i8.5.5.1 應確定並採取必要的措施，確保在計畫或非計畫生產停工期

i8.5.5.1 Necessary measures shall be determined and taken to ensure that after the planned or unplanned production downtime, the product conformity requirements are verified through first article confirmation, parameter inspection, etc. <br>8.5.5.2 Planned downtime Refers to the regular maintenance of equipment, and non-planned shutdowns refer to emergencies such as machine failures, power outages, fires, etc. <br>8.5.6 Comprehensive production and maintenance <br>8.5.6.1 The organization shall develop, implement and maintain a documented comprehensive production and maintenance system. The system shall be at least Including: <br>a identification of process equipment necessary to produce qualified products in accordance with requirements; <br>b availability of equipment replacement parts; <br>c provision of resources for machine, equipment and facility maintenance; <br>d packaging and protection of equipment, tooling and measuring tools; <br>e applicable customers Specific requirements; <br>f Documented maintenance objectives, such as: OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failures) and MTTR (Mean Time to Repair), and preventive maintenance compliance indicators. <br>g The performance of maintenance objectives should be used as input to management review <br>h Periodic review of maintenance plans and objectives and documented action plans to take corrective actions when objectives are not met; <br>i use of preventive maintenance methods; <br>j predictions Use of maintenance methods, if applicable; <br>k Periodic maintenance <br>8.5.6.2 Refer to [Equipment Maintenance Management Procedures] for implementation details. <br>8.5.7 Management of production tools and molds <br>8.5.7.1 The company must provide resources for the development, manufacturing and verification of tools, molds and measuring tools

i8.5.5.1 應確定並採取必要的措施，確保在計畫或非計畫生產停工期之後，通過首件確認，參數點檢等方式對產品符合性要求進行驗證<br>8.5.5.2 計畫停工期指設備定期保養，非計畫停工指機器故障、斷電、火災等突發事件<br>8.5.6 全面生產維護<br>8.5.6.1 針組織應制定、實施並保持一個形成文件的全面生產維護系統該系統應至少包含： <br>a 對按照要求生產合格產品所必需的過程設備的識別； <br>b 設備替換件的可用性； <br>c 機器、設備和設施維護的資源提供； <br>d 設備、工裝和量具的包裝和防護； <br>e 適用的顧客特定要求；<br>f 形成文件的維護目標，例如：OEE（全面設備效率）、MTBF（平均故障間隔時間）和MTTR（平均維修時間），以及預防性維護符合性指標。<br>g 維護目標的績效應作為 管理評審的輸入 <br>h 維護計畫和目標以及形成文件的措施計畫的定期評審，以在未達到目標時採取糾正措施； <br>i 對預防性維護方法的使用； <br>j 對預測性維護方法的使用，如適用； <br>k 週期性檢修<br>8.5.6.2 執行細則參照【設備保養維護管理程序】。<br>8.5.7 生產用工模具管理<br>8.5.7.1 公司必須提供資源，以進行工模具和量具開發、製造和驗證活動

I8.5.5.1 necessary measures shall be determined and taken to ensure that the conformity requirements of products are verified by means of first article confirmation and parameter spot inspection after planned or unplanned production downtime<br>8.5.5.2 the planned shutdown period refers to the regular maintenance of the equipment, while the non planned shutdown refers to the unexpected events such as machine failure, power failure and fire<br>8.5.6 total production maintenance<br>8.5.6.1 the organization shall develop, implement and maintain a documented comprehensive production maintenance system, which shall at least include:<br>A. identify the process equipment necessary to produce qualified products according to the requirements;<br>B availability of equipment replacement parts;<br>C provision of resources for the maintenance of machinery, equipment and facilities;<br>D. packaging and protection of equipment, tooling and measuring tools;<br>E. applicable customer specific requirements;<br>F documented maintenance objectives, such as OEE, MTBF and MTTR, and preventive maintenance compliance indicators.<br>G the performance of maintenance objectives should be used as the input of management review<br>H periodic review of maintenance plans and objectives as well as documented action plans to take corrective actions when objectives are not met;<br>I use of preventive maintenance methods;<br>J use of predictive maintenance methods, if applicable;<br>K periodic maintenance<br>8.5.6.2 refer to the equipment maintenance management procedure for detailed implementation rules.<br>8.5.7 mold management for production<br>8.5.7.1 the company must provide resources for the development, manufacturing and verification of tooling and measuring tools<br>