Glossary

Uncertainty

A lack of knowledge about a hazard, the harm, and the associated risk, arising from incomplete knowledge and from process variability.

Details

Uncertainty determines the confidence limits of a risk assessment and the formality and further investigation required. Inspections take issue with assessments expressed as a single definitive score without disclosing data gaps, assumptions, or variability. Look at the risk question, the assumptions and data sources, sensitivity and scenario analysis, and the plans for obtaining knowledge and for review.

Related sections

Related terms

Real inspection findings

See 1 findings that mention this term

Source

ICH Q9(R1) (2022), §§4.3, 5.1