The PDMA Handbook of New Product Development

28.2. Risk Analysis Tools—Hazard Analysis and Failure Mode and Effects Analysis

When using binoculars, you keep both eyes open to get an accurate view. It also can be said that you look at everything twice. The same is true in an effective risk analysis program. First, an early view of the product's development "landscape" is taken to identify general problem areas to be handled while keeping development on track—this is the role of the hazard analysis (HA). As shown in Figure 1, the HA is performed prior to any significant development effort. Wasted development effort and cost can be driven to a minimum using this approach. Later in the development process, the Hazard Analysis is replaced by the failure modes and effects analysis (FMEA) in which a more detailed view of each part of the design is taken to make sure that it is serving its purpose and working appropriately with the other parts of the design.

28.2.1. Hazard Analysis (HA)

A hazard analysis is a technique that allows the product development team to identify, prioritize, and develop mitigation strategies for potential risks very early in the product development cycle. The team starts by looking at how the product might negatively affect the user or environment (potential hazards or risks) and then produces scenarios about how the actions of the product could produce those hazards (causes). This is often referred to as a "top-down" look because it starts with a wide focus and then narrows down to specifics. The hazard ...