QSA Check List

1: Quality System ( 品質系統 )MenuAvg score:Subtotal:[94%][16]Counts:[17]ScoreYes=1No=0Remarks1.1是否制定文件化的品質政策,品質目標和品質手冊?Has the supplier defined and documented its corporate quality policy, objectives and commitments to quality?是否有形成文件的程序以确保品質政策在組織內各階層得以了解,實施並保持?Are procedures in place to ensure this quality policy is understood, implemented and maintained at all levels in theorganization?對于管理,從事與產品質量,原材料或客戶服務相關之工作的人員,供應商是否明确定義其工作職責,權限和相互關系? ( 例如.程序文件,組織架构圖,品質手冊等)Has the supplier defined the responsibility, authority and interrelation of all personnel who manage, perform andverify work that affects the quality of products, materials or services? (i.e. procedures, organization charts, quality是否提供适當的資源, 以實施內部品質驗証的活動.如:檢驗,測量,監視和產品製程評審?Has the supplier provided adequate resources for in-house verification activities such as inspection, testing,monitoring and review of processes and products?是否指定一名管理者代表, 應具有确保質量管理体系所需的過程得到建立,實施並保持的職責和權限?Has the supplier appointed a management representative who has responsibility and authority for ensuring that aquality management system has been implemented and maintained?是否按策划的時間間隔評審質量管理体系,以确保其持續的适宜性,充分性和有效性?( 例如:品質体系是否滿足客戶要求)Does the supplier conduct management reviews of the suitability and effectiveness of the quality management所有管理評審紀錄是否保持?Are records of these management reviews maintained?是否制定並保持文件化的質量管理体系文件?包括要求形成文件的程序和作業指導書?Has the supplier established and maintained a documented quality system including procedures and workinstructions?是否有效地遵守程序文件和作業指導書執行?Have the procedures and work instructions been effectively implemented?是否貫徹執行全面的內部審核,並且有計划性和文件化?Does the supplier carry out a comprehensive system of planned and documented internal quality system audits?11.211.311.411.511.611.71.81.91.11111內部審核是否遵守品質目標,客戶/製程要求和 ISO要求進行?1.11Do the internal quality system audits verify compliance with quality objectives, customer/process requirements,and ISO elements?表MPT-4-0298A1Page 11.12內部審核是否核實質量管理体系得到有效實施和保持? (例如:評審 SPC 數据和 CLCA 狀況)Do the internal quality audits verify effectiveness of the quality systems? (e.g., review SPC data and CLCA status)內部審核是否按照過程的狀況和重要性來排計划進行?Are the internal quality audits scheduled on the basis of the status and importance of the activity?內部審核和跟蹤活動是否遵守程序文件執行?Are the internal audits and follow-up actions carried out in accordance with documented procedures?111101.131.14負責受審核區域的管理者是否及時采取措施,以消除稽核時所發現的不合格項目?1.15Are the management personnel responsible for the area take timely corrective action on the deficiencies found bythe audit?是否有系統來明确識別從事與產品質量有關活動的人員的教育訓練要求?1.16Is there a system that identifies training requirements for all personnel affecting the quality of the product?1.171.181.19是否有系統存在能決定哪一個人能勝任該工作 ？Does a system exist for determining which personnel are qualified for a job function?是否有系統刪除不能胜任工作的人員資格和重新考核上崗人員資格?Is there a system to disqualify and re-qualify personnel in a job function?是否保持教育訓練紀錄?Are accurate training records maintained?1表MPT-4-0298APage 1