ABSTRACT
Once the Preliminary Hazard Analysis (PHA) is done, the design concept for safety becomes clear. It is time to assess the risks at the detailed design level for reliability and durability. That is where the Failure Mode and Effects Analysis (FMEA) and the Fault Tree Analysis (FTA) come in. They help in refining the design using the old saying “the devil is in the details,” and in developing the design structure for hardware and software. The structure can be expressed and communicated in the form of a functional block diagram. Some functions
are performed sequentially, while others are performed concurrently. The functional block diagram shows the connections among different functions. This information is critical to ensure that no new risks are created during design changes. The purpose of the functional diagram is to communicate the design functions and interfaces clearly to the entire product development team during design reviews. Preventing recalls is more effective if the criteria for selecting the right team members are given priority. The best performing teams include an outsider as an independent voice. To start with, a team charter should define the mission of the team and its objectives. The charter should include a statement of work, the background of the project, the thoroughly reviewed specifications, and should define the extent of the team’s authority, the accountability of each member, the boundary conditions for analysis (how far and deep you want to go), and responsibilities for interactions with other groups and leaders.
