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Medical Device Approval Still Lags, but the FDA Is Trying
Michael Causey
After years of decline, medical device approvals by the FDA have finally begun to hit the gas pedal, according to an interesting report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG). In hindsight, it appears the FDA hit bottom in 2010 when approval times…
Employee Needs vs. Company Fulfillment
Bob Marshall
When, nearly 20 years ago, I started Familiar it was with a very clear and declared purpose: To allow people to come together and discover what “fulfillment” means for each of them as individuals. At the time, few working with us understood the importance of that purpose, and for those observing…
You Won’t Sustain Your 5S Efforts Unless...
Mike Micklewright
Editor’s note: This article discusses topics covered at greater length in episodes 19–23 of a new streaming video training series, Creating and Sustaining Lean Improvements—Integrating Principles, Culture, and Tools by the author and 360 Performance Circle, a sister company to Quality Digest.…
Four U.S. Organizations Honored With 2014 Malcolm Baldrige National Quality Award
NIST
Penny Pritzker, the U.S. commerce secretary, has announced that four U.S. organizations are recipients of the 2014 Malcolm Baldrige National Quality Award, the nation’s highest presidential honor for performance excellence through innovation, improvement, and visionary leadership. The 2014…
Midterm Election Results vs. Main Street Reality
Quality Digest
Judging by articles from The Wall Street Journal, CNN, and Forbes, it seems the lion's share of coverage of the 2014 midterm election results concerned how the results will affect Wall Street, the Fed, and Fortune 500 companies. There's nothing wrong with that, but there is another story. A…
Hardware vs. Software: The Knockout Round?
Ron Rode
Several years back, I was asked this question: Does measurement software have the ability to determine scale without the use of scale bars? On numerous occasions in a variety of ambient conditions, I have tested and compared the results of initially setting up a system using temperature/material…
FARO Releases Edge ScanArm HD
FARO
(FARO: Lake Mary, FL) -- FARO Technologies has released the new FARO Laser Line Probe HD. The power of the high-definition 3D scanner combined with the flexibility of the FARO Edge measuring arm creates the world’s most affordable, high-performance contact/noncontact portable measurement system on…
NRK Announces 2015 SA User Conference
New River Kinematics
(NRK: Williamsburg, VA) -- New River Kinematics (NRK), producer of SpatialAnalyzer (SA), announced it will host the 2015 SA User Conference at Kingsmill Resort & Conference Center on April 21–23, 2015 in Williamsburg, Virginia. The SA User Conference allows users and partners to take advantage…
TubeInspect P8—Prized Metrology!
AICON 3D Systems
(Aicon: Braunschweig, Germany) -- The new benchmark in tube and wire measurement wins gold. An expert jury at the CONTROL-TECH in Poland has awarded TubeInspect P8, Aicon’s optical 3D tube and wire measurement system, with the Gold Medal of the Kielce Trade Fairs. It represents a great success…
InnovMetric and Brazilian Business Partner Launch PolyWorks Brasil
InnovMetric Software
(InnovMetric: Quebec, QC, Canada) -- Following four years of successful cooperation, InnovMetric Software Inc. and its Brazilian business partner, Danilo Ribeiro of PWB Suporte Técnico Ltda., have launched PolyWorks Brasil to market the PolyWorks Universal 3D Metrology software platform to Brazil’…
Verisurf Software Automates Quality Inspection
Verisurf Software Inc.
(Verisurf: Anaheim, CA) -- Verisurf Software Inc. is pleased to announce Verisurf X8 with many new enhancements that make stationary coordinate measuring machines (CMMs), portable CMMs, and 3D scanners more productive for automated inspection, guided assembly, and reverse engineering. Built on a…
Virtek Vision and Baykal Machinery Sign Distribution Agreement for LaserQC
(Virtek: Waterloo, Canada) -- Virtek Vision International, a market leader in the field of laser-based manufacturing technologies, has announced a signed distribution agreement with Baykal Machinery for the Virtek LaserQC inspection system.  Baykal is a leading manufacturer and global supplier of…
Top Reasons to Outsource 3D Metrology
Hubert Meagher
Most manufacturing facilities have to manage the seemingly never-ending cycle of having to keep costs down while increasing production levels and maintaining high quality standards. Often, this ongoing struggle includes a reduction in staff and resources, and a lower-than-ever budget for…
Structure-From-Motion Systems for Scene Measurement
The reconstruction of scenes from multiple images or video streams has become an essential component in many modern applications. Many fields, including robotics, surveillance, and virtual reality, employ systems to reconstruct a 3D representation of an environment in order to accomplish specific…
Hexagon Metrology Launches New Range of All-In-One High-Speed Laser Trackers
Hexagon Manufacturing Intelligence
(Hexagon Metrology: North Kingstown, RI) -- Leading metrology solutions developer Hexagon Metrology has unveiled the Leica Absolute Tracker AT960, a walk-around coordinate measuring machine that fits in a single flight case. The latest model in the Leica Absolute Tracker range, the AT960 answers…
Does the Impact of Your Quality Initiative Reach C-Level Executives?
Eston Martz
Here’s a shocking finding from the most recent “ASQ Global State of Quality” report: The higher you rise in your organization’s leadership, the less often you receive reports about quality metrics. Only 2 percent of senior executives get daily quality reports, compared to 33 percent of frontline…
Supply Chains: Three Levels of Oversight
Calin Moldovean
T he modern supply chain is becoming more complex, and many different levels of skill and oversight are found among suppliers and purchasing companies. Some suppliers do an excellent job of implementing lessons learned and maintaining a high level of quality, production, and safety. Other…
What Engineers Could Learn From Doctors
Gorur N. Sridhar
You might think that the medical and engineering professions would operate quite differently from each other. Yet, as we will see, not only are they similar, but there is a lot that the engineering profession could and should borrow from the medical profession. So what is it that they have in…
SME Launches #MFGis Campaign to Boost Awareness of Manufacturing Careers
Society of Manufacturing Engineers
(SME: Dearborn, MI) -- SME, an organization dedicated to supporting manufacturing through training, events, media, and membership, has announced #MFGis, an awareness campaign to help students, educators, professionals, and companies tell their stories of “what manufacturing is” through…
Protecting Data From Hackers and Security Breaches
Publically announced breaches of secured information are so common today that they almost seem routine. Last year, in the United States alone, financial companies like JPMorgan Chase and retailers such as Target and Home Depot were victimized by information system hackers that allegedly gained…
Helling 3D Scan Spray Now Available in the United States
Laser Design Inc.
(LDI: Minneapolis) -- Laser Design Inc. (LDI), developer and provider of 3-D scanning systems and dimensional inspection services, now offers Europe’s leading anti-reflection coating for laser scanning, Helling 3D Scan Spray. Reflectivity is detrimental to 3D data acquisition, so it is often…
Why You Should Underpin CAPA With Risk Assessment
Rob Harrison
Managing risk in a quality management system (QMS) is considered a clear maturity indicator and a way to determine that an organization has shifted from a reactive and less controlled state toward an agile, proactive and anticipatory approach to quality management. In this post we are going to…
Finessing an FDA 483, Part 2
The QA Pharm
Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation. Here, I’ll share my views on getting the work done to fulfill…
New Applications for Sinumetric Integrate for Production
Siemens PLM Software
(Siemens PLM: Plano, TX) -- Siemens has added new applications to its Sinumerik Integrate for Production software suite for networking machine tools with production-level IT systems. The new release now includes Manage MyMaintenance (MMM), an effective maintenance-tasks management system, and…
Zombie Coffee
James Soto
Imagine: You find someone you’d like to connect with on LinkedIn. You email the person to ask if you can pick his or her brain. A coffee date is set. You’ve just become part of the phenomenon that’s taking over industrial sales: zombie coffee. This no-frills networking strategy, fueled by a lethal…

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