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FDA Proposes Cybersecurity Guidelines for Medical Devices
Ken Miller
I wrote last month about the need to increase security for imaging devices in hospitals. The devices I cited store both personal and medical information about patients and should be subject to standard security measures. Very often they are not. Last month the U.S. Food and Drug Administration (…
Driving Effectiveness and Efficiency
Niranjan Deodhar
In the first article of this series, we explored what a process improvement (PI) function would look like if it could apply the principles of reducing waste and variation to its own processes. Here, we build on that analysis to identify the work practices that can drive better, faster, and cheaper…
Transition Successfully to ISO 9001:2015
TÜV SÜD America
The revised ISO 9001:2015 standard was published on Sept. 23, 2015. The release of this standard has many organizations preparing for the transition from ISO 9001:2008, and with transition comes uncertainty: How long will it take? What will it cost my organization? Where do I start? These and…
Modernizing Pharmaceutical Manufacturing to Improve Drug Quality
The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages. When manufacturing problems…
Resources to Expand Your Metrology Acumen
Belinda Jones
The industrial metrology sector is an ever-changing landscape for 3D measurement professionals. In the thick of it you will find the Coordinate Metrology Society (CMS), the National Institute of Standards and Technology (NIST), and the UK's National Physical Laboratory (NPL)—each offering…
Not Afraid of Heavy Parts
InnovMetric Software
Headquartered in Graz, Austria, the Andritz Group (composed of Andritz Hydro, Andritz Pulp & Paper, Andritz Metals, Andritz Separation, and Andritz Automation) is a leading global supplier of plants, equipment, and services provided to hydropower stations, the pulp and paper industry, the…
Welcome to the World of Metrology
Rina Molari-Korgel
It is my pleasure to welcome you to this issue of CMSC World. Our 3D metrology community is small compared to the bigger circles of civil engineering, manufacturing engineering, or even quality engineering. An even scarcer sight is a female 3D industrial metrologist, such as me. It has been and…
A Novel Coordinate Measurement System Based on Frequency Scanning Interferometry
Mike Campbell, Ben Hughes, Dan Veal
I n this article, we present a wide angle, frequency scanning interferometer (FSI) system capable of measuring the absolute distance to multiple targets simultaneously. A spatial light modulator has been integrated into the FSI sensor head, projecting multiple beams towards targets. Absolute…
Creating a Culture of Innovation in Your Healthcare Organization
James Brewton
The healthcare industry is under pressure to improve performance across strategic measures of performance, including delivery cost, operating revenue, employee engagement, patient safety, patient experience, and patient outcomes. A growing number of organizations turn to innovation as a way to…
How Software Can Close the Loop on Manufacturing Quality Control
Mark Whitworth
A recent article in The Wall Street Journal detailing how Boeing is facing up to 24 million dollars in FAA penalties over quality control going back several years across a number of locations shows how even the biggest manufacturers need to close the loop on quality control (QC). Closing the QC…
Make Reliability a Part of Every Decision
Fred Schenkelberg
Concurrent engineering is a common approach that pairs developing the product design and its supporting manufacturing processes through the development process. There are several reasons why this is a good idea. Design engineers may require the creation of new manufacturing processes to achieve…
Getting Real With Rapid-Cycle PDSA
Davis Balestracci
Marketers are relentless in their efforts to seduce you with fancy tools, acronyms, Japanese terminology—and promises—about their versions of formal improvement structures such as Six Sigma, lean, lean Six Sigma, or the Toyota Production System, each with its own unique toolbox. In my last column…
Ludicrous Speed
Bruce Hamilton
Mel Brooks fans will remember Spaceballs, his jocular jibe at the Star Wars franchise. In pursuit of a rebel ship, evil Lord Dark Helmet (played by Rick Moranis) orders his crew to accelerate their craft beyond the speed of light to “ludicrous speed.” Although time travel remains within the…
Thinking Outside the Cuvette
NIST
Let’s say you’re a biotechnologist working to develop new medicines or a better test for forensic analysis. You might find yourself frequently using absorbance spectroscopy, a technique that allows researchers to identify even small amounts of a substance (such as DNA) or an antibody based on how…
Untangling the Gordian Knot of ISO 9001
Dan Nelson
Have you ever noticed someone struggling with a problem because he didn’t know the “trick” to solving it? Have you ever wrestled with a problem, only to discover that it actually wasn’t a problem; you were simply approaching it improperly? In these cases, the way forward is usually apparent after…
Going Nuts Over NIST’s Standard Reference Peanut Butter
Mark Esser
Maintaining a social media account involves keeping track of the many random celebrations that can provide an excuse to post a story that otherwise might not have a timely hook. National Peanut Butter Day (Jan. 24 for the uninitiated) is just such a day. While NIST chemist Carolyn Burdette spent…
Are Quality Bonuses Right for Your Medical Directors?
Greg Anderson
A s the market gradually moves toward value-based reimbursement, hospital payments to physicians have also been in transition from purely productivity-based pay to incentives based in part on quality, patient experience, and efficiency of care. This shift has taken place in employment,…
‘Quick Test’ Station May Speed Photonic Thermometers to Market
Nikolai Klimov
Physicists at NIST’s Physical Measurement Laboratory (PML) have been working on a new class of chip-based photonic thermometers that measure temperature with light. Now the team has reached another key milestone with the creation of a system that tests and packages their photonic thermometers…
Reputation Risk Management for Boards
Chris Howells
Reputation is fast becoming one of the most important risks to manage. Build quantifiable arguments to get boards on board. Corporate reputation, the close cousin of a firm’s brand, is one of the most intangible assets a company has. If a brand is the inside-out perception of a firm, reputation…
Innovation: Out of the File Cabinet, Onto the Agenda
Jeffrey Phillips
Not long ago a new client asked our team to lead an innovation project to create a product. As always with a new client, we did a quick survey. It’s important to understand what the client knows and has attempted in the name of innovation. In this case the client had adopted another consulting…
Outlook Is Positive for Quality Management
Dan Jacob
It’s  shaping up to be an interesting year. The U.S. presidential campaign looks to be outrageous and entertaining, stocks started the year with a nasty hangover, and ranchers turned militant in Oregon. Although the outlook for quality management isn’t quite as exciting, there are a number of…
Beware of Lean Hypocrisy
Bob Emiliani
Every day, thousands of people confuse lean management with “Taylorism,” properly known as scientific management. The negative association brings out the lean bigwigs and others who work hard to create a great separation between lean and Frederick Winslow Taylor. This is an ill-informed and…
Davos and the Fourth Industrial Revolution
Kevin McKinley
Walking the snowy streets of the small Swiss town of Davos, it was impressive to know that 40 heads of state and 2,500 leaders from business and society were there to talk about some of the most important global challenges facing us today. In the main congress hall, I saw and met leading…
Why Strategy Withstands the Test of Time
John Bell
How often have you heard people say, “Our strategy is to become the biggest and the best?” This isn’t strategy. Strategy is not the what. Strategy is the how: How will you become the biggest and the best? Of course, within that definition, there are good strategies and bad ones. Good strategies…
The Oracle at IBM
Taran March @ Quality Digest
For those awake enough to respond, please supply the Jeopardy question to this answer: “A computer system that won a million dollars in 2011 with access to 200 million pages of content, including the full text of Wikipedia.” If you thought, “What is Watson?” you’d be correct as far as the…

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