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Mike Richman
In the quality profession today, the term “guru” tends to be thrown around with reckless abandon, more often than not self-referentially by the “guru” him- or herself. Don’t get me wrong; there are many outstanding people now working in our field, with interesting and perhaps even revolutionary…
Kevin Meyer
“Excellent firms don’t believe in excellence—only in constant improvement and constant change.”—Tom Peters
The plan-do-study-act (PDSA) cycle is the core component of continuous improvement programs. You may have heard it called the plan-do-check-act (PDCA) cycle—and they are very similar—but I…
AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the…
The new revision of AS9100D is now out, and clause 10.2—“Nonconformity and corrective action” will require us to “evaluate the need for action based on human factors to ensure nonconformities do not recur.” In addition, clause 7.1.4 of both ISO 9001:2015 and AS9100D require us to consider human…
Knowledge at Wharton
There were no Olympic medals up for grabs when Sim Yi Hui and Jane Lee, the co-founders of the Singapore Women’s Everest Team, set out to recruit team members to climb the world’s tallest mountain in 2004. “When we first formed the team my goal was just to climb the mountain,” Sim Yi Hui told me…
Suzanne Schwartz
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of…
William A. Levinson
Sept. 22, 2018, is the deadline for registration to ISO 9001:2015, and this seems to allow organizations plenty of time to make the transition to the new standard. The good news is that, despite the radical changes to the standard’s structure, the underlying requirements are not particularly…
NIST
The U.S. Commerce Secretary, Penny Pritzker, has named four organizations as the 2016 recipients of the Malcolm Baldrige National Quality Award, the nation’s highest presidential honor for sustainable excellence through visionary leadership, organizational alignment, systemic improvement and…
Andy Henderson
This is the third part in a series about my perspective of what the future has in store for various aspects of manufacturing. I approached each aspect by imagining what is possible using what we know to be technically possible today. In part one I covered cutting tools for machining and in part…
Mike Richman
Hard as it may be to believe, a close analysis of our extensive trove of behavioral data on the Quality Digest user group indicates that more than a handful of you don’t regularly watch our regular weekly web TV show, Quality Digest Live, which broadcasts from our studio in Northern California…
ASQ
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When flood waters ravaged portions of Colorado in September 2013—killing crops, inundating homes, and buckling many miles of roadways—countless federal, state, and municipal government workers sprang into action helping citizens. State and federal government agencies spent…
Davis Balestracci
Have you ever heard something like: “I’m committed to Dr. Deming’s approach [or Six Sigma or lean or TPS, it doesn’t matter], but executives don’t seem to listen anymore. All they do is keep interrupting my very clear explanations with, ‘Show me some results, then show me what to do.’ I was…
Gwendolyn Galsworth
In a visual workplace, information is converted into simple, universally understood visual devices and installed in the process of work itself, as close to the point of use as possible. The result transforms a formerly mute work environment into one that speaks, eloquently and precisely, about how…
Cole Cooper
A production part approval process (PPAP) is used by companies to establish confidence and rules in a production process. In a sense, it gives customers a view into their suppliers’ manufacturing capabilities.
A PPAP is required when there is a new part, engineering changes, tooling changes,…
Andy Henderson
In my last article about the future of cutting tools, I discussed a vision and road map that I created by imagining what a manufacturing ideal might look like using what we know to be technically possible today. Here, I’m going to describe a vision for a futuristic production management system…
The United State Occupational Safety and Health Administration (OSHA) estimates that $60 billion is lost annually from workplace injuries and illness. Using the administration’s $afety Pays Program calculator, 20 carpal tunnel syndrome injuries will cost a company $1,260,000 in direct and indirect…
Joel Bradbury
Healthcare professionals have a long history of caring for their patients and improving the quality of their services. During the Crimean War (1853–1856), British nurse Florence Nightingale realized that the mortality rate of soldiers was far too high. A visionary statistician as well as a…
NIST
Until recently, if a company wanted the best measurements in the world for the physical dimensions of one of its dimensional standards, it had to book time on the NIST Physical Measurement Laboratory’s (PML) Moore M48 coordinate measuring machine (CMM). Operating at NIST since 2000, this CMM—…
Bruce Hamilton
One of Shigeo Shingo’s popular status quo targets was engineers, whom he placed in three categories: table engineers, those who just sit around a table and talk about problems; catalog engineers, those who think the solution to every problem can be found in a catalog; and nyet engineers, those who…
Christian Wolcott
T he following is for mature quality audiences only. Is it unwise to take people who are new to lean on a tour of a Toyota facility running at top efficiency? Is the sight of a glossy, mature lean factory a kind of pornography for young engineers, new leaders, and even seasoned managers seeking to…
Sudeep Pasricha
American mining production increased earlier this decade as industry sought to reduce its reliance on other countries for key minerals, such as coal for energy and rare-earth metals for use in consumer electronics. But mining is dangerous—working underground carries risks of explosions, fires,…
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be…
Ryan E. Day
Handheld X-ray fluorescence (XRF) analyzers are proven analytical tools commonly used for the fast, easy, accurate, and nondestructive identification and analysis of metals and alloys. Common applications include metal alloy identification for quality control, scrap sorting and positive material…
Paula Oddy
Changes to the global economy during the last two decades have dramatically altered the landscape of business and industry. Globalization has enabled an ever-lengthening supply chain, which confers greater complexity and risk to every step of the process, whether for material goods or for services…
Rodney Petersen
Acronyms. The world, and especially the government, is overflowing with them. You’d be hard-pressed to pick a favorite. People might even look at you funny if you suggested that you had one. I’m lucky enough to have my favorite one on my business card: NICE—the National Initiative for…