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Russ King
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how the FDA uses IEC 62304, an international standard…
Alan Nicol
Connecting our information about customer desires with our designs is difficult. If it seems simple, we probably missed something. In the realm of product development, the most challenging and often the riskiest part of the design process is deciding precisely what features or functions our…
Frost and Sullivan
(Frost & Sullivan: Mountain View, CA) -- Frost & Sullivan honored recipients of its 2014 Growth, Innovation & Leadership Awards at a dinner gala held Wed., September 17, in San Jose, California, at The Fairmont San Jose. The awards gala was preceded by a 60-minute CEO leadership…
Brenda Percy
This is the fifth installment in our six-part series on how automating common business processes with enterprise quality management software (EQMS) can benefit your organization. In this installment, we’ll focus on the automated audit management process.
Manual systems often don’t provide the…
Mike Figliuolo
Along with an opposable thumb, we share one other trait with our hairy primate cousins: curiosity. We have an innate desire to understand “what happens if…” that begins in childhood. As we grow into adults, that natural curiosity dissipates, and we’re expected to have those answers (school, anyone…
Jim Frost
In a previous article, I showed why there is no R-squared for nonlinear regression. Anyone who uses nonlinear regression will also notice that there are no P values for the predictor variables. What’s going on?
Just like there are good reasons not to calculate R-squared for nonlinear regression,…
Lean Math With Mark Hamel
Full-time equivalent(s), commonly referred to as FTE(s), represents the number of equivalent employees working full time. One full-time equivalent is equal to one employee working full time. Typically, FTEs are measured to one or two decimal points.
FTEs are not people. Rather, FTEs are a ratio…
InfinityQS
(InfinityQS: Fairfax, VA) -- InfinityQS International, the global authority on real-time quality and manufacturing intelligence, offers six tips to help the automotive industry improve quality and reduce recalls across the supply chain, which will be discussed during the 2014 AIAG Quality Summit…
Arun Hariharan
Ihave worked with a number of CEOs during my many years of helping companies improve quality. Although all are different in their leadership styles, when it comes to their attitudes toward excellence, most top leaders fall into one of three categories.
The honeymoon CEO
The first is what I call…
Jack Dunigan
Rachel was a new employee at a retail outlet. She was given the requisite week in the training room and then sent out to the sales floor. Part of her job was to restock merchandise that had been returned. She had been on the job but a few days when an item was returned in a damaged box. She…
LNS Research
(LNS Research: Cambridge, MA) -- LNS Research, a technology research and advisory firm focusing on the industrial value chain, has released its Environment, Health & Safety (EHS) Research Library. Comprising research-based best practices, benchmark data, and thought leadership publications,…
Davis Balestracci
I chatted about u-charts for rates last time, and this column was going to be about p-charts for percentage data. These are the two major charts for dealing with count data and are helpful for stratifying a stable section of process performance.
But something recently happened that saddens me and…
Annette Franz
I recently read an article about a new dress code being imposed on Walmart employees (effective later this month). The purpose of the new dress code is to help customers more easily identify employees. I don't have a problem with that; given my recent experiences in a few different stores, more…
Edna Falkenberg
The regulatory landscape continues to change. One of the quality system approaches defined by regulators and the industry for mitigating risk is corrective and preventive action, better known as CAPA. Companies are often challenged by the CAPA process, which is one of the most important and…
BioCision
(BioCision: San Rafael, CA) -- BioCision LLC, a developer of advanced thermal technologies for biospecimen handling and standardization, has announced the availability of BioT Temperature Stability Systems, a new portfolio of mobile temperature management products that support transport and…
Bruce Hamilton
A recent viewing of a Marx Brothers film caused me to reflect on one of the questions I’m frequently asked: “How do you deal with people who are against lean?”
My stock response is to quote Shigeo Shingo’s advice that “99 percent of objection is cautionary,” that is, people who appear to…
Verisurf Software Inc.
(Verisurf: Anaheim, CA) -- Verisurf Software Inc. announces Verisurf X8 with many new enhancements that make stationery coordinate measuring machines (CMMs), portable CMMs, and 3D scanners more productive for automated inspection, guided assembly, and reverse engineering.
Built on a powerful CAD…
Mike Micklewright
Editor’s note: This article ties in with the new video training series, “Enhancing and Sustaining Lean Improvements While Adding Spark to the Quality Management System” by the author. Click here for more details, or check out the free preview of the series, specifically focused on the topic of…
Quality Digest
The adage that “You can’t teach an old dog new tricks” has been taken to task probably ever since it was first uttered. ThomasNet.com turned that whole idea on its ear with the newest round of upgrades to its website in 2014. In essence, instead of trying to teach old dogs (in this case seasoned…
ASM International
(ASM International: Materials Park, OH) — Hillsboro, Oregon-based FEI Co. has released the third generation of its Helios NanoLab DualBeam FIB/SEM microscope, which provides unmatched image contrast and resolution. The new Helios comes in two different workflow-specific configurations for…
Gary Phillips
Assuming there are still questions about the suitability of a gauge for a particular application after a gauge repeatability and reproducibility (GR&R) study, Measurement Systems Analysis, 4th Edition (MSA-4), published by AIAG in 2010, recommends using an additional study in the calibration…
Karen Martin
Any leader or skilled improvement professional knows that metrics are necessary to define what success looks like, to measure progress toward a defined target, and to assess performance against defined standards. Metrics also serve as a powerful way to demonstrate improvement success to people who…
Bob Emiliani
There are only two paths to lean leadership that people can take. One path, based on traditional human resource development models, nearly always results in failure. The second path nearly always results in success, but precious few leaders are willing to take this one.
The following image…
Jim Benson
Last month I was conducting a series of Boardwalks with a large company in Australia. The people in the company had an amazing array of kanban and other visual controls guiding their software development. Most important to me, they had achieved a culture not of continuous improvement, but of deep…
NIST
At the new NIST Center for Automotive Lightweighting (NCAL), workloads are fraught with stress and strain—all to help the auto industry take a heavy load off future cars and light trucks.
To meet proposed federal fuel-efficiency standards—54.5 miles per gallon by 2025, or nearly double today’s…
