東莞伟创力QSA管理(中文版).xls

1. site(s) business assessment: 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. flextronics quality systems audit 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. this information will be used to assess site facilities business system. all information will be considered business confidential within flextronics. a yes/no questionnaire that is designed to reflect a comprehensive review of all major company quality systems. the qsa self assessment has two sections: 2. site(s) self assessment survey: 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. 專專 業業 （服務，過程，服務（服務，過程，服務） 母公司 子公司子公司 機構地址 phone:email: phone:email: 廠務經理 phone:email: 品保經理品保經理 phone:email: 工程經理 business information 業務信息業務信息 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 認証認証 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. 18number of shifts (working hrs/day, days/week) 19utilization (capacity) 22other locations (name, location, specialty) quality manager engineering manager mfg. manager general business assessment subsidiary name organization address vp / gm / plant manager site name 機構地址機構地址 specialty (product, process, services) parent company name 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 are the quality policy distributed and published so that employees of all levels understood, implement and maintain same systems ? 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? 品質目標是否公司目標與客戶的期望和要求相關？ quality policy organization management review 管理評審管理評審 does the organization establish quality objectives and product requirement performance indicators that are measurable and consistent with the quality policy ? does the organization have the ability to communicate necessary information and data in the customer prescribed format ? is management with responsibility and authority for corrective action promptly informed of products or processes that become noncompliant with specified requirements ? has the organization provided adequate resources for in-house verification activities such as inspection, testing, monitoring and review of processes and products? 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: quality management systems is there a system that identifies training requirements for all personnel affecting the quality of the product? does a system exist for determining which personnel are qualified for a job function? is there a system to disqualify and re-qualify personnel in a job function? are records maintained of these management reviews? 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？ 管理下一步的處理行動？ 確保客戶的要求有在公司內部傳達？ 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？ has the quality management representative tracked and drove the improvement on quality management system performance with record/report. (d) control further processing ? (e) ensure that the need, awareness and requirement of the customer are promoted internally in the organization ? 保留的記錄是否包括各個職員教育（程度）、受訓、技能與經驗？ does the management reviews include verification of the following input: 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?) 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？ 客戶反饋，包括客戶抱怨 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？ 管理評審是否包括下面輸入的驗証？ 這些管理評審記錄是否有維持？ 是否有定義對所有能影響產品品質人員訓練要求的制度？ 有一個定義誰能完成某項工作職責的制度？ 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？ 公司有能力溝通必要的以客戶指定的格式的信息與數據？ 產品信息 詢價，合同或採購處理，包括改善？ 是否有一個剝奪人員資格/再認証人員的制度？ 5.6.21data collection, calculating method, 5.6.21 internal audit & external audit(2nd or 3rd party audit) 5.6.21 5.6.21 5.6.21 5.6.21 5.6.21organization change, process change, 5.6.21upcoming technology 5.6.31.3.41management review minutes 5.6.31 5.6.31 5.6.31 1.3.51 methods of tracking those unresolved matters in the minutes of meeting. not here1.4.112nd and 3rd level procedures masterlist etc. not here1.4.21accessible and control methods. 8.2.21.4.31documented procedure and schedule. 8.2.21.4.41documented procedure. 8.2.21.4.51 8.2.21.4.61audit checklist / reports. 8.2.21.4.71audit checklist / reports. 8.2.21.4.81previous audit report vs latest audit schedule 8.2.21.4.91 8.2.21.4.101 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？ 8.2.21.4.111audit schedule. auditor selection criteria. 8.2.21.4.121documented procedure. 8.2.21.4.131 1.5.11 4.2.21.5.21quality manual 4.1.1 / 4.2.2.1.5.31business process interaction flow 8.41.5.41 8.41.5.51 8.5.11.5.61 4.115.71 does the organization control over such outsource process that effects product conformity to the specified requirements and clearly identified within the quality management system? does the organization defined procedure, process and method to continually improve the effectiveness of the quality management system ? is there a method to determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system ? 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？ 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？ 有分析稽核結果以期得到系統的改善？ does the management personnel responsible for the area, take timely corrective action on the deficiencies found by the audit? 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。 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？ 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？ 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？ 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？ does the above analysis evaluate where continual improvement of the effectiveness of the quality management system can be made. does the quality manual include a description of the interaction between the processes of the quality management system e.g. process flow or matrix ? are the audit results analyzed for improvement from a system level? auditors selection / allocation should ensure the impartiality and objectivity so that auditors shall not audit their own work ? are the internal audits and follow-up actions carried out in accordance with documented procedures? 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？ 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？ is there an robust plan implemented to achieve iso/ts16949? 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 ? is there a procedure documented the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records ? 內部稽核與跟進行動是根據文件化程序來展開的？ have the procedures and work instructions been effectively implemented? (i.e. available to all personnel who need them) internal audit內部稽核內部稽核 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？ 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） does the organization conduct internal quality audit according to the schedule planned ? do the internal quality audits verify effectiveness of the quality management systems and its requirements? (e.g., review spc data and clca status) are the internal quality audits scheduled on the basis of the status, importance of the activity and the results of previous audits ? are the audit criteria, scope, frequency and methods defined for the internal audit? 公司是否有按照既定的計劃來實施內部品質稽核？ 有為內部稽核定義稽核標準，范圍，頻率與方法？ 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） 跟進行動是否包括以採取行動的確認與確認結果的報告？ do the follow up activities include the verification of the actions taken and the reporting of verification results ? are implementation of action items from management review tracked? (c) customer feedback (d) process performance and product conformity (e) status of preventive and corrective actions 是否有一個強有力的執行計劃來取得iso/ts16949認証？ 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 quality management systems品質管理體系品質管理體系 has the organization established and maintained a documented quality management system including procedures and work instructions? do the internal quality audits verify compliance with quality objectives, customer/process requirements, and iso elements? (b) results of the audits 品質管理系統及其過程的效率提高？ 管理結果的評審有包括有關的決定與行動？ (a) achievement of quality objectives (g) changes that could affect the quality management system, and (f) follow-up actions from previous management reviews does the output of management reviews include any decisions and actions related to: 預防與矯正行動效果？ 資源需求？ 與客戶有關的產品改善，與 品質目標的達成？ (c) resource needs (b) improvement of product related to customer requirements, and 有跟蹤管理評審的執行項目的實施？ 改善建議？ 能影響品質管理系統的變異？ 上一管理評審的跟進行動？ (h) recommendations for improvement (a) improvement of the effectiveness of the quality management system and its process? 稽核的結果？ 顧客反饋 過程能力與產品良率 comments備注備注 : iso avg score: # score 9001:2000subtotal:0counts:0yes=1no=0n/a=x 2.1.1 7.2.22.1.2 7.2.2 7.2.2 7.2.2 2.1.3 7.2.12.1.4 7.2.1 7.2.1 7.2.1 8.2.12.1.5 8.2.12.1.6 7.5.42.1.7 7.5.42.1.8 7.2.22.2.1 7.2.22.3.1 (b) requirement not stated by the customer but necessary for specified or intended use, where known, (c) statutory and regulatory requirements related to the product does the organization takes corrective action if the customer perception of the organization had fallen below the expectation of the management ? (c) the organization has the capability to meet the contractual requirements. (a) requirement specified by the customer, including the requirements for delivery and post-delivery activities 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） 與產品有關的法定和規定要求？ 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？ 不同於標書的合約要求有被解決？ 2: contract review remarks review評審評審 are there established procedures for contract review? (i.e. product specifications and quality requirements) are such procedures of requirement related to the product been reviewed to ensure that: (a) contract requirements are adequately defined and documented. (b) contract requirements that differ from those in tender are resolved. 與產品要求相關的程序有被評審以確保： 合約要求有被充分定義與記錄？ are records of contract reviews maintained? 評審合約的記錄有被維持？ does the organization identify, verify, protect and safeguard customer property provide for use or incorporation into the product. is the customer informed and are there records maintained if any of the customer property is lost, damaged or otherwise found unsuitable for use ? 公司有能力達到合約的要求？ 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） 有評審確定與產品相關要求的程序以確保： 客戶指定要求，包括運輸/運輸後要求？ 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.) are such procedures for determination of requirement related to the product been reviewed to ensure that: 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？ does the organization monitor information from the customer and then uses this information to improve the quality management system of the organization. comments備注備注 : records are there provisions to document and deploy contract amendments to the functions concerned? 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。 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？ 對於相關的功能，是否有規定來記錄與執行合約修改？ amendment to contract和約修正和約修正 7 iso avg score: # score 9001:2000subtotal:0counts:0yes=1no=0n/a=x 3.1.1 7.3.13.1.2 7.3.13.2.1 7.3.13.2.2 3.2.3 7.3.13.2.4 7.3.13.2.5 7.3.13.2.6 7.3.13.2.7 7.3.13.3.1 are organizational and technical interfaces between different groups identified, documented, transmitted and reviewed regularly? 7.3.23.4.1 7.3.13.4.2 is there a procedure for resolving incomplete or conflicting requirements with those responsible for drawing up the requirements? 3.4.3 7.3.33.5.1 7.3.3 7.3.3 7.3.3 3.5.2 7.3.33.5.3 3.5.4 has the design verification been planned, established, documented and assigned to competent personnel? 在發行前包括設計輸出文件的評審？ 有計劃，建立，記錄設計檢驗且這些工作是任命給一個有能力的人員？ (a) efforts to simplify, optimized, innovate and reduce waste? (b) if cad/cae is subcontracted, has the organization provided technical leadership? (c) feedback from testing, production and field? is there a process to deploy information gained from previous design projects to current and future ones of similar nature? are responsible personnel qualified in the “required skills“ and equipped with adequate resources as appropriate? has the design output been documented and expressed in terms that can be verified and validated against design input requirements: (a) meet the design input requirements? organizational and technical interfaces組織與技術的接口組織與技術的接口 are all the stages in design and development of the product/process determine during the design and development stages are there review, verification and validation activities that are appropriate to each design and development stage are design input requirements including the applicable statutory and regulatory requirements identified, documented and reviewed? is the organization compliant to the following, unless the customer waives them: (a) appropriate resources and facilities available to use computer aided design, engineering and analysis? 3: design control remarks general 總體要求總體要求 design and development planning 設計與研發計劃設計與研發計劃 design input 設計輸出設計輸出 design output設計輸出設計輸出 are there plans that identify the responsibility for each design and development activity? are there procedures to control and verify the design of the product to ensure it is meeting all requirements? can the design verification establish that design output meet the design input? (d) include a review of design output documents before release. was the design output a result of a process that included: (b) contain or reference acceptance criteria? are the personnel appointed to assume responsibilities and authorities of design and development (c) are cad/cae systems capable of two way interface with customer systems? are obsolete design documents removed from production and general use? 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？ 過期的設計文擋從生產與普通使用中移除？ 責任人在“要求的技能“項合格且配備有足夠的必要資源？ 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？ 有適合於每個設計與研發階段的評審，檢驗，確認行動？ 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？ 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？ 是否有計劃來確定對於每個設計與研發行動的責任？ 隨著設計的發展計劃有被更新？ are the plans updated as the design evolves? 有任命具有設計與研發責任與權利的人員? 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？ 計算機輔助設計/計算機輔助工程能與客戶系統互動？ 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？ 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？ 如果客戶沒有放棄以下條款，公司是否可以滿足？ 足夠的資源與設備來滿足計算機設計，工程設計與分析？ 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？ 滿足設計輸入要求？ 包含或參照接收標準 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？ (c) identify special characteristics? specify the characteristics of the product that are essential for its safe and proper use 設計輸出包括以下內容的制程結果： 設計確認可以確定設計輸出能滿足設計輸出？ 簡化，優化，創新與減少浪費的努力？ 行業不景氣時的成本/成效/風險分析？ (b) analysis of cost/performance/risk trade offs? 8 7.3.43.6.1 3.6.2 7.3.43.6.3 7.3.53.7.1 3.8.1 3.8.2 3.8.3 3.8.4 7.3.63.8.5 7.3.73.9.1 3.9.2 3.9.3 7.3.73.9.4 3.10.1 3.10.2 3.10.3 3.10.4 3.11.1 3.11.2 3.11.3 3.11.4 3.12.1 在實施前設計變更是否被確認，記錄並被授權人員評審、核準？ 在設計變更被實施到生產前，是否有得到客戶的書面核準或放棄？ 是否有記錄証明設計驗証已被執行以確保設計輸出能滿足設計輸入要求？ 設計驗証已被執行以確保產品符合客戶要求？ is design validation performed in conjunction with the customer timing requirements? are there records for design validation and do they include design failures? has design validation been performed to ensure that product conforms to defined user needs and/or requirements? are there records to demonstrate that design validation has been performed to ensure that design output meets design input requirements? are design failures addressed through the designated corrective and preventive action procedures? are design changes identified, documented, reviewed and approved by authorized personnel before implementation? has written customer approval or waiver been obtained prior to a design change being implemented into production? wherever possible, are the suppliers tooling and process for prototype the same as the ones that will be used in production? is the performance testing (that considers and includes as appropriate life, durability, reliability) tracked for timely completion and conformance? for proprietary designs, does the organization evaluate with the customer the impact of the design change on form, fit, function, performance and/or durability? does the organization consider the impact of design changes on the system in which the product is used?