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目 录
颁布令···························································1
1主题内容和适用范围················································2
2引用标准···························································2
3术语和定义·························································3
4厂区环境····························································5
5厂房和车间·························································5
5.1厂房························································5
5.2安全设施·························································6
5.3屋顶与天花板·····················································6
5.4车间通风··························································6
5.5墙壁与门窗························································6
5.6地面与排水·······················································7
5.7 供水供汽设施····················································7
5.8照明设施···························································7
5.9洗手设施····························································8
5.10 更衣室···························································8
5.11仓库······························································8
6机械设备····························································8
6.1设计····························································8
6.2材质····························································9
6.3生产设备····························································9
6.4质量检验设备······················································9
7管理机构与人员······················································9
7.1管理机构····························································9
7.2人员要求···························································10
7.3教育培训···························································11
8卫生管理·························································11
8.1管理要求···························································11
8.2 厂区环境卫生管理·······················································11
8.3 厂房设施卫生管理 ····················································· 12
8.4 机械设备卫生管理·······················································12
8.5 辅助设施卫生管理·······················································13
8.6 清洗和消毒管·························································13
8.7 员工健康管理························································13
8.8 员工个人卫生管理·······················································13
8.9 除虫、灭害管理····················································14
8.10 污水管理························································14
8.11 工作服管理······················································14
8.12 有毒有害物管理························································14
9 生产过程管理·······················································15
9.1 生产操作规程的制订与执行···············································15
9.2 原材料··························································15
9.3 生产过程··························································15
10 质量管理···························································16
10.1 《HACCP管理手册》的制定与执行·········································16
10.2 原辅料及包装材料的质量管理···········································16
10.3 过程质量管理··················································17
10.4 成品的质量管理························································17
10.5 贮存与运输的管理······················································17
10.6 成品售后管理·················································18
10.7 记录管理·······················································18
11 标签····························································18
12 管理制度的建立和考核····················································18
13 本手册的支持文件························································18
赤峰乳制品GMP认证
1主题内容与适用范围
本规范规定了本公司乳粉生产厂区环境、厂房及设施、机械设备、管理机构与人员、卫生管理、生产过程管理、质量管理、标签、管理制度的建立和考核等方面的良好生产规范。
本规范适用呼伦贝尔福泉乳业有限责任公司范围内生产脱脂乳粉、全脂乳粉需建立、保持和实施的条件,以确保产品安全,质量符合法律法规和国家标准,及市场和客户的要求。
2引用文件
2.1相关法律法规和规程
《中华共和国食品安全法》
《中华共和国环境保》
《中华共和国产品质量法》
《中华共和国计量法》
《中华共和国动植物检疫法》
《中华共和国食品安全法实施细则》
《食品生产加工企业质量安全监督管理实施细则(试行)》
《中华共和国乳品质量安全监督管理条例》
《企业生产乳制品许可条件审查细则》
《关于对获得生产许可的乳制品生产企业生产许可条件重新审核的通知》
《生鲜乳生产收购管理办法》
等五部门2008年第25号
《关于乳与乳制品中临时管理值规定的公告的公告》
2.2相关标准
GB/T 27341—2009 《危害分析与关键控制点(HACCP)体系 食品生产企业通用要求》
GB/T 27342—2009《危害分析与关键控制点(HACCP)体系 乳制品生产企业要求》
GB/T 14881—1994 《食品企业通用卫生规范》
GB 12693—2010《乳制品良好生产规范》
GB/T 22000—2006 《食品安全管理体系 食品链中各类组织的要求》
GB/T 19538—2004 《危害分析与关键控制点(HACCP)体系及其应用指南》
《乳制品企业生产技术管理规则》2003年中乳协26号通知
GB 19301—2010 《食品安全国家标准 生乳》
GB 19644—2010 《食品安全国家标准 乳粉》
赤峰乳制品GMP认证
二、生产资源:包括厂区环境、厂房及设施、生产设备、品质管理设备、人员等
1、厂区环境:厂区不能设于受污染河流的下游;厂区周围不能有粉尘、有害气体、放射性物质和其他扩散性污染源;不能有昆虫大量孳生的潜在场所等易遭受污染的情形。
厂区内禁止饲养动物。四周应有适当防范外来污染源,有害动物侵入的设施,GB23790要求工厂远离禽畜养殖场。厂内生产区、生活区要分开。
2、厂房及设施:
①设计:新建、扩建、改建的工程项目(乳制品厂、车间等)有关食品卫生部分要按GB/T12693和GB14881的规定进行设计和施工。将选址情况及其它有关材料(总平面布置图、平面图、剖面图、立面图,原材料、半成品、成品的质量和卫生标准,生产工艺流程等)报本地区卫生行政部门审查、备案。
②车间设置与布局:包括生产车间和辅助车间,生产车间包括收乳间、原料预处理车间、加工制作车间、半成品贮存及成品包装车间等。辅助车间要包括检验室、原料仓库、材料仓库、成品仓库、更衣室及洗手消毒室、厕所和其它为生产服务所设置的必须场所。车间设置要按生产工艺流程需要及卫生要求,有序而整齐地布局。布局应能防止乳制品加工过程中的交叉污染,避免接触有毒物、不洁物。更衣室及洗手消毒室要与加工车间相连接,并设置在员工进入加工车间的入口处。
③内部建筑结构:
屋顶、墙壁与门窗的要求:屋顶、墙壁为浅色,应无毒、无异味、平滑、不透水、易清洗;门窗应装配严密,清洁作业区、准清洁作业区的对外出入口要装设能自动关闭的门和/或空气幕。在生产车间和贮存场所宜设捕虫灯,防止或排除有害昆虫。
地面与排水的要求:地面应无毒、无异味、不透水且平坦防滑、无裂缝及易于清洗消毒(适宜时耐酸碱性)。排水系统应有坡度(不小于1.5%)、保持通畅;排水系统保持干燥(排水沟的侧面和底面接合处要有一定弧度,曲率半径要不小于3cm),以避免水残余物的产生而导致相关微生物的增长和扩散;车间内不得有积水。地面可采用耐酸碱的瓷砖环氧树脂等材料。
供水、排水设施要求:所用的水质、压力、水量等符合生产需要,水质符合GB5749要求。储水池(塔、槽)与供水管道器具应安全卫生,排水顺畅、便于清洗。不与食品接触的非饮用水(如冷却水,污水或废水等)的管道系统与食品制造用水的管道系统间,要以颜色明显区分,并以完全分离的管路输送,不得有逆流或相互交接现象。
④设施:
照明设施:厂房内要有充足的自然采光或人工照明,车间采光系数不要低于标准Ⅳ级,质量监控场所工作面的混合照度不要低于540lx,加工场所工作面不要低于220lx,其它场所不要低于110lx。光源要不至于改变食品的颜色。照明设施不要安装在食品暴露的正上方,否则要使用安全型照明设施,以防止破裂时污染食品。
通风设施:清洁作业区要安装空气调节设施,以防止室内温度过高、蒸汽凝结并保持室内空气新鲜;一般生产车间要安装通风设施,及时排除潮湿和污浊的空气。厂房内的空气调节、进排气或使用风扇时,其空气流向要由高清洁区流向低清洁区,防止食品、生产设备及内包装材料遭受污染。在有臭味及气体(蒸汽及有毒有害气体)或粉尘产生而有可能污染食品之处,要当有适当的排除、收集或控制装置。排气口要装有易清洗、耐腐蚀的网罩,防止有害动物侵入;进气口必须距地面2m以上,远离污染源和排气口,并设有空气过滤设备。通风排气装置要易于拆卸清洗、维修或更换。
洗手设施:要在适当而方便的地点(如车间对外总出入口、厕所、加工场所内)设置足够数目的洗手及干手设备。清洁作业区及准清洁作业区对外总出入口处要设置独立的洗手消毒室。洗手消毒室内要设足够数目的洗手及干手设备,并要设置鞋靴消毒池或同等功能的清洁鞋底设施或其他有效的保洁措施(设置鞋靴消毒池时,若使用氯化物消毒剂,其余氯浓度要保持在200mg/kg以上),需保持干燥的清洁作业场所要设置换鞋设施。 洗手设施的排水要具有防止逆流、有害动物侵入及臭味产生的装置。在洗手设施附近要备有液体清洁消毒剂及简明易懂的洗手方法标示。洗手台要采用不锈钢或陶瓷等不透水材料构造,其设计和构造要不易藏污纳垢且易于清洗消毒。水笼头宜采用脚踏式、肘动式或感要式等非手动式开关。其附近要有足够数目的感应式干手设施。
更衣室:更衣室要设在车间入口处,并独立隔间。更衣室要男女分设,并与洗手消毒室相邻。更衣室内要有适当的照明且通风良好。更衣室要有足够大小的空间,以便员工更衣之用。要按员工人数设足更衣柜、鞋柜及可照全身的更衣镜。
厕所:为车间员工提供的厕所宜与车间主体相连接,且设洗手消毒室,使厕所与车间相隔离,其外门不得朝向清洁作业区、准清洁作业区。厕所的外门要能自动关闭(至少要采用常闭式弹簧自由门),且不得正对食品加工区、存放区,但如有缓冲设施及排风设施(有效控制空气流向)能有效防止污染者不在此限。厕所地面、墙壁、便槽等要采用不透水、易清洗、不积垢且其表面可进行清洗消毒的材料构造。厕所要采用冲水式,其数量要足以供员工使用。 厕所洗手设施的设置要符合上面洗手设施的规定,且要设在其出口附近。厕所要设有效排气(臭)装置,并有适当照明,门窗要设置不锈钢或其它严密坚固、易于清洁的纱门及纱窗。厕所排污管道要与车间排水管道分设,且要有可靠的防臭气水封。
仓库:要依据原辅料、材料、半成品、成品等性质的不同分设储存场所,必要时要设有冷(冻)藏库。原材料仓库及成品仓库要独立分开设置,同一仓库储存性质不同物品时,要适当隔离(如分类分架存放)。仓库构造要能使储存保管中的原料、半成品、成品的品质劣化减低至低程度,并有防止污染的构造,且要以无毒、坚固的材料建成,其大小要足以使作业顺畅进行并易于维持整洁,并要有防止有害动物侵入的装置(如库门口要设防鼠板或防鼠沟)。仓库要设置数量足够的栈板(物品存放架),并使储藏物品距离墙壁、地面均在20cm以上,以利空气流通及物品的搬运。冷(冻)藏库,要装设可正确指示库内温度的温度计、温度测定器或温度自动记录仪,并要装设自动控制器或可警示温度异常变动的自动报警器。
赤峰乳制品GMP认证
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