Monday, 28 December 2020

Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare?


Often in pharmaceuticals, especially when dealing with biological data (such as relating to product formulation or to microbial contamination), things are not always very clear and can appear vague. Another word for this is ‘fuzzy’. This is particularly so when trying to decipher whether a statement is true or false. In the financial sector, similar situations arise and one of the tools used to overcome this dilemma is to employ the thought process of fuzzy logic. Does this approach have a role in the pharmaceutical and healthcare products sector?

While some approaches to risk assessment, most notably Failure Modes and Effects Analysis (FMEA), us numerical scoring approaches, fuzzy logic is based on the fact that people generally make decisions based on imprecise and non-numerical information (even if they subsequently attempt to force their decision into a numerical value, as is required with FMEA). Fuzzy models provide a mathematical means to represent this vagueness and concerns about imprecise information (or what is said to be ‘fuzzy’).

For example, a temperature to kill a given microbial population will have separate membership functions defining particular temperature ranges needed to kill the population. Each function maps the same temperature value to a truth value in the 0 to 1 range. These truth values can then be used to determine temperature should be controlled. The fuzzy logic approach provides a means for representing the uncertaint.

Tim Sandle has written a new aticle:

Sandle, T. (2020): Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare?, IVT Network, at:

The advantage of fuzzy logic is that it provides valuable flexibility for reasoning by considering the uncertainties of the situation. Sometimes where there is too much certainty at the outset, this involves important data or events from being overlooked. With fuzzy logic, the outcome of an operation can be expressed as a probability rather than as a certainty. When the scope is too narrow and something important is inadvertently excluded, this can undermine root cause analysis and hence the assessment of all hazards that require assessing when undertaking a risk assessment.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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