【正文】 裝和防護(hù) 關(guān)鍵生產(chǎn)設(shè)備備件的可得性 文件化 、 評(píng)估和改進(jìn)維護(hù)目標(biāo) 組織應(yīng)采用 預(yù)測性維護(hù)方法 以持續(xù)改進(jìn)生產(chǎn)設(shè)備的 有效性和效率 。 80 Preventive And Predictive Maintenance 預(yù)防性的和預(yù)見性的維護(hù) 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(jì)劃應(yīng)： ? 列出制造過程控制所用的控制方法； ? 包括對(duì)顧客和組織規(guī)定的特殊特性 （ 見 ） 執(zhí)行的控制進(jìn)行監(jiān)視的方法； ? 包括任何顧客要求的信息； ? 當(dāng)過程不穩(wěn)定或統(tǒng)計(jì)能力低時(shí)啟動(dòng)規(guī)定的反應(yīng)計(jì)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(chǎn)品的所有采購產(chǎn)品或材料均 應(yīng) 符合適用的 法規(guī)要求 。 應(yīng)跟蹤所有的性能試驗(yàn)活動(dòng) ， 以監(jiān)視及時(shí)完成并符合要求 。 64 Manufacturing Process Design Output 制造過程設(shè)計(jì)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(shè)計(jì)輸出應(yīng)能根據(jù)制造過程設(shè)計(jì)輸入要求驗(yàn)證和確認(rèn)的形式表達(dá) 。 開發(fā)和評(píng)審 FMEAs,包括降低潛在風(fēng)險(xiǎn)的措施 。 注 3：符合項(xiàng)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(chǔ)存 、 搬運(yùn) 、 回收 、 銷毀和處理 。 應(yīng)規(guī)定更改的驗(yàn)證和確認(rèn)活動(dòng)以確保符合顧客要求 。 Contingency Plans 應(yīng)急計(jì)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(yīng) 闡述產(chǎn)品安全和最小化對(duì)員工的潛在風(fēng)險(xiǎn)的方法 ，特別是在設(shè)計(jì)和開發(fā) 過程和在制造過程活動(dòng)中。 Training On The Job 崗位培訓(xùn) 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(yīng) 建立一個(gè) 激勵(lì)員工 達(dá)到質(zhì)量目標(biāo)的過程 ， 以進(jìn)行持續(xù)改進(jìn)并創(chuàng)建一個(gè)促 進(jìn)革新的環(huán)境 。 Review Input – Supplemental 評(píng)審輸入 補(bǔ)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(yīng) 確保負(fù)有產(chǎn)品設(shè)計(jì)職責(zé)的人員有能力達(dá)到設(shè)計(jì)要求并且熟練掌握適用的 工具和技術(shù)。 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(yīng) 規(guī)定質(zhì)量目標(biāo)和 測量方法 ,并應(yīng)被包括在 經(jīng)營計(jì)劃 中 ,并用于展開 質(zhì)量方針 . 注 : 質(zhì)量目標(biāo) 應(yīng) 表述顧客期望并且在 規(guī)定時(shí)間階段 內(nèi)可完成 . Quality Objectives – Supplemental 質(zhì)量目標(biāo) － 補(bǔ)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(yīng) 迅速 把不符合規(guī)定要求的產(chǎn)品或過程 通報(bào) 給負(fù)責(zé)糾正措施的管理者 。 NOTE: See also Purchasing process Customerapproved sources General Requirements – Supplemental 總要求－－補(bǔ)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(yīng)有一個(gè)過程以便確保根據(jù)顧客要求的日程及時(shí)評(píng)審、發(fā)放和實(shí)施所有顧客 工程標(biāo)準(zhǔn) /規(guī)范及更改。 Quality Management System Principles 19 1. Leadership 領(lǐng)導(dǎo)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(lǐng)導(dǎo)者建立其組織的方向和統(tǒng)一的目標(biāo)，他們應(yīng)該創(chuàng)造并維護(hù)內(nèi)部環(huán)境以使 6. 組織中的人們能充分參與到實(shí)現(xiàn)組織的目標(biāo)的活動(dòng)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(shí)評(píng)審應(yīng)盡快并且不超過 兩個(gè)工作周 。 負(fù)責(zé)產(chǎn)品質(zhì)量的人員 應(yīng) 有權(quán)停止生產(chǎn)以糾正質(zhì)量問題 。 適用的工具和技術(shù) 應(yīng) 被組織識(shí)別。 過程應(yīng)包括在整個(gè)組織內(nèi)促進(jìn)質(zhì)量和技術(shù)意識(shí) 。 Personnel Safety To Achieve Product Quality 與實(shí)現(xiàn)產(chǎn)品質(zhì)量相關(guān)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(yīng) 保持生產(chǎn)現(xiàn)場處于與產(chǎn)品和制造過程的需求相協(xié)調(diào)的有序、清潔和維護(hù) 的狀態(tài)。 更改應(yīng)在實(shí)施之前 進(jìn)行確認(rèn) 。 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(yīng) 證明符合顧客關(guān)于 特殊特性 的指定 、 文件化和控制的要求 。 開發(fā)和評(píng)審控制計(jì)劃 。 制造過程設(shè)計(jì)輸出應(yīng)包括： 規(guī)范和圖紙； 制造