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Your Employees: A Principal Factor in the Supply-Chain Risk Equation
Sonal Sinha
In a recent poll, employees (22.9%) were identified as the top source of supply chain fraud risk, followed by vendors (17.4%) and other third parties (20.1%), including subcontractors and their vendors. In calling new attention to the old cliché of “an inside job,” the statistics may prove to be…
Failure Analysis
Fred Schenkelberg
Why do so many avoid confronting the reality of failure? In plant asset management, we are surrounded by people who steadfastly don’t want to know about nor talk about failures. Yet failure does happen; let’s not ignore this simple fact. The blame game Unlike a murder mystery, failure analysis (…
Discovering the ‘S’ in CSR
Quality Digest
Born in Bulawayo, Zimbabwe, and raised in Cape Town, South Africa, Wayne Visser, Ph.D. is, as CSRWire USA says, “. . . one of the most prolific, creative, and original thought leaders on corporate social responsibility.” That begs a question, however—should we use the term “social” or “sustainable…
Data-Driven Decision Making
Akhilesh Gulati
The big data revolution is requiring a seismic shift inside organizations, both in the way we build relationships and the way we make decisions. Each is now driven by data rather than intuition. In general, decision making is accomplished via a thought process of selecting a logical choice from…
Pushing the Frontier of Risk Assessment and CAPA
Mary McAtee
  Technology is evolving more rapidly than at any point in history. We tend to think of seminal moments in history, such as the inventions of the steam engine or powered flight, as literal moments in time. The reality is that the invention of the steamboat by Robert Fulton was only possible…
How Exposure Affects Risk
William A. Levinson
The requirement for risk-based thinking is among the most significant changes in ISO 9001:2015. Army Techniques Publication (ATP) 5-19, Risk Management is a public domain reference that supports this requirement. ATP 5-19 includes a risk assessment approach that is similar to failure mode and…
Reviewing the U.S. Office of Personnel Management Data Breach
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…
Developing a Product Liability Program
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…
How to Delegate Effectively and Minimize the Risk
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…
Six Missteps on the Way to Sustainable Risk Management
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…
Using an Integrated Management System to Implement ISO 9001:2015
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…
Change and Risk-Based Thinking
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…
Mitigating Supplier Risk Through Cloud-Based Quality Management Portals
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…
Five Risks in How We Think About Risk
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,…
Calibration As a Risk Management Strategy
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…
Risk Management in ISO 9001 and ISO 14001
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…
Hacking Risk Management
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…
Risk Assessment and the Quality Management System
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…
Fearful Features: Making Risk Explicit
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…
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,…

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