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1、样品管理制度1目的:规范本厂样品的管理。2范围:本规程适用所有化验留样、商检留样及外寄样品的管理。3职责:服务中心和化验室责本规程的实施。4程序(内容):4.1样品瓶的灭菌:玻璃样品瓶在160c干热灭菌2小时,塑料样品瓶用二氧化氯(150ppm,30分钟)灭菌。4.2样品的采集采样方法: 无菌操作法,既将样品袋拿回实验室,在无菌室用75%酒精棉球对样品袋盖子、启盖器及工作人员的手处进行酒精消毒,然后再倒出所需样之数量,之后再对盖子和盖口进行消毒,消毒之后,立即盖上盖子将样品放回原处。4.2.1对每生产批次(共n桶)的产品,在灌装开始30min后取第一次样品(2个小无菌袋,采样各2l),4.2.
2、2在罐装一半时取第二次样品(6个小无菌袋,每袋采样2l),作为本批次产品中间样品。其中,一个作为本批次样品复测用样,标识为批次号,中间样(复测样),采样序号,采样人,采样日期,取样结束后,一个作为本批次产品微生物检验用样,表示为批次号,中间样(微生物检验用样),取样结束后化验员负责取回样品,并交微生物检验员。另一个作为本批次产品理化指标检验用样,标识为批次号,中间样(理化检验用样),采样序号,采样人,采样日期,取样结束后化验员负责取回样品。另外三个做为商检留样,标识为批次号,采样序号,采样人,采样日期。4.2.3在灌完结束前30min采第三次样品(2个小无菌袋,采样各2l),标识为批次号,采样
3、序号,采样人,采样日期。一个化验室留样;一个商检样。4.2.4 所取样品应只与对应批次同类、应置于样品桶内成品包装袋上方,顶部加盖,桶外加贴“留样桶(商检样)”或“留样桶”4.3标识桶的贮存服务中心负责将样品桶按对应批次放置于成品垛的前面,存放条件为采样员易采样为宜。4.4已售成品样品的管理发货前,服务中心应及时通知质检部发货的批次及发货的时间,样品管理员于发货前将该批次样品从样品桶中取出,存放于冷库样品柜上,并对该样品进行登记。对于存放在样品柜上的样品,再按生产时间或发货时间的顺序,整齐的存放好,作好标识,并对样品柜每隔一周进行打扫,作到干净、卫生。由样品管理员定期检查捕鼠装置并做记录。样品
4、柜每一个榨季开始,都要清理、整理一次,作到新旧样品分明,并根据实际情况对已发过货所留的样品进行处理。4.5外寄样品的管理4.5.1质检部在接到贸易部备样通知单后,根据要求及时准备所需样品,对有特殊要求的备样通知单和给重要客户的备样,须经质检部领导审核后方可备样,具体步骤如下:用已灭菌好的250ml样品瓶从外寄样品袋中(2l)分装所需数量的样品,并根据要求贴上标签。根据要求进行检测,结果记录于成品复测记录中,并对所备样品出具检验证书,同样品放在一起(同时给市场部email)。4.5.2样品的领取手续质检部及时备好样后(对有特殊要求的备样和给重要客户的备样,传递前须经部门领导审核批准),通知市场二
5、部从质检部领取,领取时在样品领用登记表中签字,注明领用日期、领取人姓名,由样品管理员在样品领用登记表中注明领用样品的批次、数量、包装形式。.样品复测制度根据需要,管理员对外采样、库存样及时进行复测,复测结果记录在成品检验记录中,必要时,每隔一月对库存所有批次样品进行复测,复测样品为样品桶中的复测样样品袋,直到本批次货发完为止。.样品的标识所有样品均应进行正式标识,标识应按具体要求执行。.样品瓶的使用化验室的留样及国内、外市场所寄样品除非特别指明,均用灭菌好的塑料样品瓶。4. 8 样品的保留期限与销毁已售完货的样品,至售出之日起10个月后样品管理员向部长报告申请销毁,根据样品的实际情况销毁可以是
6、收集用于生产回兑,以可以是当垃圾处理;外来样品的保留期限为6个月,6个月后样品管理员向部长申请销毁样品,销毁程序同上。5 相关文件:无。6 相关记录:6.1样品领用登记表6.2成品检验记录7附件:附样表2份。qcwa3ptgz7r4i30ka1dkaghn3xtkknbycudxqa7fhyi2chhi92tgkqcwa3ptgshls50clmtwn60eo8wgqv7xav2ohum32wgeauwydiawgmer4i30ka1dkaghn3xtkknbycudxqa7fhyi2chhi92tgkqcwa3ptgz7r4i30ka1dkagtgkqcwa3p tgz7r4i30ka1dk
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