1、s and change control process. How do PAD changes get communicated and 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 cont
2、rols, check sheets, etc. at the workstation. Are they understood? are 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, Ke
3、y Element, CVIS, SOS, JES)BIQ-4Product quality standards are common within 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.有文件化的程序来制订、批准和修改产
4、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更改产品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)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?后工序的产品质量标准
5、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 p
6、rocess.Look for Product Quality Standards in each area (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 sh
7、eets, etc.at the work station. Are they understood? 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
8、a process that reviews external data and makes adjustments 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
9、 Process (CPIP) should be in place and functioning. Look for meeting times and agenda.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? 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。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。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的质量标准。查
10、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。Manufacturing Process Validation The method by which processes are prepared and validated before starting full volume production.To ensure that each manufacturing process is capable of meeting defined product quality standards, while achieving schedule.制造程序验证在批量生产前准备和验
11、证程序的方法在赶进度的同时,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 involvement with the Manufacturing Process Team. If E
12、rror 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)Ask what happens if the operator puts the wrong par
13、t 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 with engineering requirements. (i.e. Key Characte
14、ristic 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 each type of KPC. Review several KPC operations and
15、look for process control plans. Try to ensure understanding of KPC Plan 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 (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)根据工程要求来鉴定和实施过程控制。(例如关键特性分布系统、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
16、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 see change Process Control documentation. Is the Yellow Dot Process
17、 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 problems identified before next build event.See BIQ 13BIQ-16Primary and bac
18、k-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 documented.(tag)BIQ-17A Total Productive Maintenance (TPM) Plan is i
19、mplemented 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?改变人员、机器、物料、方法、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?在生产条件下是否
20、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。在下阶段制造开始前鉴定过的问题实施对策。见BIQ-13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。 In Process Control and VerificationThe system of building quality in station through prevention, detection, and containment of abnormalitie
21、s.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 with defects. 过程控制与验证通过预防、发现、牵制异常状况在岗位上建造质量的系统时程序验证最少化,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
22、performed in every process (production, inspection, maintenance, etc.).Look for work instructions (SOS, ALBS, JES or IOM/IOS sheets) at each operation. Compare sheet to actual operator movement.BIQ-19Prevention - A Total Productive Maintenance (TPM) Plan is implemented.Ask if the on-line equipment i
23、s 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 is followed.Ask the Quality Manager to review the Plant Quality Plan. Is it documented? Is it understood by the organization?BIQ-21Prevention
24、- Only parts that meet defined standards are delivered to the line.Operator work instructions should include how to identify and to handle non-conforming material. (check job cert board) Is there a receiving inspection process? Is the Material Department involved in containerization issues? BIQ-22Pr
25、evention - Reviews of key process equipment are held to identify requirements for improvement (e.g., safety, torque applications, Global Customer Audit, etc.). 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。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。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
26、所理解?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 effec
27、tiveness of all process adjustments/corrective actions are verified over a specified period to assure effectiveness.(e.g., after TPM, calibration, machine maintenance).Look for documentation that would indicate changes and validation of change. Trend charts should also be available that will indicat
28、e the effectiveness of the corrective action.BIQ-24Prevention - Required tooling, error proofing devices, gauges and safety equipment are standardized across the plant.All of this information should be documented on the operation certification board. Visual verification will determine utilization.BI
29、Q-25Prevention - Function and use of error proofing devices are verified on a scheduled basis to maintain, consistent required functionality. 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
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