As a tool for the appropriate prioritization of resources, quality risk management (QRM) holds great promise for patients,
government, and industry. Just as great, however, is the potential for QRM to degenerate into a non-value added exercise of
identifying noncritical, improbable, low-risk scenarios indefinitely. The key to which way it goes is understanding a typical
distribution of uncontrolled systems, that is, the Pareto Plot.
Jason J. Orloff
As a statistician, I have never been comfortable with subjective risk analysis. The process is fundamentally imperfect because
it cannot anticipate the unknown. Furthermore, it lacks the rigor of actuarial risk analysis, which is beyond all but the
most critical factors related to safety and efficacy. After conducting tremendous research and development to turn data into
process knowledge, it seemed a disappointing end to boil all the information down to a human judgment call. Translating that
effort into a subjective scale of 1 to 10 for severity, probability, and detectability left me wanting more than a notional
approximation. However, after three days of discussion with the authors of the International Conference on Harmonization's
quality guidelines, Q8, Q9, and Q10, at an ICH workshop in Washington, DC, last fall*, I've gained a new understanding of risk assessment's value.
Risk assessment enables subject-matter experts to say to the best of their ability, "This is important, and that is not."
Risk assessment is not a perfect tool by which analysts can anticipate all dangers—known and unknown—but it is valuable precisely
because we cannot anticipate all danger. Risk assessment provides a framework within which to capture the knowledge upon which
we have made risk-control decisions. Within this framework, learning can be fed back for capture and future review. The QRM
process then enables management to establish priorities and move a project forward from the laboratory to manufacture with
an understanding of, diligent control of, and conscious acceptance of risk.
Because risk assessment and control fundamentally rely on hypothesis, judgment, and expert opinion, it is open to endless
attack and argument. The resolution of which must be the test of reason. The goal is to draw a line between the "vital few
and trivial many" scenarios. This pattern was first recognized by Dr. Joseph M. Juran in 1951 when he coined the Pareto Concept
of Quality, giving us a powerful conceptual and visual tool.