audit report newrohs

1、SEM-FRM-118-B1 of 22SEM MANUFACTURING PTE. LTD.Blk 3014A, Ubi Road #04-01/02, Kampong Ubi Industrial EstateSingapore 408703 Tel: (65)-67482922Fax: (65)-67423622 Website: http:/www.S.sgSupplier/Subcontractor Audit ReportPage 1 of 7 Company Name公司名稱Address地址Contact No. & E-mail聯系電話&E-mailNatur

2、e of Business業務性質Company Representative公司代表Designation指示Signature簽名Audit / Assessment Purpose (Check that is applicable) 稽核/評審目的Supplier / Subcontractor Self-Assessment Audit供應商/轉包商自評稽核Assessment of New / Prospective Supplier 新供應商評估Routine Audit 稽核排程Follow-up Audit 稽核跟蹤Others 其他Assessment Result Sum

3、mary 評估結果總結No of S/NSectionItems1Management Responsibility 管理職責132Customer Focus客戶向導43Document Control文件控制104Identification & Traceability鑒定&可追溯性65Purchasing Control采購控制66Design & Development Control設計/開發管控47Training訓練68Inspection, Measuring & Test Equipment檢驗/量測/測試設備59Receiving Good

4、s Acceptance來料允收610In-Process Goods Acceptance 在制品收611Finished Goods Acceptance成品允收612Material Review Board/Corrective & Preventive Actions 物料評審會/矯正預防措施913Production & Process Control生產/制程管控1014Handling, Storage & Distribution裝卸/儲存/ 分布6TOTAL 總計97Scoring Guideline : 分分數數欄欄APPROVED 批准= Min

5、imum 70% total score & minimum 60% section score.CONDITIONALLY APPROVED 有條件批准 = Minimum 60% total score & minimum 50% section score.NOT APPROVED不批准= Less than 60% total score & less than 50% section scoreAudit Comments : 稽稽核核點點評評Names of Auditees (Suppliers Representative) 被被稽稽核核人人名名稱稱(

6、供供應應商商代代表表)Name of Auditors 稽稽核核員員名名稱稱Name 名稱Designation指示Signature 簽名Name 名稱SEM-FRM-118-B2 of 22SEM MANUFACTURING PTE. LTD.Blk 3014A, Ubi Road #04-01/02, Kampong Ubi Industrial EstateSingapore 408703 Tel: (65)-67482922Fax: (65)-67423622 Website: http:/www.S.sgSupplier/Subcontractor Audit ReportPage

7、 2 of 7 S/NAssessment DescriptionScores1.0Management Responsibility1.1Is the companys quality management system certified to or planning to be certified to ISO 9001:2000 &when? 公司品質管理体系是否有獲得ISO 9001:2000 認証,或計划獲得 ISO 9001:2000認証,. 何時? 1.2Is the company certified or planning to be certified to an

8、y other internationally recognized qualitymanagement system & when? (eg ISO 14001, ISO 13485, QC 080000) 公 司是否有獲得或預計獲得其他國際品質管理系統認証? 何時?(eg ISO 14001, ISO 13485, QC 080000) 1.3Are there quality manual, procedures and/or work instruction for operation? 有無品質手冊,操作程序/ 作業指導書/1.4Has the management with

9、 executive responsibility established its policy & objectives for, and committedto quality & continual improvement? 管理及行政負責人是否有建立其政策和目標以保証品質和持續改善,1.5Is the Quality Policy & Objective disseminate and understand throughout all levels? 品質方針&目標是在各個階層宣導及被理解/1.6Are the responsibility &

10、 authority of personnel performing work affecting quality being define? 人事执行工作的责任的权力（正）在影响质量确定吗? 1.7Is there a designated management representative (MR) to ensure the quality system requirements aremet? 是否有指派管理代表以保証達到品質体系要求.1.8Is there a system of planned internal audit conducted by trained internal

11、 auditors to evaluate on thecompliance and effectiveness of the quality system? 有無由內部稽核員倡導的內部稽核体系以對品質系統的 遵守与有效性進行評估 .1.9Does management periodically review the Quality System to ensure its suitability & effectiveness? 管理者是否有定期對品質体系稽核以保証它的适應性和有效性/1.10Does management ensure that customer requireme

12、nts are determined and fulfilled - with the aim ofenhancing customer satisfaction. 管理者有無保証明确客戶的要求,并履行提高客戶滿意度的目標,1.11For company involved or planning to be involved in producing and/or supplying HSF (HazardousSubstance Free) product (also 1.12 & 1.13) : 公司是否有或預計參与生產/供應無害物質產品 / Does management pro

13、vide evidence of its commitment to the development and implementation ofpractices consistent with achieving HSF products and production processes and the continuousimprovement.1.12Does the management determine, communicate & ensure that the organization meet customer, statutoryand regulatory req

14、uirements (RoHS) and the list of hazardous substances for HSF products. 管理者是否有決定,傳達并保証公司組織符合客戶,法定及常規要求( Rohs) ,并提供無有害物質產品中的有害物質清單,1.13Does the management a) determine establish the HSF policy & objectives, b) provide resources toensure progress toward HSF products and production processes and c)

15、 include HSF in managementreviews. 管理者是否有a) 決定建立HSF 政策和目標,b) 提供資料以保証改善HSF 產品及生產制程c) 將HSF 納入到管理評審中.Section Score02.0Customer Focus 客客戶戶中中心心2.1Is procedure established & maintained to ensure that contract review is executed according to procedurefor receiving & acceptance of customer orders? 有

16、無建立并保存程序以保証合同評審有按照客戶訂單接收程序執行,2.2When an order or contract is received, are clear demands, ability to comply with demands, resources,schedule and quality demands verified. 當一筆訂單或合同簽收,是否有明确确認其需求, 滿足需求的能力,資源 ,生產排程及質要求.2.3When an order for HSF product is received, are special statutory & regulatory

17、requirements (RoHS) or anyother requirements specified by customer and ability to comply with demands verified.當收到一張需求HSF產品的訂單時,客戶是否有規定特定的法定&法規要求( rohs)或其他的一些要求, 是否有對滿足客戶要求的能力确認 .2.4Is amendment of contract properly executed & informed to relevant department & customer? 合同修改是否有适當執行,并通知相關

18、部門和客戶.Section Score0SEM-FRM-118-B3 of 22SEM MANUFACTURING PTE. LTD.Blk 3014A, Ubi Road #04-01/02, Kampong Ubi Industrial EstateSingapore 408703 Tel: (65)-67482922Fax: (65)-67423622 Website: http:/www.S.sgSupplier/Subcontractor Audit ReportPage 3 of 7 S/NAssessment DescriptionScores3.0Document Contro

19、l 文文件件管管控控3.1Is there documented system for issuance, recall & revision of internal & external quality documents,drawings, specifications & other controlled documents? 有無內部和外部品質文件,圖面,規格書和其他管控文件的發行,回收及修訂的文件体系/ 3.2Is procedure, work instruction, standard, specification reviewed & appro

20、ved by authorized personnel? 程序文件,作業指導書,標准書,規格書是否有經權威人士審核批准.3.3Is appropriate document available at location where operation is performed? 在作業執行的地方能找到适當有文件嗎? 3.4Is invalid / obsolete document promptly removed & identified? How? 無效/作廢文件是否有迅速鑒定并移除?如何操作? 3.5Is the change to document & data revi

21、ewed & approved by authorized personnel? 文件及資料的變更有經掌權人士審核批准嗎/3.6Is controlled document identified with revision level & effective date information? 有無對管制文件的版次及有效日期等信息進行确認.3.7Is there documented master-list consisting of all quality records? 文件主目錄中是否包含所有的品質記錄.3.8Is records stored & mainta

22、ined systematically to ensure they are readily available & retrievable? 記錄 是否有按系統性保存以便隨時可以找到.3.9Is there record retention & keep for an agreed period of time as stated in procedure? 記錄是否是按程序文件中規定的時間進行保存.3.10For company producing and/or supplying HSF product, is there a list of all hazardous

23、substances usedwithin the organization. 由于公司生產/供應HSF 產品,是否有組織內部使用有有害物質有清單.Section Score04.0Identification & Traceability 鑒鑒定定和和可可追追蹤蹤性性4.1Is there procedure to identify products applicable specification, or document at all stages of operation? 有無程序确定產品在各個操作時期的适應規格及文件/.4.2Is there unique identifi

24、cation for individual product or batches, for traceability requirement, including HSFproduct (if any) by suitable means throughout product realization. 有無單個/成批產品的特別的識別標志以便追蹤, 包括HSF 產品要用适當方式以便識別出來.4.3For HSF product (if any), are processes that include any restricted substance uniquely identified and

25、segregated to prevent combination with HSF product. 對HSF產品, 其制中包含的限制元素是否有特別鑒定并區隔開來以免同HSF產品混淆.4.4Is the identification of individual product or batches well maintained & recorded? 單個產品/成批產品的鑒定標准是有保存并記錄/4.5Is concern personnel able to trace the History or activity of product by means of recorded i

26、dentification? 相關人員是否可以通過鑒定記錄來追蹤產品的歷史和現有狀況.4.6Is production personnel aware & understand the requirement of product identification & traceability?生產人員是否有意識到并理解產品的識別& 追蹤性要求/Section Score05.0Purchasing Control5.1Is procedure in place to ensure purchased product conforms to requirements, in

27、cluding HSFrequirements for purchased HSF product (if any). 有無适當程序保証采購的產品符合要求,包括 HSF產品的要求.5.2Is there a system in place for selection of suppliers & Sub-contractors, for normal and/or HSFproducts (if any). 有無一般產品 和HSF產品的供應商/轉包商選擇的适當系統.5.3Is there a system to evaluate the capability of each suppl

28、ier in meeting requirements, including HSFrequirements for HSF product suppliers (if any)? 有無体系對每個供應商有滿足要求的能力進行評估,包括HSF 產品供應商的HSF 要求.5.4Is there a maintained & approved supplier list, including approved suppliers for HSF products (ifany)?有無保留核准供應商清單,包括HSF 產品供應商.SEM-FRM-118-B4 of 22SEM MANUFACTUR

29、ING PTE. LTD.Blk 3014A, Ubi Road #04-01/02, Kampong Ubi Industrial EstateSingapore 408703 Tel: (65)-67482922Fax: (65)-67423622 Website: http:/www.S.sgSupplier/Subcontractor Audit ReportPage 4 of 7 S/NAssessment DescriptionScores5.5Does purchase order clearly describe the purchased part requirements,

30、 including HSF requirementsfor HSF part (if any)? (RoHS Compliance parts must have COC & proper identification on partpackaging) 采購單上是否有明确描述采購產品的要求,包括hsf 產品的hsf 要求,( RoHs 指令下的產品必須有COC和适當的產品包裝識別標記) 5.6Is there system to notify suppliers of specification changes? What method is used to ensuresuppl

31、ier has the current specification?有無通知供應商關于規格書變更的体系/? 使用何种方法以保証供應商可獲得最新的規格書.Section Score06.0Design & Development Control設計&開發管控6.1Is there procedure to control & verify the design of product, including HSF product (if any)? 有無程序管控并确認產品的設計.包括hsf 產品.6.2Is there Design for Manufacturabilit

32、y (DFM) analysis activities to compare customers drawings &specification requirements, including customer, statutory and regulatory requirements (RoHS) for HSFproducts (if any), to your process & machine capability & capacity? 有無制造設計分析活動以符合客戶圖面及規格要求,包括HSF的產品制程/机器生產能力和的客戶要求,法定及常規要求( RoHs)

33、 . 6.3Is there a formal documented review of design results & is it planned, conducted & documented atappropriate design stages? 有無設計結果的正式文件化審核,要否有在适當的設計階段對其規划,宣導并使之文件化 .6.4Is design changes documented, reviewed, validated & approved by authorized personnel before anyimplementation? 設計變更

34、在執行之前, 需經權威人士的審核,驗証,核准,并使之文件化 .Section Score7.0Training 培培訓訓7.1Is there procedure established to identify training needs? 有無建立程序以确定培訓需求.7.2Is staff involved with activities affecting quality, provided with appropriate training? 員工是否有參与影響品質的活動,并接受适當有培訓.7.3Is personnel involved in producing HSF produc

35、t (if any) provided with specific training for theawareness, identification, use, and elimination of hazardous substances. 參与生產HSF 產品的人員是否有接受關于有害物質的意識,識別,使用及消除的特別培訓.7.4Is the qualification & training record of all staff maintained? 員工的資格及培訓記錄是否有保留.7.5Is staff trained on the awareness of defect,

36、which may occur from improper performance of specificjob? 員工是否有接受由于在特別工作中的不當操作而發生的不良意識的培訓.7.6Is there a Pre & Post training certification for all training activities? 所有的培訓活動是否有培訓証書.Section Score08.0Inspection, Measuring & Test Equipment 檢檢驗驗,量量測測和和測測試試工工具具8.1Is there a system for calibratio

37、n of inspection, measurement & test equipment? 有無檢驗,量測及測試設備的校驗体系.8.2Is there a system to ensure that the calibration is performed within its controlled timeframe? 有無体系以保証校驗是在控制的時間內進行.8.3Is there a master-list of all the inspection, measuring & test equipment? 是否有所有檢驗,量測,測試設備的目錄清單,8.4Is inspe

38、ction & test result of calibration records documented & accessible? 檢驗記錄的檢驗,測試結果是否有文件化,并易懂.SEM-FRM-118-B5 of 228.5Is there action taken for equipment detected out of tolerance in accordance to calibration controlprogram? 當偵測到設備沒有在檢驗管制公差之內時,是否有采取措施,Section Score0SEM-FRM-118-B6 of 22SEM MANUFA

39、CTURING PTE. LTD.Blk 3014A, Ubi Road #04-01/02, Kampong Ubi Industrial EstateSingapore 408703 Tel: (65)-67482922Fax: (65)-67423622 Website: http:/www.S.sgSupplier/Subcontractor Audit ReportPage 5 of 7 S/NAssessment DescriptionScores9.0Receiving Goods Acceptance9.1Is there quality plan & procedur

40、e for inspection & acceptance of incoming materials, including HSFparts (if any), which must have COC (to certify RoHS Compliance) & proper identification on partpackaging (RoHS Compliance).有無來料檢驗及允收的品質政策和程序, 包括hsf產品,必須有COC(RoHs 指令証明)和适當的產品包裝識別標記9.2Does QC inspector follow the Incoming inspe

41、ction sampling plan, frequency & methods? QC 檢驗員是否有按進料檢驗抽樣計划,頻率及方法執行.9.3Is there indication to show the inspection status of incoming materials? 有無標示表明來料檢驗狀況.9.4Is the record for indicating material passed inspection traceable to inspection authority? 有無記錄表明其物料通過權威檢驗有檢驗追蹤9.5Is material inspected

42、 & evidence of conformance recorded prior to storage or release to production?物料在儲存或投入生產前是否有經過檢驗,且有合格記錄証明.9.6Is there a proper segregation and containment area to prevent rejected material from usage? 有無适當的隔离區或暫放區以防止拒收物料使用,Section Score010.0 In-Process Goods Acceptance10.1 Is there quality plan

43、& procedure for inspection & acceptance of in-process product, including HSFparts (if any)? 有無在制品的品質計划,檢驗和允收程序同,包括HSF產品.10.2 Does QC inspector follow the In-process inspection sampling plan, frequency & methods? QC 檢驗員是否有按照在制品檢驗抽樣計划,頻率及方法進行檢驗?10.3 Is there indication to show the inspecti

44、on status of in-process materials? 有無暗示表明在制物料的檢驗狀態.10.4 Is the record for indicating material passed inspection traceable to inspection authority? 有無記錄表明其物料通過權威檢驗有檢驗追蹤10.5 Is material inspected & evidence of conformance recorded prior to storage or release to nextprocess? For HSF product (if any

45、), to ensure in-process parts do not have hazardous substancecontamination. 物料在儲存或投入下個制程前有無經過檢驗及合格記錄証明? 對HSF產品,要确保其產品不含有害物質.10.6 Is there a proper segregation and containment area to prevent rejected material from usage? 有無适當的隔离區或暫放區以防止拒收物料使用,Section Score11.0 Finished Goods Acceptance11.1 Is there

46、quality plan & procedure for inspection & acceptance of final product, including HSF parts(if any)? 有無成品的品質計划, 檢驗及允收程序? 包括HSF 產品.11.2 Does QC inspector follow the Outgoing inspection sampling plan, frequency & methods/ QC 檢驗員是否有按照出貨檢驗抽樣計划,頻率,方法進行檢驗,.11.3 Is there indication to show the i

47、nspection status of final product? 有無暗示表明成品的檢驗狀態? 11.4 Is the record for indicating material passed inspection traceable to inspection authority? 有無記錄表明其物料通過權威檢驗有檢驗追蹤SEM-FRM-118-B7 of 2211.5 Is final product inspected & evidence of conformance recorded prior to storage or release forshipment? Fo

48、r HSF parts (if any), COC (to certify RoHS Compliance) must be included in lot andpackaging must have proper identification (RoHS Compliance). 物料在儲存或出貨前有無經過檢驗及合格記錄証明.對HSF 產品,COC(RoHS 指令認証) 必須包含在lot 中,且包裝上須有适當的鑒定標志(RoHs指令)11.6 Is there a proper segregation and containment area to prevent rejected fin

49、ished product from usage?有無合适的區隔或暫放區以避免拒收成品投入使用.Section ScoreSEM-FRM-118-B8 of 22SEM MANUFACTURING PTE. LTD.Blk 3014A, Ubi Road #04-01/02, Kampong Ubi Industrial EstateSingapore 408703 Tel: (65)-67482922Fax: (65)-67423622 Website: http:/www.S.sgSupplier/Subcontractor Audit ReportPage 6 of 7 S/NAsses

50、sment DescriptionScores12.0 Material Review Board / Corrective & Preventive Actions12.1 Is there system & document to report rejected product, including HSF product (if any), to theconcerned function or the respective supplier? 有無系統或文件向相關部門或各供應商匯報拒收產品(包括HSF 產品) 12.2 Is there system to ensure

51、 that HSF products (if any) which do not conform to HSF product requirementsare identified and controlled to prevent their unintended use or delivery. 有無系統以保証不符合 HSF 產品要求的 HSF產品有進行鑒別并管控以防止其被使用或出貨.12.3 Is there a formal system to report, assess & determine on the need to initiate corrective &

52、preventive action? 有無正式的系統以匯報,評估并判定其初步改善及預防措施,12.4Is there requirement from the concerned function or the respective supplier to address the cause ofdefective material and provide appropriate corrective action? 有無相關職能部門或供應商代表對不良物料發生原因及提供改善對策提出要求?12.5 Is there authorize personnel responsible for the

53、review & disposition of defective product? 權威人士是否有負責對不良品進行審核并將其問題解決,12.6 Is there a system for investigation of defective part causes & its related process / quality system?有產品不良原因及相關制程/品質体系進行調查的系統.12.7 Is there a system to ensure that the corrective & preventive action taken is effectiv

54、e to eliminate therecurrences of similar defect? 有無系統以保証改善及預防措施有效地減少相同問題的再發生.12.8 Is the evaluation & investigation of nonconformance documented? 不良品的評估及調查是否有文件化, 12.9 Is implementation of corrective & preventive action verified for effectiveness through follow-upchecks? 矯正及預防措施的執行是否有經過跟蹤檢驗以

55、驗証其有效性.Section Score13.0 Production & Process Control13.1 Is production process developed, conducted, controlled & monitored to ensure product conforms tospecifications? 生產制程是否有開發.傳導,控制及監督以保証產品合格.13.2 Is there documented instructions, standard operating procedures & methods that define &

56、amp; control themanner of production, including production of HSF product? 有無定義和管控產品的生產方法的文件化指導書, 標准操作程序及方法,. 包括 HSF 產品/13.3 Is process parameter that directly affected quality documented, monitored & controlled throughoutthe manufacturing operation? 直接影響品質的制程參數 是否有在整個制造過程中將其文件化,監督并管控,13.3 For p

57、roduction of HSF product, are there use of suitable HSF equipment, monitoring and measuringdevices? 生產HSF 產品時,是否有使用适合的 HSF產品生產設備及監督和量測設施.13.4 For production of HSF product, are processes that have the possibility of hazardous substancecontamination identified and documented? 生產HSF 產品時,有無將程中可能含有的有害物質

58、鑒別出來,并使之文件化.13.5 Is there sample or workmanship standard for accept or reject criterion? 有無抽樣或作業手法標准作為接受或拒收標准, 13.6 Is procedures in place for changes to specification, method, process or procedure? 有無适當的規格,方法,制程及程序變更的程序文件.13.7 Is there verification/validation performed on changes before implementat

59、ion? 在以上變更執行之前是否有將其驗証.13.8 Is customer approval obtained prior to changes in specification or manufacturing process? How? 規格或制程變更之前有否有獲得客戶的批准/ 如何獲得,13.9 Is statistical process control used to monitor significant product characteristics & processvariables? 是否有使用統計制程管控方法以監控產品特性及制程差异/.13.10 Is ther

60、e Machine, Device or Tooling master record & is it maintained? 有無机器,設備,工具目錄并將其保存.13.11 Is there maintenance schedule for equipment or machine? If Yes, is the date and individualperforming the maintenance activity documented? 有無設備或机器的保養計划/ 如有,是否有將其保養日期及保養活動文件化.SEM-FRM-118-B9 of 22Section ScoreSEM

61、-FRM-118-B10 of 22SEM MANUFACTURING PTE. LTD.Blk 3014A, Ubi Road #04-01/02, Kampong Ubi Industrial EstateSingapore 408703 Tel: (65)-67482922Fax: (65)-67423622 Website: http:/www.S.sgSupplier/Subcontractor Audit ReportPage 7 of 7 S/NAssessment DescriptionScores14.0 Handling, Storage & Distribution 裝裝卸卸,儲儲存存及及分分布布,14.1 Is there procedure in handling finish