【正文】
81 Management Of Production Tooling 生產(chǎn)工裝的管理 The anization shall provide resources for tool and gauge design, fabrication and verification activities. The anization shall establish and implement a system for production tooling management incl。 . documenting, evaluating and improving maintenance objectives. The anization shall utilize predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipment. 組織 應(yīng) 確定 關(guān)鍵設(shè)備 , 為機器 /設(shè)備的維護提供資源 , 并開發(fā)有效的 、 有計劃的全 面預(yù)防性維護體系 。 . packaging and preservation of equipment, tooling and gauging。 注:推薦采用末件比較的方法 。 作業(yè)準(zhǔn)備人員 應(yīng) 易 于得到作業(yè)指導(dǎo)書 。 這些指導(dǎo)書應(yīng)來源于質(zhì)量計劃 、 控 制計劃和產(chǎn)品實現(xiàn)過程 。 ? 當(dāng)出現(xiàn)任何影響產(chǎn)品 、 制造過程 、 測量 、 物流 、 供應(yīng)貨源或 FMEA( 見 ) 的更改時 , 控制計劃應(yīng)進行評審和更新 。 77 Control Plan 控制計劃 The anization shall . develop control plans (see annex A) at the system, subsystem, ponent and/or material level for the product supplied, including those for processes producing bulk materials as well as parts, and. have a control plan for prelaunch and production that takes into account the design FMEA and manufacturing process FMEA outputs. The control plan shall ? list the controls used for the manufacturing process control, ? include methods for monitoring of control exercised over special characteristics (see ) defined by both the customer and the anization, ? include the customerrequired information, if any, and ? initiate the specified reaction plan (see ) when the process bees unstable or not statistically capable. ? Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA (see ). NOTE: Customer approval may be required after review or update of the control plan. 組織 應(yīng) : ? 針對所提供的產(chǎn)品在系統(tǒng) 、 子系統(tǒng) 、 部件和/或材料的適當(dāng)層次上開發(fā)控制計劃 , 包括散裝材料及零件生產(chǎn)過程; ? 有試生產(chǎn)和生產(chǎn)的控制計劃 , 并且考慮設(shè)計 FMEA和制造過程 FMEA的輸出 。 . delivery schedule performance (including incidents of premium freight)。 . another method agreed with the customer. 組織 應(yīng) 有一個過程 , 使用以下一個或多個方法的過程保證采購產(chǎn)品的質(zhì)量 ( 見 ) : 組織接受并評估統(tǒng)計數(shù)據(jù) 進貨檢驗和 /或試驗 , 例如按照業(yè)績進行抽樣 結(jié)合可接受的交付產(chǎn)品質(zhì)量的記錄 , 對供方現(xiàn)場的第二方或第三方評價或?qū)徍? 指定的實驗室的零件評估 其他顧客同意的方法 76 Supplier Monitoring 供方的監(jiān)控 Supplier performance shall be monitored through the following indicators: . delivered product quality。 . second or thirdparty assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality。 75 Ining Product Quality 進廠產(chǎn)品質(zhì)量 The anization shall have a process to assure the quality of purchased product (see ) utilizing one or more of the following methods: . receipt of, and evaluation of, statistical data by the anization。 74 CustomerApproved Sources 客戶批準(zhǔn)的來源 Where specified by the contract (. customer engineering drawing, specification), the anization shall purchase products, materials or services from approved sources. The use of customerdesignated sources, including tool/gauge suppliers, does not relieve the anization of the responsibility for ensuring the quality of purchased products. 當(dāng)合同規(guī)定 ( 例如顧客工程圖紙 、 規(guī)范 ) 時 , 組織 應(yīng) 從 批準(zhǔn)的貨源 處采購產(chǎn)品 、 材料或服務(wù) 。 注:供方開發(fā)的優(yōu)先順序取決于供方質(zhì)量業(yè)績和他們提供產(chǎn)品的重要程度 。 73 Supplier Quality Management System Development 供方質(zhì)量管理體系開發(fā) The anization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2023 is the first step in achieving this goal. NOTE: The prioritization of suppliers for development depends upon, for example, the supplier’s quality performance and the importance of the product supplied. Unless otherwise specified by the customer, suppliers to the anization shall be third party registered to ISO 9001:2023 by an accredited thirdparty certification body. 組織 應(yīng) 以供方符合此技術(shù)規(guī)范為目標(biāo)進行供方質(zhì)量管理體系的開發(fā) 。 注 2:當(dāng)供方出現(xiàn)合并 、 兼并或聯(lián)營時 , 組織應(yīng)確認(rèn)供方質(zhì)量管理體系的連續(xù)性 及其有效性 。 70 Control Of Design And Development Changes 設(shè)計和開發(fā)更改的控制 NOTE: Design and development changes include all changes during the product programme life (see ). 注:設(shè)計和開發(fā)更改包括在產(chǎn)品計劃周期內(nèi)的 所有更改 ( 見 )。 注:產(chǎn)品批準(zhǔn)應(yīng)在 制造過程驗證后 進行 。 當(dāng)這些服務(wù)被外包時 , 組織應(yīng)對外包的服務(wù)負(fù)責(zé) , 包括提供技術(shù)指導(dǎo) 。 組織應(yīng)在可能時使用與 正式生產(chǎn)中相同的供方 、 工裝和制造過程 。 67 Design and development validation — Supplemental 設(shè)計和開發(fā)確認(rèn)-補充 Design and development validation shall be performed in accordance with customer requirements including programme timing. 設(shè)計和開發(fā)確認(rèn) 應(yīng) 按照包括 計劃時間在內(nèi) 的顧客要求執(zhí)行 。 66 Monitoring 監(jiān)控 Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review. NOTE: These measurements include quality risks, costs, leadtimes, critical paths and others, as appropriate. 在設(shè)計和開發(fā)規(guī)定階段的測量 應(yīng) 進行規(guī)定 、 分析 , 并把總結(jié)結(jié)果作為 管理評審的 輸入 進行報告 。 制造過程設(shè)計輸出應(yīng)包括: 規(guī)范和圖紙; 制造過程流程圖 /場地平面布置圖; 制造過程 FMEAs; 控制計劃 ( 見 ) ; 作業(yè)指導(dǎo)書; 過程批準(zhǔn)的接受準(zhǔn)則; 質(zhì)量 、 可靠性 、 可維護性和可測量性數(shù)據(jù); 適當(dāng)時 , 防錯活動結(jié)果; 產(chǎn)品 /制造過程不符合的快速探測和反饋方法 。 注 : 特殊特性包括 產(chǎn)品特性 和 過程參數(shù) 。 63 Special Characteristics 特殊特性 The anization shall identify special characteristics [see d)] and . include all special characteristics in the control plan, . ply with customerspecified definitions and symbols, . identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer’s special characteristic symbol or the anization’s equivalent symbol or notation to include those process steps that affect special characteristics. NOTE: Special characteristics can include product characteristics and process parameters. 組織 應(yīng) 確定 特殊特性 ( 見 d) 并: 在控制計劃中包含所有特殊特性 。 62 Manufacturing Process Design Input 制造過程設(shè)計輸入 The anization shall identify, document and review the manufacturing process design input requirements, including . product design output