【正文】 ? 7 product realization 7 產(chǎn)品實現(xiàn) Planning of product realizationsupplemental Customer requirements and references to its technical specifications shall be included in the planning of product realization as a ponent of the quality plan. 產(chǎn)品實現(xiàn)的策劃 補充 客戶要求和參考的技術(shù)規(guī)范 應 被包括在產(chǎn)品實現(xiàn)的策劃中作為質(zhì)量計劃的一部分。 Plant, facility and equipment planning NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system. ? 6 Resource managem 6 資源管理 Contingency plans The anization shall prepare contingency plans to satisfy the customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure, and field returns. 應急計劃 組織 應 準備應急計劃以在緊急情況下，諸如供應中斷，勞動力短缺，關(guān)鍵設(shè)備故障和市場退回時，滿足客戶要求。對質(zhì)量有影響的員工，應 被通知關(guān)于不符合質(zhì)量要求對客戶的后果。 ? 5 Management responsibility 5 管理層職責 Review input The input to management review shall include information on: a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) followup actions from previous management reviews, f) planned changes that could affect the quality management system, and g) remendations for improvement. 評審輸入 管理評審的輸入 應 包括以下方面的信息 : a) 審核結(jié)果 b) 顧客反饋 c) 過程的業(yè)績和產(chǎn)品的符合性 d) 預防和糾正措施的狀況 e) 以往管理評審的跟蹤措施 f) 可能影響質(zhì)量管理體系的變更 g) 改進的建議 ? 5 Management responsibility 5 管理層職責 Review input Supplemental Input to management review shall include an analysis of actual and potential fieldfailures and their impact on quality, safety, or the environment. 評審輸入 補充 管理評審的輸入 應 包括對實際和潛在使用失效的分析以及它們對質(zhì)量，安全或環(huán)境的影響。 賦有產(chǎn)品質(zhì)量職責的人員 應 有權(quán)限停止生產(chǎn)以糾正質(zhì)量問題。 ? 4 Quality management system 4 質(zhì)量管理體系 NOTE: A change in these standards / specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc. 注：當這些規(guī)范指向設(shè)計記錄或他們影響到生產(chǎn)零件審批過程，諸如控制計劃，F(xiàn)MEA等時，這些標準 /規(guī)范中的每一個更改都要求客戶生產(chǎn)零件審批的更新記錄。 ISO/TS 16949:2023 標準講解 Quality system documentation progression Key Words 關(guān)鍵詞語 ? Shall – mandatory requirements 應 – 強制性要求 ? Should – remendation 應該 – 建議 ? Note – guidance for understanding 注 – 指南以便明白 ? Such as – for guidance 例如 – 指導性 ? Documented procedure – must have documented system procedure 文件化程序 – 必須有文件化的體系程序 Process An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Process Approach The application of a system of processes within an anization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”. 過程 通過使用資源和管理 ,將輸入轉(zhuǎn)化為輸出的活動可視為過程。 ? 4 Quality management system 4 質(zhì)量管理體系 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 記錄控制 應 建立并保持記錄 ,以提供符合要求和質(zhì)量管理體系有效運行的證據(jù) .記錄應保持清晰 ,易于識別和檢索 .應 編制形成文件的程序 ,以規(guī)定記錄的標識 ,貯存 ,保護 ,檢索 ,保存期限和處置所需的控制 . ? 4 Quality management system 4 質(zhì)量管理體系 NOTE 1: “ Disposition” above includes disposal. NOTE 2: “ Records” also include customerspecified records. Records retention The control of records shall satisfy regulatory and customer requirement. 注 1：上述的“處置”包括處理。 所有班次的生產(chǎn)運作 應 有人員看管，或委派相關(guān)職責人員以確保產(chǎn)品質(zhì)量。 ? 5 Management responsibility 5 管理層職責 Review output The output from the management review shall include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. 評審輸出 管理評審的輸出 應 包括與以下方面有關(guān)的任何決定和措施 : a) 質(zhì)量管理體系及其過程有效性的改進 b) 與顧客要求有關(guān)的產(chǎn)品的改進 c) 資源需求 . 6 Resource management 資源管理 ? 6 Resource management 6 資源管理 Provision of resources The anization shall determine and provide the resources needed: a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 資源提供 組織 應 確定并提供以下方面所需的資源 : a) 實施 ,保持質(zhì)量管理體系并持續(xù)改進其有效性 , b) 通過滿足顧客要求 ,增強顧客滿意 . ? 6 Resource management 6 資源管理 Human resources General Personnel performing work affecting product quality shall be petent on the basis of appropriate education, training, skills and experience. 人力資源 總則 基于適當?shù)慕逃?,培訓 ,技能和經(jīng)驗 ,從事影響產(chǎn)品質(zhì)量工作的人員 應 是能夠勝任的 . ? 6 Resource management 6 資源管理 Competence, awareness and training The anization shall: a) determine the necessary petence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality