精品Supplier Audit Checklista.docx

1、精品Supplier Audit ChecklistaGeneral 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 manufacture

2、d 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

3、 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)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 C

4、ompany?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 an

5、d 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 an

6、d 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 m

7、ay 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

8、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 provid

9、ed 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

10、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Adequate

11、ly 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

12、 processing 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

13、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 o

14、perating 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 Trainin

16、g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 definition

17、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

18、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

19、 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 an

20、d 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

21、 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 preve

22、nt 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 produc

23、t, 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 sys

24、tem 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 sa

25、nitary operations. (Key Practices 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 equipment install

26、ation 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 equip

27、ment, 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

28、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

29、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

30、, 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 su