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Shimada Y.,Japanese National Institute for Occupational Safety and Health | Kitajima T.,Tokyo University of Agriculture and Technology | Ling Y.,Techno Management Solutions Ltd.
11th International Probabilistic Safety Assessment and Management Conference and the Annual European Safety and Reliability Conference 2012, PSAM11 ESREL 2012 | Year: 2012

This paper proposes an integrated risk management support system which consists of risk assessment and countermeasure planning for chemical plant. HAZOP log which is analyzed by HAZOP support system is used for fault tree (FT) synthesis and fault tree analysis (FTA). Calculated probability of top event of FT (frequency of considered hazard) and severity of the hazard which is stored in HAZOPdatasheet are used for risk evaluation. Furthermore, countermeasure planning for risk reduction is supported based on the result of risk assessment and the design-concept of Independent Protection Layer (IPL).


Kawai H.,Tokyo Institute of Technology | Kitajima T.,Tokyo University of Agriculture and Technology | Fuchino T.,Tokyo Institute of Technology | Seki H.,Tokyo Institute of Technology | Naka Y.,Techno Management Solutions Ltd.
Computers and Chemical Engineering | Year: 2013

On the basis of the quality by design approach, aggregation of knowledge in process chemistry and manufacturing operations is essential for the continuous development of pharmaceutical products and processes. We develop a model-based framework to describe process chemistry oriented phenomenal sequences leading to quality hazards (process deviation scenario), which should be independent of any specific plant structural information, and manufacturing procedural error oriented event propagations (procedural control scenario), which concern a specific plant structure. We propose a system, Quality-HAZOP, to analyze the scenarios in which manufacturing errors can affect product quality via complex propagation pathways. This system supports bidirectional improvement proposal between recipe scientists and process engineers. This proposal triggers risk information exchange that supports the continuous improvement of the process in life-cycle pharmaceutical development. © 2013 Elsevier Ltd.


Kitajima T.,Tokyo University of Agriculture and Technology | Fuchino T.,Tokyo Institute of Technology | Shimada Y.,Japanese National Institute for Occupational Safety and Health | Yuanjin L.,Techno Management Solutions Ltd.
Computer Aided Chemical Engineering | Year: 2012

Risk management system for supporting process-safety management through a plant-lifecycle is developed by use case driven development. The use cases are directly derived from the business process model and associated with primary actors with consideration of the corresponding role of plant-lifecycle engineering and process-safety management activities. Functional requirements for the support system are defined in accordance with the use case analysis and implemented to the existing engineering support tools. The implemented functions are strictly combined with user requirements, because they are derived from to-be use cases based on a reference business process model. © 2012 Elsevier B.V.


Kawai H.,Tokyo Institute of Technology | Seki H.,Tokyo Institute of Technology | Kitajima T.,Tokyo University of Agriculture and Technology | Fuchino T.,Tokyo Institute of Technology | Naka Y.,Techno Management Solutions Ltd.
Kagaku Kogaku Ronbunshu | Year: 2014

In pharmaceutical industries, lifecycle management of process improvement by coordinating product design, rec-ipe design, facility development, and production activities is necessary to develop robust and consistent production processes that satisfy requirements for product quality. Te business process of pharmaceutical process lifecycle en- gineering is described in an activity model that defines the stages of plan-do-check-act. On the basis of this model, procedures and a change-management system in lifecycle engineering were developed. Te procedures and the system can be continuously improved by the activity model-based systems approach to achieve practicable process lifecycle engineering in pharmaceutical production. © 2014 Te Society of Chemical Engineers, Japan.


Kitajima T.,Tokyo University of Agriculture and Technology | Fuchino T.,Tokyo Institute of Technology | Shimada Y.,Japanese National Institute for Occupational Safety and Health | Naka Y.,Tokyo Institute of Technology | And 3 more authors.
Computer Aided Chemical Engineering | Year: 2010

Consistent and effective Management of Change (MOC) is the most important for process safety. Therefore, MOC should be logically and explicitly realized based on To-be reference model. In this study, a new scheme for MOC support based on engineering activity model through the plant-lifecycle is proposed. Practical and effective utilization of HAZOP logs obtained at plant/process design phase in reusable form by using an intelligent support tool (HazopNavi) is archived. © 2010 Elsevier B.V.

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