Course description
This course explains how to perform a process risk assessment at GenDx using the Failure Mode and Effects Analysis (FMEA) approach described in S15-PRO-01_01. You will learn when to perform a risk assessment, who is involved, and how to complete the risk form (S15-FOR-01_06). We will also look at practical examples and how process risks link to other quality management processes.
In this training you will learn
- What process risk management is and why it matters.
- When to perform a process risk assessment.
- The roles and responsibilities of those involved.
- How to use the FMEA method in the S15-FOR-01_06 form.
- How to score severity and occurrence using the risk matrix.
- How to determine if a risk is acceptable or needs action.
- How process risk management links to NCR, CAPA, audits, and change control.
