【正文】 eaction plan 具有反應計劃的過程控制計劃c) DFMEA / PFMEA 設計/過程失效模式及后果分析d) Master part(s) 標樣2. GP12( Prelaunch ) control planGP12初期生產次品遏制的控制計劃3. Tool capacity information 工 裝 能 力 情況4. Operator/inspection instruction操作 /檢驗指導書5. Prototype / pilot concerns (PR/R’s)樣件/試生產時發(fā)生的問題(如PR/R)6. Sub contractor control / capacity data分供方控制/能力數(shù)據(jù)7. Subcontractor material schedules and transportation 分供應商材料（含零件）生產計劃及運輸8. Packaging / labeling plan包裝/ 標記計劃9. Acceleration plan生產加速計劃Note : All documentation must be plete and correct 注: 所有文件都應完備及正確。B. MANUFACTURING PROCESS – ACTUAL TO PLAN制造過程– 實際相對于計劃1. The product is being manufactured at the production site using the production tooling, gaging, process, materials, operators, environment, and process settings.產品應在生產現(xiàn)場用正式生產的工裝、測量系統(tǒng)、工藝、材料、操作人員、環(huán)境和過程設定來進行生產。2. The actual process flow agrees with the process flow diagram, as documented in PPAP.實際生產流程應與PPAP 文件中的流程圖相同。3. Operator instructions/visual aids are available and adhered to at each work station.應將操作指導書/目視參考圖表置于相應的每個工作崗位。4. All inprocess documents, such as process control charts, are in place at the time of the Run @ Rate. The documentation is utilized to drive a defined reaction plan and corrective action process.在進行Run@Rate時，所有過程文件都應在工位上，如過程控制計劃。這些文件應用于實施規(guī)定的反應計劃和糾正措施。5. Production boundary samples, when required, are available at required work stations. 當需要時，在需要的工位上應擁有邊際樣品。6. Maintenance plans are in place。 repair and maintenance parts are available。 and there is planned downtime for preventative maintenance.應具備保養(yǎng)計劃和用于維修和保養(yǎng)的備件以及進行預防性維修保養(yǎng)的停機計劃。Note: All of the preceding requirements must be met to pass the Run @ Rate. 注：上述所有要求都須合格才能通過 Run @ Rate。C. MANUFACTURING CAPACITY RESULTS制造能力結果The following will be verified while the process is running. 在進 行 生產時, 要核實以下內容：1. Net output from each operation can support quoted capacity.每 道 工 序的凈產量與報價生產 能 力相符。2. During the Run @ Rate, the tooling must meet the quoted up time requirements (net vs. gross quoted output). Any unexpected downtime must be documented and corrective action taken.在按預定能 力生產時 ,工 裝 應滿 足報 價所 要求 的開機 時間要求(報價凈產量和標稱毛產量)。 記下任何意外的停工時間和要求的改進措施計劃。3. All line changeovers, if any, can be performed within the quoted tooling capacity requirements.所有在線工裝的更換應在報價工裝能力要求范圍內進行。4. The net throughput of good pieces (scrap taken out, any allowable rework) meet daily quoted capacity.合格零件的凈產量(剔除廢品, 保留返工合格零件)應與報價日生產能力相符。5. The acceleration plan is sufficient to meet requirements. 加速生產計劃足以滿足客戶要求。Note: All of the preceding five requirements must be met to pass the Run @ Rate.注：上述所有五項要求都須合格才能通過 Run @ Rate。D. PART QUALITY PLAN TO ACTUAL零件質量計劃同實際相對比1. All production checking fixtures must be plete, with acceptable measurement system studies (., gage R and R) performed, and operator instructions/visual aids available.所有生產檢驗設備應完備并且作了可接受的測量系統(tǒng)分析工作(即量具的重復性和再現(xiàn)性)。應具備操作指 導書/目視參考圖表 。 2. All in process gaging and controls must be plete, functional and in place.所有生產過程中的測量和控制設備應完備, 功能齊全并且到位。 3. The process control plan (normal and GP12) must agree with the actual process. Production part checks and statistical monitoring must take place as outlined on the process control plan過程控制計劃 (一般的和GP12)應與現(xiàn)行過程相符，應按過程控制計劃作零件檢驗和統(tǒng)計監(jiān)測。4. Potential failure modes, as identified in the PFMEA, are addressed through errorproofing or the control plan.在PFMEA中所確定的潛在失效模式應有防錯措施或控制計劃來處置5. The process control plan reaction plan as well as the supplier39。s corrective action process to ensure containment and correction should be available for review.過 程 控 制 計 劃 的 反 應 計 劃 與 供 應 商 的 改 正 措 施 一 樣 ， 確 保 在 檢 查 時 有 遏 制 措 施 及 施 改 正 措 施 。 Note: All of the preceding five requirements must be met to pass the Run @ Rate.注：上述所有要求都須合格才能通過 Run @ Rate。E. PART QUALITY RESULTS零件質量結果1. All parts produced off production tooling during the Run @ Rate meet GM39。s requirements for ongoing quality, as stated in PPAP. 在Run@Rate時,用生產工裝生產出來的所有零件應符合PPAP中記載的GM對準予持續(xù)制造的質量要求。2. The manufacturing process is in control.制造過程必須受控。3. The manufacturing process demonstrates the required capability.制造過程應證明所要求的生產能力。4. The process control plan is sufficient to effectively meet the design record requirements (., control points, frequency of checks, etc.).過程控制計劃應能有效地滿足設計要求,（即控制點, 檢驗頻率等）。5. Nonconformance 不符合性Note: The total number of parts produced, the pieces rejected and the pieces reworked need to be documented on the summary sheet.注：生產出來的零件總數(shù)，不合格零件數(shù)，返工合格零件數(shù)都應在GP9總結表上紀錄a) The nonconformances yielded by the process were identified by the normal PPAP control plan. If identified by the GP12 Process Control Plan or an activity outside documented plans, corrective action is required. 生產過程中的不符合項可由一般的PPAP控制計劃識別出來。如果是由GP12過程控制計劃或是由其他措施認別出來,則要求修改PPAP 控制計劃。b) The PFMEA identified the potential failure modes. If not, the PFMEA needs to be updated and corrective action put in place. 生產過程中的不符合項在PFMEA中應有預見，若未能做到，則PFMEA需要更新并且要采取改進措施。c) All rework and repairs effectively correct the nonconformance(s).返工及修復措施能有效地糾正不合格項。d) All prototype and pilot concerns, if any, have been corrected and validated.所有在工裝樣件及試生產件制造時發(fā)生的問題應已修正和驗證。Note: All of the preceding five requirements must be met to pass the Run @ Rate.注 ：上述所有要求都須合格才能通過 Run @ Rate。F. SUBCONTRACTOR REQUIREMENTS 分供方要求1. Subcontractor(s)39。 abilities to meet the customer39。s quality and capacity requirements must be confirmed by the supplier prior to the Run @ Rate being conducted at the supplier39。s facility. Verification of the subcontractor(s)39。 manufacturing processes should be acplished through a Run @ Rate or similar process conducted by the supplier. 在進行Run@Rate以前，供應商應該對分供方是否能滿足用戶的質量和數(shù)量要求進行確認。上述核實應由供應商采用Run @ Rate規(guī)程或相似的過程加以實施。2. Controls must be in place to isolate ining material until it has been approved. 應采取措施來隔離外來材料流入生產線，直到它被認可。Note: The preceding requirements must be met to pass the Run @ Rate.