Standards Features

Tom Taormina's picture
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...
Calin Moldovean's picture
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...
William A. Levinson's picture
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...
Michael Lueck's picture
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...
Miriam Boudreaux's picture
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...
Dirk Dusharme @ Quality Digest's picture
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...
Anonymous's picture
Quality Digest
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk...
The QA Pharm's picture
The QA Pharm
Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit! This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it...
Heather Thompson's picture
Heather Thompson
Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a...
ISO's picture
ISO
As artificial intelligence (AI) becomes increasingly ubiquitous in various industry sectors, establishing a common terminology for AI and examining its various applications is more important than...
Chad Kymal's picture
Chad Kymal
With the advent of the internet, cloud, and electronic workflows, what is the future of documented management systems? Do we continue with a structure of quality manual, processes, work instructions...
Dileep Thatte's picture
Dileep Thatte
According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne...
William A. Levinson's picture
William A. Levinson
How will the United States’ withdrawal from the Paris Agreement affect greenhouse gas emissions? Quality Digest editor in chief Dirk Dusharme and Mike Richman, principal at Richman Business Media...
Kartik Hosanagar's picture
Kartik Hosanagar
Much has been written about the challenges associated with AI-based decisions. Some documented failures include gender and race biases in recruiting and credit approval software; chatbots that turned...
Frances Brunelle's picture
Frances Brunelle
Just as baby boomers on the manufacturing plant floor are getting ready to retire, so are the owners. More than 5,000 small manufacturing operations (with annual revenues between $2 and $20 million)...
Anjalika Singh's picture
Anjalika Singh
Management system implementation reminds me of the advice my gym instructor gave when I first enrolled at my local health club: “Losing weight doesn’t happen in one day and with crash diets,” he said...
Inderjit Arora's picture
Inderjit Arora
Every company uses a system to understand the requirements and inputs of its customers, and then plans to deliver outputs meeting those requirements as a conforming product or service. The...
Paul Foster's picture
Paul Foster
When Deloitte wanted to get people excited about employee training, the company decided to adopt a gamification strategy for its online training portal. Using elements like achievement badges,...
Jon Speer's picture
Jon Speer
Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International...
Eric Weisbrod's picture
Eric Weisbrod
In manufacturing, standardization in production and process control leads to increased profitability and cuts down on many siloed problems that can plague even the most quality-focused organization....