異常處理流程_A_圖文

1、和碩聯(lián)合科技(股 公司 PEGATRON CORP. /永碩聯(lián)合國際(股 公司 UNIHAN CORP.華中營運(yùn)中心第六事業(yè)處矯正及預(yù)防措施作業(yè)規(guī)範(fàn)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(fā)行地區(qū)(Released AreaV V企總(HQ 製造中心(TY 華中營運(yùn)中心(PSZ 華東營運(yùn)中心(PSH 華西營運(yùn)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：_核準(zhǔn) 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(xiàng)Date: APR.13,2010 Rev.: A Page: 1/ 9版本 變更章節(jié) A 新版發(fā)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(yùn)中心第六事業(yè)處品質(zhì)異常處置流程，使產(chǎn)品相關(guān)之品質(zhì)異常得以即時(shí)處置，並透過矯正及預(yù)防對策之實(shí)施與追蹤，徹底消除潛在原因、落實(shí)問題之解決與預(yù)防再發(fā)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(fàn)圍Scope ：華中營運(yùn)中心第六事業(yè)處相關(guān)產(chǎn)品生產(chǎn)過程中出現(xiàn)任何有關(guān)品質(zhì)異常均屬之。 Applicable to PSZ BU6 products process quality abnormalities.3. 相關(guān)資料Relevant Documents：3.1量測儀器與設(shè)備校驗(yàn)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(yù)防措施管理辦法Corrective and Preventive Action Management Procedure(PQ2-000023.5統(tǒng)計(jì)技術(shù)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(jìn)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(guī)範(fàn)Purge/Rework Control Standard (PQ3-000164. 定義Definition ：4.1發(fā)生單位：發(fā)生或發(fā)現(xiàn)不符合製程各項(xiàng)作業(yè)規(guī)定、不合格材料及高不良率等品質(zhì)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(fù)責(zé)異常分析或矯正預(yù)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(xiàn)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(xiàn)況或不良品所造成之現(xiàn)況原因進(jìn)行分析與消除之對策，以防止再度發(fā)生。Corrective Action: Analysis the abnormal situation or defected goods to prevent them from happening again.4.5預(yù)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(diǎn)或其他不希望

9、情況的原因，並給予有效處理及標(biāo)準(zhǔn)化，以防止異常發(fā)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：4.6.1以下狀況發(fā)生時(shí)均屬於異常Following situations belong to abnormalities。 4.6.1.1凡超過檢驗(yàn)批退標(biāo)準(zhǔn)Beyond the IQC returned criteria。 4.6.1.2生產(chǎn)製程中During Production Process(a在製品超過產(chǎn)品定義異常判定標(biāo)準(zhǔn)。WIP beyond product acceptable standard (b嚴(yán)重缺失發(fā)生時(shí)Major Defect occurs。(c該項(xiàng)不良現(xiàn)象經(jīng)QA 判定為非機(jī)遇性原因時(shí)。(機(jī)遇/非機(jī)遇判定，請參考附件6.1The abnormal

11、 is a non-occasional cause which has been judged by QA. (Occasional, Please refer to 6.1(d若維修結(jié)果零件不良數(shù)大於該零件廠商所保證時(shí)。(廠商所保證之不良數(shù), 請參考發(fā)文 。The failure rate of 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(shè)備校正不合格/損壞時(shí)。When used m

12、easuring devices & equipments calibrated unqualified / damaged.4.6.1.3客訴發(fā)生時(shí)Customer Complaint occurs. 4.6.2以下狀況發(fā)生時(shí)均屬於重大品質(zhì)異常Following situations belong to Critical abnormalities。 4.6.2.1產(chǎn)品異常屬於信賴性問題。Product abnormality belongs to reliability issue.4.6.2.2產(chǎn)品之異常屬於蔓延性品質(zhì)問題。Product abnormality belongs

13、to spreading quality issue.4.6.2.3產(chǎn)品之異常危及到人的生命、財(cái)產(chǎn)安全。Product abnormality jeopardizes the people life and property safety.4.6.2.4車用產(chǎn)品之任何客訴問題均屬於重大異常。Any customer complain about car related product is belong to Critical abnormality.4.7預(yù)防措施發(fā)生條件Condition of Preventive Action：4.7.1依據(jù)以往類似產(chǎn)品生產(chǎn)時(shí)(Pilot Run，量產(chǎn)

14、，所發(fā)生在製程上、信賴性、相容性的問題，以及客戶使用後所發(fā)生的品質(zhì)問題，必要時(shí)變更製造、包裝、運(yùn)轉(zhuǎn)或儲存過程、或修訂產(chǎn)品規(guī)格、品質(zhì)管理系統(tǒng)。packing, transportation, storage, product spec and quality management system can be modified if the problem is related to the reliability, comparability and quality problem after customer usage.4.7.2製程中之生產(chǎn)治具、設(shè)備、程式等，經(jīng)修改後可符合防呆之要求者。T

15、he fixture, equipment and program can prevent from misusage after modification.4.7.3類似產(chǎn)品已發(fā)生的問題，將其預(yù)防措施引用到其它產(chǎn)品，使其它產(chǎn)品不發(fā)生相同問題。Use the preventive action in other products with similar problems to prevent the same issue from happening again.4.7.4製程中發(fā)現(xiàn)量測儀器不合格/損壞時(shí)，需由責(zé)任單位採取預(yù)防措施。The responsible departments sh

16、all take precautionary measures when there is measuring equipment found unqualified/damaged during manufacturing process.5. 作業(yè)程序與權(quán)責(zé)Operating Procedures and Responsibilities: 5.1異常處理作業(yè)流程The Procedure of Abnormality Handling: 5.2管理責(zé)任Management Responsibilities5.2.1異常反應(yīng)單位：負(fù)責(zé)對不良品、不合格狀況潛在不良原因的反應(yīng)與管制。Occur

17、ring Department：Responsible for the action and control of Defect nonconformity causes.5.2.1.1異常反應(yīng)單位依異常定義，通知品管單位確認(rèn)後，詳實(shí)填寫“品質(zhì)異常對策書”(PQ3-00060-001中各項(xiàng)資料。Issuing Dept. shall fill in the information of “BB Quality Abnormal Notice” (PQ3-00060-001 form according to the abnormal definition that confirmed by Q

18、A department.5.2.1.2異常反應(yīng)單位應(yīng)保留不良品供品管及對策單位確認(rèn)、分析其原因及對策。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.5.2.1.3依決議之處置對策執(zhí)行相關(guān)作業(yè)並確認(rèn)對策之有效性。Follow the decision of countermea

19、sure, apply to the action and make sure the validly of the solution.5.2.2問題確認(rèn)單位(Verification Dept.5.2.2.1異常發(fā)生時(shí)由品管及工程人員進(jìn)行確認(rèn)The Verification Dept. for Abnormalities is QA and Engineer5.2.2.2若反應(yīng)單位為品管單位時(shí)，需協(xié)同製造單位或工程人員確認(rèn)後始能生效。If the issuing dept. is quality dept, it is necessary to have the MFG or Enginee

20、r to verify with.5.2.2.3品質(zhì)異常確立時(shí)，品管單位將開出的QAN 進(jìn)行編號並登記於BB QAN followup 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 (PQ3-00060-002, to be followed up easily.5.2.2.4品保與工程技術(shù)單位確認(rèn)是否要對不良品進(jìn)行Purge/Rework。QA and Engineering Dept. w

21、ill confirm whether to Purge/Rework for the not good product or not.5.2.3對策單位(Countermeasure Dept.對策單位負(fù)責(zé)異常品質(zhì)分析、檢討及矯正、預(yù)防措施之?dāng)M定、施行與管制。The countermeasure department responsible for the Abnormal Quality Analysis, issuing, executing, controls the corrective action and preventive action. 5.2.3.1對策單位應(yīng)及時(shí)會同品管

22、及相關(guān)人員，決定是否需要緊急應(yīng)變措施。Should inform the QA and other related departments and members to decide if the immediate actions are needed to be taken or not.5.2.3.2若對策單位為外包或供應(yīng)商，則核準(zhǔn)欄除對策單位人員簽名外，尚須廠內(nèi)相關(guān)處理人員確認(rèn)簽名。For the countermeasure dept. or suppliers, the approval signature should be containing both countermeas

23、ure dept. and related inner dealing member.5.2.4效果確認(rèn)單位Result confirmation：矯正及預(yù)防措施執(zhí)行狀況由品管及相關(guān)單位負(fù)責(zé)跟催及效果確認(rèn)，結(jié)果提報(bào)至每週品質(zhì)檢討會議，由責(zé)任單位及品管單位彙整之確認(rèn)結(jié)果，詳記於矯正預(yù)防措施報(bào)告中，執(zhí)行追蹤管制。QA and other related departments are responsible for the follow up of the result confirmation and provide the result in the weekly quality meetin

24、g. Record and conclude the result into corrective action report and List into follow up control by the QA dept.5.3標(biāo)準(zhǔn)化Standardize ：矯正措施實(shí)施後，經(jīng)品管確認(rèn)須實(shí)施標(biāo)準(zhǔn)化作業(yè)部份，應(yīng)重新修訂或製訂標(biāo)準(zhǔn)化作業(yè)。 Once the Corrective Action has been applied, QA should carry out the standard operation issue to revise or initiate it. 5.4通知客戶Info

25、rming Customer:通知客戶時(shí)機(jī):有以下之異常發(fā)生時(shí)必需由PM 或FPM 立即通知客戶Informing Customer Occasion: For the following abnormal situations, customers must be informed immediately by PM / FPM: 5.4.1當(dāng)已出貨的產(chǎn)品有信賴度問題時(shí)Delivered products are concerned with reliability issues. 5.4.2當(dāng)有異常的產(chǎn)品已出貨到客戶端時(shí)The abnormal product has been deliv

26、ered to the customer.6. 附件Appendixes ：6.1機(jī)遇/非機(jī)遇判定標(biāo)準(zhǔn)Chance Causes/ Occasional Causes Determine Standard 原因分類細(xì)項(xiàng)分類偶發(fā)性原因 無法避免之原因 非作業(yè)人員原因輔助判定 影響範(fàn)圍生產(chǎn)中，雖具操作標(biāo)準(zhǔn)，但在操作條 影響層面小不值得件客觀範(fàn)圍內(nèi)必有變化。 調(diào)查原材料品質(zhì)在其規(guī)格範(fàn)圍內(nèi)容許之 可採加嚴(yán)抽樣檢驗(yàn)變化 判定 機(jī)遇原因氣候與環(huán)境之變化 A QL 允收區(qū)間內(nèi)允(Chance Causes經(jīng)研判非整批性或具傳染性因素 收者，不值得調(diào)查 製程中共通性、公認(rèn)之問題零材料本身製程管制範(fàn)圍內(nèi)異?？杀?/p>

27、免之原因 作業(yè)疏忽之因素造成 影響層面大，須徹作業(yè)人為原因 未依作業(yè)標(biāo)準(zhǔn)書作業(yè)，而產(chǎn)生變異 底調(diào)查 特殊性原因 雖依標(biāo)準(zhǔn)書作業(yè)，但標(biāo)準(zhǔn)書不完善，非機(jī)遇原因異常性原因 以致發(fā)生品質(zhì)變異(Occasional局部性原因 機(jī)器設(shè)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 傳染性原因 材料差異所造成之變異潛在性功能重大差異 測試設(shè)備、量具不準(zhǔn)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 investigat