東莞伟创力QSA管理(中文版).xls

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1、Flextronics Quality Systems AuditThe Flextronics QSA Self Assessment Survey goal is the development of the site(s)qualitysystem that provides a baseline and framework of Continuous Improvement Process ofsites Operations System that focus on defect prevention and variations reduction.The purpose of t

2、he survey is to improve sites Operation Systems capabilities in meetingcustomers quality expectation.The QSA Self Assessment Survey follows ISO 9000/TS 16949/TL 9000 guidelines and isintended to share Best Practices and cutting down the learning curve by leveraging thestrengthen from those capable s

3、ites.The QSA Self Assessment has two sections:1.Site(s)Business Assessment:This information will be used to assess site facilities Business System.Allinformation will be considered business confidential within Flextronics.2.Site(s)Self Assessment Survey:A Yes/No Questionnaire that is designed to ref

4、lect a comprehensive review of allmajor Company Quality Systems.The questions were devised and developed as closed questions with every attemptto avoid ambiguity.Because of the closed nature of the questions,there can only beone of two answers to any question,i.e.Yes(1)or No(0).Thus,the criterion is

5、either fully met or it is not.If the Criterion is met,a score of 1 is obtained.If theCriterion is not met,a score of 0 is obtained.If there is any doubt as to the score toaward for any given Criterion,a score of zero shall be awarded by default.AnyCriterion that scores 1 shall be clearly demonstrate

6、d,followed,and be beyondreproach.In the event that the organization clearly meets the intent of the auditquestion,but does not exactly do what the question asks,a score of 1 shall be given.General Business AssessmentSITE NAME 機機構構地地址址Specialty(Product,Process,Services)專專業業（服服務務，過過程程，服服務務）Parent comp

7、any name母公司Subsidiary name子子公公司司Organization address機構地址VP/GM/Plant ManagerPhone:Email:Mfg.ManagerPhone:Email:廠務經理Quality ManagerPhone:Email:品品保保經經理理Engineering ManagerPhone:Email:工程經理Business Information 業業務務信信息息1Years in business業務開展年數2Annual sales($)for the past 3 years過去三年每年銷售額3International cus

8、tomers(name)國際客戶（名字）4Major customers(name and business%)主要客戶（名字及其業務量）Certifications 認認証証5ISO 90006QS 9000/TS 169497U/L registered(Underwriter Laboratories)8ISO 14000 Certification9Other CertificationsPersonnel10Total number of employees11Employee#in Manufacturing 12Employee#in Quality Assurance13Num

9、ber of engineers Communication14Schedule Sharing15E-mail access16Communicate in EnglishFacility Information17Sq.Ft.18Number of shifts(working hrs/day,days/week)19Utilization(Capacity)22Other locations(Name,location,specialty)Flextronics QSA Audit SummaryCompany:Factory Location:Audit Date:Auditor:SE

10、CTIONMax ScoreEach SectionSelf AssessmentScore EachSectionActual%Each SectionActual ScoreEach SectionActual%Each SectionGoal%Each Section1Quality Systems00#DIV/0!#DIV/0!80%2Contract Review00#DIV/0!#DIV/0!80%3Design Control00#DIV/0!#DIV/0!80%4Document Control01#DIV/0!#DIV/0!80%5Supplier Quality Contr

11、ol02#DIV/0!#DIV/0!80%6Product Identification&Lot Traceability00#DIV/0!#DIV/0!80%7Process Control00#DIV/0!#DIV/0!80%8Inspection and Test/Status00#DIV/0!#DIV/0!80%9Inspection Measuring and Test Equipment00#DIV/0!#DIV/0!80%10Calibration00#DIV/0!#DIV/0!80%11Nonconforming Product Control00#DIV/0!#DIV/0!8

12、0%12Handling,Packaging,Storage&Delivery00#DIV/0!#DIV/0!80%13Quality Records00#DIV/0!#DIV/0!80%14Field Service00#DIV/0!#DIV/0!80%RESULTS03#DIV/0!0#DIV/0!80%Outstanding 95%Satisfactory81%-95%Need Improvement61%-80%Significant Deficiency41%-60%Form No.:FDSQEI-002F02.2Quality SystemsContract ReviewDesig

13、n ControlDocument ControlSupplier Quality ControlProduct Identification&Lot TraceabilityProcess ControlInspection and Test/StatusInspection Measuring and Test EquipmentCalibrationNonconforming Product ControlHandling,Packaging,Storage&DeliveryQuality RecordsField Service-100%0%100%ISO 1:Quality Mana

14、gement SystemsAvg score:#Score9001:2000Subtotal:0Counts:Yes=1No=0N/A=XRemarksWhat to look for Quality Policy4.2.11.1.1Has the organization defined and documented its corporate quality policy,objectives and commitments to quality?1Documented latest corporate quality policy in QM.Defined measurable qu

15、ality objectives whichconsistent with quality policy.貴公司是否定義並記錄貴公司的品質政策，品質目標與對品質的承諾?5.31.1.2Is the quality objectives relevant to organizational goals and the expectations and needs of the customer?1Details contents of current quality objectives.品質目標是否公司目標與客戶的期望和要求相關？5.31.1.3Are the quality policy d

16、istributed and published so that employees of all levels understood,implement and maintain same systems?1Employee awareness on quality policy andmethod used.品質政策是否有發行及公布於眾以便各個階層的員工都能理解，執行與維持系統？5.4.11.1.4Does the organization establish quality objectives and product requirement performance indicators

17、 that are measurable and consistent with thequality policy?1The significant relationship between qualityobjectives and quality policy.公司是否有建立品質政策及產品需求性能指導,以便可衡量且與品質政策一致？Organization5.5.11.2.1Has the responsibility,authority and interrelation of all personnel who manage,perform and verify work that a

18、ffects the quality of products,materials or services been defined?(i.e.procedures,organization charts,quality manual)1Latest organization chart on QM.Documentedresponsibility and authority(R&A).管理、執行與檢驗工作之所有人員之職責,權威及相互關系會影響產品品質、物料或服務是否有定義(例如程序，組織架構圖，品質手冊）5.5.21.2.2Is the Quality Management Represent

19、ative a member of management appointed by the top management to assume responsibly and authoritywhich include;1Appointment letter or any documented materialthat describe the appointment of QMR inclusivetheir R&A.品質管理代表是否是由最高管理人員任命並授與包獲以下責任與權利：5.5.2(a)ensure that the quality management system are est

20、ablished,implemented and maintained.1保証品質管理系統以被建立，執行與維持？5.5.2(b)Reporting to the top management on the performance of the QMS and any need for improvement.1向最高管理人員匯報品質管理系統的性能與任何需要改善點？5.5.2(c)ensuring the effective prevention of nonconformity,identify&record quality issues,effectiveness corrective ac

21、tion systems?1保証不良品的有效預防，標識&記錄品質問題，校正行動報告的有效性？5.5.2(d)Control further processing?1管理下一步的處理行動？5.5.2(e)ensure that the need,awareness and requirement of the customer are promoted internally in the organization?1確保客戶的要求有在公司內部傳達？5.5.21.2.3Has the quality management representative tracked and drove the i

22、mprovement on quality management system performance with record/report.1Evidence of any documented QMS improvementproject and method of monitoring.有品質管理代表是否有用記錄/報告形式來跟蹤與推動就品質管理系統性能方面的改善？5.5.21.2.4Has the improvement effectiveness verified(record/evidence required)?1Evidence review on effectiveness i

23、mplementation.Data required to support the evidence.有檢查改善的有效性？（記錄/要求的証據）5.5.31.2.5Has the top management establish appropriate communication processes within the organization1Business process flow interactions.最高管理層在公司內部有建立適當的溝通方法？5.5.31.2.6Have these communication processes bring about the awarenes

24、s and improvement of the quality management systems?1Identification of process inputs and outputs.這些溝通過程是否產生品質管理系統的意識與改善？5.5.11.2.7Has the Organization provided adequate resources for in-house verification activities such as inspection,testing,monitoring and review ofprocesses and products?1List of

25、equipment used for verification activities.Suitability to the required measurement system.公司有為內部的驗証行動提供足夠的資源，例如檢查，測試，檢測與方法與產品的評審等？6.2.21.2.8Has the Organization identified the resource requirements and provided adequate resources including the assignment of trained personnel formanagement,performanc

26、e of work,verification activities and internal audits?1Identification of related competency level andrelated training programs and records.公司確定資源要求且能夠提供包括受訓人員的評估足夠委派訓練管理人員履行工作確認行動和內部稽核6.2.21.2.9Is there a system that identifies training requirements for all personnel affecting the quality of the pro

27、duct?1Training procedure/matrix.是否有定義對所有能影響產品品質人員訓練要求的制度？6.2.21.2.10 Does a system exist for determining which personnel are qualified for a job function?1Competency matrix etc.有一個定義誰能完成某項工作職責的制度？6.2.21.2.11 Is there a system to disqualify and re-qualify personnel in a job function?1Documented proce

28、dure and current practices.是否有一個剝奪人員資格/再認証人員的制度？6.2.21.2.12 Are record maintained contain the education,training,skills and experience of individual staff?1Training records保留的記錄是否包括各個職員教育（程度）、受訓、技能與經驗？5.5.21.2.13Is there a clearly identified management representative with authority and responsibilit

29、y to ensure system compliance such as QS9000/TS16949,ISO9000,TL9000 etc,and to report on the performance of the quality system?1管理代表有被定義權利與責任來確保系統的符合性例如QS9000,/TS16949,ISO9000,TL9000等，並就品質系統性能方面作報告？7.2.31.2.14 Does the Organization have the ability to communicate necessary information and data in th

30、e customer prescribed format?1公司有能力溝通必要的以客戶指定的格式的信息與數據？7.2.3(a)product information1Product drawing/specification,Samples,產品信息7.2.3(b)enquiries,contracts or order handling,including amendments1詢價，合同或採購處理，包括改善？7.2.3(c)Customer feedback,including customer complaints1Customer QBR,complaint report(e.g.5C

31、 fromDell)客戶反饋，包括客戶抱怨1.2.15Is management with responsibility and authority for corrective action promptly informed of products or processes that become noncompliant withspecified requirements?1evidence of any action from management.具有矯正行動的責任與權利的管理員有被迅速告知不符合指定的要求的產品與（制程）步驟？Management Review 管管理理評評審審5

32、.6.11.3.1Does the Organization conduct management reviews of the suitability and effectiveness of the quality management system at appropriateintervals?(i.e.does the quality management system meet customer requirements?)1Management review frequency and minutes.公司是否有定期舉行品質管理系統的適用與有效性進行管理評審？5.6.11.3.2

33、Are records maintained of these management reviews?1Approved minutes of meeting.這些管理評審記錄是否有維持？5.6.21.3.3Does the management reviews include verification of the following input:Defined management review inputs and reviewagenda.管理評審是否包括下面輸入的驗証？5.6.2(a)Achievement of quality objectives1data collection,

34、calculating method,品質目標的達成？5.6.2(b)Results of the audits1internal audit&external audit(2nd or 3rd partyaudit)稽核的結果？5.6.2(c)Customer feedback1顧客反饋5.6.2(d)Process performance and product conformity1過程能力與產品良率5.6.2(e)Status of preventive and corrective actions1預防與矯正行動效果？5.6.2(f)Follow-up actions from pr

35、evious management reviews1上一管理評審的跟進行動？5.6.2(g)Changes that could affect the quality management system,and1organization change,process change,能影響品質管理系統的變異？5.6.2(h)Recommendations for improvement1upcoming technology改善建議？5.6.31.3.4Does the output of management reviews include any decisions and actions

36、related to:1Management review minutes管理結果的評審有包括有關的決定與行動？5.6.3(a)Improvement of the effectiveness of the quality management system and its process?1品質管理系統及其過程的效率提高？5.6.3(b)Improvement of product related to customer requirements,and1與客戶有關的產品改善，與5.6.3(c)Resource needs1資源需求？1.3.5Are implementation of ac

37、tion items from management review tracked?1Methods of tracking those unresolved matters inthe minutes of meeting.有跟蹤管理評審的執行項目的實施？Internal Audit內內部部稽稽核核not here1.4.1Has the Organization established and maintained a documented quality management system including procedures and work instructions?12nd a

38、nd 3rd level procedures masterlist etc.公司是否建立並維持包括程序與作業說明的文件化品質管理制度？not here1.4.2Have the procedures and work instructions been effectively implemented?(i.e.available to all personnel who need them)1Accessible and control methods.程序與作業說明有被有效地執行？（所有需要它的人員能輕易取得）8.2.21.4.3Does the organization conduct

39、internal quality audit according to the schedule planned?1Documented procedure and schedule.公司是否有按照既定的計劃來實施內部品質稽核？8.2.21.4.4Are the audit criteria,scope,frequency and methods defined for the internal audit?1Documented procedure.有為內部稽核定義稽核標準，范圍，頻率與方法？8.2.21.4.5Do the follow up activities include the

40、verification of the actions taken and the reporting of verification results?1跟進行動是否包括以採取行動的確認與確認結果的報告？8.2.21.4.6Do the internal quality audits verify compliance with quality objectives,customer/process requirements,and ISO elements?1Audit checklist/reports.內部品質稽核有確認符合品質目標，客戶要求/過程要求，與ISO原理？8.2.21.4.7

41、Do the internal quality audits verify effectiveness of the quality management systems and its requirements?(e.g.,review SPC data and CLCAstatus)1Audit checklist/reports.內部品質稽核有確認品質管理系統及其要求的效果？（例如，評審SPC數據與循環矯正效果）8.2.21.4.8Are the internal quality audits scheduled on the basis of the status,importance

42、 of the activity and the results of previous audits?1Previous audit report vs latest audit schedule內部品質稽核是按照狀況，行動的重要性與上次稽核的結果來計劃的？8.2.21.4.9Are the internal audits and follow-up actions carried out in accordance with documented procedures?1內部稽核與跟進行動是根據文件化程序來展開的？8.2.21.4.10 Does the management person

43、nel responsible for the area,take timely corrective action on the deficiencies found by the audit?1管理人員對所稽核的范圍負責，有就稽核發現的缺失採取及時的矯正行動？8.2.21.4.11 Auditors selection/allocation should ensure the impartiality and objectivity so that auditors shall not audit their own work?1Audit schedule.Auditor selecti

44、on criteria.能確保稽核員的選定/分派公正性與客觀性以期稽核員沒有稽核它們自己的工作？8.2.21.4.12Is there a procedure documented the responsibilities and requirements for planning and conducting audits,and for reporting results andmaintaining records?1Documented procedure.是否有程序就計劃與執行稽核與保持記錄與結果報告進行記錄？8.2.21.4.13 Are the audit results ana

45、lyzed for improvement from a system level?1有分析稽核結果以期得到系統的改善？Quality Management Systems品品質質管管理理體體系系1.5.1Is there an robust plan implemented to achieve ISO/TS16949?1是否有一個強有力的執行計劃來取得ISO/TS16949認証？4.2.21.5.2Does the quality manual include the scope of the quality management system,including details of a

46、nd justification for any exclusions asaccording to the business model of the organization?1Quality manual品質手冊有包括品質管理系統的范圍，包括認証的詳細說明與任何額外商業組織模式一致4.1.1/4.2.2.1.5.3Does the quality manual include a description of the interaction between the processes of the quality management system e.g.process flow or

47、matrix?1Business process interaction flow品質手冊有包括品質管理系統的程序之間互動的描述？例如程序流程或表格？8.41.5.4Is there a method to determine,collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality managementsystem?1有方法來確定，收集與分析合適的數據來証明品質管理系統的有效性與適用性？8.41.5.5Does the above analysis

48、evaluate where continual improvement of the effectiveness of the quality management system can be made.1上述分析有評估可以就品質管理系統的效率的那些方面做出持續改善？8.5.11.5.6Does the organization defined procedure,process and method to continually improve the effectiveness of the quality management system?1公司有定義程序，步驟與方法來持續提高品質管

49、理系統的效率？4.115.7Does the organization control over such outsource process that effects product conformity to the specified requirements and clearly identifiedwithin the quality management system?1貴公司管控范圍涵蓋能影響產品達到指定品質要求與在品質管理系統要求的採購流程。Comments備備注注:ISO 2:Contract ReviewAvg score:#ScoreRemarks9001:2000Su

50、btotal:0Counts:0Yes=1No=0N/A=XReview評評審審2.1.1 Are there established procedures for contract review?(i.e.product specifications and quality requirements)7.2.22.1.2 Are such procedures of requirement related to the product been reviewed to ensure that:與產品要求相關的程序有被評審以確保：7.2.2(a)Contract requirements ar