By James Vesper, James Vesper, Ph.D., MPH, ValSource, LLC
Few of us have ever lived in a situation when there has been so much uncertainty and lack of knowledge as we are facing now. Uncertainty and lack of knowledge contribute to risk. The ISO 9000:2015 standard defines risk as “the effect of uncertainty,” adding as a note, “Uncertainty is the state, even partial, of a deficiency of information related to understanding, or knowledge of, an event, its consequence, or likelihood.” [emphasis added]1
In the pharma/biopharma world, we have been using ICH Q9 — Quality Risk Management in varying degrees since its publication in 2005. While Q9’s definition of risk, i.e., “the combination of the probability of occurrence of harm and the severity of that harm” is different from that of ISO 9000:2015, it is reasonable to think that when we have uncertainty — when we do not know something — it is difficult to make good decisions. Decision making is one of the specific purposes of Q9, specifically, to “improve science-based decision making with respect to risk.”2
This article looks at why using a structured approach for making risk-based decisions is so important, particularly when we find ourselves in stressful conditions with competing, conflicting needs on many fronts. We will examine how our brains and bodies respond to stressful situations, the effects stress can have on our ability to make decisions, ways to improve decision making in stressful times, and how formal and informal risk assessment approaches, when properly used, can overcome some of the commonly seen barriers to good decision making.
This is the first of three articles from ValSource authors on some of the challenges of making decisions in difficult times. In the other two articles, we look at how other groups, such as the military, make decisions and specific decisions firms are needing to make in these uncharted coronavirus times.
How Our Brains Respond To Stress
Before considering decision making, we need to understand a bit about the brain, several of its component parts, and how they respond to stress. Anatomists and neuroscientists have identified many different structures and regions, but there are two parts that are most important to this discussion: the lower brain and the upper brain.
The lower brain is composed of what has been called “the reptilian brain” — the brain stem and cerebellum — and the “mammal brain” or the limbic brain — the hippocampus, the amygdala, and the hypothalamus. The lower brain is where certain memories are stored and where quick reactions such fight or flight, emotions, and intuitions (“gut responses”) originate.
The portion of the upper brain that is of interest here is the “neocortex” — it is the more recent part of brain to have developed and is found in primates and humans. Here is where, for humans, language, abstract thought, and imagination are centered. The neocortex is also where reasoning occurs — an important function, because sometimes intuition that is based on memories created and stored in the lower brain can be clouded and simply wrong due to biases, cognitive illusions, and improper heuristics (i.e., rules of thumb).3
When your brain senses danger, the body initiates its stress response by releasing the hormones of adrenaline and cortisol to get ready for “fight or flight.” The lower part of the brain is controlling things, which means that the neocortex — the more rational part of the brain that processes sensory information and decides if the stimulus is a threat or is pleasure related — is only peripherally involved. If the stress response is short-lived, things will go back to normal rather quickly. If not, there can be longer-term problems like high blood pressure, insomnia, digestive system problems, irritability, difficulty focusing, poor rational judgments, and impaired decision making. When exposed to a high level of stress, people sometimes describe their decision-making ability as being “paralyzed.” One way to reduce this paralysis is to practice a situation over and over so the response is like a reflex — it occurs almost automatically. “Drill and practice” exercises and simulator activities are examples of this.
Characteristics Of Stress-Inducing Emergencies And Abnormal Situations
When you look at an emergency or an unusual situation such as the pandemic caused by the novel coronavirus, there are three characteristics that stand out.4 The first is that the situation is dynamic — things change quickly. This may be due to new information that arises or the fact that there is a high level of uncertainty due to the lack of information. This means that actions that would be appropriate at one point as the event unfolds may not be appropriate at a later point. Second, the situation is time dependent: Decisions often need to be made when a “window” is open or there is an opportunity to have an impact; when that window closes, it is too late. Third, the situation is complex: There are many variables, some of which you can determine and understand and others that are “unknown unknowns.” Furthermore, you may not know the relationship between these variables — which of them are related and which are not. Making a “wrong” decision under these circumstances causes even more stress.
Studies conducted in the laboratory and in “natural” work environments (often involving aircraft pilots) involving high stress have shown there is a degradation of human performance.4 For example, having a high workload — attempting to do many things in a compressed time frame — can result in neglecting important tasks. (That is one reason why pilots rely on checklists for anticipated abnormal events.) A high workload can also cause a loss of situational awareness — you lose track of where you are — resulting in wrong decisions. Other research has shown that under stress, men will tend to make decisions that are riskier than the decisions made by women given the same situation.5,6
Ways To Improve Decision Making Under Stressful Conditions
Psychologists and therapists have prescribed a number of ways to reduce the impact that stress due to emergencies and abnormal situations has on individuals and their job performance and decision making. If you cannot remove yourself from the situation (difficult to do when you are in an emergency or highly abnormal situation like we find ourselves in today), some evidence-supported actions include:7
- Look for social support from others; provide support to those who need it.
- Relax your muscles.
- Practice meditation.
- Get outside/get into nature (keeping in mind distancing).
When it comes to making decisions, there are some other actions one can take. Many of these are aligned with the structured approach used in quality risk management, including:
- Identify what you can control and what you cannot control. For those items that are controllable, you may be able to find creative control strategies so as to reduce risk.
- Think before just reacting. Studies have shown that pausing for even a moment or two allows you to invoke parts of the brain (i.e., the neocortex) that can seek out and process relevant information.
- Ask questions like, what other information is out there that we should consider? Is there another way to interpret this information? How might this decision play out? Run a simulation of the decision and possible outcomes in your mind.8
- Involve others. Get different points of view. Make sure that people feel safe to express themselves, particularly if their ideas run counter to the prevailing thoughts.9 As General George Patton said, “If everyone is thinking alike, then somebody isn't thinking.”
- Have a clear understanding of the goal, particularly the longer-range strategic goal and keep this in mind.
- Use a checklist of actions to be taken in complex situations10 or a procedure or guideline.
The Role QRM Can Play
One of the reasons we use quality risk management (QRM) is to help us make better data-driven decisions. Taking a few moments and asking “what if…?” is a simple, informal way to consider potential risks and ways to avoid them. For more complex situations, tools like preliminary risk assessment (PRA) and failure mode effects analysis (FMEA) may be appropriate. Having procedures that define the process to be used, along with rating scales with descriptive key words, helps standardize the process, yielding consistent results.
Yes, this is a stressful time, full of uncertainties and risk. While COVID-19 is a black swan event, there are other situations — hurricanes, earthquakes, ash-spewing volcanoes — that can force us into making decisions under duress. Having a thoughtful process in place that includes quality risk management can help us make better risk-based decisions.
Thanks to Sarah Baker and my ValSource colleagues, Stacey Largent, Igor Gorsky, Chris Smalley, and Amanda McFarland for their help with this article.
- ISO 9000: 2015 Quality Management Systems. Geneva: International Organization for Standardization.
- ICH Q9; 2005 Quality Risk Management. Geneva: International Conference on Harmonization.
- Kahneman, D. (2011). Thinking, Slow and Fast. New York: Farrar, Strauss, Giroux.
- Bourne L. and Yaroush, R. (2003). Stress and Cognition: A Cognitive Psychological Approach. NASA Contractor Report. Available online at: https://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040034070.pdf. Accessed April 9, 2020.
- Uy Phuong J. and Galvan A. (2017). Acute Stress Increases Risky Decisions and Dampens Prefrontal Activation Among Adolescent Boys. NeuroImage Volume 146, 1 February 2017, Pages 679-689.
- Mather, M. and Lighthall, N. (2012). Both Risk and Reward are Processed Differently in Decisions Made Under Stress. Curr Dir Psychol Sci. 2012 Feb; 21(2): 36-41. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3312579/. Accessed April 9, 2020.
- Healthy Ways to Handle Life’s Stressors. American Psychological Association. Available online at https://www.apa.org/topics/stress-tips. Accessed April 9, 2020.
- Klein, G. (2017). Sources of Power: How People Make Decisions (20th Anniversary Edition). Cambridge, MA: MIT Press.
- Edmondson, A. (2019). The Fearless Organization. New York: Wiley.
- Gawande, A. (2009). The Checklist manifesto: How to get things right. New York: Metropolitan Books.
About The Author:
James Vesper, Ph.D., MPH is a director at ValSource with a focus on learning, training, quality risk management, and error investigation. With more than 35 years of pharma experience, he started his career with Eli Lilly and Company and then started the consulting firm LearningPlus. He has worked globally with pharma firms, regulatory agencies, and the World Health Organization. He has just completed his sixth book, GMP Root Cause Investigations and Corrective Actions: A Clear and Simple Guide, available this summer from PDA/DHI. He can be contacted at firstname.lastname@example.org.