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This article proposes a novel safety framework for complex systems, called Recall Mitigation Framework, that assists engineering teams in identifying recall risk factors during the systems engineering process. Current frameworks do not address recalls for complex systems. A modified ISO 42010:2011 for identifying multiple stakeholders of complex systems is also proposed, as the current architecture is tailored for systems with only one stakeholder. Existing system engineering tools such as Failure Mode and Effects Analysis are incorporated to identify risks factors. To measure recall propensity of each recall factor, a new formula, called Recall Index (pRI), was also developed and applied in this research. Four activity phases are included within the framework: Stakeholder Identification, Data Acquisition, Statistical Safety Analysis, and Risk Review. Both the Recall Mitigation Framework and pRI are validated through a case study involving the engineering of a new vehicle model in the automotive industry. Use of the framework provided better insights to the engineering team by employing statistical methods to identify three predictive factors that influence vehicle recalls: fuel economy, warranty coverage, and crashworthiness. Managers in other industries can utilize this framework early in the systems engineering lifecycle to identify potential risk factors and prevent a costly recall campaign.  相似文献   
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