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zbw2 replied to the topic Risk Management – Identification in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I mentioned in the Risk management meeting thread of a system to follow when brainstorming for potential risks
During the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of the device that cannot be avoided, followed by the risk on that can be mitigated or transferred, then lastly risks that can be accepted. this same procedure should be taken with level of parts with decreasing criticality until the entire device has been reviewed. by prioritizing types of risks during brainstorming, the risk identification process should require less rounds of analysis to properly document and address all risks involved.
Additionally, as some have mentioned above the entire team should take part in identifying risks. for all participating team members, brainstorming should take place in a two phases. first each individual should attempt to identify risks on their own, writing it down before discussing and brainstorming collectively with the team. this process helps prevent idea “anchoring” and promotes more unique perspectives during the meeting.