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法雷奥1000 提问表(中英)

法雷奥 1000 提问表 第一部分 全面质量组织

VALEO 1000 提问表 1994 年 7 月 -1-

1. TOTAL QUALITY ORGANIZATION 全面质量组织 1. Does management communicate clearly its Total Quality policy based on the

five operating strategies and associated objectives; is the Total Quality charter known and understood by all personnel, including newly employed personnel?管理部门是否已明确宣布其以法雷奥五战略轴心为基础的全面质量方针以及与此有关 的目标;全面质量宪章是否已经做到人人皆知,包括新招收的人员在内? 2. Does a summary document for the policy deployment plan enable management to ensure that all objectives are in compliance with the company's policy?旨在推 广质量政策的摘要性文件能否使管理部门了解其全部目标,以便确保这些目标与企业方针的衔接一致? 3. For each objective (general, specific or by function), is there a measurement indicator, regularly followed-up, displayed and are progress actions implemented according to the results to ensure that objectives will be attained? 对于每一个目标(总的、特定的或为某职能特有的)来讲,是否有一种衡量指标, 进行定期 跟踪衡量并予以公布?是否根据衡量的结果实施相应的改进措施以确 保目标的实现。 4. Did management define management rules for communication, delegation and discussion?管理部门是否已制定有关沟通、授权和协作方面的管理规章?

5. Does the company develop a visual communication approach, formalized in a plan and does it give personnel places to display and solve their problems?公司是 否在开发一种可视的传递信息的手段并正式编入计划?公司是否为员工提供发表意见的场所并解决他们提出的问题? 6. Does management quickly consider improvement suggestions and their implementation?管理部门是否确保对合理化建议及其实施作出迅速的反应?

7. Is an employee recognition system, based on results obtained or on attitudes, formally integrated in a quality improvement approach? Does it involve all personnel?改进质量的手段中是否已正式纳入一项以所取得的成果或以员工表现为基础的评价体系?该体系是否能使全体员工动员起来? 8. Does management regularly conduct Total Quality Policy Deployment reviews:管理部门是否定期评审全面质量方针的开展情况? ── assessment of the match between the budget and the objectives?评估预算是否与目标相适应? ── comparison of results and objectives?将取得的成果与既定目标相对比? ── definition of new objectives in comparison with the actual situation?是否根据发现的情况确定新的目标?

VALEO 1000 提问表 1994 年 7 月 -2-

法雷奥 1000 提问表 第二部分 安全与环境

VALEO 1000 提问表 1994 年 7 月 -3-

是 否 不适用

1. SECURITY 安全 1. Is a program for managing security problems (identifying potential risks) established and maintained, including all audits performed by external auditors approved by Valeo Risk management, and internal audits performed by risk managers? 是否建立和实施一项安全问题的 管理程序(旨在识别潜在的安全问题), 其中包括由法雷奥安全管理部认可的外部评审员进行的全面评审以及由安 全负责人进行的自我评估? 2. Is there a security coordinator nominated by management? Is he/she on a flowchart defining the relations between the security function and other functions?是否有一位由管理部门任命的安全协调员?公司组织机构图是否包括该岗位, 并定义该岗位与其它职 能岗位间关系? 3. Are branch, division and plant managers regularly informed of problems and are corrective actions implemented with the use of a formal reporting system 总部、分公司及工厂的经理是否通过某种正式的汇报体系定期了解安全问题和已采纳的纠正措施? 4. Are regulatory bodies, authorities and technical services of Assurance Companies associated with the projects that could modify the potential risks?相关的检查机构,官方机构及保险公司的技术部门是否参与了旨在改变潜在安全问题性质的项目? 5. Are security problems (goods and people) identified by internal or external auditors subjected to corrective actions? Are these corrective actions part of a monitored and budgeted improvement plan?在评审或自我评估中发现的与安全有关的问题(财产与人员)是否 采取了纠正措施?这类改进活动是否纳入改进计划,并对其进行跟踪并列入预算?

VALEO 1000 提问表 1994 年 7 月 -4-

是 否 不适用

2. ENVIRONMENT 环境 1. Is there an environment coordinator nominated by the management, is he/she on a flowchart defining the relationship between the environment function and other functions?是否有一位由管理部门任命的环境协调员?公司组织机构图中是否包括该岗位 并定义该岗位与其它职能岗位之间的关系? 2. Is there an environment program established and maintained? Does it include complete assessment audits conducted by external auditors approved by management as well as internal audits conducted by trained and qualified plant personnel?是否建立和实施一项环境程序, 其 中包括由法雷奥安全管理部认可的外部评审员进行的全面环境评审以及经过培训并取得资格的本厂员工进行的自 我评估? 3. Do these assessments give plant management a detailed picture of the plant's compliance with requirements; are all dangerous products identified and listed?这类自我评估是否能使工厂管理部门对工厂环境是否合格获得准确的信息;是否所有的危险品已 为员工们了解并已登记在案? 4. Are deviations reported in the monthly environment compliance report, and are they processed immediately by management? 在每月一次 的环境报告中反映出来的问题是否得到管理部门的优先处理? 5. Are all files and original copies of documents related to the environment recorded and stored in a single place (to maintain confidentiality)? 是否所有与环境有关的资料档案与原件都归档和存放在工厂内一个地方(以便对相关信息保守机密)? 6. Are problems linked to the environment and identified by audits subjected to corrective actions? Are these corrective actions part of a monitored and budgeted improvement plan?是否对在评审中发现的有关环境的问题采取纠正措施?这类改进活动是否纳入 改进计划,并对其进行跟踪并列入预算?
VALEO 1000 提问表 1994 年 7 月 -5-

法雷奥 1000 提问表 第三部分 质量保证

VALEO 1000 提问表 1994 年 7 月 -6-

1. MANAGEMENT RESPONSIBILITY 管理者职责 1.1CFS Has a mission statement been defined and communicated to personnel?企业目标是否已确定并向员工通报? 1.2CFS Has a total quality policy, in compliance with other policies and integrating the continuous improvement concept, been implemented
and maintained at all levels?是否已在企业各级实施并坚持一项与其它各项政策紧密结合并体现精益求精观念的全面质

Has the organization formalized and communicated its quality objectives? Are they understood by employees? 企业是否已将其

1.4CFS Is a quality improvement plan (covering all the functions within the organization) effectively and continuously budgeted, implemented
and respected?是否已确实为一项改进质量计划(涉及企业的全部职能)编制预算并持之以恒地予以实施?

1.5CFS Are indicators used to measure progress?是否有指标来检测已取得的进展? 1.2.1. .Responsibility and authority 责任与权限 1.6CFS Have the organization of the quality function, its status and all responsibilities of personnel involved in quality issues/activities been defined, formalized in an flowchart? Are deputies named?是否有质量职能组织,其地位以及参与质量管理人员的全部职责和指

1.7C Has organization by project been defined, with its corresponding status inside the organization?项目的组织及其地位是否已在 企业内部作了明确规定? 1.8CF On a global level, has management established a plan to reduce the variability of all processes? 领导是否已制订一项旨在减少 所有过程易变性的全面计划?
Have the necessary resources been identified and assigned to initiate action to prevent product non-conformity (preventive quality management) and to reduce the variability of all production processes (technical and administrative)?为杜绝出现不合格产品(质量的预


防性管理)和减少所有生产工序易变性(技术和行政的), 是否已对为达此目的而采取措施所必须投入的经费作过 评估?是否已投入必要的经费?

VALEO 1000 提问表 1994 年 7 月 -7-

1.10CFS Have the responsibilities, the authority and relationship been defined for people responsible for the following: 是否已对所有负 责以下事务人员的职责、权限及相互关系作了明确规定? ── initiating preventive action?开展预防性行动。 ── identifying and recording any quality problem and initiating corrective actions ?识别、记录任何质量问题并采取纠正 措施。 ── controlling non-conformity treatment until the deficiency or unsatisfactory condition has been corrected? 控制不合格产品 的处理,直至最终纠正为止。 ── conducting internal audits of the quality system?进行质量体系的内部审核。 1.11C Have the responsibilities for coordinating and controlling control/safety items and other regulatory items been clearly defined? 是否 已经对“受控项/安全项”(须服从安全标准和其它强制性规定的)的协调和控制作了明确的规定? 1.2.2. Resources 资源 1.12CFS Has the organization's overall organization/structure been defined? Have adequate resources (identification of needs and budget), both human and equipment been provided?是否已对企业的全面组织结构作了规定?是否已提供相应的人力和设备资源(识 别需要和预算)? 1.13 CFS Are all the needs of Quality organization clearly included in the definitions of the functions, in accordance with the definitions of
quality missions? Are they calculated using a formalized method? Are they identified and costed with a budget covering all necessary resources (including computerized tools for quality management)? 是否已按照质量任务的定义对质量组织的所有需要在职能手册中作了

明确的规定?这些需要是否按照某种正式的方法予以数量化? 而且为此而需要采取的相应手段是否已作了预算(包 括计算机质量管理手段)? 1.14 CFS Do guidelines exist explaining the procedures to be followed in the event of deviation from specifications, are they applicable at any moment (night work)?在出现技术偏差的情况下,为确定应采取何种程序,是否已对可在任何时候(夜班工作)都适 用的措施作了规定? 1.15 CFS Are all system, process or quality audits conducted by persons independent from the activities being audited?任何性质的评审, 无论是体系方面的、工艺程序方面的或者是产品方面的评审,是否确实由独立于被评审方的人员担任?

VALEO 1000 提问表 1994 年 7 月 -8-

1.2.3 Management representative 管理者代表 16CFS Has the quality management representative been named by management?. And does he/she have the necessary clearly defined powers (including the right to stop the production in the event of non-quality):质量代表是否被企业领导任命?是否规定了必要的权限(包 括在质量没有达标的情况下,停止生产的权利)?
- to ensure that the requirements of the quality system are implemented and maintained?以便确保质量体系的实施与执行 - to report on the performance of the quality system to management for review?以便向领导汇报质量体系运行的情况 - to initiate the necessary improvements?以便进行必要的改进行动

1. 17CFS Is the Quality representative independent, and does he/she have the same status as the production manager? 该质量代表是否 保持着独立性?是否与生产部经理同一级别?并属于管理层。 1.3 Management review 管理评审 1. 18CFS Is there a written procedure for the management's review of the Quality System? Is at least one review planned per year on the basis of a checklist? Are the corresponding results recorded?是否有文件明确领导对质量体系的评审程序?是否规定基于检查表 每年至少进行一次评审?是否记录相应的结果? 1.19CF Does the results analysis ensure that the quality system remains appropriate and efficient in:对评审结果的分析是否能保证质

- satisfying the requirements of this standard?符合本标准的要求 - remaining consistent with company policy?紧密结合企业政策 - meeting established quality objectives?与制订的质量目标相比较

1.20CFS In case of non-conformity, is a corrective action plan implemented (Quality Action Plan) to modify the Quality System? 在出现不 合格现象时, 是否采取纠正措施(质量行动计划)以便调整质量体系?

VALEO 1000 提问表 1994 年 7 月 -9-

是 否 不适用

2. QUALITY SYSTEM 质量体系 2.1CFS Have we identified and acquired all the production and inspection equipment, resources and skills necessary to meet the required quality levels?为了达到目标规定的质量水平,是否已考察并获得所有必要的生产和检验装备、资源以及必要的专业人员? 2.2CFS Are new quality control/prevention techniques and corresponding instructions developed and implemented in a satisfactory manner?

Do customer-related personnel speak the native language of the customer? Are the names of the customer R&D, Quality and Purchasing contacts known?公司是否有能讲客户语言的技术对话者?是否有了解客户处负责研究和开发、质量以及采购


的对话者? 2.4 CFS Is there a formal and effective system for the communication of quality issues within the organization? Are there performance charts for all levels? Is there a warning system in the event of serious problems?在企业内部是否有某种涉及质量管理的正式有效的沟通体 系?是否有显示企业各级质量水平情况的报表? 在发生严重问题时,是否有警报体系? 2.5 CFS
Is there a Quality Manual, referencing the current internal procedures and any associated standards? Is it used?是否有某种参

Have procedures and work instructions been prepared and implemented for all the different activities of the organization (design, production, processes, assembly, control, training, purchasing, storage, packaging, delivery, servicing, etc.)?对于企业和各类业务活动(设


计、生产、工艺程序、装配、检测、培训、采购、搬运、储存、包装、交货、售后服务??),是否已制订协调工作 的程序和作业指导书?这些程序和工作职责是否已予以实施,以使各类活动协调一致?
2.7CF Have specific quality plans been prepared before production, are they implemented and maintained?在开始批量生产前是否已制

VALEO 1000 提问表 1994 年 7 月 -10-

2.8CF Does the quality system ensure that all specified product and service requirements are taken into account? 质量体系是否能够保 证涉及产品和服务的各项规定要求得到重视? 2.9 CFS Are all standards of acceptability clearly defined, including those which contain a subjective element, in accordance with customer if
necessary (attributes - Master Samples)?是否对所有的验收标准,包括带主观因素的标准都作了明确规定?在必要的情况

Have control, testing and surveillance activities for processes at the design, production, installation and after-sales service stages been identified?对于设计、生产、安装和售后服务等过程中涉及对工序控制检测、试验和监控的活动,企业是否已予


2.11CFS Are control/safety and other regulatory items identified in procedures, drawings and work instructions ? 受控项/安全项及其他 必须符合法规规定的项目是否在程序、图纸和作业指导书中明确规定? 2.12CF Have significant characteristics for both products and processes been identified and conveyed to the relevant functions? 涉及产品 及工艺方面的关键特性是否予以明确并向有关职能部门通报? 2.13C Have specifications (covering customer requirements as an absolute minimum) been established for reliability tests (R&D, occurrence)? 对于可靠性试验(方法、频率)是否已制订技术规范(至少满足顾客要求)? 2.14CFS Has a procedure for Quality costs been prepared (failure, detection and prevention)? 是否有一套涉及质量成本的程序(损 失、鉴定和预防)?
2.15 CFS Are annual Quality cost-reduction objectives defined by management? Are the results analyzed? Is the necessary corrective action plan implemented and budgeted? 领导是否制订有关质量成本降低的年度计划?必要的纠正措施计划是否予以正式化和纳


VALEO 1000 提问表 1994 年 7 月 -11-

Has a back-up plan been developed to ensure continuity of deliveries in the event of random disruption of production (with a list of companies able to supply parts at short notice)? Is the list kept up to date?为了保证在生产作业线发生故障时交货的连续性(包括制


订一张有能力在短期内确保生产线正常运作的公司清单), 是否已制订一项后备计划?该计划是否不断调整更新?
Is the verification and implementation of the Quality System planned (audits) and are the corresponding corrective actions implemented in the event of failure?是否已就验证质量体系的工作(评审)作了规划?在出现失效时是否有相应的纠正措


Is there a written approach and method for evaluating the customer's degree of satisfaction? Are the evaluations analyzed by management, and are they compared with our competitors and the best specialized market segments? 对于客户的满意程度,是否有某种



VALEO 1000 提问表 1994 年 7 月 -12-

3. CONTRACT REVIEW 合同评审 3.1CF Is there a written procedure for the customer requirements review?是否有某种涉及评审客户要求的书面程序? 3.2CF Are the responsabilities and the necessary coordination determined by a procedure to ensure that : 该程序是否对职责和必要的

- requirements are defined and documented in an appropriate manner,对客户的要求作恰当的明文规定并制订文件。 - any differences between the offer requirements and the contract are resolved? 所有存在于供方要求与合同之间的差异得以

- the capability to meet the contract or order is achieved?能够满足合同中的要求

3.3C When supplied, are customer elements used for usage tests in order to complete the element definition? 当客户提出的意见有助 于进行产品使用情况的试验时,这些意见有否用来补充合同中原来的规定内容? 3.4CF Is a project team systematically formed to analyze customer requirements when a call for tender is received?是否从接受客户供 货要求起就成立项目小组对客户的需求作系统的分析研究? 3.5CF Is an interactive questionnaire systematically used to complete this information? 是否系统地利用双方问题征询表,以便补 充上述信息? 3.6CFS Are price/investment objectives clearly defined? Is an economic analysis prepared in order to estimate costs, facilities and quantities? 是否已对价格/投资目标作明确的规定?是否已就成本、资源和数量的评估制订了一份经济资料? 3.7CF Are additional product requirements internally specified to complete customers requirements as necessary? 当客户未提出产品的 特定技术规范时,是否制订内控标准加以完善? 3.8C Do functional specifications include critical characteristics?功能性的技术标准中是否包括关键的特性? 3.9CF Is all relevant information readily available? Is it transmitted to the heads of the functions concerned by means of a technical brief? 有益的中肯的信息是否通过技术说明书的形式提供并通报给各有关职能的负责人?

VALEO 1000 提问表 1994 年 7 月 -13-

Are feasibility studies conducted through a structured method (QFD) (including an analysis of necessary resources) to ensure customer satisfaction on contractual requirements? 为了保证能够满足合同中客户的要求, 是否利用某种程序性方法(QFD)


(包括对必要资源的分析)进行可行性研究? 3.11C Is an Advanced Quality Planning established (including "key points" required by customers)? 是否制订一项按照项目的质量阶 段划分的计划(包括客户提出的“关键点” )? 3.12CF Are dispositions forecast and recorded for the verification of contracts and/or orders compared to corresponding estimates, proposals and quotes?在将签订的合同及/或接到的订单与原估价单、建议及相关供货要求作对比方面有否规定,并作记录?

VALEO 1000 提问表 1994 年 7 月 -14-

是 否 不适用

4. DESIGN CONTROL 设计控制 4.1. General 总则 4.1CF Have procedures been drawn up to ensure that the requirements laid down at various stages of the design phase are implemented
(breakdown into elementary tasks planning and critical path analysis)? Are critical stages marked out on a contractual basis with the customer?

为了确保设计各阶段的规范要求得到满足(将设计工作化整为零, 对关键的方法制订规划并加以分析)是否制订了程 序?是否在与客户签订的合同中 对关键阶段作出划分? 4.2C Are project reviews systematically planned and documented?规划中是否包括对项目的系统性评审并制订文件? 4.2. Design and development planning 设计和开发计划 4.3C Are the project stages (P1 and P2) clearly defined and planned from feasibility analysis to comparative final review analysis to ensure objectives are met (analysis of strengths and weaknesses)? 从可行性分析起到最后的与目标相比的开发总结(分析优缺点), 是否 对项目的各个阶段(P1 或 P2)作了明确的规定和计划? 4.2.1. Activity assignment 业务活动的分配 4.4CF Are responsibilities for design defined (functional flowcharts)?是否已对涉及设计业务的职责作了规定(职能行政结构

Do the available human resources (skills, level of training, etc.) and material resources (CAD/CAM, CAE, etc.) meet design requirements? Is software compatible with the customer's systems?在人才(能力、资历)和硬件方面(CAD/CAM、CAE 等)所提


供的手段能否满足设计的需要?软件能否与客户的软件兼容? 4.6CF Does the Purchasing Function play a formal role in subcontracted studies?在分供方研究开发的情况下,采购部门是否正 式的参与其中? 4.7CF Is someone made responsible for control/safety items to handle the legal and technical implications of the product (liability for defective products)?是否任命一位“受控项/安全项”负责人, 以便处理所有与产品有关的司法 和技术方面的问题(因不合格产 品引发的责任)?

VALEO 1000 提问表 1994 年 7 月 -15-

4.3. Organizational and technical interfaces 组织与技术接口 4.8C
Is a project leader named by management for each new development (P1 or P2)? Are his/her function, role and responsibilities clearly

defined? 在开发任何新产品时,领导是否任命一位项目负责人(P1 或 P2)?其职务、作用、任务是否有明确的规定?

4.9C Is he/she responsible for preparing the Quality Assurance Plan, planning and budgeting the entire project? 该项目负责人是否负责 制订质量保证计划? 是否负责整个项目的规划和预算?
s the project team, managed by the project leader, multi functional to ensure the continuity in the use of product/process design data (simultaneous engineering)?由项目负责人管理的项目小组是否为多功能的,以保证产品/工艺设计数据使用的连续性。 (实


现工程同步) 4.11C
Are measures taken to ensure that the dimensions and tolerances specified in the design documents are compatible with the means of

production?是否能保证设计图纸中规定的尺寸/公差与生产工具相配合? Is a member of staff made responsible for confidentiality and for protecting the firm's know-how (patents and security)? Are confidentiality rules and agreements defined, applied and audited? 是否已任命一位主管企业技术保密和保护专利与安全的负责


人?技术保密的规章和义务是否有规定?是否实施?是否审核? 4.13C Are records of similar past projects (and especially customer feedback) used systematically in an effort to prevent problems from recurring (databases)?对于类似项目的历史资料(尤其是客户的信息反馈)是否都作系统地利用,以便避免老问题重新出 现?(建立资料库) 4.14C Does the design function analyze the state of the art (by keeping a technology watch)? Does it conduct a competitive analysis?设计部 门是否对技术的现状(注意最新技术动向)进行分析?是否进行技术竞争的研究? 4.15CF Are recent technical advances taken into account when a process is being designed? 在工艺设计过程中,是否已考虑到技 术的最新进展?
VALEO 1000 提问表 1994 年 7 月 -16-

4.4. Design input 设计输入 4.4.1. Product 产品 4.16C Does the design function ensure that specifications/documents supplied by the customer for the design project are available and communicated to all the functions concerned?设计部门是否采取措施使客户为设计项目提供的技术要求/文件提供给各相关

Are health and security regulatory constraints affecting design taken into account? Are they stipulated in the relevant specifications, procedures and work instructions?涉及健康和安全并影响设计的受控项规定是否予以重视?是否在有关的技术规范、程序


Are requirements in terms of labeling, special precautions, identification, traceability packaging and storage (main and after market) specified and analyzed?在标签标号、特别注意事项、标识、可追溯性、包装和储存(一次配套、二次配套)方面的要求

4.18 C

是否有详细说明和分析? 4.4.2. Process 工艺 4.19CF Does the project schedule allow for the design of the necessary manufacturing processes and verification procedures to be implemented? Are these methods adapted to the critical characteristics?项目计划中是否包括制造工艺和验证过程的设计?是否能确保这些手段 符合关键特性的要求? 4.20CF Does a procedure exist for the qualitative selection of tool and equipment suppliers?是否有对工装模具和装备供应商的质 量性选择程序? 4.21CF Are systems ensuring quality (e.g.: poka yoke, etc.) systematically studied for possible application? 旨在确保质量的各种系统 (防差错系统等)是否得到系统地研究,以便能够得到运用?

VALEO 1000 提问表 1994 年 7 月 -17-

4.5. Design output 设计输出
Does the design function provide the project leader with clear and definitive data for the following:设计部门是否为项目负责人提供确切

的、涉及以下方面的最终数据: 4.22C
Are inspections carried out to verify that all design features are as intended (design outputs meet design inputs)? 为了保证设计的

4.23C 4.24C
Procurement requirements in accordance with the purchasing function?外部供货的确定是否经过采购部门同意?

Verification of conformity of products and processes to specified requirements (acceptance and rejection criteria, including critical characteristics, compliance with regulatory requirements, packaging and storage)?是否检验产品符合规定的要求(验收标准和拒收标

准, 包括关键特性、产品符合法规要求、包装和储存)? 4.25C Are all the customer's demands in terms of reliability taken into account (including problems that may arise from improper use of the product)?客户对产品可靠性的全部要求是否都得到满足(包括在必要的情况下对产品的不正常使用)? 4.26C Are all product testing and acceptance criteria for use during the design phase specified? Are these criteria specified for their use during the production phase?在设计阶段必须使用的测试和验收标准是否都作了确切说明? 在生产阶段使用同样的测试和验收 标准是否也有确切说明? 4.5.1. Product 产品 4.27CF Is a Quality Assurance file for the product established as stipulated in the Product/Process Quality Assurance Plan (QAP.p)? 质量保 证文件的制订是否符合产品/工艺(QAP.p)质量保证计划? 4.28CF Are the results of FMEA (products and processes) analyses used to define the parameters to be controlled?产品与工艺(FMEA)的 分析结果是否被用来确定需控制的特性?
VALEO 1000 提问表 1994 年 7 月 -18-


Are all personnel informed of information on different product functions and use, including the potential consequences of


4.5.2. Process 工序 4.30CFS Have work stations been the object of an ergonomic study? Has safety been examined to guarantee the functioning security and to protect both operators and manufactured products? 是否对各工序进行过劳动经济学作业研究?是否对安全作了事先研究 以便保证运作的安全可靠性、保证对操作者和产品的保护? 4.31CF Is the purchasing of tools and machinery planned, and is a document giving references and the composition of the tools definition file (designation, status, identification and life cycle) established, classified and maintained? Are traceability requirements taken into account?工具 与机器的采购是否有规划?对工艺装备说明资料的参考数据和组成内容(名称、状况、标识和使用寿命)是否编制成文 件、归类并不断调整更新数据?是否考虑到可追溯性的要求? 4.32CF Is inoperable machinery clearly identified? Are such machines covered by an improvement plan? Pending the implementation of such a plan, are individual, automatic or built-in controls systematically used (Cmk?2)?工序能力欠佳的机器是否被识别出来?是否有改 进计划,在改进计划最终实现之前是否有系统的逐个检查、自动检查或综合检查(Cmk≥2)? 4.33CF Are there procedures for the acceptance of new or modified manufacturing and verification equipment (specifications, maintainability, capabilities, etc.)?是否有对新的或改造过的生产工具及校验设备的验收程序(技术要求、可维护性、工序能力等)? 4.34CF
Is manufacturing equipment validated by initial sampling? Are standard workpieces selected and retained as master samples in the event of characteristics that cannot be measured? 是否使用工装样件对生产设备做验证;当某些特性无法检查时,是否抽取

Is the acceptance procedure for production equipment (manufacturing, control and testing) formalized by a report prior to use? Is a preventive maintenance program defined and respected?在生产设备(制造、检验和试验)使用之前,是否书面汇报设备验收



VALEO 1000 提问表 1994 年 7 月 -19-

4.6. Design review 设计评审 4.36CF Has a procedure been established for organizing and managing project reviews? Are these reviews planned, formalized and documented in project development (including financial aspects and the identification of problems and inadequacies)? 是否有规定项目评审的组织和管 理的程序?这类评审是否在项目开发中予以规划,形成制度并制成文件(包括对项目的财务跟踪和对问题和不合格 现象的识别)? 4.37C Do project reviews include a design review, a planning review and an economic objectives review? Do critical experts participate in these reviews?对项目的评审是否包括设计评审、计划评审和经济指标评审?是否有相关专家参加评审? 4.38C Are project reviews systematically conducted at the end of each phase (P1 or P2)? Does the passage from one phase to the next depend on the analysis of all points at the project review?在项目的每个结束阶段末是否系统地进行项目评审(P1 或 P2)?从项目的一 个阶段过渡到下一个阶段是否取决于项目评审的结果(所有审核点情况良好)? 4.39C
Does design quality validate the move from one phase to the next?设计质量是否决定项目的转阶段?

4.40CF Does the design review consider the specification and the product/process Quality Assurance File requirement? 设计评审是否考 虑到技术规范和产品/工艺质量保证文件? 4.41C Are use and disposal constraints of products taken into account (environment pollution, etc.)?有关产品的使用和被淘汰的强 制性规定是否被重视(环境、 污染??)? 4.42C Do the affected functions give their approval at the various design stages and do they justify their choice? Is this approval documented?

4.43C Does the project leader ensure that the schedule is respected? Does he take formal measures in the event of non-conformity?项目负责人是否能保证设计进度?在出现不合格时,项目负责人是否采取正式措施?

VALEO 1000 提问表 1994 年 7 月 -20-

4.44CF Is part of the design review destined to determine if production capacity and logistic means are satisfactory for the new product?设计 评审的一部分内容是否用来确定生产能力和后勤保障是否满足新产品生产需要?

4.7. Design verification 设计验证 4.45C
Are independent tests carried out to validate the results?为了对设计进行验证,是否进行独立的试验?

4.46C Does the Quality Assurance file include estimated reliability and the experimental validation of calculations? 产品质量保证文件 中是否包含可靠性评价和通过试验对计算作认可? 4.47C Are adequate numbers of samples taken during the testing to provide statistical reliability in the results?是否已进行过适当数量 的样品测试,以便获取足够的可靠性统计结果? 4.48CF Do procedures and work instructions exist for controlling initial samples and pre-production samples (including supplied products)? 是否有用于控制工装样件和批量生产前零件(包括外部供应)的程序和作业指导书? 4.49CF Are the results of the application of the following methods analyzed: FMEA, planned experiments, fault tree analysis, etc.?应用以下 方法的结果是否加以开发利用?FMEA、实验计划、故障树分析??? 4.50CF Have the definition documents for products and production equipment and for inspection been approved in accordance with a specific procedure? Have those documents been classified, updated and distributed to the relevant functions?产品/生产和检验设备的定义文件是 否根据相关程序予以批准、归类、内容更新后发给各有关职能部门?

VALEO 1000 提问表 1994 年 7 月 -21-

4.51C Has a procedure been established to define the qualification stages of products and processes? Are periodic evaluations of product design
conducted and documented at the main stages of development? Does this evaluation incorporate the validation of equipment, capacity and feasibility (one day at full production capacity)? 旨在确定产品和工序各阶段验证的程序是否已建立?在产品开发的各重要

阶段是否进行定期的设计评估并制成文件?其中是否包括对设备的工序能力、生产能力和可行性的目标的认证(全 天满负载运转)? 4.52C Are prototypes used to check that design requirements are met?是否利用手工样件来验证设计的要求已满足? 4.53C Are the prototypes checked and accompanied by the corresponding control reports approved by the quality function?这些手工样件 是否已经过验证?是否附有质量部门同意的相应的检验报告?

4.8. Design validation 设计认可
Are performance, durability, safety, reliability (tests to the limits carried out until first failure) and maintainability evaluated under planned and/or specified storage and operational conditions?是否按照装配和运转规定的条件与(或)技术规定对产品的性能、耐


用性、安全、可靠性(极限性试验至出现故障止)以及可维护性进行评估? 4.55C Are all tests and evaluations documented and recorded, then analyzed and examined for validation? Are statistical tools used for treating important characteristics? 试验和评估的全部结果是否都编成文件并记录在案,然后从认证的角度进行分析和检查?在处 理重要产品特性时,是否利用统计工具? 4.56C Is corrective action taken to ensure that final design and supporting data meet customer requirements?为确保最终设计和相关的 文件资料满足客户的要求,是否采取纠正措施? 4.57CF Are manufactured products reassessed on a periodic basis to ensure that they continue to comply with all specified requirements?是 否采取定期验证的方法来确保生产的产品始终能满足全部的技术规范要求?
VALEO 1000 提问表 1994 年 7 月 -22-

4.9. Design changes 设计更改 4.58CF Are the necessary procedures established for the identification, documentation, review and approval of design changes and
modifications to products and processes?为能对产品及工艺的设计更改予以标识、文件化、评审和认可,是否已制订必要的

4.59CF Are modifications processed in accordance with the same development steps as for normal design (Quality Assurance Plan for specific products or processes; requalification and/or approval of modified product or process)?对设计更改的处理是否必须经过与开发新产品 设计同样的阶段(具体产品或工序的质量保证计划;工序或产品变更的验证和批准)? 4.60CF Do we ensure that design changes do not lead to a product quality degradation and that the consequence of proposed changes are assessed for all product characteristics with respect to the design definition?是否注意保证设计更改不致使产品质量下降?是否注意 评价设计更改 给产品性能带来的影响? 4.61CF Are changes clearly specified (modification display) and their application date respected?设计更改的内容是否作明确的说 明(更改单)实施更改日期是否予以遵守? 4.62CF Are procedures applied for the disposal of obsolete products (modified or discontinued)? Does this procedure prevent delivery of non conforming products? Are obsolete drawings, specifications and documents withdrawn?为避免交付不合格产品,是否实施旨在淘汰过 时产品的程序(更改产品或停止生产)?作废的技术规范图纸和文件是否予以回收? 4.63CF Is there an emergency exception/deviation procedure to prevent the production of non-conforming products? 为防止生产不合格 品,是否有紧急更改设计的程序? 4.64CF Are new acceptance procedures systematically applied to initial samples in the event of process modification? 在工艺更改时, 是否对工装样件进行新的验收? 4.65CF
Are the summaries of product/process modifications regularly updated?产品和工艺更改目录是否不断调整更新?

4.66CF Are there procedures to ensure that the customer is informed when a process change is planned?在发生工艺更改的情况时, 是否有确保及时通知客户的程序?
Do the procedures for implementing and monitoring product modifications make allowances for cross-referencing internal and manufacturer's indices?在产品更改的实施和跟踪程序中是否考虑内部更改指数和主机厂更改指数的对应?
VALEO 1000 提问表 1994 年 7 月 -23-


5. DOCUMENT AND DATA CONTROL 文件和资料控制 5.2. Document and data approval and issue 文件和资料的批准和发放
Is there a document control system with its associated procedures within the organization (procedure format, approval, display, distribution, updating)?是否已经结合相关程序(程序格式、审核、流通、发放、相关的更新??)实施文件控制体系?


5.2CFS Are all definition and recording documents reviewed and approved for accuracy and adequacy by authorized personnel prior to use?

Are all pertinent versions of appropriate documents available at all locations? Are obsolete documents removed from all locations?

所有必要文件的最新文本是否能在必须使用的地方供人们使用?已作废的文件是否立即从所有的发放和使用点上 收回?
5.4CF Are documents available only to the persons concerned? Does the system preserve confidentiality, as necessary?文件是否仅局限于 指定人员使用?发放体系是否注意保守机密? 5.5CFS
Do all control/safety or other regulatory items appear in relevant documents, specifications, procedures, drawings and work

instructions?所有的“受控项/ 安全项” (应服从安全和强制性法规标准)是否也列入相关的文件、技术规范、程序、


VALEO 1000 提问表 1994 年 7 月 -24-

5.3 Document and data changes 文件和资料更改 5.6CFS
Are all changes to documents reviewed and approved by the originators of the original document? 文件上所有的更改是否经

5.7CFS Are all relevant customer/supplier documents controlled and updated?涉及客户/供方所有的文件是否不断调整更新并受 到检查? 5.8 CFS
Is there a master list or equivalent control procedure to identify current revision status and holders of document? 为了统计文件

5.9CFS Is design documentation cross-referenced to the relevant product/process documentation?是否保证涉及产品和工艺的各类 文件更改指数的一致? 5.10CFS Are documents controlled and re-issued after a certain number of revisions have been made (illegible, scraped documents, etc.)? Is there a system for periodically revising documents? 文件的发放是否得到控制? 当文件作了若干修改后(文件涂改后看不清 楚??)是否发放新的文件?是否有对文件定期修订的体系? 5.4. Keeping and recording documents 文件的保存和存档 5.11CFS Are documents (in-process and archives, including computerized documents) archived. Are retention times specified to comply with customer requirements, regulations and internal needs? 文件(正在编制的和编制好的, 也包括信息化文件)是否按照规定的 期限进行存档,以便满足客户的需要,符合规定和内部需要?

VALEO 1000 提问表 1994 年 7 月 -25-

6. PURCHASING 采购 6.1. General 总则 6.1C Does the Purchasing function play an active part in defining and managing the quality of products? Does the functional organization of the Purchasing function permit close cooperation with the design departments?采购部门是否参与产品质量的定义和控制?采购部门的 职能组织是否考虑跟设计部门进行密切合作? 6.2C Are the procedures for standardizing outsourcing managed by Purchasing in collaboration with Research? 采购部门是否在研究部 门的合作下对外部供应的零部件标准化程序进行管理? 6.3C Does Purchasing systematically offer new suppliers a preventive approach to ensure progress based on Supplier Quality Assurance? 采 购部门是否系统地主动建议新的供应商实施以“供应商质量保证”为中心的预防性的进展规划?

6.2. Evaluation of sub-contractors (suppliers)分供方的评定 6.4CF
Is there a list of approved suppliers, classified according to the results of assessment audits?是否有一份根据审核结果发给许

Are suppliers selected on their ability to meet specified requirements (including deadlines)?是否根据供方满足规定要求的能


VALEO 1000 提问表 1994 年 7 月 -26-

6.3. Purchasing data 采购资料 6.6CFS Do the purchasing documents clearly describe the product or service being ordered? Are they maintained in an efficient and orderly manner and are they examined and approved before their dispatch?采购文件是否对订购的产品或服务作明确的说明?这些文件

6.7CF Does the Purchasing function (through procedures, meetings) ensure that the requirements applicable to the supplies are clearly defined, communicated and then received and understood by the supplier (especially prototypes, initial samples, critical characteristics, etc.)?采购部门 是否采取措施(程序、 会议??)确保向供应商提出的要求都作明确的规定、并使供方接受和理解(尤其是手工样件、 工装样件、关键特性??)? 6.8CFS Do these instructions contain specific clauses regarding control/safety items (tests, traceability, etc.)? 这些作业指导书中是否包 含:受控项/安全项的特别条款(检测、可追溯性??)? 6.9CF Are there certification procedures implemented for product, materials and component batches (material and PQA certification)? 当涉 及产品批次、原材料和零件时(材料验证和 AQP)是否实施认证程序?

6.4. Verification of the purchased product 采购产品的验证
Are purchasing or other representatives of the company given access to suppliers' premises to verify products, materials or services? (This verification does not absolve the supplier of responsibility for the quality of the product, materials, components or services he/she provides)


采购部门的代表或其他被任命代表企业的人是否能进入到供方的作业场地, 以便能对其产品、材料或服务进行验证 (这类验证并不能解除供方在产品、材料、零件或提供服务的质量方面应承担的责任)?

VALEO 1000 提问表 1994 年 7 月 -27-

6.5. Product Quality Assurance 产品质量保证 6.11CF Is the supplier's Surveillance Plan approved? Does it guarantee that the process, product and production site cannot be modified without the approval of the Purchasing function?供应商监控计划是否被审批通过?该计划能否保证在没有征得采购部门同意的情况 下不得更改工艺、产品和生产作业地点? 6.12CF Does the Purchasing function ensure that suppliers apply the Quality Assurance Plan for products and processes (especially for new products)?采购部门是否能确保供应商实施产品/工艺质量保证计划(对所有新产品系统化的实施“产品质量保证”)? 6.6. Initial samples 工装样件 6.13CF
Do new supplies depend on the acceptance of initial samples?对新产品供货前是否必须经过工装样件的认可?

VALEO 1000 提问表 1994 年 7 月 -28-

6.8. Suppliers problem reporting 供方事故的管理 6.14CF Does the Purchasing dept. monitor the Quality, Cost and Lead times of products delivered by suppliers and sub-contractors (defect classification, demerits and suppliers' performance level indicator, supplies quotation)? Do we use those results to establish corrective action? Is a classification prepared and displayed? 质量水平、成本、供方交货的期限是否受采购部门监控(缺陷分类、扣分和供应商 质量水平的指标,供应商报价)?是否利用这些结果采取纠正措施?是否已作了分类并张榜公布? 6.15CFS Are procedures established and implemented to identify and correct problems encountered (for non-conforming purchased products)? 是否已制订并实施了旨在识别并纠正所遇到问题的程序(针对采购的不合格产品) : a) on supplier's premises, affecting scheduling? 供应商引起的会影响企业生产问题? b) in the company (receiving, assembly, etc.)? 企业中的问题(进货检验、装配??)?
Does Purchasing monitor the corrective action which are implemented and confirmed by the supplier? Does the function ensure that incidents do not recur?采购部门是否对供应商实施的纠正措施实行监控?该部门能否确保老问题不再出现?


6.9. Products supplied to suppliers 向供应商提供产品 6.17CF Does the purchasing procedure ensure that parts and components delivered to suppliers for further processing are controlled? 采购 程序中是否确保向分供方提供产品前对产品进行检测?

7. CONTROL OF CUSTOMER SUPPLIED PRODUCTS 客户提供的产品的控制 7.1CFS Do procedures define the verification, storage maintenance and problem reporting of customer supplied products? 程序中是否规


VALEO 1000 提问表 1994 年 7 月 -29-

Do procedures exist to ensure that all products, materials and components are identified clearly according to specification requirements at all stages of production, assembly and delivery (files, marking, identification)?为了确保按照从生产直至交付 (卡片、标

8.1 CFS

记、标识??) 各阶段的技术规范对所有的产品、材料和零件作明确的标识,是否有相应的程序?
8.2CFS 8.3CFS 执行? 8.4CFS Is complete batch traceability implemented throughout the manufacturing process (quantity/reference no./time). Does marking ensure product identification in case a recall or individual control becomes necessary? 在制造工序的全过程中是否对各批产品(一个固定 时间内一种产品的数量)实施全面和可追溯性检测?产品标记是否有助于在有必要收回已发产品或对产品作特别 检查的情况下识别某产品? 8.5CFS
Are specific customer identification requirements specified and complied with?对某些客户要求的识别方法是否有明确的 Are records of identification maintained and available at all times?上述标识的记录是否及时更新并且随时可供查考? Are the identification and traceability requirements for control items/safety items or other regulatory items clearly specified and

respected?所有涉及“受控项/ 安全项(需符合安全强制性规定标准)的标识与可追溯性的要求是否都作了明确规定并


VALEO 1000 提问表 1994 年 7 月 -30-

9. PROCESS CONTROL 工序控制 9.1. General 总则 9.1 CFS Are there diagrams that describe product flows and inspections throughout the production process? Are these flows reviewed at least once a year?是否有描述每件产品生产流程和生产工序验证的示意图?是否每年至少对这种流程情况评审一次? 9.2CFS Is production scheduling sufficiently well-organized to satisfy specific delivery requirements (JIT, synchronous delivery, etc.)? Is the rate of flow interruption monitored and recorded?生产的组织规划是否能够满足发货(紧张流动、同步流动??)的要求?流 程中断率是否受到跟踪和记录? 9.3CFS
Are criteria for workmanship clearly defined with instructions (range, workstations, files)? 实施标准是否通过作业指导书的

Have process parameters and critical characteristics been defined and formalized (control charts, work instructions, etc.) in the surveillance plan? 工艺参数和关键特性是否都在监控计划中作明确说明并以具体形式固定下来(检测卡、作业说明


9.5 CFS Are there exception procedures that can be implemented if the planned processes can not be complied with?当预定的工艺不能 遵照执行时(档次降低)是否实施降级程序?

9.2. Special processes 特殊工序 9.6CFS Are special processes defined and if so, are they continuously monitored or verified? Are records of the monitoring results kept up to date?是否所有的特殊工序都持续实施或经常验证?实施结果的记录是否随时更新?
VALEO 1000 提问表 1994 年 7 月 -31-

9.3. Surveillance plan 监控计划
Has a quality surveillance plan (containing a synopsis for the entire process) been defined and formalized? Is the plan suited to the production process for workpieces and replacement parts (after market)?是否已确定质量监控计划并编制成文件(包括全部工序流


程概要文件)? 该监控计划是否适合批量加工件和备件的生产工序? 9.8CF
Are the available resources sufficient to ensure that product characteristics and control/safety items are respected? 生产设备是否

9.4. Process control 工序控制
Are the schedules for production, control and documentation completed prior to production start-up? Are steps taken to guarantee supply of raw materials?开始生产时,生产计划、检测和文件的规划是否已完成?材料供应是否能得到保证? Are all personnel involved in the process clearly informed of the product and process characteristics to be controlled in terms of quality and of the method to be used?生产人员是否已明确了解质量需要控制的产品的特性? 是否已经明确应该使用哪种



相应的方法? 9.11 CF Are systems or equipment systematically used to ensure quality? Do those methods take into account recent technological advances (Poka-Yoke, etc.)?鉴于技术的最新发展, 是否已对有助保证质量的手段或体系加以系统地利用 (防差错系统, 自动化) ? 9.12CF Is initial sample acceptance guaranteed before production is started (new or modified products or processes)? 在开始批量生产(新 的或更改的产品工序)前,工装样件的验收是否得到保证? 9.13CF Is the Process Audit method systematically applied to all processes (PQA Procedure no.02 01 15)? 工艺审核的方法是否在所 有的工序上得到系统的运用(产品质量保证程序 NO.020115)?
VALEO 1000 提问表 1994 年 7 月 -32-

9.5. Production equipment maintenance 生产设备的维修
Has a total productive maintenance approach been developed and are files for production equipment life cycle documented? Are maintenance levels and responsibilities defined? 全面生产维修方法是否得到开发? 生产设备使用寿命卡片是否已编制成文


件?维修的级别和职责是否已作规定? 9.15CF In case of prolonged non-use, is equipment properly stored, verified or re-standardized at appropriate intervals to ensure its precision and reliability. Is the verification status of the material and components identified throughout the production cycle (stamps, labels, etc.)?当企业设备 长期搁置不用时, 是否得到妥善的储存,保护或者间隔适当时间进行重新校准以确保其精确性和可靠性?在生产的全 过程中,是否对器材和全部设备的校准情况加以标识(盖章、贴标签......) ? 9.16CFS Are maintenance costs (preventive and corrective) analyzed to define improvement targets?为了确定改进的目标,是否对维修 费用(预防性的和纠正性的)进行分析? 9.17 CFS Are preventive maintenance books kept up to date. Is there a monitoring and measurement system for equipment reliability? Is the planning kept up to date? 预防性维修手册的内容是否不断调整更新?是否有跟踪和测试设备可靠性的体系?维修计划是否 不断调整? 9.18 CFS Are SPC results used to plan preventive maintenance?是否利用统计工序控制的结果来实施预防性维修计划?

VALEO 1000 提问表 1994 年 7 月 -33-

9.6 Statistical process control 统计工序控制
Are potential capability studies conducted to provide a preliminary assessment of the process? Is process capability systematically checked when a new product is introduced onto an existing production line?在初次评估工序前,是否进行潜在工序能力研究?当现有


的生产作业线上投入新产品时,是否对这种工序能力进行系统的验证? 9.20 CFS Is there a system to collate process parameters (or product characteristics) that catalogues causes of variability (including ambient conditions for certain processes and auxiliary materials: compressed air, water, electrical current, etc.)? 是否有搜集工序参数(或产品特性) 的体系用于将造成产品变化的可能原因列举出来(包括某些工序环境和辅助设施: 压缩空气、水、电??)? 9.21 CFS Are control charts used by the operator to ensure control of his or her process (correction of deviations; adjustment, etc.)?操作人员 是否运用检测卡片来保证对其工序的控制(纠正偏差:调整等等?)? 9.22CF Are process capability analysis performed? Is corrective action taken to improve capability if it is not satisfactory (Cpk ?1.67)?是否 进行工序能力分析? 如果能力指数不能达到令人满意要求(CPK≥1.67)是否采取必要的纠正措施? 9.23CF If capability indices are below the objective, are measures implemented to guarantee the unit quality (100% control)?当能力指数低 于目标时,是否采取相应的措施来确保加工件的质量(100%进行检验)? 9.7. Process capacity 生产能力 9.24CFS Is machine and process utilization checked and reported? Is downtime caused by non-Quality (product/process/service) measured and analyzed?机器的使用率是否定期进行检查和汇报? 其中与质量问题(产品/工序/服务)有关的部分是否予以重视并加 以分析? 9.8. Supplies, utilities and environment 供货、辅助手段和环境 9.25CFS Are the ambient conditions in the plant suitable for the type of operations performed? Are appropriate limits (concerning the temperature, cleanliness, etc.) specified, controlled and verified?工厂的周围条件是否适于进行作业?极限条件(涉及气温、清洁度 等)是否有明确说明?是否加以制和验证?
VALEO 1000 提问表 1994 年 7 月 -34-

10. INSPECTION AND TESTING 检验与试验 10.1. General 总则 10.1CF When testing methods are common to many functions (R&D, manufacturing engineering, quality, etc.), are quality monitoring tests related to development tests? Is a schedule established?当试验设备为几个部门所共有(研究与开发、工艺、质量??)时,涉及 质量跟踪的试验是否受到跟开发新产品试验同样的重视?是否制订相应的试验设备工作计划? 10.2CFS Are the controls and tests performed by personnel having received a appropriate training?是否所有的试验或检验均由受过相 应培训的人员来进行? 10.3CFS Do the results of the controls and tests fall within the tolerance limits accepted for initial samples?检验与试验的结果是否在工 装样件已接受的公差范围内? 10.4CFS Is there a formal procedure for Quality to authorize the start of production (following one day "full capacity")? 质量部门发出的 批量生产许可(在“满负载运转”一天后)是否已形成文件? 10.5CFS Are all process inspection and test records kept in accordance with the specifications?所有涉及在制品的检验与试验的记录 是否按照已制订的规章加以保存? 10.6CFS Are first piece/set up inspection procedures implemented and respected for each new serie or team start-up? 是否已制定关于对 首件产品/首次装配进行检验的程序? 在每次新的批量生产或班组生产开始时是否都遵照执行? 10.7CFS 附近? 10.8CFS Is there a control plan in existence, specifying at least the following:是否有检验规划?检验计划最少应明确: - parts to be tested? 必须进行试验的部件; - test frequency? 试验的频率; - sample size? 样本大小; - method of analysis? 分析的方法?
VALEO 1000 提问表 1994 年 7 月 -35-

Are master samples and Quality Standards used to assist in acceptance/rejection and are they displayed near the appropriate


10.2. Receiving inspection and testing 进货检验与试验 10.9 CFS Is there a distinction established between incoming articles/materials (controls/Product Quality Assurance)?是否清晰划分外购 的物品/零件及材料(检验/产品质量保证)? 10.10CFS Is there a procedure to ensure that any items/materials/parts are inspected before they are released to production (product which are not in PQA)?是否有旨在确保未经检验(指不属于 AQP 的产品)前任何 外购物品/材料/零件不得投入生产的程序?
Are there procedures and instructions defining the control methods and the measures to be taken in case of non-conformity (identification, information, isolation, etc.)? Are they respected? 是否有程序和作业指导书明确规定检验方法和在发现不合格时


应采取的措施(标识、通报、隔离??)?这些程序和作业指导书是否遵照执行? 10.12CFS
Does identification of products, material and component batches conform to Purchasing function requirements (origin of

traceability)? 产品、 材料和零件的标识是否符合采购部门的要求(可追溯性的起源)?

10.13CF Are certified purchased materials accompanied with the relevant statistical data or test results confirming that the shipment conforms to the specified requirements?外购材料是否经认证?供应商发货是否附试验结果及统计数据以证实发货符合技术规范的 要求? 10.14CF Are periodic checks conducted on certified products to verify certification according to a defined schedule?为了控制验证,是否 按照制订的计划对已验证的产品定期进行检查? 10.3. In-process inspection and testing 在制品的检验及试验 10.15CFS Are all relevant in-progress test and inspection requirements integrated in appropriate procedures and work instructions?所有涉

10.16CFS Is the product held until the required inspection and tests have been completed and the necessary reports have been reviewed and verified? 当需要进行的检验和试验没有完成,必要的文件还没有经过审核及验证时,是否把生产产品停发?
VALEO 1000 提问表 1994 年 7 月 -36-

10.4. Final inspection and testing 最终检验和试验 10.17CFS Are there procedures to ensure that all specified requirements have been respected (in compliance with the control plan), and that the
corresponding data and documentation is available and authorized before products are dispatched? 在产品发往用户前,应验证最终成品

Are procedures concerning night inspections included in the surveillance plan? 是否已提供并核准相关的数据和文件?监

控计划中是否已包含涉及夜间检验的安排? 10.18CFS Have personnel been given instructions on how to use the test and control equipment and to interpret the results? 员工是否有解 释文件及如何使用检验和试验装备的指导书? 10.19CFS Have all specified reliability test requirements been complied with? 所有可靠性试验结果是否符合规定要求?

10.5 Inspection and test records 检验和试验记录 10.20CFS Do the control and test records prove that the products conform to the specifications? Are they analyzed systematically with a view
to taking corrective action to improve production, if necessary? Are they available at all times? 检验和试验报告能否认证产品是否符合

技术规范要求?这些报告是否将加以系统分析, 然后采取旨在改进生产的纠正措施?必要时这些报告是否可以随时
查阅? 10.21CFS Are all inspection and test records maintained in accordance with product specifications? Are they available at all times?所有检验 和试验文件是否根据产品定义不断调整更新?是否可以随时查阅? 10.22CFS Are the time limits and conditions for storing test and control results defined and respected? 是否规定检验和试验结果存档 的时间与条件并遵照执行?
VALEO 1000 提问表 1994 年 7 月 -37-

11. CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT 检验、测量和试验设备的控制 11.1CFS Are there work procedures and instructions for managing equipment used throughout the product development cycle?是否有涉及

11.2CFS Is equipment selected according to the measurements to be conducted and to the required precision? Is it inspected, standardized and/or verified upon reception with respect to the supplier's requirements (capability, precision, repeatability, etc.)? 设备是否按照涉及的测 量和所需的精度来加以选择?在设备验收时,是否按照供方的技术规范(能力、精密性、可重复性??)进行检查、 校准及/或鉴定? 11.3CFS Are calibration and/or certification checks (capability, exactness, precision and reproducibility) conducted at regularly-scheduled
intervals? Are they planned and are environment, handling and storage conditions ensured appropriate for the standardization, controls, measures and testing conducted?校准和/或鉴定(可重复性、准确性、精密性、可复制性)是否定期进行?是否有计划?环境、搬运

以及贮存的条件是否适宜于进行校准、检查、测量和试验? 11.4CFS Is all measuring and control equipment numbered or otherwise identified on a list recording their standardization status?是否所有

的测量和检验设备均编成号或通过其它的手段来予以识别?是否对这些设备的校准状态列入清单, 并对清单作调整 更新?
11.5CFS Are all resources linked by a standardization chain and are reference equipment the object of a validated certificate, with reference to National Standards?是否所有的设备都与校准链连接?用作校准的设备是否经过现行标准验证并与国际标准接轨? 11.6CFS Is customer-supplied equipment used? Is it controlled and calibrated in compliance with specified requirements?如果使用客户提 供的设备是否按照规定的要求进行检查和校准? 11.7CFS 是否有足够的检验人员?并对他们关于测量设备的使用、维修及校正进 行培训?
VALEO 1000 提问表 1994 年 7 月 -38-

12. INSPECTION AND TEST STATUS 检验和试验状态 12.1CFS Are there procedures to control the identification and test status of product/components throughout production, especially for verification (clear distinction between verified and non-verified products)?在生产的全过程中, 是否有涉及产品/零件标识及其检验

12.2CFS Are all specified tests/inspections conducted on control items/safety items and other regulatory items? 受控项/安全项(需符合安 全/ 强制性规定和标准)是否按指定要求进行所有的试验或检验?

VALEO 1000 提问表 1994 年 7 月 -39-

13. CONTROL OF NON-CONFORMING PRODUCT 不合格产品控制 13.1. General 总则 13.1CFS Do procedures exist for the treatment of non-conforming products, and corrective actions to eliminate recurrences?是否已制订不 合格产品的处理和纠正措施的实行程序,以防止问题重复发生? 13.2CFS Is each non-conformity recorded and communicated to the level where it was detected? Is the non-conforming product identified and
isolated in a special place?是否每件不合格品都予以记录并在发现的层次予以通报?


13.2. Nonconformity review and disposition 不合格产品的检查和处理 13.3CFS Are non-conforming products examined by a designated person using documented procedures to determine the necessary action to be
taken (scrap/sort/reclassify)?不合格产品是否按照编制成文的程序由一名指定的负责人检查,以便确定应采取何种措施

13.4CFS Is the problem evaluated to determine its potential impact on performance, quality costs, reliability, safety and customer satisfaction? 是否对产生的问题进行评价,以便确定其对效率、质量成本、可靠性、安全以及客户的满意程度产生的潜在影响? 13.5CFS After repair or sorting, are non-conforming products systematically checked in compliance with the initial process to ensure
conformity to specified requirements?不合格产品经过修改或修理后是否按照最初工序系统检验,以便验证其是否符合要

13.6CFS Is there a exception procedure supervised by the Quality manager? Is it applied to non-conforming products? Is their occurrence reviewed and systematicaly dealt?不合格产品的回用程序是否由质量负责人监督管理?是否已实施?并保证回用的再次发 生获得系统化的处理?
VALEO 1000 提问表 1994 年 7 月 -40-

14. CORRECTIVE AND PREVENTIVE ACTION`纠正和预防措施 14.1. General 总则 14.1CFS Have responsibility and authority for instituting corrective and preventive action been defined as part of the Quality Action Plan? If necessary, is the requirement for informing the customer complied with?有关采取纠正和预防措施的职责与权限是否已在质量改进 计划内作了规定?如果有必要,有关明确提出的通知客户的要求是否能够满足? 14.2. Corrective Action 纠正措施 14.2CFS Are analytical methods used to solve the most important causes of non-conformity to solve problems?是否用分析的方法来优

14.3CFS Are all relevant functions been informed of the corrective action taken?是否所有的相关部门都了解已进行的纠正措施? 14.4CFS Is corrective action taken for specific problems effective? Is cost analysis carried out (taken into account in the Quality cost)?为解 决某些特定问题所采取的措施是否有效?是否实施成本评估(在质量成本报告中予以老虑)?
Do modifications resulting from corrective actions follow the usual method for the treatment of modifications (including modifications to procedures/work instructions resulting from corrective actions)? 纠正措施实施后产生的更改是否按照正常的更改处



VALEO 1000 提问表 1994 年 7 月 -41-

14.3. Preventive Action 预防措施 14.6CF Are there written procedures for detecting, analyzing and eliminating potential causes of non-conformity?是否有为发现、分析和

14.7CF Are there strict procedures and methodology to determine the most appropriate stages for addressing any problems requiring action. Is
the methodology systematically used?对于需要采取改正措施的问题是否有为确定解决问题所需的步骤而制定的程序和严

14.8CF Is the application of preventive action defined along with means used to check that preventive action has been taken and is effective?

14.9CF Is pertinent information submitted to management for review?有益的信息是否已提交管理评审?

VALEO 1000 提问表 1994 年 7 月 -42-

15. HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY 搬运、贮存、包装、防护和交付 15.1. General 总则 15.1CFS Have procedures and work instructions been established to control handling, storage, packaging and delivery methods of
materials/products and components throughout the production cycle?为了控制生产全过程中材料/产品及零件的搬运、贮存、包

15.2CFS Do audits of the transport system, of distribution centers and delivery to the customer ensure non-deterioration of units during transfer? Are packaging non-conformities and damage related to transport treated in the same way as any other non-conformity?对运输体系、中转仓 库以及交付进行的评审是否能确保产品在转运中不遭损坏?外包装的不合格和与运输有关的损坏是否都采取跟 处理其它不合格同样的方法来处理? 15.2. Handling 搬运 15.3CFS During handling, are instructions implemented to ensure products are not damaged, deteriorated or mixed?在进行搬运作业时, 作业指导书是否有助于防止发生产品损坏、变质和混淆现象?

15.3. Storage 贮存 15.4CFS Is there a first in/first out policy in all storage areas for incoming and outgoing products?所有贮存产品进出是否按照先进? 先出的方法来进行?

VALEO 1000 提问表 1994 年 7 月 -43-

15.4. Packaging 包装
Are all packaging, storage and marking processes, including equipment to be used, specified (including special customer requirements)? Are they respected?是否所有的包装、保存和标记方式,包括需要使用的设备都作了详细说明(包括客户提



15.5. Preservation 防护 15.6 CFS Are regular verifications (preservation of products and parts) conducted to determine whether storage conditions are satisfactory, and to launch corrective actions (environment, mode, security, etc.) including the security of stock?是否定期地作验证(产品-部件的防 护)以确定贮存条件是否令人满意,并采取必要的纠正措施(环境、方式、安全??)? 15.6. Delivery 交付 15.7CFS Are all shipments prepared and transported in conformity with specified requirements and carrier regulations?所有的产品交付是 否均在符合规定要求并遵守有关运输规定的情况下进行的?

15.7. Housekeeping 场地的管理 15.8CFS Is housekeeping in the plant satisfactory: are plant premises clean and orderly?场地是否实施管理?场地是否清洁整齐? 15.9CFS Have cleaning schedules been drawn up? Are they documented, kept up-to-date and properly displayed?是否制订了清洁跟踪 指标,是否编成文件,不断调整更新并予以公布?

VALEO 1000 提问表 1994 年 7 月 -44-

16. CONTROL OF QUALITY RECORDS 质量记录控制 16.1CFS Have procedures for the control and maintenance of quality records been prepared? 是否已制订质量记录的控制和保存程

16.2CFS Are retention times and techniques for storing specified and are customers' requirements respected? Are critical characteristics included?是否考虑到客户的特定要求和关键特性?对保存的技术与期限作了明确规定? 16.3CFS Are the quality records identifiable to the product/process involved? Can they be found easily?质量记录是否采取以能跟有关

16.4CFS Are the quality records stored in an environment minimizing damage and deterioration risks? e.g. Are quality records held on computer discs stored in fire-proof cabinets?质量记录是否贮存在适合的环境中,把质量记录遭损坏变质的危险降到最低限 度?例如:软盘上的记录是否保存在防火的文件橱内? 16.5CFS Can records of control/safety items be easily consulted, including those established by the supplier?受控项/安全项的质量记 录包括供应商编制的记录是否便于查询?

VALEO 1000 提问表 1994 年 7 月 -45-

17. INTERNAL QUALITY AUDITS 内部质量审核 17.1CFS Have procedures been established to set up a complete system of internal audits to verify that planned quality systems/processes are
effectively implemented?是否已制订确保内部质量审核予以实施的程序,以验证质量体系是否行之有效?

17.2CFS Is there an audit schedule? Is it kept up-to-date and communicated to all the relevant functions?是否有审核计划?该计划是否 不断更新?是否遵照执行?是否向各有关职能部门通报? 17.3CFS Have auditors been specially trained? Is there a list of qualified auditors (Is there a person responsible for managing the audit procedure)? Are auditors monitored?进行审核的人员是否经过特别培训?是否有一张质量审核员名单(特别是审核体系的负 责人)?审核员的跟踪调查是否得到保证? 17.4CFS Are audit methods and tools standardized and formalized (preparation, reference documents, processing, reporting)?审核的方法和 工具是否已制定文件?是否已规范化(准备、参照、进行、报告)? 17.5CFS Are final closing meetings held with responsible personnel and are records maintained?审核结束的会议是否得到各有关负 责人的参与?相关的记录是否予以保存? 17.6CFS Are audit reports issued to relevant functions and auditees, including senior management?审核报告是否系统地提供给审核

17.7CFS Are recommendations for corrective action budgeted for and integrated into the Quality Improvement plan? Are corrective actions requiring finance in the budget plan?纠正措施是否制订预算?是否已纳入质量改进规划? 预算是否为纠正措施的实施预备了 准备金? 17.8CFS Are corrective actions raised on previous audits assessed for effectiveness? 是否对纠正措施的效果进行评估?
VALEO 1000 提问表 1994 年 7 月 -46-

18. TRAINING 培训 18.1. Training 培训 18.1CFS Are all training needs assessed (to ensure adequate skills) and formalized in a budgeted annual training plan?对于全体员工的培 训需要(能力与需要的协调)是否根据相关程序作评估 ,是否已落实为有经费预算的年度培训计划? 18.2CFS Are training plans developed to ensure flexibility of the workforce at various work stations? Do operators possess, when necessary, certified skills or formal qualifications (special processes, etc.)? 培训计划是否注意培养多岗位人才? 在适当的情况下 , 作业

18.3CFS Are the documents related to training plans and the list of attendees kept up-to-date (i.e.: individual records)?与培训计划相关的 文件和参与者的名单是否不断调整(个人资料卡片)? 18.4CFS Do managers have priority for quality (tools and methods) training?经理人员是否优先接受质量(方法和工具)培训? 18.5CFS Does management encourage awareness of all personnel on quality issues and on the responsibilities concerning the risks of defective products? Is there an initial and continuous training program for personnel involved in Quality Assurance tasks (without necessarily being part of the Quality function)?管理部门是否鼓励全体员工了解质量问题和因劣质产品而产生的风险?是否对肩负质量保证任务 的人员 (并不一定是隶属质量部门的人员)实施上岗培训和持续培训计划? 18.6CFS Are training courses conducted in prevention and analytical quality assurance methods such as SPC, FMEA, Pareto, Quality Function Deployment, Design Of Experiment (DOE) etc.?是否进行质量保证的预防和分析方法方面的培训?(例如:SPC、FMEA、质 量功能展开、实验计划、因果分析图解??)

VALEO 1000 提问表 1994 年 7 月 -47-

18.2. Responsibilities and motivation of personnel 人员的岗位责任制与激励机制 18.7CFS Are the responsibilities of all personnel (including delegation of responsibilities) clearly defined and in accordance with the flowchart (job descriptions)?每人的岗位职责是否有明确规定(包括代理职责)? 是否与组织机构图相一致(职能定义)? 18.8CFS Are induction training schemes developed for both full-time, part-time and temporary personnel?是否对新招人员、包括临时 人员和固定期合同人员采取介绍和培训措施? 18.9CFS Is the training program regularly evaluated and revised if necessary?是否对培训计划及其结果定期进行评估?在必要情 况下,是否根据实施情况进行修订. 18.10CFS Is multifunctional teamwork widely developed at all levels in the firm? Are the results obtained measured and distributed to the widest possible audience?是否在企业各级广泛推广多功能小组的工作?是否对取得的成果进行评价并广为宣传.

VALEO 1000 提问表 1994 年 7 月 -48-

19. SERVICING 配套服务 19.1. Installation and after sales service 安装与售后服务
Does the after-sales quality function include technical advice to customers as well as training at the customer's production plant? Can members of the function be present at the customer's plant when new products are launched?发货后的质量职能中是否包括对客户提供


技术建议、 在可能情况下为客户生产厂家提供培训?新产品启动供货时是否到客户处现场服务? 19.2CFS Are procedures and work instructions established to ensure that in the event of a defect during delivery or at customer's plant (customer returns), measures will be systematically implemented to deal with the problem?在发货过程中或在客户处 (客户生产线返回)

19.3CFS Is the handling of defects and their causes integrated in an improvement plan? Is the customer informed of the progress and the results of corrective action? 质量改进计划中是否有处理产品缺陷及其原因的内容? 客户是否了解已采取纠正措施的进展及结 果? 19.2. Market feedback and product surveillance 市场信息反馈和产品监督 19.4CFS Is the cost of failure quantified and taken into account in the Cost of Quality? 损失成本是否进行评估?是否纳入质量成 本? 19.5CFS Has a program of visits to all customer plants been planned to help us to improve our level of service? 是否制订并实行访问客 户计划以便改进我们的服务?
Are procedures set up defining the action to be taken in the event of defects occurring during product use (warranty returns)? Do these procedures make provision for analysis with the customer and for the corrective action to be taken?是否有程序规定产品在使用过程中发


VALEO 1000 提问表 1994 年 7 月 -49-

19.7C Is a performance monitoring system set up to check the quality of the product throughout its life-cycle?是否在产品的整个生命周 期中实现对其使用性能的跟踪,以监控产品的质量特性? 19.8C Is the data analyzed to determine product reliability? Is this data available for design review?搜集到的数据是否从产品可靠性 的角度加以分析?在设计评审时,这些数据是否可供使用?

19.3. Spare part market 二次配套市场 19.9CFS For spare parts manufactured on existing processes, is the Quality Assurance system the same as for normal production? 在现有工 序上制造的备用件是否也适用常规生产的质量保证体系? 19.10CFS For spare parts manufactured on different processes than for normal production, is a quality assurance plan submitted to the customer? 备用件的生产工艺与常规生产不同时, 是否向客户提交质量保证计划?

VALEO 1000 提问表 1994 年 7 月 -50-

20. STATISTICAL TECHNIQUES 统计技术 20.1. Identification of need 确定需求 20.1CF Have statistical techniques been defined to check the aptitude of the process and of product characteristics at all stages of production? 是否为生产各个阶段确定应使用的统计技术,以便验证工序的能力和产品 的特性?

20.2CF Is there a summary of the various methods used? 是否有所使用的各种方法的概要性文件? 20.2. Procedures 程序 20.3CF Are the people using these methods properly trained? 使用这些方法的人员是否经过适当的培训? 20.4CF 质量部门是否能通过书面的程序确保统计技术的实施和对其实施的控制? 20.5CF Does the Quality function guarantee through written procedures the set up and the control of application of the statistical techniques? 已确定的统计技术是否在企业的各个层次得到广泛的运用?运用是否有效?

VALEO 1000 提问表 1994 年 7 月 -51-

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