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Qsauri
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risk communication
Guideline or reference source
ICHQ9 Quality Risk Management
Definition
The sharing of information about risk and risk management between the decision makers and others. Parties can communicate at any stage of the risk management process. The output/result of the quality risk management process should be appropriately communicated and documented. Communications might include those among interested parties (e.g., regulators and industry;industry and the patient; within a company, industry, or regulatory authority). The included information might relate to the existence, nature, form, probability, severity, acceptability,control, treatment, detectability, or other aspects of risks to quality.
Related Term
risk management
 

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