纠正措施/补救行动计划Is there a process to follow-up on each corrective action to ensureexecution and prevention of reoccurrence (closed loop)?
工厂是否有后续跟踪对于执行纠正/补救措施有效性的鉴定评估?以确保纠错方法行之有效并且可以防止再次发生类似问题?
Review a sampling of individual corrective action records. Do the majority of them have notes ordocumentation showing someone has verified the corrective actions were actually implemented.
Review appropriate Quality records to verify issues are not recurring.
随机抽查若干纠错记录。
验证是否大部分的后续跟踪记录表明管理部门已经监督了整个纠错过程。
核对相应的质检记录，以验证被纠错的问题没有重复发生。
纠正措施/补救行动计划Does the factory management periodically review the correctiveaction (remedial action) system for effectiveness and adoption ofpreventative actions?
工厂管理部门是否定期检查纠正措施(补救措施)的有效性和预防措施的实施?
Interview factory managers and review meeting notes that support they periodically review thecorrective action system to verify it is working.
通过与工厂管理人员面谈及核对会议纪录。
验证他们是否定期检查纠错系统，以保证其正常运作。
训练Does the factory identify the need for required training? 工厂是否清楚列明所有必要的员工培训计划?
Documentation must designate the required training per area and position. Training material mustcover all production phases or department functions, use of equipment, and quality systems andassociated defects based on the product category the factory produces.
核对工厂的员工培训计划，计划必须指出每个生产部门和岗位所需的培训项目。培训教材必须涵盖所有生产采购或职能部门，设备使用部门，质量控制部门以避免工厂生产的相关产品出现瑕疵。
训练Is there tailored training for QC, Production, Lab, and EquipmentMaintenance?
工厂是否有专为质检人员、生产部门、实验室和设备维修人员量身定做的培训计划?
Through review of training documentation and records verify maintenance, QC, Lab, andProduction departments receive training specific to area they work in.
核对培训计划和记录。
验证质检人员、生产部门、实验室和设备维修人员接受了相关的培训 Training Has the necessary training been provided? 工厂是否对相关工作人员进行了必要的培训?
While out on the shop floor select and identify some employees working in different work areas ordepartments. Ask factory management to pull the training records for employees identified.
Review these training records for the required training. Training records are to indicate theemployees had received the training.
在参观生产现场的过程中，随机选定几个在不同工作岗位和部门工作的员工。
请工厂管理人员提供这些员工的培训记录，验证这些培训记录是否证实这些员工得到了必要的岗位技能培训。
训练Are QC employees trained on how to identify defects?
工厂是否对质检人员提供了如何识别产品瑕疵的培训?
Verify the training curriculum includes actual defect samples/photos to instruct on what to look for.
核对工厂的培训记录，是否包括实际瑕疵样品/瑕疵产品的照片，用以标明检验重点。
训练Are training requirements AND records maintained? 工厂是否保存相关的培训计划和记录?
Verify HR keeps records of training of ALL factory workers in their personnel files. Sample filesand review training records. Training records provide date of training, contents of training, trainingduration and assessment result. The training records need to be current, complete and accurate.
与工厂的人力资源部核实，每个员工的培训计划和记录保存在员工人事档案中。
验证培训记录是否包含培训日期、培训内容、培训考核结果等。培训记录必须是近期的，完整的和准确的。
设备与设备维护Has all measurement and test equipment used to make accept/rejectdecisions been identified and calibrated?
工厂是否使用既定的检测标准和相关的测试仪器，对生产设备作出使用或者不能使用的判断?并且以此做为生产设备需要校验的依据?
Verify there a master list that identifies all equipment that needs to be calibrated and the calibrationfrequency. Equipment must to be marked to show the calibration status and period of validity.
核对工厂是否建立了设备维修、校验计划，以确保所有生产设备都能得到定期的维修养护。
生产设备必须要标明校准状态和校准有效期。
设备与设备维护Are procedures in place for actions to be taken if equipment is foundnot to be operating within specified tolerances and/or limits?
工厂是否有明确的设备维修程序规定，当设备的操作误差/最大操作值超出允许范围后，应该如何处理此类事件?
Review the written procedures on measurement equipment calibration. The procedure is to containa description of the actions the factory will take in the event a piece of measurement equipment isfound to be out of tolerance when being calibrated. The action taken may include investigating theimpact on product accepted by this piece of equipment including determination if product has to bereworked, recalled and if customer notification is needed, etc.
核对工厂的设备维修程序文件。该程序包含当工厂在测量设备校验时发现测量结果超出公差范围时采取措施的描述;所采取的措施可能包括调查经由此设备生产的产品质量是否可以接受。如不能接受，产品是否需要返工，召回和通知客户，等等。
设备与设备维护Are documentation and records maintained for main facilityequipment (i.e. boilers, Back up power supply , Centralized heating,工厂主要生产设施(如锅炉，后备电源，集中供热等)是否有维修保养记录?
Verify equipment and maintenance documentation is maintained and current. (This could be on fileor on the equipment).
核对工厂的生产设施清单和相关维修保养记录。 (记录可以存放在特定的文件档案中或者标示在设备上)。
设备与设备维护Is there a documented system for planned maintenance covering allequipment which are critical to product safety, legality, quality andbusiness continuity?
工厂是否有全部生产设备的维护计划?以确保这些设备生产的产品符合安全性、法律法规、质量的要求，使工厂业务的能够持续性发展。
A documented system of planned maintenance shall be in place, covering all items of equipmentsand plant which are critical to product safety, legality, quality and business continuity. This shallinclude, but not be limited to, records of: periodic maintenance schedules and completion;preventative maintenance; required safety checks; spare-part listings and replacements; contingencyplans for failure of essential equipment.
核对工厂的生产设备的维护计划，是否涵盖了所有的设备，以确保这些设备生产的产品符合安全性、法律法规、质量的要求，使工厂的业务能够持续性发展。
生产设备的维护计划包括，但不仅限于：
―定期保养计划和完成日期;―预防性维护计划;―安全性能检查计划;―配件的清单以及更换要求计划;―关键设备发生故障的应急预案。
设备与设备维护Are preventative maintenance schedules or cycles documented andon schedule?
工厂是否有设备预防性保养计划?其上列明保养周期并依此而做。
Request and review preventative maintenance program documentation. This documentation mustvalidate that equipment is evaluated at predetermined intervals with records of inspection results.
This must include all machinery, maintenance plans, and schedule timing.
核对工厂的生产设备的预防性保养计划和记录。
预防性保养记录必须包含生产设备在既定的时间内进行的评估与检查结果的记录。
预防性保养计划必须包括所有生产设备，保养计划，及时间安排。
设备与设备维护Are machines, equipment, fixtures and tools suitable to produceclients product?
工厂的机器，设备，固定设备和工具，是否适合生产客户的产品?
Look at the product that led to the request for the FE and determine if the factory has all of thenecessary equipment, etc. to produce the product.
核对Target供货商的验厂申请单上列明的将要生产的产品，以确定工厂拥有生产该类产品所必须的生产设备。
设备与设备维护Do machines, equipment, fixtures and tools appear to be clean and ingood condition?
工厂的机器设备，固定设备和工具，是否干净整洁，呈现良好的状态?
Verify machines, equipment, fixtures, and tools are not dirty, rusty, leaking oil/fluids and are wellmaintained.
核对工厂的机器，设备，固定设备和工具，是否不生锈，不漏油/液以及得到良好的维护。
设备与设备维护Is an organized spare parts inventory kept on hand at the factory?
工厂设备的备用零件是否有序的存放并有详细的库存清单?
Look for a room or area separate from production that contains spare parts for the productionequipment. Does not need to be all spare parts, but at a minimum must be critical parts needed tokeep the equipment running. Factory must have inventory list.
参观备用零件存放房间或区域。
不需要所有的备件都有库存，但至少设备运行的关键部件有备用零件以确保设备正常运转。
工厂必须有备用零件库存清单。
设备与设备维护Are tools, spare parts, fixtures, jigs, molds, etc appropriately storedto avoid rust, damage, and ensure ease of locating?
工厂是否将工具，备用零件，固定设备，夹具，模具等妥善保存，以避免生锈，损坏，以及便于收发?
Look for tools, spare parts, etc. to be stored on shelves, cabinets, pallets, etc. in enclosed area with aroof. They must not be stored outside, piled up, or mixed together.
核实工厂的工具，备用零件等是否存放在货架上，柜子里，托盘上，存储仓库必须密闭干净。
工具，备用零件不得露天存放，堆积，或混放在一起。