Mistake to avoid in an FMEA скачать в хорошем качестве

Mistake to avoid in an FMEA

Failure mode effect analysis (FMEA) is routinely used in the medical device industry for risk analysis, However, when it is the only technique utilized for analyzing the risk of harm in the context of ISO 14971, we run into a lot of problems. A common mistake is to assume that the probability of occurrence of an individual failure mode (Pfm) is equal to the probability of occurrence of a hazardous situation (P1). An unintended consequence is that you will significantly over-estimate the risk level of a potential harm. Another problem could be inconsistency in estimating the risk level associated with the same hazard that may be linked to multiple failure modes. In this video, I explain this problem in detail using an example from ISO/TR 24971 and offer a few suggestions. 👉Subscribe to the Let's Talk Risk! newsletter https://naveenagarwalphd.substack.com/ 👉Connect on LinkedIn   / naveenagarwal