不合格品控制程序.doc

不合格品控制程序1.0 PURPOSE 目的This procedure details the actions taken by individual departments when non-conforming material or products are identified, to ensure that they are not used in products or shipped to the customer. If they were shipped to customer before, it must ensure to recall the non-conforming products. 发现不合格品及可疑产品时，能确实由权责单位迅速加以处理，确保不合格品不被进一步加工，使用或出货。如已在此前出货的，则应确保从客户处收回已发出的不合格品。2.0 SCOPE 范围This procedure applies to all incoming material, non-conforming and suspected defective materials inspected by production, OQA, and customer returned goods.此程序适用于所有发生于来料、生产过程、最终检验、客户退货等不合格品/可疑产品。3.0 DEFINITIONS 定义MRB Material Review Board 不良物料处理部门NCR Non-conforming Report 不良物料报告4.0 FLOW 流程a) Non-conforming Material Generation不合格品产生Goods In进料Final Inspection成品检验IPQC过程检验Manufacture/Assemble制造Enter store (warehouse)入库In-coming material inspection来料检验Label and quarantine material标识隔离 N YNLabel and quarantine material标识隔离YNYEnter store / shipment入库/出货Ab) Non-conforming Material ReviewA 不合格物料评审NCR submitted to MRB by department相关部门提交NCR单Return Action执行退回动作Mark, label, sign and quarantine标识隔离Return to Vendor退回销售商Mark, label, sign and quarantine标识隔离UAI 照常使用WAIVE 特别采用REWORK 返工SCRAP 报废MRB decide disposition处理结果MRB meet and Review NCRMRB 处理Stop use of non-conformingMaterial and bond停用5.0 Contents: 内容5.1 Locations Where Defective Goods Can Be Identified不合格产生的区域5.1.1 Incoming Material Inspection来料检验5.1.1.1 All received material (STS or inspected) is verified by an IQC member prior to transfer to stores.IQC对仓库所收到来料进行检查,检查其是否符合规定的要求,若符合将来料入库.。5.1.1.2 If any incoming material is rejected, the IQC member will identify the materials with a Stop! label to stop using these material and an NCR to the MRB.当来料不符合规定要求时,IQC要提交NCR单,以作处理,同时将红色“STOP”标签贴在此批产品上, 停用此批产品, 待MRB会议处理。5.1.1.3 If appropriate, a CAR will be issued to the supplier, reference Corrective and Preventative Action procedure.必要时,提出 “Corrective Action Report”给供应商,参见纠正和预防措施程序。5.1.1.4 When there are some defective incoming material which can not affect the receipt of that batch, all these should be put into a non-conforming material box, collected termly and an NCR submitted to MRB.当来料检验批中有个别不良品，不影响整批接收，对这些不良品有放在不合格物料盒中，并定期收集提交NCR单。5.1.2 Process Operator过程检验5.1.2.1 In process, products/material may be damaged by the defect of machine, personnel, technology and raw material, all these damaged material should be put into a non-conforming material box and collected termly, then stick a “STOP” label with it and an NCR submitted to MRB. The material that can be reworked should be disposed directly in production department.生产过程中，产品/物料可能因机器、人员、工艺、返工、原料存在缺陷或其它原因而造成损坏。存放在不合格物料盒中，并定期收集 提交NCR单,并贴上 “STOP”标签待 MRB处理。对能返工修理就直接在生产部处理完毕。5.1.2.2 When the non-conforming products/material continue to be found in process, The product line must be stopped and notice the QC to call back this batch of material. QC must purge this batch of material from product line and warehouse and inspect again. If it is really non-conformity, QC must segregate these materials at once, segregate any product that use this batch of material, stick on STOP label and fill out NCR. MRB should immediately start up purge, fill out and trace the use status, If any this kind product is shipment, MRB must decide if these delivery products need be recalled or not. If need to recall, should be activated. Sales and logistic will contact customer and recall the products follow the delivery records. 当生产过程中，连续发现不合格产品/物料时，生产线应及时暂停生产，并通知质检员将该批物料收回。质检员将该批物料收回并对仓库中的同一批物料重新检验，如确系不良，应立即隔离，将使用该批物料的成品一起隔离，贴上“STOP”标签并提交NCR单。MRB同时启动purge程序，填写清单，立即追查该批物料的使用情况。如有已经出货的， MRB应在评审后对已发出的产品作出是否追回的决定。如决定追回，则启动Recall Procedure程序，依照出货记录联系客户追回该批产品。5.1.3 Final Quality Assurance成品检验5.1.3.1 Non-conforming products produced in process, that can be reworked should be reworked in production department, if not the non-conforming products should be identified with a “STOP” label and an NCR submitted to MRB.生产部在成品检验过程生产不合格,对能返工修理就直接在生产部处理,对不能返工贴上 “STOP”等待MRB处理。5.1.3.2 When Final Quality Assurance find a batch defective products, if that can be reworked, the production department should be informed to rework them; if not an NCR should be submitted to MRB.品管在成品检验发现不合格批，通知生产部对不合格批进行返工,对不能进行返工处理不良品，直接提交NCR单等待MRB处理。5.1.4 Customer returned客户退货5.1.4.1 When the products cant meet the customers requirement and be returned from customer, will be enabled, and sales and logistic will follow it. After receiving, QA must segregate them with stop label at once and fill out NCR. If the product / material is non-conformity, purge should be started and MRB must trace the same batch product/material. If still not use or use but not shipment, the product/material must be segregate at once and dispose with the decision. If the products are shipment, decide if recall or not. If deciding to recall, sales and logistic to contact the customer and recall the products follow the delivery records.当产品质量不能符合客户要求而被客户要求退货时，应启动RMA Procedure程序，由Sales部门和Logistic部门联系客户安排退货。QA在收到退货后，立即将之隔离，贴上“STOP”标签，并提交NCR。若判定产品或其中使用的物料不合格时，应同时启动purge程序，填写清单立即追查同批产品/物料的下落。对未使用或已使用但尚未发出的产品/物料立即隔离，按有关决定处理。对已发出的产品，立即启动Recall Procedure程序提交产品召回记录，以决定该批产品是否需要追回。如决定追回，则由Sales和Logistic部门，依照出货记录联系客户追回该批产品。5.1.5 Corrective/Preventive Actions for production process 生产过程的纠正预防If the critical or batched nonconformity occurred in the operation process, QE should fill in and give the relative department it. The responsible department should analyze the root cause and set up CA Plan. QE will trace its status and validate it. 当生产过程中发生重大品质问题或批量性不合格时，品管QE应发出Corrective/Preventive Action Request FormProcess Nonconformity，给相应责任主管部门，负责部门应及时追查原因并采取纠正预防措施，QE追踪措施的执行并验证其有效性。5.2 Non Conforming Material Review Board 不合格物料评审5.2.1 All rejected material and non-conforming material must have an NCR submitted to the MRB for review. If the event is lots or batches attribute, MRB should make a decision of how to handle the suspicious or non-conforming material within 24 hours. 对所有可疑品和不合格品都提交NCR单，送交MRB组对不合格物料 作评审。对于批量性问题MRB应在24小时内进行决策以决定可疑品或不合格品的处置方法。5.2.2 The MRB team consists of representatives from QE, PE, production and purchasing. MRB meetings are held weekly if there are NCRs to review, however, if urgent concerns arise MRB meetings can be held immediately. 评审小组由各部门代表或委托人组成品管部、工程部、生产部及采购 部。如有不良物料每周定期执行MRB会议。但QA及其他部门若发生 紧急重大品质异常情况，则立即由发生部门立即召开MRB会议。5.2.3 If the NCR is incorrectly completed the MRB team will reject it for amendment and re-submission by the owner. 如NCR单填写不完整，MRB小组将拒收并退还给提交人重写，重新提 交MRB验证。5.2.4 The defect parts submitted to the MRB must be in the following condition:- 提交给MRB做验证的不良物料，必须符合下面的条件，MRB才会接 受退料5.2.4.1 If a component is supplied by more than one supplier then the components must be packed and labeled separately. 若是相同的料号，但供应商不同，要把这些物料分放在原包装中。5.2.4.2 If there are several components supplied by a single supplier then the components must be packed and labeled separately. 不同的料号，但供应商相同的物料不要混装。5.2.4.3 Where components are to be returned to the supplier, they should be packed in their original packaging to preserve the product and to maintain credibility.元件要放在原包装内（料管或料盘），并保证包装得安全可靠。5.2.5 The MRB will review each NCR and will decide on the disposition criteria listed below:- MRB小组将审核所提交NCR单，并根据下列类别对元件/半成品/成 品作出处理决定。5.2.5.1 UAI (Use as is) 照常使用5.2.5.2 Rework 返工修理5.2.5.3 100% Sort 100%选用5.2.5.4 Return to Vendor 退回供应商5.2.5.5 Waive (Confess non-conformance) 特别采用5.2.6 The MRB decides that the materials are conforming and should be returned to good stock and “Used as is”. 经MRB小组判定不属于不合格品，贴上“USED AS IS”标签退于提交 部门，按合格品处理使用。5.2.7 If the MRB determine that the parts can be reworked a “REWORK” label is secured to the materials that are then returned to production for rework. The responsible person for rework or repair should be identified in the “remark column” of the NCR Form. If appropriate, for example batched rework job and having some difficulty in rework or repair, the person should be identified, who should be responsible for documentation of rework or repair temporary working instruction. The products, which be reworked or repaired, should be inspected by inspector again. 经MRB小组判定不合格品可以返工修理，贴上“Rework”标签，退于 生产部进行返工处理。并在NCR单的“备注”栏中注明“返工返修责任人”。必要时，如批量返工返修且返工返修技术要求较高时，须注明由谁制定返工返修临时作业指导书。对于返工返修处理后的产品，须提交检验员重新检验。5.2.8 100% Sorting and Use 100%挑选使用5.2.8.1 If the MRB decide that the materials can be 100% sorted the supplier will sort the material so that good product can be returned to production for use. The rejected parts are then re-submitted to the MRB with an NCR. Buyer is responsible of the sorting process and arranges sorting. In general, buyer should arrange supplier to sort the materials. 对于生产过程中产品经MRB小组判定不合格批中有部分可 以100%挑选使用，对于挑选后不合格品重新提交NCR单。 buyer主导整个分选过程，作出具体安排。原则上应由供应商作分选。5.2.8.2 Where the MRB decides that the materials can be sorted but the supplier cannot react in time to maintain production, the parts will be sorted by the sorter of the warehouse. Product engineer and Quality engineer should train the sorter and provide the specification or standard or boundary samples for sorting. In general the materials should be sorted in warehouse. The sorted materials are submitted to IQC and inspected by IQC again. The rejected parts are then re-submitted to the MRB with an NCR and the supplier charged the cost of sorting by the buyer. It is suggested that the RTV materials should be packed by the original packing mode. Warehouse is responsible for packing. 对于供应商提交产品，若是紧急待用料，由于供应商无法及时 替代或挑选，可以交由仓库专门人员作挑选，产品工程师和质量工程师负责对挑选工作进行技术指导培训工作，负责提供分选的依据和标准。分选的地点原则上应在仓库进行。挑选后的物料，应再次提交IQC进行检验。全检后不良品由QA开 NCR单作退货处理。仓库开具“工时费用结算单”，涉及费用由采购部要求供应商承担。退料建议按照原包装模式恢复包装，包装工作由仓库负责。5.2.9 RTV: Where the MRB decide that the materials are for RTV, the non-conforming material should be packed according to the original packing mode