The PDMA Handbook of New Product Development

28.1. Introduction

A well planned and executed risk analysis activity should be part of any significant product development project. Sometimes it's required, as in the development of medical devices. Regardless of requirement, you owe it to your customer, your company, and yourself to produce a safe product on time, within budget, and that meets the needs of its users. Effective use of risk analysis helps you meet these goals.

Risk analysis serves as the project manager's binoculars to see into the future. By spending time and money early to examine what might go wrong and how it might happen, you can make effective plans to avoid those problems and/or minimize their impact, while staying on schedule and budget. For example, Battelle's Product Development Solutions has developed an effective risk assessment methodology as part of their standard model for new product development to ensure that each product under development has appropriate attention paid to safety and performance issues (see Figure 28.1).

NOTE

The problems you don't identify early will cause the most trouble.

Figure 28-1. BATTELLE PRODUCT DEVELOPMENT METHODOLOGY (INCLUDING RISK ASSESSMENT).