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求助:生产异常处理流程

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1#
发表于 2011-11-3 03:18:36 | 只看该作者 回帖奖励 |倒序浏览 |阅读模式
生产异常处理的流程应该是怎么样的?生产、制造、质量三个部门都应该充当什么样的角色?
如何控制使这个过程行程一个良好的闭环。
生产如何确定这个异常报警的等级划分?问题分析到底应该是由ME还是QE?措施及结果的汇总应该到哪里呢?
欢迎大家发表高见,共同讨论。
2#
发表于 2011-11-3 03:18:42 | 只看该作者
3E联动模式可以去探讨
3#
发表于 2011-11-3 03:18:51 | 只看该作者
1. Purpose目的
Define the process for evaluating and disposing of raw material/products that doesn’t meet specifications. Ensure prevention of inadvertent use or delivery of nonconforming raw material/products and solve it in time.
本文对不合格原材料及产品判定及处理的流程进行了规定。以确保防止其被误用和误发货并得以及时处理.
2. Scope范围
本文件适用于xxx
3. Responsibility 职责
Project Quality Engineer (PQE) 项目品质工程师
- Make the final decision of non-conforming material/product whether quality is acceptable or not base on customer requirement. 基于客户需求,最终决定不合格材料/产品的品质是否可接受。
- Make proposal about “Sorting”, “rework”, “Scrap”, ”UAI” and “others” concerning on those confirmed defective parts or batches. 对于已确认的缺陷品或批次提供处理意见,进行“挑选“,“返工“,“报废“,“降级接受”还是“其它“。
- Harmonize production analyse cause of non-conforming, and provide evidence to QM & PM, and follow the whole process and ensure the issue to be closed,keep record and retention after all processes are finished. 协调生产分析不合格原因,并提供证据给QM(总经理)或PM(项目经理), 跟踪整个过程并确保其关闭,在所有过程完成后保留纪录。
Supplier Quality Engineer (SQE) 供应商品质工程师
- Judges the incoming batch and purchased material returns from production ‘ON HOLD’ material acceptable or not,follow the whole process of dealing with ‘ON HOLD’ material;待处理原材料的判定(包括来料和生产线上的元件)并跟踪处理全过程。
- Release DMR to supplier and get confirmation with them, monitor and follow supplier’s corrective action, and close DMR; 向供应商发布投诉报告,并与之确认, 监督和跟踪供应商的纠正措施,并关闭DMR报告。
- Review DMCF from IQC and production line, follow the succeeding process with Claim Location according to Defective Incoming Materials RTV process. 评审IQC 和生产线的DMCF,并处理随之的原材料投诉。
Incoming Quality Control (IQC) Inspector 来料检察员
- Issues IR or DMCF when defective material is found in incoming inspection stage, 在来料检查阶段发现不合格材料发布检查报告或不合格材料投诉表。
- Marks the defective material with related label, cooperate with Warehouse Keeper (if needed) transfer the defective material to the appointed place for isolation;对不合格材料进行标识,协助仓管将不合格材料移到指定位置隔离(需要时)
- Make statistical report or chart for the reference of responsible department or person. 制作来料检查的统计报告或图表供相关部门及人员参考
Quality Control (QC) Inspector品质检查员
- Responsible for sample inspection for finish goods base on Sample Inspection Plan and issue DR and mark the defective parts. 根据抽样方案对成品进行抽样出货检查,发布不合格报告并做好标示。
- QC inspector should do sample inspection for the goods which be provided by last process when production line found some defects, QC inspector decide that the goods should be returned to last process or sorting by current process, issue IR. 当生产线对上工序送来的产品有异议时,品质检查员可根据抽样方案对其进行抽检,并根据结果决定是否退回上工序或由本工序挑选, 发布检查报告。
- Responsible for sample inspection for RTV, check product name, quantity and defect type and issue IR. 对客户退货进行抽检,对产品名称,数量,缺陷类型确认并发布检查报告。
- Issues CPAR to production when necessary. 需要时发布纠正预防措施报告。
In Process Quality Controller (IPQC) 制程品质管理员
- Responsible for production process quality control. 生产过程中的品质控制。
Production (Manager/ Supervisor/Engineer) 生产(经理/主管/工程师)
- Providing the manpower necessary to complete the disposition of the non-conforming batch on time. 施加必要的权力保证不合格批次的处理得以按时完成。
- Make decision of production rhythm with Quality manager and Project manager when defect is found and not be solved in time,and according to the decision, organize the next step actions. 当发现不良并难以及时解决时与品质经理和项目经理共同决定生产的进度 并依据决定组织下一步行动。
- Approves daily ordinary Scrap Report 批准日常的报废报告。
- According to the CAR issued by Quality department, find out root cause and take related corrective and preventive action, and follow up the result. 根据质量部发出的CAR 报告,找出根本原因,并做出相应的改进和预防措施,并跟进其结果。
Quality Manager (QM) 品质经理
- Review DMR/DR Report when necessary, and monitor the claim handing performance regularly, and push the processes running smoothly; 评审DMR/DR报告(需要时),定期监督不合格的处理,推进及确保该流程的顺畅运行。
- When defects be found, discuss with Project Manager and Production Manager decide continue production or not, and have the final authority to stop the production. When stop, sign and make an obvious mark on DR report (If needed, QM could delegate the authority to related person 发现不良品时,协同项目经理和生产经理决定是否继续生产,并有决定停产的最终权限, 当决定停产时,在DR报告上进行明显标注,并签字。(需要时QM可将此权限下放给相关人员)
- Make final judgment and authority when quality issue’s dissensions ascend, and follow them until they are closed. 当有品质纠纷时,做出最终决策,并监督其直至关闭。
Warehouse Keeper/leader( 仓管)
- Identify the defective material/product in warehouse (include overdue, suspected, on hold, customer returns etc.,), mark with related label and transfer the parts to appointed place for isolation,inform IQC or QC, finish the transfer of SAP system when needed; 识别仓库中的不合格材料及产品(包括过期,可疑,待处理等) ,, 将其移至指定区域隔离并标识,, 需要时要进行SAP系统转移,同时通知IQC或QC。
- Warehouse leader should inform related QC Team leader to do sample check for return goods as soon as he receive them, it can be input SAP after getting QC approval. 当收到客户退货时须及时通知相应工序品质组长到库房进行验收,验收合格后方可收入系统。
- Dispose of ‘Scrap’ material/product负责报废材料及产品的处理。
Byer采购
- Responsible for credit note/replacement handling confirmation, 对出现的不合格材料及时和供应商联系处理。
- Update DMR of database system timely, and inform the information to related department. 及时更新系统中的DMR,并通知相关部门有关信息。
3.10Customer Service 客服人员
- Contact customer and arrange transportation to take back the customer returns and arranges replacement delivery transportation accordingly.联系客户及安排相关退货补货运输事宜, 并将有关信息通知相关人员。

4.Definitions 定义
Nonconformity 不合格:Can not meet requirements (requirement: obvious and usually crytic requirements or expectation or which need to be fulfilled compulsively。 Here we define it include all customer requirements, applicable regulatory requirements(for example: RoHS directive) and interested parties requirements.) 不满足要求(要求:明示的,通常隐含的或必须履行的需求或期望。这里我们规定它包括所有客户要求,适用的法律法规的要求(例如:RoHS 指令)和相关方的要求。)
Material原材料: Incoming, stock and on line raw material来料,在库和在线的生原材料
Product产品: Include semi-product, finished product and customer returns包括半成品,完成品和客户退货。
UAI : Use As It 照常使用
Concession or release: 让步接受或放行
DMCF: Defective Material Complain Form不合格材料投诉单
IR: Inspection Report 退货重检报告
DMR: Defective Material Report不合格材料报告
BAOS: The Bill of Application for Out Scrap 外部来料不良退库记录表
SAAF: Special Acceptance Application Form 例外放行单
CPAR: Corrective and Preventive Action Report 纠正预防措施报告
5.Process description 过程描述
5.1 Raw Material and purchased components原材料
5.1.1 Defective material found at production stage 生产过程中发现的不良材料
5.1.1.1When Production Operater find the defective material on line, they should report to Shift Leader and IQC to make judgment first. 生产操作员在线发现材料不良时,应首先通知线长和IQC作判断。
A. If the defect rate <x%, production line will do on line sorting. 如果不良率小于x%,生产线随线挑选。
B. If the defect rate >= x%, the whole batch should be returned to WH, on line sorting can be implemented if we meet urgent delievery demand. 如果不良率大于等于x%,整批需退回库房,
4#
发表于 2011-11-3 03:18:57 | 只看该作者
当遇到紧急发货时可作随线挑选.
5.1.1.2 The defective parts should be recorded in “The Bill of Application for Out Scrap “ by line leader, then hand in MC. 经确认的不良品由产线线长填写“外部来料不良退库记录表”交 给当班物料员。
5.1.1.3 MC fill in DMCF base on “BAOS” and submit to SQE, SQE make final decision and sign his/her name, the QM/PM/PQE should sign the form if it’s necessary物料员根据“外部来料不良退库记录表“填写DMCF并提交给SQE,SQE 给出最终处理建议并签字,必要时由QM/PM/PQE 签字确认。
5.1.1.4 Prodcution line MC should block the product in SAP system when she/he receive the DMC.生产物料员收到DMCF后,将相应产品在SAP系统中block住。
5.1.1.5 The product will be transfered to WH within 12 hours and enclosed the report.制造部需将此批实物在12小时内转移至仓库,并随附相关单据。
5.1.1.6 WH must check label and report, if it’s consistent, they should transfer the product to correct stock in SAP system base on DMCF requirement.库房收到货物时需对箱单与报告核实,确认无误后根据DMCF作相应库位转移。
5.1.1.7 WH must finish SAP transfer within 24 hours, the whole batch of material should be closed within 8 days by related person. 库房必须在24小时内完成库位转移,此批原材料相关人员应在8天内处理完成。
5.1.2 The procedure of Defective material found at IQC, pls follow MBJ 07.04.09 Incoming Quality Control . 来料过程中发现的不良材料,请参照xx程序执行。
5.2 Semi-Products which provided by last process 由上工序提供的半成品
5.2.1 When Production Operater find the defective products on line, they should report to Shift Leader and IPQC to make judgment first. 生产操作员在线发现材料不良时,应首先通知线长和FQC作判断。
A. If the defect rate >= x%, the whole batch should be returned to WH, on line sorting can be implemented by last process (current process will do sorting if last process meet operator shortage) if we meet urgent delievery demand.不良率大于或等于x%的产品,如果遇到紧急生产或需要及时消耗库存的情况,由上工序生产人员在线进行检选(如上工序人员紧张的情况下,本工序协调安排人员进行检选)保证正常生产, 检选出的不良品退回到上工序;如不是紧急情况,仍需上下工序QA共同确认后,方可退回上工序,生产要无条件接受本工序QA的判断结果。
B. If the defect rate <x%, production line will do on line sorting. the current process can return the defect parts to last process directly without notice QA, QA need to do judgement when the divarication exist between two process. 不良率小于x%的产品, 生产线随线挑选.退货发生时,下工序生产可以直接联系上工序生产,双方确认后可执行退货,不再需要QA进行判断。当双方生产对产品判断标准有分歧时,QA有责任帮助进行判断。
C. If the defect caused by process (such as: ), the related process should do replacement in spite of it has been used in current process. If the defect are xx and so on, the last process should do replacement if it hasn’t been used in current process, whereas the current process should take on the loss.当缺陷类型属于制程缺陷(如xx)不管此产品是否已上线使用都可以退回上工序,当缺陷类型属于xx,如此产品未上线使用可退回上工序,如已上线使用由本工序报废。
D. The defect parts should be classified base on defect description(such as: xx) when current process want to return the defect parts, it can help responsible process take correct action本工序生产人员需将随线发现的不良品按照缺陷类型---制程缺陷(如xx等),xx/xx进行分类,以便通知上工序进行确认及问题分析与改善。

E. If the defect rate >= x%, the whole batch should be returned to WH, on line sorting can be implemented if we meet urgent delievery demand. 如果不良率大于等于x%,整批退回上一工序,当遇到紧急发货时可作随线挑选.
F. If the defect caused by process (such as: sink, orange peel), the related process should do replacement in spite of it has been used in current process. 对制程产生的缺陷(如:xx),不管此不良品在本工序是否已加工,相应工序做换货处理。
G. If the defect are dirty, scratch and so on, the last process should do replacement if it hasn’t been used in current process, whereas the current process should take on the loss.当缺陷属于xx类,如此不良品未经本工序加工,由上一工序做换货处理,如此不良品已在本工序加工,由当工序承担损失。
5.2.2 If the defect rate >= x% after getting FQC confirmation, production line issue IR and fill in related information (e.g. Part Name, Part No, Qty) then FQC sign it, PQE make final decision: sorting, scrap or rework. 在FQC确认此不良达到x%,由生产开出IR并填写相关退货信息(如:名称,料号,数量),FQC签字确认,PQE给出最终处理建议:挑选,报废或返工。
5.2.3 Prodcution line MC should block the product in SAP system when she/he receive the IR, the physical goods must to be returned to WH within 2 days. 生产物料员收到后IR,将相应产品在SAP系统中block住,实物需在2天内退至库房。
5.3 Non conformity goods which be found in process. Defective products be found by OQC, pls followOP Outgoing Quality Control; Defective products be found in process, pls follow as below requirement. 出货检验时发现的不良品,请参见Outgoing Quality Control; 在制程中发现的不良品执行以下操作。
5.3.1When SPC dimension is NG, all products which were produced from current test point to last past time must be blocked by IPQC, then do sample check for each box (sample size: half of SPC sample size
A. The product can be released if the measurement result is OK.
B. The product should be blocked if the measurement result is NG, the RD will be created by IPQC and sent to production line, production line supervisor should make final decision with PE and PQE and worked out action.
C. if we meet urgent delivery, production line will issue SAAF, the goods can be released after getting customer’s approval and internal function agreement(QM,PQE,PM,GM测试不过时,QC要求将此刻直至上次合格时刻期间所有产品全部隔离,并进行抽检测试,抽检的要求执行现在抽检频率减半的原则;对SPC测试不过产品,QA会将其Block住,同时开出DR报告,如果生产有疑义或紧急出货时,生产线可提起例外放行单并取得相关人员(QM,PQE,PM,GM)及客户确认后可将此物货物放宽接收。
5.3.2 The RD and CPAR will be issued when IPQC find defective product in production line inspection and marks the defective parts. Inform related person to deal with the non-conformities in time. 在线检查时发现不合格,发布DR & CPAR并进行标识,及时通知相关人员进行处理。
5.3.3Defect be found by FQA when sampling check, Red form will be paste on this batch, and FQA should fill in QC non-conformity Notice, then block this batch, and providing DR report at same time. production line should providing SAAF report try to acceptable it when there are suspect or urgent of delivery, and the SAAF must get customer’s agreement and signature from relate person(QM,PQE,PM,GM),then evaluate defect status to fill in INSECPTIONREPORT(Only for returned goods) or/and CPARReport or/and Defect Report. FQA在抽检发现不良时,要对该批产品贴红单,并填写QC不合格通知单,然后QA会将其Block住,同时开出DR报告。如果生产有疑义或紧急出货时,生产线可提起例外放行单并取得相关人员(QM,PQE,PM,GM)及客户确认后可将此物货物放宽接收。并且评估此缺陷的严重情况提起退货重检报告(只有在退货时用此表) 或/和 纠正预防措施报告 或/和 不良品报告。
5.4 Defective products which be returned from customer, pls follow
Note: 注意
(1) Decision of the disposal of the non-confirming materials/products should be done immediately. When there are some arguments, the party should report to their higher-up immediately to settle down the problem. As to the defect parts could be transfer to ’On Hold’ location when the dispute could not be solved within 24 hour.不合格产品的处理决定应马上进行。如有纷争时,相关方应及时上报给其上一层领导处理解决。当该纷争不能在24h内解决时,可将该不良品转至‘待处理’库。
(2) Regarding degrade/Concession parts, SAAF must be used and get related person’s (QC Supervisor/PQE/PM/PE/QM/GM) signature. 不良品需做降级处理或让步接受时,须填写SAAF例外放行单并由相关人员(QC Supervisor/PQE/PM/PE/QM/GM)签字。
(3) The lead time of all material/product in the on hold location should be dealt with is within 10 days( The decision time should be less than 2 days, disposing time could not over 8 days)
5#
发表于 2011-11-3 03:19:03 | 只看该作者
待处理库中所有问题材料或产品的处理必须在10天内完成。(处理建议不多于2天,处理时间不超过8天)
(4) Transfer of SAP system should keep same pace with actual parts transference. SAP的系统转移要与实际物品的转移保持同步。
(5) All process record need to be kept well and updated timely.所有过程的纪录需要保存完整并及时更新。

6.Efficiency measurement 有效果测量方式
KPI & management review, Monthly block report. KPI, 月在库封锁材料报告和管理评审
7.Attachments/Relevant documents 附件/相关文件
Control of Non-conforming Material/Procedure
Outgoing Quality Control.
Incoming Quality Control


8. Record filing and retention 填写记录及保存
Inspection Report (only for returned goods) 退货重检报告
Defective Material Complaining Form 不合格材料报告
The Bill of Application for Out Scrap 外部来料不良退库记录表
Defective Report 不合格报告
Special Acceptance Application Form 例外放行单
QC Non-conformity Notice QC不合格通知单
Corrective Preventive Action Report 纠正预防措施报告


9. Flow chart 流程图
6#
 楼主| 发表于 2011-11-3 03:19:09 | 只看该作者
关键的流程图,怎么没有了呢?
7#
 楼主| 发表于 2011-11-3 03:19:15 | 只看该作者
可否详细的讲解一下“3E联动模式”呢?
8#
发表于 2011-11-3 03:19:21 | 只看该作者
就是三现主义,不良发生3E同时到场,现场解决问题.
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