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供应商质量体系审核评估
Supplier Quality System Assessment
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 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. 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. Receiving 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 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 Management供应商的选择和管理21. Sub-Tier Supplier Corrective and Preventative Action供应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SPC24. Problem Solving Techniques 问题解决技术25. Continuous Improvement and Mistake 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.
SCORE 1: Unacceptable - This element is not included in the organization’s 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 - Both 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 supplier’s quality management system and planning is adequate. However, execution requires improvement.边缘接受 - 此要素包含于供应商的质量体系,计划比较完善。但执行情况仍需改进。SCORE 4: Acceptable - This element is included in the supplier’s quality management system and is generally well-executed. 接受 - 此要素包含于供应商的质量体系且执行得相当完善SCORE 5: Excellent - This element is included in the supplier’s Quality Process. Planning and execution are extremely thorough.杰出 - 该要素包涵于供应商的质量过程中,计划和实施都非常完善Definitions, Terms, and Acronyms:
| Refers to customer(s) of the organization being audited. (Motorola or other customers) |
| Refers to the company that is being audited. |
| Refers to supplier(s) of the organization being audited. |
| 5S is the Japanese concept for House Keeping. (Sort, Straighten, Shine, Standardize, Sustain) |
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| Critical characteristics. |
| A six sigma problem solving process utilizing the steps: Define, Measure, Analyze, Improve, and Control. |
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| A method used along with 8D to identify root cause and implement permanent corrective actions across similar areas and/or processes. |
| Engineering Change Notice |
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| Failure Mode and Effects Analysis |
| Gauge Repeatability and Reproducibility |
| Measurement Systems Analysis |
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| Production Part Approval Process |
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| Statistical Process Control |
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SECTION 1: QUALITY MANAGEMENT SYSTEM, Responsibility and Internal audit.1. Quality Function, ISO Standard & Responsibilities质量职能,ISO标准&职责------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 Organization’s 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?·Organization has not achieved any ISO quality certification. ·Organization does not have any quality manual.·Organization has obtained ISO9000 level certification and certification has not expired.·Supplier has Quality manual and policy statement well documented and signed by top management.供应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。·Organization has obtained ISO9001 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…供应商定期的检查营销处调整的需求,保持符合OSHA,Rohs,EPA,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)·In addition to ISO 9000, the 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,供应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.------质量手册----职责·Management 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--------------绿带培训相关资料,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·The Quality function takes a leadership 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 audit 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 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.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 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?·No evidence of a quality management system internal assessment program exists. · A documented quality management system internal assessment procedure exists and 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. ·The individual areas for an internal audit are being scheduled from a master schedule.·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,两年的资料·Management is providing 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·The assessment schedule and frequency 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. 评审结果是闭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 the 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标显示其积极有效的可测量的结果·Assessor certification validation period and retraining plan is kept updated.·There is evidence that all corrective actions are closed or are being actively worked on.·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。Comments / Objective Evidence:3.Training for all levels of organization---------组织各阶层的培训Is Management’s 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 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)并将其做成书面资料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?·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 primarily 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。·There is a documented training plan for direct labor employees.·Training plan includes new hires, promotions, transfers and also covers UL, OSHA, Safety and other regulatory compliances that the 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。·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--------------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·There is a well designed training roadmap/program with strong ties to the organization’s 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 of strategic plans. Progress to plan is reviewed regularly by management.支持战略目标的指标被建立,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 solving 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·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 effectiveness 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 statistical 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,Drill Dee和Drill Wide重要特征辨识等.Comments / Objective Evidence: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 performance of the new product/technology/service launch activities being tracked with appropriate metrics and approvals? 供应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: a. New product/technology/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,包括设计审核和供应商准备工作.d. Quality data collection system or software to monitor the internal yield and performance metrics. 用品质数据收集系统或者软件监控内部生产和执行标准.e. Designated customer quality representative such as quality manager that is actively involved in the new product/technology/service launch process. 指派负责客户质量的代表(如品保主管)积极参与新产品/技术/服务的引入流程f. PPAP, PSO and test data as required by Motorola. 按照Motorola要求做PPAP, PSO, 测试数据).·No procedure exists for new product/technology/service launches. 没有任何证据证明以上新产品/技术/服务的引入流程的存在.·New product launch procedures exist, but documentation is incomplete and compliance is inconsistent. 有新产品导入程序,但文件不完整并且得不到一致的遵循.·New product launch procedures are being followed by some major areas of the business. However, some of these policies lack the requirements for appropriate approvals and defining quality objectives. 新产品导入程序被某些主要部門所遵循,但其中某些方針缺乏对适当的测量标准和质量目标定义的要求. ·New product launch flow chart and procedure is well documented and the policies require clear and complete project plans documented with appropriate quality objectives and responsibilities for implementation.新产品导入流程和程序文件化,政策要求必须根据适当的质量目标和执行责任制订一个清楚和完整项目计划并且文件化.·There are a few examples of well planned and successful new product/ technology/ service development projects. Quality objectives and responsibility for implementation are defined. 有少数计划完善及成功的新产品、工序、技术或服务开发項目的例证。定义可实施的质量目标和职責。·The qualification data per customer specification and First Article inspection data are collected and Appropriate management approvals are built into the process (include customer approval, if required).收集每个客户的质量规格数据和首件检验数据并适当管理客户的承认。以上都要汇入程序文件。(如过客户有要求要包括客户承认)。·Well-designed new product/technology/service policies and procedures exist for all appropriate areas of the business and there is evidence that all new product/technology/service projects are compliant to the policies and procedure. 所有相关部門均具備有完善制定的方針輿程序。有证据表明新产品/技术/服务项目符合程序和政策要求。·Management assigns a dedicated project manager to new product/technology/service launches and other appropriate resources to assure full compliance to supplier readiness activities and the launch process. 管理层必须为新产品/技术/服务指派一个专门的项目管理人员,并且提供适当的资源以保证供应商的准备活动和导入流程正常进行. ·A Qualification data collection system is centralized and used throughout the manufacturing area and has traceability capabilities for product, manufacture date, shift, line etc. 一个质量数据收集系统必须遍及所有的生产部门并且有足够的能力追溯产品,制造日期,班别,线别等。·PPAP, FAI , Yield data, reliability test, ALT test, visual Inspection and test data are appropriately documented and maintained. PPAP, FAI , Yield data, reliability test, ALT test, 目视检验和测试数据应当被适当地文件化和维护.·Organization has capability of performing environmental testing, reliability testing, safety testing and Failure Analysis capability in house.组织有能力进行环境测试,信赖性测试,安全测试和失效能力分析。·New product/technology/service policies and procedures are well maintained and reviewed periodically. They incorporate specific customer requirements as well as lessons learned from past launches. 新產品、工序、技術或服務政策和程序应该被周期性地维护和审核,而且应该考虑到特殊的客户要求和最近的导入流程的训练 ·The success rate and customer satisfaction level of new products/technologies/services clearly provides the organization a competitive edge. Trend chart or metric for performance of delivery and quality of new product launch is maintained. 新產品、工序、技技术服务的成功率与顾客滿意度,明显为该组织提供了竞争上的优势. 新产品的交货和质量绩效的趋势图和指标应该被维护。·Procedures exist which provide for an escalation process to delay a product not deemed ready for release.·Management requires the development of DFMEA for their own designed item or equivalent for all new products. 管理层应要求所有自己设计的新产品的DFMEA和相关文件保持更新。·Organizations with design responsibility utilize advanced computer simulation and design tools, such as: CAD, Pro, simulation etc. This results in best in class new product design cycle time and a competitive edge in bringing new products to market. 供应商的设计部门应该利用先进的计算机模拟技术和设计工具,如: CAD, Pro, 模拟工具等.通过这些得出的结果可以最佳化新产品的开发周期,形成产品快速进入市场的竞争优势.Comments / Objective Evidence:5. Capacity Planning 产能规划------PMAre new product capacity planning policies and procedures defined? Do they include tooling, production and test equipment, packaging, supplier capacity and manpower resources? Do the plans allow suppliers to meet the organization’s demand (delivery timing and quantity)? 是否定义了新产品产能规划的方针和程序?是否包括了模具,产品和测试仪器,包装,供应商的产能和人力资源?规划是否要求供应商符合组织的要求(交付时间和质量)·No policies or procedures exist for new product capacity tooling, equipment and manpower. 没有关于新产品产能模具,设备和人力的方针或文件·Organizations have documented procedures for capacity planning. 组织有产能规划的文件化程序。·There are a few examples of new product capacity planning for tooling, production / test equipment, set up time, yield factor, packaging, and manpower resources. 只有个别的新产品关于模具,产品/检测仪器,包装和人力资源规划的案例·Production planning process include check for availability of production gauge, fixture, tooling, test equipment, accessories, packaging supplies before releasing the new product for production.产能规划程序包括在新产品发行前确认产品量规,夹具,工具,测试设备,附属物,包材供给等。·Qualified personnel are assigned to each project to perform capacity planning. 每个项目的产能规划都有合格人员执行·The existing procedure requires clear and complete new product launch capacity plans to be documented with appropriate measurable and responsibility for implementation is defined. 現有程序要求新產品導入產能規劃文件化,并且有明確的,完整的,適當的可測量性和執行職責定義。·Preventive maintenance, tooling time, set up time, vacation, holidays, learning curve factors are incorporated in capacity planning estimating template. 产能规划统筹考虑到设备的预防维护保养,加工时间,时间设定,节假日,学习曲线等。·Capacity planning data is accessible to management and centralized.对于管理层和中央来说产能规划数据要容易接受。·Management allocates appropriate capital budget and resources to perform capacity planning. 管理层分配适当的资金预算和资源来进行产能规划。·Capacity plans are periodically and systematically reviewed for improvements and percent effectiveness by management. 管理层定期且有系统地对产能规划进行审核以求进步且100%达到管理效果·Capacity planning requires appropriate management visibility and approvals prior to committing to the customer. 产能规划要求适当的管理可见度和正式批准而不是仅仅答应客户。·Supplier has been tracking their new product launch cost and capacity planning metrics. 供应商跟踪他的新产品的发行成本和产能规划指标。·Supplier has successfully supported and met customer demand fluctuation供应商顺利的支持和满足客户波动的需求。·Organization has a state of the art system to manage their supplier inventory, delivery and capacity plan. 应商有一个好的系统来管理他们的供应商的存货,交付和产能规划·Timely decisions are made in order to respond to customer demand changes. 因应客户需求变更及时果断·Scorecards show excellent rating for on time delivery. 供应商评分显示及时交付非常优秀· If applicable, prototype fabrication capability and tooling capacity are available in house. 如适用,在厂内有原型制作能力和模具加工能力·Supplier has on line capacity planning data access and has automated MRP system.供应商能进行产能规划数据存取和有自动的物料需求计划系统。Comments / Objective Evidence:6. Process, product and material Change management过程,产品,物料变更管理----工程Does a process change control method exist and are customers informed of changes made to products and processes? Is there a process in place to review and implement change requests from the customer? Are changes and customer approvals received and tracked? 是否具有一个制程变更控制方法?对产品和制程的变更通知客户了吗? 有没有一个制程来审查并执行客户的变更要求?有没有获得和追踪变更和客户的批准认可?·No process change control system exists or an informal process change control procedure is used in a few areas. 没有制程变更控制体系或者在一些领域使用一个非正式的制程变更控制程序.·There is a procedure which defines the conditions under which a process change notice must be made for internal and customer distribution and approval. 具有一个程序对什么情况下制程变更必须通知内部和外部顾客作了规定.·Some areas of the organization are complying with this procedure. 组织中的某些部门已在遵守这个程序·There are some examples of process changes which are properly documented, distributed and approved by customers. 已有某些将制程变更纪录,分发及获取客户认可的例证.·Procedures clearly define process change categories which require customer notification and/or approval prior to implementation. (Note: Suppliers must inform Motorola of all potential changes in components, manufacturing locations, packaging, shipping, or status, regardless of whether the changes affect the form, fit, function or performance of the component.) 此程序明确规定了哪些制程变更需要通知顾客或在实施前得到顾客认可.(备注:对元件,他们的制造加工场所,包装,装运或是状态的所有潜在性变更,不管这些变更是否影响到元件的外形,适配性或者功能,供应商必须通知摩托罗拉.)·The procedure specifically meets Motorola requirements for customer approval prior to implementation. This includes informing Motorola in writing of a potential change at least 90 days prior to proposed implementation. Changes are not implemented without Motorola approval. 此程序明确的达到了摩托罗拉的在实施前要获得客户认可的要求. 这包括在提出实施至少90天前,以书面的形式向摩托罗拉通知潜在变更.变更必须获得摩托罗拉的认可.·There is a process for change requests received from the customer (ECN) to be reviewed and implemented. This process also includes validation of any A/I changes (i.e. BOM to A/I comparisons - validation that the machine program or automated insertion file matches the bill of materials). 具有一个接受客户(ECN)变更请求的流程,并进行审查和执行。这个流程也包括确认任何Automated Insert变更。(也就是,用BOM和A/I作对照-确认机器项目或A/I与BOM匹配)·All process changes have traceability through revision control systems and are tracked. 通过修正控制系统,所有的变更都具有可追溯性.·A well defined, documented change control system exists and is periodically reviewed for refinement and improvement. All areas of the business comply with the provisions of this system. 具有一个规范完善且书面化的变更控制系统,并被定期审查以求改进.所有业务部门均遵守此系统的规定.·A formal process change notification approval tracking and distribution system exists. All Customer notification and approvals are received and tracked (where required) prior to change implementation. 具有一个正式的制程变更通知承认追踪和分发系统.在实施变更之前通知客户并获得或追踪客户认可(若客户要求)·A Change Control Board (or similar) is utilized to evaluate the change and any implications before the change is made. The BOM is reviewed for implications of the change. 变更前,用一个变更控制会(或是相似的)来评估的变更和任何隐含的意义. 通过审查BOM来评估变更的含意.·Automated system in place to control A/I or factory shop floor system updates to ensure compliance to BOM. 自动系统是否能控制自动插入或工厂系统更新能否保证符合材料清单·There is a complete process change control system with internal audits to assure compliance. 具有一含有内部稽核以确保得到遵循的完善的制程变更控制系统。·Customers recognize its effectiveness, express confidence in the system and feel part of the change control process. 客户已认识到它的有效性,表示相信这一系统并感到自己是变更控制程序的一部分.·The process change control system compliments the continuous improvement process and facilitates rapid implementation of improvements. 此制程变更控制系统以持续改善制程且易于快速执行改善而得到称赞。·Automated system in place to control A/I or factory shop floor system updates to ensure compliance to BOM. 更新控制A/I或车间系统的自动控制系统来保证符合BOM。Comments / Objective Evidence:7. Process Capability / Process Characterization.--------工程/品保Is the capability of each operation, which controls critical-to-function characteristics for new products, fully qualified? 控制新产品关键功能特性的每项操作能力是否完全合格?·There is no evidence of statistical data being collected to determine the process capability (Cpk) of operations used to produce new products.没有收集用以生产新产品的制程能力及工序性能的统计数据。·Measurement data for first article and capability study and statistical data is being collected from a few critical operations/processes if requested by customer.,从少数有客户要求的关键的工站和流程收集到一些FAI和制程能力研究的测量数据及统计数据。·Supplier has qualification process well documented and there is evidence that a few parts have been qualified using this process.供应商已经文件化认可流程并且有证据表明一些产品已经使用此流程被认可。·A procedure is in place to determine Cp’s and Cpk’s and yield rates of critical operations/process. 已有适当的程序来确定关键操作/过程的Cp 和Cpk 或错误率·A well defined procedure exists and is used by most major areas of the business to characterize critical operations/processes used to produce new products. 具有一個完善的規范的統計過程控制(SPC)程序,且已被大多數主要部門所采用,以描述生產新產品的關鍵操作/過程 .·Most critical operations/processes have been characterized and many meet the (Cpk) requirements and the parts that do not meet cpk are screened 100%.大多數關鍵操作/工序已經過描述,並且許多零件均可達到Cpk要求,零件达不到Cpk要求被100%检出。·Management has provided resources to assure that new products are produced with stable and capable processes/operations. 管理階層了解此種需求並且提供支持,以確保這些新產品能借助有效的過程/操作來制造。·PPAP elements depending on risk level such as process flow, PFMEA, control plan, MSA , FAI , PSO, Yield data, reliability test, ALT test, visual Inspection and test data are appropriately documented and maintained, as specified in Motorola print and PPAP check list.PPAP要素取决于流程程序、PFMEA、控制计划、MSA、FAI、, PSO, Yield data, reliability test, ALT test,目视检验和测试数据,这些都被适当的文件化和维护,详见motorola出版物和PPAP清单。·Statistical data and some type of chart is used to control all critical operations/processes. 使用統計數據和一些类型的图表來控制所有關鍵的操作/過程。·Cp and Cpk data is known for all critical processes where such measurement is applicable. Cp 与Cpk 数据在所有可应用此项测量的过程中广为人知。·Process characterization is implemented for all critical processes and achieving CpK>1.5. 所有重要的流程都要执行过程关键特性,并且达到Cpk>1.5。·Supplier has assigned dedicated personnel to deliver qualification data and PPAP document and majority of qualification package are complete, accurate and is delivered on time. 供应商指定合格专人负责传送承认数据PPAP文件和多数的承认包裹是完整的,精确地,并且传送及时。·The capability of processes/operations contributes to the successful introduction of world class new products. 過程/操作的能力對於世界水平新產品的成功引進起著巨大的作用·There are no examples of customer disappointments with new products which were traced to incapable operations or processes. 沒有因操作或過程不合格而使顧客對新產品失望的案例·The organization proactively informs and provides qualification data to customers. 组织告知和提供质量数据于客户.·The organization relies on process characterization and process control systems instead of in process quality checking or inspections.组织依靠过程关键特性和过程控制体系代替制程中质量核实和检验。Comments / Objective Evidence:8. Product and Process Quality Metrics Review -----------品保Does organization’s management have established product quality goals and processes in place to monitor the performance against goal? Typical metrics used are Sigma, PPM, defect per unit, Critical to Quality (CTQ), cycle time, process audit, or Defects per Million Units (DPMU). Are goals/plans established for continual improvement?是否供应商的管理层已经建立了产品的质量目标和对其执行情况监控的流程?典型的控制方法包括: Sigma, PPM, 不良率, CTQ, cycle time, 流程审核, or DPMU.是否建立了对目标/计划的持续改善·There are no signs of using performance measures to establish product quality and process goals and improvement plans. 沒有使用測量跟蹤來建立質量和程序目標及改進計劃的標記·Some areas have used performance measures to establish product quality and process goals and improvement plans. 在某些領域使用測量跟蹤來建立質量和程序目標和改進計劃·New Product Performance review to goal is not conducted. 新产品绩效检讨对于目标不具指导性。·Performance measures and improvement goals have been established in a majority of production areas. 大部分生产部门建立了测量和改进目标的系统.·Critical, high impact areas are meeting established goals. 關鍵影響較大的領域達到了內部目標·Management reviews are conducted on products, subassemblies, and processes for cost, delivery and quality in most major areas of the business unit. 在業務單位的大部分關鍵領域對產品、組件和程序進行管理審查·Quality System has well design traceability for tracking finished good.质量系统设计了对于成品的好的追溯体系。·Goals and improvement plans with the appropriate measurement systems are in place for all products, subassemblies, and processes. Measurements, at minimum, include quality, scrap, process improvement, on time delivery, and cycle time improvement plans. 所有產品、組件和程序,包括質量和程序改進、准時交貨、周期时间改善計劃,都存在目標、改進計劃和適當的監測系統.·Quality metrics and records of reviews are maintained as quality records. 將質量制度和管理審查記錄作為質量記錄予以保存·There is an exceptional product and process performance goal setting and measurement system in place. Goals are tightened based on past performance. 有在适当位置設置产品和过程绩效的額外目标和測量系統。所設立的目標緊密建立在過去的事實上·There are regularly scheduled reviews that focus on innovative mistake proofing devices and on line process monitoring system. 對於新開發的防错设备和线伤流程监视系统有规律的進度評價·Product and process improvement is demonstrated by a decrease in defects escaping to the customer. Improvements are in line with established goals and demonstrate positive sustained results. 证明产品和流程改善可以减少流入客户不良品的数量.改善活动可以符合确定的目标和获得积极持续的成效.·New Product cost estimating and yield monitoring methods are routinely reviewed.新产品成本评估和收益检测方法例行检讨。Comments / Objective Evidence:9. Customer and Field Performance Quality Data------------品保Is customer failure and field performance information recorded and used for corrective action? 否记录顾客遇到的故障及现场性能情况,并用于纠正措施?·The organization does not solicit or collect customer failure data. 该组织没有征求或搜集顾客故障数据·No documented procedure exists for processing customer return.没有文件化的程序规定来处理客户退回。·A system has been defined to obtain customer and field performance data and there is evidence that data is provided to the quality organization and some key business areas. 已确定一个系统以获取顾客及现场性能数据,有证据表明,已将数据提供给质量组织和某些主要業務部門·There is a formal process to review the available customer and field data. 有检讨所提供的顾客及现场数据的正式过程。·Goal setting for improvement is pursued in some major areas of the business. 用于改进的目标设定仅追踪一些主要的业务部门。·Root cause analysis is also performed on some major field issues but documentation is inconsistent. 针对一些重要问题也进行根本原因分析,但是文件不一致。·Containment actions are implemented in a timely and effective manner in response to sudden degradation or negative trends of field performance. 针对现场性能的突然降低或不良趋势及时并有效地采取控制行动·The organization emphasizes root cause corrective action for chronic customer or field quality problems. 对于顾客或现场的长期质量问题,该组织强调针对根本原因的纠正措施·The organization seeks and uses customer incoming and factory failure data for internal review and improvement goal setting. 该组织搜集来自顾客及工厂的故障数据并将其用于内部检查及改进目标的制订·Organization has on site test lab facility to analyze the field non confirming unit.厂内有分析实验仪器来进行场内不良品。·There is a well defined, proactive program for obtaining, tracking and reporting both customer and field performance data. 具有一规范完善且积极的计划以获取、追踪并报告顾客及现场性能数据·Organization is updating manufacturing document (Process flow, control plan and PFMEA design spec) that has direct impact on root cause and corrective actions implemented. 进行分时间段的产品缺陷舆生产任务的相关分析·Root cause analysis is performed on all failure modes of returned product and validation of the related manufacturing processes is performed. 对所有退货产品的故障模式进行根本原因分析,并对相关制造过程进行审验·Customer and field data is tracked to verify the effectiveness of corrective actions and reliability of enhancements. 追踪顾客及现场数据以验证纠正措施的有效性及可靠性的提高·All defect modes reported by customers are logged in a computer database. Paretos are compared to defect management systems to ensure process revisions are effective. 所有顾客反映的缺陷模式存入计算机数据库中,并制成柏拉图同缺陷管理系统相比较以确保工序修正的有效性·Customer application field failures are analyzed to provide quality and reliability data for product/process review and improvement. 分析顾客应用上的现场故障为产品/过程的检查舆改进提供质量和可靠性的数据·Field failure information is used by the design organization and reliability engineering to drive more robust product designs. 现场故障信息为设计部门舆可靠性工程部门所利用以推动更健全的产品设计·Accelerated reliability test methods verify product improvements. 使用快速的可靠性测试方法以验证产品的改进效果Comments / Objective Evidence:10. Quality Data and communications 质量数据和信息传达-----------品保Is a system in place to adequately communicate the quality data and performance to customer expectations (scorecard, satisfaction data, etc.) to all employees? To follow progress versus goal? To measure trends? 是否有一个向员工充分传达质量数据和客户期望成绩(如评分,满意度等)地系统,这个系统可以追踪目标进展,测量趋势.·There is not a system to monitor progress, measure trends, or to communicate quality data to the employees of the organization. 没有可以监控制程,测量趋势或向员工传达组织质量数据地系统.·Quality goals are established using either industry standard or customer requirement, or historical data or Score Card or any similar program.确定的质量目标或者使用业界标准或者是客户要求,或者是历史数据,得分表或者任何相似的项目。·There is documented procedure about how the quality data progress against goal is communicated to all levels of employees, from direct labor to senior level of managements. 有文件化的程序描述:相对于目标质量数据的进步有关于各阶层员工,从直接人员到资深管理者。·The quality collection system is manual or independent and not centralized.质量收集系统是手工的或者独立的,不是集中地。·There is an effective quality data communication method in use by nearly all major areas of the organization (posting quality result, town hall meeting, production review meeting are examples of commonly used method) 组织内几乎所有的部门有有效的质量数据交流方法(张贴质量结果,市政厅会议,产品检讨会议是经常用到的方法举例。)·Quality goals are reviewed and updated annually at minimum (or on a similar periodic basis). These updated goals are communicated to employees. 质量目标至少每年检讨更新一次(或以类似的周期)·An organization management is monitoring progress to goal and measuring trends.组织管理层监控目标的进步和量测趋势。·Quality goals include scrap reduction and cost of poor quality components.质量目标包括报废降低和低质量产品的成本降低。·There is an organization wide method for the communication of quality data to all employees and it is found to be effective. 在全组织范围内具有一个向全体员工通报质量数据的制度.·Quality metrics have step down or step up goals and these goal lines are shown on the measurement and trend charts. Progress to these goals and trends are measured and reported regularly. 对于质量衡量有相应的目标,这些目标线在测量和追踪图表中有所体现,目标的进步和趋势得到测量和定期报告·A single automatic quality data collection system is used throughout the manufacturing area and has capabilities for product traceability.整个工厂范围内有一个单独的自动质量数据收集系统,并且此体系有能力进行产品追溯。·Senior Management is conducting periodic review of improvement actions for negative trends and providing feedback.高层管理者对于改善的负面趋势和提供的反馈定期作指导性的检讨。·Employees are actively involved in improvement programs related to quality and customer satisfaction. 员工积极参与与质量和客户满意相关的进步活动·All quality goals are being met and trends are positive. For any trends that are below goal, there are corrective actions in place to address the issue. 所有目标均已达到而且显示是积极的,低于目标的趋势有恰当的改善对策·A reward system, or equivalent is used to recognize those employees making contribution to improved progress. 具有一个奖励或类似制度,以用于肯定对促进发展做出贡献的员工Supplier has ability to upload their quality data (Electronic on line SPC, qualification data, FAI report) electronically to customer data base.供应商有能力在客户数据库中上传他们的质量数据(电子在线SPC,承认数据,FAI报告)Comments / Objective Evidence:Section 3: Production Process and control.生产过程和控制11. Calibration System校准系统------------品保Are all measurement equipment/systems maintained, serviced and calibrated to ensure consistent quality standards? 是否对所有地测量设备/系统进行了维护,维修及校准以确保质量标准地一致性?·Measurement equipment systems are not maintained, serviced or calibrated. 测量设备系统没有得到维护维修或校准·A few measurement tools, instruments/systems are being calibrated. 仅有少量地测量工具,一起/系统被校准·A basic system for tracking calibration, equipment maintenance and services exists. 有一个可追踪校准,设备维护及维修地基本系统·Detailed calibration procedures are not available for all equipment requiring calibration. 不是所有需要校准地设备都有详细地校准程序·Some calibration standards are traceable to National Institute of Science and Technology (NIST) or equivalent. 一些校准标准可追溯到NIST或类似机构地校准·Detailed calibration procedures are available for most equipment requiring calibration.所有需要校准地设备都有详细地校准程序·All calibration standards used internally and externally are traceable to an appropriate national standards agency, such as the NIST. 所有內部或外部使用的校准標准均可主的追溯到某一適當的國家標准機構,如NIST·Most equipment is calibrated to the published schedule. There is a system in place to address out of calibration conditions. 大多數設備可按照排定的計劃表進行校准,並且具有一個系統可以處理未校准的情況·At minimum, a set of calibration records is maintained for each piece of measurement equipment, i.e., pass/fail and date calibration was performed. Calibration records are maintained as quality records. 对于每一件测量设备均保持一套最基本的校准记录,即通过/未通过校准以进行校准的日期,校准记录作为质量记录保存·Calibration schedules is computerized. The tracking system includes specified schedules which have been established using industry standards and manufacturer’s recommendations, and are adjusted using current in-house history预防维护及校准日程表也计算机化,追踪系统包括根据行业标准和厂商的建议而确定的时间计划,并可以根据当前场内历史记录予以调整·Standards traceability to a national standards agency is all documented. 标准对国家标准机构的可追溯性全部有书面记录·Controls are in place to safeguard inspection, measuring and test equipment from adjustments that would invalidate the calibration settings·All numeric calibration data is retained in accordance with the organization's quality records retention policy. 所有數字化的校准數據都根據該組織的質量數據保存方針予以保管·Non-manufacturing related equipment/systems and software are properly maintained, serviced and kept current. 非制造相关的仪器/系统和软件得到适当地维护,维修并保持最新状态·Calibration frequency are periodically reviewed and adjusted as necessary.校准频次有必要进行周期性检讨和调整。·There are examples of innovations in the calibration process, such as computerized and/or automated calibration procedures. 在校准过程中有创新的范例,例如:计算机化舆/或自动校准程序·Equipment users have assumed responsibility to assure that the calibration system is functioning properly. 設備的使用者已負起確保校准系統正常工作的責任·The equipment control system used by the organization is a model for others to follow. 該組織所使用的設備控制系統已成為其它單位仿傚的榜樣·Organization has periodic audit performed to assure that no out of calibration tool is used on production part.组织应该执行周期性的稽核来保证生产的产品过程中没有无校验工具在使用。·No equipment is found out of calibration to the published schedule在规定日程中没有发现有无校验的仪器设备。Comments / Objective Evidence:12. Measurement System Analysis (gauge R and R) 测量系统分析------------品保Are Repeatability and Reproducibility (R & R) studies conducted on measurement equipment and systems using appropriate methodologies? Are % R & R acceptable?是否使用适当的方法对测量设备和系统进行R&R研究, R&R是否可以接受·There is no evidence that GR&R studies have been performed or are planned. 沒有證據表明已進行或要計劃進行R&R研究·No formal training in GR&R/MSA has occurred.没有进行正式的GR&R/MSA培训。·Some formal training in MSA has occurred, but meaningful GR&R studies have not been performed. 关于MSA的正式教育训练已经进行过,但是未进行过GR&R研究·There is little sensitivity to the value of GR&R studies as the significance of this discipline is not understood. 对于GR&R研究的重要性只有很少的了解.·Gauge Rand R study is only conducted if customer spec required for critical parameters. GR&R研究仅仅在客户关键特性中有要求有要求时实施。·A written procedure exists for performing GR&R studies on all critical measurement systems and equipment. However, there is no formal time based schedule to perform such studies. 应该存在一个书面的程序指导GR&R研究的执行,并应用于所有重要的量测系统和设备.但是没有一个正式的基于时间的进度表.·Formal training in GR&R/MSA has occurred and there is some deployment of this discipline in areas within the operation. However, the commitment to perform GR&R studies on appropriate equipment is not consistent throughout the organization. 关于GR&R/MSA的正式的教育训练已经进行,而且应用在一些操作中.但是在适当设备上执行这些GR&R研究的支持在机构内并不统一.·All visual inspection and test station workers have documented Gauge R and R study results using Attribute Agreement Method.所有的目视检查和测试工站作业员都有文件化的Attribute Agreement方法的GR&R学习效果记录。·A formal written procedure exists to perform Gauge R&R studies on all critical measurement equipment and systems via a computerized time based schedule. These studies have been completed on most of these systems. 应该存在一个书面的程序指导GR&R研究的执行,并应用于所有重要的量测系统和设备根据电子化的时间进度表.这些研究已经应用于绝大多数系统.·Where the %GR&R is greater than 10%, an action/improvement plan is in place and proves to be effective当GR&R值大于10%时,应该提出一个改善行动/计划并进行追踪.·Employees involved in performing Gauge R&R studies are sensitive to Gauge R&R requirements and understand their significance. 进行GR&R研究的人员应该熟悉GR&R的要求并懂得其重要性.·Management is committed to providing measurement equipment and systems whose results are consistently repeatable and reproducible. 管理階層承諾提供結果具有一致的可重復性輿可復現性的測量設備和系統·The ANOVA method is used to compute percent Gauge R&R. 使用ANOVA的方法计算R&·GR&R studies are performed routinely for all appropriate equipment and systems of the organization. GR&R研究被作为常规检验应用于所有适合的设备和系统.·% GR&R values are known and documented with no deficiencies to established % Gauge R&R standards and requirements. In most cases these standards exceed customer requirements. 所有GR&R值的获得和记录完全符合GR&R标准和要求,大部分情况中这些标准超过客户的要求.·There is a comprehensive system for updating GR&R studies and new measurement equipment purchases are anticipated and planned. 具有一个完善的系统以更新R&R研究和进行新设备购置预测和计划·Gauge R &R’s schedule for all measuremfent device use for product specification are meeting targets and reviewed by management. 管理阶层定期检讨有关产品规格的所有测量设备达到GR&R目标的进度表。Comments / Objective Evidence:13. Control and Disposition of Nonconforming Material form receiving to shipping不合格物料从进料到出货的控制和处理------------品保/各制造单位Has a nonconforming material handling, storage and disposition procedure been properly defined and implemented? Is all nonconforming material segregated from regular production material, and properly disposition?不合格物料的处理,储存和处置程序是否被明确定义和实施? 从正常生产材料中分离出来并做正确处理?·A Non-conforming material procedure does not exist. 没有不合格物料的控制程序·There is a procedure for the control and disposition of nonconforming material. It includes identification and segregation of nonconforming material/product. 有不合格物料的控制和处理程序,其中包括不合格物料/成品的鉴别与隔离·Opportunities for error and delays in identification and disposition are apparent. 鉴别与处置中有明显的错误和延期情况·Nonconforming material is properly identified (labeled or somehow denoted), segregated (dedicated area, clearly held separate from work in progress or finished goods), and with timely disposition in most areas. There is no opportunity of nonconforming material escaping to the customer. 能正确地识别(贴标签或别的指示),隔离(专门区域,严格将其舆制作品或制成品隔离)不合格材料,且在大部分领域有适时的部署,不合格物料没有机会出货给客户·If allowed by customer order or contract, nonconforming products may be reworked to meet a specification or accepted by the customer without repair. Traceability is maintained for any rework. 假如客户的定单和合同允许不合格产品重工以符合规格或无须修理被客户接受,任何的重工都必须能够被追溯·Records of nonconforming material/product disposition are maintained as quality records. 不合格物料和成品的处置记录最为质量记录被保留·There are procedures and documentation (scrap tickets and Material Review Board disposition) to properly dispose of the nonconforming material and track its history. 具有相关程序舆文件(废料单和材质证明会议部署)以正确处理不合格材料并追踪其根源·Nonconforming material is quantified, analyzed, and reduction plans are established. 確定不合格材料的數量,對其進行分析並確立減少此類情況的計劃。·Procedures identify proper authority, such as Material Review Board, to identify what circumstances and approve before allowing nonconforming material to be used for production. 有适当的鉴别程序,如材质证明会议部署,以鉴别什么情况和核准下不合格物料可以被用于生产·Receiving, work in process, packaging and quality areas comply with nonconforming material controls. 进料,制程,包装和质量部门遵循不合格物料控制。·No inadvertent, nonconforming product escapes to the external customer. 无疏忽,避免了不合格产品流泻至外部客户·If customer contracts specify, customers or their representative are notified of nonconformities prior to disposition. 如果客户合同规定,相关的不合格情况要优先通报客户或其代理人,以便于管理部署·All dispositions are timely, exceeding internal goals. 所有部署都很适时,且超过了内部控制要求·There are no cases of nonconforming material being inadvertently mixed or confused with good material. 没有不合格物料之间意外混料或与良品混料的案例·Any rework performed on non confirming material is well documented and rework procedure is approved by customer prior to performing rework. 对不良品的所有重工必须很好的归档并且重工之前重工过程要经过客户核准。·There is evidence that world class results have been achieved. Performance is tracked and improvements are identified. 有证据显示已达到了世界公认水准,绩效可以追溯而且确认有改善·Obsolete material is controlled to requirements and is properly purged. There is a well-defined and established control system with no exceptions废弃物料按照要求控制并且适当的清理。有建立清晰定义的控制体系,没有例外情况发生。·Products with parameters that exceed statistical process control limits and/or nominal distribution are considered nonconforming.产品参数超过统计过程控制线或者常态分布就被认为不符合。Comments / Objective Evidence:14. Receiving Incoming Material Quality System and control-------品保Does a system exist to assure that purchased materials, as received, conform to specification requirements prior to use? 是否存在一个系统以确保收到的采购物料在使用前满足书面规定的要求·There is no system (sampling, 100% screen or similar) to assure that purchased materials conform to specification and other engineering requirements prior to use. 没有一个系统(抽样,100%检验或者类似的)确保采购物品在使用前符合规格和其他工程要求·Incoming inspection of purchased materials is evident in a few areas of organization. 在该组织的某些部门对采购物品做进货检验·Inspection procedures, sampling method if applicable, testing incoming material procedure is well documented. 检验程序,抽样计划是否可用,进料测试程序都很好的文件化。·Inspection results are kept as a part of quality record.检查结果都被作为质量记录保存。·A complete system is in place to assure that all purchased materials are in compliance with product spec, manufacturing and other applicable requirements prior to use. . 具有一个完善的系统以确保所有采购物品在使用前符合产品设计,制造和其他适用的要求·An incoming acceptance sampling plans include both attribute and variable data.进料验收抽样计划包括特性和可变数据。· There is a procedure for certified suppliers or parts, where sub-tier suppliers assure outgoing materials conform to requirements.有一个程序鉴定供应商或零件,能够使次级供应商保证出货符合要求。·Inspector are trained and certified to check the product to specification.检验员都经过培训并且有资格检查产品规格。·Suppliers of certified materials have procedures for verifying outgoing materials comply with requirements and maintain records of results of their verification process. 生产合格物品的供应商具有相关程序以验证出货物品是否满足要求并保留检验记录·Exceptions to the purchased material conformance policy are rare, but comply with documented policy governing such exceptions. 未遵守物品采购制度的情况很少,但它们符合关于这些例外情况的制度·All purchased material measurement and test data are documented with records maintained. 所有采购物品的验货过程已记录并保存下来·Dock to Stock or similar programs are evident for many supplied materials. 對輿許多采購物品均有免检入库制度或類似計劃。·A comprehensive purchased material compliance system is in place with results fully traceable throughout the system including their sub-tier supplier. 具有一套使采购物品符合要求的全面系统,通过这个体系其结果可完全追溯包括他们的次级供应商。·Periodic reviews of incoming or outgoing inspection plans or other conformance methods are performed both internally and at suppliers and such reviews focus on adequacy and appropriateness to meet customer requirements. 该组织定期检查内部及供应商的进货或出货检验的计划或采取其它符合度验证方法,这些检查侧重舆在数量及适用方面满足顾客要求·Trend analyses are preformed and results reviewed regularly with their suppliers. 定期进行趋势图分析舆供应商共同检查分析结果·There are no exceptions to the purchased material conformance policy prior. 没有不符合物品采购制度而被使用的情况·Sub tier supplier qualification data has been audited for accuracy and completeness.稽核次级供应商质量数据的精确性完整性。Comments / Objective Evidence:15. Work Instructions for component mfg process, sub assembly and assembly.--------各制造单位/工程Are the operators within the process provided with written work instructions and are they trained to perform outstanding work? 是否为生产工序中的操作人员提供书面工作指南,它们是否接受过培训以作出优秀的工作·There are no written work instructions and no operator training program exists. 沒有書面的作业指导书没有操作培训项目。·Most parts written work instructions from receiving, manufacturing component, sub assembly and assembly, packaging, testing and shipping are available and some operators receive on job training.所有作业指导书从进料,制造零件,次级装配和装配,包装,测试和运输都可用并且一些作业员有在职培训。·All manufacturing Work instructions are update and have revision control.所有作业指导书都更新并且有版本管控。·Most operations have documented work instructions. The work instructions are well defined and readily available in close proximity of work station in appropriate language/s. 大多数操作人员用以书面的工作指南, 工作指南规定明确,更新及时并且在工作地点容易获得·There is a structured training program which includes operational procedures, job mechanics and acceptance criteria. 具有一个结构化的培训计划,包括操作程序、工作机理及接受标准·Work instruction at minimum should include detail on use of fixtures, gauge, tool spec, any special parameter to monitored , acceptance criteria and visual aid and limit sample, (if required) are available for most work stations作业指导书至少应该包括使用设备和量规细节,检具规格,任何需监控的特殊参数,接受标准,目视样板,限度样板(如果有需求),以上对于大多数作业指导书都是可用的。·First piece approval process and set up instruction are well documented.首件承认过程和建立的指导书都文件化。·Operators are properly trained in appropriate operational procedures, job mechanics, and acceptance criteria. There is a qualification period where workmanship is closely monitored until the operator is fully qualified to perform the function and work meets acceptance criteria. 操作人员均接受有关操作程序,工作机理并接受标准的培训,在考核期间严密检测其工作质量直到操作人员在履行其职责方面完全合格且工作达到接受标准·Training system includes periodic recertification of operators with documentation.训练体系包括定期对作业员换发上岗证,并文件化记录·There is an internal audit for work instruction accuracy and compliance results are well documented.对于作业指导书的精准性和一致性有内部稽核的结果要文件化。·Many operators are cross-trained to perform multiple functions and their records are well maintained. 许多操作人员接受过多岗位培训以从事多种工作他们的记录被保留维护。·Operators are fully trained to perform outstanding work in their respective jobs. 操作人员再它们各自的工作上都受过完整的培训以做出优秀的工作·There is a best in class operator training and certification program. 有最好的作业员训练和认证程序·Work instruction audit metrics are reviewed by management and improvements action has taken place.管理阶层检讨作业指导书稽核目标并且实施改善措施。·There is an effective feed back from worker to improve the quality of work instruction.对于员工改善作业指导书的质量有一个有效的反馈体系。·There is a program in place to train contract labor on work instructions and quality controls. 对于工作说明和质量控制有强制性的训练约定Comments / Objective Evidence:16. Final Inspection and Acceptance最终检验和允收---------品保Are final acceptance procedures documented, controlled and followed, and are all specified customer product audits conducted as required? 最终验收程序是否文件化,被控制和追踪,分别按照各个客户要求进行稽核?·Final inspection is performed though Final acceptance procedures are not documented. 最终验收程序没有文件化。·A few areas have documented their final acceptance procedures but they are not well control or maintained. 少數部門的最終驗收程序已有文件,但未得到完善的控制或遵循。·The procedures are accessible and understood by employees who are qualified to conduct final acceptance procedures. 最终验收程序可以被相关执行检验的合格人员所理解和执行.·Any product that is reworked or repaired per customer contract must be retested and inspected per the original quality plan. There is traceability to the rework and repair product.任何产品通过和客户约定进行重工和维修必须根据原始质量计划执行检验。重工和修复品要可追溯。·Final acceptance procedures contain specific sampling plans, sample sizes (variable and attribute), test equipment, test conditions, measurement scales, visual aid and measurement processes. 最終驗收程序必须有文件,并指示抽样方法和数量,测试仪器,测试条件,量测范围和流程. ·Final inspection, testing, Test Equipment set up procedures is supported with detail visual aid and if necessary with golden sample or limit sample建立终检,测试,测试仪器程序支持详细目视样板,如果需要的话要有golden sample和限度样品。·Records are maintained and indicate that inspections and final tests have been performed and meet product acceptance criteria. 检验和最终测试执行的记录被维护,且显示出符合产品验收的标准.·Failures at final acceptance testing points are investigated in most cases and appropriate corrective action is taken. Defect found in manufacturing process is communicated in timely manner to worker. 在大多數情況下,對最終驗收測試中發現的產品不合格問題將進行調查並采取適當糾正措施。在制造过程中发现缺陷及时向作业员传达。·All failures from final acceptance testing are analyzed with results fed back to the manufacturing process for corrective action. 所有在最終驗收測試中發現的產品不合格問題都經過分析並將結果反饋給生產工序以進行糾正措施·All failure analysis in out going audit, root cause and verification are well documented.·Containment and screening of lots is done, as required, to protect the customer. 已根據要求對該批產品進行控制和甄別以保護顧客的利益·Specified customer requirements are included in the final acceptance process. 最終驗收流程中指出特殊的客户要求. ·Final Inspection data are charted using SPC tool and defect reduction plan is in place.使用SPC把终检数据绘成图表和使用合适的不良降低计划。·Final product acceptance procedures contain all appropriate elements to assure that accepted product meets or exceeds customer requirements. 最終產品驗收程序包括所有相關的要素以確保通過驗收產品達到或超過顧客的要求·Any failure immediately shuts down the test system until the root cause is determined and appropriate action has been taken to eliminate such failure. 如發現任何產品不合格問題則立即關閉測試系統直至確定根本原因並采取適當的行動以消除這類缺陷·There is good back up equipment and trained personnel plan for equipment break down or absenteeism. 关于设备故障和停机有一个好的备品机器和个人培训计划。·Audits are regularly conducted to monitor the final acceptance process and results are documented. 监控最終驗收流程的稽核有规律的执行,结果文件化。The final authority for release of product is indicated in the documentation. These are retained as quality records.最终决定发包产品的人要留有文件化的记录。这些都作为质量记录被保留。Comments / Objective Evidence:17.Packaging, Storage, shipping a Material Handling and Bar Code Label requirements------------仓库/物流/工程(工程主要针对3.3项)Is the receipt, handling, storage, packaging and release of all material including customer provided items, at all stages, specified and controlled to prevent damage (including ESD damage) or deterioration and to address obsolete material? Is there traceability of final product back through the manufacturing process? 对包括顾客提供的物品在内的所有材料在签收、搬运、储存、包装及发放各阶段是否有规定和控制以防止损坏或恶化,并处理过期材料?成品的全部制造过程是否可以追溯?·There is no documented procedure and standards in place to control receipt, internal handling, storage, preservation, packaging and release of materials. 沒有书面的程序和標准指導材料的簽收、搬運、儲存、包裝及發放的控制·There are no well define handling or control specific to product such as ESD, FM, contamination, material storage, shelf life and Semi conductors.像ESD, FM,污染物,物料储存,保存期限和Semi conductors之类的产品没有对运输和控制细节的定义。·Procedures exist in a few areas for the proper handling, receiving, storage, protection and release of materials. 少數部門具有材料的妥善搬運、簽收、儲存、包裝及發放的程序·There are handling or control specific to product such as ESD, FM, contamination, material storage, shelf life and Semi conductors is in place but process is not formally documented.有对诸如静电防护,异物污染,材料库存,储存期限和半导体的使用和控制的细节但没有明确的文件规定·There is a procedure to identify and purge obsolete material from the system, including inventories, warehouses and distribution systems具有一個可以從系統中鑒別和處理過期材料的程序·Documented procedures exist to control the receipt, handling, storage, proper packaging and release of products and materials including customer provided items. . 具有控制產品和材料(包括客戶提供的)的簽收、處理、儲存、妥善包裝和發放的書面程序·When production operators are required to execute special handling or operating of packaging equipment, appropriate work instructions are provided and posted in a language/s readable by the operators. 当工作人员需要进行特殊的操作程序,应该给他们提供适合的易懂的工作介绍,·Product/material Packaging process meets customers’ requirements and supplier has capability to meet Motorola spec for in bound shipment 12S10601A.产品/物料包装过程达到顾客的要求并且供应商有能力达到moto规格要求12S10601A。·An in-plant product/material traceability system is followed. There is a method used to track material transferred from one point to another. (If current Motorola supplier, Motorola Receiving Bar Code Specification 1213933A01 must be met) 具有一套成品/物料的追溯系统,可以追查厂内物料的移动状况.(现行moto供应商,motorola所接受的规范1213933A01必须遵守。)·There is a method to receive and handle customer RMA material, such that it is appropriately labeled, segregated, and controlled per quality standards and Customer requirements. 具有一个签收和搬运RMA物料的方法,如根据质量标准和客户要求贴标识,隔离和控制.·All shipments use a date and barcode which meet customer requirements. Labels placed on containers reflect latest revision level of the part being shipped. 所有出货使用的date code和 barcode必须符合客户要求,外箱上的标识必须反映出货产品的最新版本。·Documented process controls ESD with respect to grounding systems (test, SMT equipment), personnel grounding, protected area (flooring / matting), handling and packaging. Periodic audit system in place showing compliance for all areas.文件化控制ESD关于接地系统(测试,SMT机器),人员接地,保护区(工具/材料),搬运,包装。周期性进行适当的稽核保证所有区域符合性。·There is a system which ensures that packaging material fully conforms to purchase order and specification requirements and is acceptable for release to customers有体系确保包装材料符合购买订单和规范要求并且可以发包给客户。·There is a customer focused, error proof system in place for all material conditions previously defined. 具有一個以顧客為中心的針對前沿所述的所有材料狀況的防錯系統·Packaging, labeling, bar code and traceability Compliance is verified by periodic audits with a closed loop corrective action process.周期性的稽核查证和施行闭环矫正措施来确保包装,labeling, bar code和追溯性的符合性。There are no customer dissatisfaction incidents due to packaging or handling related errors or damage. 包装和运输中没有使客户不满意的错误和损失。Comments / Objective Evidence:18.Housekeeping, Proprietary Information and Preventive Maintenance整理整顿、知识产权和预防维护---------各生产单位/品保Is the work area uncluttered and free of excess work in process, supplies, debris, etc.? Is the environment conducive to producing quality work? Is proprietary information adequately protected? 工作地点是否整洁且没有额外的工作及生活用品、碎片等杂物?工作环境是否有益于产品之质量管理?知识产权是否得到充分的保护?·There is insufficient housekeeping discipline. 沒有足夠的housekeeping 管理訓練·The working environment is not controlled. Proprietary information is not protected. 没有对工作环境进行控制。智慧财产权不能得到保护.·A few areas demonstrate good housekeeping practices or are beginning to implement environmental controls for more sensitive products and equipment. 只有少數區域證實有改善housekeeping 管理,但某些區域開始為更多的敏感產品及設備進行環境控制·Work stations are clean, well lighted, organized and not cluttered.工站干净,整洁,有序,不混乱·There are documented policies and procedures which define proper housekeeping practices, protection of proprietary information (including customer proprietary information) and environmental conditions. 有文件化的政策和程序定义了适当的housekeeping方法和知识产权的保护方法(包括客户的相关信息),环境条件等.·A good housekeeping program including lock out/tag out is implemented and periodically audited. 好的housekeeping项目包括实施lock out/tag out和周期性稽核。·Proprietary information control and protection is evident in most areas. 大多數區域都對智慧財產權進行明確的控制和維護·Most areas meet defined environmental requirements. 大多數區域都達到了指定的環境要求·All production equipment have well define maintenance schedule, check list and repair log.所有的生产设备都有保养计划,查检表和维修记录。·All areas comply with the housekeeping program and appear neat and organized. All tools, paperwork and test/production equipment are maintained in a clean and orderly manner. 所有區域都遵循housekeeping 程序要求,且整潔有序.所有的工具,文书工作和测试/生产设备也需要在一个整潔有序的方法中维护.·Proprietary information is well controlled in all areas as evidenced by the results of frequent audits. 频繁的稽核结果证明,所有区域智慧财产权都得到很好的控制·Environmental conditions are well documented and control charted for all work areas with minimum and maximum temperature, and humidity limits defined, where required, for sensitive products or equipment. 有書面文件規定所有工作領域的環境條件,包括對要求的敏感產品和設備制定最小和最大溫、濕度控制界限·Maintenance program showing positive results and tool and die’s life and being replaced proactively before End of life. 维护项目显示实际的结果和工具及寿命在寿命前更换掉。·There are regular housekeeping and proprietary information control audits with excellent results across the organization. 組織內都有正規的housekeeping 和智慧財產權控制,稽核結果優秀·Work places are well designed for efficiency and quality of work. The 5S (Sort, Straighten, Shine, Standardize, Sustain) method, or a similar program is utilized to manage housekeeping policies. 工作區域設計有利於效率及工作品質的改善, housekeepin管理还应包括5S或者类似的方法·Environmental conditions are continuously monitored using SPC or equivalent chart with established warning and shutdown limits for temperature and humidity, where required. 在要求的區域,制定了溫濕度警告控制界限並且據此連續監控環境條件Organization has well executed 5S program.组织出色完成5S项目。Comments / Objective Evidence:19. Out of Control Actions for an internal defect for mfg/assembly/Service. 制造/装配/服务内部缺陷失控状况-----------各生产单位/品保Are the procedures that control the reaction to process and product out of control situation adequate and effective? 工序舆产品失控状态下的放映控制程序是否适当及有效·No written procedures exist for out-of-control conditions. 没有针对失控现象的程序·A procedure exists but it is vague and not well understood by employees. 具有一个程序但它不明确,员工也不完全了解·A few areas are beginning to react to out of control situations but responses are inconsistent. 有少数部门正开始对失控情况采取行动,但响应并不一致·An acceptable procedure has been defined for reaction to out-of-control conditions for products and processes. 已经确定了一个可以令人接受的程序开对产品和工序的失控现象作出反应。·All major out of control situations are documented on 8d or equivalent corrective action format. 所有的主要失控情况都用8D或同等改善措施格式文件化。·The corrective action required short term action and containment, root cause and long term action and verification prior to closure.改善措施要求短期对策和围堵措施,根本原因和长期对策结案前要有验证。·All appropriate personnel are trained in how to properly respond to out-of-control situation. 所有相关人员均已接受如何正确处理失控状况的培训·A well-defined, documented procedure exists which indicate the proper steps to follow when an out of control condition is detected, e.g., shutdown, 100% screen, check equipment, check product and notify supervision, and is used in most areas with a disciplined approach. 有完善规范的文件化程序来规定当发生失控状况时的处理和追踪步骤,如停产,检查仪器,检查产品和通报监督,这一程序以一种规范的方法应用舆大多数部门·There is evidence of follow-up to eliminate special and common causes of these out of control situations. 有证据表面采取了后续措施来消除失控现象的特殊及共同根源·All out of control action are tracked and metric shows reduction of repeat occurrence and positive over all trends.所有的失控措施都得到追踪并且指标显示重复发生的减少和所有好的趋势。·Every out of control condition has a well documented out of control action plan at critical operations. 在关键作业中,每个失控状态都有文件化的失控行动计划·There is documented evidence of the consistent use of a disciplined approach to determining true root causes of out-of-control conditions with successful corrective actions. 有证据表明,一种必须严格遵守的方法得以持续使用已确定失控的根本原因并采取了成功的纠正措施·Management regularly reviews out of control conditions and drives reduction of out of control occurrences. 管理层定期审核失控状况并且推动减少失控发生·There is a system in place to communicate out of control situation to all level of employee and proven to be effective.有体系传达给各个阶层员工失控状况,并且使人印象深刻。Comments / Objective Evidence:Section 4: Sub-Tier Quality Control and Quality Improvements20. Sub-Tier Supplier Selection, Management & Continuous Improvement program------------采购Is there an effective Sub-Tier supplier selection, Quality Management and continuous quality improvement program? 是否具有一种有效的下一级供应商选择,质量管理,质量持续改进计划? ·There is no Sub-Tier Supplier Quality Management System and Procedures. 沒有供應商质量管理程序和体制·The organization is beginning to define their needs for sub-tier supplier quality Metric and improvement activity. 该组织开始确定对供应商质量指标改善措施的要求。· Supplier performs systematic periodic audit of personnel training, use of key equipment, manufacturing methods, and material specification compliance in the performance review of the Sub-Tier supplier’s processes to assure positive control at all times. 供应者对个人培训进行有系统的定期审计, 使用关键设备,生产方法和物料规格保证有效的控制。·Supplier has documented procedure of selecting, approving and maintaining their sub-tier supplier’s quality system that may includes, on-site quality audit. 供应者文件化选择,承认程序并且维护他们供应者质量系统包括现场的品性稽核等。· Supplier review Score Card or similar performance measure of their Sub-Tier suppliers. 供应商检讨他们的供应者的记分卡片或者相似的性能测量。·The organization’s procured products and services have implemented dock to stock or similar supplier certification program and some sub-Tier suppliers have been certified. 组织取得产品和服务有执行从卸货到存货货类似的供应商承认制度并且二级供应商是被承认过的。·Records pertaining to quality, performance improvement programs and Sub-Tier supplier certification are retained as quality records. 有关于质量记录保存及执行改善的制度,确保保存二级供应商的质量记录。·All Sub-Tier suppliers work instruction for testing, Inspection and packaging and handling are reviewed by the supplies 确保供应商检讨所有二级供应商关于测试,检验,包装,操作的作业指导。·Supplier has documented and communicated PCN (process change and engineering change) and ECN procedure to their Sub-Tier suppliers. 供应商有文件并且和下一级供应商交流PCN和ECN(过程变更和工程变更)·There is a defined early supplier involvement program that is used with key Sub-Tier suppliers.有明确的供应商联系制度用于管理主要的二级供应商。·Most of the Sub-Tier suppliers are active in the quality improvement program. Quality performance is monitored through Score cards or similar method is utilized. 大部分二级供应商有积极的质量改进制度,质量执行可以通过评分表或类似的方法得到有效的监控。·There is evidence that the quality improvement activities are having positive results on total cost of quality and improved product quality.有证据表明质量改进行动对于降低质量成本和改善产品质量有积极的效果。·Sub-Tier supplier has well documented qualification procedure and it assure parts are received are meeting specification and has zero defect。二级供应商有零件承认制度并且它可以确保零件符合规格和零缺陷。·A policy exists which allows customer verification of supplied material. It is part of the purchasing agreement/order, if required. 有允许顾客确认所供应物料的政策,如必须,它是采购协议/订单的组成部分。·Sub-Tier supplier has well documented RMA procedure and corrective actions are documented using 8D or equivalent tool.二级供应商有RMA的程序文件且矫正行动使用8D或相似的工具。·The Sub-Tier supplier quality improvement program is exceptionally effective.二级供应商的质量改进制度非常有效·On-site audits are conducted and documented. meetings are held regularly with Sub-Tier suppliers to review performance and progress on corrective actions. 有实施第二方稽核且文件化,定期的和二级供应商举行会议来检讨矫正措施的执行进展。·The early supplier involvement program is actively used. The organization and their Sub-Tier suppliers work as partners throughout the launch process.. 供应商联系制度是积极使用的,组织和他们的二级供应商是合作者的关系·Sub-Tier suppliers have been monitored for PCN and ECN process compliance and managed very effectively. 对于二级供应商的PCN和ECN的管理非常有效·There is evidence that certified suppliers are rewarded as preferred suppliers when making sourcing decisions. 有证据表明档做采购决定时有资格的供应商会被首先考虑。Comments / Objective Evidence:21.Sub –Tier Supplier Corrective and Preventative Action-----------采购Has a method been established with the sub Tier suppliers for identification and verification of corrective action? 是否舆下一级供应商共同建立一套可以确定并验证纠正措施的方法? ·There is no method for Sub –Tier Supplier identification and verification of corrective action. 没有对下一级供应商纠正措施予以确定和验证的方法·An informal method exists for assuring identification and verification of supplier corrective actions. 具有一个非正式的制度以确保对供应商纠正措施的确定舆验证·A basic procedure has been established, with the participation of some suppliers, for identification and verification of sub-tier supplier corrective actions. 在某些供應商的參與下已經建立了一個用來確定輿驗證供應商糾正措施的基本步驟·All records pertaining to Sub –Tier Supplier corrective actions are retained as quality records. 所有舆供应商纠正措施相关的记录均作为质量记录予以保存·The system includes the use of formal corrective action requests and enables follow-up on Sub –Tier Supplier corrective actions. 该系统包括了正式的改善措施要求并能够追踪下一级供应商的改善措施·Evidence indicates that most supplier corrective actions are timely and adequate. 有证据表明大多数供应商的纠正措施及时而充分。·The system provides for verification of the effectiveness of corrective actions. There is evidence that a few sub-tier suppliers have provided corrective actions which have been properly identified and verified to be effective. 该系统对验证纠正措施的有效性作了规定。有证据表明少数次级供应商提供矫正措施并且都经过验证是有效的。·There is evidence that some suppliers use formalized problem solving methods to determine the root causes of problems.有证据表明一些供应商使用正式解决问题的方法来决定问题的根本原因·The system for identification and verification of sub-tier supplier corrective actions is well designed and has proven to be effective. 用来确定舆验证供应商纠正措施的制度是经过完善设计且经证明是有效的。·There is evidence that the system is successful in reducing the number of problems with supplied products. 有证据表明,该制度成功地减少了供应物品中的问题·The system includes a method of preventing reoccurring defects. 该制度包括防止缺陷再产生的方法·Metric or Score card is used to monitor performance of sub-tier suppliers.使用指标和评分表来监控下一级供应商的绩效。·Supplier is proactively working on continuous improvement activity with key sub tier suppliers.供应商和关键次级供应商致力于持续改善·The organization’s system for supplier corrective action identification and verification is exceptionally well defined. The system application is pervasive across all areas of the business. 该组织用以确定舆验证供应商纠正措施的制度设计得异常之好,它广泛应用舆所有业务部门·There is evidence of excellent cooperation and support by all sub-tier suppliers. 有证据表明次级供应商均给予良好地合作舆支持·Supplier quality and cycle time incidents have been reduced significantly. 供应商的质量舆周期问题明显地减少。 ·Supplier procedure requires closed loop verification system to assure that sub-tier supplier has addressed true root cause.供应商程序中要求用闭环验证体系来保证次级供应商找到根本原因。·Supplier is auditing the sub-tier supplier qualification data and change management process.供应商稽核次级供应商质量数据和变更管理程序。Comments / Objective Evidence:22.Process Flow, FMEA, Control plan, SPC and Statistical tool. --------------各制造单位/品保/工程Are processes step identified and documented, control systems established, and quality checks promptly acted upon?流程步骤是否被定义和文件化,控制系统是否建立,质量检验是否快速实施?·There are no control plans, quality checks or measurement points built into the operations. 没有控制计划,质量检查或者操作中没有测量点。·Procedures have been defined for quality checks and control plans, but they are fragmented and results are inconsistent.定义了质量检查和控制计划的程序,但它们是零散和结果不一致。·The control plan is not link to PFEMA and PFMEA is not updated with engineering or process changes. 控制计划没有链接到PFEMA,PFMEA没有根据工程和制程变更而修订·Use of SPC (attribute chart and parametric chart) and PFMEA is not evident. 没有明显证据表明使用了SPC(属性和参数)和PFMEA·Customer specified requirements have not been incorporated. 客户指定的要求没有被纳入。·Process flow and process FMEA has used to develop control plans. Control plans are maintained for most significant processes with corresponding measurement samples size and frequencies. 工艺流程和PFMEA被用于制定控制计划。大多数重要制程有包括相应的测量样本的大小和频率的控制计划。·PFMEA and Control Plans are utilized to identify critical parameters and controls. PFMEA和控制计划被用来确定关键参数和控制。·Quality checkpoint procedures include customer specified requirements and inspection acceptance criteria based on achieving zero defects. 质量检查点的文件包括基于零缺陷的客户指定的要求和检查接收标准。·SPC charts and quality checks data are analyzed to continuously improve processes and control plans. Some process improvement activities have been put in place where operations were found to be incapable or low yield based on statistical data. 分析SPC图表和质量检查数据以持不断改进流程和控制计划。针对统计数据显示的某些未达到的指标的操作已采取一些过程改进行动 ·PFMEA, control plan for all critical manufacturing processes, including all customer specified requirements, inspection and test methodologies, are well defined, documented, and maintained. 所有重要生产过程的PFMEA和控制计划,包括所有客户指定要求,检查和测试方法被明确定义,文件化和维护·When not required, data indicates why a specific process is not identified as a critical process. 当不需要时,数据显示 , 为什么一个特定过程不被视为一个关键的过程。·Well defined sampling plans and reaction plan for inspection and testing is implemented to ensure zero defects. 明确定义检查和测试的抽样计划和反应计划, 以确保实施零缺陷。·SPC chart for attribute and parametric data are used through out manufacturing to monitor critical process and functional test performance. 产品属性和制程参数的SPC图表,被用于从生产到监控重点过程和功能测试的过程 ·Key employees who are responsible for collecting, charting and analyzing the SPC data are well trained for the use of chart and reaction plan.PFMEA, control plan for all critical manufacturing processes, including all customer specified requirements, inspection and test methodologies, are well defined, documented, and maintaine SPC chart for attribute and parametric data are used through out manufacturing to monitor critical process and functional test performance.负责收集,制作和分析SPC数据的关键人员需经过良好的图表应用以及反应计划的培训。Key employees who are responsible for collecting, charting and analyzing the SPC data are well trained for the use of chart and reaction plan.·Process FMEA control plan documents are updated on going basis (treated as a living document) from lessons learned, internal corrective action, customer return analysis, supplier feed back, process improvements, spec changes and any other factor that impact form, fit, function and performance. PFMEA和控制计划文件作为动态文件,基于总结经验教训,内部纠正措施,客户退回分析,供应商反馈,工艺改进,规格变化和任何其他因素的影响形式,配合,功能与性能等方面进行更新·A positive correlation exists between internal quality performance and external customer satisfaction results as indicated by customer survey results. 客户审核结果显示,内部质量表现和外部客户满意结果之间有积极的关联性The organization has an exceptionally well defined SPC system in place with focus on reducing variation and continuous improvement. The organization has an exceptionally well defined SPC system in place with focus on reducing variation and continuous improvement.组织已有了一套非常明确的专注于减少变差和持续改进的SPC系统。 Comments / Objective Evidence:23. Statistical Methods (SPC Tools) / Data on Box X Dimensions-------品保/工程/各制造单位Are all pertinent methods of statistical quality/process control properly, effectively, and efficiently used? 所有相关的统计质量控制方法是否得到了正确、有效且高校的应用? ·There is no evidence that statistical quality control methods are used. 沒有證據顯示使用了統計質量控制方法·If existing Motorola Supplier: In an audit of parts being produced for Motorola, supplier was not able to show evidence that they are measuring and tracking data on all Box X parameters (per 1280967A78). 若存在Motorola 供應商:在稽核為Motorola 生產的零件時,供應商能夠提供證據表明他們有測量和追蹤所有X參數·SQC and SPC tools are used in some areas with positive, but inconsistent results. 某些領域已經使用SQC 和SPC 工具,但沒有一致的結果·Management is only committed to implementing a SQC/SPC for critical Box X parameters. 管理應致力輿於執行SQC/SPC 为重要的Box X参数。·If existing Motorola Supplier: In an audit of parts being produced for Motorola, supplier was able to show evidence that they are measuring and tracking data on all Box X parameters (per 1280967A78). 若存在Motorola 供應商:在稽核為Motorola 生產的零件時,供應商能夠提供證據表明他們有測量和追蹤每箱產品的X參數·SQC/SPC (control chart) techniques are properly applied for all design (Box-X) critical parameter, process critical variables or attribute data in most cases with results interpreted and used to improve the process. SQC/SPC 技术被恰当地应用于设计的关键参数,过程关键变量或数据在多数情况中有结果说明和被用来改善制程。·There is evidence that, in most cases, the proper Statistical Quality Control (SQC) or Statistical Process Control (SPC) tool selection verification was determined. 有證據顯示,在大多數場合,確立了SQC,SPC工具的恰當選擇、查證和確認·Management review of SPC performance and internal audit results are maintained as quality records. 將SPC 的管理審覈和內部稽核結果作為質量記錄予以保存·Statistical studies, Design of Experiments (DOE) or equivalent, are performed to identify critical process parameters and evaluate process capability and stability. 進行統計研究,試驗設計(DOE)和儀器設計以定義關鍵參數和評估程序能力和穩定性·All CpK’s are >1.5 or an aggressive plan to achieve this is part of the routine management quality reviews. 所有的CpK 值都大於1.5,或有一個具有實戰性的計劃來實施這一質量審查的日常管理·SPC data collected throughout the process is being used to predict the quality level of the entire process. 使用通過此過程采集的SPC 數據來預報整個過程的質量水平·There is evidence that out of control situations are rare. 有證據顯示很少有脫離控制的情況·Internal SQC/SPC audits are performed periodically and results indicate rarely is there noncompliance to procedures. If they occur, detailed corrective actions are timely with permanent solutions and no repeat occurrences. 每次內部SQC/SPC 稽核都按計劃完全進行,且結果顯示很少有輿程序不符的的情況. 如果發生上述情況,能及時地找出詳細的糾正措施和永久性的解決方法且保證錯誤不重復發生·The organization extensively uses statistical quality control. 該組織在生產輿行政部門廣泛使用統計質量控制方法·There is a successful system for applying the most effective SQC/SPC methods to each critical process. 具有一個成功的制度使最有效的SQC/SPC 方法應用輿每一格過程·The automated SPC software is innovative and preventive/predictive. 自動操作的SPC 軟件是最新版的且具預防性/預言性·Internal audit results show compliance was consistently accomplished and innovative system improvements have occurred. 內部稽核結果顯示已經達成一致性並開始改進新系統·There is evidence that world class results have been achieved. 有證據顯示達到了世界公認水准Comments / Objective Evidence:24. Problem Solving Techniques-------------品保Does the organization use quality data for participative and preventive problem solving methods to identify, measure, and resolve internal and external problems? Are problem solving efforts timely and effective? 組織是否使用質量數據來參與和預示問題的解決方法,來鑒別、衡量和解決內、外部問題?能否及時有效地解決問題?·No participative problem solving is utilized within the organization. 組織沒有引用共享問題解決技術·Problem solving techniques are employed within different areas of the organization (e.g. within engineering, manufacturing, and quality). Employees are encouraged to identify problems. 问题解决方法在组织的不同区域内使用(制造,工程,质量),鼓励员工发现问题·There is some evidence that teams are analyzing quality data and using basic problem solving tools (e.g. DMAIC, 8D, Pareto charts, trend analysis or other quality tools). 有一些证据表明团队开始分析质量数据并且运用一些基本的问题解决工具·Most efforts are directed toward internal problems and tend to be reactive. A few of the existing participative problem solving teams are addressing external problems. 大多数努力是针对内部问题并且已经开始起作用.少数的问题解决行动小组从事外部问题解决工作.·Cross functional teams include members across different areas of the organization (e.g. engineering, manufacturing, and quality). 跨功能小组包括组织不同部门的成员(工程,制造,质量)·Cross functional teams are using internal and external quality data to define areas of focus for problem solving and improvements. 跨功能小组运用内部和外部数据定义问题解决和改善的关注范围.·There is evidence that many root causes have been found, verified and eliminated. 有证据表明大部分根本原因已经被找到,证实和削除.·Participative problem solving techniques are routinely used in manufacturing, quality, engineering and in some administrative areas. In all such cases there is good documentation of team efforts, problem measurement, tracking and reporting. 在制造、质量,工程技术和某些行政部门经常使用共享问题解决技术。所有这类领域的组团成效、问题度量 追踪和报告都制定了良好的文件·Problem solving team accomplished are being tracked and rewarded for outstanding performance. 问题解决小组完成情况被追踪,表现杰出给与奖励。·Management often reviews participative problem solving activities and status. Specific goals for timeliness of problem solving are set and performance tracked against them. 管理部门经常审覈共享问题解决行动及其地位,规定合时地解决问题这一特殊目标,并执行反跟踪方案. ·Cross functional teams are using participative methods and statistical tools to identify, measure, and resolve problems. Some of these tool commonly used are DMAIC, 8D, DDDW, brainstorming, cause and effect diagrams, process mapping, SPC, DOE, Weibull analysis.跨功能小组使用共享方法和统计技术定义,测量,解决问题。经常用到的工具有DMAIC, 8D, DDDW, brainstorming, cause and effect diagrams, process mapping, SPC, DOE, Weibull analysis。·There is evidence that these tools are also being used for prevention activities.有证据表明这些工具用来制定预防措施。·The timeliness of problem solving meets or exceeds organizational and customer expectations in all cases. 問題的解決時效性達到或超越了組織和客戶期望值·There are frequent management reviews of all problem solving efforts. There are examples of management recognition of successful participative problem solving teams. 經常對所有問題解決結果進行管理審查,有成功地解决问题团队被管理层表彰地案例·Elimination of root cause and future problem prevention are key objectives of all such problem solving efforts. 消除問題根源和預防問題發生是所有問題解決的關鍵目標·There is system in place to communicate all lesson learned from problem solving team out put to management.有一个体系从问题解决小组吸取经验并传达给管理层。Comments / Objective Evidence:25. Continuous Improvement---------------品保Is management focused on continuous improvement in the organization’s processes and performance? Does the organization have a Zero Defect Plan, Continuous Improvement program, and utilize mistake proofing or poka-yoke methods? 管理层是否关注于组织的流程与实积的持续改进?组织是否有0缺陷计划,持续改进计划?防错?·There is no evidence of a continuous improvement program in place. 没有适当的持续改进计划的证据·Continuous improvement activities have not been initiated. 持续改善还没有实施。·Management is aware of the need for a continuous improvement program and has assigned resources to implement a continuous improvement program. 管理层认识到持续改进的需求并且有推行持续改进行度的计划·There are some examples of improvement activities, focused on manufacturing processes. 有一些着重于制造过程的持续改进案例.·The organization has a Zero Defect Plan, or equivalent. There is some evidence of improvement activities from this plan being tracked and implemented. 有零缺陷计划或相同内容,有证据表明这一计划在被贯彻实施·Continuous improvement projects are assigned a project owner and team members. 持续改善有项目负责人和团队成员·The organization utilizes mistake proofing or Poka-Yoke methods to improve processes.. 组织利用防错方法改进制程·The Zero Defect Plan, or equivalent, is reviewed by the organization’s management and with the customer on a periodic basis. 零缺陷计划或类似内容定期有组织管理者与客户审核·There is evidence of improvement in processes / performance as a result of the continuous improvement activities. 由因持续改进活动的结果使流程或实积改善的证据·Continuous Improvement projects are reviewed and tracked by management. Management takes action on issues that are escalated during reviews. 持续改善项目被管理层审核并追踪,管理层在审核时会对问题提出措施·There are improvement activities in other than manufacturing areas, including HR, finance, IT, supplier quality etc. 改进行动在许多业务区域展开,包括制造,人力资源,财务,IT等·Continuous improvement program shows positive results in PPM, Cost of Quality. 持续改善项目用PPM,质量成本显示积极地结果。·There is a significant focus on continuous improvement in the organization. There are multiple examples of completed and ongoing continuous improvement activities. 组织中对持续改善非常重视,有很多已经完成或正在执行的持续改进的案例·There are examples of continuous improvement activities that involve the organization’s suppliers and/or customers as team members. 有包括组织的供应商和/或客户作为团队成员的持续改善案例·Improvements made from Zero Defect Plans, or equivalent, have been integrated into the organization’s processes. 由零缺陷计划或类似内容得到的改进已经整和到组织的流程中·There are many examples of process / performance improvement resulting from continuous improvement activities. 有很多通过持续改进活动达到过程和实积改进结果的案例 Comments / Objective Evidence:完结——以下无正文
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