Variation mode and effect analysis

In this paper, we introduce an engineering method, variation mode and effect analysis (VMEA) developed to systematically look for noise factors affecting key product characteristics (KPCs) early in product development. Conducted on a systematic basis, the goal of VMEA is to identify and prioritize noise factors that significantly contribute to the variability of KPCs and might yield unwanted consequences with respect to safety, compliance with governmental regulations, and functional requirements. As a result of the analysis, a variation risk priority number (VRPN) is calculated which directs the attention to areas where reasonably anticipated variation might be detrimental.