In this paper, we report on the activities of the Study Group on the Comprehensive Quality of Healthcare Management and the background to the review and revision of the “ Seven Tools of TQM in Healthcare. ”In particular, the frequency and background of intentional noncompliance ( Ma-Iika ) and the continuous improvement of MIBM ( Ma-Iika-Boshi-Method ) were described, and the framework of the “ Seven Tools of TQM in Healthcare ”.
　The “ Seven Tools of TQM in Healthcare ” alone are not enough to improve the quality of healthcare. It is necessary to utilize the “ Seven Tools of TQM in Healthcare ” for management by policy,day to day management, and small group improvement activities, including QC seven tools. Within such a framework, by continuing to implement the PDCA cycle, it will be possible to put TQM activities into practice.

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　The cause-and-effect diagram was not included in Seven Tools of TQM in Healthcare (2012), as it was considered a basic QC tool, frequently used without question, and not requiring detailed explanation. However, inappropriate diagrams have been reported across various fields, including healthcare. Due to the lack of systematic training materials, I developed internal content at Nerima General Hospital and conducted employee workshops. This led to training sessions at All Japan Hospital Association. Based on these efforts, we published Basics and Applications of Cause-and-Effect Diagrams in 2018 for educational use. Despite these activities, misuse persisted. In 2022, I proposed adding the cause-and-effect diagram as the “ eighth tool ” of healthcare TQM. Reflecting continued outcomes from training sessions, the second edition of Cause-and-Effect Diagrams was published in March 2025. This report outlines the theoretical background and practical development of cause-andeffect diagrams to improve their proper use in the healthcare field.

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　Failure Mode and Effects Analysis ( FMEA ) is widely used across various fields as a proactive risk management tool. The author has implemented quality management ( QM ) tools as part of Total Quality Management ( TQM ) in the healthcare field. When FMEA was introduced to Nerima General Hospital (1998), there were no reported use cases in healthcare, so references from industrial applications were used. However, certain terms and concepts were unacceptable for healthcare professionals. Therefore, I developed a healthcare-adapted training material, and tested in workshops with our employee and those from other hospitals, and refined accordingly. Through the “ Total Quality of Healthcare Management Study Group ” of this academic society, we developed and published the “Seven TQM Tools for Healthcare,” which was also presented at the this society’s conference. While FMEA is useful for safety management and often accepted uncritically, this paper highlights its issues and proposes revised concepts and practices.

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　Many accidents and incidents are caused by human behaviors of intentionally not following rules. Nagai et al. focused on the fact that the not well organized relationship between intentional noncompliance and workplace’s activities makes it difficult to determine how to improve workplace’s activities based on the status of intentional noncompliance, and proposed the Ma-Iika Boshi Method ( MIBM ) as a method to overcome this difficulty. They also demonstrated the effectiveness of MIBM by applying it to comparisons of infection prevention measures and safety control measures among different workplaces and occupations. This paper reports on what the authors have learned about MIBM through more than 10 years research since its proposal, including discussions on the definition and occurrence mechanism of intentional noncompliance, the actual situation of intentional noncompliance in the medical field, systematization of measures to prevent them, and the influence of organizational culture and its overcoming.

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　The JSQC division of healthcare quality and safety has been engaged in promoting and establishing quality management systems in healthcare through activities such as the QMS-H Research Group,the QMS-H Audit Research Group, the Comprehensive Quality in Healthcare Management ResearchGroup, and the Basic Course on Healthcare Quality Management. This report outlines the division’s activities since 2021. Each study group has advanced research on various themes and achieved notable outcomes, including the Deming Prize awarded to Iizuka Hospital. Additionally, the BasicCourse has adopted a QMS-based curriculum and delivered it via e-learning, enhancing educational impact nationwide. Looking ahead, the division is considering a shift to a hybrid format and will focus on improving educational quality and fostering instructors. In 2025, the division transitioned to a new organizational structure, continuing to emphasize human resource development and the sustainability of its initiatives.

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　This paper discusses the dual aspect of process capability information and the role of the Shewhart control chart as a control chart for process control ( type 2 control chart ), by exploring their essence through a return to the origin.
　The dual aspect of process capability information refers to the idea that the variation in assurance characteristics for process downstream is Process Performance, and the ability to create Process Performance is Process Capability. It is proposed that process quality be assured through “ Process Performance backed by Process Capability. ”
　The role of control charts for process control is to prove the effect of intentional intervention, namely standardization that creates a controlled state, during the phase of routine mass production.Then it is important to select control characteristics that are conscious of the need to know the process. The anomaly signaling from a control chart for management serves as a clue for transitioning to a control chart for process analysis. This phase should be located as phase 3 in road map of control chart in SPC. 　

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