Automated generation of failure modes and effects analysis for a medical device

A method of generating Failure Modes and Effects Analysis using SysML Block Definition Diagrams and Internal Block Diagrams is described. Additional annotations describing the failure propagation or transformation between neighboring components can be contained either within properties of the connections between blocks or in an external data file. An external Java program traverses the Internal Block Diagram based on the defined nearest neighbor failure propagations to generate the Failure Modes and Effects Analysis. The technique is demonstrated on a microprocessor-controlled medical infusion pump published by the Object Management Group as a SysML challenge problem. The resulting analysis showed that without addition of failure detection features, the challenge problem design contained multiple high severity failure modes that had previously not been identified.