雅诗兰黛验厂清单之设备保养

J. FACILITIES – EQUIPMENT - MAINTENANCE   Estee Lauder/雅诗兰黛验厂清单之设备保养

1.  Are the facilities adequate in design, size, and condition to produce the required materials?
     设施的设计，大小条件生产所需的材料是否充足？

2.  Is an effective, documented pest control program implemented and maintained?
     是否有有效的成文的害虫防治项目正在实践和维持

3.  Is there proper security to prevent unauthorized entry?
     是否有阻止未经同意的进入

4.  Are there records of the assessment of all utilities (e.g. air, gases, steam, water) for their potential impact on the quality of the product and any associated risks?
     所有的设施是否都有评估记录（如空气，气体，蒸汽，水）为了保证其对产品质量的潜在影响和任何相关的风险？

5.  Does the assessment include other fluids (e.g. lubrication fluids, cooling fluids, hydraulic oils, etc.), which may accidentally come into contact with the product? Depending on the risks, food-grade fluids should be considered
     无意中接触到的物品是否经过评估，包括其他液体（如润滑油，冷却液，液压油，等等），根据不同的风险，食品级液体应考虑

6.  Where necessary are there appropriate ventilation and exhaust systems to minimize contamination? Particular attention shall be given to recirculation systems.
     在必要的地方是否有适当的通风和排气系统，应注重减少污染？应特别重视再循环系统。

7.  Is the quality of water determined and controlled, if water comes into direct contact with primary components, or its starting material, or is used for cleaning the equipment in contact with the product?
     如果水与原部件，或它的起始材料直接接触，或用于与产品接触的设备清洗？水的质量是否经过确定和控制，

8.  Are there documented requirements for maintenance activities (e.g. production processes, systems and equipment), when such activities or lack thereof may affect product quality?
     是否有程序文件规定维护要求（如生产流程，系统和设备），如果缺乏这样的程序是否可能影响产品质量？

9.  Are records of maintenance maintained?
     维护记录是否保存着

10.  Is the infrastructure managed, operated, cleaned and where appropriate, maintained in accordance with GMP to avoid product contamination?
      基础设施的管理，操作，清洗和适当的维护，是否按照GMP标准执行，避免产品污染？

11.  Is a set of technical documentation for quality critical equipment and installations maintained?
      对于质量关键设备和装置维护是否有一套技术性文件