品質
Online ISSN : 2432-1044
Print ISSN : 0386-8230
43 巻, 3 号
選択された号の論文の14件中1~14を表示しています
特集
  • 福丸 典芳
    原稿種別: 特集 『有効な審査技術とQMSの能力向上のためのツール 』
    2013 年 43 巻 3 号 p. 268-273
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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.
  • 亀山 嘉和
    原稿種別: 特集 『有効な審査技術とQMSの能力向上のためのツール』
    2013 年 43 巻 3 号 p. 274-279
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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.
  • 中島 武
    原稿種別: 特集 『有効な審査技術とQMSの能力向上のためのツール 』
    2013 年 43 巻 3 号 p. 280-285
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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.
  • 池田 輝雄
    原稿種別: 特集 『有効な審査技術とQMSの能力向上のためのツール 』
    2013 年 43 巻 3 号 p. 286-289
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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.
  • 川原 啓一, 木村 信一, 緒方 博通, 渡邉 淳一
    原稿種別: 特集 『有効な審査技術とQMSの能力向上のためのツール 』
    2013 年 43 巻 3 号 p. 290-295
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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.
  • 及川 忠雄
    原稿種別: 特集 『有効な審査技術とQMSの能力向上のためのツール 』
    2013 年 43 巻 3 号 p. 296-302
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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".
  • 上月 宏司
    原稿種別: 特集 『有効な審査技術とQMSの能力向上のためのツール 』
    2013 年 43 巻 3 号 p. 303-311
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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.
連載
  • 兼平 靖夫
    原稿種別: 連載 『ISO 26262 - 自動車業界における機能安全に対する取り組み - 』
    2013 年 43 巻 3 号 p. 312-317
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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.
  • 金子 雅明
    原稿種別: 連載 『変化の時代を生き残る中小・中堅企業の得意技を探る』
    2013 年 43 巻 3 号 p. 320-324
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    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?
研究会報告
論文誌編
報文
  • 河村 敏彦, 高橋 武則
    原稿種別: 報文
    2013 年 43 巻 3 号 p. 364-371
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    ロバストパラメータ設計は使用環境条件などの誤差因子に対してロバストになるように制御因子を設計することにより,特性のばらつきを低減させる方法である.本論文では動特性のパラメータ設計に対する統計的モデリングアプローチおよび探索的設計による最適化手法を提案する.特性に対し制御因子と誤差因子の2次モデルを想定し切片のある比例式に基づく統計モデルを構築する.これにより従来の動特性に対するSN比解析を拡張し最適化を行う.さらに降雪地域用タイヤの発泡ゴムの実験の事例を用いて,その方法論の有効性を検証する.
  • 金 海哲, 棟近 雅彦, 金子 雅明, 佐野 雅隆
    原稿種別: 報文
    2013 年 43 巻 3 号 p. 372-386
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    医療事故に占める与薬事故の割合は,いずれの病院でも高い.そのため,医療の質保証において与薬事故の低減は重要な課題の一つとなっている.医療事故の防止策は様々考えられるが,エラーの発生しにくい作業方法にすることが有効である.本論文では,与薬業務に着目し,発生防止の視点から,エラープルーフ化の対策を容易に導くための手法を提案する.提案法では,与薬作業中にエラープルーフ化対策の対象となりうる要素を,改善対象要素として提案する.その中から,エラー要因を引き起こした改善対象要素の抽出方法として,改善対象要素抽出シートを設計する.また,各改善対象要素にエラープルーフ化の実現方法を対応付けし,対策発想観点リストとして提案する.このことにより,エラープルーフ化の原理を,何に対して,どのように適用するかが示され,容易にエラープルーフ化の対策が立案できる.医療従事者が本提案法を使うことにより,具体的かつ体系的にエラープルーフ化の対策を立案できたことが確認できた.また,立案した対策案を病院に導入した結果,与薬事故の低減が確認できた.
技術ノート
  • 佐野 夏樹, 黒木 学
    原稿種別: 技術ノート
    2013 年 43 巻 3 号 p. 387-400
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    主変数選択法は,多変量連続データが与えられたとき,それらのばらつきの状態をなるべく少ない数の変数を用いて説明することを目的として,興味ある統計的変数選択基準(主変数選択基準)に基づいて少数の適切な変数(主変数)を選択する「基準変数(目的変数)を持たない多変量解析法」のひとつであり,McCabe(1984)によって提案された.しかし,McCabe(1984)の主変数選択法では,標本共分散行列に基づいて主変数選択基準が定式化されているために,非線形データに適用した場合には,変数間の従属関係を考慮した変数選択が行われるとは限らない.本論文では,この問題を解決するために,非線形データに対する主変数選択法として,カーネル主変数選択法を提案する.また,数値実験と適用例をとおしてカーネル主変数選択法の有用性を検証する.
クオリティ レポート
  • 中條 武志
    原稿種別: クオリティ レポート
    2013 年 43 巻 3 号 p. 401-405
    発行日: 2013/07/15
    公開日: 2017/08/30
    ジャーナル 認証あり
    品質と価格が顧客の購買意欲に与える影響を定量的に表現する一つの指標として価値指数がある.しかし,価値指数と購買意欲との関係を調べると,製品・サービスごとに良い直線性が得られるものの,製品・サービスによってその傾きが大きく異なることが知られている.本論文では,顧客が各品質項目を魅力的,一元的,当り前のいずれに感じているかを考慮した新しい価値指数を提案した.また,この式を実験的に得た5製品の購買意欲のデータに当てはめ,その可能性を検討した.結果として,提案した価値指数を用いることで様々な製品・品質水準についての価格と購買意欲の関係を統一的に表すことができる可能性があること,この価値値数においては総合的品質評価点の中の魅力的品質,一元的品質,当り前品質の寄与率をすべて考慮する必要があること,どのように考慮するのがよいのかは日常性や耐久性などの製品属性によって異なることがわかった.
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