risk identification
- Guideline or reference source
- ICHQ3D Guideline for elemental impurities
- ICHQ9 Quality Risk Management
- Definition
- The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description. Information can include historical data, theoretical analysis, informed opinions, and the concerns of stakeholders. Risk identification addresses the “What might go wrong?” question, including identifying the possible consequences. This provides the basis for further steps in the quality risk management process.
- Related Term
- risk analyses
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