This FMEA Risk Analysis and Risk Management template will enable you to identify, analyze, and evaluate risks and the impact of prioritization and assess the residual risks after mitigation activities implementation. This procedure template is based on the Failure Mode and Effect Analysis (FMEA) to evaluate the process and identify where and how it might fail, assess the relative impact of different failure, and ensure systematic identification, analysis, evaluation, and control of risks. The template includes a Risk Analysis table that enables monitoring the effectiveness of the control over risks and compliance with the FDA, Eu and ISO regulatory requirements
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