In an era of budget, time, and labor constraints, is it possible to sell your ideas and concepts (which often require money, time, and labor to implement) to the CEO, CFO, Board of Directors, or whoever is in charge of the final decision? The answer is yes! You can sell your ideas up; it simply depends on how you frame the opportunity. Continue reading
The Dept of Defence (Australia) assesses capability in 7 categories: Purpose, Environment, Organisation, People, Process, Data, and Material. Below I have used this methodology to lay out the guiding principles for achieving a successful Enterprise Risk Management (ERM) system. Continue reading
General Motors (GM) in the United States recalled more than 2.6 million autos due to defective ignition switches. And unfortunately the defective switch was linked to accidents that may have killed at least 13 people according to the Wall Street Journal (‘GM Board Forms Operational Risk Committee, June 12, 2014). Continue reading
Since its birth, it seems that the human kind has to run risks for its own survival. ISO 9001:2015 revision recognizes this as opportunity or upside risk.
Jared Diamond in some of his books describes how running risks is instrumental to humanity’s survival, and history tells us the same, too.
As I had the occasion to write before, risk is some kind of enemy with which we have to live with. We have to fight against it but we cannot eliminate it. Continue reading
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this. Continue reading