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1、本模块作为审核指南，完成模块中内审的考核以确定被审公司是否符合可乐要求1) Questionnaire:YesDivNo1. Is the design of the water treatment area adequate to prevent contamination (outside, inside)?2i水处理设计能有效防止污染吗2. Is the water treatment area free of any obvious sources of potential contamination?2水处理没有明显的潜在污染源是吗3. Does the plant comply w
2、ith general requirements on water treatment?2工厂水处理符合总要求吗4. Does the plant comply with all requirements on raw water (source water)?2工厂源水符合所有的要求吗5. Does the plant follow the requirements on full analysis for raw water?2工厂按要求对原水进行全分析吗6. Is the water treatment system multi-barrier in design?2水处理设计是多层过滤
3、吗7. Are specific requirements fulfilled for the water treatment system?3水处理的特殊要求得到执行吗8. Are the chemicals / contact materials used in the water treatment authorized for contact with drinking water?3水处理中所有化学品或接触型物质是取得了认可的吗9. Are all required tests performed at the required frequency?3所有要求的实验按要求的频率作了吗
4、10. Are all Company requirements regarding Total Trihalomethane (TTHM) covered?4公司要求涵盖了TTHM吗11. Do records indicate that the treated water (as an ingredient) meets specifications?4有记录显示处理水作为一种成份符合要求吗12. Are the requirements for equipment maintenance followed?6符合设备保养要求吗13. Does the plant follow the r
5、equirements on recycling (potable reuse) of water (as source water)?6工厂用水符合循环用的要求吗14. Is water stored according to the Company requirements (if applicable)?7（如果适用）水的贮存符合公司要求吗2) Reference Standards List:Beverage Operations ManualBO-RQ-200Good Manufacturing Practices Design CriteriaBO-RQ-210Water Trea
6、tment SystemsBO-RQ-247Source WaterBO-SP-240Treated Water SpecificationsBO-RQ-245Water Quality MonitoringBO-RQ-250Water Storage and TransportationBO-RQ-235Raw Water MonitoringReference ManualRF-WA-266Total Trihalomethanes MonitoringTCCQS updates are captured till December 15, 20053) Specifications an
7、d Requirements Summary:Specifications / Requirements1Is the design of the water treatment area adequate to prevent contamination (outside, inside)? 水处理设计能有效防止污染吗Does the water treatment area meet all approved conditions for the GMP design criteria?水处理区的设计符合认可的GMP要求吗The listed items are “approved con
8、ditions” in order to comply with the general requirement “to prevent contamination in the water treatment area”认可 条件是指水处理区不被污染. If some of these approved conditions are not fulfilled, the auditor will judge on the possible contamination resulting from water treatment area design observed during the
9、audit.如果一些认可条件没有得到执行，审核员要判断这种已发现的设计不足可能造成何种污染。BO-RQ-200 Water treatment area separated or enclosed. 水处理区是单独或是附属的 Prevent or restrict traffic by non-essential personnel. 防止或是限制无关人员进入 Minimize number of doors and openings. 最少化门窗数量 Non-opening windows in the water treatment area. 水处理区窗应是不可开的 Self-closi
10、ng doors. 自动式门关闭系统 Air ventilation system in place (typically 6 changes / hour). 空气换送系统每小时6次 If bulk acid is stored inside the plant and/or ion-exchange system is in use, extra ventilation needs are investigated & applied. 如果室内贮有大量的酸或是使用离子交换系统则要另外考虑所需的通风系统 Water treatment area to be easy cleanable.
11、水处理区易清洁 No use of wooden materials in the water treatment area (as a construction material, desks, chairs wooden fixtures, ) 水处理区不用木制品（如建筑材料、桌子、椅子） Storage of liquid chlorine cylinders in a self-contained shed with outside ventilation. Local requirements to be met. 液氯贮存罐应在自我封闭区且有通风系统，并且符合当地法规 Adequa
12、te draining provided (worst case water load). 有足够的排水设施（最糟糕排水量） Floors are self-draining / drains have water traps and screen traps. 地面和自排系统/拦水排水系统2Is the water treatment area free of any obvious sources of potential contamination?水处理没有明显的潜在污染源是吗These requirements are results from the general require
13、ments in BO-RQ-200 “Implement GMP procedures throughout each section”.这些要求都是由BO-RQ-200衍生出来的，对每个部分实施GMP要求BO-RQ-200 The area is clean, organized and well maintained 区域清洁、有条理和易保养 No potential contamination points such as for instance: 没在潜在污染点诸如：- Standing water in the area- 地面积水- Wet wooden pallets- 湿木
14、托板- Storage of chemicals in the area- 有化学品贮存- Strong off-odors detected in the area- 有强烈的异味- Dirty floors, wall, ceiling - 地面、墙壁和天花板脏 SOPs available on the housekeeping of the water treatment area 有关于水处理区清洁的SOP No uncovered water tanks openings located under dirty sealing, pipework or light fixtures
15、. 没有无盖的水罐位于脏的焊接处、工程管道或灯具下面。3Does the plant comply with general requirements on water treatment?工厂水处理符合总要求吗Exception: Packaged Water when legal limitations for water treatment exist; see Package Water module.例外：如果包装水的水处理有相关法律限定，参见包装水模块BO-RQ-210 Only treated water to be used for production of carbonated and non-carbonated beverages (simple & final syrup
