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...
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...
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...
Sheng Lin-Gibson
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...
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...
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...
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
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
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
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
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
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...
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
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
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
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
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
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
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
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...
