SUPPLIER AUDIT REPORT供 應 商 審 核 報 告SupplierQuality System質量系統Section 1:Quality Assurance System Overview質量保證系統概述序號Item1Max Possible:實際總分Max Possible:實際總分Actual Score:實際得分450477NoSystem0ReportNo. 編#REF!Actual Score實際得分0SignifiaNeedntImprovSatisf.Deficiee-ment123Score評 審 內 容 Review ContentsBe awarded ISO 9001 certificate or other equivalent QMS certificates.(通過了ISO9001認證或等效的質量管理體系(QMS)證書。) ZeroToleranceSupplier has an Organization Chart with clear assignedresponsibilities. (有組織架構圖。)The organization chart describe management responsibilitiesincluding quality control, technology management, productionmanagement, facility/fixture/mold management, measuringequipment, worker training and customer complaint handling, etc. (組織架構圖職責描述中含蓋了質量控制, 技術管理、 生產管理、 設備/工裝/模具管理、 儀器/儀表計量、 員工培訓、 客戶投訴處理等管理職責Supplier has an Organization Chart of Quality function and theQuality Control Organization Chart involves relevant responsibility onIncoming Quality Control, In-Process Quality Control, Finished QualityControl, Customer Complaint Disposition and Prevention etc. (有質量控制架構圖, 含蓋了來料質量控制、 過程質量控制、成品品質控制、投訴處理及預防等管理職責.)The supplier has appointed a Management Representative who hasresponsibility and authority for ensuring that a quality managementsystem has been implemented and maintained. (供應商有指定一個对于保證質量管理系統的執行和維護有責任和權利的管理者代表。)Supplier has established annual Quality Objectives which aremeasurable, consistent with Quality Policy and created by detailedquality targets. (供應商制定了可測量的並與質量方針保持一致的年度質量目標, 年度質量目標由具體質量指標組成。)The management representative has tracked record on drivingimprovement on quality management system performance. (管理者代表有追蹤質量管理系統改善的記錄 。)Supplier reviewed Quality goals achievement at least monthly, andeffectively tracked the result if the Quality goals were not achieved.(Observe consecutive three months records). (至少每月總結質量目標的完成情況， 完不成質量目標時， 進行了檢討並有效地跟進 。查連續三個月質量目標評審記錄）。There are evidences shows supplier has done the formal internalquality audit at least once a year. (有記錄證明至少每年做一次正式的內審。)The internal audits comply with plan, ISO standards and qualitymanagement system. (內部稽核有遵照計劃的安排, 遵循ISO標準和品質管理系統。)All nonconformities were followed up until closed. (內部評審不符合項都得到了跟進，直到關閉。) Documented OJT (on-job- training) procedure is available. (制定了成文的員工培訓程序。)Training plan is available and established according to the demand ofdifferent operation stations. It is executed and completed. Trainingeffectiveness was measured. (供應商有根據不同崗位的需求製定培訓計劃,並且按時完成培訓和確認了培訓效果.)審 核 記 錄Evidence or Records22.1345671011121314Does the supplier have the continues improvement activity? Anyrecords ? (是否有推動品質持續改善的活動和記錄.)All department heads have held routine quality meeting. (各部門負責人周期性舉行質量會議：)Follow up implementation status of improvement actions taken for14.1critical quality issue. (跟蹤重大品質問題改善措施實施情況。)14.2Review quality performance. (回顧本時間段各環節質量表現。)14.3Quality performance is measurable. (質量表現可以量化。)14.4Improvement plan is available. (制訂了改善計劃。)The official meeting minutes is reserved for at least one year. (該會議有正式記錄，該記錄至少保存一年。)15Quality Cost Control. (質量成本控製.)a. Supplier has established detailed quality cost objectives, andmanagement has reviewed the achievement at least once a month.15.1(建立了具體的質量成本目標 ，並且管理層至少每月一次評估了質量成本目標的達成情況。)b. Supplier has recorded the expense of rework, scrap, deliverydelay, rejected by customer and customer complaints handling etc15.2that caused by quality problems. (記錄了因質量問題造成的返工、報廢、交期延誤、客戶退貨、客戶投訴處理等費用的損失。)14.5審核員:Auditor:供應商協審員:Supplier:日期:Date:SignifiaNeedNontImprovSatisf.SystemDeficiee-mentncy0123ScoreSection 2:Technology Support System技術支持系統序號Item1Max Possible:實際總分Actual Score:實際得分審 核 記 錄Evidence or Records570評 審 內 容 Review ContentsThere is a documented plan for new product development and alsofor any change of it. (對全新產品或重大更改產品的開發和行動前， 以書面形式對開發項目進行了規劃.)There are appropriate and up-to-date international standards/national standards for the raw materials, processes and inspectionmethods, and were executed and followed accordingly. (產品涉及的原材料、加工工藝、檢驗方法，有國際、國家行業標準的，保存了該標準的最新版本,並且有按此標準執行.)Supplier obtained the certificates of product compliance as required.(取得了符合零件要求的產品認證證書。)Product performance validation includes customer specificrequirements. (產品性能確認包括了客戶明確的要求。)Supplier is able to communicate with customer via electronictransmission for product specifications and testing information. (有能力與客戶就產品規格、測試資料進行電子數據交換。)There is a Project Leader to follow up the project plan ensure theproject to be completed as per schedule. (項目負責人定期按項目計劃跟蹤了項目各項活動按期保質保量完成。)The supplier has a defined PPAP(Production Part Approval Process)process and there is evidence that supplier follows the relatedrequierment (供应商有规定的PPAP流程并且有证据证明工厂有按照相关要求执行）Before mass production, product EOD, processing flow, technicalrequirements and product packaging information should be ready andavailable. (產品正式生產前，制定了產品總成圖、加工工艺及技術要求, 產品包裝圖。)Supplier has conducted pilot run per relevant procedures beforemass production. (批量生產前按規定程序進行了小批量試產活動。)23456710111213141516171819After pilot run, there are official review records done by qualitydepartment, engineering department and technical department. Massproduction can be released only when the review result is positive orpassed. (試產活動完成後， 有正式記錄表明至少包括了質檢部、 技術部、工藝部三個部門對試產進行了評審，只有評審合格後方能進行批產。)Pilot run reviewed items at least includes documented preparationand proper processes / proper facility / jig / operator skills / in-processinspection result and finished-goods inspection result. (試產評審至少包括了：文件準備及工藝適合性,設備工裝的適合性, 員工熟練性,工序檢驗結果和成品檢驗結果。)Those records of pilot run review are distributed to relateddepartments in time and should be preserved at least three years.(評審記錄及時發到相關部門，並至少保存三年。)Does the supplier define the specific quantity for NPI to MP, such asQty for pilot run, safe launch, etc. in documented procedure ? (是否有文件定義从試產到量产的最少數量, 是否有執行?)Supplier has validated the items before mass production: productperformance / product safety and reliability tests / packaging andtransit reliability with positive result. (May refer to other test reportsreleased by authorized institution) Got customer approval/releasebefore MP as required. (量產前已確認了產品功能特性/安全性、可靠性測試/包裝、運輸测试合格。(可引用同行業公認的中間機構的測試報告).有按要求取得客户的认可。Has the supplier defined the NPI goal and implemented it. (是否有文件定義新產品導入的目標並且有執行它?)Is there a documented ECO (engineering change order) procedureand has been implemented? (是否有工程變更的處理程序並有執行?)Any changes that affect assembly, product performance, safety andreliability, got customer approval before implementation? (影響客戶裝配的尺寸變化，產品性能指標、安全及可靠性指標變化時，材料，设备，工艺等变化影響客戶时，得到客户批准后才执行？)There is a procedure on customer required changes validation,internal documents update. The procedure was implementedeffectively. (有程序規定了如何確認客戶要求的更改，並如何跟蹤更新相關內部文件，該程序得到了有效執行。)All obsolete technical documents are removed from any points ofissue or use and disposited. There is identification of obsoletedocuments to avoid miss-use if they are retained for any purpose. (舊版技術檔及時销毀，有保存的，有明確標誌示明，以防止誤用。)供應商協審員:Supplier:日期:DateSignifiaNeedNontImprovSatisf.SystemDeficiee-mentncy0123Score審核員:Auditor:Section 3:Purchasing and Supplier Control采購及供應商控製序號Item123456Max Possible:實際總分Actual Score:實際得分390評 審 內 容 Review ContentsIs there a purchase control procedure for direct and indirectmaterials? Is procedure followed? (有直接物料和間接物料的采購控製程序,並有按程序執行.)The new sources were audited and qualified prior to purchasing. (供應商開發時必須經過資格評審，評審合格後方能採購其產品。)There is document to define score guideline. Audit results arerepresented by score. (文件規定了評分細則, 評審結果以評分形式體現)The quality personal should participate the audit. (質量部參予了評審.)There are formal and complete supplier audit reports and they arereserved for at least three years. (有正式和完整的供應商評審報告，該報告至少保存三年。)There is the latest Approval Vendor List (AVL) and was well kept. (有經過評審合格的供應商名單，並及時更新以最新狀態保存。)審 核 記 錄Evidence or Records79.19.29.39.49.510All the sub- suppliers who provide material to supplier are on AVL. (正在供貨的所有供應商都能在該名單中得到資格追溯。)Performance of qualified suppliers was assessed at least once a yearand assessment records are available. (对合格供應商至少每年進行一次持續質量表現評估并且有評估記錄。)The assessment should contains at least as below contents: (評估至少包括以下內容：)Incoming material quality performance - from IQC (來料入庫檢驗質量表現。)Incoming material quality performance - from production line. (生產線使用時反映的來料質量表現。)Incoming material performance - Feedback from market andconsumer. (市場及用戶投訴反映的來料質量表現。)Failure handling. (質量失效的處理.)delievry performance. (交货的状况.)There is score criteria & ranking system with disposition plan untildisqualified if supplier fails the assessment. (該評估也有評分細則，按評分細則，評估不合格有處理辦法，直到取消資格。)For critical materials purchased, there is contract or other formaldocument to inform the supplier about following information ofpurchased materials, part number, part description, quantity to bepurchased, technical agreement, engineering drawing and deliverydate. (對所採購的重要原材料，有合同或其他正式文件知會供應商所採購原材料的以下信息：原材料編號和/或名稱、數量;技術協議/技術圖紙和/或要求;供貨時間。)Has the supplier pushed the sub-tier supplier on improvement plan,verified effectiveness of actions？ (是否推動供應商改善的計劃和行動,以及確認了改善效果.)There is written document defined material sample evaluation beforemass shipment under following situations: (有正式書面文件規定：來料有下列情況發生時，批量來料前，有樣品确认的活動：)Temporary or long-term changes of raw materials. (來料的原材料臨時或長期更改。)New/dup. source. (分供方新增。)Resume the sub-supplier who has been no delivery to supplier formore than half of year. (原分供方終止供貨半年或以上重新供貨。)Significant changes of fitting dimension and function. (裝配尺寸、功能等重大更改。)供應商協審員:Supplier:Max Possible:實際總分Max Possible:實際總分Actual Score:實際得分870日期:Date:Actual Score:實際得分11121313.113.213.313.4審核員:Auditor:Section 4:Quality Control System質量控製系統I Incoming Materials Quality Control 來料質量控製165NoSystem00SignifiaNeedntImprovSatisf.Deficiee-ment123Score序號Item1評 審 內 容 Review ContentsWas IQC equipped with adequate inspection personnel anddocumented procedure? (是否有书面的進料檢驗程序,並有專門的檢驗人員執行它?)Inspectors are familiar with incoming materials sampling plan, theinspection key points and criteria, incoming inspection statusidentification, reading the drawings and technical requirements,testing equipment/ instruments operating & monitoring, dispositionprocess of nonconforming materials. (檢驗員熟悉來料抽樣準則、來料檢驗要點及判定標準、本公司來料檢驗狀態標識及其意義、圖紙及技術要求的理解、實驗儀器操作及監控、來料不合格反饋及處理流程等。)審 核 記 錄Evidence or Records2344.14.24.34.44..65678Inspectors were qualified and records are available. (檢驗員有上崗證或有資格考核相關記錄。)There is written document for inspection and includes (at least) : (檢驗有正式書面文件支持，內容至少包括：)Incoming materials sampling plan and AQL. (抽樣計劃及接收準則。)Incoming inspection key-points and acceptance criteria, drawing,technical requirements or component specification. (來料檢查要點及判斷標準；圖紙及技術要求或零件規格書。)Function, safety and reliability testing plan includes test method anddevice, operation process(功能、安全、 可靠性實驗的實驗方法, 實驗條件設置、操作流程。)Identification flow for receiving inspection. (來料檢驗標識流程。)Feedback and handling process for nonconforming materials. (不合格物料信息反饋及處理流程。)The procedure for materials urgent release (緊急放行流程。)Documents mentioned above are approved by authorized personnelwith latest version. Actual condition comply with the doc. (以上文件由具備資格的人員認可,有版本控制,並且與實際操作保持一致。)There are appropriate and complete incoming inspection records. (有適當且完整的來料檢驗記錄。)Incoming inspection records are maintained for at least three year.(來料檢驗記錄至少保存三年。)Incoming inspection department has the latest Approval Vendor List(AVL). (來料檢驗部門有最新版的合格供應商清單(AVL)。)Clear segregation and identification of goods at the area of beforeinspection, passed the inspection, nonconforming, and goods to bereworked/scraped/returned. 待檢、檢驗合格，檢驗不合格待處理，待返工/報廢/退貨的物料隔離清楚,標識易辨。MRB (material review board) meeting to determine the disposition ofnonconformity material. Quality personal should participate to themeeting. 所有不合格物料有進行物料評審處理，至少有質量部人員參與。)The final disposition for nonconformity material should be aprroved byQuality personal. (不合格物料評審處理由質量部人員最終決定。)There are nonconformity disposition records reserved for at leastthree years. (不合格物料處理有正式記錄，該記錄至少保存三年。)Are the golden samples or limited samples identified and controlledproperly? (是否有對標準樣品進行區分標識統一管理?)Material samples are evaluated in accordance with relevantprocedure. (是否按程序進行了樣品的评估。)Sample evaluation activities are approved by quality departmentand/or engineering department. Samples passed evaluation prior tomass delivery to suppliers. (以上樣品確認活動至少經過質量部和/或技術部認可，合格後方可批量供貨。)Sample evaluation records are retained for at least three years. (樣品確認有專門的記錄，記錄至少保存三年。) All the information of nonconforming incoming material isdocumented formally and communicated to supplier.)(所有來料不合格信息有正式書面記錄傳遞給供應商。)Such information should include requesting supplier to analyze theroot cause of nonconformity, to correct the cause and how to preventre-occurrence. (該記錄包括了要求供應商分析不合格原因，糾正已發生的不合格和預防不合格重新發生的措施。)Supplier is required to response within two weeks and supplier did it.(要求供應商兩周內回復，供應商都如期進行了回復。)Supplier provided corrective and preventive actions with details,actions are effective, re-write may deem necessary. (供應商承諾的糾正及預防措施具體，合理，有效。否則，該記錄需供應商重新回復。)There is written process to handle the situation that supplier didn'treply within requied timeframe or if corrective and preventive actionsare proved uneffective. (有正式的流程處理供應商逾期不復或糾正預防措施驗證無效的事件並執行。)91011121314151617181920212223242526272829審核員:Auditor:The records are maintained for at least three years. (該記錄至少保存了三年。)For critical materials, at least annual quality objective of rejected rateis established and reviewed. (對重要物料至少按年度制定了不合格率的目標，並按目標進行了總結。)The defective rate is calculated, including at incoming station,production line returned and market failure return. (該不合格率包括了來料部分、生產線返回部分、市場投訴返回部分。)Summarization of monthly incoming material performance data isdistributed to Purchasing and top management. (每月進行的物料合格率目標完成情況的總結分發到了採購部、最高管理層。)For these suppliers whose actual quality performance is far below thegoal (20% or above) and no any improvement within 6 months, thesuppliers should be considered disqualified. (對於實際質量水平偏離目標太遠（20%或以上)，而長期（六個月）得不到改善的供應商，進行了淘汰。)Is there a procedure to defined shelf life control of incoming materialsand it's followed firmly? (是否有文件定義對來料存放的有效期進行控製.並按照執行.)Supplier utilizes FIFO methodology for inventory management (供应商使用先进先出原则管理库存）Does the warehouse check the environmental situation liketemperature and humidity daily? (是否有倉庫的環境進行評估和點檢確認,如溫濕度.)供應商協審員:Supplier:Max Possible:實際總分Actual Score:實際得分NoSystem0日期:Date:SignifiaNeedntImprovSatisf.Deficiee-ment123ScoreII In-Process Quality Control 過程質量控製480序號Item1評 審 內 容 Review ContentsWas IPQC equipped with adequate inspection personnel anddocumented procedure? (是否有專門的过程檢驗程序,並有專門的檢驗人員執行它?)Inspectors are familiar with sampling size, the inspection key pointsand criteria, inspection status identification, reading the drawings andtechnical requirements, testing equipment/ instruments operating &monitoring, disposition process of nonconforming materials. (檢驗員熟悉抽樣準則、檢驗要點及判定標準、本公司檢驗狀態標識及其意義、圖紙及技術要求的理解、實驗儀器操作及監控、不合格反饋及處理流程等。)Inspectors were qualified and records are available. (檢驗員有上崗證或有資格考核相關記錄。)There is written document for inspection and includes (at least) : (檢驗有正式書面文件支持，內容至少包括：)Defined IPQC process including sampling frequency, sampling plan(有规定巡檢程序包括抽樣頻次、抽樣計劃)In-process inspection key-points and acceptance criteria or QualityControl Plan. (各檢驗工序檢驗要點及判斷標準，或質量控制計劃。)Technical drawing and/ or technical requirements. (工藝圖和/或技術要求。)Identification flow of inspection status. (檢驗狀態的標識流程。)Nonconforming handling process. (不合格信息反饋及處理程序。)Is there a first piece inspection procedure defined and wasimplemented? (製程首件的確認,並有按照執行.)Does the golden samples or limit samples for IPQC are available andkept properly. (是否有標準樣品和限度樣品供过程檢驗使用,並且有對該樣本進行專門管理.)審 核 記 錄Evidence or Records2344.14.24.34.44..6566.16.26.36.46.57For in-process and finished-goods inspection, following items areinspected as per written procedure. (過程檢驗及產品入庫檢驗時，下列項目已按即定程序進行檢驗)Appearance. (外觀。)Nameplate/ label/ printing or other marks. (銘牌/標簽/印字或其他要求的符號。)Dimension. (尺寸。)Basic performance test. (產品基本性能測試。)Other performance test as specified in drawing. (圖紙要求的其他性能實驗。)There are appropriate records for above check items.(以上檢驗項目進行後，都有適當和完整的記錄。)The records are to be maintained for at least three years.(該記錄至少保存三年。)All detected defectives goods are to be properly identified andsegregated. (當以上檢測發生不合格時，有有效的方式對壞樣品及/或其余不合格品進行標識和/或隔離。)Each piece of goods or its packaging / inner packaging have datecode and shift time or a simple tag with product serial / numberincluding date / code and shift time. (每件產品或其包裝/ 每個小包裝上有生產日期及班次或含有生產日期、班次的簡單易識的產品流水/序列號之標識。)There is a written procedure to be define reaction plan of line downstatus and review and handling of production line nonconformity . (有正式且完善的程序規定了怎樣處理停線和產線不合格品的確認和處理。)The procedure is effectively implemented and prevents defectiveproducts from escaping to next process. (此正式程序得到了有效實施，以防止不合格品流入下道工序。) A written procedure on feedback and handling process fornonconforming products. (不合格物料信息反饋及處理流程。)Physical evidence showed the procedure was performed effectively:(有客觀記錄表明此程序已有效實施：)Nonconformity information was communicated. (不合格信息按要求進行了反饋。)Analyzed root causes as required. (按要求進行的原因分析。)Set corrective and preventive actions as required. (按要求制訂了糾正及預防措施。)Supplier has verified and validated improvement actions as required.(按要求進行驗證與確認。)The records are maintained for at least three years. (該記錄至少保存三年。)There is an official document defined the disposition if corrective &preventive actions are ineffective. The re is evidence that procedureis implemented effectively. (有正式文件規定糾正及預防措施長期得不到實施如何處理，並證明已有效實施。)供應商協審員:Supplier:日期:Date:SignifiaNeedNontImprovSatisf.SystemDeficiee-mentncy0123Score101112131414.114.214.314.41516審核員:Auditor:III Outgoing Quality Control 出貨質量控製Max Possible:實際總分Actual Score:實際得分300序號Item12評 審 內 容 Review ContentsWas OQC equipped with adequate inspection personnel anddocumented procedure? (是否有專門的成品檢驗程序,並有專門的檢驗人員執行它?)The inspectors are qualified. (該檢驗員具备相应資格。)審 核 記 錄Evidence or Records3455.1There are official documentation to define the outgoing inspectionactivity including sampling plans, inspected items, inspectionrequirements and inspection methods etc. (正式文件規定了出廠檢驗活動：抽樣計劃、檢測項目、檢測要求、檢測方法等。)There are formal sampling plans for final inspection and they areadequate to assure shipment qiality (e.g. C=0) (終檢抽樣計劃合適，能夠確保成品的品質。)(例：C=0)Inspected items at least include following: (檢驗項目中，至少有：)Check if customer name, customer part number and part name & lotquantity & product quantity are correct. (客戶名稱、客戶零件號及零件名稱、批量，數量的正確性。)The critical items in technical documentation (drawing) and otherinspection items requested by customer. (技術文件(圖紙)中的關鍵項目及客戶規定的檢驗項目。)Packing is proper and reliable and ensure the materials are wellprotected. (按規定的要求進行包裝，並包裝完好。)Finished goods in shelf life control. (有產品有效期控制，產品在有效期範圍內。)Appropriate inspection records are maintained for three years atleast. (保存了合適的檢驗記錄至少三年。)Official and complete inspection/ testing reports for every lot areavailable for customer verification. (每批貨有正式且完善的檢測報告向客戶提供。)Are continual improvement actions for the nonconformity conductedand tracked until closed? (是否有對出貨檢驗不合格品狀態進行持續改善和跟蹤直到得到完全的改善?)Does the golden samples or limit samples for the out-going inspectionare available and kept properly. (是否有標準樣品和限度樣品供出貨檢驗使用,並且有對該樣本進行專門管理.)Finished goods storage. (成品储存：)5.25.35.4671010.1Products are identified and segregated accroding to customers andmodels. (不同客戶、不同產品隔離清晰，標識明顯。)The finished goods are received/ delivered according to FIFO. (有执10.2行产品的先進先出(FIFO)。)審核員:Auditor:供應商協審員:Supplier:日期:Date:SignifiaNeedNontImprovSatisf.SystemDeficiee-mentncy0123ScoreSection 5:Manufacturing Process Control製造過程控製序號Item11.1Max Possible:實際總分Actual Score:實際得分510評 審 內 容 Review ContentsIs there a process flow chart to be used for process control ? (有流程圖用于製程控制。)There is general product process flow chart. (至少有通用的產品製作流程圖。)There is unique flow chart for products with different processesincluding all operation and inspection processes from raw materials tofinished goods. (對不同製作流程的產品， 有唯一的流程圖，該圖包括了從原材料進倉到成品入庫的所有操作及檢測工序。)There is version control for the flow chart. (該流程圖有版本控制。)Work instructions for all operation and testing processes are availableand put in process . (生產流程中的所有操作、測試工序制訂了作業指導書並有懸掛於現場。)Work instructions include as follow items: (作業指導書中至少有以下內容：)The process operation instruction. (本工序的操作內容。)審 核 記 錄Evidence or Records1.21.3233.13.23..33.44The self-inspection items and quality requirement. (本工序自檢項目及質量要求。)Defined operation and testing parameters. (規定了操作/加工測試參數。)Defined instruments / equipment working parameters. (規定了儀器/設備工作參數。)The technical document is approved by auth. personnel, and revisionis control. (有相關人員審批工藝文件，並有版本控制。)All work instruction are current and operators show objectiveevidence that they follow the documents firmly 所有作业指导书为最新版本，有证据证明工人遵守操作文件There is formal technologic drawing for machining at each process.(涉及尺寸加工時，各加工工序有正式工藝圖紙。)Critical process operators and test personnel are qualified.(重點加工工序及測試工位員工有上崗證。)Each operator is qualified for operation, parameter setting / qualitycontrol Points / reaction to abnormal situation (各工序操作員能熟悉該工位的操作內容包括工藝參數設定/質量控制點/異常問題處理.)Statistical techniques e.g. pareto diagram, fishbone diagram andcontrol chart are applied to quality issue analysis and qualityimprovement. (進行質量問題分析或質量水平提高時，應用了統計過程控制的方法，如排列圖、因果圖、控制圖等。)The Supplier has documented Process Failure Mode & EffectsAnalysis (PFMEA) process and there is evidence of continuousimprovement (corrective / preventive / RPN reduction). (供应商有书面的PFMEA流程和改进RPN的证据)Are quality control plan developed for new products?(是否有针对新产品制定质量控制计划？）Key characteristics are clearly identified in the control plan and arederived from FMEA. Actions are in place to control all keycharacteristics. 控制计划中有定义关键特性。There is an appropriate reaction plan for each characteristic on theControl Plan. 对控制计划中需要控制的特性都有适当的反应计划Good housekeeping, tidy and clean throughout whole plant(整个工厂5S良好, 整潔乾淨。)There are official production records for critical processes, therecords comply with following requirements: (對質量有重大影響的各工序有正式的生產記錄，該記錄至少符合了以下要求：)Recorded passed quantity and nonconforming quantity. (記錄了合格數與不合格數。)Recorded name of operator/ test personnel and date. (記錄了作業員/測試員及日期。)In-process products/ finished goods are traceable to the records. (在製品/產品能追溯到此記錄。)The records are maintained for at least three years. (此記錄至少保存三年。)Supplier has applied process capability studies (Cp/ Cpk) and controlchart to critical machining/ assembly/ testing process. (重要的加工/裝配/測試工序，應用工序能力Cp/Cpk（設備能力）分析/控制圖進行了過程能力的跟蹤。)Is process capability study conducted for new parts, processchanges, new equipment? (是否对新零件，新设备或工艺变更做过过程能力研究？）供應商協審員:Supplier:日期:Date:SignifiaNeedNontImprovSatisf.SystemDeficiee-mentncy56710111213141515.115.215.315.41617審核員:Auditor:Section 6:Facility, Tooling Maintenance and Repairing設備、模具、工裝的保養與維護Max Possible:實際總分39Facility, Tooling Maintenance and Repairing設備、模具、工裝的保養與維護序號Item122.12.22.33456Actual Score:實際得分00123Score評 審 內 容 Review ContentsThere is an written procedure for facility and tooling management. (有正式的設備、模具、工裝的管理程序。)Supplier has facility and tooling profile, and the profile is incompliance with the actual status and contains : (設備、模具、工裝有台帳、檔案並與實際相符，內容至少包括：)Name, model and control number. (名稱/規格、編號。)Initial using time, served location. (啟用時間、服務位置。)Review if facilities and toolings are in good condition, and reviewtime. (完好狀況確認及時間。)There is annual maintenance plan of facility/ tooling including existingcritical facilities/ toolings (至少有設備、模具、工裝的年度保養計劃, 該計劃含蓋了現有的重大設備、模具、工裝。)Facility / tooling have unique control number that complied with doc.(設備、模具、工裝有唯一性編號，此編號與台帳/檔案登記的一致。)Facilities, toolings and storage areas are tidy and clean. (設備、模具、工裝及其庫房整潔、乾淨。)Facilities and toolings are proper identified and segregated? Recordscomply with actual (設備、模具、工裝有明確的隔離和標識，使得易於識別其完好狀況，該狀況與台帳/檔案登記的一致。)There is written procedure defined facility/tooling maintenancerequirements, including daily maintenance and periodic maintenance.(有正式且完善的文件規定了設備及模具各級保養的項目及要求, 包括日常保養和周期性保養)There are facility/ tooling's maintenance and significant repairingrecords. The records and files match each other. (保養及大修有記錄，該記錄能與設備檔案相互追溯。)Supplier does the mould validation before the initial utilization asfollowing (模具開發完畢，投入使用前，須有確認活動如下：)Mould pilot run and quantity is no less than 50pcs for pilot run. (試模并且數量不低於50模。)At least mould designer, mould user/maintained person, productdesigner and inspector participate in mould pilot run activity. (試模至少有模具設計人員、模具使用/保養人員和產品設計人員、質檢人員參與。)Pilot run validation includes following items at least (試模至少驗證以下項目：)審 核 記 錄Evidence or Records79.19.21010.1Mould configuration. (模具結構。)10.2Technical characteristic. (工藝性。)10.3Product quality. (產品質量。)There are official records for mould pilot run with auth. person10.4signature. (試模有正式的記錄由有权限的人簽署。)Mould pilot run records can be tracked back to mould file, and those10.5records should be reserved until mould dead. (試模記錄可與模具檔案相互追溯，試模記錄隨模具終生保存。)Only after the mould passed the validation it can be released for10.6production. (只有當試模合格，該模具方可投入生產。)Supplier has proper actions to assess the life of mould and implement11it, e.g maitenance plan . (有模具壽命的跟蹤措施並且執行, 例如保养计划。)There is official mould repairing records and conform to following12requirements: (模具的維修有正式的維修記錄，並符合以下要求：)Mould trouble description and happened time. (模具問題描述及發生時12.1間。)The analysis of effect on finished goods and further disposition. (對12.2有可能涉及的產成品影響分析及處理。)12.3Mould validation after repairing. (維修後，模具狀況的確認。)13審核員:Auditor:Facility/ tooling maintenance and repairing personnel were qualified.(設備及模具維護/維修人員持有同行業認可的上崗證書或職稱。)供應商協審員:Supplier:日期:Date:SignifiaNeedNontImprovSatisf.SystemDeficiee-mentncy0123ScoreSection 7:Testing Equipment/ Instrument Management儀器/ 儀表的管理序號Item1Max Possible:實際總分Actual Score:實際得分0評 審 內 容 Review ContentsThere is an official and appropriate procedure for testing equipment/instrument management and procedure was followed. (有正式且完善的儀器/儀表的管理程序並執行。)Supplier has a calibration laborator if supplier does calibration in-house. (如果工厂做内校应有符合儀器/儀表檢定或校驗要求的計量檢定/校準實驗室。)The master standard for internal calibration has adequate capability(e.g. 10x higher resolution) (針對內校儀器/儀表部分, 標準儀器有足夠的精度。（例如，高出10倍的精度）)There is official and appropriate internal calibration instruction of testequipment/ instrument if calibration is done in-house(如果工厂做内校应有正式且完善的儀器/儀表內部校驗規程。)There is testing equipment/ instrument list and the it is accordancewith the actual status . It should include followings: (儀器/儀表有台帳/檔案並與實際相符，內容至少包括：)Name, type/ model and number, location (名稱/規格、編號，位置。)Calibration interval. (校驗周期。)Calibration expiry date. (校驗有效期截止時間。)Precision. (精度。)The calibration schedule should cover all testing equipment/instruments which may effect product quality. ( Includes customerowned test equipment/ instruments) (有儀器/儀表的年度檢定/ 校驗計劃， 該計劃含蓋了現有全部的影響產品品質的儀器/儀表(包括客戶提供的儀器/儀表)。)All testing equipment/ instruments are identified by proper labels withtest equipment/ instrument number, calibration expiry date andcalibrator's signature or stamp. (儀器/儀表都貼有校驗有效性標貼，上面至少標有儀器/儀表編號、有效期截止時間、校驗人簽名或蓋章。)The testing equipment/ instruments that were damaged, out ofcalibration and stop to use for any reasons are segregated andidentified clearly. (損壞或校驗不合格，或實際精度不合格或其他原因而停用的儀器/儀表，有明顯標識注明。)Equipments are exempt from calibration are clearly marked as such.(免校儀器/儀表有被正確地識別並有明顯標識。)All testing equipment/ instruments used are calibrated within intervals.(正在使用的儀器/儀表，都在有效的校驗/檢定周期內。)There are formal records that disposition can be tracked when testingequipment/ instruments are out of calibration or damaged, the recordsinclude following: (有正式記錄追溯儀器/儀表精度發生不合格或損壞及其處理狀況.)Test equipment/instruments are protected from unauthorizedadjustment or modification. (儀器/儀表有安全裝置/指示來防止沒有授權的調整和改動。)There are appropriate calibration records, and those records arereserved for at least three years (計量有適當的記錄，計量記錄至少保存三年。)審 核 記 錄Evidence or Records23455.15.25.35.467101112131415161718審核員:Auditor:Calibration records includes testing equipment/ instruments'accuracy, and the accuracy can be traceable to relevant standards.(計量記錄明確標明了該儀器/儀表的精度、該精度能追溯到有關的行業標準。)The personnel in charge of internal calibration have been qualifiedand certified. (有资质的計量員。)Reliabilities and accuracies of measuring/testing instruments areable to satisfy the test requirement. (儀器/設備的可靠性、精確度，能滿足檢測條件。)Written procedure on testing instrument daily check/maintenance,firmly follow procedure and keep record. (有程序规定测试仪器日常维护及保养，有遵守程序并且保留记录）Gage R&R (repeatability and reproducibility) study is conducted priorto mass production or after process change?(量具重複性和再現性(GR&R)在產品量產前或者在制程變更後被量測。)供應商協審員:Supplier:日期:Date:SignifiaNeedNontImprovSatisf.SystemDeficiee-mentncy0123Section 8:Customer Complaints Review and Disposition客戶投訴評審及處理Max Possible:實際總分Actual Score:實際得分270序號Item11.11.21.31.41.5評 審 內 容 Review ContentsThe documented procedures are established to define therequirements as following, procedures are implemented(有正式且完善的文件規定了流程並且執行：)Related department and personnel for handling customer complaints.(應對客戶投訴的部門和人員。)Customer complaints review. (When, where, how?) (投訴的確認（何時、何地、如何確認）。)Internal corrective and preventive actions establishing,implementation effectiveness follow-up and verification. (內部糾正及預防措施制訂、實施效果跟蹤與驗證。)The feedback to customer (when and how). (向客戶的反饋（何時、如何反饋)。)There is a department responsible for the urgent situation andreaction plan at customer, such as production line down. (對客戶緊急情況的應對,如客戶產線停線情況.)There are records for implementation of procedure above, and therecords meet the following requirements: (有適當的記錄跟蹤了以上流程的實施，並符合以下要求：)Recording customer name, product name and complaint date. (記錄了客戶名稱、產品名稱、投訴時間。)Quality issue description and defects quantity/ defective rate. (投訴質量問題描述及不合格數量/比例。)The root causes analysis. (原因分析。)Disposition of inventory at customer & supplier and in-processproducts (客戶處、自身倉庫內已完工的不良成品/在製品處理。)Corrective/ short-term action. (糾正措施/短期措施。)Preventive/ long-term action. (預防措施/長期措施。)Verification for the effectiveness of corrective & preventive actions.(糾正及預防措施效果的驗證。)It's no longer than two weeks from receiving complaints to responseto customer, clarified any queries within the time. (從接到投訴到糾正及預防措施的制訂時間，最長不超過二周。對投訴有疑問的，在此期間內已進行了確認。)審 核 記 錄Evidence or RecordsScore22.12.22.32.42.52.62.734567審核員:Auditor:Supplier should reply her customer within required timeframe orconfirmed timeframe, and should not be later than one month(當客戶要求了回答時間時，能在要求的時間內答復或與客戶達成了約定時間，但最遲不超過一個月。)Set the goal of customer complaint, there is at least a monthly routinemeeting to review customer complaints and corrective & preventiveactions implementation. (有製定客戶投訴的目標,並且各部門負責人至少每月召開一次會議，總結客戶投訴情況及糾正預防措施的落實。)There is evidence that organization has reviewed customercomplaints and relevant corrective & preventive actionsimplementation situation in top management meeting. (最高管理層會議中有記錄證明評審了客戶投訴情況及投訴的糾正及預防措施的實施。)If corrective & preventive actions related to technical documentchanges, the documents were changed and distributed to relevantdepartments. (當糾正預防措施的落實中涉及工藝文件等更改時，該文件已更改，並發到相關部門。)Customer complaint reports and internal corrective & preventiveactions records are maintained for at least three years, and bothreports can be tracked each other. (客戶反饋的投訴報告及內部糾正預防措施的跟蹤報告至少保存三年，二者能相互追溯。)Does the supplier survey the customer satisfaction, reviewperiodically and take action to improve? (有定期進行客戶滿意度調查,並有對反映的狀況時行跟進和改善.)供應商協審員:Supplier:日期:DateSignifiaNeedNontImprovSatisf.SystemDeficiee-mentncy0123ScoreActual Score:實際得分0Hazardous Substance Process Management System (HSPM System)有害物質過程管理系統序號Item11.1Max Possible:實際總分Actual Score實際得分1440評 審 內 容 Review ContentsProduct Design. (產品設計.)Is an updated \"Restricted Substance List\" available on site? (在現場有最新的\"受限物質清單\"嗎?)Are technical information of green components/parts completed andavailable on site? Note down the types and specifications of greencomponents/parts assessed on site) (現場可以提供綠色零件/部件產品的技術信息嗎?(記錄現場零部件的型號、規格))Were BoMs (bill of material) updated to distinct inclusive of greenrequirements? (最新的BOMs清楚地包含了綠色要求嗎?)Is there any technical file review mechanism? (是否有技術文件審核機製?)Is there any person dedicated to review the technical file? If yes, arethe person competent? (especially on the test report review) (是否有專人審批這些技術文件?若有,這些人員是能夠勝任的嗎?(尤其針對測試報告的審核人員).)For any design changes, has the changes been properly reviewed forthe HSF compliance? (對於設計變更,是否對HSF符合性進行評審嗎?)Is there a procedure to identify any changes that may affect the HSFcompliance? (是否針對任何影響HSF符合性的變更通知建立程序?)Has supplier signed any \"Declaration of Conformity (DOC)\" to hercustomer?(\"符合性聲明(DOC)\"已經簽给客户了嗎?)Are there any critical component/material without hazardoussubstance test report? (是否有重要物料不能提供有害物質測試報告?)Supplier Selection & Evaluation (供應商評估與選擇)審 核 記 錄Evidence or RecordsMax Possible:實際總分271.21.31.41.51.61.71.81.92Max Possible:實際總分15Actual Score:實際得分02.12.22.32.42.53Are new component/material evaluation mechanism established andimplemented against the HSF requirements? (遵循HSF要求的新的受限物質成分、物料評價機製是否建立、執行?)Are new supplier evaluation mechanism established and implementedagainst the HSF requirements? (遵循HSF要求的新的供應商評價機製是否建立、執行?)Are responsibility and authority for components, materials/substancesand suppliers evaluation established and implemented? (成分、物料/物質、供應商評價的職責及權限是否建立、執行?)Are evaluation results recorded? (這些評價結果保留記錄了嗎?)Is a \"Green\" Supplier List established and implemented? (有建立、實施\"綠色\"供應商名錄?)HSF Product Purchasing. (HSF產品采購)Does supplier understand the purchased route and identify thepossible course polluted by hazardous substance clearly? Hassupplier listed all the purchasing activities that are related tohazardous substance de-rating course in procedure document? (是否了解采購物品的采購路線,並充分識別可能被受限物質污染的任何過程? 是否在程序文件中列明與有害物質減免過程相關的采購活動?)Does supplier make sure that all hazardous substance de-ratingparts/materials avoiding of the pollution from hazardous substance?(是否確保所有的有害物質減免部件/材料免於受限物質的可能污染?)Does supplier make sure that purchased products meet requirementof hazardous substance de-rating? (是否確保采購的產品符合有害物質減免要求?)Have subcontractors and vendors (OEMs and cooperatingcompanies) established management system to ensure free of useHS. (對于零組件外包, 是否建立了不使用環境關聯物質的管理體系?) Incoming Control (進料控製)Have inspection process and criteria been clear defined in incominginspection procedure regarding to ban of HS ? (進料檢驗程序是否有明確定義有關環境禁用物質的檢驗程序與標準？)Is each incoming lot verified according to inspection criteria to ensurefree of HS? (是否根據檢查標準,按每個收貨批號確認未使用禁止物質？)Have the suppliers clearly identified the incoming components,production material and substances? Were test report checked atincoming inspection and IQC took sample for analysis? (對於來料的成分/生產物料/物質,供應商清楚地識別了嗎?對來料的測試報告進行了檢查了嗎?IQC進行了抽樣檢查,並進行了分析嗎?)What is reaction plan at IQC if any incompliance or suspecting found?(在不符合或可疑時,IQC如何处理?)Are non-conforming components/materials segregated and identified?(不符合的零部件/材料進行隔離和標識嗎?)Are inspection records available? (這些檢查的記錄可以得到嗎?)Process Control (過程控製)Are components, materials and substances which are temporarilystored in the production line segregated and identified? (臨時存放在生產現場的物料/物質有進行隔離、標識嗎?)Are extra components, materials and substances identified andsegregated? (剩餘物料有進行隔離、標識嗎?)Are green and non-green parts and products clearly identified on theproduction floor? (在生產現場綠色/非綠色部件及產品清楚地標識了嗎?)Green production lines were segregated from non-green productionline to avoid potential contaminations? (為了避免潛在的污染,從非綠色生產線生產的綠色產品進行了隔離?)Are there a check list and HSF label for the indirect material ? (生產線上使用的間接物料(如清洗劑)是否有检查清單, 是否有HSF標示?)Max Possible:實際總分36Actual Score:實際得分0Max Possible:實際總分18Actual Score:實際得分0Max Possible:實際總分12Actual Score:實際得分03.13.23.33.444.14.24.34.44..655.15.25.35.45.5Have procedures been established and implemented for IPQC toensure all parts / components used for green products are correct?5.6(為確保所有的部件/成分正確的用在綠色產品上, IPQC的要求是否程序化,並執行?)Have procedures been established and implemented for in-process5.7environmental checks to prevent cross-contamination? (生產過程中是否進行環境檢查以防止交叉污染?這些要求是否建立程序並執行?)Is there a procedure to identify the risk and sampling plan for finished5.8goods? (是否對成品設定物料風險級別,及按風險級別製訂抽樣測試計劃.)Is there a HSF label on the carton of finished product ? (出貨成品外5.9箱是否有貼HSF標簽?)5.10Are inspection records available ? (有检验記錄吗?)Is there any HSF non-conforming product control procedure? Doesthis procedure been implemented effectively?(e.g.identification,5.11segregation and disposition, authorization) (是否建立不合格HSF產品控製程序?是否得到有效實施?(如:標識,隔離,處理以及批準))Has the corrective and preventive action been taken to prevent the5.12HSF NC reoccurring? (是否建立糾正預防措施程序並得到適當的實施以防止HSF不合格的再發生?)66.16.2Warehouse Control (倉庫控製)Are components, materials, substance segregated and identified?(成分/物料/物質進行隔離、標識了嗎?)Are components, materials/substance, which are returned fromproduction line, clearly segregated and identified? (從生產線退回的成分/物料/物質進行隔離、標識了嗎?)Has procedure been established for proper releasing of materials toproduction line? (是否建立了适当的生產物料的發放程序?)Is inventory record clear for material tracing? (物料追蹤是否有清楚的清單記錄?)Green System Maintenance (系統維護)Is HSF- awareness training provided to employees? (是否提供給員工HSF方面的培訓?)Are training records available for audit upon request? (檢查所需要的培訓記錄能否得到?)Is documented internal audit procedure available? (內部審核程序是否文件化?)Have internal auditor been trained and qualified as specified? (內稽員是否有訓練與資格鑒定?)Is Internal Audit conducted periodically? Does the Internal Auditcover HSPM related requirements? (內部審核是否周期性地舉行?是否包含HSPM的要求?)Are Internal Audit results recorded and reviewed by management?(內部審核的結果是否記錄並得到管理層的評審?)Have corrective and preventive actions been taken as necessary? (如果需要,是否采取了相應的糾正預防措施?)Does the factory establish P/N system to distinguish the HSF or Non-HSF material ? (是否建立適當的P/N系統區分HSF 與Non-HSF物料?)供應商協審員:Supplier:日期:Date:Max Possible:實際總分24Actual Score:實際得分0Max Possible:實際總分12Actual Score:實際得分06.36.477.17.27.37.47.57.67.77.8審核員:Auditor:表单编号：HQ-QR-QC-36-A1
