• Journal of Korean Society for Quality Management
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• v.50 no.4
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• pp.635-646
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• 2022

Purpose: In this study, the detailed implementation plan for product safety evaluation and management suggested by KS A ISO 10377 to reduce the risk of harm to consumers and users is presented so that companies can strategically implement it. Methods: In order to achieve the purpose of this study, the upper elements and detailed execution plans shown in KS A 10377 are classified into hierarchies and set as a decision hierarchy. A pairwise comparison is performed to derive it. Results: Among the top factors, 'design safety (D)' was the most important factor, with 0.314. Therefore, ensuring safety in the design stage that can prevent defects in advance is the most important action plan for companies to supply safe products. Conclusion: The results of this study, it is intended to help companies and related organizations more easily understand and continuously apply KS A ISO 10377.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.44 no.2
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• pp.124-131
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• 2021

In the recent business environment, risks related to product safety problems are increasing. These are arising from various factors such as increasing product and production complexity, supply chain diversification, enhanced PL (product liability) law and strengthening regulations of the government. Accordingly, ISO (international organization for standardization) published standards of PSMS (product safety management system) for suppliers such as ISO 10377 and ISO 10393. Meanwhile, the ISO 9001 QMS (quality management system) was revised in 2015, and it has established itself as an effective tool that can consistently meet the various requirements of stakeholders and promote customer satisfaction. This study aims to suggest an integration framework of QMS and PSMS based on the recent ISO international standards. To this end, firstly, the relationship between QMS and PSMS is studied based on the quality and product safety definitions, PDCA (plan-do-check-act) cycle and risk-based thinking. Secondly, the requirements of ISO 10377 and ISO 9001 are compared and classified as the common and ISO 10377 specific requirements. Finally, integration steps of two systems are suggested and guidelines that can systemize the integrated requirements are presented in the aspect of processes and documentation. This study is expected to be used as a guideline that helps companies those have already acquired QMS certification to build an international-level product safety management system early.