QualityCompanion入门手册
QSBPlus中文版S
在快速反应板上跟踪问题。问题负责人需要在快速反应会 议上定期更新。
问题负责人负责完成所有退出标准包括经验教训。问题解 决结果的沟通。快速反应跟踪板显示退出标准是绿色的。
7
快速反应
(案例)
8
快速反应
快速反应
快速反应会议，我们要看什么？
编号
要求
考核标准
1) 这是一个由制造部门领导，跨部门参与的每日快速反应会议。
2) 快速反应会议是一个沟通会，每个问题的各时间节点的变更要慎重。
FR1
每日召开跨部门、多层 3) 所有内外部重大问题都要通过快速反应会议获得跟踪。 级的领导层会议，关注 4) 为每一个问题指定一个恰当的负责人，并规定好下次汇报日期。
QSB+的流程
全球性地支持GM&PSA供应商的质 量体系基础&认证
- 审核供应商识别差距
- 关闭差距的行动计
- SQE认证审核
- 监控
3
质量体系基础+
这个培训材料是一个QSB+的总体概述，用大量的案 例关注基本要求。建议课堂培训。
每个要求标准的所有细节可以在每一个关键要素教材 中找到。 这些关键要素教材都在SupplyPower QSB的 工具箱中。
Global Purchasing and Supply Chain
16
快速反应
交接班的信息传递
• 确保所有班次之间有开放的沟通渠道; • 对其他班次发生的问题，避免在不同班次的潜在的沟通失误 • 在问题解决活动中，驱动管理层和支持团队
Global Purchasing and Supply Chain 17
QualityCenter用户指南
目录前言 -------------------------------------------------------------------------------------------------- 3 1.需求说明书------------------------------------------------------------------------------------------------------------- 71.1需求定义工作流（T HE R EQUIREMENTS S PECIFICATION W ORKFLOW） --------- 71.1.1定义测试范围（Defining the Testing Scope） --------------------------------------------------- 81.1.2创建测试需求大纲（Creating the Testing Requirements Outline）---------------------- 91.1.3定义需求（Defining Requirements）--------------------------------------------------------------- 101.1.4分析需求定义（Analyzing your Requirements Specification）-------------------------- 10 1.2需求模块概述（T HE R EQUIREMENTS M ODULE）-------------------------------------------- 111.2.1需求模块 ------------------------------------------------------------------------------------------------------111.2.2需求菜单栏（The Requirements Menu Bar）------------------------------------------------------ 141.2.3 需求工具栏（The Requirements Toolbar） ------------------------------------------------------ 151.2.4需求树（Requirements Tree） ------------------------------------------------------------------------ 16 1.3开发需求树（D EVELOPING R EQUIREMENTS T REE）----------------------------------------- 171.3.1关于需求树（About the Requirements Tree） -------------------------------------------------- 181.3.2 创建需求（Creating Requirements） -------------------------------------------------------------- 181.3.3更新需求（Updating Requirements） ------------------------------------------------------------- 201.3.4 查找需求（Finding Requirements）---------------------------------------------------------------- 211.3.5替换值（Replacing Field Values） ---------------------------------------------------------------- 221.3.6查看需求树（Viewing the Requirements Tree） ----------------------------------------------- 221.3.7查看需求历史（Viewing Requirement History） ----------------------------------------------- 241.3.8 邮寄需求（Mailing Requirements）---------------------------------------------------------------- 241.3.9 查看关联缺陷（Linking Defects） ----------------------------------------------------------------- 271.3.10修改需求树（Modifying the Requirements Tree）------------------------------------------- 281.3.11 从需求创建测试（Creating Tests from Requirements） ---------------------------------- 302.测试计划--------------------------------------------------------------------------------------------------------------- 352.1测试计划工作流（T HE T EST P LAN W ORKFLOW） ----------------------------------------- 352.1.1定义测试策略（Defining Testing Strategy） -------------------------------------------------- 362.1.2定义测试主题（Defining Test Subjects） ------------------------------------------------------- 372.1.3设计测试（Planning Tests）-------------------------------------------------------------------------- 372.1.4创建需求覆盖（Creating Requirements Coverage）------------------------------------------- 382.1.5设计测试步骤（Designing Test Steps） ---------------------------------------------------------- 382.1.6自动测试（Automating Tests）----------------------------------------------------------------------- 392.1.7分析测试计划（Analyzing Your Test Plan） ---------------------------------------------------- 39 2.2测试计划模块概述（T HE T EST P LAN M ODULE）----------------------------------------- 402.2.1 测试计划模块 ---------------------------------------------------------------------------------------------- 402.2.2 测试计划菜单栏（The Test Plan Menu Bar） --------------------------------------------------- 412.2.3 测试计划工具栏（The Test Plan Toolbar）----------------------------------------------------- 422.2.4测试网格（The Test Grid） --------------------------------------------------------------------------- 43 2.3开发测试计划树（D EVELOPING T EST P LAN T REE）-------------------------------------- 452.3.1关于测试计划树（About the Test Plan Tree） ------------------------------------------------- 462.3.2 创建测试计划树（Creating a Test Plan Tree）----------------------------------------------- 472.3.3 添加测试到测试计划树（Adding Tests to a Test Plan Tree）--------------------------- 482.3.4查看测试计划树（Viewing the Test Plan Tree）---------------------------------------------- 516.5关联缺陷到测试（Associating Defects with a Test） ----------------------------------------- 532.3.6 邮寄测试（Mailing Tests） -------------------------------------------------------------------------- 562.3.7在树中查找测试（Finding Tests in the Tree） ----------------------------------------------- 592.3.8排列测试计划树（Sorting a Test Plan Tree） ------------------------------------------------- 602.3.9修改测试计划树（Modifying the Test Plan Tree）------------------------------------------- 61 2.4连接测试到需求（L INKING T ESTS TO R EQUIREMENTS） --------------------------------- 622.4.1关于连接测试到需求（About Linking Tests to Requirements） ---------------- 632.4.2 连接需求到一个测试（Linking Requirements to a Test）--------------------- 652.4.3 连接测试到一个需求（Linking Tests to a Requirement）--------------------- 682.4.4分析覆盖（Analyzing Coverage） ------------------------------------------------------------------- 71 2.5建立测试（B UILDING T ESTS）------------------------------------------------------------- 72 2.6 ------------------------------------------------------------------------------------------------- 723．测试执行 ------------------------------------------------------------------------------------------------------------ 72 4．缺陷跟踪 ------------------------------------------------------------------------------------------------------------ 72 5．质量中心分析 ------------------------------------------------------------------------------------------------------ 72前言欢迎您使用Quality Center, 它是Mercury Interactive 公司推出的基于WEB 浏览器环境下的管理工具，无论是在Internet环境下还是在公司内部的以太网环境下你都可以通过浏览器来访问Quality Center。
Quality-Manual-质量手册
The manual can be used for providing quality assurance or third-party audit. The manual issued and implemented on 20th， April 2006.
0.4 质量政策 Quality Policy
0。5 质量手册说明 Quality Manual Description
0。6 质量管理体系结构图 Quality Management System Structure Chart
1.0 质量管理体系过程间的关系图 Process Relation Map of QMS
本手册中的有关术语按 ISO9000:2000 标准质量管理体系术语中的规定。 The manual follows the terms and definitions of ISO9000：2000. 本 QM-01《质量手册》具体阐述了本公司的质量方针、质量目标和质量管理体系，是本公司 质量活动和行为准则的纲领性文件，也是证实本公司质量活动能满足顾客期望和相关法律法规 要 求的 依据 .公 司各 部门 、全 体员 工应 认真 学习 、深 刻领 会、 坚决 贯彻 执行 。 The manual describes the quality policy， objectives and quality management system， as the primary document of quality activities and behavior criteria of the organization， as well as the guidelines to demonstrate that the quality activities can meet the customer expectations and related legal requirements. The members of the organization will review fully and implement the manual firmly.
质量管理体系五种核心工具教材之APQP
质量管理体系五种核心工具培训教材（一）APQP产品质量先期策划和控制计划（第二版）Advanced Product Quality Planning and Control Plan上海伟众汽车科技有限公司二00九年三月前言第二版2008年11月1日生效，APQP和控制计划第二版取代APQP和控制计划第一版，除非您的客户特别说明。
APQP和控制计划第二版包括：●纳入以客户为中心的进程方法●更新的术语和概念符合ISO/TS16949和克莱斯勒，福特和通用汽车的其它核心工具手册●适当参考全文没有提供的客户细节此手册继续提供通用指南以确保先期产品质量策划的实施符合客户的要求。
它没有具体说明如何到达每个APQP或控制计划条目，这一项任务最好留给每一个组织。
尽管这些指南希望覆盖通常发生在早期策划、设计阶段或过程分析中的大多数情况，但还会出现一些问题，这些问题应该让授权顾客代表来指导。
目录前言 (2)目录 (2)引言 (5)产品质量策划的基本原则……………………………………………………………组建小组………………………………………………………………………………确定范围………………………………………………………………………………小组间的沟通…………………………………………………………………………培训……………………………………………………………………………………顾客与组织的参与……………………………………………………………………同步工程………………………………………………………………………………控制计划………………………………………………………………………………问题的解决……………………………………………………………………………产品质量的进度计划…………………………………………………………………与进度表有关的计划…………………………………………………………………第1章计划和确定项目……………………………………………………………引言……………………………………………………………………………………1.1 顾客的声音………………………………………………………………………1.2 业务计划和营销策略……………………………………………………………1.3 产品/过程标杆数据………………………………………………………………1.4 产品/过程设想……………………………………………………………………1.5 产品可靠性研究…………………………………………………………………1.6 顾客输入…………………………………………………………………………1.7 设计目标…………………………………………………………………………1.8 可靠性和质量目标………………………………………………………………1.9 初始材料清单……………………………………………………………………1.10 初始过程流程图………………………………………………………………1.11 产品和过程特殊特性的初始清单……………………………………………1.12 产品保证计划…………………………………………………………………1.13 管理者支持……………………………………………………………………第2章产品设计和开发引言2.1设计失效模式及后果分析（DFMEA）2.2可制造性和装配设计2.3设计验证2.4设计评审2.5样件制造-控制计划2.6工程图样（包括数学数据）2.7工程规范2.8材料规范2.9图样和规范的更改2.10 新设备、工装和设施要求2.11 产品和过程特殊特性2.12 量具/试验设备要求2.13小组可行性承诺和管理者支持第3章过程设计和开发引言3.1 包装标准和规范3.3 产品/过程质量体系评审3.3 过程流程图3.4 工厂平面布置图3.5特性矩阵图3.6过程失效模式及后果分析（PFMEA）3.7试生产控制计划3.8过程指导书3.9测量系统分析计划3.10程能力研究计划3.11管理者支持第4章产品和过程确认引言4.1一定数量的生产运行4.2测量系统分析4.3初始过程能力研究4.4生产件批准4.5 生产确认试验4.6 包装评价4.7 生产控制计划4.8 质量策划认定和管理者支持。
品质管理质量手册amf服装行业质量手册包括所有程序文件
最新卓越管理方案您可自由编辑3．0质量手册管理说明1．手册内容本手册系依据GB/T19001：2000idtISO9001：2000《质量管理体系——要求》并结合本公司的实际情况编制而成，主要包括以下内容：a.公司质量管理体系范围，除了7.5.4顾客财产不适用删减外，GB/T19001：2000idtISO19001：2000标准其他过程都已覆盖。
b.公司质量管理体系运行需要新增加的和GB/T19001：2000idtISO9001:2000《质量管理体系——要求》要求的程序文件。
c.公司质量管理体系所包括各过程的顺序和相互作用的阐述。
d.质量方针和质量目标及分质量目标e.质量管理体系组织结构图以及职能分配表f.管理者代表任命书g.质量手册管理说明2．适用范围适用于公司产品服装的设计、生产与销售过程。
3．术语和定义本手册除了采用GB/T19000：2000idtISO9000:2000《质量管理体系——基础和术语》中的有关术语和定义外，并对以下术语进行定义规定：（本）公司——广州市安约璐服装有限公司安约璐——广州市安约璐服装有限公司总（副）经理——最高管理者4．本手册为公司质量管理体系文件的一部分，属于受控文件，由公司最高管理者之一总经理批准颁布实施，本手册管理的所有相关事宜均由办公室统一负责，包括编号、发布、更改回收等，未经管理者代表批准，任何人不得以任何理由提供给公司以外人员，手册持有者调离工作岗位时，应将手册直接移交给接替其职位的人员并办理移交手续。
5．手册持有者应妥善保管，存放于通风干燥之文件柜或适宜之处，以防潮、防霉、防丢失或不期望情况出现。
6．在手册实施期间，若因实际情况需要更改时，应按《文件控制程序》有关规定程序执行。
4.2文件控制程序1.目的有效控制与公司质量管理体系有关的文件，确保文件各使用处所使用的文件为最新或有效版本。
2.适用范围适用于与公司质量管理体系相关的文件。
3.职责3.1总经理负责质量手册的批准颁布；3.2管理者代表负责组织质量管理体系文件的编制工作及工作性文件的批准；3.3公司办公室负责质量管理体系文件的编写、发布、回收及外来文件的获取更新等管理；3.4各相关职能部门负责本部门与质量管理体系相关文件的整理、归档、保护等。
APQP质量管理体系五种核心工具教材(一)
质量管理体系五种核心工具培训教材（一）APQP产品质量先期策划和控制计划Advanced Product Quality Planningand Control Plan目录一、计划和确定项目——--——-—--——--—————-——- 6二、产品设计和开发 -—-----————--—-——---——- 10三、过程设计和开发 -———-——--——-——-—-—--—-—- 13四、产品和过程确认—--—-——————-———————--———16五、反馈、评定和纠正措施—--——--—--—--—— 18六、控制计划方法论——-————-—-—————--———-—-——-19产品质量策划的基本原则定义：产品质量策划是一种结构化的方法,用来确定和制定确保某产品使顾客满意所需的步骤。
目标：是促进与所涉及的每一个人的联系，促进参与各方相互信任和支持，以确保所要求的步骤按时完成.有效的产品质量策划依赖于公司高层管理者对努力达到使顾客满意这一宗旨的承诺。
产品质量策划的好处● 引导资源，使顾客满意；● 促进对所需更改的早期识别；● 避免晚期更改；● 以最低成本及时提供优质产品。
每一个产品质量计划是独立的。
实际的进度和执行次序依赖于顾客的需要和期望/或其他的实际情况而定。
实际工作、工装和/或分析技术能在产品质量策划循环中越早实施越好.产品质量策划循环产品质量策划的基本步骤●组织小组：产品质量策划中供方的第一步是确定横向职能小组职责。
有效的产品质量策划不仅仅需要质量部门的参与。
跨功能小组可包括:技术、制造、材料控制、采购、质量、销售、现场服务、分承包方和顾客方面的代表.●确定范围：-- 选出项目小组负责人负责监督策划过程；——确定每一代表方的作用和职责；——确定顾客（内部和外部）；——确定顾客的要求；——确定小组职能及小组成员，哪些个人或分包方应被列入,哪些可排除；理解顾客的期望,如：设计、试验次数；-- 对所提出来的设计、性能要求和制造过程评定其可行性；——确定成本、进度和应考虑的限制条件；-—确定所需的来自于顾客的帮助；——确定所采用的报告过程或形式.● 小组间的联系：建立顾客、供应商和小组的联系渠道（如定期会议).联系程序取决于需要解决的问题的数量。
QA MANUAL 品质手册
Quality Assurance Handbook for SuppliersOak Lawn Marketing GroupDecember 5, 2006INTRODUCTION (2)PHILOSOPHY (2)PROCESS (2)Pre-Testing 1 (3)Pre-Testing 2 (3)Roll-out (4)ON GOING QUALITY ASSURANCE (5)INSPECTIONS (5)Appendix 1(materials from the supplier) (8)ALL PRODUCTS WITH A SHOW (8)ELECTRICAL TESTING (8)FOOD CONTACT TESTING (8)For Rollout (9)Appendix 2 (Specifications from supplier) (10)Appendix 3 (Design Specifications for freeze) (11)Appendix 3 (Batch Release Inspection Report) (15)Appendix 4 (Goods Inspection Standard) (16)Appendix 5 (Terms) (17)Quality Assurance Handbook for Suppliers INTRODUCTIONOak Lawn Marketing has put in place a comprehensive Quality Assurance program with the mandate of improving quality for customer satisfaction, and increasing real profit through reduced returns, and the increase in repeat sales due to raised customer satisfaction.Our Quality Assurance program is also much to the benefit of our suppliers and their manufacturers. Suppliers are able to reduce their return rates, manufacturers are able to receive feedback indirectly from customers, hence improving product production; creating a cycle of multilevel multilateral benefit for all parties from factory worker to end user.In the industry of direct marketing, our service to our customers is revolutionizing, not only the way we market products but also customer opinion of DRTV products. The day is fast approaching when those left behind in Quality, will be left out of our industry. Oak Lawn Marketing will continue leading the way in Quality, not only for our customers, but for our whole industry, for stability, for market share, and of course for profit.PHILOSOPHYTo understand the necessity for quality control, it is important to bear in mind the basic goals of our business. We want to sell products, we want our customers to be satisfied with those products, we don’t want those products to come back to us, we want to make profit, and we want our customers to come back to us, so that we can do it again. This cycle can either spiral outwards getting wider, and wider, ever increasing in volume, or lose momentum, and fade into nonexistence.It has been almost a tradition in our industry to completely lack control over the quality of the products we sell, and to be relatively patient of the return rate. This has created an unfortunately poor public image of both the products we sell, and the methods we use to sell them. In Japan, the UK and Germany however, Oak Lawn Marketing, has been able to create a new image for DRTV, and DRTV products; and through QA support of products distributed to the Global Alliance through Global Infomercial Services, we are changing the face our industry.PROCESSA brief understanding of the OLM internal QA process can help to answer a lot of questions about why things are done the way they are and why certain things are requested at different stages of the process. Therefore this document will give a brief overview of the OLM internal QA process, with indications of supplier responsibility and requirement for each stage of the process. It is important to note that this document is written from a strictlyOLM QA perspective, and that it is in no way an indication of supplier requests and responsibilities in regards to other departments within OLM, our world wide distributor network.Pre-Testing 1Upon the initial decision to test a product by Oak Lawn Marketing, our QA department must prepare a “To Test” QA check sheet. This sheet is produced subsequent to product analysis, with the goal of determining what mandatory standards the product must comply with, and for which of these we need to submit the product to third party testing agencies, to assure legality, and access any risks involved with marketing in Japan, UK or Germany. In addition to this, practical testing, safety testing, durability testing, and also, determination of which aspects of the product must be 100% inspected at the factory prior to dispatch from the factory.In order for this general assessment to be performed, samples will be required by our QA department. The number of samples is entirely dependent on the type of product, and the number of tests anticipated as necessary. The number of samples, although usually accurately quoted on the ASAP list of the Global Launch Book (GLOB), may differ depending on results internal product analysis, and the necessity for additional testing. In such cases the supplier’s cooperation is requested. Upon internal QA, and legal checks, and prior to the commencement of test sales, the final “To Test” check sheet will be issued. Upon internal approval, testing shall begin.It is important to note that electrical products which require conformance to mandatory standards, For example S-mark, or PSE in Japan, or CE or GS in Europe, may take up to six weeks (or more) for approval from the required agencies. Likewise, food contact testing in regards to the Japanese Food Sanitation Law, can also take up to 4 weeks. The OLM QA team can assist, and guide suppliers through these processes, if prior certification has not been obtained.Pre-Testing 2Upon approval of the “To Test” check sheet, testing can begin. In the case where there are legally required tests, we will request the supplier to submit the required product information to us. At this point we may also request the supplier to submit additional samples for testing.After the reception of test results the OLM QA team will share the information both internally with the pertinent departments, externally with relevant distributors, and with the supplier. If at this point any product modifications need to be made to make the product saleable in Japan the UK or Germany, communications with the supplier shall begin.If fundamental product change is unnecessary, and the product is deemed saleable, any necessary localization can begin. Items such as manuals, warrantees, safety seals, wash labels, and the contents shall be determined at this point. Upon the design and approval, and production of these items, the OLM QA team will request 2 final samples for use in the production of a simplified design specification. Upon completion of the simplified design specification, the document shall be sent to both the supplier and circulated internally within OLM. Upon approval of this document OLM QA shall draft our receiving inspection standards for our warehouse to use for goods inwards inspections.It is important to note that this whole part of our process shall be synchronized with the issuance of our first PO to the supplier.From this point on, from an OLM QA perspective test sales can begin.Roll-outIf the test-sales have been successful, and the decision to roll out the product is made; a more comprehensive design specification needs to be drawn up for the purposes of a design freeze. (see appendix 2)A design freeze is a mutual contract between the supplier and the distributor that states that no aspects of a product maybe altered by the supplier without prior written notification to the distributor and written approval from the distributor. This means the supplier shall not ship altered products that differ from the agreed specification. This agreement is in no way an indication of reluctance to product improvement; so much as reluctance to be left out of the decision making process that affects a product that a distributor has committed time and money into marketing, and a reluctance to incur any possible penalties, or customer dissatisfaction.It is important to note that depending on the type of product, and the territories in which it is to be sold, a design freeze may encompass various types of attributes of a product, with varying degrees of detail. In the most rigid of circumstances a design freeze may encompass all raw materials, including color additives for polymer resins; such as in the case of Japan where violation of food contact regulations could result in full product recall, heavy fines, jail time, and loss of license to do business. Likewise in Europe where violation of the RoHS directive also could result in harsh penalties and expensive fines.There are a number of reasons why a design freeze is necessary, some less obvious than others. The possibility of customers complaints after receiving a product that looks different from that in the commercial is fairly obvious, however those in relation to the law may not be.In Japan there are very strict laws which dictate material usage in regards to electrical certification, and food sanitation laws. If a supplier changes a component within an electrical device, then the device being sold may no longer be legally certified, and the distributor may unknowingly sell such illegal goods. Likewise with kitchen tools, if one of the materials changes, the distributor may again be inadvertently be selling goods are not in correspondence to Japan’s laws dealing with food contact and sanitation.Many problems, both predictable, and otherwise can be prevented for both parties through this agreement.In order for a design freeze to occur, a more detailed design specification will need to be drafted. These documents are usually either produced by OLM’s China Product Management team (CPM), or by the OLM Japan QA team. During the drafting process, additional information from the supplier may be requested. Upon internal approval of the design specification, the design documentation will be sent to the supplier, and the factory. The document shall be signed or stamped by these parties, and returned to the OLM QA team. From this point no changes can be made to a device without the first notifying, and obtaining the approval of the other signing parties.Upon the multiparty approval of the design specification, our CPM team will then proceed to produce the final Goods Outwards Inspection Standard. From this design specification, and inspection standard shall be drawn up, which shall be used as the guideline for all subsequent Batch Release Inspections.ON GOING QUALITY ASSURANCEAs product sales progresses and more customers obtain a product, occasionally the necessity for improvements may become apparent. OLM in response to this will from time to time make suggestions or requests based on customer feedback, and our in-house engineer’s expertise. In the event of a quality related issue, the supplier’s cooperation requested.Through our QA teams feedback based on real customer opinion, and data reflecting those opinions, a product can not only improve but also become more successful. INSPECTIONSIt is important to mention before talking about inspections, that because Oak Lawn Marketing performs Batch Release inspections for all rolled out product, full container loads, for all members of it’s world wide distributor network, that the supplier is not released from the responsibility of performing their own inspections. Just as OLM shall share its inspection reports with the supplier, so shall the supplier share theirs with OLM.Oak Lawn Marketing conducts two kinds of inspections: Goods Outwards inspections at the factory before goods are approved for shipment, and Goods Inwards inspections at our warehouse, upon reception of the goods. The OLM sampling method for inspection is based on JIS Z9015-1, which is based on U.S. Military standard 105E, and based on world class procedures.(Just as OLM performs its own goods inwards inspections, we strongly encourage GA members to also perform their own good inwards inspections. Goods Inwards inspection guidelines can be supplied upon request.)Based on the afore mentioned standard, sampling quantities are determined using the following charts. A sampling code is determined based on the lot size, and the code determines the quantity of goods to be randomly pulled and inspected. The severity, and level of inspection, is based on the type of product being inspected. In general electrical appliances fall into the Normal Severity I category, and other products will fall under Special Severity 1. If a product continuously fails inspections, or if the rate of return due to defect increases above our standard levels, the severity level within the category will be increased. Likewise certain products, which are more complicated, and could have a greater possibility of defect, or products which could be potentially dangerous if defective, will also have a higher severity level. And again the criteria for inspection will come from the inspection standard, which is based on the design specification.2.FigFig1.Using the lot size and severity level, from Fig 1, the sampling code is determined. Once determined, using Fig 2, the sampling quantity, and AQL is determined.For each PO placed, OLM’s CPM team will perform a goods outwards inspection, or Batch Release Inspection. For each inspection, a Batch Release Inspection Report is issued. The report shall contain all the pertinent information about the order, and contain detailed descriptions about any defects, including pictures of the defects, and suggestions about any possible improvement action. (see appendix 3)Batch Release Inspection Reports, upon review by OLM Japan QA staff shall be circulated to GIS, the manufacturer, and relevant GA world wide distributors.Through the course of inspection, OLM CPM inspectors shall seek, and note three categories of defects – “Critical”, “Major” and “Minor” and the normal definitions are: -Critical: A defect which could potentially result in the harm of a customer, or makes a product that is not in compliance to mandatory regulations and standards. Major: a defect which could potentially result in failure or cosmetic defects of a degree which would reduce the sale-ability or significantly reduce customer satisfaction, Minor: A defect that does not reduce the usability of the product, but is nevertheless a workmanship defect beyond the defined quality standard.There are four possible outcomes for a Batch Release Inspection.In the case of few defects, falling within our AQL, the result will be: pass. It is important that even in the event of a pass, there may have been defects, and the report may contain useful suggestions from the inspector, which may be utilized by the manufacturer. Likewise a result of a pass from our inspectors does not waive any responsibility of the supplier in regards to possible defects, returns, recall, or any other contractual obligations.In case of too many minor or major defects the result may be either fail, or passed due to future improvement. If the level of defect is determined to render the products completely un-saleable, then the result of fail will result in a request for the factory to rework the order. In the event that our in-house QA team deems the products saleable, in light of the defects, or deems the defects to be acceptable, as long as there is no future occurrence, then the result would be: passed due to future improvement.Finally, if the there are defects which are deemed as being critical, the result would be rejected. A critical defect would be a defect which would either render the units inoperable, illegal for sale, or dangerous for customers to operate. In the event of a rejected lot, the supplier will be contacted directly by OLM or GIS.The goal of our QA process is simple. It is our mandate to monitor sales, returns, and production defects through our inspections, and analyze all the data to be used if feedback to the supplier with the goal of perpetual product improvement to ensure a long product life, and mutual profitability.We hope that suppliers will work with us GIS, and our world wide distributor network towards the mutual goal of perfect quality.Appendix 1Anticipated list of materials to be requested from the supplier.(Note: depending on product, and local laws, materials may change based product and country. All materials listed may not be necessary, and other materials not listed may be requested. This is only a guideline.)For Testing.ALL PRODUCTS WITH A SHOW1.Substantiation data for all claims in the show.2.Make, and model of any comparative goods used in the show.ELECTRICAL TESTING1. 3 working product samples for target market (minimum)2.Bill of Material3.Mandatory standards certification i.e. PSE*, SMARK CE, UL4.Without approval (Number 3.)a.circuit diagramb.parts list (maker name, model number, rating / grade)c.parts compositiond.Process testing chart for the product.e.Parts testingf.Goods inward inspection standard for major electrical parts. i.e. motor, plug5.Foreign Test Results (other certifications)FOOD CONTACT TESTING1. 3 working product samples (minimum)2.Material break down (composition, plastic, grade, color, maker. Per part)samples3.TestingMaterialof4.Bill5.Foreign Test results (if any)* It is important to note that for certain devices classified as “specialty products” that a copy of the original PSE certificate must be held by the importing company (OLM) in order to legally import. Therfore an original or certified copy muct be included.For Rollout.1.Factory Informationa.Addressb.Mapc.Contact Named.Phone Numbere.Email Addressf.Fax Numberg.Hours of operation2.Exploded view, and parts list3.Design Spec with dimensions and tolerances4.Configurations (What is in the box per territory)bel list (with Data or photos)6.Adapter configurations i.e. V, HZ, W (if applicable, and if sold in multipleterritories)7.Spare parts and price list.8.Material Break Down (for RoHS in Europe, or food contact testing in Japan)9.Circuit Diagram, and parts list (if releasable)10.Samples of each configuration to be distributed, sent to CPM11.Life Test Data12.Battery Maker, and grade of battery (if applicable)13.Charging cycle life test (if applicable)14.Data spec sheets for all major parts. I.e. motors,15.Explanation of quality control system of the factory.16.Copies of all certifications for each territory i.e. PSE, SMARK, CE etc.17.Drop test.18.Design Specifications (from the supplier)19.Packing list. (master pack and palletization)20.Factory certifications, and international standards information. I.e. ISO9002Appendix 2 (Specifications from supplier)Example of Exploded view with parts and prices (from Supplier)Example of design specification with dimensions and tolerances from supplier.Appendix 3 (Design Specifications for freeze)Product Name Big Dice Issued Date 2005/3/27 Product Code See Table 1 # of Pages 4 Supplier Name Big Dice Company of Las VegasFactory Name The Big Dice FactoryCountry of Origin ChinaSpec. Number AAttachment:1.Product CodeTable1Product Name OLM Product Code Big Dice SKU# GIS Product Code Big Dice (red) XX000001 30001 BD3003Big Dice (blue) XX000002 30002 BD3004Big Dice (clear) XX000003 30003 BD30082. Specifications:Table2PRODUCT NAME BIG DICEMATERIALS NBRWEIGHT 50ｇLIFE TEST 1,000,000 timesLIFE TEST CONDITIONS Height 50cmFree fallRevision No. Description Revised Date Approved Inspected CreatedApprovedGIS ApprovedSupplierApprovedFactoryApprovedOthersDate: Date: Date: Date:3. Specifications Table 34. Parts List:Table. 4Big Dice VariationsParts NameSKUPhotographMaterialRemarks Red DiceFX000001NBRBlue Dice FX000002NBRClear Unit FX000003NBR5. Master Pack and Mail Order Box with JAN Code Sticker:Table 5Master Pack Product NameOLM Product CODEsizeQuantity GW JANCodeStickerSize Spec: 15 x 45mmMO box SizeBig Dice (Red) FX00000152 34.557.3cm 1000 sets50Kg5 5 5 cm Big Dice (Blue) FX00000252 34.557.3cm 1000 sets50Kg5 5 5 cm Big Dice (clear) FX00000352 34.557.3cm1000 sets50Kg5 5 5 cm6.Date Code: Stamp Production Date: Table 6Date Month Year Spec. Number1 A 2000Z2 B 2001 Y3 C 2002 X4 D 2003 W5 E 2004 V6 F 2005U7 G 2006 T 8 H 2007 S 9 I 2008 R 10 J 2009 Q 11 K 2010 Z 01~3112 L 2011 YSee the front page.ExampleProduction on 11th March,2004 Spec. Number A 11CVA7. Carton Box Figure (JAN Code Sticker & Stamp Positions):Big Dice8. QTY/ContainerProduct Name20’ container40’ container40’ HQ containerBig Dice105,140 sets 210,280 sets 415,475 setsAppendix 3 (Batch Release Inspection Report)Appendix 4 (Goods Inspection Standard)Appendix 5 (Terms)ASAP list: The third for form of the Glob used to request necessary information, and items from the supplierBatch Release Inspection: An inspection performed at the factory. A lot is inspected, and if the goods are acceptable, the goods are released for shipment.CE: Electrical safety standard in Europe.CPM: China Product Management is Oak Lawn Marketing’s sourcing, and Quality Assurance teamDesign Freeze: A mutual agreement between the supplier and the distributor, whereby the design of a product is agreed upon, ensuring that no design changes can occur without notification to the distributor.Design Specification: The document used to specify the design criteria for a design freeze.GA: Global Alliance – Oak Lawn Marketing’s Global Distribution Network.GIS: Global Infomercial Services – An OLM group Company. GIS Functions as OLM’S exclusive purchasing, sourcing, total support, and GA distributor relations company.GLOB: Global Launch Book. The book used to gather, and share information between supplier, OLM, GIS, and GA distributors.GS: German Electrical mediatory standard.Goods Outwards Inspection: An older, broader term for Batch Release Inspection.Life Test: Testing to show the potential life span of a product.Localization: The application for certifications, and mandatory conformance standards, as well as the development of manuals labels, etc to make a product saleable in a specific territory.OLM: Oak Lawn MarketingPSE: An electrical safety standard in Japan.QA: Quality AssuranceRoHS: The Restriction of Hazardous Substances directive in the UK, which limits the quantity of certain substances which can be used in a product. Said ingredients are: cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardantsS-Mark: An electrical safety standard in Japan.Substantiation: Results of testing, and data to show that a product can do the things that it is claimed to be able to do. To-Test Check Sheet: An OLM Internal document where all the aspects of a product that need potential testing before sales are listed.UL: An electrical safety standard in Germany.。
Q7讲座教材
25
20
15
規格下限
10
規格上限
5
0 72.95 77.95 82.95 87.95 92.95 97.95 75.45 80.45 85.45 90.45 95.45 100.45
例：制品厚度的直方图
mm
16
4. 层別
层别是为整顿数据的思维办法 多个事物以持有相似特性的组别来分类做比较（层别），使得问题因素明了
15 10 5
11
3.2 直方图的形状：基本形
通过看分布的图形来确认数据（组）的状态，调查偏差的因素并对其进行対策。
普通工程若无习惯性或异常的状况下，产品的偏差呈正规分布。 除此以外的图形，表达会有异常发生的可能性，因此必须调查因素。 常见形式有7种。
名称 状況
(1)一般型 左右对称 （正规分布）
A
Action
P
Plan
C
D
Check
Do
管理手顺
(1) Plan 分析现状，明确目的・目的
(2) Do
按照计划实施活动
(3) Check 验证明施的成果，若成果不佳再対策
(4) Action 为使得事后不反弹而进行控制（再发避
免）
尚有在进行改善活动的基础上作为重要视点
例举下列事项
￭ 用事实（数据）说话 ￭ 重视过程 ￭ 罗列重点 ￭ 找出真因
检查日 2007/02/09
检查员 (NAME)
不良数
计
6 2 4 3
普通的流程 (1) 决定检查目的 (2) 决定表格的种类 (3) 决定检查项目 (4) 检查表作成 (5) 数据记入 (6) 累计必要的检查結果
注意 ￭ 现场使用时要能够简朴记入（基本）
五大工具-APQP学习教程(详细版)
04:36:07
25
APQP小组组成
多功能小组 • 设计、技术 • 品保 • 采购 • 制造 • 生产计划 • 营业 • 顾客代表 资源 可能包括顾客和供应商的参与
04:36:07
26
确定范围
• 任命一名项目小组组长—LEADER
• 确定小组成员的权利和责任
• 确认和了解顾客（内、外部）及其期望
初始材料清单和过程流程图
Ex. CAJSA材料清单 小组根据产品/过程设想的基础上制定的 一份初始材料清单,并包括早期分包商名单
• ＥX. CAJSA FLOW CHART预期的制造过程流程图
04:36:07
22
APQP阶段1：计划和确定项目 PLAN AND DEFINE PROGRAM
关键术语和基本概念
小组 – 人员组成及任命负责人
04:36:07
30
顾客的特殊要求
Customer-Specific Requirements
顾客可能有特殊要求，开始APQP之前 应首先了解这些特殊要求。
此外，顾客可能有特定的表单或格式。 在此情况下，只有经过顾客书面批准方可使 用其它的格式。
04:36:07
产品/过程指标 关键术语和基本概念 • 何为指标
-- 用于识别可供比较的标准的系统性方法，提出 可测量的性能目标
-- 包括世界水平或最优水平的识别 • 成功的基准确定方法
-- 识别合适的基准 -- 了解你目前状况和基准之间产生差距的原因 -- 制定一缩小差距，符合基准或超过基准的计划
04:36:07
• ACT 如果试验成功，将此变动纳入正常工作中，如果不成 功重新开始P阶段
04:36:07
QualityCenter实用手册v1.0
Quality Center项目管理1系统管理员操作系统管理员负责整个测试工程在Quality Center系统中的工程建立、人员团队构建、权限分配、模块流转模式建立等系统维护工作。
是整个测试工作在Quality Center中得以充分展现的驱动者角色。
一般该角色应由测试负责人（测试经理）来充任。
作为Quality Center管理员，需要创建和维护Quality Center项目、用户、服务器。
Site Admistration包括以下内容：1.Site Projects 管理quality center工程。
包括增加新的域和项目，查询项目数据，存储项目，项目重命名，激活和挂起项目。
2.Site Users增加用户、定义用户属性、修改用户密码。
3.Licenses 监控所有正在使用的Quality Center licenses ，修改license关键字。
4.Servers 修改服务器信息，比如日志文件和邮件协议。
5.DB Servers 管理数据库服务器。
增加新数据库服务器，编辑服务器的连接串，改变服务器默认管理员用户名、密码，修改用户密码。
6.Site Configuration 修改Quality Center的配置参数。
7.Site Analysis监控连接到Quality Center用户1.1 创建项目根据项目情况，可以在Quality Center上为其创建一个Domain，在这个Domain上创建项目，来进行工程的实际管理与跟踪。
下面介绍如何创建一个项目。
1.1.1管理员登录1.1.2新建Domain 1．进入”Site Projects”页面2．点击“Creat Domain”按钮，打开新建domain的对话框，输入domain的名称，点击“OK”。
1.1.3新建project点击，新建一个project，按照对话框的提示填写项目信息。
1.2 创建组别1.2.1组别的定义测试过程的管理，需要不同角色的的参与来共同实现，不同的项目管理需要不同的角色组别。
Quality Center使用指南
上海懋图信息科技有限公司(DCISH)
QC的下载安装
Win7系统环境下（这里强调Win7系统，不是此系统的用户可跳过， 直接看Step III ）
Step I：关闭UAC （User Account Control)
通过开始菜单搜索框，输入UAC，会出现Change User Account Control菜单项。选择该菜单，弹出如下一个User Account Control Settingde 对话框。通过滚动条选择“Never notify”。 然后重启机器。
c).创建成功后，点击“选择测试”后，右边出现测试用例的选择框
QC测试人员使用篇（执行测试用例）
d).正确选择测试用例里的功能文件夹，点击“向左箭头”
QC测试人员使用篇（执行测试用例）
e).选择测试集，再点击“运行”功能图标，弹出，运行框
QC测试人员使用篇（执行测试用例）
f).再点击运行里的“运行”
QC开发人员使用篇
4.当开发人员不理解缺陷的意思时，或不清楚缺陷产生的操作步骤，请及时与测试人员进 行沟通
缺陷的定义及等级
缺陷的定义 • 软件未实现产品说明书要求的功能。 • 软件出现了产品说明书指明不会出现的错误。 • 软件实现了产品说明书未提到的功能。 • 软件未实现产品说明书虽未明确提及但应该实现的目标。 • 软件难以理解、不易使用、运行缓慢或者——从测试员的角度看——最终用户会认为 不好 • 5-致命：发现下列可重复出现的致命问题： • ——导致系统崩溃； ——导致程序模块丢失； • ——主业务流程出现断点； ——导致功能失效； • ——导致死机。 • 4-严重：发现下列可重复出现的严重问题： • ——被测功能不能正确实现； ——软件错误导致数据丢失； • ——被测数据处理错误； ——用户需求未实现； • ——性能不符合要求。 • 3-高：一般性的错误或功能实现有不完美处： • ——输入控制错误； ——删除操作未给出提示； • ——正常逻辑错误。 • 2-一般：细小的错误： • ——提示信息不准确； ——打印内容、格式错误； • ——界面风格不一致； ——错别字； • ——未使用或使用不当默认值。 • 1-低：建议性问题。 •
Quality Center LDAP 认证配置指南说明书
Information Services Quality Assurance Quality Center LDAP GuideVersion 1.0Quality Center LDAP GuidePage 2 of 10Lightweight Directory Access Protocol( LDAP) authentication facilitates single sign on bysynchronizing Quality Center (QC) user passwords with user passwords set in Active Directory (AD). When a user logs into QC, a connection is acquired with the LDAP server, and the QC username and password is verified against the AD username and password.LDAP Authentication Configuration for ImportThe purpose of the import is to verify and import Site User credentials.1. Login to QC Site Administration.2. Select “Site Users ” tab.3. Select “User Settings” icon downarrow to display setting options.4. Select “Authentication Settings ”. Enter/Verify authentication settings.When LDAP is enabled, the Authentication type button should be set to “LDAP”. Select the “Test Connection” button to verify comm unication with the LDAP server. Once connection is successful, select “OK” to close the dialogue window.5. Select LDAP Import Settings.Quality Center LDAP GuidePage 3 of 106. Enter/Verify LDAP Import settings.7. Select the “Next>” button .8. Select the “Advanced Button”. The default settings for Import Field Mappings will display.Ldap://XXXXXDomain\usernameQuality Center LDAP GuidePage 4 of 109. Delete all field mappin g values except the “User name”.10. Select Finish.11. Value the following QC parameters:Quality Center LDAP GuidePage 5 of 10Set LDAP_SEARCH_USER_CRITERIA parameter = username Set “LDAP_TIMEOUT” parameter= 5. Default is 10 minutes.Set PASSWORD_RESET_DISABLE = “Y” to disable the password reset option.Set PASSWORD_RESET_UNAVA ILABLE_MESSAGE to “Pas sword reset is not available with LDAP authentication. Please contact your Quality Center system administrator at ext.“Fill in with Ad m inistrator‟s phone extension .”Once the authentication type is set in QC Site Administration, the parameters are saved to the QC database. If there are login or LDAP verification issues, and the Authentication type needs to be changed, the database administrator should make the following database changes:In qcsiteadmin_db databse, find the PARAMS table.Look for the record where PARAM_NAME = …AUTHENTICATION‟. Change the PARAM_VALUE to …QualityCenter ‟.Look for the records where PARAM_NAME starts with …LDAP‟, and delete all of them except one …LDAP_SEARCH_USER_CRITERIA‟.The QC system Administrator should restart the Quality Center service and test for login.Quality Center LDAP GuidePage 6 of 10New User Import from ADUsers are authenticated against AD via LDAP as part of the QC login process, so all QC user logins must have an authenticated domain entry in the QC site users table. Use this only for users that don‟t exist in QC yet. When an import is done, it replaces existing user profile fields, which may be undesirable.1. Verify user does not exist in the Quality Center Site User list.2.Create Active Directory User Report:Logon to Quality Center server Select “Start > Command Prompt”XXXXX >QualityCenter.csv] to the command line. Exclude brackets when copying thecommand.The report produces a csv file with username, full name, and domain name.3. Use the Active Directory User Report to obtain the QC user domain names. The domain name formatis:CN=XXX,OU=XXX,OU=XXX,OU=XXX,DC=XXXXX,DC=XXX4. Login to Site Administration5. Set LDAP Import Settings. Settings can be adjusted to import Username, Fullname, Description, E-mail, and Phone. Username is the minimum requirement. (See page 3 – LDAP Import Settings).6. Select “Site Users ” tab.Quality Center LDAP GuidePage 7 of 107. Select “Import LDAP Users “ icon.8. The directory base is not valued.9. Reference the user‟s domain name(e.g. CN=XXX,OU=XXX,OU=XXX,OU=XXX,DC=XXX,DC=XXX10. Select appropriate domain name components. (Check the CN (username) box.)11. Select the Import button.12. QC will import fields based on import authentication field settings. When duplicates exist, it willprompt for actions to:Skip – record will not be importedUpdate – this will overwrite QC fields with the AD fields used for authentication Rename user – another record will be created in QC for the user - do not use. Append to existing username – appends suffix to existing username - do not use.13. Update QC user profile fields as required.14. Proceed to add user to the appropriate projects in Site Administration.15. Login to the project and add user to the appropriate group(s).Add a New User without Import1. Verify user does not exist in the Quality Center Site User list.2. Create Active Directory User Report:The report produces a csv file with username, full name, and domain name.Quality Center LDAP GuidePage 8 of 10Use the Active Directory User Report to obtain the QC user domain names. The domain name format is:CN=XXX,OU=XXX,OU=XXX,OU=XXX,DC=XXX,DC=XXX3. Log into Site Administration4. Select “Site Users” tab.5. Select “Add new user”.Quality Center LDAP GuidePage 9 of 106. Enter as much data as possible. Copy the Domain Authentication string from the Active DirectoryUser report into the Domain Authentication field. 7. Add user to appropriate projects in Site Administration and to the appropriate groups in eachproject. 8. When the user logs in, the username and password will be authenticated against ActiveDirectory.Update Existing User’s DomainCreate Active Directory User Report:Logon to Quality Center server Select “Start > Command Prompt”>QualityCenter.csv] to the command line. Exclude brackets when copying the command.The report produces a csv file with username, full name, and domain name.Use the Active Directory User Report to obtain the QC user domain names. The domain name format is:CN=XXX,OU=XXX,OU=XXX,OU=XXX,DC=XXX,DC=XXXQuality Center LDAP GuidePage 10 of 101. Log into Site Administration.2. Select “Site Users” tab.3. Select Site User.4. Copy the Domain Authentication string into the Domain Authentication field, and change stringcomponents as required. Save the user detail changes.5. When the user logs in, their username will be authenticated against AD based on the domainauthentication entry in User Details.。
APQP学习教程(详细版)
*
12
APQP阶段1：计划和确定项目 PLAN AND DEFINE PROGRAM
第一阶段 输出 • 设计目标 • 可靠性和质量目标 • 初始材料清单 • 初始过程流程图 • 特殊产品和过程特性的初始清单 • 产品保证计划 • 管理者支持
*
13
DR-0 meeting
• 在我们正式项目批准之前我们要召开一次 DR-0会议进行评审我们目前项目所有项目的 的计划是否充分和完全.并给出每个计划的达 成日期和责任人.
AND DEVELOPMENT
*
VERIFICATION
21
APQP阶段2：产品设计开发和验证
PRODUCT DESIGN AND DEVELOPMENT VERIFICATION
目的
• 使设计接近定型 • 对设计进行验证，以保证达到全部要求 • 对生产和质量保证需求进行评估
*
22
APQP阶段2：产品设计开发和验证
*
6
*
7
每个APQP是唯一的
• 产品和程序不同 • 顾客需求和期望的时间和顺序不同 • 产品的复杂程度 • 新的 • 更改的
8
APQP的五个阶段
• 阶段1 计划和确定项目 • 阶段2 产品设计和开发验证 • 阶段3 过程设计和开发验证 • 阶段4 产品和过程确认 • 阶段5 反馈、评定和纠正措施
*
32
APQP阶段2：产品设计开发和验证
PRODUCT DESIGN AND DEVELOPMENT VERIFICATION
产品和过程的特殊特性清单 关键术语和基本概念
• 通过设计特性的发展重新评审和更新第一阶段的 初始清单 信息来源 DFMEA SFMEA 如适用 以往的历史
QC全面介绍
Quality Companion 3全面介绍为何选择Quality Companion?我们经常会遇到这样的问题：•提供路线图么•是否能够提供我们需要的类似于流程图的工具•有什么工具能够减轻管理人员的负担•有什么工具能够从项目开始到结束一直支持和指导六西格玛团队Quality Companion使用范围六西格玛DMAIC精益六西格玛LEAN六西格玛设计DFSS创新TRIZ流程改善、项目管理更多…….Quality Companion 项目管理团队管理数据共享任务管理器路线图项目路线图模板工具可客户化的标准模板工具分析捕获工具教练表单教练项目阶段教练路线图项目管理路线图QualityCompanion 3.0 Coach工具项目管理使用DMAIC（或者客户化的）步骤实施用整个项目。
帮助在项目的关键阶段进行项目总结。
输入在一个工具内的时间数据可以自动地被其他工具调用。
如果数据改变，可以用Processmap data功能自动更新数据。
增强项目管理器双击项目名字，快速进入：•具体项目数据•项目汇总数据•财务数据•能力报告（多行和单一值数据）可在项目管理器中显现自定义的数据类别数据库改名为流程图数据项目管理项目摘要Process map data编辑流程图中需要共享的变量、流程数据、或者精确数据的时候，Quality Companion会自动地更新贯穿于整个项目的流程数据。
Quality Companion的数据共享功能不需要再次地录入数据，只需要拖放或者双击这样的操作就可以共享数据。
Project Today中的财务数据项目管理器新增一个节点，用于财务数据的导入。
该节点还支持用户创建自定义的财务字段。
路线图项目管理路线图QualityCompanion 3.0 Coach工具项目路线图组织项目的不同阶段，并为每个任务需要的工具创建启动面板。
为任何类型的改进项目自定义路线图。
项目任务在项目任务中，我们清晰看见当前项目进展情况、最近的项目，所有变量，团队成员。
品质人员教育
~品质部门基础知识~
职务简述
IPQC：
简单的说：工作内容包括：首件检查、各类变更文件的跟踪。4M1E的巡查。 发现异常的提出、跟踪与验证。 详细的说 ：过程检验（IPQC，in process quality contrl） 目的是为了防止出现大批不合格品，避免不合格品流入下道工序去继续进行加工。 因此，过程检验不仅要检验产品，还要检定影响产品质量的主要工序要素（如 4MIE）。实际上，在正常生产成熟产品的过程中，任何质量问题都可以归结为 4M1E中的一个或多个要素出现变异导致，因此，过程检验可起到两种作用： 1.根据检测结果对产品做出判定，即产品质量是否符合规格和标准的要求； 2.根据检测结果对工序做出判定，即过程各个要素是否处于正常的稳定状态； 从而决定工序是否应该继续进行生产。为了达到这一目的，过程检验中常常与使 用控制图相结合 。 过程检验通常有三种形式： （1）首件检验： 首件检验也称为“首检制”，长期实践经验证明，首检制是一项尽早发现问题、 防止产品成批报废的有效措施。通过首件检验，可以发现诸如工夹具严重磨损或 安装定位错误、测量仪器精度变差、看错图纸、投料或配方错误等系统性原因存 在，从而采取纠正或改进措施，以防止批次性不合格品发生。 通常在下列情况下应该进行首件检验： ① 一批产品开始投产时； ② 设备重新调整或工艺有重大变化时； ③ 轮班或操作工人变化时； ④ 部品种类或材料发生变化时 。 首件检验一般采用“三检制”的办法，即操作工人实行自检，班组长或质量员进 行复检，检验员进行专检。首件检验后是否合格，最后应得到专职检验人员的认 可，检验员对检验合格的首件产品，应打上规定的标记，并保持到本班或一批产 品加工完了为止。 对大批大量生产的产品而言，“首件”并不限于一件，而是要检验一定数量的样 品。特别是以工装为主导影响因素（如冲压）的工序，首件检验更为重要，模具 的定位精度必须反复校正。为了使工装定位准确，一般采用定位精度公差预控法， 即反复调整工装，使定位尺寸控制在1/2 公差范围的预控线内。这种预控符合正 态分布的原理，美国开展无缺陷运动也是采用了这种方法。在步步高工作期间， 他们对IPQC的首件检查非常重视，毕竟国内从事AV家电生产的企业，工艺自动 化程度低，主要依赖员工的操作控制。因此，新品生产和转拉时的首件检查，能 够避免物料、工艺等方面的许多质量问题，做到预防与控制结合。