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1、This module serves as a guide to the auditor in completing an audit of thecleaning and sanitizing processes. The auditor will determine whether or notthe facility is complying with the specifications and requirements of The CocaCola Company by completing this module.此模块可作为审核员在完成清洁和消毒审核过程的指导。通过完成此模块审
2、核员将决定工厂设施是否符合可口可乐公司的要 求。Plant 工厂:Date 日 期:Auditor(s)审核人:1) Questionnaire 调查表:Ye Div No sEquipment Cleaning & Sanitizing清洗和要求:1Is a cleaning and sanitation program developed andimplemented清洗和消毒程序是否执行和元成？2Are all requirements fulfilled on cleaning and sanitizing agents 清洗和消毒剂是否符合条件？3Is a full Product
3、Changeover Matrix in use covering all products?是否有针对所有产品的转换模式?4Are good cleaning &sanitizing practices applied是否使用良好的清洗和消毒习惯？5Is an adequate microbiological monitoring program in use tovalidate the effectiveness of the cleaning & sanitation是否启个适当的微生物监控程序来评估清洗和消毒的有效性？6Do records indicate that the cle
4、aning and sanitizing of allequipment is effective是否启记录显小所后 的设备清洗和消毒是由效的？7Is appropriate corrective action taken when microbiological test results show trends or problems?当微生物出现杲种趋势或是问题时是否启适当的纠正行动？2) Reference Standards List:Beverage OperationsManualProcess Equipment CleaningBO-BO-Cleaning and Saniti
5、zingand SanitizingI青洗和消毒要求PR-RQ-220Procedures清洗和消毒操作程序629Microbiological Mon.BO-BO-PR-Product Changeovers 转换广Requirem. for Cleaning &RQ-+634品Sanitizing清洗和消毒的微生物434要求3) Specifications and Requirements Summary:标准和要求概要Specifications / Requirements标准/要求Equipment Cleaning & Sanitizing:设备清洗消毒1Is a cleanin
6、g and sanitation program developed and implemented?是否制定清洗和消毒执行和完成？Division must specify the required frequencies and methods. 区域公司对频率及方法要求的规定 The Division must approve all procedures and agents used.区域公司必须认可所有程序及使用溶剂However, the division can delegate the responsibility for evaluating and approving c
7、leaning and sanitizing agents to the beverage plants. In that case, the facility must maintain the required documentation.然而区域公司能够授权把评估和认可的清洗及 消毒剂责任交给饮料厂。但是工厂必须要有保 养的文件要求BO-RQ-220 The program covers all equipment and areas 程序必须覆盖所有设备及区域 SOP s are available per equipment / cleaning process SOP适用于每一台机
8、器青洗过程 Required frequencies for cleaning& sanitizing clearly specified 清洗和消毒的频率要有明确的规定 Cleaning agents, concentration and contact times are specified 清洗剂、浓缩液和接触时间要有规定 Any changes in procedure to be approved by the division. 所有清洗和消毒程序的改变必须经过区 域公司认可 Effectiveness of cleaning and rinsing procedures to b
9、e checked 检查清洗和冲洗的过程肩效性 Test methods and frequencies for these checks are specified 检查测试方法及频率要有明确规定 All cleaning & sanitizing activities fully recorded (date, time, operator, traceability) 所有清洗及消毒过程要有完整的记录 (日期、时间、操作者、追溯性)2Are all requirements fulfilled on cleaningBO-RQ-220and sanitizing agents?清洗和消毒
10、剂是否符 List of Division approved agents合条件？available on site现场有区域公司认可的溶剂的清单Divisions can delegate the responsibility All agents in use are listed 清单上有for evaluating and approving cleaning and所有溶剂使用记录sanitizing agents to the beverage plants. Purchasing records to be kept. 保存In that case, the facility m
11、ust maintain the采购记录required documentation.然而区域公司能够 All necessary documentation on授权把评估和认可的清洗及消毒剂责任交给饮these agents available料厂。但是工厂必须要有保养的文件要求这些清洗消毒剂要有必要的文件说明- Statements of compliance to local regulations- 符合当地的规定的要求- Safety Data Sheets / User Instruction 安全使用日期/使用说明3Is a full Product Changeover Ma
12、trix in useBO-PR-634 / BO-RQ-220covering all products? Matrix defines all possibilities是否有针对所有产品的转换模式？ 模式包括所有的可能性 Matrix approved by the Division 区域公司批准模式 Matrix in line with basicrequirements: 模式与基本要求T：- batches of same prod. ( 1h): no cleaning required- 同样产品(75 C at exit) or 热水15分钟(一旦热水 750 )BO-PR
13、-629Recommended sanitizing practices:推荐消毒方法 3-step CIP:- rinse with potablewater处理水冲洗- clean with caustic (1.0 %; ambient or 60- 77o)or hot water 850 C15 minutes- 用浓度1.0 %温度为60- 77o热碱或是热水温度85 oC循环15-分钟rinse with treatedwater (cold or hot)用冷或是热处理水冲洗 5-step CIP:- rinse with potablefo- 10 hot water (on
14、ce hot water 85 C at exit) or热水15分钟(一旦热水 85 )- 30 chlorine solution (50 mg/l)- 50PpM的氯水30分钟Final rinse always to be with treated water! 最后用冲洗水冲洗Rinsing after caustic (or other chemical): until all traces are removed + additionally 3 minutes.碱洗后或(其匕化学方法清洗后) 再加上三分钟清洗：直到所有的微量元素被清 除water用处理水冲洗- clean wi
15、th detergent (caustic1.0 %)-用浓度1.0 %碱液清洗- rinse with potable water 用处理水冲洗- sanitize 消毒- rinse with treated water 用处理水冲洗 6-step CIP:- rinse with potablewater用处理水冲洗-clean with hot caustic (1.0% / 60-77 C)- 用热碱(1.0% / 60- 770 C)-rinse with potable water 用处理水冲洗- rinse with acid (phosphoric acid H 3PO4,
16、3%)-用3%磷酸冲洗-rinse with treated water 有处理水冲洗-sanitize with water 9399 C (85oC if tunnel pasto in use).用93- 99 0热水消毒5Is an adequate microbiological monitoring program in use to validate the effectiveness of the cleaning & sanitation? 是否启一个适当的微生物监控程序来评估清洗 和消毒的有效性？Equipments are: Mix tanks / Storage tan
17、ks/ Fillers / Etc.设备：混比缸/储存缸/灌装机等 See also Microbiological Module.BO-RQ-434 SOP s available on sampling and testing (final rinse water) SOP规定取样及测试(最后冲洗水) Random, periodic sampling of all process equipment 所有生产设备随机和周期取样测试 Roles and responsibilities for the monitoring are defined 明确监控人员的角色及职责参见微生物模块 E
18、very piece of equipment is at least samples once per week 每台设备每周至少取次 Special frequency for equipment used in the production of microbiologically sensitive products加强生产敏感产品时对机器的微生物取 样。 Final rinse water only sampled when below 400 C 最后冲洗水在低于40。C取样 Use swab test if sampling of final rinse water is not
19、 possible 如果最后冲洗水样品不可能，做擦拭实 验 Use final rinse water reference samples (just before inlet)用最后冲洗水做参照样6Do records indicate that the cleaning and sanitizing of all equipment is effective?是否有记录显示所有的设备清洗和消毒是有效 的？See also Microbiological Module.参见微生物模块BO-RQ-434 Final rinse water: - Yeast / Mold 10 CFU per
20、100 ml醉母菌/霉菌最后冲洗水-Total count: 25 CFU per ml总菌7Is appropriate corrective action taken when microbiological test results show trends or problems? 当微生物出现杲种趋势 或是问题时是否启适当的纠正行动？BO-RQ-434 Appropriate action when samples are out-of-spec 当样品超过标准的纠正行动 In that case, corrective action initiated on cleaning & s
21、anitizing 如果有的，用清洗和消毒的方法来纠正 Review of testing technique whencontrol samples are bad如果对照样品结果是坏的，请回顾测试方 法Note 注释:For Systems, Certification and Follow-Up audits, use this process assessment to verify the status of implementation and effectiveness for the following System Elements:对于系统，认证和持续审核，使用这个过程评估来确认下列系统组成部分的有效性：- Document Management文件管理- Record Keeping记录保存- Process Integrity流程完整- Calibration 校正- Training 培训- Internal Audits 内审- Continual Improvement (Corrective & Preventive Actions)持续改进(更正/预防行动)4) Comments & Remarks 备注: