Journal of The Japanese Society for Quality Control
Online ISSN : 2432-1044
Print ISSN : 0386-8230
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Volume 43, Issue 3
Displaying 1-14 of 14 articles from this issue
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Features
  • Solution Concerning Problem in Audit and Operation Activity of Management System
    Noriyoshi FUKUMARU
    Article type: Features 〔Activity Situation of Division of Research Association for Effective Use of Management System and Audit〕
    2013 Volume 43 Issue 3 Pages 268-273
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_268
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    In the third party certification, the audit activities according to ISO/IEC 17021 are obligated to the auditor. In the audit activities, the preparing audit activities, adequacy of the audit findings, and evaluating the nonconforming report influences the quality of the audit. Therefore, it is necessary to try the maintenance and improvement of the audit technology concerning these matters as for the auditor. An idea for this and a concrete method are shown. On the other hand, to fill the requirement, the organization should manage and improvement for management system. But the organization has the problem of understanding shortage of the standard, effectiveness of internal audit, and integration of management systems. Therefore, the method for the solution of these problems is shown.
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  • Study for an Audit to Certify Conformity, No.2 － Case Studies for Applying the Concept of Joint ISO/IAF Communiques, Expected Outcomes for Accredited Certification to ISO 9001 －
    Yoshikazu KAMEYAMA
    Article type: Features 〔Activity Situation of Division of Research Association for Effective Use of Management System and Audit〕
    2013 Volume 43 Issue 3 Pages 274-279
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_274
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    ISO/IEC 17021:2011 4.4.2 requires that "it (certification body) makes a decision to grant certification if there is sufficient evidence of conformity, or not to grant certification if there is not sufficient evidence of conformity", whereas it has been sometimes conducted in management system certification services that an organization is certified if there is no nonconformity found in a certification audit. Auditors should collect evidences which confirm the ability of an organization to meet the intent of the management system standard. This study is to show an audit method to collect sufficient evidences for confirming the ability of an organization to attain the expected outcomes mentioned in Joint ISO/IAF Communiques, Expected Outcomes for Accredited Certification: July 2009 and case studies applying this method in the actual audits.
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  • Positioning of QMS in Business Processes
    Takeshi NAKAJIMA
    Article type: Features 〔Activity Situation of Division of Research Association for Effective Use of Management System and Audit〕
    2013 Volume 43 Issue 3 Pages 280-285
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_280
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    If an organization utilized the preface of the ISO 9001 : 2008 management system effectively and built QMS, we were convinced that the organization could use it as a tool of the management system. The organization does not build QMS only for standard requirements of ISO 9001 and it is necessary for a current management system to build "New QMS" which let ISO 9001 fuse and suggests an architectural point to it. On the other hand, the organization couldn't but build a management system every standard because the ISO management system standard of various fields existed. However, the ISO standards revised in a purpose to plan the consistency of the ISO management system standard after 2015 will be unified as a text common throughout MSS except some management systems. It is thought that it is the tool of the management system of the organization administration, and New QMS becomes the core of MSS. Therefore we collaborate it with an organization from April to evaluate the effectiveness of New QMS.
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  • The Study of “ the Self-Declaration of Conformity ” which Helps　Management － The innovation to Make a Profit on Useful ISO from Useless One －
    Teruo IKEDA
    Article type: Features 〔Activity Situation of Division of Research Association for Effective Use of Management System and Audit〕
    2013 Volume 43 Issue 3 Pages 286-289
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_286
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    When taking a glimpse at the current state of Third Party Certification in the QMS Certification Examination System, each challenge can be found in the Certification Organization (Examining Authority) and Certified Organization (Examined Organization). Therefore WG4 focused on "the Self-Declaration of Conformity" based on its own identity regarding the Examined Organization's Challenge especially within the Examined Organization's Challenge which appears for being on the defensive and the Examination Organization's Challenge which appears for being on the subjectivity as the WG4 research subject. So WG4 is convinced that the Examined Organization's Challenge is solved by posture of the Examined Organization which works on the initiative and the Examining authority also is refreshed. This study is proposed for the Organization (Examination Organization and Examined Organization) has been established in society.
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  • A Research of Technical Method for Second-Party Audit －Guide Line for Second- Party Audit－
    Keiichi KAWAHARA, Shinichi KIMURA, Hiromichi OGATA, Junichi WATANABE
    Article type: Features 〔Activity Situation of Division of Research Association for Effective Use of Management System and Audit〕
    2013 Volume 43 Issue 3 Pages 290-295
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_290
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    The importance of relationships between organization and suppliers increased in supply chain with economic globalization. Surroundings of products, many management systems have been developed such as quality, environment, labor safety, security and so on. Advancement for mutually beneficial supplier relationships, second-party audit tool is needed to effective improvement. This guide line is established as tools for second-party audit contains audit programs, plans and resources to achieve audit targets based on Japanese organization models research. To solve significant problem continuously consideration is needed not only single management system but also other related system and individual technology. Programs components are setting objectives, achieve method, resource preparation, risk assessment and audit plan do check act cycle. Risk assessment supports to obtain emphasize audit points such as strong or weak management system and individual technology. According to guide line, second-party audit program is carried out with consideration such as business plan, trading scale, comprehensive rate, management system mutuality and individual technology performances, bring desired outcome to organization and suppliers.
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  • Study of the ISO 9001 Promotion that Medium and Small-Sized Business Manager Want to Use － Guideline to Run QMS－
    Tadao OIKAWA
    Article type: Features 〔Activity Situation of Division of Research Association for Effective Use of Management System and Audit〕
    2013 Volume 43 Issue 3 Pages 296-302
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_296
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    The registration organization of ISO 9001 work on improvement of the quality awareness, reinforcement of the system infrastructure. On the other hand, the interest of the manager are sales amount improvement and profitability improvement. This difference is regarded as the reason why the interest of the manager is light. Therefore we studied promotion for ISO 9001 to contribute to an administrative action. The interest aim that there is of the organization are quality, cost, price and delivery. Furthermore, we study structure and the technique of the process to achieve them. We are going to finally edit them as "guideline to run QMS".
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  • In order to Improve the Effectiveness of a Management System － Basic Guideline for the System Audit Procedure －
    Koji KOZUKI
    Article type: Features 〔Activity Situation of Division of Research Association for Effective Use of Management System and Audit〕
    2013 Volume 43 Issue 3 Pages 303-311
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_303
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    In order to improve the effectiveness of a management system, what is necessary for the system audit is our subject. The results were presented in the book "Basic guideline for the system audit procedure". In this thesis, we presented one part of this book, namely the preparation process for the system audit. For the other parts of this book, I presented only the summary of it in this thesis.
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Serial
  • Necessary Requirements of the Data Management Infrastructure for ISO 26262
    Yasuo KANEHIRA
    Article type: Serial [ISO 26262 - Approaches to Functional Safety in Automotive Industry - ]
    2013 Volume 43 Issue 3 Pages 312-317
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_312
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    ISO 26262 requires safety related work products managements throughout its safety lifecycle. To guarantee a defined item satisfies safety goal(s), related work products must be managed well organized by means of a process management, a configuration management, a change management and a traceability in a small granularity. Electrical/Electronics (E/E) system is getting larger and complex for new sophisticated control system, applying ISO 26262 for such E/E system meet the exigencies of the moment. This paper mainly intends to explain the data infrastructure to be used for managing ISO 26262 related system. First it explains the safety lifecycle and the defined V process in ISO 26262 and explains how to manage the V process in a product data management system. Following the chapter requirements of support system written in ISO 26262 part 8 are explained and also very important concept of 'Tool Confidence Level' is described. In the last some advice to built ISO 26262 management infrastructure is shown.
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  • The Survival Strategy at TSUGAWA Corporation
    Masaaki KANEKO
    Article type: Serial [Understand the Specialty Skills for the Small and Medium-Sized Companies to Survive this Age of Change]
    2013 Volume 43 Issue 3 Pages 320-324
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_320
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    In this serial, the survival strategy of TSUGAWA Corporation in this age of change is presented through the two interviews with Mr. Yoshikazu KOMADA who is the CEO of TSUGAWA. TSUGAWA is established in 1953, and provides the financial equipments, medical devices, image processors, amusement machines and so on to the domestic big companies as a middle sized electronics manufacturing service maker. First of all, the history and the profile are explained. Then, the business environment surrounding TSUGAWA is described from the viewpoints of customer market, competitive situation and relationship with the partners such as parts supplier, technical supporting company, distributing agent and so on. Based on the business environment, the following four aspects to understand the specialty skill of TSUGAWA are presented. ●What kinds of customer values are provided? ●What is the key organizational capability to provide the customer value compared with competitors? ●Which of characteristics of the management resources in TSUGAWA are utilized to fulfillment the key organizational capability? ●How did TSUGAWA establish the quality management system in order to utilize the management resources for the key organizational capability effectively?
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Report of the Research Group
Research Papers
Contributed Paper
  • A Statistical Modeling and Optimization of Dynamic Parameter Design
    Toshihiko KAWAMURA, Takenori TAKAHASHI
    Article type: Contributed Paper
    2013 Volume 43 Issue 3 Pages 364-371
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_364
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    Robust parameter design aims to make the signal-response relationship insensitive to noise variation by enabling the choice of appropriate levels for the control factors. This article presents a statistical modeling methodology and an exploratory design approach to dynamic parameter design. The response is modeled as a second order of both the control and noise factors. A statistical formulation is presented for a practical optimization of Taguchi's dynamic signal-to-ratio analysis. The modeling methodology is illustrated using an experiment involving foam rubber in tires designed for snowy conditions.
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  • Studies of Error-Proofing in Medication Incidents － A Method of Planning Countermeasures Focused on Improvement Objects －
    Haizhe JIN, Masahiko MUNECHIKA, Masaaki KANEKO, Masataka SANO
    Article type: Contributed Paper
    2013 Volume 43 Issue 3 Pages 372-386
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_372
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    Incidents during the medication process occur at high rates in most hospitals. Therefore, reducing medical incidents is vital to guarantee healthcare quality. It is an effective countermeasure that improves the working method. In this paper, an error-proofing method is applied to reduce the frequency of such medical incidents. In order to simplify the process of planning error-proofing countermeasures, the following approaches are employed in this study. First, improvement objects are extracted in order to planning error-proofing countermeasures. Second, the extraction set of improvement objects are designed for extracting the improvement objects which caused the error-factors. Third, the appropriate error-proofing solutions are adapted to each improvement objects. Using this method, "what is the improvement objects" and "how to apply error-proofing solutions" can be easily identified and error-proofing countermeasures can become easily. Additionally, this paper presents the results of the application of the proposed method in hospitals. In conclusion, the proposed procedure can facilitate the planning of error-proofing countermeasures and can reduce the medical incidents.
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Technical Note
  • The Kernel Principal Variable Method and Its Application
    Natsuki SANO, Manabu KUROKI
    Article type: Technical Note
    2013 Volume 43 Issue 3 Pages 387-400
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_387
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    The principal variable (PV) method, which was proposed by McCabe (1984), is one of multivariate analysis without objective variables. In the PV method, a fewer appropriate variables, which are called PVs, are selected based on a given PV criterion. However, since the PV method is based on a sample covariance matrix from quantitative data, we may not be able to select appropriate variables when we apply the method to non-linear data. In order to solve this problem, we propose the PV method based on the kernel function. In addition, we compare the proposed method with McCabe's PV method through numerical experiments, and show that the proposed method can select an appropriate set of PV from non-linear data.
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Quality Report
  • A Value Index Considering Attractive Quality and Must-be Quality
    Takeshi NAKAJO
    Article type: Quality Report
    2013 Volume 43 Issue 3 Pages 401-405
    Published: July 15, 2013
    Released on J-STAGE: August 30, 2017
    DOIhttps://doi.org/10.20684/quality.43.3_401
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    The Value Index has been proposed as a tool that can numerically present the effects of quality and price on customer's buying will. The detailed investigation on the relationship between the index and buying will, however, shows that there exists a good linearity for each product but the slope of the line differs product by product. This paper proposed a new value index considering the fact that customer feels some quality items as attractive and others as must-be. Moreover, in order to consider the possibility of the proposed index, it was applied to customer's buying will data for five different products, which were experimentally collected. As the results, it was found that the proposed index has a a possibility of uniformly presenting the relationships between price and buying will for various products in different type/quality, all contributions of attractive quality, one-way quality and must-be quality to overall quality evaluation score should be incorporated, and how to incorporate depends on type of product like necessity and durability.
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