7. Determining criticality
Once the FMECA has been completed, you need to assess the risks for all the failures identified.
This assessment results in a criticality calculation based on estimated severity, frequency and non-detection indices.
Criticality is used to assess the importance of the risk generated by each cause, and to rank failures in order to determine priority actions that are greater than or equal to the selected threshold. It is calculated as follows:
C = F X G X D.
7.1 Frequency index F
This index represents the probability of occurrence of the cause leading to the failure mode under consideration. The rating...
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Determining criticality
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Reference standards
ISO 9001:2015 Chapter 8.3.2 Design and development planning
ISO 9001:2015 Chapter 8.3.4 Design and development control
ISO 9001:2015 Chapter 8.5.1 Control of production and service provision
ISO 9001:2015 Chapter 8.5.6 Change control
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