可口可乐供应商检查表

1、General Information:普通信息Suppliers Name :供应商名称Address of the site:地址Parent Organization name:母公司名称Country :国家Phone :电话Fax :传真Web site :网址FDA Registration No: FDA 注册号Audit Date:审核日期Auditor(s):审核人员Contacts:联系人Name名字Title / job position 职位e-mailProducts currently manufactured for The Coca-Cola Company (

2、TCCC):提供给可乐公司的产品Name名称Specification or Revision Number 标准及代码Shipping Destination (country)发运目的地Ingredient 原料Shelf Life 寿命Storage Conditions 储存要求EXPECTATIONS 指标As FoundAuditors Notes 发现问题A: Quality System 质量体系Supplier has a documented quality policy.供应商有质量手册The effectiveness of the quality system is

3、periodically reviewed by management.管理层对质量体系的有效性进行定期评审The supplier has an effective document management system. (Key Practices - see notes) 供应商有有效的文件管理体系B: Quality Programs 质量程序Conformance to Specifications 标准的符合性The supplier has the most current specifications from The Coca-Cola Company?供应商是否有最近更新的

4、可乐公司标准？Good Manufacturing Practices GMPThere is not any improperly stored equipment, litter, waste, refuse, uncut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place or harborage for rodents, insects and other pests.尢不符合

5、要求的储存：垃圾、废品、未切割的种 子或者草，适合昆虫繁殖和鼠类藏匿的场所There is adequate drainage in all areas to prevent the contamination of components through seepage or foot- borne filth.有足够的排水系统，防止污染Floors, walls and ceilings in the plant are of such construction as to be adequately cleaned and are kept clean and in good repair

6、.厂区的地面、墙和天花板要保持清洁和维护Fixtures, ducts and pipes that drip or form condensation are not suspended over working areas where a potential of contamination may occur.生产区域上方，设备、管路上的冷凝水、滴漏将 是潜在的污染Separation by partition, location or other effective means is provided for those operations that may cause contam

7、ination of food products with undesirable microorganisms, chemicals, filth or other materials.将区域分隔是为了提供适宜生产的区域，以避免 微生物、化学品、污物以及其它原料对食品的污 染Adequate lighting is provided to all areas where merchandise or ingredients are examined, processed, or stored and where equipment and utensils are cleaned. 产品和原

8、料检查、加工、储存，设备和器具的清 洁区域需提供足够的照明Light bulbs, fixtures, skylights or other glass suspended over any ingredient or packaging material exposed in any step of the operation are protected to prevent contamination.在原料和包装材料上方的灯具、天窗以及其他悬 挂的玻璃制品，必须有防护Adequate ventilation or control equipment is provided to mini

9、mize odors and noxious fumes or vapors in areas where they may contaminate components足够的换气设备使得异味、有害气体、蒸气降低 到最少The plumbing used throughout the plant (sewage, liquid waste, and potable water) is designed so as to not constitute a source of contamination of create an unsanitary condition.在厂区使用铅管(于用污水，

10、饮用水)的设计， 使之不成为一种污染源Each plant provides toilet facilities that are adequately stocked, maintained in a sanitary condition and kept in good repair at all times. Signs are posted instructing employees to wash hands with soap before returning 工厂内的厕所必须充足的，且应进行必要的清洁 和维护。洗手规程应张贴以提示员工在洗手前要 擦肥皂Adequately sto

11、cked hand washing stations are provided at each location in the plant where good sanitary practices require employee to wash or sanitize and dry their hands.在需要清洗消毒的区域，必须提供足够的清洗设 备(包括皂液、干手器)Personnel Practices:Documented clothing and sanitary practices are in place for all personnel handling or proc

12、essing food.(Key Practices - see notes)个人习惯：食品生产和交付的区域，应规定人员的着装、清 洁操作Good Laboratory Practices GLPTesting facilities and equipment are adequate for the degree of accuracy required.(Key Practices - see notes)- All test equipment is calibrated at regular intervals, and records of these calibrations ar

13、e kept测试设备的精度和量程要符合要求所有测试仪器必须定期校正，校正记录需保存Published, recognized, and validated testing methods are in use.采用经过验证确认并文件化的测试方法进行测试Reagent solutions, reactants and standards are handled properly (due dates, normalization, etc.)试剂溶液、反应物、标准的操作应符合规定(到 期日、标准化等)All quality testing follows written standard ope

14、rating procedures (SOP).所有测试方法应参照标准操作规范The accept / reject criteria and responsibilities are clearly defined接受/拒绝的评估标准应定义清楚Retained final product samples policy and procedure 成品的留样规定和程序What tests does the supplier perform for finished product?厂商的成品检测项目是哪些？Which test does the supplier recommend that

15、the Concentrate plants perform in their incoming inspection program?哪些测试是厂商推荐且关键的？Which specification parameter does the supplier consider is a low quality risk one?哪个质量指标是厂商认为低风险的？Specification Monitoring gaps (tests not performed, material specification, etc.测试监视方法的差异(测试方法，原料标准等)Personnel Training

16、 人员培训An effective employee training program is in place for company and quality policies on hygiene, GMPs, HACCP/Food Safety, sanitation, safety, and security.(Key Practices - see notes)有效的人员培训规划：质量方针、GMP、 HACCP、食品安全、清洁消毒、安全和保安Supplier has a training program for contract employees (Provide definitio

17、n for contract employees).厂商对合同工有培训规划，并对其有评估Pest Control Program 昆虫控制Pest control is effective and carried out by competent personnel.由胜任的人员执行有效的昆虫控制Records and schedules available indicate regular inspection, treatment, customer response, as 叩p ropriate, and signed off when completed.记录和日程表要显示：定期的检

18、查、处理、客户 的反馈，结尾Pesticides are properly secured when stored on site.在储存区，杀虫剂得到有效防护All areas are accessible for inspection. A gap of at least 45 cm (18 in) is maintained around the inside building perimeter.对所有区域进行检查。物品堆放距离墙45厘米Cleaning and Sanitation Controls 清洁消毒The supplier has an effective program

19、for maintenance of building and grounds?厂商对建筑物和周边环境有有效地清洁消毒纲 要。The supplier has a documented and effective program for the cleaning and sanitation of work areas and equipment? 厂商是否有文件化和有效的对生产区和设备的清 洁消毒纲要？There is a system for verifying the effectiveness of the sanitation program that includes microb

20、ial and allergen controls.有对清洁消毒的效果进行评估的程序，包括微生 物和过敏反应Equipment is designed to be effectively cleaned and sanitized.设备的设计应便于设备的清洁消毒Cleaning agents are appropriate and clearly marked for use in food areas; stored in a designated, secure place, hand restricted in use.清洁剂应是食品级，且标识清楚；在指定的安全 区域储存，领用须受控Wa

21、ter used for sanitation in the plant has the appropriate quality for its 叩 plication.厂内用于消毒的水质需符合质量要求Warehouse and Shipping Containers 仓储、发运Controls are in place to ensure that warehouses and shipping containers are clean and well maintained? 保证仓储和发运干净、有效维护Products are stored and handled in a manner

22、 to prevent deterioration, damage, or contamination?产品的储存和交付要防止污染、损坏Suppliers products are not transported with other goods which could contaminate the product by strong odors, etc.?厂商在交付产品过程中，不得与其他货物(有浓 重的异味等)混放The supplier has an effective process for segregating and tracking raw materials, finish

23、ed product, product on hold, released and reworked materials.J商有对原料、成品、隔离品和放行返工的原料 的隔离、跟踪程序r t rJhe supplier has an effective finished goods and raw material inventory management system and can ensure hat shipments are according to specifications and equirements.厂商有成品和原料的储存管理程序，来保证发运 符合标准要求The suppl

24、ier has a system in place to prevent the inadvertent shipment of non-conforming products or ingredients to The Coca-Cola Company.J商有防止小合格产品和原料因疏忽流向可乐公 司的程序Facilities and Equipment Design 设备、工具的设计Buildings and Grounds:建筑和周边环境Facilities are of suitable size, design, and construction to facilitate main

25、tenance and sanitary operations. (KeyPractices - see notes)建筑设计便于维护清洁Equipment:设备Does supplier have an equipment design approval policy or procedures? Note whether the procedure includes review of new equipment for sanitary design considerations.厂商是否有用于设备设计的认可程序?注意该程 序是否将新设备的清洁设计包含其中？Is there an equ

26、ipment installation approval policy/procedure?是否有设备的安装认可程序？Is there a procedure for verifying and challenging sanitary design and installation of new equipment?是否有对设备的清洁、安装的评估程序？Equipment Maintenance and Calibration Controls 设备的维护和校正Supplier has a formal Calibration program in place that identifies

27、critical equipment, identifies accuracy and precision, uses app ropriate traceable standards and methods, and includes appropriate calibration and calibration verification frequencies.- Provide definition for critical equipment (equipmentthat can affect product quality）厂商有正式的设备校正计划：设备的重要性、精 确度、精密度、基

28、准的追溯和方法、校正的频率 一对关键设备的定义（设备对产品质量的影响 程度）Is there an effective maintenance program in place that identifies critical equipment, monitors performance and schedules routine maintenance?是否有有效的设备维护程序，鉴别关键设备，监 控其表现，制定维修保养日程？Record Keeping 记录保存Systems are in place for managing and controlling quality system

29、data and records.有管理控制质量体系的记录的系统Records are accurate, legible and proper procedures are utilized for making corrections.记录准确、清晰，并有对涂改方法的规定Corrective and Preventive Action 纠正和预防措施Facility has a systematic approach or program for corrective and preventive actions to react to problems, e.g., non-confor

30、mances, complaints, audit deviations 有系统对问题项、不符合项、投诉、审核发现的 不符合项进行纠正和预防措施Does the process include identification of issue, investigation of root cause, timely corrective action, and follow-up to confirm implementation and effectiveness? 该过程是否包含问题的评估、根本原因的分 析、纠正措施的时限、以及纠错的有效性跟进？C: Supplier Guiding Pri

31、nciples 厂商的指导政策Supplier has designated responsibility for dealing with Environmental, Health, and Safety issues.厂商应对环境、健康、安全进行有责任规划Does the supplier sub-contract any of the goods or services that we buy?厂商是否有我司购买的产品和服务的合同？If the supplier sub-contracts any of the goods /services that they purchase, t

32、he supplier shall demonstrate that sub-contractors are in compliance with our SGP.如果以签合同的形式采购货物/服务，厂商需以 SGP为原则将合同加以描述The supplier has a Code of Conduct or Ethics Policy.厂商必须有道德和行为准则There are no observed violations to SGP.(Key Practices - see notes)无违背SGPWho deals with social responsibility and human

33、 rights issues?谁负责处理社会职责和人权？Has the company been cited or fined for any violations of local laws regarding workplace practices or environment? 厂商是否因违法(生产或环境)受到处罚？Any legal action initiated against the supplier for its workplace practices or environmental impact?厂商是否因违法(生产或环境)受到起诉？D: Purchased Materi

34、als/Services 原材料/服务的采购T she supplier has an effective process for authorizing their uppliers.厂商有认可供应商的有效程序Supplier communicates raw material specifications to their suppliers.厂商就原材料的标准同供应商讨论Supplier monitors the performance of their suppliers.(Key Practices - see notes)厂商对供应商的表现进行监控Incoming material

35、s are assessed to determine fitness for use and compliance to specification.对入库原料以标准和生产的符合性进行评估T sphe supplier has an effective inventory management ystem for controlling nonconforming material within the )lant.一商有对不合格原料的储存管理系统Describe how the supplier ensures that the packaging material do not nega

36、tively impact finish ingredient quality (e.g. contamination of threads from super sacks, etc.). How does the supplier know that their containers and packaging materials are appropriate for food use? 描述厂商如何保证包装材料对内容物的保护。 厂商如何了解他们的容器或包装是符合食品生产Process Water Quality:Process water has appropriate water q

37、uality for the process application.Add comment water source, purification steps.生产用水的质量：生产用水必须符合生产的质量标准对水源有论证，有净化工艺E： Process Monitoring and Control 过程控Need to use a bolt on checklist for specific ingredient or packaging制material (manufacturing process work-aid)制必须有原物料的标准Is manufacturing process bat

38、ch or continuous? 生产有连续批号What is considered as the manufacturing date?如何对应生产日期The supplier is able to track batch and critical processing parameters and maintains these records.厂商能够追溯生产批号、关键工艺参数，并保存 这些记录Quality control points in the process have been identified and appear to be properly selected.在生产

39、过程中经过评估选定质量控制点An effective system is used to monitor the quality control points.对质量控制点有有效的监控体系Based on historical and current test results and process controls, the supplier can demonstrate the capability of consistently producing products within the specifications of The Coca-Cola Company.根据历史和现今的测

40、试结果和过程控制，厂商能 对连续生产符合可乐公司的标准产品的能力进行 描述Weight Controls: Describe how supplier assures compliance to net content tolerance requirements of TCCC重量控制：描述厂商如何保证产品净重符合可乐 公司标准For ingredients that are shipped directly to bottlers:What is the tolerance used by the supplier?How was the supplier informed about t

41、he tolerance?NOTE: Refer to MFG-R-Q535 (Concentrate Plant Operations Manual)向装瓶厂直接提供原料：厂商如何设置的公差厂商如何标识公差的注意：参考MFG-R-Q535How is the supplier controlling labeling of the material?厂商如何控制产品上的标签F: Finished Product Management 成品管理How are tamper evident seals handled and controlled? 如何处理和控制丝封How is a batch

42、 / lot defined (e.g. 24 hrs production) and how is it identified (e.g. lot number)?产品的批号是如何定义的Describe packaging types and sizes available (such as kilograms, liters, pounds, gallons).描述包装的形式和规格(公斤、升、磅、加仑)Are external transportation and storage facilities or terminals used as part of the distributio

43、n process? If yes, where are they located? How are they monitored?外部的运输和包装工具是发运规程的一部分？如 是，他们的位置？如何监控？The supplier has a process for segregation and tracking finished product, product on hold, reworked, and released materials.厂商对隔离品、跟踪成品、产品扣留、返工、原 物料放行有程序操作Describe the distribution process and how do

44、es the supplier ensure material integrity is not affected during distribution process.描述发运程序，厂商如何保证原物料在发运过程 中的完整性The supplier has a system in place to prevent the inadvertent shipment of non-conforming products for The Coca-Cola Company.厂商有防止不合格产品发运至可乐公司的系统G: Food Safety (HACCP)食品安全Describe how phys

45、ical contamination (e.g. metal particles) is monitored and controlled? What equipment (e.g. metal detectors, magnets, filters) is used? Where are they located? How are they monitored / maintained? 描述防止物理污染的监控(金属探测)？相关设 备？位置？如何监控/维护？Equipment 设备Location 位置Monitoring Frequency监控频率Maintenance维护Automati

46、c metal detectors used where app ropriate and practical. (Powerful magnets are not in themselves adequate as they do not remove all metals.)- Metal detectors checked regularly using ferrous and non-ferrous test pieces. Results are recorded with details of any corrective action taken.适当地使用自动金属探测仪用金属颗

47、粒检测金属探测仪的有效性。检测 操作和纠正操作应记录Filling process filtration devices used where app ropriate and practical适当的过滤装置用于灌注产品Supplier has a documented and effective food safety protection system (HACCP).(Key Practices - see notes)The CODEX HACCP Standard is an example of an effective food safety system.厂商有成文的HACC

48、P程序A hazard analysis is documented for each process. Potential significant hazards are identified and control procedures are in place. Critical control points are identified and established in the manufacturing processes.工艺的危害点分析以文件化。在程序中对重要的 潜在危害加以确定。在生产工艺中建立关键控制 点Monitoring procedures and records

49、are present to assess control of CCPs.有对CCP点的控制评估的监控程序和记录Supplier has an established procedure for re-checking rejected product, tracing the origin of the foreign material to prevent recurrence.厂商建立对拒绝品的复查程序，追踪异物的源头 以防止再发生Regulated HACCP for US fruit juice procurement (CFR120):(The United States FDA

50、 regulations require all suppliers and manufacturers of juice beverages to have an effective HACCP plan (compliance required by January 2019). TCCC must have a copy of their suppliers HACCP plan on file. TCCC has adopted this policy internationally following the regulations as outlined in the Codex

51、Alimentarius)How do you ensure the companys compliance with US FDA regulation, as appropriate? Please have HACCP System available for review.G: Allergen Controls过敏物的控制How do you ensure the companys compliance with US FDA regulation, as appropriate? Please have HACCP System available for review.G: Al

52、lergen Controls过敏物的控制Supplier has evaluated their manufacturing systems and finished products to determine allergenic components.(Key Practices - see notes)厂商对生产体系和成品有过敏物的评估Manufacturing of allergen-containing products are scheduled to minimize cross-contamination.生产含过敏物产品应有计划的减少交叉污染Incoming materia

53、ls are identified as allergen containing, as appropriate.适当地对入库原料进行过敏物鉴别tSupplier has a documented procedure to inspect the )roduction line after cleaning or changeover, including esting to ensure allergen removal.厂商有成文的程序来检查，清洁后的生产线H: Chemical Residue & Contamination Control 化学品残余和污染的控制The supplier

54、 has an effective program for receiving, handling, segregating, storing and use of nonfood chemical agents (e.g. cleaning and sanitizing agents, water treatment chemicals, refrigerants, and lubricants). 厂商对接受、处理、隔离、储存和使用工业用化 学品有有效的操作规程(清洁消毒剂、水处理用 化学品、制冷剂、润滑剂)Supplier has an effective program to ensu

55、re that only legally-permitted chemicals, ingredients and additives are present in their final products.厂商保证只使用法律允许的化学品、成分、添加 剂用于成品1Supplier has an integrated pest management system jtilizing universally-accepted agronomic practices. 厂商有完整的虫害控制系统:Traceability 追溯性The supplier has an effective trackin

56、g system in place and is able to demonstrate complete traceability (“mock ram心 frnm rnw mtprinlc thrnunh finichprl nrndiint(Jielivery to their customers.厂商有有效地的追溯系统，能完成从原料到成品 发放的追溯演习Finished product retention samples are stored in an appropriate and secure manner. The sample retention period is appr

57、opriate for its end use.- If the retention period is less than the shelf-life of theHow do you ensure the companys compliance with US FDA regulation, as appropriate? Please have HACCP System available for review.G: Allergen Controls过敏物的控制suppliers finished product, investigate reason and include in

58、report.成品留样被适当的储存，并保存至保质期后 如果留样保存期比保质期短，则应调查原因并写如报告Mock / Simulated recalls are conducted to validate the effectiveness of the Traceability process.用追溯程序来验证假冒品的回收操作J: Scientific and Regulatory Affairs 科技和调整If applicable, confirm that the supplier has completed and submitted the required forms/inform

59、ation requested by SRA.如适用，确定厂商完成和提交的SRA所要求的 表格和信息If applicable, supplier has registered with the FDA as required by the US FDA Public Health Security and Bioterrorism Preparedness Act of 2019.如适用，厂商在FDA注册情况Supplier has implemented a system to consistently comply with Prior notice provision of US FD

60、A Public Health Security and Bioterrorism Preparedness Act of 2019.厂商能执行符合FDA要求的体系K: Notification of Regulatory Action 调整的通知The supplier has an effective system to immediately notify The Coca-Cola Company when any product produced in this facility is the subject of a Regulatory Contact or Regulatory