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.

The ISO 9000 Quality Management System(QMS) standard is an effective tool that can consistently meet the various requirements of stakeholders and promote customer satisfaction management. However, in the recent business environment, not only quality issues but also risks in various other areas are increasing. In particular, risks related to product safety problems which are arised from product convergence, diversification of methods of production and globalization of supply chain pose a great threat to the sustainability of companies. Accordingly, ISO published standards of Product Safety Management System(PSMS) for suppliers such as ISO 10377 and ISO 10393. This study aims to suggest an integration framework of QMS and PSMS based on ISO international standards. To this end, the relationship of QMS and PSMS are analyzed and the requirements of the both systems are integrated based on the Plan-Do-Check-Act(PDCA) cycle and risk-based thinking. In addition, 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 that have already acquired QMS certification to build an international level product safety management system early.

Virtual metrology(VM) is a promising technology which can convert off-line sampling inspection into on-line total inspection at the manufacturing process. This paper provides an economic evaluation model of VM system which predicts the defects of a target process with Bernoulli sampling inspection. For this purpose, we build M/G/1 queueing models of two systems. One is VM non-applied system and the other is VM applied one. We derive total costs per unit time of each system and conduct sensitivity analysis according to variations of input parameters such as defect rates, various process costs and VM prediction error rates. The proposed analysis model is expected to be used for evaluating economic values of VM system implementation projects.

This study aims to reveal how EA affects BAX and NF-kB involved in cell deaths from global ischemia, and to do this, observes the changes of BAX and NF-kB caused by EA application after transient global ischemia. The experimental method is to give rise to global ischemia and apply EA to 27 SD rats with the particulars of being six-week-old, male, around-300 gram-weighing, and adapted to laboratory environment for more than a week, and divide them into three groups, that is, GV20 EA group(n=9), L14 EA group(n=9), no-treatment GI group(n=9), and then observe their changes of BAX and NF-kB at the time lapse of 6 hours, 9 hours and 12 hours after ischemia, using western blotting. The numerical decrease of BAX expression at the time lapse of 9 hours after EA application, though not statistically significant, was observed in GV20 EA group and L14 EA group, and the NF-kB expression appeared statistically significant decrease in GV20 EA group and L14 EA group, but the expression was higher in the group with EA application. Therefore, EA application at the early phase of global ischemia is considered to affect BAX and NF-kB and play a positive role in decreasing apoptosis and cell deaths by inflammation.