Page 176 - Safety Risk Management for Medical Devices
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Integration of Risk Analysis 155
we can incorporate the performance of the supplied product in the safety performance of
the System. Occurrence rating helps us derive P1. Knowledge of Causes of the Failure
Modes can help with estimation of P1s, and also with design of Risk Controls.
Recognize that what is the Failure Mode to us, is the End Effect to the supplier’s FMEA.
Knowledge of other entries in the supplier risk management file would be inter-
esting for R&D engineering, Supply chain, and Quality departments, but not
required from the risk management perspective.
