CR Audit Finding Summary.xls

Sheet3 Sheet2 Summary 2 Summary 1 搪膠鋦爐溫度沒有控制(要求130-140度) A9-5 车间内的變色油漆用冰箱儲存，不在溫度控制范圍內 SMT車間冰箱溫度輿指引不符合 針對2009年CAR問題重復出現:膠水未按温度要求存儲 A5-5 靜電部油漆記錄輿生產記錄有2天(抽10天)不相符合(两天分别是7/11,7/19). 在危險倉庫有1桶非CS开油水(潤峰)和CS开油水放在一起 非生產油漆在A3-5 維修部有7桶油漆未有貼非生產油標識 電池過期仍然摆放在合格区 A3-4 车间内的膠水有存儲對溫度的要求，但是存放在常溫下 A9-5 變色油漆用冰箱儲存,温度过低,不在溫度控制范圍內 膠紙機和封箱膠紙機未列入利器范圍，被當作利器進行控制。 工程師自帶利器鉗至A1-3 工場生產線使用，未綁住及登記 EL内部程序EL-OP008 要求供應商評審80分以上,但合格供應商清單中有小於80分的 采購部/貨艙部使用的Mattel CSCS清單無更新 5家no surface coating外发厂未做PI、GMP AUDIT. 2家no surface coating外发厂營業執照過期. 1.5a:Control point:Is there a process in place to identify,analyze document and implement the corrective and preventive actions when potential nonconformity detected? 上次CR AUDIT的GMP发现的问题部分没有跟进记录 1.8a:Control point:Are procedures defined and implemented to ensure all non-conforming materials including raw materials, work-in-process, and finished goods are clearly identified, segregated, reworked and/or disposed off? 装配车间有一个检查位没有不良品的存放筐,可是在桌面有一个不良品 1.10a:Control point:Are procedures defined and implemented to ensure all needle and sharp tools are controlled and secured to prevent improper use and contamination at production and storage? i:封箱机没有做为利器控制. ii:有一个车间的利器柜没有上锁.(工厂解释是前几天锁子刚坏,已经申请购买.有7/5号的采购单) 2.2a:Control point:Does the factory have defined and implemented procedures for the approval and monitoring of its subcontractors to ensure they are meeting all quality and safety requirements? 外发厂有PI的审核记录,部分没有GMP的审核记录. 4.1c:Control point:Does the factory ensure the products are produced according to Mattels requirements? 产品没有做完就打了DC.(i有一款产品是用热烫打DC,打完DC后再装配,在后序工位贴贴纸时发现贴纸尺寸大,而不得不停止做,已经热烫打DC 180个放暂存区贴了标签.ii:)现场问操作人员也清楚这个要求) 4.2a:Control point:Does the factory have a process in place to control work-in-progress and finished goods to assure its conformance prior to release? CTS没有及时做,即下午4:00查时发现当天抽的3批没有做出CTS结果 1. V3016产品上打week code用2011年的周排列表,没有依据QSOP 3598 week code table. (依据QSOP 3598正确应该为D25,错打为D24); 2. 在当天的早上(8:30am)，夹具房还没来