RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 60

There are two stories I use in my classes about assessing risk and the impact of
outside influences. I call them “The tale of two risk assessments” and “Everyone
is a speed demon.”
A Tale of Two Risk Assessments
Consider the following:
• You are on a material review board/disposition team. It is the end of the
quarter, and a batch of your highest volume product has been quarantined for
potential quality issues. The team has also been notified that their business
has met all of its financial goals for the quarter.
Question: Does this financial information influence the team's disposition (which
is a risk assessment process)?
Now consider:
• The following quarter the material review board/disposition team must
decide the disposition of a batch of the exact same product for the same
quality issue. Again it is the end of the quarter, but this time the team
knows but the business unit is not meeting its financial goals.
Question: Does this change in the external context in which the risk of the batch
is reviewed change our internal risk calculus? Why?
There is only one change, one piece of information that is different between
the two scenarios of this real-life example. Whether we like to admit it or not,
our decision-making process on the risk of releasing the product or not will be
different in each of these occasions. Even if we make the same deposition decision
on the lots (accept both, reject both), the context in which those decisions are
made will be different.
Everyone is a Speed Demon
The legal speed limit on most major highways in the United States is 65
mph. When you drive on these highways, it seems that most folks are driving
above the speed limit to a different degree. In the graduate classes I teach or in
industry talks I give, as a part of our risk-management-related discussion, I ask
the students/audience: “ at what speed above the posted 65 MPH speed limit do
you think you will get a ticket? ”; the vast majority answer “ above 75 MPH .”
Question: What is the “true” speed limit?
There are internal and extra influences that are always present when we assess
risk. We apply our internal risk “sensor” based on the external context we see
applied. These are always influencing our risk decisions. They cannot be com-
pletely eliminated. We can create training programs and procedures that assist in
minimizing their influences in our risk management systems if we have better
understanding of how our risk-making decisions are influenced.