The role of rework in high volume controlled manufacturing operations.

摘要

High volume manufacturing activities face competitive and economic challenges that may preclude the ability to eliminate all non-conforming products. Quality systems such as ISO 9001 and the Food and Drug Administration's current Good Manufacturing Practices allow non-conforming material to be accepted as-is, scrapped, or reworked to remove the non-conformance. Rework is a deviation from established manufacturing processes and involves risk to the organization. Despite the risks, organizations may justify performing rework on manufactured products for the following reasons: economics, technical issues, customer relations, logistics, and internal politics.; If organizations were to utilize rework activities to identify and eliminate causes of non-conformances, future defect situations could be avoided and continuous improvement could be realized. The root causes of non-conformances that create the need for rework can be found using known problem solving tools. Four methods for solving manufacturing concerns are compared and the advantages and disadvantages of each are detailed.