Glossary

Risk-Based Decision-Making

Deciding how to control, accept, communicate, and review on the basis of risk together with knowledge and uncertainty.

Details

Risk-based decision-making sets the effort, the formality, and the level of documentation to match the importance, uncertainty, and complexity of the matter. Inspections may cite scores fitted to a conclusion decided in advance, or decisions made without considering data integrity, residual risk, or the evidence against. Look at the decision criteria, the supporting data, the comparison of alternatives, approval and communication, and the subsequent review.

Related sections

Related terms

Real inspection findings

See 1 findings that mention this term

Source

ICH Q9(R1) (2022), §§5.2 and 7 Definitions