The Product Design Development Procedure outlines the steps for the planning, development, and review of new products. It applies to all new product developments and significant changes to existing products. (10 pages, 2,411 words)

The design phase is the most important phase in the life cycle of a product. The inherent quality, effectiveness, safety, and customer satisfaction of a product are established during this phase. No matter how carefully a product may be manufactured or how perfect the quality control program, these inherent qualities cannot be improved except through design enhancement. Therefore, it is crucial that adequate planning and controls be established, implemented, and maintained during the design phase to assure that the quality, effectiveness, safety, and customer satisfaction of a product are optimally enhanced prior to manufacturing.

Further, product developments should be managed in such a way to assure timely development of new products in order to reach completion quickly and capitalize on market opportunities.

Product Design Development Definitions:

Failure Mode and Effects Analysis (FMEA) – Technique for testing and evaluating design of products in which failures are assumed to occur.

Fault Tree Analysis – Deductive (top-down) approach to failure mode analysis. First, a system failure or safety hazard is assumed. Next, through the use of detailed logic diagrams, basic component failures or events are identified that could cause the assumed system failure or safety hazard. Once identified, computational techniques are used to analyze the basic defects, determine failure probabilities and establish severity of effect.

Failure Mode Effects Criticality Analysis (FMECA) – Inductive (bottom-up) process; assumes basic defects at the component level and determines their effects on higher levels of assembly. Failure modes are analytically induced into each component and failure effects are evaluated and noted, including severity and probability of occurrence. FMECA can be performed using either actual failure data derived from field failures or hypothesized failure modes derived from design analysis or other sources. In addition to providing information about failure cause and effect, FMECA provides a structured method for proceeding component-by-component through the system to assess failure effects.