糾正措施/補救行動計劃Is there a process to follow-up on each corrective action to ensureexecution and prevention of reoccurrence (closed loop)?

　　工廠是否有后續跟蹤對于執行糾正/補救措施有效性的鑒定評估？以確保糾錯方法行之有效并且可以防止再次發生類似問題？

　　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.

　　隨機抽查若干糾錯記錄。

　　驗證是否大部分的后續跟蹤記錄表明管理部門已經監督了整個糾錯過程。

　　核對相應的質檢記錄，以驗證被糾錯的問題沒有重復發生。

　　糾正措施/補救行動計劃Does the factory management periodically review the correctiveaction (remedial action) system for effectiveness and adoption ofpreventative actions?

　　工廠管理部門是否定期檢查糾正措施（補救措施）的有效性和預防措施的實施？

　　Interview factory managers and review meeting notes that support they periodically review thecorrective action system to verify it is working.

　　通過與工廠管理人員面談及核對會議紀錄。

　　驗證他們是否定期檢查糾錯系統，以保證其正常運作。

　　訓練Does the factory identify the need for required training? 工廠是否清楚列明所有必要的員工培訓計劃？

　　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.

　　核對工廠的員工培訓計劃，計劃必須指出每個生產部門和崗位所需的培訓項目。培訓教材必須涵蓋所有生產采購或職能部門，設備使用部門，質量控制部門以避免工廠生產的相關產品出現瑕疵。

　　訓練Is there tailored training for QC, Production, Lab, and EquipmentMaintenance?

　　工廠是否有專為質檢人員、生產部門、實驗室和設備維修人員量身定做的培訓計劃？

　　Through review of training documentation and records verify maintenance, QC, Lab, andProduction departments receive training specific to area they work in.

　　核對培訓計劃和記錄。

　　驗證質檢人員、生產部門、實驗室和設備維修人員接受了相關的培訓 Training Has the necessary training been provided? 工廠是否對相關工作人員進行了必要的培訓？

　　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.

　　在參觀生產現場的過程中，隨機選定幾個在不同工作崗位和部門工作的員工。

　　請工廠管理人員提供這些員工的培訓記錄，驗證這些培訓記錄是否證實這些員工得到了必要的崗位技能培訓。

　　訓練Are QC employees trained on how to identify defects?

　　工廠是否對質檢人員提供了如何識別產品瑕疵的培訓？

　　Verify the training curriculum includes actual defect samples/photos to instruct on what to look for.

　　核對工廠的培訓記錄，是否包括實際瑕疵樣品/瑕疵產品的照片，用以標明檢驗重點。

　　訓練Are training requirements AND records maintained? 工廠是否保存相關的培訓計劃和記錄？

　　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.

　　與工廠的人力資源部核實，每個員工的培訓計劃和記錄保存在員工人事檔案中。

　　驗證培訓記錄是否包含培訓日期、培訓內容、培訓考核結果等。培訓記錄必須是近期的，完整的和準確的。

　　設備與設備維護Has all measurement and test equipment used to make accept/rejectdecisions been identified and calibrated?

　　工廠是否使用既定的檢測標準和相關的測試儀器，對生產設備作出使用或者不能使用的判斷？并且以此做為生產設備需要校驗的依據？

　　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.

　　核對工廠是否建立了設備維修、校驗計劃，以確保所有生產設備都能得到定期的維修養護。

　　生產設備必須要標明校準狀態和校準有效期。

　　設備與設備維護Are procedures in place for actions to be taken if equipment is foundnot to be operating within specified tolerances and/or limits?

　　工廠是否有明確的設備維修程序規定，當設備的操作誤差/最大操作值超出允許范圍后，應該如何處理此類事件？

　　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.

　　核對工廠的設備維修程序文件。該程序包含當工廠在測量設備校驗時發現測量結果超出公差范圍時采取措施的描述；所采取的措施可能包括調查經由此設備生產的產品質量是否可以接受。如不能接受，產品是否需要返工，召回和通知客戶，等等。

　　設備與設備維護Are documentation and records maintained for main facilityequipment (i.e. boilers, Back up power supply , Centralized heating,工廠主要生產設施（如鍋爐，后備電源，集中供熱等）是否有維修保養記錄？

　　Verify equipment and maintenance documentation is maintained and current. (This could be on fileor on the equipment).

　　核對工廠的生產設施清單和相關維修保養記錄。 （記錄可以存放在特定的文件檔案中或者標示在設備上）。

　　設備與設備維護Is there a documented system for planned maintenance covering allequipment which are critical to product safety, legality, quality andbusiness continuity?

　　工廠是否有全部生產設備的維護計劃？以確保這些設備生產的產品符合安全性、法律法規、質量的要求，使工廠業務的能夠持續性發展。

　　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.

　　核對工廠的生產設備的維護計劃，是否涵蓋了所有的設備，以確保這些設備生產的產品符合安全性、法律法規、質量的要求，使工廠的業務能夠持續性發展。

　　生產設備的維護計劃包括，但不僅限于：

　　—定期保養計劃和完成日期；—預防性維護計劃；—安全性能檢查計劃；—配件的清單以及更換要求計劃；—關鍵設備發生故障的應急預案。

　　設備與設備維護Are preventative maintenance schedules or cycles documented andon schedule?

　　工廠是否有設備預防性保養計劃？其上列明保養周期并依此而做。

　　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.

　　核對工廠的生產設備的預防性保養計劃和記錄。

　　預防性保養記錄必須包含生產設備在既定的時間內進行的評估與檢查結果的記錄。

　　預防性保養計劃必須包括所有生產設備，保養計劃，及時間安排。

　　設備與設備維護Are machines, equipment, fixtures and tools suitable to produceclients product?

　　工廠的機器，設備，固定設備和工具，是否適合生產客戶的產品？

　　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.

　　核對Target供貨商的驗廠申請單上列明的將要生產的產品，以確定工廠擁有生產該類產品所必須的生產設備。

　　設備與設備維護Do machines, equipment, fixtures and tools appear to be clean and ingood condition?

　　工廠的機器設備，固定設備和工具，是否干凈整潔，呈現良好的狀態？

　　Verify machines, equipment, fixtures, and tools are not dirty, rusty, leaking oil/fluids and are wellmaintained.

　　核對工廠的機器，設備，固定設備和工具，是否不生銹，不漏油/液以及得到良好的維護。

　　設備與設備維護Is an organized spare parts inventory kept on hand at the factory?

　　工廠設備的備用零件是否有序的存放并有詳細的庫存清單？

　　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.

　　參觀備用零件存放房間或區域。

　　不需要所有的備件都有庫存，但至少設備運行的關鍵部件有備用零件以確保設備正常運轉。

　　工廠必須有備用零件庫存清單。

　　設備與設備維護Are tools, spare parts, fixtures, jigs, molds, etc appropriately storedto avoid rust, damage, and ensure ease of locating?

　　工廠是否將工具，備用零件，固定設備，夾具，模具等妥善保存，以避免生銹，損壞，以及便于收發？

　　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.

　　核實工廠的工具，備用零件等是否存放在貨架上，柜子里，托盤上，存儲倉庫必須密閉干凈。

　　工具，備用零件不得露天存放，堆積，或混放在一起。