Quality Management 2.0 Blog

Cyber Threat Risk Assessment for Products and Consumers

Posted by Mary McAtee on Mar 17, 2015 @ 03:00 PM

Understanding your Role and Responsibility for Risk Assessment and Controls

In almost everything in Quality there are multiple facets of responsibility. The same applies when we talk about cyber security and threat assessment. The last time I spoke about this topic I addressed our responsibility for protecting our own organization’s intellectual property and security. This time I am concerned with how we protect those who depend on the products and services we provide. Market demands for increasingly intelligent products coupled with rapidly evolving software and wireless technology provides the means for companies to deliver exactly what the market demands. What is equally clear is that the ability of companies to assess the risk for the user and their privacy is not coming close to keeping pace with these advances. Just because the capability for smart devices is more readily available is no guarantee that prudent product management decisions are being made. The media is filled with stories about misuse of everything from baby monitors to auto-assist parking in late model vehicles.

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Topics: Risk Management, Risk Assessment & Analysis, quality and compliance, Risk assessment, Mitigation and Controls

Leveraging Risk Assessment to Avoid Crisis

Posted by Mary McAtee on Jan 16, 2015 @ 11:33 AM

People who know me are very aware of how much I love boats and getting out on the water. My father was a Merchant Seaman and my spouse and close friends tend to all have seawater in their veins.  This love of the water includes a deep respect for the power and unpredictable nature of the ocean. Most misadventures at sea seem to be a case study in the precise definition of a “Cluster F&$@”.  Every major and even minor disaster at sea seems to always involve several of the fates conspiring together to allow the progress of a bad situation to become worse. Let’s take just one recent example from the news. Rob Konrad, a former player for the Miami Dolphins, was several miles offshore on his 36 foot fishing boat. He fell overboard and ended up swimming over 9 miles through shark infested waters to reach shore in Palm Beach. Several contributing factors put him in that water swimming for his life. Almost any other person would have become another sad obituary but his physical conditioning overcame some really bad decisions on his part:

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Topics: Risk Management, Risk Assessment Software

Risk Management - Depend on your QMS Tools

Posted by Mary McAtee on Jul 02, 2014 @ 03:15 PM

Risk Management as a Career Tool

In the last blog I vented my most annoying compliance issue. This week I thought I would switch gears to my most amusing and embarrassing Quality moments.

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Topics: Quality Management Software, QMS, Mary McAtee, Corrective Actions and Preventive Actions, Risk Management Software, Risk Management, FMEA, Risk Assessment Software, Risk Assessment & Analysis

Applying Risk Management to Supplier Qualification

Posted by Mary McAtee on May 21, 2014 @ 12:00 PM

A couple of blog posts ago I wrote about a warning I had once received to carefully distinguish between fads and fashion versus legitimate innovations and quality tools that stand the test of time. Risk Assessment is certainly not new but it seems to currently be the popular kid in the class. The idea of risk analysis as part of Design and Process FMEAs have been the standard within the Auto Industry for many years. Likewise, Risk Assessment is and has been an important element of Environmental Risk Management.  

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Topics: Supply Chain Management, IBS America, CompliantPro, Mary McAtee, APQP, Risk Management Software, EH&S, Supply Management Software, Risk Management, FMEA

Quality Control Risks in Ignoring or Misreading Data...?

Posted by Mary McAtee on Dec 11, 2013 @ 11:00 AM

“Lies, Damned Lies and Statistics”

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Topics: IBS America, CAPA, Mary McAtee, Quality Assurance and Quality Control, Corrective Actions and Preventive Actions, Quality, Risk Management Software, Risk Management

The Human Side of Product Recalls and CAPA

Posted by Mike Richman on May 08, 2013 @ 11:11 AM

As publisher of Quality Digest, I often take a somewhat dispassionate view of process and performance errors. After all, our typical reader is a quality professional whose job, in part, is to figure out why something went wrong and prevent it from occurring again.

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Topics: Automotive Quality Management, Quality Management Systems, Process Control, IBS America, CAPA Software, CAPA, Guest Blog on Quality Management, Corrective Actions and Preventive Actions, Food and Beverage Control, Quality, Risk Management, FMEA, Product Quality Control, Automotive, Cost of Quality, Continuous Improvement, NC/CAPA, Mike Richman, Quality Digest

Taking EQMS Beyond NC/CAPA

Posted by Matthew Littlefield on Apr 01, 2013 @ 10:21 AM

The Business Case for taking EQMS beyond NC/CAPA

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Topics: Quality Management Software, Enterprise Quality Management, CAPA, IBS Quality Whitepapers, Supply Management Software, Risk Management, ISO Quality Management System, EQMS, NC/CAPA, Enterprise Manufacturing Software, LNS Research, Matthew Littlefield

Task Tracking in EQMS

Posted by James Hartford on Nov 20, 2012 @ 10:02 AM

In today’s fast paced business environment, it is has become harder and harder for those concerned with quality management and service delivery related activities to keep track of all of their responsibilities as well as their required tasks without something falling through the cracks.   The days of the yellow sticky note no longer suffice as a tool for us to organize the myriad of activities we are not only responsible to complete but also monitor and oversee.  Our never ending attempts to remain focused appear to be futile in that we are growing ever busier and become easily derailed by sidebar activities and impromptu scheduled events.  One advantage of having IBS software to manage quality processes is its ability to organize and streamline activities to address just these problems.

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Topics: IBS Company News, Automotive Quality Management, CompliantPro, Quality Assurance and Quality Control, Customer Management Software, Corrective Actions and Preventive Actions, Compliance Software, Risk Management, Cost of Quality, Quality Data Management, Customer Q&A, Track & Trace, Crisis Management

Resilience and Risk Management - An Automotive Story

Posted by IBS America on Aug 27, 2012 @ 10:07 AM

Andrew Zolli, coauthor of the book "Resilience: Why Things Bounce Back," in a recent Harvard Business Review interview relates a story from the auto industry that illustrates the importance of resilience to an organization. He also discusses the strategies for improving the resilience of an organization. 

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Topics: Automotive Quality Management, Process Control, Manufacturing Software, Supply Chain Management, Enterprise Quality Management, Process Management Software, Enterprise Risk Management, Risk Management Software, Risk Management, Manufacturing Productivity, Enterprise Manufacturing Software, Crisis Management, Resilience, Andrew Zolli

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