Frank Lafleur
Sponsored Content Among the many test and measurement tools available to the shop-floor professional, the videoscope (also known as a video borescope) is one of the most practical, with great portability and ease of use. Videoscopes allow users to inspect for flaws, faults, or deformations in…
Are CEOs Asking Themselves ‘What If?’
Tab Wilkins
Recently I came across the PriceWaterhouseCoopers U.S. CEO Survey and watched several videos about leadership challenges for manufacturers. The speakers talked about new and old trends they’re focused on as company leaders, as well as several trends that could apply to small and medium-sized…
Indefinite Postponement
Bruce Hamilton
Today’s article is inspired by the politically-charged gobbledygook we call presidential primaries. This battle of principles turned battle of wills reminds me that the role of the change agent can be as much theater as science. In a public forum, at least, the positions of the opponents are…
The Business Case for a Great Employee Experience
Annette Franz
I have written many times about the importance of the employee experience, both on its own in terms of retention and performance, and with regard to the effect of the employee experience on the customer experience. Sadly, many companies still aren’t focusing on the employee experience. IDC’s 2015…
Better Home$ and Baseboards
Greg Fox
People say that I overthink everything. I’ve given this assertion considerable thought, and I don’t believe that it’s true. After all, how can any one person possibly overthink every possible thing in just one lifetime? For example, suppose I live 85 years. That’s 2,680,560,000 seconds (85 years…
What We Mean When We Talk About EvGen, Part 1
Rachel E. Sherman, Robert M. Califf
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
The Masters: A Stable or Unstable Tradition?
Beth Savage
The 2016 Masters Tournament is in the history books. Jordan Spieth had what some are calling an epic meltdown on the final nine holes of the tournament, and in a come-from-behind victory, Danny Willett earned the green jacket. The tournament is touted as a tradition unlike any other. Edge-of-your…
How Biases Can Ruin Our Decisions
Naveen Khajanchi
Adam Grant, a professor of psychology at Wharton, admitted how wrong he was to pass up on the opportunity to invest in an online startup selling glasses. Because the company didn’t have a functioning website the day before its launch, and because other competitors were already operating in the…
A DOE in a Manufacturing Environment, Part 2
Bruno Scibilia
In yesterday’s column, I discussed how a DOE was chosen to optimize a chemical-mechanical polishing process in the microelectronics industry. This important process improved the plant’s final manufacturing yields. We selected an experimental design that let us study the effects of six process…
Cutting Down on Airtime
Ryan E. Day
Sponsored Content W hen you work on projects like NASA’s Space Launch System and deep-space radio telescopes, the opportunity for accolades and large revenues can be great. However, due to the massive scale and demanding tolerances of such projects, the opportunity to have your lunch eaten by…
A DOE in a Manufacturing Environment, Part 1
Bruno Scibilia
Ionce worked in the manufacturing industry. Some processes were so complex that even a very experienced and competent engineer would not necessarily know how to identify the best settings for the manufacturing equipment. You could make a guess using a general idea of what should be done regarding…
Transparency Is a Leader’s Best Friend
A leader’s ability to communicate is fundamental to building trust and forming a cohesive team. Transparency has become a necessary element of team support. It may be scary to share everything, but the benefits are undeniable. As I was walking back from the gym one morning, I passed by the local…
Engine Design Takes a Major Leap Forward
Argonne National Laboratory
The search for a truly revolutionary engine design that can make dramatic gains in efficiency requires deep scientific understanding and tools. Lots and lots of tools. In the past, tools were needed to make prototypes, requiring repeated testing and retrofitting along with a healthy dose of…
What Are Degrees of Freedom in Statistics?
Patrick Runkel
About a year ago, a reader asked if I could try to explain degrees of freedom in statistics. Since then, I’ve been circling around that request very cautiously, like it’s some kind of wild beast that I’m not sure I can safely wrestle to the ground. Degrees of freedom aren’t easy to explain. They…
The Power of C.P.R.
Amy Williams
My first exposure to manufacturing was nearly 21 years ago. My on-the-job training was brief and mainly consisted of general safety, machine operating, and maintenance instructions with little focus on problematics or quality requirements. After all, I wasn’t forming sheet metal for an airplane; I…
Risk Management Outside Your Four Walls
Tim Lozier
When we look at business dynamics, regardless of industry, we see an increasing rate of change in products, processes, and regulations. One process affects the next, and with a growing focus on regulations and standards, complexity becomes an ever-expanding theme, whether related to quality…

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