#52 – RISK OF NOT RUNNING RISKS – UMBERTO TUNESI

Umberto Tunesi pixSince 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

#52 – FDA DISCOURAGING THIRD PARTY MDSAP – GRANT RAMALEY

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

#52 – THE ‘RISK CULTURE’ MYTH – GREG CARROLL

GregCarrollRisk Culture is the greatest myth perpetrated on business since the Y2K bug.  Just like Y2K, an industry has now grown up around it assisting companies to improve their “risk culture”.  The problem with “risk culture” is that it has been hijacked from its original practical intent to now being an impossible (and unrequired) philosophical pursuit. Continue reading

#52 – THREE KEYS TO HIRING TOP TALENT – ELIZABETH LIONS

Elizabeth Lions PixEvery leader knows they are only as good as their team, and oddly enough we spend hours in the hiring process and even then there is a chance of hiring the wrong candidate.

Hiring the wrong person can be very expensive.  The U.S. Department of Labor currently estimates that the average cost of a bad hiring decision can equal 30% of the individual’s first-year potential earnings. That means a bad hire with an annual income of $50,000 can equal a potential $15,000 loss for the employer.

On the flip side, wise executives hire with these three keys in mind: Continue reading

#52 – HOW WELL DO RISK ASSESSMENTS INFORM DECISION MAKERS? – CHRIS PEACE

Chris Peace pixSometimes, it seems that every newspaper edition, news broadcast or news website carries yet another story about a disaster – an event that might have been avoided by better decision making.

But do we ask whether such decisions were informed by risk assessments?  And if so, how effective were those risk assessments for informing the decision makers about the risks?  Which techniques were used in the risk assessments? Were the results presented in a way that made sense to the decision makers?  Do risk assessors follow a good process and so achieve some consistency in results, or do they just get lucky? Continue reading