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Some Thoughts on FMEAs and Unknown Risks
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…
What’s Risk Got to Do With It?
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…
Building a Practical Risk Management Process into Your QMS
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…
Must-Know Risk Facts for Quality Professionals
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…
Does Your QMS Speak Risk?
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…
Linking Quality Management and Risk Management
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,…
Statistical Tools for Pharmaceutical Manufacturing
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…
To-Do or Kanban? That Is the Question
Laurel Thoennes @ QD
“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…
21st Century Leadership—Enterprise Risk Management
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…
AS9100:2009: Managing Risk in Manufacturing
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…
Root Cause Analysis: Addressing Some Limitations of the 5 Whys
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…
Cyber Security
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,…

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