An activity-based defect management framework for product development

As competition intensifies, development of complicated hardware products and the decrease in development cycle lead to increasing design defect risk in hardware products, resulting in all kinds of problems such as unsafe product, product development failure and so on. Therefore, it is important to manage design defect during all stages of product development to improve product design quality and product development success rate. Factors influencing design defects injection vary according to the different attributes of a product development, including the product complexity, the experience of the developers, the development cycle and tool. The most significant challenge in design defect management is to identify design activities that are likely to cause defects. This paper proposes a design defect management framework based on design activities that assess and identify design defects. First, the product development process is decomposed by using a work breakdown structure (WBS) to obtain design activities. Subsequently, a Bayesian network is adapted to construct defect assessment model using design activities as network nodes. Finally, the defect control activities such as review, verification, and validation are used to identify design defect. The proposed risk management framework enables an product development to be focused on the key defect activities in which the most serious defect risk exists and provides a more effective way to assess, identify defect risk along the product development cycle. A case study on medical syringes is presented to validate the capability of the proposed approach in providing low residual defect in delivered products.