GUIDE TO OUTSOURCING
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Using a robust supplier management process, the device manufacturer works with the supplier to develop a complete description of materials, specifications, test methods, equipment capabilities, and process parameters that affect final product quality. A formal program is implemented to address the areas of concern, and the program is concluded with validation of the supplier’s process. All requirements and specifications are clearly communicated and formally documented in supplier agreements for material certification.
Within two months, the resulting validated process delivers consistent production yields between 86 and 91%, and material variation is within acceptable limits for improved final-product quality. Statistical sampling of materials replaces 100% manual inspection. In such an example, the total benefit of validated processes far exceeds the expectations of the organization in all areas. And the resulting decrease in the cost of goods sold can enable greater profitability and competitiveness in the market.



