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標題: 持續不是連續或不斷,改進不只是改善,持續改進是改善 [打印本頁]

作者: hlperng    時間: 2016-1-12 11:53:27     標題: 持續不是連續或不斷,改進不只是改善,持續改進是改善

本帖最後由 hlperng 於 2016-1-12 14:41 編輯

持續不是連續或不斷,改進不只是改善,持續改進是改善。
(延伸自 http://redi.org.tw/forum.php?mod ... ge=1&extra=#pid1213 #9 的內容)

ISO 9001 第三版 (2000)、第四版 (2008) 對於第 8 章「量測、分析、與改進」(measurement, analysis and improvement) ,第 8.5 節 「改進」一節,有三小節:8.5.1 「持續改進」(continual improvement)、8.5.2 「改正行動」(corrective action, CA)、8.5.3 「預防行動」(preventive action, PA)。

2014 年 ISO 9001 的 DIS 版,將原在第 8 章中的改進獨立出來,改為第 10 章「改進」(Improvement),包括 3 節,10.1 概述(general)、10.2 不符合性與改正行動(nonconformity and corrective actions)、10.3 持續改進 (continual improvement)。第 10 章最大的意義在於「持續」 (continual) 與「改進」 (improvement) 兩個名詞的意義。2015 年 ISO 9001:2015 FDIS 版,除少數修正外,大致與 DIS 版類似。

比較 2015 年第五版與 2008 年第四版,ISO 9001 對於改進的論述改變很大,主要的重點有兩項,第一是點出章標題:10. 「改進」 (improvement) 與第 10.3 節標題「持續改進」或「時常改進」 (continual improvement),兩者有大小範圍的差異,第二是取消過去大家已經習慣常用的「預防行動」(preventive action, PA) 與「改正行動」(corrective action, CA) 兩大改進法寶中的「預防行動」(PA)。對於習慣於標準化作業名稱者會相當苦惱,不知如何分解 PACA。

不過預防行動只是表面上被取消,取代之的是基於風險思維或風險為基思維 (risk-based thinking)。主要的觀念在於,當發現品質管理系統發生不符合情事時,就要馬上改進,若使用預防行動作為其手段,在觀念有可能會誤導到「改進的動作可以延到以後再說」的疑慮,這一點符合現代許多管理常採用的行動方式,那就是將過去的事先規劃的預防 (preventive),改為較務實的預測 (predictive) 或互動或調適 (proactive or adaptive) 的趨勢。

至於改進與持續改進,首先應該了解英文 continual 一字的意義,continual 是指的持續、時常、常常發生,但是有開始有結束,反複不斷地頻繁的意思,而 continuous 則是連續不中斷、不停止。所以 continual improvement 是持續改進、continuous improvement 則是不斷改進。管理系統不可能一直再改變,因此可以想像,ISO 9001 使用使用較為嚴謹的 continual 而不是大家習慣常用的 continuous。中文翻譯為持續,因此可以稱 continual improvement 為持續改進,若是使用持續不斷改進或不斷改進,則會超過英文的原義。當然在一般論述時,不會也不需要像標準制定機構那麼嚴謹,可以將 continual improvement 和 continuosu improvement 視為同義字。

有關改進 (improvement) 部分,可以從第 10.1 節第二段後面的注釋 (NOTE) 看出它的意義,改進可以考量的方式包括:改正 、改正行動、持續改進、突破式變更、創新、和組織重整,由此可知持續改進只是改進的方式之一。其中,改正一般是指發現不符合馬上處置 (disposition) ,例如重工或修理等消除之;改正行動是擬訂行動方案 (action plan or cure plan),然後指定擔當人員或單位負責執行決議的行動項目 (action items);突破式變更,採取脫胎換骨的行動,改變現行作法 (變更 SOP) 以消除不符合;創新則是增加新的考量,消除或避免不符合發生;若不符合是源自組織職能與權責分工問題,則可進行組織重整。
FDIS 版與 DIS 版的內容分別為:
FDIS 版:「改進的範例可以包括改正(或矯正)、改正行動、持續改進、突破性變更、創新、與組織重整。」(Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.)
DIS 版:「改進效果的產生可以反應式(例如改正行動)、漸進式(例如持續改進)、階梯式變更(例如突破)、創造式(例如創新)、或藉由組織重整(例如轉變或轉型)。」(Improvement can be effected reactively (e.g., corrective action), incrementally (e.g., continual improvement), by step change (e.g., breakthrough), creatively (e.g., innovation) or by re-organization (e.g., transformation). )

改進與改善之區別,可能就要追溯到西方人對於改善 (Kaizen) 與改進 (improvement) 的看法。日本改善之父、美國持續改進研究院院長今井正明 (Masaaki Imar) 先生在 1997 指出,管理 (management) 有兩項功能,包括維持(或維護) (maintenance) 與改進 (improvement)。其中維護指的是維持現有技術、管理及運作標準有關的活動,以及透過訓練與紀律保持這些標準。改進 (improvement) 指的是提升現有(技術、管理及運作)標準有關的活動,又分為改善 (kaizen) 與創新 (innovation) 兩部分,亦即:改進 (Improvement) = 持續改進 (continuous improvement) + 創新 (innovation)。改善或持續改進 (continuous improvement, CI) 為小改進 (small improvements),是一種持續的努力 = 現場改善 (Gemba Kaizen) 。

改善 (kai-zan) = Kai (change) + zen (for the better),大部分討論 Kaizen (改善)的文章中,對應的英文大多寫為 continuous improvement。配合 ISO 9001:2015 的澄清,或許日後大家可以將 continous improvement 改為 contiual improvement。否則日常管理會變得很辛苦,難免會影響到效率。


管理上常用的改進相關日式英文包括:






ISO 9001 2000 版與 2015 年版改進要求比較

2000 & 2008

2015

8.5 Improvement10. Improvement
8.5.1 Continual improvement10.1 General
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as well as to address future needs and expectations;
b) correction, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management system.
NOTE.  Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.  
8.5.2 Corrective action10.2 Nonconformity and corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.  
A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken, and
f) reviewing the effectiveness of the corrective action taken.  
10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
    1) take acton to control and correct it;
    2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
c) implement any action needes;
d) review the effectiveness of any corrective action taken;
e) update risk and opportunites determined during planning, if necessary;
f) make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and nay subsequent actions taken;
b) the results of any corrective action.  
8.5.3 Preventive action10.3 Continual improvement
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.  Preventive actions shall be appropriate to the effects of the potential problems.
A documented procedure shall be established to define requirements for
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) records of results of action taken, and
e) reviewing the effectiveness of the preventive action taken.  
The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.  
The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.  










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