【正文】 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(jìn)行供方質(zhì)量管理體系的開發(fā) 。 符合 ISO9001： 2023是達(dá)到此目標(biāo)的第一步 。 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 。 除非顧客規(guī)定 ， 組織的 供方 應(yīng)被認(rèn)可的第三方認(rèn)證機(jī)構(gòu)進(jìn)行 第三方 ISO9001： 2023 注冊 。 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(shí) ， 組織 應(yīng) 從 批準(zhǔn)的貨源 處采購產(chǎn)品 、 材料或服務(wù) 。 采用 顧客指定的貨源 不能免除組織確保采購產(chǎn)品的質(zhì)量的責(zé)任 。 75 Ining Product Quality 進(jìn)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。 . receiving inspection and/or testing such as sampling based on performance。 . second or thirdparty assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality。 . part evaluation by a designated laboratory。 . another method agreed with the customer. 組織 應(yīng) 有一個(gè)過程 ， 使用以下一個(gè)或多個(gè)方法的過程保證采購產(chǎn)品的質(zhì)量 （ 見 ） ： 組織接受并評(píng)估統(tǒng)計(jì)數(shù)據(jù) 進(jìn)貨檢驗(yàn)和 /或試驗(yàn) ， 例如按照業(yè)績進(jìn)行抽樣 結(jié)合可接受的交付產(chǎn)品質(zhì)量的記錄 ， 對(duì)供方現(xiàn)場的第二方或第三方評(píng)價(jià)或?qū)徍? 指定的實(shí)驗(yàn)室的零件評(píng)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。 . customer disruptions including field returns。 . delivery schedule performance (including incidents of premium freight)。 . special status customer notifications related to quality or delivery issues. The anization shall promote supplier monitoring of the performance of their manufacturing processes. 應(yīng) 通過以下指標(biāo) 監(jiān)視供方業(yè)績 ： 交付產(chǎn)品質(zhì)量 包括現(xiàn)場退貨的對(duì)顧客的困擾 交付日程業(yè)績 （ 包括超額運(yùn)費(fèi)指標(biāo) ） 與質(zhì)量或交付問題有關(guān)的特殊狀況的顧客通知 組織應(yīng)促進(jìn)供方對(duì)他們制造過程業(yè)績監(jiān)視 。 77 Control Plan 控制計(jì)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(duì)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(jì)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(jì)劃 ， 并且考慮設(shè)計(jì) FMEA和制造過程 FMEA的輸出 。 ? 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 )。 ? 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(shí) ， 控制計(jì)劃應(yīng)進(jìn)行評(píng)審和更新 。 78 Work Instructions 作業(yè)指導(dǎo)書 The anization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. These instructions shall be accessible for use at the work instructions shall be derived from sources such as the quality plan, the control plan and the product realization process. 組織 應(yīng) 為所有負(fù)責(zé)影響產(chǎn)品質(zhì)量的過程操作的所有員工準(zhǔn)備 文件化的作業(yè)指導(dǎo) 書 ， 這些指導(dǎo)書在工作崗位應(yīng)易于得到使用 。 這些指導(dǎo)書應(yīng)來源于質(zhì)量計(jì)劃 、 控 制計(jì)劃和產(chǎn)品實(shí)現(xiàn)過程 。 79 Verification Of Job Setups 作業(yè)準(zhǔn)備驗(yàn)證 Job setups shall be verified whenever performed, such as an initial run of a job, material changeover or job change. Work instructions shall be available for setup personnel. The anization shall use statistical methods of verification where applicable. NOTE: Lastoffpart parisons are remended. 無論何時(shí)進(jìn)行作業(yè)準(zhǔn)備 (如作業(yè)的初步運(yùn)行 、 材料的交轉(zhuǎn) 、 作業(yè)更改 )， 均 應(yīng) 進(jìn)行作 業(yè)準(zhǔn)備驗(yàn)證 。 作業(yè)準(zhǔn)備人員 應(yīng) 易 于得到作業(yè)指導(dǎo)書 。 適用時(shí) ， 組織應(yīng)使用 統(tǒng)計(jì)方 法 進(jìn)行驗(yàn)證 。 注：推薦采用末件比較的方法 。 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。 . packaging and preservation of equipment, tooling and gauging。 . availability of replacement parts for key manufacturing equipment。 . 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(jī)器 /設(shè)備的維護(hù)提供資源 ， 并開發(fā)有效的 、 有計(jì)劃的全 面預(yù)防性維護(hù)體系 。 這個(gè)體系至少應(yīng)包括： 計(jì)劃性維護(hù)活動(dòng) 設(shè)備 、 工裝和量具的包裝和防護(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 。 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 in