產品標識和可追溯程序.doc

1 目的規(guī)定了產品的標識與可追溯性管理程序，以識別不同的產品和過程，實現(xiàn)產品的追溯。2 范圍適用于從原材料接收至產品交付整個過程中各階段的產品標識和規(guī)定場合的產品跟蹤追溯。3 參考文件3.1 001-7502過程控制程序3.2 001-7505產品防護程序3.3 001-8203 產品的監(jiān)視和測量程序3.4 001-8301不合格品控制程序4 定義與縮寫MD：指Medical device ,醫(yī)療器械產品：本文件內所提到的產品，包括生產各階段的物料、在制品、成品。5 職責5.1 生產物料控制部負責從原材料接收到產品交付整個流程的跟蹤，并會同相關部門確定需作追溯的產品的控制與管理。質量保證部、生產部、倉庫負責實施并做好記錄。5.2 生產物料控制部對顧客提供的產品標識，經(jīng)工程部共同確認后進行控制和管理。對顧客提供的產品標識有異議時，通過生產物料控制部與顧客協(xié)商決定。 5.3 質量保證部負責制定檢驗和試驗狀態(tài)標識標準，及特殊場合下產品的可追溯性的確定。5.4 工程部負責將合同規(guī)定/公司規(guī)定需進行追溯的產品編訂相關文件。5.5 進料檢驗、工序檢驗和最終檢驗狀態(tài)的標識由質量部負責，生產現(xiàn)場所有人員均應自覺保護有關檢驗和試驗狀態(tài)的標識。生產控制部負責成品檢驗和試驗狀態(tài)標識的延續(xù)。 5.6 MD產品的狀態(tài)標識:應根據(jù)監(jiān)視和測量的要求,識別產品的狀態(tài)。在產品的生產、貯存、安裝和服務的全過程中保持產品狀態(tài)的標識,以確保只有通過所要求的檢驗和試驗(或在授權讓步下放行)的產品才能被發(fā)送、使用或安裝。 6 工作程序6.1 產品的檢驗和試驗狀態(tài)標識采用的方法有標簽、標記、容器、隨產品的檢驗記錄及放置地點(并非指正常生產流程中產品所處的位置）。 6.2 標識的名稱和用途6.2.1 標簽a.合格標簽：產品經(jīng)檢驗且合格（蓋有藍色“ACCEPT”章的標簽）。b.不合格標簽：產品經(jīng)檢驗但不合格（蓋有紅色“REJECT”章的標簽）。 若產品經(jīng)確認不符合RoHS有害物質含量要求，此時還需加蓋有紅色“RoHS NG”章予以特別標示.c.待處理標簽：產品須經(jīng)處理才可判定結果。（填寫相應的“HOLD LABLE”見附件1及附件3，QA部門還需蓋紅色“HOLD”章）。d.條件使用標簽：產品經(jīng)客戶或相關部門經(jīng)理認可特采。（蓋有“WAIVE”章的標簽）。6.2.2 區(qū)域a.不合格區(qū): Non-RoHS不合格區(qū)：放置Non-RoHS不合格品的區(qū)域。該區(qū)域用“Non-RoHS不合格區(qū)”字樣加以標識。 RoHS不合格區(qū)：放置RoHS不合格品的區(qū)域。該區(qū)域用“RoHS不合格區(qū)”字樣加以標識。在此區(qū)域的HSF不合格產品需有紅色“RoHS NG”章予以特別標示。b.合格區(qū): Non-RoHS合格區(qū)：放置Non-RoHS合格品的區(qū)域。該區(qū)域用“Non-RoHS合格區(qū)”字樣加以標識。 RoHS合格區(qū)：放置RoHS合格品的區(qū)域。該區(qū)域用“RoHS合格區(qū)”字樣加以標識。c.待檢區(qū)： Non-RoHS待檢區(qū): 放置未經(jīng)檢驗Non-RoHS產品的區(qū)域。該區(qū)域用“Non-RoHS待檢區(qū)”字樣加以標識。 RoHS待檢區(qū): 放置未經(jīng)檢驗RoHS產品的區(qū)域。該區(qū)域用“RoHS待檢區(qū)”字樣加以標識。d.檢驗區(qū)： Non-RoHS檢驗區(qū)：放置正在檢驗的Non-RoHS產品的區(qū)域。該區(qū)域用“Non-RoHS檢驗區(qū)”字樣加以標識。 RoHS檢驗區(qū)：放置正在檢驗的RoHS產品的區(qū)域。該區(qū)域用“RoHS檢驗區(qū)”字樣加以標識。e.待處理區(qū)： Non-RoHS待處理區(qū):放置須經(jīng)處理的Non-RoHS產品的區(qū)域。該區(qū)域用“Non-RoHS待處理區(qū)”字樣加以標識。 RoHS待處理區(qū):放置須經(jīng)處理的RoHS產品的區(qū)域。該區(qū)域用“RoHS待處理區(qū)”字樣加以標識。 放置于待處理區(qū)的產品必須按批標貼相應的“HOLD LABEL”。6.2.3 容器a.原包裝容器：放置合格品的器具。b.貼有紅色標簽的容器：放置不合格的產品的器具。c.貼有黃色標簽的容器：放置待處理的產品的器具。待處理的產品指無法立即作判斷是否可以接收的、需進一步確認的產品。6.2.4 個別產品的質量狀態(tài)直接掛或粘在產品上。6.3 物料接收工作程序 6.3.1 補充說明6.3.1.1 經(jīng)檢驗和試驗合格，由質量保證部檢驗員貼上合格標簽，倉庫管理人員置于接受區(qū)域；如不合格，倉庫管理人員負責置于NCRB區(qū)域。NCRB會議后，檢驗員根據(jù)會議決定貼相應的標簽，倉庫管理人員將該批物料轉移至接受區(qū)域或退貨區(qū)域。 6.3.1.2 成品、半成品入庫公司制作的成品、半成品，倉庫憑質量保證部檢驗員的標簽及驗收章入庫，將其擺放在規(guī)定的區(qū)域，以標簽形式在貨架上標明成品、半成品名稱，并在物料卡（BIN CARD）上記錄。 6.4 工序過程的標識6.4.1 工序標識a.對需要追溯的產品或客戶指定要追溯的產品，物料部發(fā)放工單時必須按客戶或工程部的要求作好相關的產品標識。 b.對需要追溯的產品或客戶指定要追溯的產品在生產線流轉時，產品標識規(guī)定用跟蹤卡。生產部負責管理并正確填寫跟蹤卡或按工藝文件要求在產品上做好追溯標識。標識的資料應包括工單號、生產日期、班次等。 c. 沒有規(guī)定或要求追溯的產品，在生產線流轉時必須有產品的標識，可以用標簽作產品追溯標識。6.4.2 過程檢驗標識過程檢驗的標識由質量部負責以印章的形式在跟蹤卡上或產品標簽上標明。6.4.3 最終檢驗后的標識a. 對成品最終檢驗后的標識由生產部負責在包裝標簽上注明產品名稱、工單號（即批號）、跟蹤卡號(當有時）、包裝日期等。b. 對半成品檢驗完成后由生產部負責在工序標簽上注明產品名稱、員工號等。有追溯要求時，還應注明工單號、跟蹤卡號、包裝日期等。c. 經(jīng)檢驗合格的Non-RoHS半成品、成品，由質量保證部的檢驗員貼合格標簽,置于Non-RoHS合格區(qū)域；對于合格的RoHS半成品、成品，則置于RoHS合格區(qū)域. 經(jīng)檢驗不合格的Non-RoHS半成品、成品，由質量保證部的檢驗員貼不合格標簽，置于Non-RoHS不合格區(qū)域；對于RoHS不合格的半成品、成品，則置于RoHS不合格區(qū)域； 待處理的Non-RoHS半成品、成品，由質量保證部的檢驗員貼上待處理標簽，置于Non-RoHS待處理區(qū)域。對于待處理的RoHS半成品、成品，則置于RoHS待處理區(qū)域。6.4.4 緊急放行的標識a. 生產物料控制部負責在工單上注明“緊急放行”并在工單上注明緊急放行物料的批號或供應商發(fā)票號。b. 生產部負責在跟蹤卡上注明。6.4.5 特采的標識a. 對于特采的來料，質量保證部負責在來料標簽上以檢驗章的形式注明“特采”（WAIVE）。b. 對于特采的自制半成品，質量保證部負責在工序標簽上注明“特采”。c. 對于成品特采，客戶要求時，在包裝標簽備注欄內注上“特采”，并預先通知客戶。6.4.6 客戶提供產品的標識a. 倉庫負責將客戶提供的產品放置于適當區(qū)域，并單獨建立OW（客供）BIN卡，且區(qū)分于OA（自供）BIN卡管理。內外包裝標簽上的產品代碼以庫別的形式加以區(qū)分，客戶提供材料以“OW”為字首。當客戶有特別要求時按客戶要求處理，例如將客戶的P/N置于內外包裝上。 b. 發(fā)料至生產線時，生產物料控制部負責在工單上以物料代碼的形式注明客戶提供產品或以客戶的要求作相應的標識。6.4.7 客戶投訴后的庫存品，由質量保證部檢驗員貼上“待處理標簽”，并立即置于待處理區(qū)域。庫存品經(jīng)復檢后，合格的重新貼合格標簽，置于合格區(qū)域，不合格的按不合格品控制程序執(zhí)行。 6.4.8 當顧客要求時，應對產品進行附加的驗證/標識。6.4.9 質量保證部負責合格品的放行，具有獨立的質量判決權。6.4.10 MD產品的標識:應在產品實現(xiàn)的過程中,使用適宜的方法識別產品,以確保返回組織的MD均能被識別,且能與合格的產品區(qū)分開來.6.5 產品的追溯6.5.1 產品追溯場合的確定a. 當合同規(guī)定或根據(jù)產品質量實際要求需進行追溯的產品b. 特殊情況（如對某工序、某材料等發(fā)生疑義時）c. 工藝性試驗6.5.2 追溯產品的確認和管理a. 對于6.5.1 a 情況，由生產物料控制部組織協(xié)調負責，必要時由工程部編入相關文件，由實施部門進行實施。b. 對于6.5.1 b 情況，由質量保證部組織協(xié)調及負責，生產物料控制部和生產部配合。c. 對于6.5.1 c 情況，由工藝試驗負責人確定與協(xié)調，生產物料控制部和生產部配合。6.5.3 MD產品的可追溯性:其范圍為從原材料接收至產品交付各階段的產品的可追溯性,并保留相應的記錄。有源植入MD和植入型MD專用要求：記錄應包括可能導致MD不滿足其規(guī)定要求的所有組件、材料、工作環(huán)境條件的記錄，應要求其代理商或經(jīng)銷商保持MD的分銷記錄以便追溯,當檢查需要時,可獲得此類記錄,并保持貨運包裝收件人的名字和地址。6.5.4 追溯的標識a.對于6.5.1 a 情況，生產物料控制部負責根據(jù)合同或文件規(guī)定在工單上注明所使用來料的資料，包括供應商發(fā)票號碼或來料批號、自制半成品的工單號以及客戶要求填寫的任何資料。生產部以跟蹤卡形式跟蹤?？蛻粢髸r，跟蹤卡將跟隨產品一起發(fā)往客戶。b.對于6.5.1 b 及6.5.1 c 情況，生產物料控制部負責按追溯要求部門的要求在工單上注明所使用的來料的資料，包括來料批號或供應商的發(fā)票號、自制半成品的工單號等。生產部以跟蹤卡進行跟蹤。根據(jù)客戶特殊要求,為準確追蹤LED的生產批次,須在LUMILEDS產品的RUNCARD上完整填寫每個REEL上LED的BIN號,BUNDLE ID 或DATE CODE,若PCB板上有多個LED,應記錄不同BIN號對應PCB板上位置編號.6.5.5 物料的封存與清查當產品出現(xiàn)質量問題時，由質量保證部下達指令，由生產部、生產物料控制部負責對被追溯到的相關來料半成品、成品進行封存和清查。7. 質量記錄所有質量記錄應根據(jù)記錄控制程序處理。8. 附頁8.1 附頁1：各標簽的樣品及RoHS NG章樣版 Attachment 1： Attachment 2: Sample of“RoHS NG”stamp Attachment 3: Sample of HOLD LABEL for PD 1. Purpose Establish procedure to identify different products and processes and realize the traceability of product.2. ScopeAdapt to the product identification from material receiving to product delivery and products traceability.3. Reference Documents3.1 001-7502Process Control Procedure3.2 001-7505Product Preservation Procedure3.3 001-8203 Monitoring and Measurement of Product Procedure3.4 001-8301Control of Nonconforming Product Procedure4. Definition and Abbreviation MD：Medical device Product: what mentioned in this procedure, including material, semi-product and finish goods throughout the production.5. Responsibility5.1 PMC is responsible for product and status tracking from material receiving to product delivery, and coordinate with other dept. to define the need of control and management for tracing. QA, PD and warehouse are responsible for implementation and record. 5.2 PMC identify customer provided products and perform control and management after confirmed by engineering department. If theres any dissension about customer products identification, PMC communicate with customer. 5.3 QA department is responsible for establishment of inspection and testing status identification standard and determination of product traceability in special situation.5.4 Engineering department is responsible for establishing documents according to contract and companrequirements.5.5 QA department is responsible for coming material, in-process products and finished products inspection status identification. Operators shall self-consciously protect inspection and testing identification. PMC is responsible for identification extending. 5.6 Status identification for MD: Shall identify the product status with respect to monitoring and measurement requirements.The identification of product status shall be maintained throughout production,storage,installation and servicing of the product to ensure that only product that has passed the required inspections and tests(or released under an authorized concession) is dispatched,used or installed. 6. Procedure6.1 Identification can use label, mark, case, inspection record and placed area. The placed area is not products located area in normal process. 6.2 Label Name and Use6.2.1 Labela. Accept Label: Products are through inspection and accepted, which stamp with blue ACCEPT.b. Reject Label: Products are through inspection and rejected, which stamp with red REJECT. If products are through confirmation and harzardous substances nonconformance with RoHS requirement, should add red “RoHS NG”stamp to identify specially.c. Hold Label:Products need to dispose, refer to related HOLD LABEL in attachment 1&3, if hold by QA, need to stamp with red HOLD.d. Waive Label: Products can be special used after approved by customer or related department managers, which stamp with WAIVE.6.2.2 Areaa. Reject Area: Non-RoHS Reject Area: Place rejected Non-RoHS products, and marked with Non-RoHS Reject Area. RoHS Reject Area:Place rejected RoHS products, and marked with RoHS Reject Area. HSF Nonconforming product in this area should add“RoHS NG”stamp to identify specially.b. Accept Area: Non-RoHS Accept Area: Place accepted Non-RoHS products, and marked with Non-RoHS Accept Area. RoHS Accept Area: Place accepted RoHS products, and marked with RoHS Accept Area.c. Waiting Area: Non-RoHS Waiting Area : Place Non-RoHS products waiting for inspection, and marked with Non-RoHS Waiting Area. RoHS Waiting Area : Place RoHS products waiting for inspection, and marked with RoHS Waiting Area.d. Inspection Area: Non-RoHS Inspection Area: Place Non-RoHS products being inspected, and marked with Non-RoHS Inspection Area. RoHS Inspection Area: Place RoHS products being inspected, and marked with -RoHS Inspection Area.f. Hold Area: Non-RoHS Hold Area: Place Non-RoHS products being disposed, and marked with Non-RoHS Hold Area. RoHS Hold Area: Place RoHS products being disposed, and marked with RoHS Hold Area Products on hold area must be identified with HOLD LABEL by lot no.6.2.3 Casea. Original Packing Case: Place accepted products.b. Sticking Red Label Case: Place nonconforming products.c. Sticking Yellow Label Case: Place the pending products. The pending products mean the products cant be judged immediately and need to be verified. 6.2.4 Some products quality status can hang or stick on product itself.6.3 Material Receiving Procedure 6.3.1 Supplement6.3.1.1 QA inspector sticks accept label on the products through inspection and warehouse put it in accept area, if reject, warehouse put it in NCRB area. After NCRB meeting, inspector will stick relevant label according to decision and warehouse will transfer the material to accept area or returned area.6.3.1.2 Finished and Semi-finished Products StoreWarehouse stores the products according to label and stamper and put in related area.Mark products name on label at shelf and record on Bin Card. 6.4 Process Identification6.4.1 Process Identificationa. As for required or customer appointed products need for tracing, PMC shall make relevant identification according to customer or engineering departments requirement when issue work order.b. Shall use run card as identification for the products that need for tracing or customer required tracing. PD department is responsible for management and filling in R/C correctly or making the traceable mark on products according to documents requirement. Identification information should include work order, production date, shift and so on. c. As for the products that have no requirement or need to trace, shall have identification when use in production line, which should use label as product identification.6.4.2 In-process Inspection IdentificationQA stamp on run card or remark on product label.6.4.3 Final Inspection Identificationa. As for finished products, PD remark on packing label with product name, work order, R/C if has, inspector,packing date and so on.b. As for semi-finished products, PD remark on in-process label with product name, inspector, inspection date and so on. If has traceable requirement, shall also remark work order, R/C, packing date and so on.c. As for accepted Non-RoHS semi-finished and finished products, QA inspector stick accept label and put in Non-RoHS accept area; For accepted RoHS semi-finished and finished products, stick accept label and put in RoHS accept area; As for rejected Non-RoHS products, stick reject label and put in Non-RoHS reject area; For rejected RoHS products, stick reject label and put in RoHS reject area; As for Non-RoHS hold products, stick hold label and put in Non-RoHS hold area; For RoHS hold products, stick hold label and put in RoHS hold area.6.4.4 Identification of Urgent Releasea. PMC remark Urgent Release and lot number or supplier invoice number of urgent release material on work order.b. PD remark on run card.6.4.5 Identification of Special Usea. As for special used incoming material, QA stamp on incoming label with Waive.b. As for special used semi-finished products, QA remark Waive on in-process label.c. As for finished products, when customer requires, remark Waive on packing label and inform customer in advance.6.4.6 Identification of Customer-Supplied Productsa. Warehouse put customer-supplied products in seperate area and build the OW (customer supplied) BIN card separated from OA (self-supplied) BIN card. Product code of internal and external packing label is distinguished by warehouse. The first letter OW represents customer-supplied product. Dispose the material according to customer requirements if any. For example, mark part number on internal and external package. b. When the material is used in production line, PMC shall remark customer-supplied products with material code on work order or identify according to customer requirements.6.4.7 Stock products complained by customer shall be stick Hold label by QA and put in Hold area. After stock products are re-inspected, sticks Accept label and put in Accept area if accept otherwise handle the products according to the Control of Nonconforming Product Procedure.6.4.8 Perform additional verification or identification when customer requires.6.4.9 QA is responsible for accepted products release and has individual quality judgement puissance. 6.4.10 Identification for MD:Shall identify the product by suitable means throughout product realization,and shall establish documented procedures for such product identification to ensure that MD returned to the organization are identified and distinguished from conforming product.6.5 Product Traceability6.5.1 Determination of Product Traceability Situationa. The products that contract required or product quality required.b. Special situation, such as doubtable process or material.c. Process experiment.6.5.2 Determination and Management of Traceable Productsa. As for 6.5.1 a, PMC is responsible for organization and coordination. If necessary, engineering department draft it into documents and performed by responsible departments.b. As for 6.5.1 b, QA is responsible for organization and coordination. PMC and PD are responsible for cooperation.c. As for 6.5.1 c, the principal of process experiment is responsible for determination and coordination. PMC and PD are responsible for cooperation.6.5.3 Traceability for MD:The product traceability is from material receiving to product delivery and retain the records.Particular requirements for active implantable MD and implantable MD:In defining the records required for traceability ,the organization shall include records of all components,materials and work environment conditions,if these could cause the MD not to satisfy its specified requirements. And shall require that its agents of distributors maintain records of the distribution of MD to allow traceability and that such records are available for inspection. Records of the name and address of the s