All Features
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…
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…
Oscar Combs
With the emergence of the coronavirus (Covid-19), many organizations are doing their part to prevent the spread of infection by practicing social distancing. Some organizations have implemented no-visitor policies, which helps prevent the spread of the disease, but is not so good when it comes to…
Anjalika Singh
The toughest part of being in a relationship is finding a perfect gift for your loved one. Gifting is an essential part of any relationship. You gift your better half for every reason and every season. Gift as a form of bribery in love is a time-tried tool.
Being a system believer, I use the…
Inderjit Arora
ISO 9001 lead-auditor training should enable auditors to focus on the requirements when auditing and to stay away from the pitfall of guidelines.
Take the case of ISO 9001 or, for that matter, any management system standard. The standard has notes to explain the clauses. ISO 9001’s clause 4.1, for…
Sean Spence
The outbreak of the Covid-19 virus in China and the railway disruptions across Canada represent two different yet similar classic case studies. They remind us that nations and global economies are becoming increasingly interconnected. Incidents thousands of kilometers away are being felt locally.…
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…
Sheng Lin-Gibson, Vijay Srinivasan
Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore,…
Tom Taormina
In part one of this series, I said that I want to help my colleagues use their ISO 9001 implementation as a profit center and to turn risk-based thinking into risk avoidance. To do this I will share a set of tools that help evolve quality management into business management.
These tools include…
Gwendolyn Galsworth
Two of my articles (the first regarding standards, standardization, and standard work; and the second on visual standards) drew a lot of response. Readers were kind enough to share their thoughts and definitions. Some offered new terms to include in the mix: standardized work and visual standard…
Tom Taormina
In 1989, I was handed a copy of ISO 9001:1987 by my employer with the direction to find out what it was all about. Our company was headquartered in Europe, and we would be compelled to implement the standard straightaway.
My first reaction was that I wished it had been published 20 years earlier…
Calin Moldovean
As today’s industries and operations become increasingly more global, an effective management system is rapidly becoming an essential part of a sustainable business strategy. A management system defines how work is done, the desired results, and the controls imposed to ensure those outcomes.
Your…
William A. Levinson
The Automotive Industry Action Group’s (AIAG’s) and German Association of the Automotive Industry’s (VDA’s) new Failure Mode and Effects Analysis Handbook (AIAG, 2019) offers significant advances over FMEA as practiced 15 or 20 years ago.1 The publication is definitely worth buying because the new…
Michael Lueck
After the first crash, of Lion Air in Indonesia in October 2018, people blamed poor maintenance and insufficient pilot training. When a second airliner, an Ethiopian Air aircraft, crashed in March 2019, similarities quickly transpired. There was no apparent external influence such as poor weather.…
Miriam Boudreaux
If you are wondering whether your organization could benefit from formal root cause analysis (RCA) and corrective action training, read on to see if any of these issues are present in your day-to-day operations. RCA and corrective actions are some of the most useful tools for continual improvement…
Dirk Dusharme @ Quality Digest
What a year.
No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX, Hong Kong riots, North Korea, Brexit, impeachment. What a mixed bag of ups and downs that has…
