risk review
- Guideline or reference source
- ICHQ9 Quality Risk Management
- Definition
- Risk management should be an ongoing part of the quality management process. A mechanism to review or monitor events should be implemented. The output/results of the risk management process should be reviewed to take into account new knowledge and experience. Once a quality risk management process has been initiated, that process should continue to be utilized for events that might impact the original quality risk management decision, whether these events are planned (e.g., results of product review,inspections, audits, change control) or unplanned (e.g., root cause from failure investigations,recall). The frequency of any review should be based upon the level of risk. Risk review might include reconsideration of risk acceptance decisions.
- Related Term
- risk management
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