SY 1 Traceability is managed through well identified specific procedures.
可追溯性要通过恰当地确定具体的程序来管理
SY 2 The whole information relative to traceability is kept at least until end of shelf life + 1 year. In every case this length has to be in compliance with the national or local regulation in force.
与可追溯性有关的全部资料要保存至少保质期加一年,并且必须要与国家或当地的法规相一致。
SY 3 There is a procedure specifying traceability documents archiving rules. 有一个程序详细说明可追溯性文件的存档规则。
SY 4 A system is in place to identify the quality status (on hold / useable/ non conform) of the products (ingredients, packaging materials or finished products 有一个适当的系统来确定产品(原料,包装材料或成品)质量的状况(扣留/可用/不合格)
二. TREAM TRACEABILITY 上游的可追溯性
Requirements
UT 1 There is a CBU procedure for Supplier & Materials (RM-PM) Approval coherent with the Beverage Division Procedure (WTC QM 1.10
有一个与WTC规定相 一致的CBU层面的原材料及供应商的认可程序
UT 2 RM and PM Technical Specifications clearly define the traceability requirements the supplier has to comply with (batch identification, emergency contacts,.)
原料和包装材料的技术标准要清楚地说明供应商必须要遵循的可追溯性的要求(批号,紧急情况下的联系人等)
UT 3 The plant has an updated list of Suppliers and Materials (RM-PM) that are approved.工厂有一份最新的批准的供应商和原材料的清单。
UT 4 Supplier Quality Audits are performed and systematically include a traceability audit according to a frequency defined in a CBU procedure.
进行了供应商的质量审核和系统地包含了根据CBU程序规定的频率进行的可追溯性的审核。
UT 5 The system in place for managing the receipt of RM-PM allows to record and keep the whole information pertaining to traceability (date of receipt, supplier name, Danone and/or Supplier reference, quantity delivered, batch number,.)
有适当的系统来管理原料和包装材料的接收,记录并保存所有的与可追溯性有关的信息(收货日期,供应商、达能和/或供应商目录、到货数量、批号等等)
UT 6 RM delivered in bulk: inventory of stock status in tanks and silos before and after delivery, product name, supplier name, batch number, time and date of filling, tanks and silos cleaning schedule)
以散装形式送货的原料:记录收货前后罐和筒仓的存货情况,产品名称,供应商,批号、卸货时间,罐和筒仓的清洁计划。
三. ASCENDING INTERNAL TRACEABILITY 内部的向上的可追溯性
Requirements
AI 1 The Traceability system enables the identification of the whole lots of ingredients and processing aids used in a given finished product.
可追溯系统能够识别在指定的成品中使用的所有的原料和过程中使用的助剂。
AI 2 The Traceability system enables the identification of the whole lots of primary Packaging Materials used in a given finished product.
可追溯系统能够识别在指定的成品中使用的所有的一级包装材料。
AI 3 "The Traceability system enables to trace the production history (Specifications, formula, control plan, cleaning & disinfection plan,.)
可追溯系统能够追溯生产过程的历史记录(标准、配方、控制计划、清洁和消毒计划等等)
"
AI 4 The Traceability system enables to identify the corrective actions and/or to ensure the follow-up of non conformities related to a production batch (destruction procedure, withdrawal/recall procedure,.)
.可追溯系统能够确定与不合格产品有关的改进的行动和/或保证的跟踪行动(报废程序,回收/招回程序)
AI 5 The Traceability system enables the identification of exceptional events (production incidents, changes in production planning,.) related to a given production batch.
可追溯系统能够识别异常事件(生产事故,生产计划变更等等)
AI 6 The Traceability system enables the identification of maintenance operations (preventive and curative) for production equipment as well as of internal (CIP) and external cleaning & disinfection operations for each finished product batch. 可追溯系统能够识别生产设备的维修保养工作(预防性的和紧急抢修)以及针对每批成品的内部(CIP)和外部清洁和消毒。
AI 7 The Traceability system enables to trace all analysis results (microbiology, chemistry, sensory) linked to a given production batch.
可追溯系统能够追踪所有的检验结果(与指定批号相关连的微生物的、理化的、感官检验等指标)
四. DESCENDING INTERNAL TRACEABILITY 内部的下游的可追溯性
Requirements
DI 1 The Traceability system enables, for each lot of ingredients and processing aids, to trace the finished product lot(s) in which they have been used.
可追溯系统能够由原料和过程中使用的助剂的批号追踪到使用它们的成品的批号。
DI 2 The Traceability system enables, for each lot of primary packaging, to trace the finished product lot(s) in which they have been used.
可追溯系统能够由包装材料的批号追踪到使用它们的成品的批号。
DI 3 A representative sample (retained sample) for each lot of production is kept in the water library in appropriate conditions according to the rules defined in the Beverage Division Traceability Instruction (WTC FS 3.3-1 Traceability Instruction / Chapter II.3.d )
每批产品要保留一个有代表性的样品(留样)存放在合适的样品间,样品间的条件要满足饮料事业部可追溯性指导书中规定的要求。
DI 4 The Traceability procedure specifies the frequency at which the accumulation tables must be emptied as well as the requirements regarding repacking of unpacked finished products.
可追溯性程序要详细说明有堆积物的工作台要多久清空一次,以及关于重新包装的未包装成品的要求。
DI 5 The plant has a procedure for release of finished product lots.工厂有一个成品放行的程序
DI 6 Consumption Units (CU) identification is made in compliance with rules set in the Beverage Division Traceability Instruction (WTC FS 3.3-1 Traceability Instruction / Chapter II.3.e )
消费单位的认定符合达能饮料事业部关于可追溯性指导书的规定。
DI 7 In the case of products the identification of the Consumption Unit is made on the bottle and in no way on the cap.产品的消费单位认定应该在桶身上而不是在桶盖上。
DI 11 In the specific case of HOD every pallet or rack is identified with a tag bearing at least the production batch number, the name and type of product
.特殊情况下产品的每一卡板或一架至少要用不干胶标示产品的名称,规格和批号。
"五、. DOWNSTREAM TRACEABILITY 下游的可追溯性
"
Requirements
DT 1 There is a procedure for storage of finished products (management of blocking and release of pallets, management of incomplete pallets,.)
有一个关于成品储存的程序
DT 2 The Shipping management system enables to trace, for each lot of finished product, the type and history of deliveries, the list of shipped pallets, destinations and names of customers( transfer of ownership) and the link with production data.
运输管理系统能够追踪每一批成品的批号,规格和运输的历史记录,运输的托盘的清单,目的地和客户的名称(运输商或货主)以及相关的生产日期。
DT 3 The link between mother-pallets and daughter-pallets is traced. 母女托盘的关系可以追踪到。
DT 4 There is a Transport Specification signed by each transport company
有一个每一个运输公司都要签署的运输标准。
DT 5 There is a procedure for traceability of products that fall outside the usual sales channels (e.g. products produced for consumer or clinical tests, products sold to the company’s personnel or to Works Council, product donations, product sampling for Sales Teams,…
有一个针对已经进入销售渠道以外的产品追踪程序(例如:为客户生产的产品,或诊断用,买给公司员工或工会的产品,捐赠的产品或销售用于取样的产品)
DT 6 A simulated non conform product recall exercise is carried out at least once per year.每年进行一次的不合格产品的模拟回收。
"5. DOWNSTREAM TRACEABILITY 下游的可追溯性
5.2. HOD Products HOD 产品"
Requirements
DT 6 There is a procedure to ensure a FIFO management of finished product storage areas within the plant as well as within warehouses or distribution centers associated to the plant.
工厂内的储存区域、或与工厂有关联的仓库或配送中心有一个程序保证成品是“先进先出”的。
DT 7 For each production batch the quantity of products loaded in the truck or any other means of transportation is recorded (at the departure from the plant as well as at the departure from warehouses or distribution centers)
装车产品或任何其它方法的运输的产品每个生产批号的产品数量要记录(在离开工厂以及离开仓库和配送中心时)
DT 8 At each delivery route corresponds a list of delivered customers
.每一次发货的路线要与要发客户的名单相符。
DT 9 There is a procedure to manage the return of full bottles from delivery routes in order to ensure that these returned bottles be delivered from the next delivery.
有一个程序来管理送货中返回来的完整的产品从而保证这些返回来的产品在下次送货时被送出。
制造执行系统 (MES) 主要工作是在车间跟踪产品制造过程并管理加工订单。 MES 在车间进行实时数据收集,让制造商可以分析和管理整个制造过程,它具有深入了解车间详细数据的能力,如物料跟踪、运行监控和质量管理,它可以通过电子调度指令,直接对车间员工下达工艺或调度更改要求,同时在此平台上,通过工艺执行、早期问题诊断和纠正,持续提升质量并降低成本。
根据开发系统和制造执行系统的完善性,系统的可追溯层次会有不同。系统的最低限度是能跟踪产品结构树信息,这就意味着它能识别什么部件组装到什么产品中去了。本文中所说的部件,既指单一的分立单元,如印制电路板上的 IC 器件,也指装配级组件在装配前的一部分,如个人电脑组装前的主板。如果发生召回或发现缺陷部件,可追溯系统可以通过条形码查到使用了同一批次缺陷部件的其它产品的具体信息。