Rick Bollinger - Management Consultant

2017

He was supposed to have retired. He thought he could take it easy and just relax. Then he read an article in 2017 about an FDA Recall Epidemic[1].
The flaming question mark on the July 2016 MDDI magazine was a challenge. Article author’s conclusions were wrong and their recommendations made no common sense.
After doing some research, he found a combination of Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA) that would be a great solution.

5 Ways to Stop FDA Recalls

“Lean Risk Management”
Project Management Institute
2010 Global Congress
Washington D.C.

“PDSA into the Unknown: Moving ahead in the face of uncertainty”
13th International Deming Research Seminar
Fordham University, New York NY

 “Optimizing Risk Management”
NDIA 9th Annual Systems Engineering Conference
San Diego CA

“Process Improvement as a Project”
Western Michigan PMI Keynote Speaker
Grand Rapids MI

“The Future of Metrics and Human Dignity”
W. Edwards Deming Institute Fall Conference
Purdue University, West Lafayette IN

Taught Project Management Institute  PMP Preparatory Class and Risk Management section many times.

Managed medical device development using FMEA and FTA.

So, I wrote a method that integrates them along with Benefit-Risk Assessment such that they cover each others' weaknesses and iteratively and incrementally reduce medical device failure mode probabilities.
In his spare time, he supervised American Red Cross First Aid volunteers for twenty years at University of Michigan sporting events.  GO BLUE!

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