供應商審核檢查表(編輯修改稿)

　

【文章內容簡介】 _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________總計（POINT TOTAL）：________ 文件與資料變更的控制（DOCUMENTATION AND CHANGE CONTROL） 書面化的資料是否包含以下各項？Are the following documented? 主要的設計特性（適用時）Major design characteristics (if applicable) _____ 使用的材料Materials used. _____ 過程控制程序Process procedures. _____ 檢驗程序Inspection procedures. _____ 有關成品的制造及測試所必須的程序和記錄是否被控制？ All other necessary procedures needed for manufacturing and testing of finished products. _____ 有否建立文件變更的管理系統？ Has a system been established to make changes in controlled documentation? _____ 有否建立文件變更的審批準則？ Is there an established level of approval needed for documentation changes? _____ 更改內容、生效日期是否在圖紙、程序等文件上標明或證實？ Are change levels and effectivity dates indicated and verifiable on drawings, procedures, etc.? _____ 若允許，手工的改動是否有受控文件的控制？ If permitted, are handwritten changes to controlled documentation limited? _____ 依靠什么手段？By what means?_____________________________ 在規定的期限內，文件總清單上是否被更新以反映經認可的手寫變動？ Are specification masters upgraded to reflectauthorized handwritten changes withi n a specific time period? _____ 如何控制？How is this controlled?________________________________________ 現行的文件是否有有效文件總清單？ Are there master document files for active specifications? _____ 是否保留文件變更的記錄？ Is the revision history for specifications retained? _____ 有無一既定的方法用來清除所有生產、檢驗現場內作廢的圖紙的程序及說明？ Is there a method for removing obsolete drawings, procedures, and specifications from all production and inspection areas? _____ 對于受控文件及其它公司的記錄是否建立或已有一個糾正措施程序？ Have error correction procedures for controlled documentation and other pany records been establishedand implemented? _____ 程序是否包含以下各項？Does the procedure include the following: 不允許使用修正液No use of correction fluid allowed. _____ 不允許使用鉛筆No use of pencil allowed. _____ 不允許使用鋼筆No use of felttip pens allowed. _____ 不允許涂改錯誤No obliteration of errors allowed. _____ 糾正人能識別Identification of person making the correction. _____ 修正的日期（年、月、日）Date (month, day, year) of the correction? _____ 是否注明修正的原因Reason for correction if not obvious. _____ 在自動分發系統中對可能會沒有被接收的是否每年定期審閱？ For specifications not received by automatic distribution, is there an annual review of specifications that assures that only the latest specifications are in use? _____ 必要的標準、圖紙是否在現場易于得到并被理解？ Are necessary specifications, required drawings, and other drawings accessible to inprocess personnel? _____意見（COMMENTS）: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________總計（POINT TOTAL）：________ 記錄保存（RECORD RETENTION） 以下記錄是否被保存至所列出的期限內？ Are the following records retained for the minimum time periods listed? 人員的培訓及測試（一年內的有效保存在整個雇用期間的記錄） Personnel training and testing (one year active file retention, then archived for entire period of employment). _____ 檢驗操作記錄、生產過程記錄、進料和過程記錄（一年） Inspection operations: production processes, ining, and inprocess (one year). _____ 有關圖片、認證、質量一致性的檢驗（五年） Screening, qualification, and quality conformance inspection (five years). _____ 不良記錄及分析（五年）Failure reports and analysis (five years). _____ 有關設計、材料、過程變更的書面記錄（五年） Initial documentation and subsequent changes in design, materials, and processing (five years). _____ 設備的校驗記錄（五年）Equipment calibration (five years). _____ 預防性維護記錄（五年）Preventive maintenance (one year). _____ 有關過程、利用率及材料控制的記錄（一年） Process, utility, and material control (one year). _____ 證明產品的記錄（5年）Product lot identification (five years). _____ 追溯產品的記錄（5年）Product traceability (five years). _____意見（COMMENTS）: ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________