Quality Management 2.0 Blog

Risk Assessment - What Could Possibly Go Wrong?

Posted by Mary McAtee on Oct 22, 2014 @ 04:00 PM

Like pretty much everyone else with a pulse I have watched the sad spectacle of Ebola marching into my living room on every news outlet. Much like an anvil hitting a cartoon character repeatedly, I am gob smacked by the cascading series of lousy decisions made at every level.

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Topics: CAPA, APQP, Risk Management Software, FMEA, Risk Assessment & Analysis

FMEA as a Business Process Tool

Posted by Mary McAtee on Oct 03, 2014 @ 12:00 PM

More and more industries are discovering what the Automotive and Heavy Equipment companies have known for years. The same tools they use and trust to define, quantify and control risk around manufacturing design and associated processes can be used for defining, analyzing and controlling risk for any business process. Investing in the education, structure and discipline of a Design and process centric approach to developing and refining your company’s strategy to almost anything you need to do reliably and repeatedly can yield huge and immediate benefits.

If the entire concept of Design and Process FMEAs (Failure Mode Effects Analysis) is new to you here is the Cliff Notes explanation of the basics.

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Topics: IBS America, CAPA, Mary McAtee, APQP, FMEA

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

FMEA - An Underestimated Tool

Posted by Daniel Schmitt on Jan 27, 2014 @ 11:00 AM

Failure Mode and Effects Analysis (FMEA) is very often underutilized in many companies.  The key is to catch failures before they happen, thus reducing costs in the long run.  And in today’s world reducing costs while keeping quality up is an indicator for success in this global economy.  A lot of companies I visited recently have need for a tool that helps them manage their FMEA process.  But sometimes they just do it because they “have to” – their customer requires it, government regulations require it or it’s just to simply please someone else’s needs.  A more functional approach would be to use software solutions to help manage their overall process. Microsoft Excel is great and probably the most commonly used tool but it has its limitations.  Using a more sophisticated software solution gives you additional tools to grow the use of FMEA throughout your company. Leveraging parent-child relationships between FMEAs, the ability to report with a one click on Risk Priority Numbers (RPN), visualize defect nets and accessing libraries of data points gives you the edge in growing a foundation of thought leadership and lessons learned within your company.  Following an Automotive Industry Action Group (AIAG) approach utilizing both Design Failure Mode Effects Analysis (DFMEA) and Process Failure Mode Effects Analysis (PFMEA) referencing both is crucial for successful FMEA implementation.

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Topics: IBS America, Daniel Schmitt, APQP, FMEA, Risk Priority Numbers, Failure Mode and Effects Analysis, DFMEA, PFMEA, Design Failure Mode Effects Analysis, Process Failure Mode Effects Analysis

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