aiag cqi9热处理系统评估中英文.doc

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1、Special Process: Heat Treat Process Assessment特殊过程：热处理过程评估Question Number Question问题Requirements / Guidance要求/指导Objective Evidence客观证据Assessment 评估N/A 不适合Satisfactory 满意Not Satisfactory 不满意Needs Immediate Action 需要立即改进Section 1 - Management Responsibility & Quality Planning管理职责&质量计划现场是否配备有资格的热全职、在册员

2、工处理专业人员?具备冶金和热处理专业知识至少5年热处理操作经验或至少5年基础冶金教育及热处理经验Is there a dedicated and qualified heat treat person on-site? To ensure readily available expertise, there shall be a dedicated and qualified heat treat person on site. This individual shall be a full-time employee and the position shall be reflected i

3、n the organization chart. A job description shall exist identifying the qualifications for the position including metallurgical and heat treat knowledge. The qualifications shall include a minimum of 5 years experience in heat treat operations or a combination of a minimum of 5 years of formal metal

4、lurgical education and heat treat experience. 1.2 是否进行热处理的先期质量策划？（APQP） 有APQP程序，每个零件进行了可行性研究和内部批准相似零件能够组成零件族并得到定义PPAP后，无顾客 未批准的过程更改重大过程更改的澄清应联系顾客并保持记录1.2 Does the heat treater perform APQP? The organization shall incorporate a documented Advance Product and Quality Planning (APQP) procedure. A feasi

5、bility study shall be performed and internally approved for each part. Similar parts can be grouped into part families for this effort as defined by the organization. After the Production Part Approval Process (PPAP) is approved by the customer, no process changes are allowed unless approved by the

6、customer. The heat treater shall contact the customer when clarification of process changes is required. This clarification of significant processes change shall be documented. 具有文件化的PFMEA管理程序并确保PFMEA得到更新以反映当前零件的质量状态PFMEAs适用与每个零件或零件族，体现了从接收到发运的所有过程步骤和所有关键的过程参数有组织或顾客确定的重要或关键特性应得到识别、定义和体现在FMEAs中应有包括生产

7、操作者在内的跨功能小组来开发PFMEA 每年应考虑解决高的风险系数（RPNS）的项目PFMEAs是否得到更新，并与目前的过程相一致？Special Process: Heat Treat Process Assessment特殊过程：热处理过程评估Question Number Question问题Requirements / Guidance要求/指导Objective Evidence客观证据Assessment 评估N/A 不适合Satisfactory 满意Not Satisfactory 不满意Needs Immediate Action 需要立即改进The organization

8、 shall incorporate the use of a documented Process Failure Mode and Effects Analysis (PFMEA) procedure and ensure the PFMEAs are updated to reflect current part quality status. The PFMEA shall be written for each part or part family or they may be process-specific and written for each process. In an

9、y case, they shall address all process steps from part receipt to part shipment and all key heat treat process parameters as defined by the organization. A cross-functional team, including a production operator, shall be used in the development of the PFMEA, and items with the highest Risk Priority

10、Numbers (RPNs) shall be addressed annually. All significant or critical characteristics, as defined by the organization and its customers, shall be identified, defined, and addressed in the PFMEA. Are heat treat PFMEAs up to date and reflecting current processing? 具有文件化的控制计划管理程序确保控制计划得到更新，以反映当前的控制使用

11、于每个零件或零件族，体现了从来料接收到零件发运的所有过程步骤、所有关键的过程参数和所使用的设备应有包括生产操作者在内的跨功能小组来开发控制计划与作业指导书（Work Instructions) 、工艺流程卡（Shop travelers）、PFMEAs保持一致性由组织或顾客确定的重要或关键特性应得到识别、定义和体现针对过程和产品特性评估的样本大小和抽样频率应该与该过程表中的和节中的最低要求保持一致控制计划是否得到更新，并与目前的过程相一致？The organization shall incorporate the use of a documented Control Plan proced

12、ure and ensure the Control Plans are updated to reflect current controls. The Control Plans shall be written for each part or part family or they may be process-specific and written for each process. In any case, they shall address all process steps from part receipt to part shipment and identify al

13、l equipment used and all key heat treat process parameters as defined by the organization. A cross-functional team, including a production operator, shall be used in the development of Control Plans, which shall be consistent with all associated documentation such as work instructions, shop traveler

14、s, and PFMEAs. All significant or critical characteristics, as defined by the organization and its customers, shall be identified, defined, and addressed in the Control Plans. Sample sizes and frequencies for evaluation of process and product characteristics shall also be addressed consistent with t

15、he minimum requirements listed in the Process Tables, Sections 3.0 and 4.0. Are heat treat process control plans up to date and reflecting current processing? Special Process: Heat Treat Process Assessment特殊过程：热处理过程评估Question Number Question问题Requirements / Guidance要求/指导Objective Evidence客观证据Assessm

16、ent 评估N/A 不适合Satisfactory 满意Not Satisfactory 不满意Needs Immediate Action 需要立即改进1.5 1.5 1.6 1.6 所有相关的或引用的规范是否为最新的和可用的？包括但不限于：SAE、AIAG、ASTM、GM、FORD、DC等Are all heat treat related and referenced specifications current and available? For Example: SAE; AIAG, ASTM, General Motors, Ford, and DaimlerChrysler.

17、对所有的操作过程是否有书面的过程规范？Is there a written process specification for all active processes? 所有相关的或引用的规范应是最新的和可用的。包括但不限于：SAE、AIAG 、ASTM、GM、FORD、DC等应有一个形成文件的过程，适时评审、分发和执行顾客的工程标准和规范（Customer requirments），该过程一般不超过两周，文件规定由谁、如何得到、如何维护、如何建立最新状态跟踪和如果传递到生产现场？To ensure all customer requirements are both understood

18、and satisfied, the organization shall have all related heat treat and customer referenced standards and specifications available for use and a method to ensure that they are current. Such standards and specifications include, but are not limited to, those relevant documents published by SAE, AIAG, A

19、STM, General Motors, Ford, and DaimlerChrysler. The organization shall have a process to ensure the timely review, distribution, and implementation of all relevant customer and industry engineering standards and specifications. This process shall be executed as soon as possible and shall not exceed

20、two weeks. The organization shall document this process of review and implementation, and it shall address how customer and industry documents are obtained, how they are maintained within the organization, how the current status is established, and how the relevant information is cascaded to the sho

21、p floor within the two-week period. The organization shall identify who is responsible for performing these tasks. 对所有的操作过程都应有书面的过程规范，并包含所有过程的步骤操作参数包括过程温度、时间周期、装载率、气氛流量设置、传送速度、淬火搅拌速度等，应确定其公差范围以便进行控制过程规范可以采用工作指导书、作业卡、计算机系统的参数设定表单（Computer-based recipes）或其它类似的文件形式The heat treater shall have written pr

22、ocess specifications for all active processes and identify all steps of the process including relevant operating parameters. Examples of operating parameters include process temperatures, cycle times, load rates, atmosphere or gas flow settings, belt speeds, quench agitation speeds, etc. Such parame

23、ters shall not only be defined, they shall have operating tolerances as defined by the organization in order to maintain process control. All active processes should have a written process specification. These process specifications may take the form of work instructions, job card, computer-based re

24、cipes, or other similar documents. Special Process: Heat Treat Process Assessment特殊过程：热处理过程评估Question Number Question问题Requirements / Guidance要求/指导Objective Evidence客观证据Assessment 评估N/A 不适合Satisfactory 满意Not Satisfactory 不满意Needs Immediate Action 需要立即改进生产初始阶段、过程设备重新布置和大修改造之后是否进行了有效的能力验证？新购过程设备或重新布置或

25、大修改造后的设备是否有效的完成了过程能力研究？为证明每一个过程能够生产出可接受的产品，供应商应对每一个过程进行生产能力研究，包括在初始验证、任何过程设备重新布置或大修（应定义何为大修）之后初始能力研究应包括指定了年度工作范围的每一条热处理炉生产线的热处理过程，一条热处理炉生产可能包括很多设备的组合以集成需要的热处理工艺，如硬化、淬火和回火能力研究技术应针对热处理产品特性参数是适当的，这些参数包括抗拉强度、硬化深度、硬度任何顾客的特殊要求均应满足，当没有顾客特殊要求时，应建立一个能力的接受准则（Acceptable ranges）以测量过程能力，一旦超过顾客的特殊要求和内部规定的接受准则时，应采

26、取行动计划Has a valid capability study been performed initially and after process equipment has been relocated, or had a major rebuild? To demonstrate each process is capable of yielding acceptable product the organization shall perform product capability study for the initial validation of each process,

27、 after relocation of any process equipment, & after a major rebuild of any equipment. The organization shall define what constitutes a major rebuild. Initial product capability studies shall be conducted for all heat treat processes per furnace line defined in scope of work & annually thereafter. A

28、furnace line may include a combination of equipment that is integrated in the performance of a heat treatment process, i.e. hardening, quenching, and tempering. Capability study techniques shall be appropriate for the heat treat product characteristics, i.e. tensile strength, case depth, hardness. A

29、ny specific customer requirements shall be met, in the absence of customer requirements, the organization shall establish acceptable ranges for measures of capability. An action plan shall exist to address the steps to followed in case capability indices fall outside customer requirements or establi

30、shed ranges. 热处理产品和过程数据的分析能提供缺陷预防的重要信息是否针对整个过程搜集分应建立一个全过程收集、分析、和反映产品和过程数据的系统1.8 析数据，并针对这些数据分析方法包括对重要产品和过程参数的现行趋势和历史数据的分析进行适当的反应？应确定哪些参数需要列入分析范围The analysis of products and processes over time can yield vital information Does the heat treater for defect prevention efforts. The organization shall have

31、 a system to collect, collect and analyze data analyze, and react to product or process data over time.1.8 over time, and react to Methods of analysis shall include ongoing trend or historical data analysis of this data? significant product or process parameters. The organization shall determine whi

32、ch significant parameters to include in such analysis. Special Process: Heat Treat Process Assessment特殊过程：热处理过程评估Question Number Question问题Requirements / Guidance要求/指导Objective Evidence客观证据Assessment 评估N/A 不适合Satisfactory 满意Not Satisfactory 不满意Needs Immediate Action 需要立即改进管理者应每24小时评审热处理监控系统管理者是否每24小

33、时评审监视包括但不限于：温度纸带记录、气氛纸带记录、计算机数据日志、热热处理炉监控系统处理炉及操作者日志（Furnace Monitoring 评审包括对失控状态或报警状态的探测。热处理炉数据的评审过程应进行Systems）？ 记录，该记录要求同样适用于计算机数据Is management reviewing the heat treat monitoring system every 24 hours? Management shall review the furnace monitoring systems at intervals not to exceed 24 hours. The

34、 heat treat monitoring system includes but is not limited to temperature strip charts, atmosphere strip charts, computer data logs, furnace and operator logs, etc. The management review shall include efforts to detect out-of-control conditions or alarm conditions. The process of reviewing the furnac

35、e data shall be documented and this requirement also applies to computerized data. 是否每年至少一次按每年最少一次按AIAG的HTSA进行内部审核，应及时发布审核时发现的问1.10 AIAG的HTSA进行内部审题点核？Are internal assessmentsbeing completed on anThe organization shall conduct internal assessments on an annual basis, at 1.10 annual basis, at a a mini

36、mum, using the AIAG HTSA. Concerns shall be addressed in a timely minimum, using AIAG manner.HTSA?应有一个文件化的返工（reprocessing）批准系统，包括对指定人的授权该程序应描述哪些产品特性允许，哪些不允许是否有一个文件化的返工任何一个返工，需要有资格的技术人员编制一个新的过程控制表，表明热1.11 批准系统？处理更改的必要性应记录何时、有多少材料被返工质量经理或指派的授权人员应批准再处理零件的发运Is there a system in place to authorize reproc

37、essing and is it documented? The quality management system shall include a documented process for reprocessing that shall include authorization from a designated individual. The reprocessing procedure shall describe product characteristics for which reprocessing is allowed as well as those character

38、istics for which reprocessing is not permissible. Any reprocessing activity shall require a new processing control sheet issued by qualified technical personnel denoting the necessary heat treat modifications. Records shall clearly indicate when and how any material has been reprocessed. The Quality

39、 Manager or a designee shall authorize the release of reprocessed product. Special Process: Heat Treat Process Assessment特殊过程：热处理过程评估Question Number Question问题Requirements / Guidance要求/指导Objective Evidence客观证据Assessment 评估N/A 不适合Satisfactory 满意Not Satisfactory 不满意Needs Immediate Action 需要立即改进针对顾客和内部

40、关注的问质量管理体系应包括一个针对文件化、评审和识别外部顾客关注和任何其题，质量部门是否评审、他内部关注问题的过程处理并形成文件？可以采用有纪律的问题解决方法Does the Quality The quality management system shall include a process for documenting,Department review, reviewing, and addressing customer concerns and any other concernsaddress, and document internal to the organizatio

41、n. A disciplined problem-solving approach shall becustomer and internal used.concerns? 应建立一个持续改进过程，适用热处理审核范围的每个过程，这些过程的是否针对热处理审核范围设计应带来质量水平和生产率的持续改进内的每个过程，建立了适行动计划应体现优先顺序和日期要求（完成时间）用的持续改进计划？应提供该项目运行有效性的证据1.13 1.14 1.14 1.15 Is there a continual improvement plan applicable to each process defined in

42、the scope of the assessment? 质量管理者或指定的责任人是否批准对隔离材料进行处置？Does the Quality Manager or designee authorize the disposition of material from quarantine status? 是否建立覆盖整个热处理过程适用于操作者的操作手册？The heat treater shall define a process for continual improvement for each heat treat process identified in the scope of

43、the HTSA. The process shall be designed to bring about continual improvement in quality and productivity. Identified actions shall be prioritized and shall include timing (estimated completion dates). The organization shall show evidence of program effectiveness. 质量管理着有责任批准和文件规定适当的人员对隔离材料进行处置The Qua

44、lity Manager is responsible for authorizing and documenting appropriate personnel to disposition quarantine material. 应建立覆盖整个热处理过程（从接收到发运）的、适用的作业指导书（或操作手册）这些程序或作业指导书包括潜在情况（如动力中断）设备开动和停止、产品隔离、产品检验及一般操作程序这些程序或作业指导书应覆盖从原材料接收到产品发运的所有操作步骤并能由车间人员方便获取Special Process: Heat Treat Process Assessment特殊过程：热处理过程

45、评估Question Number Question问题Requirements / Guidance要求/指导Objective Evidence客观证据Assessment 评估N/A 不适合Satisfactory 满意Not Satisfactory 不满意Needs Immediate Action 需要立即改进1.15 1.16 1.16 1.17 Is there an operations manual available to heat treat personnel covering the entire heat treating process? 管理着是否始终为所有热

46、处理员工（包括后备的、临时的）提供培训？Is management providing employee training for heat treating? 是否建立责任矩阵表证明所有关键的管理和监控活动都由有资格的人员完成？An operations manual shall be available to heat treat personnel covering the entire heat treating process. The manual shall include procedures or work instructions addressing potential

47、emergencies (such as power failure), equipment start-up, equipment shut-down, product segregation (See 2.8), product inspection, and general operating procedures. These procedures or work instructions shall cover all steps of the operation from product receipt to product shipment and shall be access

48、ible to shop floor personnel. 管理者必须始终为所有热处理员工（包括后备的、临时的）提供培训必须保持文件化的证明以表明员工得到了培训和进行了培训有效性的评估必须确定每项活动所需要的资格要求及现在和将来的培训需求The organization shall provide employee training for all heat treating operations. All employees, including backup and temporary employees, shall be trained. Documented evidence shall be maintained showing the employees trained and an assessment of the effectiveness of the training. Manage