Once the meeting is set up and the purpose and function of the device is fully understood, it would be a good idea to have a group discussion about the potential risks associated with that product. Once the basic ones are identified, have everyone in the group fill out a risk analysis questionnaire that further uncovers any and all risks that could happen. Once the “quality person” compiles this information together, that is when the risk analysis should be done and each risk is categorized into a risk matrix.