CQI-9热处理过程审核.xls

Que stio n Num ber 问题问题 编号编号 Question问题问题Requirements and Guidance要求与标准要求与标准Objective Evidence客观证据客观证据 N/A 不不 合合 适适 Satisfa ctory 满意满意 （目（目 的）的） Not Satisfa ctory 不满意不满意 Needs Immed iate Action 须立即须立即 纠正纠正 1.1 Is there a dedicated and qualified plating person on-site?现场是否有专门 的，具有相关资格的电 镀人员？ To ensure readily available expertise, there shall be a dedicated and qualified plating person on the site. This individual shall be a full-time employee and the position shall be reflected in the organization chart. A job description shall exist identifying the qualifications for the postition including chemical and plating knowledge. The qualifications shall 1:培训记录/资质证书/上岗证/劳动合同 组织结构图（过程审核） 1.2 Does the plater perform advanced quality planning?电镀厂是否进 行先期质量策划？ The organization shall incorporate a documented advance quality planning procedure. A feasibility 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 part approval process is approved by the customer, no process changes are allowed unless approved by the customer. The plater shall contact the customer when clarification of process changes is required. This clarification of process changes shall be documented.工厂应该有文件化的APQP程 序，应该对每个零件进行可行性研究和内部批准,组织可以将类似的零件 定义为零件组来完成上述的研究与批准活动。在零件批准过程得到顾客批 准后，除非顾客批准，否则不准许有过程更改，当对过程更改的说明有要 求时，电镀厂应联系顾客并保持过程更改说明的记录。 APQP程序文件/可行性分析报告/阶段验 证报告及输出文件/PSW/PPAP/变更管 理流程/项目计划（过程设计/开发） 1.3 Are plater FMEAs up to date and reflecting current processing?FMEA是否 是更新状态，并反映了 目前的工艺过程？ The organization shall incorporate the use of a documented Failure Mode and Effects Analysis (FMEA) procedure and ensure the FMEAs are updated to reflect current part quality status. The FMEA 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 all key plating process parameters as defined by the organization. A cross- functional team shall be used in the development of the FMEA. All characteristics, as defined by the organization and its customers, shall be identified, defined, and addressed in the FMEA.厂商应具有文化的 FMEA管理程序并确保FMEA及时更新以反映当前零件的质量状态。应为 FMEA是最新状态 Special Process: Plating Process Assessment (General Facility Overview) 特殊过程：电镀系统评估（工厂概要）特殊过程：电镀系统评估（工厂概要） Assessment Section 1 - Management Responsibility and Quality Planning第一章：管理职责与质量策划第一章：管理职责与质量策划 1.4 Are finish process control plans up to date and reflecting current processing?控制计划是 否是最新状态，并反映 了目前的工艺过程？ The organization shall incorporate the use of a documented Control Plan procedure 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 all equipment used and all key plating process 控制计划是最新状态 1.5 Are all plating related and referenced specifications current and available? For example: SAE, AIAG, ASTM, General Motors, Ford, and To ensure all customer requirements are both understood and satisfied, the organization shall have all related plating 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, ASTM, General Motors, Ford, and DaimlerChrysler. The organization shall have a process to ensure the timely review, distribution, and 客户规范文件 规范文件评审记录 1.6 Is there a written process specification for all active processes? 对所有当前 实际的过程，是否有书 面的过程规范？ The plater shall have written process 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, rectifier settings, etc. Such parameters 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 recipes, or other similar documents.对所有当前使用的过程，应有书面的过程规范，并包含所有 的过程步骤和相关操作参数，例如过程温度，时间周期、装载率、整流器 设置等。这些过程参数不仅应清晰的定义，还应由厂商确定其操作范围以 便进行控制。所有当前使用的过程都应有过程规范。这些过程规范可以采 控制计划/作业指导书/设备点检表/参数 记录表/质量检测表 1.7 Has a valid product capability study been performed initially and after process change? 在生产初始阶段和过程 To demonstrate each process is capable of yielding acceptable product the organization shall perform product capability studies for the initial validation of each process, after relocation of any process equipment, and after a major rebuild of any equipment. The organization shall define what constitutes a major rebuild. Initial product capability studies shall be 变更管理规定有 1.8 Does the plater collect and analyze data over time, and react to this data? 电镀厂商是否随时间收 集和分析数据，并针对 The analysis of products and processes over time can yield vital information for defect prevention efforts. The organization shall have a system to collect, analyze, and react to product or process data over time. Methods of analysis shall include ongoing trend or historical data analysis of special product or process parameters. The organization shall determine which parameters to include in such analysis.随时间对 持续改善管理规定 各类过程测量数据 1.9 是否保持记录并可查 取？ 所有过程控制和测试记录必须至少保持到记录产生的当年并再加一年。 文控数据管理程序（ERP系统） 1.10 Does management review and verify bake oven logs for parts requiring hydrogen embrittlement relief every 24 hours?管理部 门是否对需要每24小时 Management shall review the oven monitoring systems/logs at intervals not to exceed 24 hours or prior to parts being released for shipment. The plater shall have reaction plans for non-conformances to process requirements. This is to contain, at minimum, requirements for quarantining material and notifying customer.管理部门必须不时地检查烤 炉监测系统/记录，而不要超过24小时或在零部件发运之前。对于不符合 工序要求的部件，电镀厂必须有相应的反应计划，至少包括隔离材料，并 N/A 不不 合合 适适 1.11 (1.9) Are internal assessments being completed on an annual basis, at a minimum, The organization shall conduct internal assessments on an annual basis, at a minimum, using the AIAG PSA. Concerns shall be addressed in a timely manner. 企业必须根据AIAG每年进行一次内 部评估。对发现的问题应及时进行处理。 没有进行定期的CQI的审核 1.12 Is there a system in place to authorize reprocessing and is it documented? 是否存在一个系统以批 准授权返工，并且它是 否被文件化？ 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 characteristics for which reprocessing is not permissible. All reprocessing activity shall require a new processing control sheet issued by qualified technical personnel denoting the necessary plating modifications. Records shall clearly indicate when and how any material 1：不合格品处理程序书 3:返工品放行批准文件、作业人指导书 1.13 Does the Quality Department review, address, and document customer and internal The quality management system shall include a process for documenting, reviewing, and addressing customer concerns and any other concerns internal to the organization. A disciplined problem- solving approach shall be used.质量管理体系有一个过程对来自客户及 1：投诉管理程序有 2：有进行投诉的追踪 1.14 Is there a continual improvement plan applicable to each process defined in the scope of the assessment?对电镀审 核范围内的每种过程， The plater shall define a process for continual improvement for each plating process identified in the scope of the PSA. 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.厂商应对定义一个过程以对PSA范围内的每种过 程进行持续改进，这一过程应促成质量和生产效率的持续改进，确定的行 1：数据收集，进行持续改善 1.15 Does the Quality Manager or designee authorize the disposition of material from quarantine status? 质量经理或指定的责任 The Quality Manager or designee is responsible for authorizing and documenting appropriate personnel to disposition quarantine material.质 量经理或指定人员应负责授权和文件规定适当的人员对隔离材料进行处置 。 1：处理授权有进行 1.16 Are there procedures or work instructions available to plating presonnel that define the plating process?是 There shall be procedures and work instructions available to plating personnel covering the plating process. These procedures or work instructions shall include methods of addressing potential emergencies (such as power failure), equipment start-up, equipment shut-down, product segregation (See 2.8), product inspection, and general 1：电镀过程作业指导书有揭示 2：本产品上挂作业指导书无 1.17 Is management providing employee training for plating?管理 者是否为电镀员工提供 培训？ The organization shall provide employee training for all plating operations. All employees, including backup and temporary employees, shall be trained. Documented evidence shall be maintained showing the employees trained and the evidence shall include an assessment of the effectiveness of the training. Management shall define the qualification requirements for each function, and ongoing or follow-up training shall also be addressed.厂商应为电镀员工提供所有电镀操作的培训。所有电 镀员工，包括后备的和临时的，都应接受培训。应当保留书面的证据以表 明员工得到了培训和进行了培训有效性的评估。管理层应当定义每个职位 1：管理职责 2：技能矩阵图 3：培训记录 1.18 Is there a responsibility matrix to ensure that all key management and supervisory functions are performed by qualified personnel?是 The organization shall maintain a responsibility matrix identifying all key management and supervisory functions and the qualified personnel who may perform such functions. It shall identify both primary and secondary (backup) personnel for the key functions (as defined by the organization). This matrix shall be readily available to management at all times.厂商应维护职责矩阵识别所有关键的管理和监督职责，以及实施 1：管理矩阵图 1.19 Is there a preventive maintenance program? Is maintenance data being utilized to form a predictive maintenance program? 是否有预防性维护计 划？是否用这些维护保 养数据数据形成预见性 维护计划？ The organization shall have a documented preventive maintenance program for key process equipment (as identified by the organization). The program shall be a closed-loop process that tracks maintenance efforts from request to completion to assessment of effectiveness. Equipment operators shall have the opportunity to report problems, and problems shall also be handled in a closed-loop manner. Company data, e.g., downtime, quality rejects, first time-through capability, recurring maintenance work orders, and operator-reported problems, shall be used to improve the preventive maintenance program. Maintenance data shall be collected and analyzed as part of a predictive maintenance program.对关键设备（由电镀厂商定义）应建立一个预防性 维护计划，该程序必须是一个从请求到实施到有效性评估的闭环过程，操 作者有机会报告问题，并且问题应以闭环方式被处理。公司的数据如停机 时间、质量拒收，一次通过率，重复维修工单、操作者问题报告应被用来 改善预防性维护计划。应当对维护数据进行收集和分析，将其作为预见性 维护计划的一部分。 设备维护保养计划规定有 有按规定实施保养 1.20 Has the plater developed a critical spare part list and are the parts available to minimize production disruptions?是否建立了 一份关键备份清单，这 些备件是否可获得以使 The plater shall develop and maintain a critical spare parts list and shall ensure the availability of such parts to minimize production disruptions. 应建立并维护一份关键零件部件备份清单，确保这些备件在需要时可用， 从而将生产中断的可能性降到最低程度。 关键备件管理有明确的要求，但是备件 整理整顿需要加强 2.1 Does the facility ensure that the data entered in the receiving system matches the information Documented processes and evidence of compliance shall exist, e.g., shop travelers, work orders, etc. The facility shall have a detailed process in place to resolve receiving discrepancies.应有文件化的过程和 符合的证据如：工艺流转卡、工作订单等。工厂应具有详细的过程来处理 客户信息处理流程 （订单、流转单、出货检验报告、客户 签收记录、异常处理流程） 2.2 Is product clearly identified and staged throughout the plating process?在电镀全过程 中产品是否清楚地标识 Procedures for part and container identification help to avoid incorrect processing or mixing of lots. Appropriate location and staging within the facility also help to ensure that orders are not shipped until all required operations are performed. Customer product shall be clearly identified and staged throughout the plating process. Non-plated, in-process, and 1: 不同工序区域划分及标识 2：产品生产阶段标识 3：产品正确堆放 产品 状态 明 确， Section 2 - Floor and Material Handling Responsibility第二章节：工厂和物料处理责任第二章节：工厂和物料处理责任 2.3 Is lot traceability and integrity maintained throughout all processes?在电镀过程 中是否维护了批次可追 溯性和完整性？ Out-going lot(s) shall be traceable to the incoming lot(s). The descipline of precisely identifying lots and linking all pertinent information to them enhances the ability to do root cause analysis and continual improvement.出货的批次应能追溯到来料的批次。准确的识别批次信息以 及与批次相关的信息链接能提高分析原因和持续改进的能力。 1:工艺流转卡 2：追溯性记录 3：产品标识出货记录 4：来料记录进出库记录 5：半成品委外二次加工进出货记录 2.4 Are procedures adequate to prevent movement of non- conforming product into the production system? 程序是否可充分地预防 不合格产品流入到生产 The control of suspect or non-conforming product is necessary to prevent inadvertent shipment or contamination of other lots. Procedures shall be adequate to prevent movement of non-conforming product into the production system. Procedures shall exist addressing proper disposition, product identification and tracking of material flow in and out of hold area. Non-conforming hold area shall be clearly designated to maintain segregation of such material.必须对可疑品或不合格品进行控 1：不合格品控制程序文件 2：不合格品的标识、存贮、放置 3：可疑品处置记录 2.5 Is there a system to identify trap points in the entire plating process to reduce risk The plater shall have documented procedures to identify and monitor trap points for each process/equipment. Monitoring of potential trap points shall occur for every part changeover.必须有死角区的清单和工作 指导书以说明检查频率。 1：现场是否识别 2：各类区域 3：现场产品 2.6 Are containers free of innappropriate material?容器是否避免 了不适当材料的影响？ Containers handling customer product shall be free of inappropriate material. After emptying and before re-using containers, containers shall be inspected to ensure that all parts and inappropriate material have been removed. The source of inappropriate material shall be identified and addressed. This is to ensure that no nonconforming plating parts or inappropriate material contaminate the finished lot.装有顾客产品的容器 内应无不适当材料的影响。在容器空出后或再使用前应检查容器以确保所 有零件和不适当材料被清除。不适当材料的来源应被识别和处理，以确保 1：异物管控流程 2：周转容器标识 3：不合格品处理流程及相关记录文件 2.7 Is part loading specified, documented and controlled?零件装 载是否得到规定并文件 化并加以控制？ Loading parameters shall be specified, documented and controlled. Examples include parts per rack and load size.零件装载参数是否得到规 定并文件化并加以控制。例如，每个挂具上的零件和装载数量。 1：部件上挂SOP: 2：挂具维护保养记录 3：部品同期产量 挂具 保养 计划 不明 确 2.8 Are operators trained in material handling, containment action and product segregation in the event of an equipment emergency Unplanned or emergency downtime greatly raises the risk of improper processing. Operators shall be trained in material handling, containment action, and product segregation in the event of an equipment emergency including power failure. Training shall be documented. Work instructions specifically addressing potential types of equipment emergencies and failures shall be accessible to and understood by equipment operators. 1：应急处理程序 2：应急处理员工培训计划和记录 作业指导书 3：不合格品隔离处理流程 4：应急处理记录、反应计划 异常 处置 流程 未进 行明 2.9 Is the handling, storage and packaging adequate to preserve product quality? 在电镀 搬运、存储和包装过程 中是否能充分保护产品 的质量？ The platers loading/unloading systems, in process handling and shipping process shall be assessed for risk of part damage or other quailty concerns.厂商应针对防止零件损坏和其他质量风险，对电镀的装 货/卸货系统、在线搬运和发运过程进行评审。 有进行有效的包装 2.10 Are plant cleanliness, housekeeping and environmental and working conditions conducive to control and improved quality? 工厂的清洁、内部管理 、环境及工作条件是否 有益于质量控制和改 Plant cleanliness, housekeeping, environmental, and working conditions shall be conducive to controlling and improving quailty. The plater should evaluate such conditions and their effect on quality. A housekeeping policy shall be clearly defined and executed. The facility shall be reviewed for the following items: loose parts on floor; spillage around tanks; overall plant lighting; fumes etc.工厂的清洁、内部管理、 环境及工作条件应有益于质量控制和改进。应评审这些条件对质量的影响 。应清楚地规定和执行内部管理制定和政策。应对设施中有害于质量的条 件进行评审如：零件散落在地面上、槽液溢出、工厂总体照明及烟雾等。 1：产品置放置场没有明确的规定 4：进行有效的安全体系 抽风机系统 2.11 Are process control parameters monitored per frequencies specified in Process Tables? 是否按过程表 Process control parameters shall be monitored per frequencies specified in Process Tables. Computer monitoring equipment with alarms and alarm logs satisfy the verification requirement. A designated floor person shall verify the process parameters, e.g., by initialing a strip chart or data log. 应按过程表规定的频次要求进行过程控制参数的监控。 1：参数的点检表 2：授权人员 2.12 Are out of control/specification parameters reviewed and reacted to?失控/不 符合规范的参数是否得 Are there documented reaction plans to both out of control and out of tolerance process parameters? Is there documented evidence that reaction plans are followed?失控及过程参数超差是否有文件化 的反应计 划？是否有遵守了反应计划的文档证据？ 1：不合格品管理程序 2.13 Are In-Process / Final Test Frequencies performed as specified in Process Tables?是否 In-Process / Final Test Frequencies shall be performed as specified in Process Tables. Refer to Process Tables.应该过程表规定频次要求进行 在制品和最终的检验/试验，详见过程表。 过程参数确认表，有按照控制计划进行 测定 2.14 Is product test equipment verified?产 品测试设备是否得到验 证？ Test equipment shall be verified/calibrated per applicable customer specific standard or per an applicable consensus standard, e.g., ASTM, SAE, ISO, NIST, etc. Verification/calibration results shall be internally reviewed, approved and documented. Refer to Process Tables for frequency of checks.测试设备应 按照适用的 顾客特殊标准或ASTM/ISO/NIST/SAE等一致认可的标准进行验证/校准。 1：测量设备的管理规定 2：有进行定期的校正 2.15 水洗对否得到控制并详 细列在过程控制计划中 以反映全过程过程参 数？ 识别操作参数包括：-过程步骤之间的水洗槽的数量 -槽的类型（单向水洗、逆流、固定、喯淋） -水流速度-水质要求（城市自来水、去离子水、反渗透水） -过滤（如果适用） -控制方法 1：CP有有涉及此内容，以及与下级文 件的整合 2：水洗的水质有进行浑浊度的测试 Questio n Number 问题编问题编 号号 Question问题问题 Require ments and Guidanc e要求与要求与 标