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se courses. [4]內部課程開展-當組織開展內部培訓課程時應當建立并維護一個程序以確保課程的計劃、開展及實現(xiàn)。[4] Training Requirements and Awareness – Training requirements shall be defined for all positions that have a direct impact on the quality of products. Employees shall be made aware of training opportunities. [4]培訓需求和意識-培訓需求應針對所有對產品質量有直接影響的職位。 ESD Training – All employees with functions that involve any handling, storage, packaging,preservation, or delivery of ESDsensitive products shall receive training in electrostatic discharge (ESD) protection prior to performing their jobs.ESD 培訓-所有包括操作、倉儲、包裝、保存及運輸ESD敏感產品的員工都應接受靜電放電培訓,以確保他們開展工作。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。這些要求應注明員工教育背景、工作經歷、培訓及技能。 Infrastructure基礎設施 Work environment工作環(huán)境 Work Areas – Areas used for handling, storage, and packaging of products shall be clean, safe, and organized to ensure that they do not adversely affect quality or personnel performance. [5] 工作區(qū)-用于操作、儲存及包裝產品的區(qū)域應保持干凈、安全并且有序,以確保不會對質量或個人造成負面影響。該框架應盡可能包括國過程、功能、以及觀念、定義、發(fā)展、產品、操作、維護,以及產品的處理(如果必要),跨度產品的生命周期。 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,試制產品,需求及產量計劃,銷售及服務人員培訓,新產品定位估計。 End of Life Planning – The organization shall establish and maintain a documentedprocedure(s) for the discontinuance of manufacturing and/or support of a product by the operation and service organizations. The documented procedure(s) should include:最終策劃-組織應為保質期和服務組織終止生產或支持產品建立并維護一套文件化的程序。[10] 1: General work instructions defining general configuration management tasks and responsibilities need not be replicated as part of a specific documented configuration management plan.注解1:總的工作指令規(guī)定總的配置管理任務并且責任不必轉述為配置管理策劃的部分文件。 Computer Resources – The organization shall establish and maintain methods for estimating and tracking critical puter resources for the target puter, the puter on which the software is intended to operate. Examples of these resources are utilization of memory, throughput, real time performance, and I/O channels. [11]計算機資源-組織應建立并維護一種方法用以評估和追蹤目標計算機的重要資源,計算機中的軟件是否預期運行。[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品中的內部開發(fā)的支持軟件及工具在整個產品生命周期中的質量。[11] Service Delivery Plan – Suppliers that are responsible for the delivery or implementation of a service, and are not responsible for the design and development of that service, shall ply with the Project Plan requirements of .服務交付策劃- 廠商有責任交貨或提供服務,但是對服務的設計及發(fā)展不負責任,應符合。[9] 2: The product acceptance plan should include as appropriate:注解2:產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 procedure(s), 文件化的檢測程序d) test environment, 檢測環(huán)境e) test cases, 檢測實例f) test data, 檢測數(shù)據(jù)g) resources involved, 相關資源h) method(s) for problem tracking and resolution, and 問題追蹤及解決方法,等i) required acceptance test reports. [10] 必要的檢驗報告 Customer munication 顧客溝通 Notification About Problems – The organization shall establish and maintain a documented procedure(s) to notify all customers who may be affected by a reported problem that is service affecting. [5]關于問題的通知- 組織應建立并維護一套程序文件以通知可能受已報告的服務問題影響的所有顧客。組織根據(jù)嚴重程度確定答復時間。 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。 Organization’s Recall Process – The organization shall establish and maintain a documented procedure(s) for identifying and recalling products that are unfit to remain in service.組織的回收過程-組織應建立并維護一套程序文件以鑒定和回收不適合維修的產品。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。 Requirements Traceability – The organization shall establish and maintain a method to trace documented requirements through design and test. [11] 必要的可追蹤性-組織應建立并維護一種方法對設計和測試過程的文件進行必要的追蹤。 Test Planning – Test plans shall be documented and result