ABSTRACT
The new Quality System Regulations, incorporating the required design controls, went into effect June 1, 1997. The new quality system regulation contains major additional requirements in the areas of design, management responsibility, purchasing and servicing. Design for Manufacturability (DFM) assures that a design can be repeatably manufactured while satisfying the requirements for quality, reliability, performance, availability, and price. One of the fundamental principles of DFM is reducing the number of parts in a product. Design for Assembly is a structured methodology for analyzing product concepts or existing products for simplification of the design and its assembly process. Reduction in parts and assembly operations, and individual part geometry changes to ease assembly are the primary goals. The Production Run is to produce high quality product on time, while continuing to fine tune the process using controls which have been put in place.
