In Japan, the lessons learned from Fukushima Dai-ichi nuclear accident have been reflecting and implementing to the nuclear facilities in order to re-start their operations. However, when we review the Fukushima nuclear accident from the viewpoint of the quality assurance, it is regrettable that this nuclear quality assurance could not contribute to prevent from Fukushima nuclear accident. The nuclear quality assurance up to now was mainly focused to the quality of the products and maintaining and operating activities of the nuclear facilities. Essentially, the quality assurance is a scientific approach to achieve the objectives and consists of identifying quality problems, providing their solutions and corrective actions to prevent from recurrence. It should be also effective to achieve nuclear safety. Fukushima Dai-ichi nuclear accident taught us that nuclear safety is achieved by the efforts of all participants of the nuclear business. Nuclear safety starts from siting and terminates decommissioning including emergency preparedness. It is important to reconsider wide-ranging and more in-depth management systems to contribute safety. It should be a kind of social system involving all participants.

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Transportation safety management system is a system that is intended for land, sea and air all of the transportation operators. This system, in response to the serious accident occurred in transportation in 2005, was introduced in 2006. The purpose of this system is to prevent accidents caused by human error. In this system, transportation operators turning the Plan-Do-Check-Act cycle for accident prevention and building a safety culture, government agencies to evaluate the operators' efforts. The most important in this system is the active involvement of top management with respect to safety, because it is basic for the functioning of the safety measures. This system has been established as a system to ensure the safety of transport in these days. However, there are the following problem with this system. Despite the evaluation of the country is being performed, it happened accidents due to the problem of organizational culture. Now that time has elapsed from the introduction of the system, there is a need to consider how to operate the system effectively.

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I gave some outlines in regulation, third party evaluations and the process improvement activity in healthcare and discussed healthcare characteristic and the problems in the biological information monitoring devices and electronic medical records

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According to the conventional legal mechanism, even if a new scientific knowledge such as new earthquake resistance standards was provided, the new findings could not be retroactively applied to the existing facilities and to the sold products (back fitting) without special laws. However, since the first Fukushima nuclear plant accident occurred, this way of thinking has been reviewed, and a "back fitting mechanism" has been adopted in some fields as the new laws or rules. The back fitting based on systematic activities of quality assurance including the upstream management should be carried out by enterprises as the autonomous activities, and the regulations by the government should stimulate these activities. Additionally, quality assurance system is a kind of a basic common language for building social consensus of the back fitting among enterprises, the government, engineers (risk managers) and users, inhabitants (risk owners). This paper proposes a quality assurance system for safety focusing on the top event mode and the predicted effect to construct the back fitting mechanism, and its role of risk managers and risk owners.

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Since the early 2000s, violation-caused accidents and misconducts have got a lot of social attention. Violations has been referred to as a new type of human error, which is very difficult to prevent. In order to encourage compliance to safety regulations and rules, the following 4 steps should be considered; 1) make good rules, 2) make everyone informed about the rules, 3) check the conformity of the rules, 4) apply just praise and blame.

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"What is the society with safety and trustworthiness?" In order to provide an answer to the question, first, the author illustrated the relationship between safety and risk in this paper. A definition of safety is "freedom from unacceptable risk." Next, the author discussed the relationship between risk management and communication through the explanation about risk communication. The risk communication is "an interactive process of exchange of information and opinion among individuals, groups, and institutions." In the risk management, it is seriously important for the risk owner to develop the partnership with the stakeholders related the risk problem. After that, the author introduced the trustworthiness, which is based on the development of stakeholders' partnership. The trustworthiness includes the expectation of competence and intention. The stakeholders of a risk problem may expect the intention of the risk owner through communication on the risk management. At the same time, the risk owner have to provide such opportunities to manage the risk appropriately. Finally, the author indicated both risk owners and stakeholders should collaborate the risk management, based on the trustworthiness each other.

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My first project at Hitachi, Ltd. was the development of control computers. As the computers were used as core systems, the reliability of them was essential. Therefore, I was taught to study system architecture in depth. This was a good opportunity for me to learn TQM approach which can optimize the entire operation, and became a key approach in my business operations. Further, later experiences told me that the importance of reliability, safety and service in high-valued system creation for end customers as well as our customers; and, the importance of service quality level. In the business administration of an automobile parts manufacturer, I focused on three policies to make the company be competitive in a fierce global business environment: 1) to establish a business operation system corresponding to international business community, 2) to achieve good production and quality that can satisfy our customers, and 3) to cultivate human resources for supporting quality enhancement globally. These are just as the basic of TQM defined by JSQC: so, we can further say that TQM is a part of management itself.

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To prevent defective products or accidents due to human error, it is essential to apply error proofing solutions before hands. However, estimation of the occurrence rate of each error depends on the qualitative judgment of operators in charge, with the method for qualitatively estimating the rate based on objective data not being studied well except a few previous researches. This paper focused on machining typically adopted in manufacturing and proposed a method of qualitatively estimating human error occurrence rates for a wide range of operations. In this method, work elements included in the operations are identified and the error occurrence factors are scored for each work element, and then the error occurrence rates are estimated based on the formulas between error occurrence factors and error occurrence rates, which have been produced in advance. This method was applied to two machining processes. As the results, it was found that error occurrence rates can be estimated precisely using a small number of error occurrence factors, different formulas should be used depend on type of error, and as for a certain type of error, stratification by type of work element is needed.

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The operating window method is a novel tool which reduces two defect modes with a tradeoff relationship by assigning an operating window factor to the outer array. However, there are more than one tradeoff relationships in general. In this article, we consider two tradeoff relationships with four kinds of defect modes. The design of experiment using two operating window factors and the analysis of experimental observations are proposed. In practice, the proposed method is applied to a circuit design. As a result, we can find the optimal design condition which reduces four defects simultaneously.

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