Glossary
Formality in Quality Risk Management
The degree of structure, rigour, and documentation applied to a quality risk management activity, which sits on a continuum from low to high.
Source · ICH Q9(R1) (2022), §5.1 Formality in Quality Risk Management
Details
Formality does not mean using the same tool for everything; it sets the team, the tools, and the level of reporting in proportion to uncertainty, importance, and complexity. Inspections may cite a lack of resources given as the reason for low formality, or a high risk matter handled only through an informal note. Check the criteria for deciding formality, the risk question, the choice of team and tools, the report, and how it is recorded within the quality system.
Related sections
Related terms
Source
ICH Q9(R1) (2022), §5.1 Formality in Quality Risk ManagementGRM Regulatory Glossary
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