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halates)?過去一年內有無有害物質不合格(如重金屬及鄰苯二甲酸鹽)發(fā)生?Findings:調查的結果:3. Manufacturing processes 制造過程Yes是No否Remark備注 Manufacturing management 制造管理 Are the workfloors clean and tidy? 工作地面是否干凈整潔? Have all main equipments used in inspection, measuring and testing been controlled and recorded effective? Including maintain effective. Are the records of daily maintained? And termly maintenance kept? 在用的主要設備是否有控制及記錄?包括有效的保養(yǎng)? 日常維護和定期維護的記錄是否得到保存? Is the quality ensured by the clear manufacture control procedure? Can the control information and process abnormity disposing records be provided?是否有明確的生產控制程序來確保質量?是否能提供控制數據和制程異常處理記錄? Is the main and special process controlled effective? Any Records can be reviewed? 對關鍵和特殊過程是否得到有效控制,并有記錄可查? Is the SOP in the work locale? Is the regulation clear? Do the operators do as the SOP?作業(yè)指導書是否懸掛在作業(yè)現(xiàn)場?規(guī)定是否清楚明了?操作員是否按照作業(yè)指導書的規(guī)定作業(yè)? Is suitable Inprocess quality control adopted in production? 生產中是否采取有效的質量控制? Is suitable quality control adopted to ensure the finished product plying with requirement? 是否采取恰當的質量控制來保證成品符合要求? Is there a Training procedure? Have the persons who affect the quality and work in special process been trained? 是否有培訓程序?是否對所有從事質量有影響和特殊工作的人員進行了培訓? Traceability and Identification 追蹤及確認 Are the raw materials, WIP and finished product in the workshop clearly identified? 在車間原材料,半成品和最終產品是否清楚地區(qū)分? Does factory maintain clear records on traceability? 工廠是否保留清楚的追蹤記錄? Are all inprocess and finished goods activities records traceable to a specific lot? 所有的半成品和成品是否都具有可追溯性?Findings:調查的結果:4. Measurement測量Yes是No否Remark備注 Is there a procedure to control the production process? Do the operators perform inspection and acceptance criteria ply with the procedure? 是否有制程檢驗程序?是否能按照程序規(guī)定檢驗?