11. Filling

This module serves as a guide to the auditor in completing an audit of the proportioning, carbonation and filling processes.  The auditor will determine whether or not the facility is complying with the specifications and requirements of The Coca-Cola Company by completing this module.该模块对审核员关于均质、注碳、充填过程的指导，通过完成模块审核员决定被审核厂是否有能力符合要求 Plant: 工厂        Date: 日期    Auditor(s):审核员     1) Questionnaire:问题     Yes Div No 1 Is the design of the filling area adequate to prevent contamination? Does the filling area meet all approved conditions for the GMP design criteria?充填区的设计是否可以防止污染？充填区域是否符合GMP设计要求？       2 Is the filling area free of any obvious sources of potential contamination?充填区有无潜在的污染源？       3 Does the plant have an effective glass fragment program in place? 工厂是否有有效的玻璃碎片处理程序？       4 Are finished products tested according to all required frequencies and specifications for product and package quality?终产品的检测是否按照规定频率和产品及包装质量要求？       5 Is the plant conducting the Caffeine Detection test as required by the Company?工厂是否根据我司要求监察咖啡因？       6 Is the plant conducting the Sugar Detection test as required by the Company? 工厂是否根据我司要求监察糖？       7 Do the packages meet the Company specifications?物料包装是否符合要求？       8 Are filled cans handled in such way to reduce risk for stress cracking?听装饮料的处理是否减少了易拉环的风险？       9 Does the plant control the Package Warmer according to Company requirements? (if applicable)工厂是否根据可乐要求控制包装的保暖性？       10 Does the plant have a program to ensure temper-evidence sealing?是否有程序确保封口处的韧度？       11 Does the plant apply on each primary package a coding according to the Company requirement?是否根据要求在原始包装上喷码？       12 Does the plant use the age and durability standards as specified by the Company?工厂使用带有年限的 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 还是不变更的标准？       13 Does the plant enforce a no code no run policy?工厂是否强制要求政策指令性的执行？       14 Are full Refillable Glass and REFPET bottles inspected according to the Company requirements?回收的玻璃瓶和塑料瓶是否按照公司要求进行检测？       15 Does the filling process meet the Company Process Performance Requirements?充填过程是否按照公司要求？       16 Are appropriate corrective actions taken when out-of-specification results are obtained?当发现不符和要求的结果时是否采取了恰当的纠正措施？       16 Are retention samples maintained as required?是否按照要求留样？       18 Is measuring and testing equipment calibrated (when applicable)?度量与检测仪器是否校正？       19 Does the plant follow the requirements on Equipment Maintenance?工厂是否按照设备的维护要求去做？                 2) Reference Standards List:参考文献： Beverage Operations Manual       BO-RQ-200 Good Manufacturing Practices - Design Criteria良好操作作业规范 BO-RQ-180 Package Warming Requirements包装恒温要求 BO-RQ-175 Handling Glass Bottle Breakage玻璃瓶粉碎处理 BO-RQ-190 Beverage Date Coding and Labeling Requirements饮料喷码与标签要求 BO-RQ-170 Beverage Testing Requirements for Product and Package产品与包装的检测要求 BO-RQ-145 Refillable Glass Bottle Inspection玻璃瓶再充填检测 BO-SP-165 Finished Product Specifications产成品规范 BO-RQ-055 REFPET Bottle Inspection回收塑料瓶检测 BO-SP-166 Package Quality Specifications包装质量规范 BO-RQ-174 Process Performance Requirements过程控制要求 BO-RQ-920 Retention Samples留样 BO-RQ-935 Temper Evidence封口 BO-RQ-960 Equipment Maintenance设备维护 BO-RQ-955 Calibration校正                   3) Specifications and Requirements Summary:规范与要求总结     Specifications / Requirements规范/要求   1 Is the design of the filling area adequate to prevent contamination? Does the filling area meet all approved conditions for the GMP design criteria? 充填区设计是否保证防止污染？充填区域是否符合GMP设计要求？? The listed items are “approved conditions - guidelines” in order to comply with the general requirement “to prevent contamination in the filling room”. 清单上的条款是“被证明的条件-指导”为了符合总要求“防止充填间的污染” BO-RQ-200 l Filling area separated from non processing areas充填间与非生产区域隔离 l (Enclosed filling area is recommended)建议关闭充填间 l Prevent (restrict) traffic by non-essential personnel严禁非相关人员进入 l Minimize number of doors and openings at filling areas充填区最少限度门的开启 l Self-closing doors in the filling areas充填门自动关闭? l Tight-fitting frames (stainless steel or aluminum) for doors, windows门窗闭合要严（用不锈钢或铝） l Non-opening windows (to the outside) in the filling areas充填间窗户不可开（与外界相连） l Positive pressure ventilation system (20μ) ; (typically 15 a 20 cph)正压房系统(20μ) l No open gaps between walls and roofs or floors墙、屋顶、地板间不可留有空隙 l Filling areas to be easy cleanable充填区域易清洁 l Covering for unsealed filled package conveyors up to the sealer封盖前的包装传送符合封盖头 l No use of wooden materials in the syrup room (as a construction material, desks, chairs, wooden fixtures, …)调配区不使用木制材料（比如建筑材料，桌椅，木家具等） l Adequate draining provided (no drains directly beneath equipment)足够的排水沟（设备下不可直接安装排水沟）? l Floors are self-draining / drains have water traps and screen traps地板内装排水沟/排水沟有水网 l Conveyor lubricants and rinse water is captured and drained 运输过程中的润滑剂和冲瓶水被排掉 l Food contact surfaces are 304 or 316 stainless steel (min. 2B finish) l 与食品接触面用304或316不锈钢 l Pipe works to be self-draining / no dead ends or dead legs管路自动排水/无死角 l Filling equipment has contamination guards充填装置有防污染保护 l Clearance around all equipment (typically 60 cm) for cleaning清洁所有设备管路 l Lights covered (protective shields) / no use of mercury vapor bulbs.灯上有防护罩/不使用水银灯管 l Protective shield to keep glass fragments, oil, grease, dust or debris from scattering.防护罩避免碰碎产生碎片，油圬、润滑油、灰尘   2 Is the filling area free of any obvious sources of potential contamination? 充填区是否远离显著的污染源？ BO-RQ-200 l No possible contamination with fuel emission (e.g. electric fork lifts)避免因燃料产生的污染可能（如电叉车） l No possible contamination from conveyor motors (to be covered)避免传送污染 l Proper storage of non-fixed equipment未安装设备的适宜储存 l The area is clean, organized and well maintained保持区域清洁 l Fillers and proportioners are in sanitary condition充填头与均质器保持清洁 l SOP’s available on the housekeeping of filling area充填区作业SOP l Frequencies, cleaning agents and concentrations specified频率、清洁方式和注意事项 l No possibilities for contamination at filler area such as for instance充填区不可有以下污染: l fuel emission from diesel fork lifts燃料污染 l standing water in the area水污染 l wet wooden pallets 木栈板 l storage of chemicals in the area化学药剂 l strong off-odors detected in area or equipment强气味的监控或设备 l dirty floors, walls, ceiling脏地板、墙、屋顶   3 Does the plant have an effective glass fragment program in place? 是否有有效的玻璃碎片处理程序？ Normally, a study is conducted to validate the effectiveness of the program (amount of bottles rejected) on a regular basis. 通常，在规则的基础上研究用以严整过程的有效性（当大批瓶子废弃时） BO-RQ-175 l Program to prevent glass particles in the bottles is in place, including:防止玻璃碎片进入瓶子的程序包含： - inspection of valve seals (for embedded glass) after each failure每次废弃后检查密封性 - bottles near the failure bottle to be rejected接近废弃瓶的瓶子也废掉 - regular review of consumer complaints on glass fragments 定期回顾消费者关于碎片的投诉   4 Are finished products tested according to all required frequencies and specifications for product and package quality?终产品是按照要求频率和产品与包装要求进行检测吗？ In-line monitoring (with correct limits and alarms) can reduce / eliminate the need for some tests (e.g. Brix, Carbonation, Net content). 在线控制（正确的限制和预警）可以减少/根除某些检测要求 All tests must also be performed at start-up and upon product/package change.当产品/包装变更一开始必须进行所有检测 Air content measurement is only required for cans.仅易拉罐产品要求检测空气含量 Crowns; two different designs exist: Intermediate and Standard. In Europe, most crowns are Intermediate design. 瓶盖有2中不同设计：媒介和标准， 在欧洲大多数瓶盖是媒体设计 BO-RQ-170 / MN-SP-165 (Min routine quality control testing required) Test检测 Frequency频率 Specification标准 Taste/odor:口味/气味 every 30 min每30分钟 normal正常 Appearance:外观 every 30 min normal °Brix / ratio:糖度 every 30 min see Mix. Instr. ± 0,15o / ± 5% Carbonation:二氧化碳 every 30 min see Mixing Instruction ± 0.25 Air content:空气含量 every 30 min < 2.0 ml per can Net content:净含量 every 30 min nominal ± 2.5% nominal ± 1.5% (>= 1 l PET) l Crown crimp:卷封环 every shift 每班 intermedi.: 28.58 - 28.83 mm Standard: 28.83 - 29.08 mm l Closure torque: every hour 每小时 28 mm: 6 – 17 inch pounds 内衬垫 43 mm: 10 – 25 inch pounds l Seam evaluation:密封 every 4 hours每4小时 see specs by suppliers可由供应商提供 l Date coding:喷码every shift每班 coding applied and legible l Microbiology: 微生物see microbio. Module见微生物模块 < 10 per 20 ml yeast & mold l Package condition / appearance:包装/外观 normal; must meet spec.   5 Is the plant conducting the Caffeine Detection test as required by the Company?工厂是否按照要求检测咖啡因？ This requirement is always valid; also after 3 or 5 step CIP is made.正确的要求：执行3步或5步CIP BO-RQ-170 l Each changeover to caffeine-free products每次转换到无咖啡因的产品 l Every change in final syrup tank最后调配罐的每一次改变   6 Is the plant conducting the Sugar Detection test as required by the Company?工厂是否根据要求对糖进行检测？ This requirement is always valid; also after 3 or 5 step CIP is made. BO-RQ-170 l Clinistix test conducted each changeover to sugar-free products每一次转成无糖产品检测Clinistix l Clinistix test conducted every change in preparation tank每次回流罐变更检测Clinistix   7 Do the packages meet the Company specifications? 包装是否符合公司要求 The general condition of the packages has to be investigated. 应调查总的包装条件Examples of damage created by the handling and / or filling processes are:比如包装人为破损或在充填过程-PET墙边或狭道刮伤 - Dents in cans - scratches at PET sidewall or neck area - … In case of damage (dents, scratches, …), the plant has to investigate the source of the problem. 一旦损坏，工厂必须寻找根源。 MN-SP-166 general defects on bottles, closures, cans:瓶子、瓶盖、听的缺陷 l Bottle Container Condition: dirty, scuffed (> 4 mm or affect legibility, 8 mm for REFPET), scratched, damaged, pearlescent, …瓶的保存条件：脏、混乱（> 4 mm或影响到正常使用，REFPET8 mm），划伤、破损、有光芒 l Bottle Label Condition: poor lithography, off-center, off-register, off color, misaligned, incorrect placement, missing, wrong, over-labeled, …瓶标条件：印刷不良、中心不正、注册错误、颜色不正、线不吻合、定位不对、缺少、错误、重合 l Bottle Closure Condition: cocked, damaged tamper evident band, poor lithography, rusty, scuffed, off-color, …瓶盖条件：突起、卷边、印刷不良、生锈、刮伤、异味 l Can Container / Label Condition: damaged, dirty, rusty, corroded, poor lithography, off-color, faded, …听保存/标签条件：损坏、脏、生锈、受腐蚀、印刷不良、异味、重影 For more detailed information; see full document.   8 Are filled cans handled in such way to reduce risk for stress cracking? 是否对听装饮料的控制以减少冲气压力的风险？ BO-SP-166 (as a consequence of the Package Quality Specifications)根据包装物料要求 l Filled cans to be thoroughly rinsed after seaming缝合后听罐必须被完全冲洗 l Cans to be dried (e.g. hot air) before packing (after final rinse)包装前（最后充填后）听罐必须烘干（如热空气） l Can ends to be completely dry before packing (no water drops) )包装前（无水滴）听罐必须完全烘干   9 Does the plant control the Package Warmer according to Company requirements? (if applicable)工厂是否根据公司要求控制包装的温度？（如果提供的话） Package warmers are used when filling cans at low temps (4 °C). Package warmers will heat up the product to above the dew-point to avoid condensation. 当听罐产品充填时低于4 °C时包装需保持温暖。包装的温暖可使产品温度高于露点温度以避免浓缩。 As a result of these warmers, the cans must be dry before packing.为了保证温度必须在包装前使听罐干燥。 BO-RQ-180 l Product temp at package warmer discharge end must be minimum 2°C higher than the dew point in the plant. 包装温度至少比露点温度高2°C l The product temperature must not exceed 27°C.产品温度不能超过27°C BO-RQ-170 l Package warmer temperature setting measured before start-up & every shift包装的保温温度必须在开机和轮班前测量   10 Does the plant have a program to ensure temper-evidence sealing? 是否有程序确保封口处的放盗？ Crowns are accepted as tamper evident closures BO-RQ-935 l All packages are sealed with Division approved tamper evident closures or features l Company identification on tamper evidence features公司要求韧度 l Frequency and responsibility for testing the application is specified提供检测频率及责任 l Records of the testing are kept记录检测结果. l All products without temper evident feature to be treated as nonconforming韧度不合格的产品列为不符和项   11 Does the plant apply on each primary package a coding according to the Company requirement? 是否根据要求在原始包装上喷码？ BO-RQ-190 l Procedure to be implemented on date coding and durability labeling喷码及标签强度的补充条款 l Production date and plant identifiable in the code产品生产日期及生产厂名称 l Production line and timing identifiable in the code (if possible)产品线别和生产时段 l Open date code / durability code only if required by law (best before)公开日期喷码/法规规定的喷码要求 l Coding is complete and legible喷码完全并合法 l Coding also on secondary packaging if primary code is obscured 若原始喷码模糊不清可在第二层包装上再次喷码   12 Does the plant use the age and durability standards as specified by the Company? 工厂是否使用不变更的标准？ Durability standard is to be used for the Best Before Date on the label. 耐用标准以在标签标注的日期前使用为宜 Light Products can have a blend of Aspartame and other non-sugar sweeteners. .口味淡的产品可与天(门)冬氨酰苯丙氨酸甲酯或其他不含糖的甜味剂混合 BO-RQ-190 l Durability standards:接受标准 - glass bottles & cans: 玻璃瓶/听罐 18 months - Pet bottles > 1l: 9 months = 1l: 6 months < 1l: 4 months - aseptic packages:无菌包装 6 months - aspartame containing (100%)天(门)冬氨酰苯丙氨酸甲酯保存 4 months (blend) 6 months   13 Does the plant enforce a no code no run policy? 工厂是否强制要求政策指令性的执行？ BO-RQ-190 l Procedures indicate that lines are stopped if coding fails (no or illegible code)如果喷码错误要求生产停止   14 Are full Refillable Glass and REFPET bottles inspected according to the Company requirements? 回收的玻璃瓶和塑料瓶是否按照公司要求进行检测？ BO-RQ-145 / BO-RQ-055 l All full Refillable Glass bottles to be inspected visually目测所有回收玻璃瓶 l This inspection can be reduced or eliminate via Division approval if:以下情况可减少或不必检测 - empty bottle inspection system is optimal最佳的空瓶检测系统 - all recommended precautions on glass fragments taken产生碎片前期预警 - closure appl. is checked in-line (eg electronic closure detection)瓶盖的在线检测 - no local legal requirements当地无法规要求   15 Does the filling process meet the Company Process Performance Requirements? 充填过程是否按照公司要求？ Cpk = Process Capability Index = lowest of: - (USL - avg.) / 3*S- (avg. - LSL) / 3*S Cpk =过程能力指数=最低：(USL - avg.) / 3*S- (avg. - LSL) / 3*S “S” is Standard Deviation of all samples included in capability study. A representative sample for Cpk calculation is minimum 100 values. On several software packages, this capability index is referred to as Ppk and not as Cpk. BO-RQ-174 / BO-SP-165 l Equipment process parameters to be defined l Control charts and process capability analysis for each control point. l Process control plan for each control point l Production processes to have Cpk >= 1.0 As production processes, the following parameters were mentioned in the previous manual set: l Proportioning: tolerance - sugar products; ± 0.15 °Brix - diet products; ± 5% assay l Carbonation: ± 0.25 volumes l Filling; Net Content: - nominal < 1l; ± 2.5% - nominal >= 1l; ± 1.5%   16 Are appropriate corrective actions taken when out-of-specification results are obtained?当不符合要求的结果被采用的是否采取补救措施？     17 Are retention samples maintained as required? 留样是否按要求采样？ BO-RQ-920 l Retention samples taken to ensure full traceability of final product. 成品留样应确保足够。 l Division requirements on retention samples (frequency, storage time) to be available and followed. 对样品留样的部门要求应了解符合。   18 Is measuring and testing equipment calibrated (when applicable)?测量和检测设备是否校正？ BO-RQ-955 l Equipment is calibrated and labeled with calibration status 仪器应校正并用标签注明校正状态   19 Does the plant follow the requirements on Equipment Maintenance? 工厂是否符合设备维护的要求？ This maintenance requirement applied to all key production equipment in the plant; not only to the filling equioment.设备维护仅适用于充填设备，而且适用于工厂里所有关键生产设备。 BO-RQ-960 l Procedures implemented for the maintenance of plant equipment 配备工厂仪器设备养护的器械工具 l Adequate and qualified resources to perform maintenance 有足够的资源进行维护 l Corrective, routine, preventive and predictive maintenece included 应包括补救性、惯例性、保护性的和提前的养护 l Maintenance schedules available 应了解养护程序 l Replacement parts and inventory levels for key equipment 应了解备件数量           Note: For Systems, Certification and Follow-Up audits, use this process assessment to verify the status of implementation and effectiveness for the following System Elements:证明和跟进审核，用此程序来评估落实情况和以下系统要素的有效部分。 l Document Management文件管理 l Record Keeping记录保存 l Process Integrity程序规范 l Calibration校正 l Training培训 l Internal Audits内部审核 l Continual Improvement (Corrective & Preventive Actions)不断提高（补救和预防性措施） 4) Comments & Remarks: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _