ABSTRACT

Failure Mode and Effects types of System Safety Analyses have been in use for over 30 years to identify hazards in systems under design/development. The rationale behind the use of these analyses techniques is the identification of hazards associated with the system while there is still the time and resources to effectively control them. They provide an excellent mechanism for exercising legal foreseeability for product hazards. Where used, these analyses have become a viable element in Product Safety Programs and have contributed significantly to product quality and liability mitigation.

This paper addresses the methodology used in Failure Mode and Effects Analysis, and similar analyses. Also covered are the planning and administration of the system safety analysis to include system documentation requirements, the system definition process, establishment of a limit of resolution and the selection of system modes for analysis. The construction of Functional Block Diagrams is explained and the use of matrix methodology to complete the analysis. Finally the paper addresses the formulation of system design changes based on risk information produced by the Failure Mode and Effects Analysis. Each of the topics above is also illustrated through the presentation of an analysis example.