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Bruce Hamilton
On May 5, 1961, Alan Shepard became the first U.S. astronaut to journey to the “final frontier.” Atop a Mercury rocket, Shepard launched into a 15-minute suborbital journey reaching an altitude of about 100 miles before returning to Earth. His space capsule, Freedom 7, was a wonder of science,…
Katina Sawyer, Christian Thoroughgood
In times of organizational crisis, some companies are able to right the ship, while others sink under the pressure.
Recently, Uber has been under fire for a bad corporate culture, which promoted, among other things, sexism and other forms of toxic behavior. This led to a four-month investigation…
Pam Bethune
Every company is in business to take risks.
Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to identify opportunities and take them when beneficial, but the amount of risk must be understood. Whether it’s…
Mike Richman
The July 17, 2017, episode of QDL focused on some of the nitty-gritty of quality improvement, from the value of personal certifications to the opportunities of disruptive innovation, and to the fundamentals of risk management to the challenges of customer service. In case you missed it, here’s a…
Rick Barker
Operations and safety don’t always speak the same language, not because operations isn’t committed to keeping people safe at work or safety isn’t concerned with meeting operational goals, but rather because each area has its own methods, processes, and measures. This communication gap can increase…
Claire McCluskie
With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some uncertainty about the effect that one of the standard’s key changes might have on their business: computer…
Harish Jose
There is a great Greek paradox/puzzle called the Ship of Theseus. There are multiple versions and derivations to it. My favorite version is as follows (highly watered down).
Theseus bought a new ship. Each day he replaced one part of the ship. Plank by plank, sail by sail, and oar by oar. Finally…
Harish Jose
In today’s column, I will be looking at process validation and the problem of induction. Yesterday, I looked at process validation through another philosophical angle by using the lesson of the Ship of Theseus.
The U.S. Food and Drug Administration (FDA) defines process validation as “the…
Pat Toth
Recently a segment on my favorite morning news program stopped me in my tracks. The young and attractive hosts (why are they always so young and attractive?) were demonstrating new appliances, among them a smart refrigerator. The fridge was equipped with all kinds of high-tech features including…
Dirk Dusharme @ Quality Digest
In our July 7, 2017, episode of QDL we look at apprenticeships, the Antikythera mechanism, and risk-based thinking in operations.
“Demand-Driven Education to Close Skills Gap”
Speaking at the National Association of Manufacturers Summit in Washington, D.C., Secretary of Labor Alexander Acosta and…
Amie Whittington
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (dual status). The…
Tim Lozier
The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it.
The biggest question often asked is, “I’m aware my company needs to pay great attention to the detail of risk, but…
Gwendolyn Galsworth
The one complaint—the one problem—that nearly every company puts at (or very near) the top of its list of challenges is communication. George Bernard Shaw, the famous Irish playwright, sets us straight on this when he said: “The single biggest problem in communication is the illusion that it has…
Mike Richman
The June 30, 2017, episode of QDL offered a wrinkle in time, of sorts: not only orbiting debris and medieval medicine, but moments in the here and now such as our interview with Keith Bevan of the Coordinate Metrology Society and the UK’s National Physical Laboratory, and an on-the-go version of…
Erin Connelly
For a long time, medieval medicine has been dismissed as irrelevant. This time period is popularly referred to as the “Dark Ages,” which erroneously suggests that it was unenlightened by science or reason. However, some medievalists and scientists are now looking back to history for clues to…
Intertek
Sponsored Content
As widely useful and broadly applicable as it may be, the ISO 9001 standard covering general requirements for quality management systems (QMS) cannot address all stakeholder needs in every sector. Component functions and operations of discrete industries often require additional…
Kevin Meyer
Before you can improve something, you must first have a very clear understanding of what its current state is. Don’t assume you know what it is. Go to the gemba, be it the factory floor, the shipping and receiving area, your office, or even take a minute to focus on yourself, and observe what is…
Intertek
Sponsored Content
For organizations within the aerospace sector, certification to the AS9100 family of standards—including AS9110 for aerospace maintenance, repair, and overhaul (MRO) organizations; and AS9120 for aerospace warehouse and distribution operations—is a necessity for doing business.…
Intertek
Sponsored Content
Organizations that build, supply, design, or maintain products, parts, or services for the aerospace industry generally must be certified to the AS9100 family of standards (including AS9110, which is specifically for aerospace maintenance, repair, and overhaul [MRO] organizations…
Douglas C. Fair
Plant-floor quality issues tend to focus on a company’s technical resources. When products fall out of spec, alarms sound and all hands are immediately on deck to fix things. Despite large technology investments to monitor and adjust production processes, manufacturers are still bedeviled by…
Matthew Barsalou, Robert Perkin
As you drive east on I-70 coming from the Rockies, there is a point where you seem to have stopped descending, but a sign says, “Trucks: Don’t be fooled. Four more miles of steep grades and sharp curves.” The message is that it would be premature to relax at this point, and vigilant driving is…
Michael Ray Fincher
To meet the 2018 deadline for becoming certified to ISO 9001:2015, organizations are scrambling to overhaul their quality management systems. One major revision to ISO 9001 is the requirement to identify, evaluate, and address risks. Unfortunately, a tool most appropriate for these actions has…
Christopher Martin
Many of us are familiar with the concept of the Ohno Circle, innovated by Taiichi Ohno at Toyota during the 1940s. While familiarity with the technique and the goals it sets to accomplish is one thing, how many of us have actually participated? The surprising answer is… probably all of us, in a…
Roger Lehman, Julius Koh
Lucy felt hollow and dissatisfied. She was a star performer and had just helped her team clinch a large government deal that they had been working on for months. At the celebration that evening, Lucy was forced to put on a smile and a dynamic front. She had good relationships with her team members…
Robert A. Brown
Lean thinking has taken its rightful place in the effort to improve efficiency in manufacturing. However, it isn’t fulfilling its potential in many areas, most notably with knowledge workers. This is due to a fundamental flaw in how lean is presented and utilized. With a better constructed…