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1、Supplier Quality System Assessment 供应商质量体系评估Section 1: Quality Management System 质量管理体系1. Quality Function, ISO standard & Responsibilities 质量机能，ISO标准&职责 2. Internal Audits Quality System and other Compliance 内部稽核质量体系和其他3.Training for all Level of Organization 对组织各层次的训练Section 2: Resource Management
2、 and Capacity Planning 资源管理和能力培训4. New Product Introduction and Qualification Process 新产品介绍和承认过程5. Capacity Planning 能力培训6. Change Management Process, Product and Material 管理过程，产品和物料变更7. Process Capability / Process Characterization 制程能力和制程关键特性8. Product & Process Quality Metric Review 产品&过程的质量基准检讨9
3、. Customer and Field Performance Quality Data 客户和现场性能质量数据10. Quality Data and Communication 质量数据和传达Section 3: Production Process生产过程11.Calibration System and Control校验系统和控制12. Measurement System Analysis (Gauge R and R)量测系统分析13. Control & Disposition of Non-conforming Material 不合格物料的控制和处理14. Receivi
4、ng Material Quality System and Procedure进料质量系统和控制15. Work Instructions for Manufacturing Processes 作业指导书和制造过程16. Final Inspection and Acceptance Procedure 终检和允收程序17. Packaging, Storage, Shipping, Material Handling and Bar Code Requirements 包装，储存，运输，物料搬运和Bar code要求18. Housekeeping, POPI（protection of
5、 proprietary information 知识产权保护） and Preventive Maintenance Housekeeping，知识产权和预防性的保持Housekeeping19. Out of Control Actions for an Internal Defect for Mfg/Assembly/Service Site制造/组装/服务地点内部缺陷失控的措施Section 4: Sub-Tier Quality Control and Quality Improvements质量控制和质量改进20. Sub-Tier Supplier Selection and M
6、anagement供货商的选择和管理21. Sub-Tier Supplier Corrective and Preventative Action供货商的纠正和预防措施22. Process Flow, FMEA, Control Plan and Statistical Tool 流程，FMEA，控制计划和统计工具23. Statistical Methods / SPC on Box X Dimensions 统计方法/ box X 尺寸SPC 24. Problem Solving Techniques 问题解决技术25. Continuous Improvement and Mist
7、ake Proofing 持续改进和缺点预防Use the ED12695 Quality System Assessment Scoring Form to document the results of the audit and any required actions.Rating:SCORE 1: Unacceptable - This element is not included in the organizations quality management system.无法接受 - 这个要素没有被组织的质量管理体系所包涵 SCORE 2: Unacceptable - Bot
8、h planning and execution for this element require substantial improvement.无法接受 - 这个要素的计划和执行都需要进一步改进SCORE 3: Marginally Acceptable - This element is included in the suppliers quality management system and planning is adequate. However, execution requires improvement.边缘接受 - 此要素包含于供货商的质量体系，计划比较完善。但执行情况
9、仍需改进。SCORE 4: Acceptable - This element is included in the suppliers quality management system and is generally well-executed. 接受 - 此要素包含于供货商的质量体系且执行得相当完善SCORE 5: Excellent - This element is included in the suppliers Quality Process. Planning and execution are extremely thorough.杰出 - 该要素包涵于供货商的质量过程中
10、,计划和实施都非常完善Definitions, Terms, and Acronyms:CustomerRefers to customer(s) of the organization being audited. (Lenovo or other customers) 供方的审核者OrganizationRefers to the company that is being audited.被审核的供方SupplierRefers to supplier(s) of the organization being audited.供方的供方5S5S is the Japanese conce
11、pt for House Keeping. (Sort, Straighten, Shine, Standardize, Sustain)A/IAutomated insertion自动插入Box X parameterCritical characteristics.关键特性DMAICA six sigma problem solving process utilizing the steps: Define, Measure, Analyze, Improve, and Control. 六西格玛解决问题过程利用步骤:定义、测量、分析、改善和控制。DOEDesign of Experime
12、nts 实验设计Drill Deep Drill WideA method used along with 8D to identify root cause and implement permanent corrective actions across similar areas and/or processes. 方法以及8 d识别根本原因并在类似地区执行永久纠正措施和/或流程。ECNEngineering Change Notice 工程变更通知ESDElectro Static Discharge静电释放FMEAFailure Mode and Effects AnalysisGR
13、&RGauge Repeatability and Reproducibility测量重复性和再现性MSAMeasurement Systems AnalysisPCNProcess Change Notice制程变更通知PPAPProduction Part Approval ProcessPSOProcess Sign-Off工艺认证PSO工作程序确保了供应商显示其满足PPAP要求的能力SPCStatistical Process ControlSMTSurface mount technology 表面安装技术A/IAutomated insertionSECTION 1: QUALIT
14、Y MANAGEMENT SYSTEM, Responsibility and Internal audit.1. Quality Function, ISO Standard & Responsibilities質量機能，ISO標準&職責-品保Is there a Quality function or organization which provides customer advocate guidance to the total organization, and is this position fully supported by management? Is the Organ
15、izations quality management system properly documented, maintained and has measurement metric? 是否存在一个质量部门或组织，它能够为客户提供整个组织的支持性的指导；并且它的地位得到管理层的鼎力支持？这个组织的质量管理体系是否恰当的文件化，维护和标准化？SCORE 1: Organization has not achieved any ISO quality certification. 组织没有完成任何ISO质量认证 Organization does not have any quality ma
16、nual.组织没有任何质量手册。SCORE 2: Organization has obtained ISO9000 level certification and certification has not expired.组织获得ISO9001认证，并且在认证有效期内。 Supplier has Quality manual and policy statement well documented and signed by top management.供货商有质量手册和形成文件的质量政策并且经过最高管理者签名。SCORE 3: Organization has obtained ISO
17、9001 and ISO 14000 certification and other nationally recognized quality certifications.组织已经获得ISO9001和ISO14001认证和其他国际组织质量认证。-证书复印件 Supplier is regularly reviewing the regulatory agency requirement and keeping up compliance such OSHA, Rohs, EPA, Product Safety, ESD, and Contamination control etc供货商定期
18、的检查营销处调整的需求，保持符合OSHA，Rohs，EPA（美国环保局），产品安全，除静电，污染控制等等。-管理审查报告,会议记录(两年) The role of the Quality function is clearly defined. Quality manual is periodically reviewed by senior management and updated as necessary质量部门的角色被清晰的定义。最高管理者需定期检讨质量手册如果有必要需要进行更新。-管理审查报告,会议记录(两年)SCORE 4: In addition to ISO 9000, th
19、e organization has a plan to pursue a higher level quality certification or award (such as TL 9000, TS16949, Malcolm Bald ridge National Quality Award, etc.). 除了ISO9000,供货商已经或计划进行一些更高级别的质量认证或奖项.-QC080000 Quality function clearly serves in the customer advocacy role. 质量部门明确地扮演维护客户利益地角色.-品质手册-职责 Manag
20、ement is supporting a Six Sigma or Zero defect and cycle time improvement program. 管理支持6西格玛或零缺陷和周期时间改进项目-绿带培训相关数据,项目 Quality system compliance annual audit is performed by external registrar and has very few findings.质量体系符合外部稽核员实施的年度稽核并且审核发现很少。-外审缺失汇总SCORE 5: The Quality function takes a leadership
21、role in promoting the Six Sigma process, The Green Belt, Black Belt, lean enter prize or similar certification program is encouraged by management.质量部门在推进6sigma过程中担任领导角色。管理层鼓励绿带，黑带，倾向输入奖励或者相似认证项目 Senior Management regularly reviews effectiveness of the closed loop corrective action of the external a
22、udit findings.高层管理者定期的检讨外部稽核发现的改善措施的有效性。 The role of the Quality function is well recognized and supported by all levels of management (Quality metric is part of the business review). 所有级别地管理阶层都清楚地认识到质量功能部门地作用并给予支持 The Organization works directly with Customers not only in resolving issues, but also
23、 in understanding Customers businesses/needs to anticipate their requirements. 组织直接管理的事项不仅包括帮助客户解决问题,还包括充分理解客户的业务/需求以及更好地预测他们地需求.Score:Comments / Objective Evidence:2. Internal Quality system and other compliance Audits内部质量系统和其他符合性审核-品保Does an internal assessment program exist as part of the quality
24、 system review process and does Management regularly report on the results?是否有作为质量体系评审过程中某一环节的内部评价程序,管理阶层是否定期报告评价的结果?SCORE 1: No evidence of a quality management system internal assessment program exists. 没有内部评价计划SCORE 2: A documented quality management system internal assessment procedure exists an
25、d a few areas of the business such as manufacturing and inventory storage area are being assessed. 有文件化的质量管理体系内部评价程序,有少数的业务单位像制造单位和仓管单位开始被评价 Some corrective action has taken place based on the results of the assessments. 基于评价结果一些改善措施开始实施。 The individual areas for an internal audit are being schedule
26、d from a master schedule.内部稽核的单独区域按照时间表进行预先安排。SCORE 3: Management has established a documented procedure and audit check list for conducting quality management system internal audits for all major areas of the business. 管理阶层已经建立了文件化的程序和查检表，来指导对企业的主要区域进行质量管理体系内部稽核。-准备文件及查检表,两年的数据 Management is provid
27、ing resources to conduct an internal audit and corrective action to assure that all business areas are audited per specified interval in the procedure.管理阶层提供资源指导内部稽核和改善措施来保证企业所有区域依程序中的固定时间间隔被稽核。-准备文件及内审计划 Assessors are sufficiently trained and independent of the area assessed. 评审员接受培训并且独立实施区域的审核。-内审
28、员培训记录 Metric is used to monitor on time audit, close rates for corrective action items, reductions in # of corrective actions from year to year by various area of business and repeat rate of non conformance.指标被用来监控按时稽核，改善措施的结案率，改善措施在企业的各方面的一年比一年减少，不符合的重复率。-需要新作SCORE 4: The assessment schedule and fr
29、equency is sufficient to enable management to determine if a business unit is in control. 评价计划和频率能够使管理层充分确认各业务单位是否受控。-准备文件及内审计划 Assessment results are part of a closed-loop corrective action process. 评审结果是死循环式矫正措施的一部分-缺失改善证据Management is actively reviewing results of internal assessments and using t
30、he data to initiate continuous programs. 管理层积极检讨内部评审的结果并且应用这些数据开始持续的过程-管理审查报告,会议记录(两年) Metrics utilized to track the internal audit program are showing positive measurable results. 用以追踪内部评价计划的指针显示其积极有效的可测量的结果 Assessor certification validation period and retraining plan is kept updated.评价认证有效周期和再培训计划
31、保持更新。SCORE 5: There is evidence that all corrective actions are closed or are being actively worked on有证据表明所有的矫正措施已经关闭或被积极实施 The quality management system internal audit program is deployed in all major areas of the business and has become a routine part of the business unit review process. 内部评价程序在所
32、有关键领域内扩展,且已经成为日常检查系统的一部分 All Corrective actions have been well documented using 8D or similar tools and have verified that root cause and solution has been implemented and supported with data. Management has a method or metrics in place to ensure that corrective actions are effective. 所有的矫正措施都通过8D或类
33、似的工具文件化并且被验证问题根源和解决办法已经实施并且有数据支持。管理层有适当的方法或指标保证矫正措施是有效的。 Records and schedules pertaining to the quality management system internal assessment program are quality records and are collected, retained, and maintained per the quality record procedure记录和计划在质量管理体系内部评价程序中就是质量记录并按照质量记录管制程序被收集，保留，维护。Comment
34、s / Objective Evidence:Score:3. Training for all levels of organization-组织各阶层的培训Is Managements support of ongoing training (including problem solving, statistical technique, and quality training) sufficient and is it documented by an organizational training plan? Do employees have training plans to
35、fill knowledge gaps in areas applicable to their job function? 管理层是否充分支持不断培训(包括问题解决手段,统计方法,质量培训)并将其做成书面数据列入组织培训计划中? 是否体现了组织的需求?是否有在与工作职能相关的适当范围内弥补员工知识缺陷的培训计划？SCORE 1: No written training plan exists. 没有书面的培训计划 Some training is performed as time and budget allows and training tends to be limited prim
36、arily to manufacturing related skills. 在时间和预算允许的条件下进行了一些培训并且培训基本上限于与生产相关的技能方面SCORE 2: There is a documented training plan for direct labor employees.对于直接劳动雇佣人员有文件化的培训计划。 Training plan includes new hires, promotions, transfers and also covers UL, OSHA, Safety and other regulatory compliances that the
37、 business demands. 培训计划包括新近人员，晋升人员，岗位转换人员和同样包括UL，OHSAS，安全和企业要求的其他规章规定。SCORE 3: Annual training plans for the entire organization are required by management. The training plan is fully documented and includes all new hires, transfers and managers. 管理层要求订出整个组织的年度培训计划,这个计划已经书面化,其中包括新近人员,内部调动人员和经理人员的培训-
38、过去两年的培训计划,各部门调动人员的培训资料 Training plans generally tie to business and quality objectives. 培训计划通常与业务和质量目标相关联-根据培训计划展开,6sq培训的要求打印出来 The quality and quality related staff training curriculum includes process improvement topics, for example: Failure Mode Effect Analysis (FMEA), Control Plan, 8D and SPC. 一
39、些过程改善的主题，例如FMEA, Control plan, 8D和SPC是质量和质量相关员工培训课程的一部分。-根据培训计划展开,6sq培训的要求打印出来 A training program with a full curriculum and complete training records is implemented across all areas of the organization.有完整课程和全部培训记录的培训计划在组织的所有区域实施。-培训记录SCORE 4: There is a well designed training roadmap/program with
40、strong ties to the organizations business plan. 有计划良好的质量培训标的/系统,且与组织的业务计划密切相关-根据培训计划展开,6sq培训的要求打印出来 Employees have comprehensive training plans that account for individual needs and development. 员工有全面的关于其个人需求及发展的培训计划-入职条件展开 Metrics have been established to evaluate training effectiveness in support
41、of strategic plans. Progress to plan is reviewed regularly by management.支持战略目标的指针被建立，用来评价训练的有效性。 管理层应该经常对计划的进步检讨。-质量目标,上课时数及出勤率 Key employees of the quality group and other related areas have received process improvement training that includes GR&R, Process flow, control plan, SPC, 8D problem solvi
42、ng or equivalent. 在质量团队和其他相关领域里关键员工接受过程改进培训，包括GR&R, Process flow, control plan, SPC, 8D问题解决等等。-根据培训计划展开,6sq培训的要求打印出来SCORE 5: Training at all levels is driven by strategic objectives, customer requirements and expectations, and individual development needs. 各层次的培训要由策略性目标和客户要求及希望和个人发展需求来推动 Training ef
43、fectiveness measures clearly demonstrate a positive impact of training in accomplishing business and customer satisfaction objectives. 培训效果的检查清楚地证明,培训对完成业务和实现客户满意目标有积极地作用。 The training plan is updated as new training needs are identified. The program for quality area includes a variety of statistica
44、l tools including but not limited to: Pareto diagrams, cause and effect diagrams, stratified sampling, advanced problem solving techniques, DOE, 8D, Drill Deep and Drill Wide and identification of critical characteristics, etc.当有新的培训需求时培训计划需做更新.培训体系包括多种统计问题解决方法,包括但不仅限于：柏拉图,因果分析图,层别法,提升问题解决技术,试验设计，8D
45、，Drill Dee和Drill Wide重要特征辨识等.Comments / Objective Evidence: Score:SECTION 2: Resource Management and Capacity Planning 4. New Product Introduction and qualification process新产品导入和质量过程-R&DDoes the organization have a new product/technology/service launch process flow and procedure documented? Are the
46、performance of the new product/technology/service launch activities being tracked with appropriate metrics and approvals? 供货商是否有文件指导将新产品/技术/服务的导入流程和程序?是否可以追踪这些活动的执行是否有适当的标准和是否被承认？Organization shall provide evidence, as a minimum, of the following items: 供货商需提供证据,要求最少包含以下项目:a. New product/technology/
47、service introduction process flow, procedure, milestone tracking and performance metrics. 新产品/技术/服务的引入流程,程序,可追踪的重要时间,执行标准.b. Capability of receiving customer data, prints, specs and art work using industry standard software. 完成客户数据,图纸,规格和根据工业标准软件工作的能力.c. Dedicated personnel to support customer new product/technology/service launch activities, including design reviews, and supplier readiness activities. 专人负责客户新产品/技术/服务的导入行动,包括设计审核和供货商准备工作.d. Quality data collection syste
