Question classification Insufficient Clean Insufficient Clean Staff awareness Staff awareness

时间 2014.03.21 2014.03.21 2014.03.21 2014.03.21 房间发现有昆虫

具体问题

房间号B117 B110 B106,B116 B122 B123 B101 B100 B100

已清洁设备有小丸残留 门未及时关闭 记录填写不及时 地漏损坏 兰索小丸装桶未按规程操作 门未及时关闭 记录填写不及时

The damage of the 2014.03.21 facilities and equipment The management of the 2014.03.21 room Staff awareness 2014.03.31 Staff awareness Temperature and humidity is not standard The damage of the facilities and equipment The damage of the facilities and equipment The management of the room Staff awareness Staff awareness2014.03.31

2014.03.312014.03.31 2014.03.31 2014.03.31 2014.04.04 2014.04.04

温湿度超标仓库进出物料门损坏 地漏损坏 模具未上锁存放 门未及时关闭 记录填写不及时

B111,B110,B108,B109,B115H114,H115 B119 B102 B110 B119

Temperature and humidity 2014.04.04 is not standard The damage of the facilities and equipment 2014.04.04 The damage of the 2014.04.04 facilities and equipment The management of the room The management of the room2014.04.04 2014.04.04

温湿度超标包衣间地板损坏 男二更门坏 半成品库乱 推车应统一管理

B111,B106,B108,B104,B117B123 B112 B105 B130

Staff awareness

2014.04.11

设备清洁后无标签 A楼灭蚊虫器损坏 地漏损坏 物料未避光 L30D散落地板,未及时清洁 设备清洁后无标签 消毒剂过期 记录填写不及时

B127 A119 B123 B121 B135 B127 B113 B122

The damage of the 2014.04.11 facilities and equipment The damage of the facilities and equipment 2014.04.11 The management of the room Insufficient Clean Staff awareness Staff awareness Staff awareness2014.04.11 2014.04.18 2014.04.18 2014.04.18 2014.04.18

Temperature and humidity 2014.04.18 is not standard The damage of the 2014.04.18 facilities and equipment The damage of the 2014.04.18 facilities and equipment Insufficient Clean 2014.04.25 Instrument did not check 2014.04.25 Temperature and humidity is not standard The damage of the facilities and equipment The management of the room Staff awareness 2014.04.252014.04.25 2014.04.25 2014.04.30

温湿度超标地漏损坏 烘干机损坏 设备清洗不干净 电子称未及时校验

B111,B110,B108,B123 B317 B127 B108

温湿度超标地漏损坏 物料未避光 设备清洁后无标签

B109,B115B123 B121 B127

Temperature and humidity 2014.04.30 is not standard The damage of the 2014.04.30 facilities and equipment The management of the 2014.04.30 room

温湿度超标地漏损坏 物料未避光

B111,B110B109,B115B123 B121

The management of the room Insufficient Clean Staff awareness Staff awareness Staff awareness Staff awareness Staff awareness Staff awareness Staff awareness The management of the room Staff awareness Staff awareness Staff awareness The management of the room The management of the room

2014.0

4.30 2014.05.09 2014.05.09 2014.05.09 2014.05.09 2014.05.09 2014.05.09 2014.05.09 2014.05.09 2014.05.09 2014.05.16 2014.05.16 2014.05.16 2014.05.16 2014.05.16

合格后未更换房间状态牌 房间清洁，还是污垢 设备清洁后无标签 记录填写不及时 设备清洁后无标签 仓库物料状态牌填写错误多 门未及时关闭 消毒剂过期 配液桶无标签 生产利必非胶囊发现有美沙拉嗪胶囊 门未及时关闭 配液桶无标签 消毒剂过期 房间搅拌机状态与实际不符 房间同时有2张状态标签 更衣间乱 暂存间物帐不符 电子称未及时校验 照明灯损坏 清洗间锁坏 地板损坏

B106 B135 B127 B104,B119 B127 H117 B117 B113 B100 B111 B100 B100 B130 B100 B123 H124 B101 B108 B130 B116 B119

The management of the 2014.05.16 room The management of the 2014.05.16 room Instrument did not check 2014.05.23 The damage facilities The damage facilities The damage facilities of the 2014.05.23 and equipment of the 2014.05.23 and equipment of the and equipment 2014.05.23

The management of the room The management of the room The management of the room Insufficient Clean Insufficient Clean

2014.05.23 2014.05.23 2014.05.23 2014.05.30 2014.05.30

无关物品未及时移出配液间 搅拌机未及时清洗 设备清洁期已过，未及时重新清洁. 房间发现有昆虫. 清洁的水分测量仪中发现有小丸的存在. 电子称未及时校验. 压差表安装错误. 房间地漏损坏. 照明灯损坏. 房间待整理. 酮诺芬原料未避光处理. 配液间用过的桶未及时移出房间. A楼无房间与设备状态牌的卡槽. 门损坏. 房间状态牌填写不完整. 温湿度仪无显示. 工具生锈未及时清洁处理. 门未及时关闭. A楼走廊与房间有美沙拉嗪残渍. 电子称未及时校验.

B100 B100 B127 A139 B117 B108 A119 B122 B130 B100 B121 B100 A126,A127 B135 B110 B100 B115 B100 Building A B108

Instrument did not check 2014.05.30 The damage of the facilities and equipment The damage of the facilities and equipment The damage of the facilities and equipment The management of the room The management of the room The management of the room The management of the room The damage of the facilities and equipment The management of the room The management of the room Insufficient Clean Staff awareness Insufficient Clean2014.05.30 2014.05.30 2014.05.30 2014.05.30 2014.05.30 2014.05.30 2014.05.30 2014.06.05 2014.06.05 2014.06.05 2014.06.06 2014.06.06 2014.06.13

Instrument did not check 2014.06.13

The damage of the facilities and equipment The management of the room The management of the room The management of the room The management of the room The management of the room Insufficient Clean

2014.06.13 2014.06.13 2014.06.13 2014.06.13 2014.06.13 2014.06.13 2014.06.20

搅拌棒损坏(A1149). 房间有2只空桶. 房间有剩余未知溶液的桶. 房间无设备状态牌. 原料未避光. 房间无状态牌. 走廊中有飞虫存在.

B100 B10

0 B100 B125 B121 B111 Building A

Temperature and humidity 2014.06.20 is not standard The damage of the facilities and equipment 2014.06.20 The damage of the 2014.06.20 facilities and equipment The management of the 2014.06.20 room Insufficient Clean 2014.06.27 Insufficient Clean Insufficient Clean Insufficient Clean Insufficient Clean Insufficient Clean Staff awareness Staff awareness Staff awareness2014.06.27 2014.06.27 2014.06.27 2014.06.27 2014.06.27 2014.06.27 2014.06.27 2014.06.27

房间在08:35-10.20的湿度为66.5%,超出 规定.房间的烘手机损坏. 传递窗的门坏了. 配料间没有酒精消毒液. 房间门口还是有美沙拉秦颗粒残渍. 女一更有蚊子出现. 房间未晾干的设备放入塑料袋中. 房间地面有粉末出现，未及时清理. 房间有昆虫出现. 房间在做清洁验证时发现在毛刷下有未知粉 末. 房间门没有及时关闭 配液期间人员不在现场而放水龙头正打开着. 房间门在早上经常没有关闭. 房间的地板开裂.

B119H123 H125 H121,H124 A123 Building B B111 B108 B125 B111 B135 B100 B100 A122

The damage of the 2014.06.27 facilities and equipment

The damage of the facilities and equipment The damage of the facilities and equipment The management of the room The management of the room The management of the room The management of the room Staff awareness

2014.06.27 2014.06.27 2014.06.27 2014.06.27 2014.06.27 2014.06.27 2014.07.04

房间的烘手机损坏. 房间的防爆开关松动，存在不安全性. 房间有空酒精桶未及时搬离房间. 房间搅拌器需要清洁. 包衣间待清洁状态下应及时移除上批物件，再 挂上待清洁标签. 配液间有不相关酒精桶未及时移出房间. 仓库的出库门要及时关闭. 地板有明显的损坏，已见到水泥. 清洗间地板衔接条有较大损坏. 房间的地板开裂. 配液间9空桶，未及时移出房间. 物料暂存间的M14004批25%单硝酸异山梨酯乳 糖混合未避光. 房间有空酒精桶未及时搬离房间. 缓冲间有2只虫子尸体. 房间磷酸三钠桶未做标签. 房间的地板开裂. 十几袋已磨好粉的14181批茶碱未作标签，且 三块垫仓板上标记为“茶碱 14081. 房间有2只空酒精桶未及时搬离房间,且已使用 好的搅拌器有残渍. 房间有4只空酒精桶未及时搬离房间.

H123 B124 B100 B100 B122 B100 Building H Building B B116 B116 B100 B123 B100 A121 B108 B116 B122 B100 B100

The damage of the 2014.07.04 facilities and equipment The damage facilities The damage facilities of the 2014.07.04 and equipment of the and equipment 2014.07.042014.07.04 2014.07.04 2014.07.04 2014.07.11 2014.07.11

The management of the room The management of the room The management of the room Insufficient Clean Staff awareness

The damage of the 2014.07.11 facilities and equipment The management of the 2014.07.11 room The management of the room The management of the room2014.07.11 2014.07.11

The management of

the room The management of the room The management of the room The management of the room Staff awareness The management of the room Insufficient Clean The management of the room The management of the room Insufficient Clean The management of the room Insufficient Clean The management of the room The management of the room Staff awareness Insufficient Clean

2014.07.11

物料暂存间M1004批25%ISMN乳糖混合未避光. 半成品暂存间140201批非诺贝特胶囊(II)代 验状态却未贴“HOLD”标签； 房间有1桶95%乙醇溶液配好溶液后未放回物料 暂存间； 房间有一块百洁布。

B121 B105 B100 B127

2014.07.18 2014.07.18 2014.07.18 2014.07.18 2014.07.182014.07.18

房间的搅拌器未及时清洁；复称间地上有2只塑料勺；

B100B108

房间门框滴水；A117房间压差为0,A115房间压差为4Pa; A111房间无状态牌，且房间内颗粒包装机上有 用剩的美沙拉秦纸铝； A楼美沙拉秦走廊及A120走到均有虫尸。

B116A117,A115 A111 A120

2014.07.18 2014.07.182014.07.18

2014.07.182014.07.18

房间的地上有2只空桶及1块毛巾；

B100A120

A楼美沙拉秦走廊及A120走到均有虫尸；房间磨粉已结束三天尚未清洁。 原本非诺贝特小丸的二袋滑石粉的二张标 签贴在一个塑料袋上，另一袋无标签，且 标签信息与实际不相符合.

2014.07.18 2014.07.18 2014.07.18 2014.07.18

B115 B123 A119 A120 A128 A129 A123 B130

退库物品桶上的标签未及时清除.地面与墙面有发霉情况. 房间灯管坏. 房间的温湿度仪未及时校验 房间的湿度为67.7%,且出风口有水滴出 现 房间有几只蚊子；

The damage of the 2014.07.18 facilities and equipment Instrument did not check 2014.07.18 Temperature and humidity 2014.07.18 is not standard Insufficient Clean 2014.07.22

Insufficient Clean The management of the room The management of the room Staff awareness

2014.07.22 2014.07.22 2014.07.22 2014.07.23

待检查的房间胶囊填充机操作台面有小 丸； 房间的纯水龙头上挂着未清洁干净的搅 棒； 房间放着清洁工具。 兰索拉唑铝塑的包装前密封性检查未及时 B111 复核

B110 B125 B116

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Staff awareness

Insufficient Cleaning The management of Instrument did not The damage of the the room check facilities and equipment

Temperature and humidity is not standard