IEEE Transactions on Device and Materials Reliability · 2011 · 27 citations · 17 references
ManagementQuality ManagementSystems EngineeringNew Product DevelopmentQuality EngineeringRequirements EngineeringEquipment QualificationPerformance QualificationProduct DevelopmentProduct SpecificationsProduct TestingProduct ValidationCompliance With Industry StandardsIndustry Standards FrameworksProduct Development ProcessProduct DiagnosticsProduct QualificationQualification
Qualification, which is the process of demonstrating that a product is capable of meeting specified requirements, is a costly and lengthy part of the product development process. This paper discusses the challenges that companies face when qualifying their products in an environment of abbreviated product development cycles, changing environmental regulations, which require the use of new materials or processes, and a complex and diffuse supply chain. A more comprehensive approach to product qualification involving the use of physics-of-failure principles, prognostics and health management techniques, and qualification at every stage of product development that builds on earlier work and industry standards is presented here.
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