Why does changing the material have virtually no effect on cost at low plastic

366 CHAPTER 12 Wrapping Up the Design Process and Supporting the Product Documentation is like the poor crust on a good pie, you must eat it to clean your plate. 12.2 DESIGN DOCUMENTATION AND COMMUNICATION In the previous chapters, many design best practices were introduced to aid in the development of a product. The documentation generated by these techniques, along with the personal notebooks of the design team members and the drawings and bill of materials, constitute a record of a product’s evolution. Additionally, summaries of the progress for design reviews also exist. All of this information constitutes a complete record of the design process. Most companies archive this information for use as a history of the evolution of the product, or in patent disputes or liability litigation. Beyond the information generated during the process, there is still much to be done to communicate with those downstream in the product’s life. This section briefly describes the types of additional documents that need to be developed and communicated. 12.2.1 Quality Assurance and Quality Control Even if quality has been a major concern during the design process, there is still a need for Quality Control QC inspections. Incoming raw materials and manufactured components and assemblies should be inspected for conformance to the design documentation. The industrial engineers on the design team usually have the responsibility to develop the QC procedures that address the questions, What is to be measured? How will it be measured? How often will it be measured? Quality Assurance QA documentation must be developed if the product is regulated by government standards. For example, medical products are controlled by the Food and Drug Administration FDA, and manufacturers of medical de- vices must keep a detailed file of quality assurance information on the types of materials and processes used in their products. FDA inspectors can come on site without prior notification and ask to see this file. 12.2.2 Manufacturing Instructions A good drawing should have all the information needed to manufacture a compo- nent. Nonetheless, each plant has a certain set of manufacturing equipment, jigs and fixtures, and processes to make each component. Industrial engineers have the major responsibility for developing these manufacturing instructions. In very small companies, those with no industrial engineers, manufacturing instructions may become the responsibility of the product designers.