管理系统文件化.pptVIP

管理系統文件化 張書奇 Shu-Chi Chang, Ph.D., P.E., P.A. Assistant Professor1 and Division Chief2 1Department of Environmental Engineering 2Division of Occupational Safety and Health, Center for Environmental Protection and Occupational Safety and Health National Chung Hsing University Tuesday, December 16, 2008 Why 文件化 一切有所依據 可確保品質一致 流程管理之首要工作 知識管理之起步 Why 文件化 provide people with all the safety, health, environmental and operational information production operations are performed consistently to maintain quality control of processes and products processes continue uninterrupted and are completed on a prescribed schedule no failures occur in manufacturing and other processes approved procedures are followed in compliance with company and government regulations training document for teaching users about the process for which the SOP was written a checklist for co-workers who observe job performance to reinforce proper performance a checklist for auditors an historical record of the how, why and when of steps in an existing process an explanation of steps in a process so they can be reviewed in accident investigations 流程管理 “the quality of a system or product is highly influenced by the quality of the process used to develop and maintain it,” 流程管理 流程管理 Unified model for 22 process areas Two different representations Structure of CMMI staged representation Staged representation Taiwan is adopting CMMI 一般管理系統之四階文件 標準作業程序SOP 廣泛用於軍事規範中 因品質管理與流程管理之需要，廣泛應用於各行各業 定義：detailed, written instructions to achieve uniformity of the performance of a specific function. ISO 9001文件化要求 4.2文件要求 4.2.1概述 ：品質管理系統文件化應包括 品質政策與品質目標之文件化敘述， 品質手冊。 本標準要求之文件化程序。 組織為確保其過程的有效規劃、運作及管制所需之文件。 本標準要求之品質紀錄。 本標準中所出現之〝文件化程序〞一詞，係指此程序之建立、文件化、實施及維持。 品質管理系統文件化之程度，各組織間可由於下列因素而有所差異 組織之規模與作業之型態。 過程與其相互作用之複雜性。 人員之能力。 文件化可以採用任何形式或型態之媒介。 文件要求-手冊 4.2文件要求 4.2.2品質手冊：組織應建立與維持品質手冊，並包括 品質管理系統之範圍，包括任何排除之細節及其理由。 為品質管理系統而建立之文件化程序或其對照引用者。 品質管理系統各項過程間相互作用之敘述。 文件要求-文件管制 4.2.3文件管制：品質管理系統所需之文件應依照第4.2.4節所定的要求建立文件化程序予以管制。 在文件發行前核准其適切性。 必要時