All Features
Yo Delmar
In June 2015, it was initially reported that the U.S. Office of Personnel Management (OPM) experienced a massive data breach, potentially affecting as many as 4 million current and former federal employees. Updated reports indicate that the actual number of people compromised is more than five…
Randall Goodden
E
very year in the United States, an estimated 80,000 product liability lawsuits are filed, and thousands of products recalled—and that’s happening to companies with certified quality programs in place.
In 2014 alone, some of the highest fines were imposed by government agencies because…
Jesse Lyn Stoner
Delegating is often one of the hardest things for a manager to do. You give away your authority to make decisions but are still responsible for the outcome if something goes wrong.
Often managers don’t delegate because they hold one or more of these beliefs. Do any sound familiar?
“If you want…
Marc Dominus, Douglas Montgomery
The key challenge for risk professionals is no longer how to establish an enterprise risk management (ERM) program, but how to sustain its effectiveness. Often, ERM programs get off to a great start but soon lose their momentum because of certain missteps that occur.
Misstep 1: Assuming that the…
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 Supplement,” some elements of the standard will be restructured to allow for easier integration of…
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 as repairs or replacement of equipment, and process startups) creates a safety risk.
This principle…
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 stakeholders not only rely on their suppliers to help bring products to market—they also rely on them to help…
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 risk is a thing. It’s rarely a thing. Risk is part of the system we’re creating. It’s the variation,…
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 their planning process for organizational management. This article will take a narrowly focused…
Paula Oddy, Jeffrey Eves
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 systems haven’t been utilized to effectively manage risk. Many have been minimally developed to meet…
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 and compliance management, we see risk as a function of operations. We’re being told to manage our…
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 thorough risk assessment process replaces the need for preventive action.
In fact, risk management and…
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 two make us uncomfortable. We might even place a hard estimate on a task (“It’ll take six hours!”), but…
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 and been covered by numerous authors. Still, the daunting challenge remains: How can one conduct…
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 Press, 1992) and former member of ISO/TC 176
During an Aug, 16, 2013, interview on Quality Digest’s…
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
During the past few years, risk management continues to be a topic of interest. There are plenty of benchmarking trends that point to risk. We see it in enterprise strategic initiatives…
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 consciously or unconsciously calculating probabilities, quality professionals make intelligent decisions…
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/11 a.m. Pacific.
When we look at the dynamics of commerce, from any industry, we see an increasing…
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 definitions of quality: zero defects, customer satisfaction, control of process variance, reliability,…
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 of Rick Friedman, director of the manufacturing and product quality division at the Food and Drug…
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, it becomes tangible, you get kinesthetic feedback, it’s flexible, contextual, and it promotes…
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.”
(Source: “Managing Risk in the New World,” Harvard Business Review, October 2009)
My basic message is…
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 demands, presents ongoing risks. To minimize potential failures, it is necessary to identify and…
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 sophisticated problem-solving techniques, the 5 Whys doesn’t involve data segmentation, hypothesis…
Greg Hutchins
This is the first of a new QualityInsider column that will discuss new practices, processes, tools, and lessons learned in what I think is the future of quality—risk management. I’ll feature quality and other professionals who use quality and risk in supply management, auditing, health care,…
