整合六標準差及精實生產於ISO 9000品質管理系統

INTEGRATING SIX SIGMA AND LEAN PRODUCTION INTO ISO 9000 QUALITY MANAGEMENT SYSTEM

俞凱允(Calvin K. Yu) ； 蘇力萍(Li-Ping Su)

《品質學報》 26卷2期 (2019/04) Pp. 92-113

https://doi.org/10.6220/joq.201904_26(2).0002

摘要

因應新版ISO 9001：2015條文要求強調風險管理，為了降低不確定因素所造成的影響，本研究藉由結合六標準差與精實生產的改善管理手法，建立一套符合ISO 9000品質管理系統之明確且有效率及持續改善的文件標準作業程序，用以補強ISO 9000著重於條文標準，卻未能具體提供改善手法或工具的缺點。個案公司藉由重新審視新產品設計開發作業流程，運用六標準差設計（design for Six Sigma, DFSS）之DMADV（define, measure, analyze, design, verify）及精實生產（lean production）的概念，以發覺風險源，再針對關鍵問題重新設計新的作業流程，運用DMADV及價值溪流圖（value stream mapping, VSM）等一系列的改善動作並制定新的管理作業程序，讓作業時程由改善前的8個多月至改善後縮短為6個月，而成本亦節省20%，新產品開發時間縮短25%。經由實證得到將六標準及精實生產的改善手法結合於ISO 9000品質系統，可使企業降低成本、減少浪費、提升作業效率、培養與提升人員能力及創造組織文化。

關鍵字

ISO 9000品質管理系統 ； 六標準差 ； 精實生產 ； 六標準差設計 ； 價值溪流圖

並列摘要

The new ISO 9001:2015 standard explicitly expects organizations to identify and address risks affecting product and service compliance; resulting in improved customer satisfaction. To prevent and correct unwanted actions and outcomes, this research proposes a framework for integrating Six Sigma and lean production into ISO 9000 quality management system in order to overcome the lack of addressing ＂how to do＂ in the ISO 9000 system and to establish an efficient and effective documentation system that will support continuous improvement. A case study is included which describes the experience of a local company using the proposed approach in its new product development department. By reviewing its procedure manual, several possible sources of risk were identified. After applying design for Six Sigma (DFSS) methodology DMADV (define, measure, analyze, design, verify) and lean production with value stream mapping (VSM) problem solving steps, a new procedure has been developed and implemented to improve operating efficiency in the department. The result shows that the time needed to develop a new product is shortened by 25% and the cost is down by 20%. The study also shows that by integrating Six Sigma and lean production into ISO 9000 system can help companies reduce costs/wastes, improve efficiencies, and increase profits. Moreover, to ensure continuous improvement of business continuity.

並列關鍵字

ISO 9000 quality management system ； Six Sigma ； lean production ； design for Six Sigma (DFSS) ； value stream mapping (VSM)

參考文獻

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