Risk Features

Chad Kymal's picture
Chad Kymal
The final draft international standard (FDIS) of ISO 9001:2015 will be released in July, and the revised standard is slated for publication in September. Per Annex SL of the “Consolidated ISO...
William A. Levinson's picture
William A. Levinson
Management of change is a safety-related phrase from the chemical process industry that is adaptable to risk-based thinking. The basic premise is that anything new, different, or nonroutine (such...
Benjamin Mack's picture
Benjamin Mack
Suppliers play a major role in bringing products to market. This means that the product received from suppliers must be safe and of the highest possible quality, which is a must because...
Jim Benson's picture
Jim Benson
Risk mitigation, risk assessment, risk management: We insure ourselves against risk, put buffers in our estimates to compensate for risk, and we make decisions based on risk. Or do we? We think...
Phil Wiseman's picture
Phil Wiseman
All the technical journals are abuzz with the changes to ISO 9001:2015. One significant paradigm shift is to a risk-based management approach. Most companies already apply risk-based thinking in...
Paula Oddy's picture
Paula Oddy
In the years since ISO 9001 and ISO 14001 were first published, many organizations have followed the models of these standards in designing their own management systems. However, many of those...
Glen Fraser's picture
Glen Fraser
No matter what industry you’re in, you’re probably hearing about risk management. It’s in compliance, governance, quality management—it’s everywhere. It’s also a broad-reaching topic. In quality...
Hermann Ries's picture
Hermann Ries
In the world of quality management systems (QMS), the nature of the relationship between risk management and preventive actions is often confused and misunderstood. Indeed, some believe that a...
Jim Benson's picture
Jim Benson
Sometimes work is terrifying. We’re asked to do something that we know, or at least strongly suspect, won’t work. Maybe we’re asked to do several things, some of which are are simple, but one or...
James Lamprecht's picture
James Lamprecht
Anyone who has done an online search using the terms “risk analysis,” “managing risk,” “risk management,” or any other variation will have discovered that the subject has been around for a long time...
Quality Digest's picture
Quality Digest
Some of the [ISO 9001: 2015] requirements are relatively clear; others are more “euphemisms,” and you don’t know how to react… —James Lamprecht, author of ISO 9000: Preparing for Certification (CRC...
Tim Lozier's picture
Tim Lozier
Editor’s note: Tim Lozier will be a guest on Quality Digest Live this Friday, Oct. 18, 2013, at 11 a.m. Pacific A webinar on this topic will held on Oct. 22, 2013, at 11 a.m. Pacific. Register here...
Greg Hutchins's picture
Greg Hutchins
In Against the Gods: The Remarkable Story of Risk (Wiley, 1998), Peter Bernstein says the mastery of risk is the foundation of modern life and is what divides modern from ancient times. By...
Morgan Palmer's picture
Morgan Palmer
Editor’s note: Quality Digest hosted Morgan Palmer’s webinar, “Defining and Building a Risk Management Strategy for Quality and Compliance Management Systems” on Tuesday, April 30, at 2 p.m. Eastern...
Ed Perkins's picture
Ed Perkins
Much has been written and discussed about “risk” being the future of “quality.” But what does this really mean, and how does it work? Definitions of quality Let’s us look at common working...
Jim Colton's picture
Jim Colton
Story update 12/13/2011: Additional information was added to the first paragraph pointing out the connection between FDA requirements and statistical tools. According to a September 2010 interview...
Laurel Thoennes @ Quality Digest's picture
Laurel Thoennes @ Quality Digest
“What makes a personal kanban any better than a to-do list?” asked Julie, crossing out a completed task on her “ta da!” list with exaggerated strokes. “With personal kanban you visualize your work,...
Greg Hutchins's picture
Greg Hutchins
“I think we now live in an era when many of the concerns in running organizations are being reframed in terms of risk, which suggests that risk professionals are likely to rise to the top.” (...
Stephen J. Marshall's picture
Stephen J. Marshall
Printed circuite board (PCB) manufacturing is moving rapidly up the technology ladder. Keeping internal processes current (and compliant) with new requirements, without disrupting existing customer...
Stewart Anderson's picture
Stewart Anderson
The 5 Whys is a well-known root cause analysis technique that originated at Toyota and has been adopted by many other organizations that have implemented lean manufacturing principles. Unlike more...