伊莱克斯验厂质量评估调查问卷

MANAGEMENT SYSTEM ASSESSMENT - PRE ASSESSMENT AUDIT  伊莱克斯质量管理体系评价-预评价审核

PRE-ASSESSMENT AUDIT - SECTION QUESTIONNAIRE 伊莱克斯验厂评估前审计 - 部门调查问卷

1、 MANAGEMENT 伊莱克斯质量评估问卷 - 管理

1.1 Does the supplier organisation hold a current ISO9001 or equivalent certification (e.g. ISO/TS16949) from an accredited certification body for the scope of product/services to be supplied?
工厂是否有认证机构颁发的ISO9001证书？

1.2 Have quality objectives (both internal and external) been established and agreed using feedback from customers and other available information?
是否有建立的质量目标（包括内部的和外部的），是否同意使用来自客户、内部及其他可用信息的反馈资料？

1.3 Have objectives been analyzed and are actions being taken if the targets are not achieved? Internal targets and consequent activities have to be considered, too.     质量目标是否进行过分析，目标未达到是否采  取相应措施？内部目标和结果分析也需要考虑？

1.4 Is there a system to measure quality costs that monitor internal failures, external failures, prevention, and appraisal?
是否有测量质量损失（监控内部损失、外部损失、预防和评价）的系统？

1.5 Have specific improvement projects been identified and are they managed with appropriate measurables and verified for effectiveness?
详细的改进方案是否进行了鉴定？方案是否考虑了有效性、适当性、可测量性及可证实性？

1.6 Is there a system established to investigate the causes of non-conformance (internal and external, i.e. customer complaints and returned parts analysis) and are appropriate corrective actions developed to eliminate them?
是否建立系统来调查不合格品原因（内部和外部，如顾客投诉和召回部件分析），是否有适当的整改措施来消除这些原因？

1.7 Is the effectiveness of corrective action verified in a proper way (including targets, trends, PDCA method etc) in order to prevent recurrences?
是否运用恰当的方式（包括目标、趋势、PDCA方法等）来验证整改措施的有效性以便预防错误重复发生？

1.8 Has a system been established to identify training needs and conduct training of all personnel performing activities affecting quality?
是否建立系统来确定培训需求和进行全员培训来执行影响质量的措施？

1.9 Are management reviews performed at defined intervals with active participation of senior management?
管理评审是否在明确的时间间隔内进行并且有高级管理层的积极参与？

2、 QUALITY PLANNING Electrolux验厂 - 质量策划

2.1 "Is there a new product introduction process in place which addresses the following?
- Review of customer requirements;
- Involvement/interfaces with customers and suppliers;
- Feasibility studies;
- Tooling planning;
- FMEA’s;
- Identification/control of critical characteristics;
- Measurement Systems Analysis;
- Control Plans and Flow Charts;
- Sample identification and submission;
- Evaluation of process capability and use of appropriate statistical methods;
- Evaluation of products over intended lifetime;
- Management of changes in the above." "新产品采用过程中是否有以下的品质计划？
1）客户要求评审；
2）与客户和供应商共同参与/介入；
3）可行性研究；
4）工装计划；
5）FMEA；
6）关键特性的鉴定/控制；
7）测量系统分析；
8）控制计划和流程图；
9）抽样鉴定和提交；
10)工序能力评估、合适的统计方法的使用；
11）超过预定使用寿命产品的评估；
12）以上内容的变更管理。"

2.2 Can the supplier organization demonstrate capability to undertake Risk Assessment / Failure Mode and Effect Analysis (FMEA)?
工厂能否证明其从事风险评估/失效模式及原因分析（FMEA）的能力？

2.3 Can the supplier organization demonstrate that they are able to perform statistical process capability studies and utilise statistical process control methods? 工厂能否证明其能够进行统计工序能力研究和使用统计过程控制方法？

2.4 Is there an effective system for approval/ validation of parts and where necessary, processes both internal and external prior to commencement of production at the supplier organization’s facility?
在零部件提交批准/确认时或必要时在生产开始前的内外部工序、模具、机器和设备，工厂是否有有效的系统？

3、 Purchasing 伊莱克斯质量验厂 - 采购

3.1 Is there an effective system for ongoing monitoring of supplier performance capability and is QS Management a requirement?
针对进行中的供应商绩效能力的监控是否有有效系统，且是否要求质量标准（QS）管理？

3.2 Is there an effective system ensuring corrective actions are established on the basis of "suppliers’ classification and performance" results?
是否有有效的系统来确保纠正措施是建立在“供应商分类和绩效”结果的基础上？

3.3 Is there a defined process for sample submission from suppliers and for sample evaluation?
对供应商的样品提交和样品评估是否有明确的过程？

3.4 Are suppliers required to notify the organization of any changes made to supplied products? Relevant engineering changes must be formally communicated to and responded by suppliers.
是否要求供应商在供应产品发生任何变更时通知工厂？供应商必须正式地传达和反映相关的设计变更。

4、 CONTROL OF PRODUCTION, MONITORING & MAINTENANCE Electrolux验厂 - 生产、监控和维护的控制

4.1 Do procedures (or control plans)/work instructions specify requirements for operation, inspection, testing, gauging, production start-up approval (including appointed responsible) as well as product, process and tooling changes, with recorded results? Availability of necessary procedures/work instructions at the work station is mandatory.
程序（或控制计划）/作业指导书对操作、检验、测试、测量、生产启动批准（包括指定的责任人）是否规定了要求，同样生产、过程、模具变更是否有记录结果？工作站上的必要程序/作业指导书强制要求其可实用性。

4.2 Are special processes identified and subjected to planned complementary activities to ensure that products shall meet product specifications?
特殊工序是否被鉴定和承受计划的补充措施，来确保产品符合产品规格？

4.3 Are statistical methods, SPC, implemented? Process capability index Cpk ≥1.33 where applied to relevant parameters.
是否实施了统计方法和统计过程控制（SPC）？应用于相关参数的工序能力指数Cpk≥1.33。

4.4 Are inspections and tests performed at defined stages with clear indication of inspection/test status?
检验和测试是否在明确阶段根据检验/测试状态的清晰指示执行？

4.5 Has an effective system been implemented for handling, storage, packaging, delivery and preservation of the product?
在产品搬运、储存、包装、交付和保存过程是否实施了有效系统？

4.6 Is the cleanness of the work environment in general well tailored and well organized to ensure that products comply with requirements and are not contaminated or otherwise affected?
工作环境的清洁通常是否被很好地组织和整理来确保产品遵守要求且没有受到污染或其他影响？

4.7 Are written procedures used to monitor the product quality (including special process parameters) from incoming, through the in process controls, to the final statistical product audit of ready to ship products?
是否使用书面程序来监督产品质量（包括特殊工艺参数）从通过过程质量控制的来料到最终的统计产品准备审核再到运输产品？

4.8 Is there a planned maintenance system for all equipment including a maintenance schedule, defined criteria, frequencies and assigned responsibilities and records?
对所有的设备是否有计划维护系统包括维护计划、明确的标准、频率、指定的职责和记录？

4.9 Is there a system to manage key manufacturing equipment spare parts including their identification and availability?
是否有一个系统来管理关键制造设备的备用配件包括它们的标识和有效性？

5、 CALIBRATION, IDENTIFICATION, TRACEABILITY & DOCUMENTATION 伊莱克斯质量验厂 - 校准、标识、可追溯性和文件

5.1 Is there a system in place which ensures that appropriate measuring and test equipment is properly calibrated at periodic intervals with traceability to national/ international standards and the performance of MSA (Measurement Systems Analysis) studies?
是否有合适的系统来确保测量和测试设备在一定周期间隔内很好地被校准，可追溯到国家/国际标准和测量系统分析（MSA）研究成果？

5.2 Are materials, products and constituent components, and are homogeneous batches kept separated identified at all stages of production including incoming and final warehousing?
物料、产品、组成部件、同种批次是否在生产所有阶段包括来料仓库和成品仓库进行隔离识别？

5.3 Has provision been made for a recorded and maintained traceability system of product to source and through all the relevant process parameters?
记录和维护的生产 追溯系统是否制定了相应规定来追溯来源和通过所有相关的过程参数？

5.4 Does the system for document control, by means of a master list, include review, approval, issue dating and distribution of documents and procedures? This must include control of relevant computer software, masters, and customer drawings?
借助于总清单的文件控制系统是否包括文件和程序的评审、批准、签发日期、分发？必须包括对相关计算机软件、持有者和客户图纸的控制。

5.5 Has an effective system been implemented to handle engineering and process changes to ensure that they have been properly approved and implemented?
是否实施 有效系统来处理设计和过程变更以确保这些变更得到正确的认可和实施？

6、 DESIGN CONTROL 伊莱克斯验厂 - 设计控制

6.1 Is there a system established and maintained to identify, control and verify design inputs and outputs, targets, development stages, review, verification and validation?
是否有建立和维护一个系统来识别，控制和验证设计的投入和产出，目标，开发阶段，评审，验证和确认？

6.2 Is there a system clearly defining when the design review, engineering changes included, is conducted, the frequency and at which stages?
是否有一个系统明确界定时，包括设计评审，工程变更，传导，频率以及哪些阶段？

6.3 Are the safety, regulatory, customer, and validation requirements clearly defined and the relevant responsible authorities appointed and competent?
是安全，法规，客户和验证的要求明确规定和任命能胜任的主管部门？

6.4 Does it exist a system for validation and acceptance plan of the design? This must include reliability and testing plans.
是否存在一个系统的验证和验收设计计划？这必须包括可靠性和测试计划。

6.5 Are all records of project inputs and outputs targets, safety / regulatory / statutory / customer included, design validation and relevant competent authorities’ approvals maintained, traceable and retrievable for the required time?
是否项目的输入和输出记录指标，安全/管理/法律/客户包括，设计验证和有关主管部门的认同维护，规定时间内的所有记录可追溯和检索？