糾正措施/補(bǔ)救行動(dòng)計(jì)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(xù)跟蹤對(duì)于執(zhí)行糾正/補(bǔ)救措施有效性的鑒定評(píng)估？以確保糾錯(cuò)方法行之有效并且可以防止再次發(fā)生類似問(wèn)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(jī)抽查若干糾錯(cuò)記錄。

　　驗(yàn)證是否大部分的后續(xù)跟蹤記錄表明管理部門已經(jīng)監(jiān)督了整個(gè)糾錯(cuò)過(guò)程。

　　核對(duì)相應(yīng)的質(zhì)檢記錄，以驗(yàn)證被糾錯(cuò)的問(wèn)題沒(méi)有重復(fù)發(fā)生。

　　糾正措施/補(bǔ)救行動(dòng)計(jì)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(bǔ)救措施）的有效性和預(yù)防措施的實(shí)施？

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

　　通過(guò)與工廠管理人員面談及核對(duì)會(huì)議紀(jì)錄。

　　驗(yàn)證他們是否定期檢查糾錯(cuò)系統(tǒng)，以保證其正常運(yùn)作。

　　訓(xùn)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(xùn)計(jì)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(duì)工廠的員工培訓(xùn)計(jì)劃，計(jì)劃必須指出每個(gè)生產(chǎn)部門和崗位所需的培訓(xùn)項(xiàng)目。培訓(xùn)教材必須涵蓋所有生產(chǎn)采購(gòu)或職能部門，設(shè)備使用部門，質(zhì)量控制部門以避免工廠生產(chǎn)的相關(guān)產(chǎn)品出現(xiàn)瑕疵。

　　訓(xùn)練Is there tailored training for QC, Production, Lab, and EquipmentMaintenance?

　　工廠是否有專為質(zhì)檢人員、生產(chǎn)部門、實(shí)驗(yàn)室和設(shè)備維修人員量身定做的培訓(xùn)計(jì)劃？

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

　　核對(duì)培訓(xùn)計(jì)劃和記錄。

　　驗(yàn)證質(zhì)檢人員、生產(chǎn)部門、實(shí)驗(yàn)室和設(shè)備維修人員接受了相關(guān)的培訓(xùn) Training Has the necessary training been provided? 工廠是否對(duì)相關(guān)工作人員進(jìn)行了必要的培訓(xùn)？

　　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(chǎn)現(xiàn)場(chǎng)的過(guò)程中，隨機(jī)選定幾個(gè)在不同工作崗位和部門工作的員工。

　　請(qǐng)工廠管理人員提供這些員工的培訓(xùn)記錄，驗(yàn)證這些培訓(xùn)記錄是否證實(shí)這些員工得到了必要的崗位技能培訓(xùn)。

　　訓(xùn)練Are QC employees trained on how to identify defects?

　　工廠是否對(duì)質(zhì)檢人員提供了如何識(shí)別產(chǎn)品瑕疵的培訓(xùn)？

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

　　核對(duì)工廠的培訓(xùn)記錄，是否包括實(shí)際瑕疵樣品/瑕疵產(chǎn)品的照片，用以標(biāo)明檢驗(yàn)重點(diǎn)。

　　訓(xùn)練Are training requirements AND records maintained? 工廠是否保存相關(guān)的培訓(xùn)計(jì)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(shí)，每個(gè)員工的培訓(xùn)計(jì)劃和記錄保存在員工人事檔案中。

　　驗(yàn)證培訓(xùn)記錄是否包含培訓(xùn)日期、培訓(xùn)內(nèi)容、培訓(xùn)考核結(jié)果等。培訓(xùn)記錄必須是近期的，完整的和準(zhǔn)確的。

　　設(shè)備與設(shè)備維護(hù)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(cè)標(biāo)準(zhǔn)和相關(guān)的測(cè)試儀器，對(duì)生產(chǎn)設(shè)備作出使用或者不能使用的判斷？并且以此做為生產(chǎn)設(shè)備需要校驗(yàn)的依據(jù)？

　　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(duì)工廠是否建立了設(shè)備維修、校驗(yàn)計(jì)劃，以確保所有生產(chǎn)設(shè)備都能得到定期的維修養(yǎng)護(hù)。

　　生產(chǎn)設(shè)備必須要標(biāo)明校準(zhǔn)狀態(tài)和校準(zhǔn)有效期。

　　設(shè)備與設(shè)備維護(hù)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(shè)備維修程序規(guī)定，當(dāng)設(shè)備的操作誤差/最大操作值超出允許范圍后，應(yīng)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(duì)工廠的設(shè)備維修程序文件。該程序包含當(dāng)工廠在測(cè)量設(shè)備校驗(yàn)時(shí)發(fā)現(xiàn)測(cè)量結(jié)果超出公差范圍時(shí)采取措施的描述；所采取的措施可能包括調(diào)查經(jīng)由此設(shè)備生產(chǎn)的產(chǎn)品質(zhì)量是否可以接受。如不能接受，產(chǎn)品是否需要返工，召回和通知客戶，等等。

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

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

　　核對(duì)工廠的生產(chǎn)設(shè)施清單和相關(guān)維修保養(yǎng)記錄。 （記錄可以存放在特定的文件檔案中或者標(biāo)示在設(shè)備上）。

　　設(shè)備與設(shè)備維護(hù)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(chǎn)設(shè)備的維護(hù)計(jì)劃？以確保這些設(shè)備生產(chǎn)的產(chǎn)品符合安全性、法律法規(guī)、質(zhì)量的要求，使工廠業(yè)務(wù)的能夠持續(xù)性發(fā)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(duì)工廠的生產(chǎn)設(shè)備的維護(hù)計(jì)劃，是否涵蓋了所有的設(shè)備，以確保這些設(shè)備生產(chǎn)的產(chǎn)品符合安全性、法律法規(guī)、質(zhì)量的要求，使工廠的業(yè)務(wù)能夠持續(xù)性發(fā)展。

　　生產(chǎn)設(shè)備的維護(hù)計(jì)劃包括，但不僅限于：

　　—定期保養(yǎng)計(jì)劃和完成日期；—預(yù)防性維護(hù)計(jì)劃；—安全性能檢查計(jì)劃；—配件的清單以及更換要求計(jì)劃；—關(guān)鍵設(shè)備發(fā)生故障的應(yīng)急預(yù)案。

　　設(shè)備與設(shè)備維護(hù)Are preventative maintenance schedules or cycles documented andon schedule?

　　工廠是否有設(shè)備預(yù)防性保養(yǎng)計(jì)劃？其上列明保養(yǎng)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(duì)工廠的生產(chǎn)設(shè)備的預(yù)防性保養(yǎng)計(jì)劃和記錄。

　　預(yù)防性保養(yǎng)記錄必須包含生產(chǎn)設(shè)備在既定的時(shí)間內(nèi)進(jìn)行的評(píng)估與檢查結(jié)果的記錄。

　　預(yù)防性保養(yǎng)計(jì)劃必須包括所有生產(chǎn)設(shè)備，保養(yǎng)計(jì)劃，及時(shí)間安排。

　　設(shè)備與設(shè)備維護(hù)Are machines, equipment, fixtures and tools suitable to produceclients product?

　　工廠的機(jī)器，設(shè)備，固定設(shè)備和工具，是否適合生產(chǎn)客戶的產(chǎn)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(duì)Target供貨商的驗(yàn)廠申請(qǐng)單上列明的將要生產(chǎn)的產(chǎn)品，以確定工廠擁有生產(chǎn)該類產(chǎn)品所必須的生產(chǎn)設(shè)備。

　　設(shè)備與設(shè)備維護(hù)Do machines, equipment, fixtures and tools appear to be clean and ingood condition?

　　工廠的機(jī)器設(shè)備，固定設(shè)備和工具，是否干凈整潔，呈現(xiàn)良好的狀態(tài)？

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

　　核對(duì)工廠的機(jī)器，設(shè)備，固定設(shè)備和工具，是否不生銹，不漏油/液以及得到良好的維護(hù)。

　　設(shè)備與設(shè)備維護(hù)Is an organized spare parts inventory kept on hand at the factory?

　　工廠設(shè)備的備用零件是否有序的存放并有詳細(xì)的庫(kù)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(qū)域。

　　不需要所有的備件都有庫(kù)存，但至少設(shè)備運(yùn)行的關(guān)鍵部件有備用零件以確保設(shè)備正常運(yùn)轉(zhuǎn)。

　　工廠必須有備用零件庫(kù)存清單。

　　設(shè)備與設(shè)備維護(hù)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(shè)備，夾具，模具等妥善保存，以避免生銹，損壞，以及便于收發(fā)？

　　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(shí)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(chǔ)倉(cāng)庫(kù)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。