Prospective Hindsight - Tool for effective continuous improvement and compliance

I recently discovered the term "Prospective hindsight" while watching a TED talk on managing stress. The term intrigued me because it seems paradoxical - how can one have hindsight in advance? I decided to explore the concept further.

Prospective hindsight, also known as pre-mortem, is a strategy developed by y psychologist Garry Klein and later written by Daniel Kahneman. Pre-mortem involves imagining a project or organisational failure and then working backwards to identify potential causes and implement preventive actions.

At first glance, pre-mortem may seem similar to the risk assessments we commonly perform in the life science industry. However, what sets pre-mortem apart is its focus on "what did go wrong" rather than "what could go wrong." In a pre-mortem exercise, the team is told that the project has already failed, and individuals are asked to identify the factors that led to the failure. This approach encourages open and transparent analysis, reducing fear and stress among team members.

To me, this approach can be much more effective than a traditional risk assessment within the life science/regulated industry.

1. The individuals performing the pre-mortem are given a very precise and clear failure scenario which makes it easier to visualise the risk. e.g. The team at a drug innovation company is told that the management failed to secure investment and the company is been closed. The team is asked to list all the reasons that led to the investors pulling out.
2. In a pre-mortem, the project team is analysing a situation or assessing failures in an open, transparent way. The disaster or failure hasn't occurred so the stress that comes with having to deal with real one is taken out of the equation, allowing individuals to contribute their thoughts without fear.

I feel that using the concept of a pre-mortem (prospective hindsight) in our risk assessment process can be highly beneficial in addressing potential failures like data integrity, product recalls, adverse reactions, clinical and commercialisation challenges.

Instead of..

" What are the risks of microbial contamination during the final filling operation?"

Let's say..

"The batch of 50,000 vials of a crucial drug has shown microbial contamination. The entire batch has been rejected and destroyed. This has caused a shortage in the pharmacy. What are the reasons for this failure?"

Using pre-mortem to write problem statements can lead to more productive risk assessments and drive continuous improvement and compliance.

Would love to hear an example of how you would use the pre-mortem question to write a problem statement.

#drugdevelopment #pharmaceuticalmanufacturing #medicaldevice #clinical trials #quality #compliance