【正文】 ons. 注解 1－新產(chǎn)品介紹程序應(yīng)包括以下程序：質(zhì)量及可靠性預(yù)測計(jì)劃，試制產(chǎn)品，需求及產(chǎn)量計(jì)劃，銷售及服務(wù)人員培訓(xùn)，新產(chǎn)品定位估計(jì)。 Infrastructure 基礎(chǔ)設(shè)施 Work environment 工作環(huán)境 Work Areas – Areas used for handling, storage, and packaging of products shall be clean, safe, and anized to ensure that they do not adversely affect quality or personnel performance. [5] 工作區(qū)－用于操作、儲(chǔ)存及包裝產(chǎn)品的區(qū)域應(yīng)保持干凈、安全并且有序，以確保不會(huì)對(duì)質(zhì)量或個(gè)人造成負(fù)面影響。高級(jí)質(zhì)量培訓(xùn)可以包括統(tǒng)計(jì)技術(shù)、過程能力、統(tǒng)計(jì)取樣、數(shù)據(jù)收集及分析、問題判斷、問題分析積極糾正預(yù)防措施等。 [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(xùn)需求和意識(shí)－培訓(xùn)需求應(yīng)針對(duì)所有對(duì)產(chǎn)品質(zhì)量有直接影響的職位。 Supplier Input – The anization shall implement methods for soliciting and using supplier input for quality planning activities. [4] 供應(yīng)商輸入－組織應(yīng)將供應(yīng)商輸入納入質(zhì)量策劃中。 Performance to these goals shall be monitored and reported. These plans shall address: 實(shí)現(xiàn)這些目標(biāo)需要監(jiān)控和匯報(bào)。該程序文件應(yīng)包括： a) a strategy and criteria for customer selection, 選擇顧客的策略及標(biāo)準(zhǔn) b) a method for the anization 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(zhì)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(huì)同顧客安既定的時(shí)間間隔評(píng)審期望目標(biāo)的狀況，并且應(yīng)有可以追蹤決定流轉(zhuǎn)的方法。1 Section 4 Quality management system 第四章 質(zhì)量管理體系 General requirements 一般要求 Documentation requirements 文件要求 General 總則 Quality manual 質(zhì)量手冊(cè) Control of documents 文件控制 Control of CustomerSupplied Documents and Data – The anization shall establish and maintain a documented procedure(s) to control all customersupplied documents and data (., work architecture, topology, capacity, installation termination assignments, and database) if these documents and data influence the design, verification, validation, inspection and testing, or servicing the product. 客戶提供文件及數(shù)據(jù)控制－ 組織將建立并且維護(hù)文件化程序以控制所有客戶提供的文件和數(shù)據(jù)（例如，網(wǎng)絡(luò)體系結(jié)構(gòu)，布局，容量，安裝結(jié)束任務(wù)及數(shù)據(jù)庫）如果這些文件和數(shù)據(jù)影響設(shè)計(jì)，驗(yàn)證，確認(rèn)，檢查及測試，或服務(wù)于產(chǎn)品。 1: It is recognized that it is not possible for an anization to provide the same level of munication with all its customers. The level provided may depend on the amount of business with the customer, the history of problems, customer expectations, and other factors (see Appendix F, “Guidance for Communication with Customers”). 注解 1：眾所周知，組織不可能對(duì)所有顧客提供同樣級(jí)別的溝通。這些策劃應(yīng)注明： a) cycle time, 循環(huán)時(shí)間 b) customer service, 顧客服務(wù) c) training, 培訓(xùn) d) cost, 成本 e) delivery mitments, and 交貨承諾，等 f) product reliability. 產(chǎn)品可靠性 1: Top Management should demonstrate their active involvement in long and shortterm quality planning. 注解 1：最高管理者應(yīng)積極參與到長期和短期質(zhì)量策劃中。 Responsibility, authority and munication 職責(zé)、權(quán)限與溝通 Responsibility and authority 職責(zé)和權(quán)限 Management representative 管理者代表 Internal munication 內(nèi)部溝通 Organization Performance Feedback – The anization shall inform employees of its quality performance and the level of customer satisfaction. [4] 組織成績反饋－組織應(yīng)通知其員工關(guān)于質(zhì)量成績以及顧客滿意程度。員工應(yīng)該知曉培訓(xùn)的機(jī)會(huì)。 [5] Training Content – Where the potential for hazardous conditions exists, training content should include the following: 培訓(xùn)內(nèi)容－有潛在危險(xiǎn)的地方，培訓(xùn)內(nèi)容應(yīng)包括： a) task execution, 作業(yè)執(zhí)行 b) personal safety, 個(gè)人安全 c) awareness of hazardous environment, and 危險(xiǎn)意識(shí)，等 6 d) equipment protection. 設(shè)備保護(hù) Operator Qualification – The anization shall establish operator qualification and requalification requirements for all applicable processes. These requirements, at a minimum, shall address employee education, experience, training, and demonstrated skills. The anization shall municate this information to all affected employees. [4] 操作員資格－組織應(yīng)當(dāng)為所有必要過程建立操作員資格及要求條件。 7 Section 7 Product realization 第七章 產(chǎn)品實(shí)現(xiàn) Planning of product realization 產(chǎn)品實(shí)現(xiàn)的策劃 Life Cycle Model – The anization shall establish and maintain an integrated set of guidelines that covers the life cycle of its products. This framework shall contain, as appropriate, the processes, activities, and tasks involved in the concept, definition, development, production, operation, maintenance, and (if required) disposal of products, spanning the life of the products. [10] 生命循環(huán)模式－組織應(yīng)當(dāng)建立并維護(hù)一套覆蓋產(chǎn)品生命循環(huán)的完整的指導(dǎo)手冊(cè)。 Disaster Recovery – The anization shall establish and maintain methods for disaster recovery to ensure the anization’s ability to recreate and service the product throughout its life cycle. [10] 事故處理－組織應(yīng)建立并維護(hù)事故處理的方法以確保組織有能力在生命周期內(nèi)進(jìn)行維修和服務(wù)。 Estimation – The anization shall establish and maintain a method for estimating and tracking project factors during project planning, execution, and change management. [11] 評(píng)估－組織應(yīng)建立并維護(hù)一種方法用以在方案策劃、實(shí)施及更改過程中評(píng)估和跟蹤方案因素 1: Project factors should include product size, plexity, effort, staffing, schedules, cost, quality, reliability, and productivity. 注解 1：方案因素應(yīng)包括產(chǎn)品尺寸，復(fù)雜性，成就，員工，進(jìn)度，成本，質(zhì)量，可靠性及生產(chǎn)能力。應(yīng)當(dāng)考慮的工具包括：設(shè)計(jì)開發(fā)工具、測試工具、配置管理工具，以及文件工具。 Problem Severity – The anization shall assign severity levels to customer reported problems based on the impact to the customer in accordance with the definitions of critical, major, and minor problem reports contained in the glossary of this handbook. The severity level shall be used in determining the timeliness of the anization’s response. [11] 問題嚴(yán)重性－組織應(yīng)根據(jù)對(duì)顧客的影響向顧客指明問題的嚴(yán)重程度，根據(jù)手冊(cè)中的術(shù)語可分為嚴(yán)重，重 大，一般問題。 [11] Customer Feedback – The anization shall establish and maintain a documented procedure(s) to provide the customer with feedback on their problem reports in a timely manner. 顧客反饋－組織應(yīng)建立并維護(hù)一套程序文件及時(shí)處理顧客問題反饋。 2: General work instructions defining tasks and responsibilities mon to all development projects