東莞伟创力QSA管理(中文版).xls

flextronics quality systems audit the flextronics qsa self assessment survey goal is the development of the site(s) quality system that provides a baseline and framework of continuous improvement process of sites operations system that focus on defect prevention and variations reduction. the purpose of the survey is to improve sites operation systems capabilities in meeting customers quality expectation. the qsa self assessment survey follows iso 9000/ts 16949/tl 9000 guidelines and is intended to share best practices and cutting down the learning curve by leveraging the strengthen from those capable sites. the qsa self assessment has two sections: 1. site(s) business assessment: this information will be used to assess site facilities business system. all information will be considered business confidential within flextronics. 2. site(s) self assessment survey: a yes/no questionnaire that is designed to reflect a comprehensive review of all major company quality systems. the questions were devised and developed as closed questions with every attempt to avoid ambiguity. because of the closed nature of the questions, there can only be one of two answers to any question, i.e. yes (1) or no (0). thus, the criterion is either fully met or it is not. if the criterion is met, a score of 1 is obtained. if the criterion is not met, a score of 0 is obtained. if there is any doubt as to the score to award for any given criterion, a score of zero shall be awarded by default. any criterion that scores 1 shall be clearly demonstrated, followed, and be beyond reproach. in the event that the organization clearly meets the intent of the audit question, but does not exactly do what the question asks, a score of 1 shall be given. general business assessment site 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 company 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 customers (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 9000 6qs 9000/ts 16949 7u/l registered (underwriter laboratories) 8iso 14000 certification 9other certifications personnel 10total number of employees 11employee # in manufacturing 12employee # in quality assurance 13number of engineers communication 14schedule sharing 15e-mail access 16communicate in english facility information 17sq. ft. 18 number of shifts (working hrs/day, days/week) 19utilization (capacity) 22other locations (name, location, specialty) flextronics qsa audit summary company : factory location : audit date : auditor : section max score each section self assessment score each section actual % each section actual score each section actual % each section goal % each section 1quality 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 control02#div/0!#div/0!80% 6product identification 1 appointment letter or any documented material that describe the appointment of qmr inclusive their 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 established, 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 action 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？ 5.5.21.2.3 has the quality management representative tracked and drove the improvement on quality management system performance with record/report. 1 evidence of any documented qms improvement project 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)? 1 evidence review on effectiveness implementation. 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 organization 1business 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 awareness 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？ 5.5.11.2.7 has the organization provided adequate resources for in-house verification activities such as inspection, testing, monitoring and review of processes and products? 1 list of 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？ 6.2.21.2.8 has the organization identified the resource requirements and provided adequate resources including the assignment of trained personnel for management, performance of work, verification activities and internal audits ? 1 identification of related competency level and related 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 product?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 procedure 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？ 5.5.21.2.13 is there a clearly identified management representative with authority and responsibility 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 the 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 amendments 1 詢價，合同或採購處理，包括改善？ 7.2.3(c) customer feedback, including customer complaints1 customer qbr, complaint report (e.g.5c from dell) 客戶反饋，包括客戶抱怨 1.2.15 is management with responsibility and authority for corrective action promptly informed of products or processes that become noncompliant with specified 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 5.6.11.3.1 does the organization conduct management reviews of the suitability and effectiveness of the quality management system at appropriate intervals? (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？ 5.6.11.3.2are 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 review agenda. 管理評審是否包括下面輸入的驗証？ 5.6.2(a) achievement of quality objectives1data collection, calculating method, 品質目標的達成？ 5.6.2(b) results of the audits1 internal audit & external audit(2nd or 3rd party audit) 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 previous 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 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 action items from management review tracked?1 methods of tracking those unresolved matters in the 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 and 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 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 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 do the internal quality audits verify effectiveness of the quality management systems and its requirements? (e.g., review spc data and clca status)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 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 personnel 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 selection 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？ 8.2.21.4.12 is there a procedure documented the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining 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 analyzed 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？ 4.2.21.5.2 does the quality manual include the scope of the quality management system, including details of and justification for any exclusions as according 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 / 4.2.2.1.5.3 does the quality manual include a description of the interaction between the processes of the quality management system e.g. process flow or 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？ 8.41.5.4 is there a method to determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system ?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 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？ 8.5.11.5.6 does 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理系統的效率？ 4.115.7 does the organization control over such outsource process that effects product conformity to the specified requirements and clearly identified within 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 : 7 iso 2: contract review avg score: # score remarks9001:2000subtotal:0counts:0yes=1no=0n/a=x review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 are adequately defined and documented. 合約要求有被充分定義與記錄？ 7.2.2(b) contract requirements that differ from those in tender are resolved. 不同於標書的合約要求有被解決？ 7.2.2(c) the organization has the capability to meet the contractual requirements. 公司有能力達到合約的要求？ 2.1.3 are there established procedures for new product introduction/transfer? (e.g., established work instructions, documentation checklist, equipment checklist, conduct pilot run, pre-production, first article review, etc.) 有確定的新產品的導入/轉移程序？（確定的作業說明，文件列表，設備清單，執行試產，試量產，首件評審等） 7.2.12.1.4 are such procedures for determination of requirement related to the product been reviewed to ensure that: 有評審確定與產品相關要求的程序以確保： 7.2.1(a) requirement specified by the customer, including the requirements for delivery and post-delivery activities 客戶指定要求，包括運輸/運輸後要求？ 7.2.1(b) requirement not stated by the customer but necessary for specified or intended use, where known, 客戶沒有說明的要求但眾所周知的對指定的/有目的的用途有必要（的要求） 7.2.1(c) statutory and regulatory requirements related to the product 與產品有關的法定和規定要求？ 8.2.12.1.5 does the organization monitor information from the customer and then uses this information to improve the quality management system of the organization. 公司有重視客戶的聲音且使用這些信息來提高公司的品質管理水平？ 8.2.12.1.6 does the organization takes corrective action if the customer perception of the organization had fallen below the expectation of the management ? 當客戶感到公司已達達不到管理層的期望時有採取矯正行動？ 7.5.42.1.7 does the organization identify, verify, protect and safeguard customer property provide for use or incorporation into the product. 公司有標示，檢驗，維護顧客的產品應用和組裝入產品后保証和維護安全系數。 7.5.42.1.8 is the customer informed and are there records maintained if any of the customer property is lost, damaged or otherwise found unsuitable for use ? 顧客會被通知且如果客戶任何利益受到損失且發現（產品）已不可用？ amendment to contract和和約約修修正正 7.2.22.2.1 are there provisions to document and deploy contract amendments to the functions concerned? 對於相關的功能，是否有規定來記錄與執行合約修改？ records 7.2.22.3.1 are records of contract reviews maintained? 評審合約的記錄有被維持？ comments備備注注 : 8 iso 3: design control avg score: # score remarks9001:2000subtotal:0counts:0yes=1no=0n/a=x general 總總體體要要求求 3.1.1 is there a process to deploy information gained from previous design projects to current and future ones of similar nature? 對於現在與未來的類似的設計，是否有程序來使用從前一設計項目得來的信息？ 7.3.13.1.2 are there procedures to control and verify the design of the product to ensure it is meeting all requirements? 是否有程序來管制並檢驗產品的設計以確保設計能滿足所有的要求？ design and development planning 設設計計與與研研發發計計劃劃 7.3.13.2.1 are there plans that identify the responsibility for each design and development activity? 是否有計劃來確定對於每個設計與研發行動的責任？ 7.3.13.2.2 are the plans updated as the design evolves? 隨著設計的發展計劃有被更新？ 3.2.3 are obsolete design documents removed from production and general use? 過期的設計文擋從生產與普通使用中移除？ 7.3.13.2.4 are responsible personnel qualified in the “required skills“ and equipped with adequate resources as appropriate? 責任人在“要求的技能“項合格且配備有足夠的必要資源？ 7.3.13.2.5 are all the stages in design and development of the product/process determine during the design and development stages 在設計、研發階段有決定在產品/制程設計與研發中的所有步驟？ 7.3.13.2.6 are there review, verification and validation activities that are appropriate to each design and development stage 有適合於每個設計與研發階段的評審，檢驗，確認行動？ 7.3.13.2.7 are the personnel appointed to assume responsibilities and authorities of design and development 有任命具有設計與研發責任與權利的人員? organizational and technical interfaces組組織織與與技技術術的的接接口口 7.3.13.3.1 are organizational and technical interfaces between different groups identified, documented, transmitted and reviewed regularly? 不同部門之間的組織與技術對應窗口有被定期確定，記錄，宣導，評審？ design input 設設計計輸輸出出 7.3.23.4.1 are design input requirements including the applicable statutory and regulatory requirements identified, documented and reviewed? 適用的法定的/規定的要求的設計輸入要求有被確定，記錄，評審？ 7.3.13.4.2 is there a procedure for resolving incomplete or conflicting requirements with those responsible for drawing up the requirements? 是否有一個程序來解決不完整的或與擬定的相互矛盾要求？ 3.4.3 is the organization compliant to the following, unless the customer waives them: 如果客戶沒有放棄以下條款，公司是否可以滿足？ (a) appropriate resources and facilities available to use computer aided design, engineering and analysis? 足夠的資源與設備來滿足計算機設計，工程設計與分析？ (b) if cad/cae is subcontracted, has the organization provided technical leadership? 如果計算機輔助設計/計算機輔助工程是外包，公司是否作技術指導？ (c) are cad/cae systems capable of two way interface with customer systems? 計算機輔助設計/計算機輔助工程能與客戶系統互動？ design output設設計計輸輸出出 7.3.33.5.1 has the design output been documented and expressed in terms that can be verified and validated against design input requirements: 設計輸出是否被記錄並表述明確以期能夠檢驗設計輸入要求？ 7.3.3(a) meet the design input requirements? 滿足設計輸入要求？ 7.3.3(b) contain or reference acceptance criteria? 包含或參照接收標準 (c) identify special characteristics? specify the characteristics of the product that are essential for its safe and proper use 有確定特殊的特性？對於有要求安全性與適用性的產品有指定特性？ 7.3.3(d) include a review of design output documents before release. 在發行前包括設計輸出文件的評審？ 3.5.2