The PDMA Handbook of New Product Development

28.3. A Few Final Thoughts

The techniques described here are tools, and as with any other tool, it is the responsibility of the user to execute it properly for professional results. When performing a risk assessment, keep the following in mind:

Your attitude:

Completing the forms for a HA or FMEA can be somewhat tedious (several companies offer software that may help relieve some of the tedium). The team needs to approach the development of a hazard analysis or failure modes and effects analysis with a positive attitude so they can exercise the creativity needed to produce a high-quality result. As the leader of the product development team, you should make sure that the team understands the importance of the HA or FMEA and how it will help them during the development of the product. You might encourage the team to view the work as if they were solving the crime in a mystery novel. This technique helps keep the team interested and focused, while encouraging them to use their knowledge of the product's operation creatively to produce a high-quality risk assessment.

Stay balanced:

Some models still describe an FMEA as a means to identify all failure modes and all causes for a product. More realistic definitions, such as the one used by the Automotive Industry Action Group (AIAG, 2001: 9), understand that the FMEA is an analytical technique used "to ensure that, to the extent possible, potential failure modes and their associated causes/mechanisms have been considered and addressed." ...