可口可乐供应商检查表.doc

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 (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 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)- Record Keeping and Document Control Systems appear to assure the products and services supplied meet the specifications and performance expectations of The Coca-Cola Company. - Formal procedures are followed to establish, document, maintain control, preparation, approval, issuing and modifying of all critical documents.- A formal system exists to control the distribution of documents to all locations.- All documents found are current and controlled.All changes are reviewed and approved though a formal procedure.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.无不符合要求的储存：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.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 contamination 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 minimize 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，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 stocked 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 processing food.(Key Practices see notes) - Personnel comply with any requirement for hand washing, hair coverings, special clothing, or other protection in the various manufacturing, packaging, and testing areas.- Personnel suffering from any infectious illness not allowed to work in contact with food materials.- Unsecured jewelry not allowed in the food processing or packing areas.Take into consideration processes were material is fully enclosed: Material synthesis not necessarily needs GMP, material purification and packaging/filling must comply GMP requirements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) Are test instruments / apparatus operational, readily accessible, in an appropriate location and in good overall condition? Appropriate location equals a suitable office or building with a controlled environment. Laboratory instruments are calibrated routinely and records are kept. Qualified personnel do calibrations using calibrated traceable to national standards.- All test equipment is calibrated at regular intervals, and records of these calibrations are 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 operating 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 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)- All skills and competencies necessary to perform each job are formally documented.- Training is an element of a formal Quality System and training records are maintained.- All equipment and process changes are supported by training.- Review of the employee training records indicate the following:- Documented, completed training dates, and required signatures.- Documented performance competency requirements.- Supplier supports continuous improvement with formal training programs.A qualified person is assigned to educate and train employees on appropriate hygiene practices.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 definition 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 appropriate, and signed off when completed.记录和日程表要显示：定期的检查、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 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 microbial 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Water used for sanitation in the plant has the appropriate quality for its application.厂內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 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, finished product, product on hold, released and reworked materials.厂商有对原料、成品、隔离品和放行返工的原料的隔离、跟踪程序The supplier has an effective finished goods and raw material inventory management system and can ensure that shipments are according to specifications and requirements. 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 supplier has a system in place to prevent the inadvertent shipment of non-conforming products or ingredients to The Coca-Cola Company.厂商有防止不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 maintenance and sanitary operations. (Key Practices see notes) - Walls, floors and ceiling are crack and crevice free and finished with smooth impermeable, easily cleaned materials.- Floors drained and designed to prevent pools of water forming.- Dirt traps such as ledges are eliminated.- Overhead equipment, pipes and ducting kept to a minimum and maintained in good condition i.e. free from dirt, flaking paint, rust, mold, etc.- Toilet separated from food production areas and hygienically maintained.- Plant perimeter kept clean and tidy, free of accumulated debris, e.g. rubbish, redundant equipment, pallets, etc.- Grounds kept tidy and the vegetation kept short to discourage pest harborage.Take into consideration processes were material is fully enclosed: Material synthesis not necessarily needs GMP, material purification and packaging/filling must comply GMP requirements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 equipment 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 critical equipment, identifies accuracy and precision, uses appropriate traceable standards and methods, and includes appropriate calibration and calibration verification frequencies.- Provide definition for critical equipment (equipment that 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、基准的追溯和方法、校正的频率 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 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-conformances, 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 Principles 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, the 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) Observations at Suppliers: Do you see any children on site? Does the air seem clean? Does the noise level allow you to carry on a conversation? Does the lighting appear adequate for work and safety? Is the temperature in the work areas comfortable? Is the work floor uncluttered and without debris or structural obstacles? Does the water in and around the facility appear clean? Is there a bathroom for workers to use with unrestricted access? Is there a first aid kit that is easily accessible? Is there any trash or dumping around the factory? If there was a fire, would everyone be able to escape? Can you see a fire alarm system? How many days a week do the employees work? Is there security in and around the facility? Do employees appear to have free movement in unrestricted areas? Is the eating area clean and adequate? Do the workers live on site? Do the workers appear happy? Do any workers have any apparent physical injuries? Will all the work for us be completed in this factory?无违背SGPWho deals with social responsibility and human 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 Materials/Services 原材料/服务的采购The supplier has an effective process for authorizing their suppliers. 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) - Suppliers suppliers monitoring depend on supplier processes. If synthesis is conducted, surveys would be fine; if mixes are conducted, a more comprehensive monitoring (i.e. on site audits, is recommended)厂商对供应商的表现进行监控Incoming materials 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The supplier has an effective inventory management system for controlling nonconforming material within the plant.厂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 negatively 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 quality 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过程控制Need to use a bolt on checklist for specific ingredient or packaging material (manufacturing process work-aid)必须有原物料的标准Is manufacturing process batch 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 the 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 / 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 distribution 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