【正文】 改進(jìn) () ISO/TS16949:2023 Document Procedure 28 4Quality Management System 29 Ensuring control over outsourced processes shall not absolve the anization of the responsibility of conformity to all customer requirements. 確保對 外包過程 的控制不能免除組織符合所有顧客要求的責(zé)任。 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(shí)施所有顧客 工程標(biāo)準(zhǔn) /規(guī)范及更改。及時評審應(yīng)盡快并且不超過 兩個工作周 。 組織應(yīng)保存每項(xiàng)更改在生產(chǎn)中實(shí)施日期的 記錄 。實(shí)施應(yīng)包括文件的更新。 注： 當(dāng)設(shè)計(jì)記錄引用這些規(guī)范或這些規(guī)范影響生產(chǎn)件批準(zhǔn)過程的文件 （例如 Control Plan, FMEA等）時，這些標(biāo)準(zhǔn)、規(guī)范的更改要求對客戶的 生產(chǎn)件批準(zhǔn)記錄進(jìn)行更新。 Engineering Specifications 工程規(guī)范 31 注 1：上述處置包括 處理 ； 注 2：記錄也包括 顧客規(guī)定 的記錄 。 Control Of Records 記錄控制 32 The control of records shall satisfy regulatory and customer requirement. 記錄的控制 應(yīng) 滿足 法律和顧客要求 。 Records Retention 記錄保存 33 5Management responsibility 34 Top management shall review the product realization processes and the support processes to assure the effectiveness and efficiency. 最高管理者 應(yīng) 評審產(chǎn)品實(shí)現(xiàn)過程和其支持過程以確保它們的 有效性和效率 。 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 。 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 。 跨 所有班次 的生產(chǎn)操作 應(yīng) 配備人員負(fù)責(zé)或指派職責(zé) ， 以確保產(chǎn)品質(zhì)量 。 Responsibility For Quality 質(zhì)量職責(zé) 37 Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development. 最高管理者 應(yīng) 指派人員有職責(zé)和權(quán)限確保顧客要求被闡述 。 這包括：選擇特殊特性 、 確定質(zhì)量目標(biāo)和相關(guān)培訓(xùn) 、 糾正和預(yù)防措施 ， 產(chǎn)品設(shè)計(jì)和開發(fā) 。 SLR Customer representative is PM Customer Representative 客戶代表 38 These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality. These results shall be recorded to provide, as a minimum, evidence of the achievement of : the business plan quality objectives customer satisfaction with product supplied. 作為持續(xù)改進(jìn)過程的一個重要部分 ,這些評審 應(yīng) 包括質(zhì)量管理體系的所有要求及 其業(yè)績的趨勢。 管理評審的部分內(nèi)容 應(yīng) 是 質(zhì)量目標(biāo)的監(jiān)視和不良質(zhì)量成本 （見 ） 的定期報(bào)告和評估。 這些管理評審的結(jié)果 應(yīng) 被記錄以便提供達(dá)到以下結(jié)果最基本的證據(jù) : 在經(jīng)營計(jì)劃中規(guī)定的質(zhì)量目標(biāo) , 顧客對提供產(chǎn)品的滿意程度 . Quality Management System Performance 質(zhì)量管理體系業(yè)績 39 Input to management review shall include an analysis of actual and potential fieldfailures impact on quality, safety, or the environment. 管理評審輸入應(yīng)包括實(shí)際和潛在 外部 失效 ,以及它們對質(zhì)量 、 安全或環(huán)境的影 響的分析 。 Review Input – Supplemental 評審輸入 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)。 適用的工具和技術(shù) 應(yīng) 被組織識別。 Product Design Skills 產(chǎn)品設(shè)計(jì)技能 42 The anization shall establish and maintain documented procedures for identifying training needs and achieving petence of all personnel performing specific assigned tasks shall be qualified, as required with particular attention to the satisfaction of customer requirements. 組織 應(yīng) 建立并保持 形成文件的程序 ,識別培訓(xùn)需求和達(dá)到所有從事影響產(chǎn)品質(zhì) 量工作的人員能力。從事特殊指派任務(wù)的人員應(yīng)被資格考核，如要求對顧客 要求的滿意程度予以特別關(guān)注。 注 1：此要求適用于組織所有影響質(zhì)量的 所有層次上的員工 。 注 2：顧客規(guī)定要求的一個例子是數(shù)字化的 數(shù)學(xué)數(shù)據(jù) 的應(yīng)用。 Training 培訓(xùn) 43 The anization shall provide onthejob training for personnel in any new or modified job affecting product quality including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements. 組織 應(yīng) 為包括合同工或代理在內(nèi)的從事新的或更改的影響產(chǎn)品質(zhì)量的工作的人 員提供 崗位培訓(xùn) 。對于 不符合質(zhì)量要求對顧客造成的后果 應(yīng) 通知 其工作影響質(zhì) 量的人員。 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