Include top management. They can delegate work but not the responsibility of a mission critical process. Note that risk management
is a not an event but an ongoing reevaluation. Management must fight the danger of complacency, distraction, and stagnation.
Risk analysis cannot simply become window dressing for the regulators. Risk reduction is costly, and management reflects the
importance of the task with support, finances, and resources.
At least one person in the risk team must understand probability well enough to teach it to the other members. Few people
have studied probability and even fewer have practical experience of using probability. Real life probability estimation is
much more difficult than textbook exercises. Yet, probability theory is the core of determining risk.
Risk assessment cannot be seen as a check-the-box activity; it is a serious issue and requires serious effort and commitment.
The success of the assessment is a direct result of the skill, education, and experience of the company's team members. Technical
experts are absolutely necessary even if external experts must be called in. All stakeholders must work to agreement.
Industry in general is less interested in the risk of an everyday occurrence, such as the risk of failing the moisture test
for the next production run. What is more important is estimating risks such as a recall or another Heparin type tragedy.
The difficulty in doing so is compounded by the lack of information and actionable data. In the absence of historical data,
we are left with a gut-feeling, which can often underestimate the risk. The best experts must be consulted.
"For every complex and difficult problem, there is a solution that is simple, intuitive, easy to understand—and completely
Estimating probability and severity on scales of low, medium, and high (or on a scale of 0–4) are so simplistic as to be almost
worthless; like using third grade English to study a college subject. Formal training in probability is needed to advance
beyond this simplistic approach.
Finally, focus on the patient, build for the future, collect relevant data, and store it for easy access and analysis. Expand
the knowledge base of the team and the company. Learn from others and learn advanced probability theory. Continue to refine
and improve. Only through our best efforts can industry say with confidence that it understands the risks facing patients.
Lynn D. Torbeck is a statistician at Torbeck and Assoc., 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314, Lynn@Torbeck.org
1. N. Popper, Chicago Tribune, June 13, 2011.