2019年可乐公司生产过程审核检查表

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. 此模块为 审核员完成对混比，碳酸化和灌装生产过程进行审核提供指导。审核员完成此模块可 以确定该工厂是否符合可口可乐公司的标准和要求。Plant 工厂: Date 日期:Auditor审核员：1) Questionnaire调査表:YesDivNo1Is the design of the filling area adequate to prevent contamination? Does the filling area meet all approved conditions for the GMP design criteria?注入间的设计是否足以防 止污染？注入间符合GMP设计标准的条件吗？2Is the filling area free of any obvious sources of potential contamination?注入间是否存在任何潜在污染3Does the plant have an effective glass fragment program in place?工厂是否有个有效的玻璃瓶破碎处理程序？4Are finished products tested according to all required frequencies and specifications for product and package quality? 成品的检测是否按照产品和包装质量要求的频率和规定来测试？5Is the plant conducting the Caffeine Detection test as required by the Company?工厂是否按照可乐公司要求进行咖啡因检测？6Is the plant conducting the Sugar Detection test as required by the Company?工厂是否按照可乐公司要求进行糖的检测？7Do the packages meet the Company specifications?包装是否符 合公司要求？8Are filled cans handled in such way to reduce risk for stresscracking?罐装饮料的处理是否减少了密封易拉环的风险？9Does the plant control the Package Warmer according to Company requirements? (if applicable)工厂是否根据可乐要求控制 包装的保温？10Does the plant have a program to ensure temper-evidence sealing?工厂是否有程序保证防盗环的密封性？11Does the plant apply on each primary package a coding according to the Company requirement?装瓶厂的每一次包装 上编码是否符合公司的要求？12Does the plant use the age and durability standards as specified by the Company?工厂使用的货龄和保质期是否符合公司的特定要 求？13Does the plant enforce a no code no run policy?工厂是否强调没 有编码就不能出厂的政策？14Are full Refillable Glass and REFPET bottles inspected according to the Company requirements?可重灌的玻璃瓶和可重灌塑料瓶检 查是否符合公司的要求？15Does the filling process meet the Company Process Performance Requirements?灌装过程是否符合公司生产过程？16Are appropriate corrective actions taken when out-ofspecification results are obtained?当发现低于标准结果时是否采取 了恰当的纠正措施？17Are retention samples maintained as required?是否有按要求进行 留样？18Is measuring and testing equipment calibrated (when applicable)?测量和测试设备是否有校正？19Does the plant follow the requirements on Equipment Maintenance?工厂的设备维护是否符合要求？2) Reference Standards Lis参考标准清单BO-RQ-200Good ManufacturingPractices - Design Criteria 良 好制造习惯-设计标准BO-RQ-180BO-Handling Glass BottleBO-RQ-175Breakage 处理玻璃瓶破损RQ-190Beverage OperationsManuall 饮料操作手册Package Warming Requirements 包装暖瓶要求Beverage Date Coding and Labeling Requirements 饮料 日期及标签要求Beverage TestingBO-Requirements for ProductBO-Refillable Glass BottleRQ-170and Package 饮料测试要求产 品和包装RQ-145Inspection 可重灌玻璃瓶检查BO-SP-Finished ProductBO-REFPET Bottle Inspection 可165Specifications 最终产品标准RQ-055重灌PET瓶检查BO-SP-Package QualityBO-Process Performance166Specifications 包装质量标准RQ-174Requirements 生产执行要求BO-Retention Samples 留样BO-Temper Evidence 防盗环RQ-920RQ-935BO-Equipment Maintenance 设备BO-Calibration 校准RQ-960维护RQ-9553) Specifications and Requirements Summa标准和要求概要Specifications / Requirements1Is the design of the filling area adequate to prevent contamination? Does the filling area meet all approved conditions for the GMP design criteria? 注入间的设计是否足以防止污染？注入间 符合GMP设计标准的条件吗？The listed items are “approved conditions -guidelines” in order to comply with the general requirement“to prevent contamination in the filling room”.所列条款是得到批准的，符合防止灌装间 污染的要求BO-RQ-200 Filling area separated from non processing area灌装间和非加工区域是 分开的。 (Enclosed filling area is recommendec(建议灌装区域是密闭的) Prevent (restrict) traffic by nonessential personnel防止不必要人员进入 车间 Minimize number of doors and openings at filling areas 在灌装间最少 数量的门和通道。 Self-closing doors in the filling areas 在灌装区要有自闭门 Tight-fitting frames (stainless steel or aluminum) for doors, windows 对门禾和 窗必须有坚固的框架(不锈钢或铝)。 Non-opening windows (to the outside) in the filling areas 在灌装区域 没有扌开的窗户Positive pressure ventilation system (20p) ; (typically 15 a 20 卬h)正压通风 系统(20卩)；(每小时换气15-20 次)。 No open gaps between walls and roofs or floors墙壁和屋顶或地板之间不 得有间隙 Filling areas to be easy cleanable 灌装 区容易清洁 Covering for unsealed filled package conveyors up to the sealer 未封口的灌)装瓶传输带要盖在打盖机的上面 No use of wooden materials in the syrup room (as a construction material, desks, chairs, wooden fixtures,)在糖浆间不能使用木质材料 (例如；建筑材料，桌子、椅子、木质家具 Adequate draining provided (no drains directly beneath equipment)要 提供充分的排水系统(在设备下面不能有 直接的排水系统) Floors are self-draining / drains have water traps and screen traps 地板必须 要有自动排水的装置/排水要有盖子Conveyor lubricants and rinse water is captured and drained Food 运输过程中 的润滑剂和冲瓶水被排掉 contact surfaces are 304 or 316 stainless steel (min. 2B finish)食品类连 接表面必须是304和316的不锈钢。 Pipe works to be self-draining / no dead ends or dead legs 管路自动排水/ 无死角 Filling equipment has contamination guards灌装设备要有防止污染装置 Clearance around all equipment (typically 60 cm) for cleaning清洁所有设备周围 Lights covered (protective shields) / no use of mercury vapor bulbs.所有灯要罩起来，不得使用含汞灯泡 Protective shield to keep glass fragments, oil, grease, dust or debris from scattering.有保护罩阻止玻璃片、油渍、灰尘或其它碎片散射2Is the filling area free of any obvious sources of potential contamination?注 入间是否存在任何潜在污染？BO-RQ-200 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) No possible contamination from conveyor motors (to be covered)避免 传送污染 Proper storage of non-fixed equipment未固定设备的适当保存 The area is clean, organized and well maintained保持灌装区域清洁，井井有 条。 Fillers and proportioners are in sanitary condition灌装头与均质器保持 清洁清洁 SOPs available on the housekeeping of filling area灌装区域要有SOP Frequencies, cleaning agents and concentrations specified 规定频率、清 洁剂和注意事项 No possibilities for contamination at filler area such as for instance充填区不 可有以下污染- fuel emission from diesel fork lifts柴油叉车的尾气- standing water in the area 区域积水- wet wooden pallets 木栈 板- storage of chemicals in the area存放化学药剂- strong off-odors detectedin area or equipment 在灌 装区或设备有强烈的异味 dirty floors, walls, ceiling 脏地板、墙、屋顶3Does the plant have an effective glassBO-RQ-175fragment program in place?工厂是否有 Program to prevent glass particles in个有效的玻璃瓶破碎处理程序？the bottles is in place, including:防止玻璃粒留在瓶里的措施包括：Normally, a study is conducted to-inspection of valve seals (forvalidate the effectiveness of theembedded glass) after each failureprogram (amount of bottles rejected)每次故障后检测阀门封口on a regular basis.（含有玻璃）通常会通过定期硏究来确认此计划的有效-bottles near the failure bottle to be性（部分瓶子被拒收rejected故障瓶附近的瓶子要扔掉-regular review of consumercomplaints on glass fragments定期反馈顾客对玻璃片的投诉4Are finished products tested accordingBO-RQ-170 / MN-SP-165 (Min routineto all required frequencies andquality control testing requiredspecifications for product and packageTest Frequencyquality?成口口的检测疋否扌女照产口口和包装Specification质量要求的频率和规定来测试？测试频率说明In-line monitoring (with correct limits Taste/odor:every 30 minand alarms) can reduce / eliminate thenormalneed for some tests (e.g. Brix, 口味/气味每30分钟Carbonation, Net content).正常在线控制（正确的限制和报警）可以减少 Appearance: every 30 min根除某些检测要求例如:糖度二氧化碳净normal容量）夕卜观每30分钟All tests must also be performed at正常start-up and upon product/package Brix / ratio:every 30 minseechange当产品换包装一开始必须进行所Mix. Instr. 0,15。/ 5%有检测白利糖度/比例 参考混比规程每30分钟Air content measurement is only Carbonation:every 30 minseerequired for cans仅易拉罐产品要求检测Mixing Instruction 0.25空气含量 一氧化碳 参考混比规程每30分钟Crowns; two different designs exist: Air content:every 30 min=1 丨 PET)正常士 1.5% ( =1 l PET) Crown crimp:every shiftintermedi.:28.58 - 28.83 mm卷封每班中等 28.58 - 28.83 mmStandard:28.83-29.08 mm标准 28.83 - 29.08 mm Closure torque: every hour28mm: 6 - 17 inch pounds旋盖转矩每小时28 mm: 6 一17英寸磅43 mm: 10 一25 inch pounds Seam evaluation: every 4 hours see specs by suppliers密封评估每4小时见供应商说明 Date coding: every shiftcoding applied and legible日期代号每班代号有使用且清晰 Microbiology: see microbio. module 10 per 20 ml yeast & mold微生物见微生物模块 4 mm or affect legibility, 8 mm for REFPET), scratched, damaged, pearlescent,瓶的条件：脏、磨损( 4 mm或影响到正常使用，REFPET8 mm),划伤、破损、有光芒 Bottle Label Condition: poor lithography, off-center, off-register, off color, misaligned, incorrect placement, missing, wrong, overlabeled, 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 Bottle Closure Condition: cocked, damaged tamper evident band, poor lithography, rusty, scuffed, offcolor, 瓶盖条件：突起、卷边、印刷不 良、生锈、刮伤、异味 Can Container / Label Condition: damaged, dirty, rusty, corroded, poor lithography, off-color, faded, .易拉罐 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 fulldocument更多的细节参考原文BO-SP-166 (as a consequence of the Package Quality Specifications!)据包装 物料质量要求 Filled cans to be thoroughly rinsed after seaming密封后易拉罐必须被完全冲洗 Cans to be dried (e.g. hot air) before packing (after final rinse)包装刖(最后 充填后)易拉罐必须烘干(如热空气) Can ends to be completely dry before packing (no water drops)包装前(无 水滴)易拉罐必须完全烘干9Does 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温？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.当易拉罐产品充填时低于 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 度必须在包装前使易拉罐干燥。BO-RQ-180 Product temp at package warmer discharge end must be minimum 2C higher than the dew point in the plant. 包装温度至少比露点温度高2C The product temperature must not exceed 27C 产品温度不能超过27CBO-RQ-170 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10Does the plant have a program to ensure temper-evidence sealing?工厂 是否有程序保证防盗环的密封性？Crowns are accepted as tamper eviden closures皇冠盖是防盗环的盖子BO-RQ-935 All packages are sealed with Division approved tamper evident closures or features所有包装的密封要有公司批准的t防盗盖子或作用 Company identification on tamper evidence features厶司要确认盖了有防作用 Frequency and responsibility for testing the application is specified11 Does the plant apply on each primarypackage a coding according to the Company requirement?装瓶厂的每一个 次包装上编码是否符合公司的要求？Does the plant use the age and durability standards as specified by the Company?工厂使用的货龄和保质期是否 符合公司的特定要求？规定测试此应用的频率和责任 Records of the testing are kept.保留测 All products without temper evident feature to be treated as nonconforming所有没有防盗作用的产 品都是不符合BO-RQ-190 Procedure to be implemented on date coding and durability labeling执行生产日期标志和保质期标签的程序 Production date and plant identifiable in the code生产日期和工厂可以在编码里确认 Production line and timing identifiable in the code (if possible)生产线和时间可以在编码里确认(如果可 能) Open date code / durability code only if required by law (best before)如果法律有要求(最佳使用期)时才标明公 开的日期代码和保质期代码 Coding is complete and legible 编码要 完整且清晰 Coding also on secondary packaging if primary code is obscured如果第一次编码很模糊，在二次包装上打 上编码BO-RQ-190 Durability standards 保质期标准: -glass bottles & cans: months玻璃瓶&易拉罐the Best Before Date on the label. 产品保质期标准是用来表示标签上最佳使 用期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-Pet bottles 1l:9months9 个月塑料瓶=1l:6months6 个月 = 1.0生产过程有Cpk = 1.0As production processes, the following parameters were mentioned in the previous manual set作为生产过程，下列 参数在以前手册里有提到： Proportioning:t olerance混比偏差-sugar products; 0.15 Brix 糖度含糖产品-diet products; 5% assa y化验不含糖丿品 Carbonation: 0.25volumes 容量碳酸类 Filling; Net Content:灌装：净含量-nomina正常 = 11; 1.5%BO-RQ-920Retention samples taken to ensure full traceability of final product.留样以确保最终产品的可追踪性Division requirements on retention samples (frequency, storage time) to be available and followed.遵守公司关 于留样的要求(频率、储存时间)BO-RQ-955 Equipment is calibrated and labeled with calibration status仪器应校正并用 标签注明校正状态BO-RQ-960Procedures implemented for the maintenance of plant equipment 执行保养工厂设备的制度Adequate and qualified resources to perform maintenance有充足合格的资源来完成设备保养Corrective, routine, preventive and predictive maintenece included 包括纠正性的、例行的、预防的保养 Maintenance schedules available 有保 养进度表Replacement parts and inventory levels for key equipment对关键设备要有替换部件和库存This maintenance requirement applied to all key production equipment in the plant; not only to the filling equioment. 设备保养要求适用于所有工厂所有关键生 产设备，不只是灌装设备NotemIB:For system Certification and Fouowup audit use this processassessment to verify the status of impmmentation and effectiveness for the fo=owing synemsement 橡4ljK 爾 AEafl稱敲Document ManagemenProcess IntegritsK c.ibation4$IEmining 埴=Intema- Audit&nContinua-Impovement (COITeaivepreventive AaiomKES4) Comments6?Remaki