1、不合格品處理規范 不合格品處理規范Nonconforming Product Control SOP目的Purpose為規范和處理不合格物料建立本標準，防止不合格物料非預期使用。This document is to define nonconforming product control to prevent unintended use of nonconforming products.適用范圍Scope適用于進料檢驗和制造車間的不合格物料處理。This document is applied for nonconforming found in incoming inspection

2、and production line.術語和定義Terms and Definitions不合格品（不合格物料）Nonconforming(Nonconforming material)任何已購買或已生產的，不符工程圖紙、標準或規范要求的原材料、部件、半成品或成品。Any purchased or produced raw material, component, in-process product or finished product, which doesnt fulfill requirements in the drawing, standard or procedure. 退貨

3、 RTV (Return to vendor)將不合格品退供應商，僅限外購、外協原材料、部件。Return nonconforming to supplier, only applied to purchased raw material or component.返工 Rework將不合格品返工成符合工程圖紙、標準或規范要求的原材料、部件、半成品或成品。Actions taken on the nonconforming so that it will fulfill the requirements in the drawing, standard or procedure報廢 Scrap

4、將不能接收或退回供應商或返工成本高的不合格品報廢處理。Scrap Nonconforming which cant be returned to supplier or of high rework cost讓步接收/放行 Use as is不合格品的一項或多項特性不符合預期要求，但不直接影響產品質量，或影響可忽略的，經過評估及授權人員審批后可對該不合格品讓步接收/放行。必須在讓步接受或放行的書面認可經過授權人的批準后方可使用或放行不合格品；對于不滿足產品規格和法律法規要求的不合格，不允許讓步放行。One or more characteristics of the nonconforming

5、 dont fulfill specified requirements, if they dont directly impact the product quality or the impact is negligible, the nonconforming can be used as is after evaluation and approval by authorized person. For nonconforming doesnt conform to specification or regulatory requirements, it should not be u

6、sed as is.CAPA糾正預防措施（Corrective Action and Preventive Action）SCAR供應商質量問題反饋單（Supplier Corrective Action Request）MRB:物料評審會議（Material Review Board），是針對不合格物料進行評審以確定處置方式的活動。MRB is to evaluate nonconforming and determine nonconforming disposition.工程技術人員 Engineering Personnel產品工程師、工程技術員、品質工程師、工藝工程師、SQA工程師（

7、PCBA）、測試工程師、維修技術員、質檢技術人員(IQC)、QE；Product engineer, engineering technician, quality engineer, process engineer, SQA engineer (PCBA), test engineer, repair technician, quality inspection technician (IQC), QEQualityMQA、IPQC、MQA經理、管理者代表MQA、IPQC、MQA manager、management representativeQEQE工程師、QE技術員、品質主管、品質部

8、經理QE engineer, QE technician, QC supervisor, QC managerR&D 研發工程師、法規工程師、產品安全工程師Design engineer, regulatory engineer, product safety engineerSQA/TQCSupply quality assurance/ Technical Quality control發現人Finder操作員、組長、多能工Operator, team leader, multifunctional operator職責與權限Roles and Responsibilities序號

9、No角色/崗位Roles職責描述Responsibilities1發現人Finder負責對發現的不合格品進行標識、隔離，并記錄填寫發現信息。Responsible for Labeling and quarantining nonconforming and record information.2QE負責對不合品信息進行確認是否需要啟動不合格品處理流程，針對需要的則啟動不合格品處理流程。Responsible for judging whether nonconforming product control process need be initiated and initiating t

10、he process when applicable.3工程技術人員Engineering Personnel負責主導進入不合格品處理流程的不合格品處理；負責及時準確的將生產過程中的不合格品處理單信息錄入至制造過程質量信息庫。Responsible for handling nonconforming initiated and input information from Nonconforming product control Record into manufacturing quality information system4Quality負責對不合格品處理單處理過程符合性審查及參

11、與MRB過程；跟進處理方案的落實結果并記錄；負責不合格品處理涉及的所有相關記錄的符合性和齊套性檢查；歸檔管理不合格品處理單。Responsible for compliance checking for nonconforming product control process, participating MRB, following up conformance disposition, checking records and filing Nonconforming product control Record5錄入人Input man負責將不合格品數據錄入，錄入至制造過程質量信息庫。

12、Responsible for input conformance data into manufacturing quality information system 第12頁 共12頁 流程圖 Flow Chart不合格品處理流程內容及流程描述Description of the procedure不合格品發現和記錄 Nonconforming finding and record來料檢驗或生產過程中發現不合格品時，發現人應對不合格品進行標識、隔離和記錄，標識和隔離方法按生產過程標識管理規范的要求執行。零星不良應用零星不良物料記錄表記錄；整機成品生產過程發現的不良應送維修工序返工，并用零星

13、不良半成品處理記錄表記錄；不良板卡應送PCBA維修工序返工，并用PCBA不合格品處理記錄表記錄；零星不良的處置可由組長/多能工/工程技術人員/維修人員進行處置。When nonconforming is found in Incoming inspection or manufacturing process, finder shall label and quarantine nonconforming according to Manufacturing Process Identification Management Procedure. For single nonconformin

14、g material, it shall be recorded in Single Nonconforming Material Control Record form. For nonconforming in devices production, it shall be recorded in Single Nonconforming In-process Product Handing Record form and sent to repair team for rework. For nonconforming board, it shall be recorded in PCB

15、A Nonconforming product control Record form and sent to PCBA repair process for rework. For Single nonconforming, disposition can be made by team leader, multifunctional operator, engineering technician and repairman.組長或多能工每天應將零星不良物料記錄表、零星不良半成品處理記錄表和PCBA不合格品處理記錄表給至QE工程師或QE技術員確認，QE工程師或QE技術員應按照不合格品處理準

16、入條件進行確認是否需要進一步處理，并在記錄表審核簽名欄確認；需要進一步處理的則提出不合格品處理單。Single Nonconforming Material Control Record, Single Nonconforming In-process Product Control Record and PCBA Nonconforming product control record shall be submitted to QE engineer or technician daily by team leader or multifunctional operator. QE eng

17、ineer or technician shall follow nonconforming input criteria to determine the need for further actions, review the record and sign. For those further actions are needed, Nonconforming product control Record need to be initiated.數據錄入員應將不合格品記錄信息錄入至制造過程質量信息庫，具體參照制造過程質量信息庫維護及評分指南執行。Data input personnel

18、 shall enter nonconforming information to manufacturing quality information system following Manufacturing Quality Information System Maintenance and Scoring Guidance.不合格品處理準入條件：準則1：抽樣批退準則2：RPN27，RPN=S*O*D，S為嚴重度，O為發生概率，D為可探測性。準則3：S（嚴重度）5S、O、D的評價參考附件一推薦的評價準則。Nonconforming handing input criteria,Crite

19、ria 1: Lot rejected by sampling inspectionCriteria 2: RPN27，RPN=S*O*D，S: Severity，O: Occurrence，D: DetectabilityCriteria 3: S (Severity) =5S, O, D evaluation can refer to appendix 1.不合格品處理流程 Nonconforming product control procedure編號No.活動名稱Activity角色Role活動描述Description主要輸入、輸出信息Input & Output010提出

20、不合格品處理單Nonconforming product control Record initiatedQE提出人填寫不合格品處理單。Fill in Nonconforming product control Record輸入In：/輸出Out：不合格品處理單Nonconforming product control record020確認不合格品狀態Status confirmingQE確認不合格品是否已經隔離或以暫停生產，并在制造過程質量信息庫中獲取不合格品處理單編號。Conform nonconforming is quarantined or production is stoppe

21、d and get in record No. from manufacturing quality information system輸入In：/輸出Out：不合格品處理單Nonconforming product control record030復核ReviewQuality復核不合格品處理單中異常信息填寫的規范行、正確性，復核準入條件判定的準確性及不合格品狀態。Review for information filling in, input criteria and nonconforming status.輸入In：不合格品處理單Nonconforming product cont

22、rol Record輸出Out：不合格品處理單Nonconforming product control Record040不合格評價Evaluation工程技術人員Engineering Personnel1. 根據對不合格品的初步判定組織MRB委員會對不合格進行評價；來料檢驗不合格除讓步接收外可直接由工程技術人員完成040和050活動。Organize MRB committee to evaluate nonconforming according to preliminary judgment; for Incoming inspection nonconforming, step 0

23、40 and 050 can be handled directly by engineering personnel except for use as is. 2. MRB組織按MRB流程工作規范執行Follow MRB Procedure to organize MRB meeting3. 確定不合格范圍，分析不合格原因及劃分不合格類別。原因分析可從人、機、料、法、測、環等要素分析是否存有變異。Confirm nonconforming range and analyze cause. Cause can be analyzed from 5M1E.4. 不良分析過程發現不良可能導致成品

24、暫停出貨，則參照異常事件涉及暫停生產或出貨處理規范處理。If nonconforming is related to finished product hold, follow Production Hold or Delivery Hold Procedure.5. 不良類別的定義參考附件三Cause category is defined in Appendix 3.6. 是否需要調查并進入CAPA/SCAR，按糾正預防措施控制程序執行。Whether Investigation is needed and CAPA/SCAR will be initiated, follow Corre

25、ctive Action and Preventive Action Control Procedure7. 口頭/郵件告知負責不合格產品的組織/人員。Notify person or organizations responsibility for the nonconforming orally or by email.輸入In：不合格品處理單Nonconforming product control Record輸出Out：不合格品處理單Nonconforming product control Record050制定不合格品處置方案Disposition Determination工程

26、技術人員Engineering Personnel1. MRB委員會應制定不合格涉及范圍的處置方案；MRB committee shall determine the nonconforming disposition.2. 處置方案為返工，應建立具體的返工方案和返工后的檢驗方案，同時應評估返工對產品的不利影響；返工后應對不合格品進行重新測試。If the disposition is rework, procedure for rework and inspection after rework shall be established and adverse effect shall be

27、 analyzed. Retest shall be done after rework.3. 處置方案為讓步接收/放行，應說明理由或輸出故障風險分析報告或輸出物料讓步接收影響分析報告或輸出機械結構件讓步接收/放行驗證報告。If the disposition is use as is, reason shall be documented, or Failure Risk Analysis Report, Material Acceptance with Deviation Impact Analysis Report or Mechanical Part Acceptance with D

28、eviation Impact Analysis Report shall be completed.4. 不合格品涉及售出產品時，應反饋給產品質量部DQA，按警戒響應管理程序處理。If the nonconforming is related to products in the field, information shall be provided to DQA and handled following Vigilance Response Management Procedure.5. 按附件二要求組織MRB人員會簽批準處置方案；來料檢驗非讓步接收的處置方案的批準為部門經理。MRB

29、approval requirements are defined in Appendix 2. For incoming inspection nonconforming, it shall be approved by dept. manager except for use as is.輸入In：不合格品處理單Nonconforming product control Record輸出Out：不合格品處理單Nonconforming product control Record060方案執行Disposition Implementation所涉及部門人員Related personne

30、l1. 工程技術人員將通過MRB評審的不合格品處置方案需通知所涉及部門人員執行。Disposition need to be notified by engineering personnel to related Dept for implementation. 2. 執行處置方案的記錄應及時歸檔，并按照DHR管理工作規范的要求進行管理implementation record shall be filed in time, following DHR Management Procedure.3. 將不合格品處理單轉交IPQC。Transfer Nonconforming product

31、control Record to IPQC輸入In：不合格品處理單Nonconforming product control Record輸出Out：不合格品處理單Nonconforming product control Record070處置結果跟進Disposition Follow-upQuality1. 監督不合格品處置執行過程，確保處置方案得到有效落實。Monitor disposition implementation to assure actions are taken.2. 檢查處置記錄的合規性和齊套性。Review the record for compliance a

32、nd completeness 3. 記錄處置跟蹤結果及處置記錄檢查結果。Record follow-up result and review result.輸入In：不合格品處理單Nonconforming product control Record輸出Out：不合格品處理單Nonconforming product control Record080記錄歸檔FilingQuality1. 不合格品處理單電子檔由填寫部門錄入，不合格品處理單的填寫要求見不合格品處理單模板中的填寫說明； Electronic record of Nonconforming product control Re

33、cord is entered by filling Dept., paper record filling requirements is defined in the Nonconforming product control Record template.2. Quality負責不合格品處理單的封閉和存檔。Quality is responsible for closing and filing the Nonconforming product control Record.輸入In：不合格品處理單Nonconforming product control Record輸出Out：不

34、合格品處理單Nonconforming product control Record相關文件及記錄Relevant Documents and Records本文件產生的質量記錄Recording Forms記錄編號Record No.記錄名稱Record NameMRSZ/R08N01.24.04零星不良物料記錄表MRSZ/R08N01.24.03零星不良半成品處理記錄表MRSZ/R08N01.24.01不合格品處理單MRSZ/R08N01.24.02PCBA不合格品處理記錄表MRSZ/R08N01.24.06機械結構件讓步接收/放行驗證報告MRSZ/R08N01.24.05物料讓步接收影響

35、分析報告借用的質量記錄Referenced Recording Forms記錄編號Record No.記錄名稱Record NameMRSZ/R08N05.03故障風險分析報告MRSZ/R06N01.10.01供應商質量問題反饋單MRSZ/R08N02.00.01糾正預防措施處理單相關聯的文件 Relevant Procedures文件編號Document No.文件名稱Document NameMRSZ/S07N06-02生產過程標識管理規范MRSZ/G08N04-02-05制造過程質量信息庫維護及評分指南MRSZ/S01N01-03DHR管理工作規范MRSZ/P08N05警戒響應管理程序M

36、RSZ/P08N02糾正預防措施控制程序MRSZ/S08N01-20異常事件涉及暫停生產或出貨處理規范MRSZ/S08N01-25MRB流程工作規范附件附件一1）推薦的嚴重度（S）評價準則嚴重度（S） 嚴重度是一個已假定失效模式的最嚴重的影響后果的級別；后果評定準則：后果的嚴重度 (對于產品)評定準則：后果的嚴重度(對于制造過程)等級嚴重潛在失效模式可能影響產品使用的安全性或違反體系、法律法規的要求或，潛在失效模式可能危及操作者的安全。5高產品喪失主要功能，無法使用；或性能下降，超出產品規格；或，產品必須要報廢（含部分報廢）或機器要在修理小組花多于半個小時來修理。4中等產品功能可實現，方便性項目失效。或，產品必須要100%糾正，或機器要在修理小組花少于15分鐘來修理。3低產品運行時會發出異響或產品的外觀缺陷等項目?；颍a品可能需要分檢，無需報廢，但部分產品需糾正（含在線糾正）。2無無影響或，對操作或操作者而言有輕微的不方便或無影響。1當潛在失效模式導致產品缺陷和/或一個制造過程影響時便得出相應的定級結果。如果兩種可能都存在的，采用兩個嚴重值中的較高者。2）推薦的發生概率（O）評價準則頻度：是指某一特定的起因/機理發生的可能性。描述出現的可能性的級別數具有相對意義，而不是絕對的