All Features
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),…
Natalie Weber
Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s every…
Steven Stein
Recently there have been a number of articles whose authors discuss conducting assessments remotely because of the pandemic. This article will discuss my experience with an actual assessment conducted remotely, how the plan changed in response to the pandemic, lessons learned, and some of my…
Suneel Kumar
Remote auditing (RA) has become a norm during the Covid-19 pandemic. Remote auditing is one of the audit methods prescribed in ISO 19011:2018—“Guidelines for Auditing Management Systems.” Although RA has surged due to pandemic constraints, this method of operation will surely gain ground as a…
Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory…
Tom Taormina
After more than 50 years as a quality control engineer and having worked with more than 700 companies, it is my observation that the vast majority of quality professionals hold their prime directive to be reducing defects to the lowest acceptable level by minimizing process variability. Most of us…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
William A. Levinson
Face masks and respirators may well offer the only way to return to an even remotely normal living and working style in the second half of 2020, which means they will play a vital role in any kind of economic recovery. This article’s purpose is to discuss what we know about respiratory protection,…
Del Williams
Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the nation’s…
Carson MacPherson-Krutsky
Since the days of painting on cave walls, people have been representing information through figures and images. Nowadays, data visualization experts know that presenting information visually helps people better understand complicated data. The problem is that data visualizations can also leave you…
Greg Hutchins
My recent epiphany was that the lens for all work and even for everyday living during the next few years will be risk-based. Why do I make this case?
In January 2020, my company was selected to participate in the largest pitch fest in the Northwest, TechfestNW, which was originally scheduled for…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
William A. Levinson
The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)1 which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19.
Under section 120302 the legislation says…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
Mary Rowzee
During the first six months after the publication of its first edition in June 2019, the AIAG & VDA FMEA Handbook gained popularity in the global automotive industry. Both U.S. and European OEMs have started to require the AIAG VDA approach to failure mode and effects analysis (FMEA) in their…
Dawn Bailey
In this article series, we explain some of the successful strategies and programs shared by Baldrige Award recipients to highlight categories of the Baldrige Criteria and how your organization might consider using them as inspiration.
Part of the purpose of the Malcolm Baldrige National Quality…
Stanley Chao
‘Can you help me source PPEs from China?” asks a caller on the phone. I have received dozens of these inquiries since March from local governments, medical clinics, and mom-and-pop shops after hospitals and first responders began reporting massive shortages of N95 masks, latex gloves, and surgical…
Quality Digest
It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth.
But masks are more than just stitched-together cloth. Medical-grade masks use multiple layers of nonwoven material, usually polypropylene,…
Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in the use of fake ISO 13485 certificates. ISO 13485 is a quality management system standard particular to…
Gleb Tsipursky
So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.
An example of this is what one of my coaching clients experienced more than a…
Tom Taormina
Each article in this series presents new tools for increasing return on investment, enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system. They will help implementers evolve quality management to overall business…
Julius DeSilva
ISO 9001 certifications have seen a decline during the past two years, per data from ISO. Some say the standard has gotten too complicated with the introduction of organizational context, risk-based thinking, and the removal of mandatory documented procedures. Even a few of QMII’s clients have…
Donald J. Wheeler, Al Pfadt
Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data…
Mark Rosenthal
Sometimes I see people chasing their tails when trying to troubleshoot a process. This usually (though not always) follows a complaint or rejection of some kind.
A few years ago I posted “Organize, Standardize, Stabilize, Optimize” and talked in general terms about the sequence of thinking that…
Eric Stoop
According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety.
Companies conducting layered process audits (LPAs) can help get the United States get…
