Content By Quality Digest

Grant Ramaley’s picture

By: Grant Ramaley

As the 2020 pandemic threatened world health, a large number of unscrupulous companies began generating fake International Organization for Standardization (ISO) quality management system (QMS) certificates in an attempt to fool governments into buying personal protective equipment (PPE), ventilators, thermometers, and Covid-19 test kits. The credibility of ISO 13485 certificates used to certify medical devices suddenly became a crisis.

Aside from the obvious fake certificates, other companies were paying to get certificates with little or no oversight as to how they were earned. If the goal of getting certified is to gain worldwide recognition, it’s important to understand what makes an ISO certificate valid, especially when paying thousands of dollars for an ISO QMS certificate that may not be considered valid by ISO. Companies may think they are getting a credible certificate but find themselves exposed later when trying to sell their products to those who require certificates issued from accredited certification bodies.

L.S. Starrett Co.’s picture

By: L.S. Starrett Co.

(L.S. Starrett Co.: Athol, MA) -- The L.S. Starrett Co., a leading global manufacturer of precision measuring tools and gages, metrology systems and more, has announced the introduction of DataSure 4.0, an advanced wireless data collection system for acquiring precision measurement data. With unprecedented range and data security, multiple gateways, compact size, and high speed, Starrett, a forerunner in the development of data collection solutions for quality control manufacturing applications, claims the system has taken data acquisition to a new level. “Using the very latest technology, our new DataSure 4.0 system enables manufacturers to leverage digital manufacturing for Industry 4.0 by reliably utilizing measurement data to the fullest extent,” says Emerson Leme, vice president, Industrial Products, North America at Starrett.

Gleb Tsipursky’s picture

By: Gleb Tsipursky

Should quality professionals be worried about the new Covid strains originating in the United Kingdom, South Africa, and elsewhere, and recently identified in the United States?

Authorities have focused on downplaying concerns about vaccine effectiveness against these new variants. While some legitimate concerns exist that our vaccines might be 10–20 percent less effective against the new strains, this small difference shouldn’t make you too worried.

However, another aspect of these new variants should make you very worried indeed: They’re much more contagious. Unfortunately, the implications of their contagiousness has received little news coverage.

ASQ’s picture

By: ASQ

The leading global association for quality professionals, ASQ, announces that Ann Jordan has been confirmed as the society’s CEO, effective immediately. Jordan has served as interim CEO since January 2020. She joined ASQ in 2017 as general counsel and has worked extensively with the board of directors to develop and drive strategic growth and business transformation initiatives.

“Ann’s leadership has been critical over the past year as ASQ navigated the Covid-19 pandemic and its impact on our membership,” says 2021 ASQ chair, Janet Raddatz. “Her substantial knowledge in business operations and dedication to delivering greater member value allowed the society to overcome remarkable obstacles and look ahead to the advancement of the mission of quality.”


Ann Jordan has been confirmed as the ASQ’s new CEO

Michigan Metrology’s picture

By: Michigan Metrology

(Michigan Metrology: Livonia, MI) -- Michigan Metrology, experts in solving problems related to surface texture, wear, finish, and friction, announce an online, two-day class in surface texture, friction, and wear. The class, which will be held online March 10–11, 2021, is part of a suite of online training options that the company has made available to further understanding of surface roughness concepts.

“The March class is designed for engineers, technicians, and researchers working in automotive, aerospace, materials, medical devices, polymers, and other fields,” says Donald Cohen, Ph.D., who will present the course. “The online format makes it possible for our viewers to continue to grow their understanding of how texture affects component function—even while we can’t easily travel to attend trainings in person.”

COUNTERPART: Integrating engineer-to-order with ERP

Legacy ERP systems don't often play well for engineer-to-order manufacturers. Andrew Schutte, general manager, at Smooth Logics, tells us how integrating SolidWorks with ERP addresses the problem.

COUNTERPART-ERP solution

Loretta Marie Perera’s picture

By: Loretta Marie Perera

Recently, the team at 4C Creative Cad CAM Consultants in Emmen, Netherlands, was given a unique task: How to get a vintage Harley Davidson motorcycle back on the road again.

What was fun about this project wasn’t how challenging it was, or how much expertise it required. The joy was in the end itself, to provide a straightforward solution to a question that had been on the mind of one man for decades: How to get his vintage motorcycle capable of starting and riding on the streets. The solution was to scan a broken part that could no longer be found and 3D print a replacement.

The problem was brought to Carl van de Rijzen of Visual First in the Netherlands, who has been working with Edwin Rappard of 4C Creative CAD CAM Consultants for more than two years. Living on opposite ends of the country, the two have never met in person. “I send something to Edwin, he scans it and sends it back,” says van de Rijzen. The same thing occurred in this case.

James J. Kline’s picture

By: James J. Kline

Ever since the International Organization for Standardization (ISO) included risk-based thinking in ISO 9001:2015, an idea has arisen among some in the quality profession that quality managers can move into the risk management arena without any competition from other professions. This article looks at two recent reports that demonstrate how competition will occur. Further, the competition will come from professions that have more organizational clout than quality managers.

The reports are Gartner Audit Leadership Council’s “2021 Audit Plan Hot Spots Report1 and the International Federation of Accountants’ (IFAC) “Enabling the Accountant’s Role in Effective Enterprise Risk Management.2 The Gartner report indicates the key concerns that auditors should be focusing on in upcoming audits. The IFAC report discusses the how accountants can promote and become more involved with an organization’s enterprise risk management (ERM) process.

NVision Inc.’s picture

By: NVision Inc.

NVision’s engineering services are helping managers of coal-fired power plants converting to natural gas to determine more quickly where to install updated instrumentation necessary to retrofit turbines to accommodate the new power source.

“By measuring the equipment via laser scanning, then creating precise 3D models of the turbine assemblies for engineers to analyze for optimal installation points, we can significantly expedite the plants’ transitions,” says Steve Kersen, president of NVision. “This can result in huge cost savings for projects that would otherwise have been budgeted for a lengthier period using less sophisticated measurement methods. In one recent project, a Southeast power plant converting to a combined-cycle gas turbine (CCGT*) system will increase wattage output by more than 30 percent and save more than $250,000 by using our services.”

Douglas Allen’s picture

By: Douglas Allen

Any number derived from real observation is made up of three components. The first of these is the intended signal, the “perfect” value from the object being observed. The second is error (or noise) caused by environmental disturbance and/or interference. The third is bias, a regular and consistent deviation from the perfect value.

O = S + N + B, or observation equals signal plus noise plus bias

The signal usually is predictably constant, as is the bias. Identifying and eliminating bias requires a set of techniques beyond the scope of this article, so for the remainder of this, we will consider both as components of the signal, leaving a somewhat simpler equation for our observation.

O = S + N, or observation equals signal plus noise

This article focuses on removing the random noise component from the observation and leaving the signal component. The noise is in the form of chance variation, which sometimes enhances the signal and sometimes detracts from it. If we could separate the noise from the signal and eliminate it, our observation would be pure signal, or a precise and consistent value.