【正文】 裝和防護 關鍵生產設備備件的可得性 文件化 、 評估和改進維護目標 組織應采用 預測性維護方法 以持續(xù)改進生產設備的 有效性和效率 。 80 Preventive And Predictive Maintenance 預防性的和預見性的維護 The anization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. As a minimum, this system shall include the following: . planned maintenance activities。 ? 控制計劃應： ? 列出制造過程控制所用的控制方法； ? 包括對顧客和組織規(guī)定的特殊特性 （ 見 ） 執(zhí)行的控制進行監(jiān)視的方法； ? 包括任何顧客要求的信息； ? 當過程不穩(wěn)定或統(tǒng)計能力低時啟動規(guī)定的反應計劃 (見 )。 . receiving inspection and/or testing such as sampling based on performance。 72 72 Regulatory Conformity 法規(guī)符合性 All purchased products or materials used in product shall conform to applicable regulatory requirements. 用于產品的所有采購產品或材料均 應 符合適用的 法規(guī)要求 。 應跟蹤所有的性能試驗活動 ， 以監(jiān)視及時完成并符合要求 。 64 Manufacturing Process Design Output 制造過程設計輸出 The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output shall include . specifications and drawings, . manufacturing process flow chart/layout, . manufacturing process FMEAs, . control plan (see ), . work instructions, . process approval acceptance criteria, . data for quality, reliability, maintainability and measurability, . results of errorproofing activities, as appropriate, and . methods of rapid detection and feedback of product/manufacturing process nonconformities. 制造過程設計輸出應能根據(jù)制造過程設計輸入要求驗證和確認的形式表達 。 開發(fā)和評審 FMEAs,包括降低潛在風險的措施 。 注 3：符合項目 c)的要求包括所有適用的政府 、 安全和環(huán)境法規(guī) ， 適用于材料的 獲得 、 儲存 、 搬運 、 回收 、 銷毀和處理 。 應規(guī)定更改的驗證和確認活動以確保符合顧客要求 。 Contingency Plans 應急計劃 47 Product safety and means to minimize potential risks to employees shall be addressed by the anization, especially in the design and development process and in manufacturing process activities. 組織 應 闡述產品安全和最小化對員工的潛在風險的方法 ，特別是在設計和開發(fā) 過程和在制造過程活動中。 Training On The Job 崗位培訓 44 The anization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole anization. The anization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see d)]. 組織 應 建立一個 激勵員工 達到質量目標的過程 ， 以進行持續(xù)改進并創(chuàng)建一個促 進革新的環(huán)境 。 Review Input – Supplemental 評審輸入 補充 40 6 Resource Management 41 The anization shall ensure that personnel with product design responsibility are petent to achieve design requirements and are skilled in applicable tools and techniques. Applicable tools and techniques shall be identified by the anization. 組織 應 確保負有產品設計職責的人員有能力達到設計要求并且熟練掌握適用的 工具和技術。 Process Efficiency 過程有效性 35 Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy. 最高管理者 應 規(guī)定質量目標和 測量方法 ,并應被包括在 經營計劃 中 ,并用于展開 質量方針 . 注 : 質量目標 應 表述顧客期望并且在 規(guī)定時間階段 內可完成 . Quality Objectives – Supplemental 質量目標 － 補充 36 Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements. Personnel responsible for product quality shall have the authority to stop production to correct quality problems. Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality. 應 迅速 把不符合規(guī)定要求的產品或過程 通報 給負責糾正措施的管理者 。 NOTE: See also Purchasing process Customerapproved sources General Requirements – Supplemental 總要求－－補充 30 The anization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/ specifications and changes based on customerrequired schedule. Timely review should be as soon as possible, and shall not exceed two working weeks. The anization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents. 組織應有一個過程以便確保根據(jù)顧客要求的日程及時評審、發(fā)放和實施所有顧客 工程標準 /規(guī)范及更改。 Quality Management System Principles 19 1. Leadership 領導作用 2. Leaders establish unity of purpose and direction of the anization. They 3. should create and maintain the internal environment in which people can 4. bee fully involved in achieving the anization’ s objective. 5. 領導者建立其組織的方向和統(tǒng)一的目標，他們應該創(chuàng)造并維護內部環(huán)境以使 6. 組織中的人們能充分參與到實現(xiàn)組織的目標的活動中去 。 Quality Management System Principles 20 ? Involvement of People 全員參與 People at all levels are the essence of an anization and their full involvement enables their abilities to be used for the anization’ s benefit. 組織中所有層次的員工是組織的基本，他們的充分參與能使他們的才能被用 于使組織的獲利。及時評審應盡快并且不超過 兩個工作周 。 負責產品質量的人員 應 有權停止生產以糾正質量問題 。 適用的工具和技術 應 被組織識別。 過程應包括在整個組織內促進質量和技術意識 。 Personnel Safety To Achieve Product Quality 與實現(xiàn)產品質量相關的人員安全 48 The anization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs. 組織 應 保持生產現(xiàn)場處于與產品和制造過程的需求相協(xié)調的有序、清潔和維護 的狀態(tài)。 更改應在實施之前 進行確認 。 56 CustomerDesignated Special Characteristics 顧客指定的特殊特性 The anization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics. 組織 應 證明符合顧客關于 特殊特性 的指定 、 文件化和控制的要求 。 開發(fā)和評審控制計劃 。 制造過程設計輸出應包括： 規(guī)范和圖紙； 制造