异常处理流程_A

1、和碩聯合科技(股 公司 PEGATRON CORP. /永碩聯合國際(股 公司 UNIHAN CORP.華中營運中心第六事業處矯正及預防措施作業規範PSZ BU6 Corrective and Preventive ActionOperating StandardDoc. No.: PQ3-00060 Date: APR.13,2010 Revision: A Page: 9 Grade: General請打勾(V 文件發行地區(Released AreaV V企總(HQ 製造中心(TY 華中營運中心(PSZ 華東營運中心(PSH 華西營運中心(PCQ 捷克(PCZ 墨西哥(PMX 客服中心(

2、CSC 凱碩(Casetek其他Other ,請逐一列舉 one by one to list：_核准 Approved bySteven5 Lin(林憲基_PSZ審核 Reviewed byHellen Wu(吳曉艷_PSZ擬案Issued byAlly Xin(信文靜_PSZForm No. : PD2-00001-001 Rev.07Operating Standard變更事項Date: APR.13,2010 Rev.: A Page: 1/ 9版本 變更章節 A 新版發行擬案單位 擬案人修訂日期 PSZ BB QA信文靜Issued Revised Dept. by DateAlly

3、 Xin ModifiedA First releaseModified Description1. 目的Objective ：建立華中營運中心第六事業處品質異常處置流程，使產品相關之品質異常得以即時處置，並透過矯正及預防對策之實施與追蹤，徹底消除潛在原因、落實問題之解決與預防再發生。 Establish an abnormal handling process for PSZ BU6 to timely handle the abnormalities of quality. Though the correction and prevention countermeasures to th

4、oroughly eliminate the route cause and solve the problem.2. 範圍Scope ：華中營運中心第六事業處相關產品生產過程中出現任何有關品質異常均屬之。 Applicable to PSZ BU6 products process quality abnormalities.3. 相關資料Relevant Documents：3.1量測儀器與設備校驗管理辦法Device and Equipment Calibration ManagementProcedure (PE2-000023.2採購管理辦法Procurement Managemen

5、t Procedure (PP2-000013.3不合格品管理辦法Nonconforming Product Control Management Procedure(PQ2-000013.4矯正及預防措施管理辦法Corrective and Preventive Action Management Procedure(PQ2-000023.5統計技術管理辦法Statistical Methods Management Procedure (PQ2-000033.6出貨品管管理辦法Outgoing Quality Control Management Procedure (PQ2-00008

6、3.7進料品管管理辦法Incoming Quality Control Management Procedure (PQ2-00009 3.8製程品管管理辦法Manufacturing Quality Controlling Management Procedure(PQ2-000113.9 Purge/Rework 管制規範Purge/Rework Control Standard (PQ3-000164. 定義Definition ：4.1發生單位：發生或發現不符合製程各項作業規定、不合格材料及高不良率等品質異常之單位。Occurring Department: Quality Manag

7、ement System: Abnormal quality has been found or detected in department with nonconforming production process, material and high quality failure rate.4.2對策單位：指負責異常分析或矯正預防措施之研擬單位。Countermeasure Department: Responsible Department of abnormal analysis or corrective and preventive action.4.3立即措施：對該不良現況或

8、不良品予以立即矯正或維修之動作。Immediate Action: Immediate corrective or preventive action for abnormal or defected goods.4.4矯正措施：對該不良現況或不良品所造成之現況原因進行分析與消除之對策，以防止再度發生。Corrective Action: Analysis the abnormal situation or defected goods to prevent them from happening again.4.5預防措施：對整體異常狀況做綜合判斷，採取措施以消除潛在之不符合缺點或其他不希望

9、情況的原因，並給予有效處理及標準化，以防止異常發生之對策。Preventive Action: Determine the whole abnormal situation and take action to eliminate potential nonconforming or other unacceptable condition, effectively dealing with the problem and standardize the actions taken to prevent them from happening again.4.6異常定義Definition o

10、f Abnormal：(a在製品超過產品定義異常判定標準。WIP beyond product acceptable standard (b嚴重缺失發生時Major Defect occurs。(c該項不良現象經QA 判定為非機遇性原因時。(機遇/非機遇判定，請參考附件6.1The abnormal is a non-occasional cause which has been judged by QA. (Occasional, Please refer to 6.1(d若維修結果零件不良數大於該零件廠商所保證時。(廠商所保證之不良數, 請參考發文 。The failure rate of

11、 repaired component is over venders guarantee pcs (The guarantee Rate of Vender, please refer to issued out documents (e使用之量測儀器設備校正不合格/損壞時。When used measuring devices & equipments calibrated unqualified / damaged.Product abnormality belongs to reliability issue.Product abnormality belongs to spr

12、eading quality issue.Product abnormality jeopardizes the people life and property safety.Any customer complain about car related product is belong to Critical abnormality.4.7預防措施發生條件Condition of Preventive Action：問題，以及客戶使用後所發生的品質問題，必要時變更製造、包裝、運轉或儲存過程、或修訂產品規格、品質管理系統。packing, transportation, storage,

13、product spec and quality management system can be modified if the problem is related to the reliability, comparability and quality problem after customer usage.The fixture, equipment and program can prevent from misusage after modification.問題。Use the preventive action in other products with similar

14、problems to prevent the same issue from happening again.The responsible departments shall take precautionary measures when there is measuring equipment found unqualified/damaged during manufacturing process.5. 作業程序與權責Operating Procedures and Responsibilities: 5.1異常處理作業流程The Procedure of Abnormality

15、Handling: 5.2管理責任Management ResponsibilitiesOccurring Department：Responsible for the action and control of Defect nonconformity causes.(PQ3-00060-001中各項資料。Issuing Dept. shall fill in the information of “BB Quality Abnormal Notice” (PQ3-00060-001 form according to the abnormal definition that confirm

16、ed by QA department.Save the nonconformity products for QA and countermeasure department to check and analyze its reason then find resolution for abnormal situation happening in Quality Management System.Follow the decision of countermeasure, apply to the action and make sure the validly of the solu

17、tion.The Verification Dept. for Abnormalities is QA and EngineerIf the issuing dept. is quality dept, it is necessary to have the MFG or Engineer to verify with.up list (PQ3-00060-002中，以便於追蹤。When the QAN is confirmed, QA will assign number to the QAN, and key-in the BB QAN follow up list (PQ3-00060-

18、002, to be followed up easily.QA and Engineering Dept. will confirm whether to Purge/Rework for the not good product or not.對策單位負責異常品質分析、檢討及矯正、預防措施之擬定、施行與管制。Should inform the QA and other related departments and members to decide if the immediate actions are needed to be taken or not.處理人員確認簽名。For th

19、e countermeasure dept. or suppliers, the approval signature should be containing both countermeasure dept. and related inner dealing member.矯正及預防措施執行狀況由品管及相關單位負責跟催及效果確認，結果提報至每週品質檢討會議，由責任單位及品管單位彙整之確認結果，詳記於矯正預防措施報告中，執行追蹤管制。QA and other related departments are responsible for the follow up of the resul

20、t confirmation and provide the result in the weekly quality meeting. Record and conclude the result into corrective action report and List into follow up control by the QA dept.5.3標準化Standardize ：矯正措施實施後，經品管確認須實施標準化作業部份，應重新修訂或製訂標準化作業。 Once the Corrective Action has been applied, QA should carry out

21、the standard operation issue to revise or initiate it. 5.4通知客戶Informing Customer:通知客戶時機:有以下之異常發生時必需由PM 或FPM 立即通知客戶The abnormal product has been delivered to the customer.6. 附件Appendixes ：6.1機遇/非機遇判定標準Chance Causes/ Occasional Causes Determine Standard 原因分類細項分類偶發性原因 無法避免之原因 非作業人員原因輔助判定 影響範圍生產中，雖具操作標準

22、，但在操作條 影響層面小不值得件客觀範圍內必有變化。 調查原材料品質在其規格範圍內容許之 可採加嚴抽樣檢驗變化 判定 機遇原因氣候與環境之變化 A QL 允收區間內允(Chance Causes經研判非整批性或具傳染性因素 收者，不值得調查 製程中共通性、公認之問題零材料本身製程管制範圍內異常可避免之原因 作業疏忽之因素造成 影響層面大，須徹作業人為原因 未依作業標準書作業，而產生變異 底調查 特殊性原因 雖依標準書作業，但標準書不完善，非機遇原因異常性原因 以致發生品質變異(Occasional局部性原因 機器設備之變動所造成之變異Causes整批性原因 操作人員之變動所造成之變異 傳染性原

23、因 材料差異所造成之變異潛在性功能重大差異 測試設備、量具不準確所造成之變異Operating StandardCause ClassifyDate: APR.13,2010 Rev.: A Page: 9/ 9Detail Classify Determine Coverage Accidental Causes The Different between Operation Spec and Un-Avoidable Causes operation condition objective scope Spec. be investigated No Workmanship Can use sticker Causes The variation of weather and environment sampling test toChance Causes Not whole lot Cause or