• Yash S.

Demystifying the Role of Uncertainty - Whitepaper

Updated: Apr 2

In the assessment of risk, uncertainty is often a difficult topic. We've seen confusion and challenges firsthand as uncertainty is a configurable part of our risk model. Questions on how to properly use this method come from pharma companies of all types and sizes.

At the root of this confusion are inconsistent definitions in various publicly available case studies. We also commonly see uncertainty muddled with an occurrence concept or the probability of an out-of-specification (OOS) event since they are both represented by probabilities.

The reality is that the uncertainty layer of risk can be used to express two different ideas: Certainty of Knowledge or Likelihood of Severity.

When used correctly both approaches can bring clarity and specificity to a risk assessment.

We put together Quality Risk Management - Understanding Uncertainty, a whitepaper, to clarify the concepts and remedy some of the confusion around the proper usage.


ICH Q9 outlines the expectations for the management of risk related to final product quality. This guidance document describes several approaches to risk management and risk assessment but does not recommend a specific approach.

This lack of recommendation, along with inconsistent definitions provided in various case studies, creates confusion and challenges the consistent application of risk concepts during an assessment. One area of confusion is the use of the Uncertainty versus Likelihood of Severity of Harm. Many questions have been raised as to how and when Uncertainty should be defined and used.


In the whitepaper, we cover:

  • A framework for thinking about uncertainty

  • A review of a case study example

  • The discussion on ISO 14971 standard and its relation to the topic

  • The relationship of ISO 14971 and ICH Q9

  • A discussion on the role of uncertainty in the assessment of criticality


We hope that our whitepaper, Quality Risk Management - Understanding Uncertainty, provides practical guidance on the role of uncertainty in assessing criticality.

After reading it, you may also enjoy our broader whitepaper on risk management.

As product complexity increases rapidly, regulators expect teams to show an exhaustive understanding of their products and processes based on risk. With QbDVision, you can go deeper than ever.

Our platform provides an unprecedented view of all connections between your product attributes, process parameters, risk factors, and more. Contact us today to learn more.


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