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第4部分質量管理系統(tǒng)-文庫吧在線文庫

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【正文】 mers”).注解1:眾所周知,組織不可能對所有顧客提供同樣級別的溝通。該程序文件應包括:a) a strategy and criteria for customer selection,選擇顧客的策略及標準b) a method for the organization and its customers to share joint expectations and improve the quality of products, and組織和顧客共同參與策劃及提高產(chǎn)品質量的方法,和c) a joint review with the customer at defined intervals covering the status of shared expectations and including a method to track the resolution of issues. [4]會同顧客安既定的時間間隔評審期望目標的狀況,并且應有可以追蹤決定流轉的方法。 Supplier Input – The organization shall implement methods for soliciting and using supplier input for quality planning activities. [4]供應商輸入-組織應將供應商輸入納入質量策劃中。高級質量培訓可以包括統(tǒng)計技術、過程能力、統(tǒng)計取樣、數(shù)據(jù)收集及分析、問題判斷、問題分析積極糾正預防措施等。 1: The new product introduction program should include provisions for such programs as: quality and reliability prediction studies, pilot production, demand and capacity studies, sales and service personnel training, and new product postintroduction evaluations.注解1-新產(chǎn)品介紹程序應包括以下程序:質量及可靠性預測計劃,試制產(chǎn)品,需求及產(chǎn)量計劃,銷售及服務人員培訓,新產(chǎn)品定位估計。[11] Support Software and Tools Management – The organization shall ensure that internally developed support software and tools used in the product life cycle are subject to the appropriate quality method(s). Tools to be considered include: design and development tools, testing tools, configuration management tools, and documentation tools. [11]支持軟件及工具管理-組織應該保證用在產(chǎn)品中的內部開發(fā)的支持軟件及工具在整個產(chǎn)品生命周期中的質量。 Problem Escalation – The organization shall establish and maintain a documented escalation procedure(s) to resolve customerreported problems. [11]問題升級- 組織應建立并維護一套程序文件解決升級的顧客報告問題。 Test Planning – Test plans shall be documented and results recorded. Test plans should include: 檢測策劃-檢測策劃應形成文件并對結果加以記錄。[9] Design and development outputs 設計和開發(fā)輸出 Software Design and Development Output – Software design and development outputs should include, but are not limited to:a) system architecture,b) system detailed design,c) source code, andd) user documentation. [9] 軟件設計和開發(fā)輸出-軟件設計和開發(fā)輸出應包括(但不限于):a) 體系結構b) 系統(tǒng)詳細設計c) 源代碼,和d) 用戶文件〔9〕 Services Design and Development Output – The required output from the services design and development shall contain a plete and precise statement of the service to be provided. Design and development outputs shall include, but are not limited to:a) service delivery procedures,b) resource and skill requirements,c) reliance on suppliers,d) service characteristics subject to customer evaluation, ande) standards of acceptability for each service characteristic. [13] 服務設計和開發(fā)輸出-服務設計和開發(fā)的輸出應包含完整的和精確的提供服務的闡述。這特別包括用于制造的原有設備制造商(OEM)產(chǎn)品和用于軟件系統(tǒng)的商業(yè)性現(xiàn)有(COTS)產(chǎn)品。s operation for each patch. [11] 修補程序-組織應建立和維持一個程序文件指導通過修補解決問題的決定a) 程序文件應寫出修補發(fā)展程序,發(fā)展(向前和向后),和解決方案b) 程序文件應和用于維護支持的客戶需求或合同需求一致。 Traceability of Design Changes – The organization shall establish and maintain adocumented procedure(s) which provides traceability of design changes to identifiable manufacturing dates, lots, or serial numbers. 設計變更的可追溯性-組織應建立和維持一個程序文件,提供設計變更可追溯性,象制造日期,份額或系列號。 Tool Changes – The organization shall have a documented procedure(s) in place to ensure that substitutions or changes to tools used in performing the service do not adversely affect the quality of the service. 工具變更-組織應適當?shù)赜幸粋€程序文件去確保用在服務上的工具的替代或變更不反過來影響服務的質量?!?〕 Installation Plan – The organization shall establish and maintain a documented installation plan. The installation plan shall identify the resources, the information required, and list the sequence of events. The results associated with the installation sequence shall be documented. [10] 安裝計劃-組織應建立和維持一個文件性的安裝計劃。變化的管理應包括:a) 影響分析b) 規(guī)劃c) 實施d) 試驗e) 文件f) 信息,和g) 檢討和批準 Informing Customers – The organization shall establish and maintain a documentedprocedure(s) to ensure that customers are informed when design changes affect contractualmitments. [5] 通知客戶-組織應建立和維持一個程序文件以確保當設計變更影響合同承諾時通知客戶。[10] Migration Planning – The organization shall develop and document a migration plan when a system or software product is planned to be migrated from an old to a new environment. The plan should include the following: 遷移策劃-組織應建立遷移策劃并形成文件,該策劃適用于當一個系統(tǒng)或軟件產(chǎn)品計劃從舊的環(huán)境中遷移到新的環(huán)境中。該計劃應包括:a) project organizational structure, 方案組織結構b) project roles and responsibilities, 方案角色及職責c) interfaces with internal and external organizations, 與內部或外部組織交流d) means for scheduling, tracking, issue resolution, and reporting, 計劃進度、跟蹤、問題決定及報告的方式e) budgets, staffing, and schedules associated with project activities, 與方案活動相關的預算、人員、進度f) method(s), standards, documented procedure(s), and tools to be used, 方法,標準,程序文件以應用工具g) references to related plans (., development, testing, configuration management, and quality), 策劃相關的參考資料(例如:發(fā)展,測試,配置管理,及質量)h) projectspecific environment and physical resource considerations (., development, userdocumentation, testing, and operation), 方案詳細考慮的環(huán)境及物質資源(例如:發(fā)展,用戶證書,測試及操作)i) customer, user, and supplier involvement during the product life cycle (., joint reviews, informal meetings, and approvals), 產(chǎn)品生命周期內顧客,用戶及廠商(例如:聯(lián)合評審,非正式會議,以及批準)j) management of project quality, 方案質量管理k) risk management and contingency plans (., technical, cost and schedules), 風險管理及意外事故策劃(例如:技術,成本以及進度)l) performance, safety, security, and other critical requirements, 執(zhí)行、保險、安全以及其它緊急需求m) projectspecific training requirements, 方案詳細培訓需求n) required certifications, 必須的證明,o) proprietary, usage, ownership, warranty, licensing rights, and 所有者,用法,所有權,授權,許可權力,等p) postproject analysis. [10] 方案定位分析. [10] 1: The project plan and any related plans may be an independent document, a part of another document, or prised of several documents.注解1:方案策劃或其它相關策劃可能是獨立的文件,其它文件的由部分或由幾個文件組成。[9] 2: The product acceptance plan should include as appropriate:注解2:產(chǎn)品驗收策劃應當包括以下內容作為補充:a) acceptance review process, 驗收評審過程,b) acceptance criteria, 驗收標準c) documented test proced
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