Abstract

The design review is the most important first step in a product's life cycle. It is the ideal, and least expensive, time to recognize and propose changes or improvements to the conceptual design. The legal community fully expects a manufacturer to hold a thorough design review on a new product at its conception, as much as they would expect the manufacturer to follow known industry standards and state of the art techniques in the design and engineering of the product. The design review is an industry standard for manufacturing. There is typically a significant difference, however, in the scope and depth of the design review, versus that which many manufacturers are likely conducting. Design engineers may discuss certain aspects of a new product design with various department heads or supervisors to get answers to questions that the engineer may have, or select members of the management team might participate in discussions regarding specific aesthetic or mechanical attributes or the selection of certain components of a proposed new product, but this still doesn’t satisfy the required objective or effectively prevent the ultimate potential of manufacturing defects which could then lead to product liability. When you combine the requirements of these two presentations, it will go well beyond the normal quality & engineering programs and efforts and the content of most total quality management and ISO standards-based programs. The primary objectives of this stage in a design review are to address the following issues: manufacturability, product reliability, material/component concerns, industry standards and state of the art, user/operational concerns, operator instructions, field serviceability.