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1、bulit-in-quality制造质量element name:product quality standardsdefinition:measurable requirements for product characteristics, which when satisfied, ensure our products meet internal /external customer requirements.purpose:to provide criteria for product evaluation.要素名称:产品质量标准定义:当客户满意时为确保我们的产品满足内部、外部客户的要

2、求的产品特点的可测要求目的:为产品评估提供标准biq-1a documented process is in place to develop, approve and revise the product quality standards.look for product assembly documents (pads, process sheets, engineering data sheets, etc.), references to pads and change control process. how do pad changes get communicated and

3、updated on the floor?biq-2product quality standards are clearly communicated to the user/operator at the work place.look for evidence that quality standards were communicated to the operator. look for boundary samples, visual controls, check sheets, etc. at the workstation. are they understood? are

4、there tools to measure the standard? is the standard defined and applied? biq-3the product quality standards are incorporated into the standardized work. look at standardized work sheets, for necessary standards. (bpp, iom/ios, key element, cvis, sos, jes)biq-4product quality standards are common wi

5、thin platforms.engineering change process should be in place and understood. (engineering change meeting agenda and minutes)biq-5product quality standards are not tighter than those applied in upstream processes.biq-1有文件化的程序来制订、批准和修改产品质量标准。查看产品装配文件(pad、工艺卡片、工程数据单等),参考pad更改控制程序。怎样让现场知道并实施pad更改biq-2产品

6、质量标准要让现场使用者/操作工都清楚。要查看质量标准已传递给操作工的证据。要在工作现场查看边界样板、可视化控制、检查单等。操作工理解这些东西吗?他们有量具去测量这些标准吗?标准是明确的和已执行的吗?biq-3将产品质量标准溶入标准化工作。查看标准化工作单(bpp、iom/ios、关键要素、cvis、sos、jes)biq-4当发生工程更改时,要确保产品质量标准处于同一水平。当要进行工程更改时,是否召开了评审会,并形成会议纪要;是否考虑了对同一系列车质量标准的影响?biq-5后工序的产品质量标准不能比前工序的产品质量标准更严格。比较操作工位和检验工位的检验标准。检验站的标准要比care线的标准更

7、严。compare inspection criteria for a specific element at the operation, inspection station (if applicable), standards should be tighter at verification station than at care.biq-6product quality standards are defined and applied at each stage of the process.look for product quality standards in each a

8、rea (body, paint, chassis, ga, etc.) are the pqss included in the standardized work documentation and are they understood by the operator.biq-7product quality standards are measureable.look for boundry samples, visual controls, visual aids, check sheets, etc.at the work station. are they understood?

9、 are there tools to measure the standard? are the standards defined and applied?biq-8product quality standards must satisfy customer (as determined from external data such as surveys, clinics, etc.), engineering and regulatory requirements.look for a process that reviews external data and makes adju

10、stments or corrective actions accordingly (mob, glove box, gds, warranty, j.d. powers)biq-9a formal process exists to feed back to engineering, plant capability to meet quality standards for future product development.the current product improvement process (cpip) should be in place and functioning.

11、 look for meeting times and agenda.biq-6质量标准要定义并应用于制造过程的各个阶段。查看每个区域的质量标准(车身、涂装、总装车间等),产品质量标准已纳入标准化文件中并被操作工理解吗? biq-7产品质量标准是可测量的。查看现场的边界样板、可视化控制、可视化辅助、检查单等。操作工理解这些东西吗?他们有量具去测量这些标准吗?标准是明确的和已执行的吗?biq-8产品质量标准必须满足顾客需要(从外部调查、测评得到的数据而确定)和工程、调整要求。查看是否使用了外部数据对产品质量标准进行了调整和改进。biq-9要有一套正是的程序来反馈工程能力和产能,以满足未来产品开发

12、的质量标准。查看现有产品的改进程序的实用性和有效性,以及产品改进会议的纪要。element name:manufacturing process validation definition:the method by which processes are prepared and validated before starting full volume production.purpose:to ensure that each manufacturing process is capable of meeting defined product quality standards, wh

13、ile achieving schedule.要素名称:制造程序验证定义:在批量生产前准备和验证程序的方法目的:在赶进度的同时,确保每一个制造程序能够达到要求的产品质量标准biq-10error proofing is incorporated in process/product design activity.review operation for error proofing devices. if error proofing was installed as part of the manufacturing process ask if the plant had any inv

14、olvement with the manufacturing process team. if error proofing was not part of the manufacturing process ask if error proofing was part of a corrective activity (biq-38)biq-11failure mode and effects analysis method is used in the development of processes. (minimum requirement: critical processes)a

15、sk what happens if the operator puts the wrong part on the vehicle. is it possible and if so when is it first identified. was front load teams involved in early development of processes and are countermeasures in place if failure occurs.biq-12process controls are identified and implemented to comply

16、 with engineering requirements. (i.e. key characteristic designation system, process control plans).ask what the process is if the operator or tool is unable to perform a key product characteristic (kpc) element.(does the operator utilize the andon cord?) there should be process control plans for ea

17、ch type of kpc. review several kpc operations and look for process control plans. try to ensure understanding of kpc plan biq-10将防错应用到过程/产品设计中。检查制造过程中是否应用了防错;检查改进过程中是否应用了防错biq-11 (pfmea)失效模式及影响的分析要应用在过程的开发中(最低要求:评审相关程序)。询问是否操作工可能装上错误的零件?如果装上了错误的零件何时能发现?错误发生后是否有相应的对策?(pfmea)biq-12根据工程要求来鉴定和实施过程控制。(例如

18、关键特性分布系统、过程控制计划)当操作者和工具无法执行kpc要素,程序如何运作?每种kpc都应有过程控制计划。相关员工是否理解kpc控制计划?biq-13processes are validated in case of changes to man, machine, material, method and environment (e.g. conduct structured workstation readiness program).ask what the process is for making and validating changes, explain. ask to

19、 see change process control documentation. is the yellow dot process used? is pfmea applied?biq-14manufacturing validation is conducted under production conditions.review ptr process to see if trial builds were conducted in full production conditions.biq-15countermeasures are implemented for problem

20、s identified before next build event.see biq 13biq-16primary and back-up tools, equipment, containers and methods are validated prior to use.the on-line back-up equipment should have a schedule for testing and should be visible. back-up hand power tools are validated in tool crib and this should be

21、documented.(tag)biq-17a total productive maintenance (tpm) plan is implemented prior to system fill. was the tms plan utilized during the start up process.was a production maintenance partnership (pmp) developed that involves production in the responsibility for quality processes? biq-13改变人员、机器、物料、方

22、法、环境(例如管理已有的固定化工作程序)时要进行过程验证。检查过程变更的验证程序,检查过程变更控制文件。使用了黄点流程和pfmea吗?biq-14在生产条件下是否实施了制造确认。评估ptr程序,看看在产品试制时是否考虑了批量生产需要。biq-15在下阶段制造开始前鉴定过的问题实施对策。见biq-13biq-16各个阶段的工具、设备、工位器具和方式在使用前都要加以验证。应制定备用设备的检查计划并目试化。备用手动工具应放在工具箱中确认并记录结果biq-17在系统填充前要实施tpm计划。涉及质量的生产过程都要有pmp。 element name: in process control and ver

23、ificationdefinition:the system of building quality in station through prevention, detection, and containment of abnormalities.purpose:to minimize process variation to ensure that all products are ok in station and are confirmed as soon as possible following manufacture and to reduce waste associated

24、 with defects. 要素名称:过程控制与验证定义:通过预防、发现、牵制异常状况在岗位上建造质量的系统目的:时程序验证最少化,确保所有的产品在岗位上是合格的并尽快确定随后的制造,减少因缺陷造成的浪费biq-18prevention - standardized work is performed in every process (production, inspection, maintenance, etc.).look for work instructions (sos, albs, jes or iom/ios sheets) at each operation. compa

25、re sheet to actual operator movement.biq-19prevention - a total productive maintenance (tpm) plan is implemented.ask if the on-line equipment is checked/tested on a regular basis by the on-line operator and it is documented. (pmp is used in north america.) biq-20prevention -a documented quality plan

26、 is followed.ask the quality manager to review the plant quality plan. is it documented? is it understood by the organization? biq-21prevention - only parts that meet defined standards are delivered to the line.operator work instructions should include how to identify and to handle non-conforming ma

27、terial. (check job cert board) is there a receiving inspection process? is the material department involved in containerization issues? biq-22prevention - reviews of key process equipment are held to identify requirements for improvement (e.g., safety, torque applications, global customer audit, etc

28、.). biq-18在每个过程(生产、检查、维修等)都贯测标准化工作。在每个工位上查看sos、albs、jes或iom/ios操作单以及工人是否按单操作。biq-19实施了tpm计划。操作工是否定期检查了在线使用的设备并作了记录。 biq-20文件化的零件质量计划要得以贯彻。询问质量主管来评估车间质量计划。是否文件化并被团队所理解?biq-21只有符合标准的零件能送到线旁。操作者工作指导要写明如何鉴定和处理不合格物料。有物料验收程序吗?物料部门是否管理货柜运输问题?biq-22关键过程的设备要坚持检查和维护以满足不断提高的要求(例如安全、扭矩控制、gca、)。召开了专门会议来讨论这些问题吗?谁

29、参加?使用了车间问题解决程序吗?are there specific meetings held that review these issues? who attends? is the plant problem solving process used? follow-up?biq-23prevention - the effectiveness of all process adjustments/corrective actions are verified over a specified period to assure effectiveness.(e.g., after tp

30、m, calibration, machine maintenance).look for documentation that would indicate changes and validation of change. trend charts should also be available that will indicate the effectiveness of the corrective action.biq-24prevention - required tooling, error proofing devices, gauges and safety equipme

31、nt are standardized across the plant.all of this information should be documented on the operation certification board. visual verification will determine utilization.biq-25prevention - function and use of error proofing devices are verified on a scheduled basis to maintain, consistent required func

32、tionality. ask if error proofing devices are checked on a specified schedule. look for evidence that the error proofing devices have been validated for proper function.biq-26detection - required quality checks are included in standardized worklook for this information in the work sheets that make up

33、 standardized work. (i.e. bpp, iom/ios, key elements, jes, sos, cvis) biq-23所有工艺调整和改善活动的效果都要经过一段时间的跟踪以验证其有效性。查看更改纪录和更改确认纪录,还有反映改善效果的趋势图。biq-24车间必需的工具、防错设施、量具、安全设备都要标准化。所有信息都要文件化biq-25防错设施的功能和使用情况要按计划检验和维修。防错设施是否按特定计划进行了检查,寻找证据证明防错设施处于正常工作状态。biq-26质量检查要溶入标准化工作中。在工作单中是否包含了bpp、iom/ios、关键要素、jes、sos、cvis

34、?biq-27detection - quality check items are based on defined criteria (e.g., shipping priority audit standards, jd power, appearance, risk, regulation, global customer audit, global delivery survey and frequency).ask why that specific item is checked at this particular operation and not somewhere els

35、e. look for understanding and purpose.biq-28detection - sufficient resources are allocated in accordance with the quality plan (e.g., space, time, people, equipment) to assure required as shipped quality levels.is the operation being preformed within the footprint. are there quality inspectors at ea

36、ch verification station. does the operator have the required tools for quality checks.biq-29detection - quality check systems are updated to reflect changes in technical data.ask how pad changes are implemented and verified. (torque, fit, fluids, welds etc)biq-30detection - inspection frequencies of

37、 critical operations are established to prevent defects from leaving the department / shop.review check sheets for frequency to insure that defects do not leave department / shop.biq-27质量检查内容是依据特定的标准。(例如货运优先权评估标准、jd power调查报告、外观要求、风险、法规、gca、gds、频率)评估检查内容的合理性。检查项目是否被工人理解?biq-28要配备充足的资源来完成质量计划(例如空间、时间

38、、人员、设备),已达到高标准的质量水平。检验工作是否按规定进行?每个检验点是否都有检验员?操作工是否都有所需的质量检验工具?biq-29当技术数据改变时,质量检查系统也要相应更新。怎样执行和确认pad的变更(例如扭矩、配合、焊接等)。biq-30确定合理的检验频率以确保缺陷不传递到下工序。查看检查表的检验频率是否能确保缺陷不传递到下工序。biq-31detection - the repair of documented discrepancies is verified by independent inspection.verify who confirms repair of docum

39、ented discrepancies found by inspection of critical operations. critical operations are defined as product characteristic for which reasonably anticipated variation could significantly affect the products safety or compliance with governmental standards or regulations. or is likely to significantly

40、affect customer satisfaction with a product.biq-32detection - inspection verification is located, as a minimum, at the end of each shop / department.look for locations of verification stations.biq-33detection - inspection verification is increased in case of quality risks, such as new model launch a

41、nd major changes.understand current status (start-up, steady state, line rate change, jd power improvements) within the plant and ask if additional inspections are in place.biq-34detection - inspection verification is diminished to a auditing/confirmation role if/when capability reaches targeted lev

42、els over a specified time.ask if inspection levels have been changed and based on what information. look for trend charts. (special cause items)biq-31产品缺陷的返修要由专门的检验员来确认。是否指定专门的检验员来确认对缺陷的返修情况(尤其是影响产品的安全性、不符合政府制定的标准和法规或降低顾客的满意度的缺陷)。 biq-32每个车间至少要在车间的尽头设置一个质量门。察看质量门的设置情况。biq-33当新产品投产或发生产品重大更改时,检验验证项目和频

43、率应增加。当车间生产重新启动、状态不稳定、提高生产节拍、jd power需改进时,是否增设额外检查?biq-34只有当质量水平达到目标值并保持相当长一段时间(该时间的长短应有明文规定),检验工作才能相应减少。如果检验级别发生变化,要察看其依据是什么。biq-35detection - point, touch, listen and count inspection methods are incorporated in standardized work.look for inspection operator method/inspection operator summary (iom/

44、ios) sheets and observe the operator to the details.biq-36detection - audio/visual signals exist and procedures are implemented for alarm response and escalation to manage abnormal conditions.look for stack lights, andon cords, etc., and validate function if possible. also ask for understanding of p

45、rocess. biq-37containment - an andon system is implemented at all production and inspection stations which when activated will stop the process at a fixed position.look for fps marks on the floor and pull cord presence. validate function if possible. ask for understanding of process. biq-38containme

46、nt - a process is stopped when discrepancies that impact downstream activities must be controlled in station.observe the process to see if this takes place. look for a reaction plan (andon).biq-35听、数、触摸等检验方法应标准化。查看iom/ios并检查操作工的执行情况。biq-36建立了声像系统,又报警流程来管理异常情况。验证应急灯、暗灯拉索的可靠性,询问操作工是否知道其实用程序。biq-37暗灯系统

47、应安装在所有的生产和检验场所,并设好固定停止点。查看fps和暗灯拉绳,可能的话再验证其功能。询问操作者是否知道实用程序。biq-38当影响下工序的缺陷产生且必须在本工序控制好时,应该停线。观察是否照章执行。查看响应计划。biq-39containment - a documented containment procedure is followed and the containment is verified as being effective.ask about the procedure for containment and control plans when applicabl

48、e. (torque, welds, spills, etc.) biq-40containment - a problem solving process is initiated to identify permanent corrective actions which is verified as being effective.ask how corrective action are verified for effectiveness. (inspect repair set-up before vs by production) biq-39是否有一套文件化的包容程序在运行,并

49、且经验证是有效的。查询包容程序和控制计划(扭矩、焊接、溢出等)。biq-40启动一套问题解决程序来验证长期改进措施的有效性。询问如何鉴别改进措施是有效的。element name:quality feedback/feedforwarddefinition:the communication of quality expectations and results between customers and suppliers through standardized communication pathways.purpose:to ensure that information on qua

50、lity reaches those who need it.要素名称:质量前馈/反馈定义:通过标准化的交流途径与客户和供应商进行的对质量的期望值和绩效的交流目的:确保关于质量的信息能够传递给需要的人biq-41identifies customers and suppliers of each process.ask how defects are documented. (cqis, msdb should be utilized and broken out by dept. group and operation)biq-42defines timing, content, and f

51、orm of information required by customer/supplier at all organizational levels.ask to see the latest report of defects from a given inspection point and review content. verify that information is being used to effect the problem solving process.biq-43use a defined and documented communication system

52、that establishes and tracks in-process measurements(e.g. ok rate and/or defect ratio quality inspection station).targets and goals should be available at each verification station.biq-44feeds forward in cases of escaped defects, backup tool/equipment use, problem resolution and changes in process/pr

53、oduct.review containment process of identified escaped defects. review backup tool/equipment use process, resolution of problem and process / product changes process.biq-45feeds back in cases of identified defects and problem resolution.look at alarm sheets at the verification stations for responses

54、 and containment. go to operation and look for evidence that defect was communicated to operator. biq-41每一个流程都包含与顾客、供应商交流的信息反馈系统。缺陷是如何纪录的?部门人员与操作供应使用cqis、msdb。 biq-42信息反馈应标明信息的时间、内容和交流形式以满足顾客、供应商的需要。查看检查点提供的最新缺陷报告并审核其内容。验证这些信息已被用于问题解决流程中。biq-43用一个清晰且文件化的信息交流程序来建立过程跟踪办法(例如:ftq、pph)等。每一个质量确认站都应有目标值。bi

55、q-44当发现漏检缺陷、使用备用工具/设备、问题已解决、产品/工艺变更时要进行前馈。验证漏检缺陷的包容程序。验证备用工具/设备使用程序。验证问题确认、产品/工艺变更程序。 biq-45确认缺陷和解决问题时要进行进行反馈。查看检验站的报警表,了解其响应和包容情况。查看检验工位是否将缺陷情况告知操作工。biq-46provides input to the problem solving process.look for evidence that identified defects are entered into the problem solving process for root cause, corrective action and measured for effectiveness.biq-47has a tracking element for follow-up of problems.within the problem solving process is there a documented process that tracks, reviews status and effective

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