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中文版品质控制标准 Quality Control Standard(Ver7) (1)


For Supplier

Quality Control Standard

Established on Apr. 2007 Jan 2009 Rev.7

Toko, Inc. Coil Material Design Section Purchasing Section

Index 索引<

br />1. Standard
标准 1.1 Purpose 目的 1.2 Scope 范围 1.3 Glossary 术语

2.

Basic idea related to quality assurances. 涉及到品质确认的基本观点
2.1 Here is our basic policy toward quality assurance. 这是我们的基本政策倾向于品质保证 2.2 Purchased parts quality assurance by us. 采购的部品需向我们保证品质 2.3 Quality assurance to the supplied parts by supplier. 供应商保证提供产品的质量

3. Requirements concerned to quality assurances
对品质保证有必须的关注 3.1 Supplied parts quality assurance 产品供应质量保证 3.2 Production control 产品管控 3.3 Control of important characteristics 重要特性管控 重要特性管控 3.4 Delivery control 纳期管控 3.5 Change control 更改管控 3.6 Identification and traceability 鉴定和可追溯性 3.7 Corrective action 纠正措施 3.8 Nomination of quality assurance representative 任命品质保证负责人

4. 5.

Audit by TOKO
TOKO 审核

Additional
附件
1

1.

Standard 标准 1.1 Purpose 目的 This Quality Standard is to determine quality control standard towards assurance of specifications requested by TOKO against key 这是 TOKO 公司为了品质控制而要求供应商提供的品质保证说明书来确保 TOKO 购买的关键产品能用于 TOKO parts (hereinafter referred to as supplied products) used in TOKO’s manufacturing line purchased by TOKO Co., Ltd (hereinafter 的生产线。 referred to as us or we or our) from supplier. For us, it is considered as purchased parts, but for supplier it will be called as supplied products. 对于我们来说认为是购买产品,但是对于供应商来说是叫提供产品 1.2 Scope 范围 This Qualiry Standard is to supplement “General Quality Agreement” and applicable to the parts supplied to us determined as key 这个品质标准是用于补充一般品质协议和应用于一些重要产品对于我公司的制造 parts that our company necessary for manufacturing. 1.3 Glossary 术语 The terms used in this Quality Standard defines as follow. 这个术语应用于如下品质标准定义 (1) Required specification by us 我们需要的说明书 ①Documents issued by us to the suppliers such as drawings, specifications, standards, every document related to these 我们发行文件给供应商如:图档、规格、说明、标准等,任何文件都涉及于此。 documents. ②Drawings and specifications prepared by the supplier and approved by us. 图档和说明书由供应商提供,我们审核。 ③Others such as document agreed by both parties. 其他文件由双方协商。 (2) Important characteristics 重要特征 The characteristics among those characteristics deemed to when excessive unevenness occurred, it will have impact to the products 这些特征包含如下:当太多争执发生,由可能影响到产品特征、功能、安全、应用的规章制度,安装、外观的质 characteristics, functions, safety, compliance issue to rules and regulations, quality to the fitting, appearance and next process, and, 量及下道工序和认为有必要贯彻于一些特殊的控制方法要详细列入指导书或者这些特征将会影响到设计工序和 deemed to have necessity of implementing special control measure as specified in our specifications, or the characteristics that will 产品的结构。 effect the design process and structural of purchased parts at the supplier. (3) General parts,key parts, and specified parts 一般部件,关键部件和特殊部件 2

① general parts: Parts that does control based on ISO9001 in general electronic equipment etc. 一般部件:部件控制应该基于 ISO9001 中一般电子设备等。 ② key parts: TS16949 object parts, in-vehicle electrical equipment parts, and customer specification parts. 关键部件:以 TS16949 为对象审核部件,车辆电子设备和客户特别区分的部件 ③ Specified parts: Parts that CFT(Cross Functional Team) specifies of key parts. 特殊部件:部件要过功能团队因此而列入的关键部件

2.

Basic idea related to quality assurances.

涉及到品质确认的基本观点
2.1 Here is our basic policy toward quality assurance. 这里是我们的基本政策倾向于质量保证 Achieve built-in quality with our utmost, fulfill our goal of complete customer satisfaction by continual improvement. Fulfill our commitments to customers, while complying with the law and regulations as well as performance standards of the market and organizations concerned. 尽我们的最大努力去获取内定的品质目标,通过不断的进步来达到令客户满意的目的,向我们的客户履行义务, 遵守法治法规并履行市场标准和关注客户群体。 (1) Practice “Quality First” principle to each manufacturing location. 落实“质量第一”的原则到每一个生产场所 Practice “Quality Focus” principle to all the processes. 落实“关注品质”的原则到所有的制程 For this principle, develop and practice effectively our continuation and development origin and management method towards the 为了这个原则,有效的推广和实践并延续和发展管理方法朝着“质量” “纳期” “成本”这些观念。 ideas of “Quality” “Delivery” “Cost”. (2)Enforcement quality assurance. 执行品质保证 Stand in a customer point of views, develop and enforce quality assurance through the 4 functions of “Improvement of customer 站在客户的角度, 发展和推动品质保证通过 4 种功能 “提高客户满意度” “成就必要的实质问题” “可靠性管理” satisfactions” “Achievement of required matter” “Reliability management” and “Quality information management”. “质量信息管理” (3)Implementation of quality system. 执行品质系统 We are targeting zero-defect to our products. 我们的目标是 0 缺陷 To achieve this, there are needs to improve quality of works involved from product development to manufacturing, sales and 为了获取这个目标,需要提高品质工作中涉及到的生产制造、销售、服务和介绍连续的品质改善通过用测量、 services, and introduce continuing improvement through constructing and practicing quality system with measurement, analysis and 分析、改善措施来构建和实践品质系统。 improvement actions. 2.2 Purchased parts quality assurance by us. 让我们确保购买产品的质量 We are going to give quality assurance to our customer for our product. 3

我们将会给产品品质保证给我们的客户 As for supplied parts, the precondition is to purchase from the supplier that can give zero-defect, and take the basic thought so called 就产品供应来说,前提是从供应商处购买产品,他们能有零缺陷的基本想法也叫作相互信任、自重自爱和系统化 mutual trust and independence respect and systemize the quality assurances as follows. 品质保证 如下所示: Basic Business Contract 基本的贸易合同 General Quality Agreement 一般品质协议 Quality Control Standard for Supplier 给供应商提供品质控制标准 TOKO Group Green Procurement Guideline 东光集团绿色购买方针
Memorandum Regarding Environmental Conservation

关于环境保证的备忘录 (1) We need to clarify the requirements of the supplied parts. 我们需要申明一些必要的提供。 (2) Towards these requirements, we need to carry out confirmation through out evaluation and approval method that the supplier is 为了这些必要的提供,我们必须去执行和验证通过评估和审核的方法,就是供应商能够有优质的品质保证 always having adequate quality assurance, base on necessity, requests for improvement. 基于这些必须的,改善的要求。 2.3 Quality assurance to the supplied parts by supplier. 供应商提供的品质保证 The supplier is to supply zero-defect product that is to say, means product that meet all our requirements. 供应商提供零缺陷产品也就是意味着产品符合我们所有的需求,因为这样,我们希望供应商 By this, we hope that the supplier to establish the quality assurance system as the following items and maintain it. 去建立如下的品质系统并维持它。 (1) Clarify the company policy about quality assurance and independent assurance plan. 申明公司政策关于品质保证和独立地品质计划。 a) Quality assurance for new purchased part: Establish system in order to have quality that satisfy all our required specifications 品质保证为新购品:建立系统是为了有一个好的质量保证来满足我们的规格需求并通过每一个产品发展、 through each stage of product development, design and production preliminary stages. 和产品的初期研发阶段。 b) Production management: Establish mechanism that ready to supply product from stable production process at mass production 产品管理确定机制是为了有一个稳定的生产流程在量产阶段。 stage. (2) Establish and manage the organization which can be carrying out the quality assurance system. 建立和管理组织去执行这些品质保证。 (3) Manage the quality information required by us and submit it in timely manner. 管理这些品质信息并能够及时地向我们提供。 (4) Correspond to the trouble occurred to the supplied product, clarify the corrective action and plan thorough prevention of the 积极对应不良发生,提供改善措施和预防不良再发生。 4

reoccurrence. (5) The supplier shall maintain a certified quality management system according to ISO 9001:2000 as a minimum requirement and the 供应商应该维持这种品质管理系统去通过 ISO 9001 2000 作为最低要求,并为了能达 ISO/TS 16949 2002 supplier ultimately develops its quality management towards to ISO/TS 16949:2002. 从根本上去推动品质管理 3. Requirements concerned to quality assurances 对品质保证有必需的关注 Supplier is to establish quality system concerned to “Supplied Part Quality Assurance” at each stage of product design and pre-launch 供应商建立品质系统关注“提供产品的品质保证”在产品设计、试产的每一个阶段,能够满足我们的所有需求并 stage in order to provide quality that satisfy all our requirements, and manage it base on this system. 利用这个系统去管理品质。除此之外,建立品质系统是为了那些被我们所制订的部品和材料如:“产品供应品质保 In addition, establish quality system for the appointed parts and materials by us and including the followings as “Supplied Part Quality 证”基于这个系统去管理它。 Assurance” and manage it base on this system.

5

購入品の品質管理ステップ 東 光
購入先選定
Selection TOKO Steps of Quality Control on Purchased Product

購入先

Supplier

試作品の評価

Evaluation of Sample

試作サンプル
Sample

仕様の決定

Determination of Spec.

購入品の認定
Qualify the Purchased Product

認定用サンプル 試験データ 法規(環境負荷物質)への適合
Regulatory Conformity Quality Sample Data

登録?認定
Register/Qualify

購入品の仕様締結
Conclude the Specification Purchase Spec. or Drawing

購入品の仕様締結
Conclude the Specification

購入仕様書又は図面
Qualify Notice

認定通知書 購入品品質保証協定書

Order

Supplier Quality Assurance Agreement




Initial Lot

量産初回ロット生産 量
Initial Lot Received Mass Product 重要部材又は 一般部材 Important material or general material



初回ロットの受入
In-coming Inspection Inspection Report

受入検査

検査結果通知書 品質異常連絡書
Record

記 録 保管

Quality Failure Occurrence Information on Parts

是正処置
Corrective Action

Keeping

In-coming 受入検査 Inspection (重要部材受入検査又は部材確認検査) ( Important material receipt inspection inspection) or material confirmation inspection ) Re-assessment of Supplier

購入品の特別採用 購入品の不具合 購入品の変更?廃止

Special Adoption Nonconformed Purchased Product Disposal/Change of Purchasing Product Self Audit

購入先再評価
On-site Audit

自主監査 品質保証体制 自主監査評価報告書
Quality Assurance System Assessment Report Quality Assurance System Self Audit Report

工場監査 品質保証体制評価報告書

Record

記 録 保管

是正処置
Corrective Action

Keeping

資材部門による購入先再評価 購入先評価通知書
Record

Re-assessment of Supplier

Evaluation Notice for Supplier

記 録 保管

是正処置
Corrective Action

Keeping

6

3.1 Supplied parts quality assurance 产品供应品质保证 (1) Applicable supplied parts 可应用的产品供应 Applicable for newly-designed supplied part and new order supplied part. 应用于新设计的产品供应和新秩序的产品供应 (2) Overall activities The supplier shall nominate a quality assurance representative. 供应商应该有代表性的通告质量保证 The quality assurance representative for the supplier, to take the responsibility and authority 供应商有代表性的质量保证应该采取负责任和有权信的行动去符合产品供应 pertaining to the supplied part quality assurance and as general rules he/she must be a 品质保证,和按照一般法规有一个代表人物他必须是总经理或者是相等职位 person with rank of general manager or equivalent. (Quality assurance representative) (品质保证代表) Quality assurance Prepare the systematic policy for quality assurance process for each stage from design, system chart manufacturing, until delivery and each responsible sections. 品质保证系统框架 准备关于品质保证流程的系统政策,从开发设计到、制造、交货到每一个责 图 任部门。 Process review The quality assurance representative is to make the necessary measures such as evaluating 流程评定 这个品质保证代表要实行一些必要的措施:评估成绩的情况在每一个变化的 achievement conditions at the time of shift of each stage, clarify the problems and justify the 过程中,澄清一些问题和调节每一个阶段的动作。 each stages movement. Non-conformity part Take record concretely about the non-conformity of quality which is caused by design or record 详细记录在设计、试产过程中因设计、流程方法而引起的不一致产品,保存 不一致产品的记 process method when go through design/ pre-launch and production preparation activity, and 录 和利用他防止他再发生。 keep it and utilize it for reoccurrence prevention. In addition, it is desirable that take co-operation with our part technical section for proceeding the implementation. 除此之外,最好是与我们的部分技术部门合作去推动执行。 (3) Design/ pre-launch stage 设计和试产阶段 Quality assurance activities at design/ pre-launch stage. 品质保证行动在设计和试产阶段 Descriptions 描述 Content 内容 Prior examination of ?Examine the method of prediction of actualization the non-conformity 检查预报实现的方法和潜在不一致的因素以 预先检查不一致 and potential non-conformity factor and it’s exclusion 及排除它, method. ?Review of previous non-conformity records. 回复以前不一致的记录 Evaluation based on ?Confirm that it satisfy the required specifications. 评估建立在试验基 确定它符合必需的规格。 础上 experiment (4) Production preparation stage 预备生产阶段 Quality assurance activities at production preparation stage 7 Concrete example 具体案例 Check previous trouble record. 核查以前的问题记录 全面行动 Notification of quality assurance representative 有代表性的通告质 量保证

Measurement 测量 可靠性测试 Reliability test

品质保证行动在预备生产阶段 Subject 项目 Setting up target 设定目标 Method of quality 品质保证方法 assurance Prior examination of the non-conformity 不一致前的预先检查 Concrete example 具体案例 Process NG 制程 NG 供应 NG Supply NG ?Method of quality assurance based on required Process Control Chart 流程管制图 condition and quality target. 品质保证方法基于必需的条件和品质目标 Check previous trouble record ?Prediction of non-conformity factor and it’s 检查以前的问题记录 预估不一致因素和纠正方法 corrective action method. 回顾以前的不一致记录 ?Review of previous non-conformity records. Measurement ?Supplied parts manufactured using prepared 用于预产流程的部品要满足必须的条件 测量法 可靠性测试 production process satisfy the required condition Reliability Test ? Standard documents needed in ensuring Standard Operation Procedure 标准操作程序 continuing quality even at mass production stage Process Control Chart 标准文件确保持续的品质在量产阶段 流程管制图 Inspection Standard 检验标准 Standard Operation Procedure ?Provide education and training to the worker Process Control Chart 提供教育或训练给员工 Process Capability Chart ?Implement production trial and process 贯彻教育考核和制程能力教育 确保符合 标准操作程序 制程管制图 capability study, and confirm that meet product 制程能力图 生产质量目标 quality target Content 内容 ?Set up quality target 设定品质目标

Evaluation test 评估测试 Preparation of standard documents 标准文件的预备

Education/Training and Process Capability 教育/训练 制程能力

(5) Approval materials and sample for us 让我们承认材质和样品 The supplier is to provide the following approval materials and sample to our procurement division and part engineering division. 供应商要提供如下的材质和样品给我们的调度和工程部去确认 ■ Must submit 必须提交 □ Submission based on necessity Document name 文件名 Supplied Part Specification or Drawing 提供产品规格和图纸 Submission period 提交日期 During approval 在审核的时候 Applicable product (Content) 可应用的产品(内容) All parts supplied with purchase specification 所有的产品供应与购买规格要发行出 来 were issued. Specify the important control items into 8 满足基本需要 Format 格式 Possible to use supplier format 可以使用供应 商的表格 Applicable 可应用 性 ■

指定的重要控制项目要写入交货规格 delivery specification or drawing 和图纸 Measurement data 测量资料 Molding die 冲模核准 approval During approval 在审核的时候 All parts supplied with purchase specification were issued 所有的产品供应与购买规格要发行出 来 All parts supplied with purchase specification were issued 所有的产品供应与购买规 格要发行出来 Appointed test items and contents by us 我们指定测试项目和内容 Appointed items or items decided by supplier 指定项目或项目由供应商确定 Possible to use supplier format 可以用供应商 的表格 Possible to use supplier format 可以使用供应 商的表格 Possible to use supplier format 可以使用供应 商的表格 ■

Reliability test data 可靠性测试资料



Cpk data 制程能力资料

Every lot 每批



Approval sample 样品审核 Limit Sample 限度样品 Approval Notification (Issued by us) The Approval Notification is issued by us after pass the sample evaluation test 通告审核(我们发行) 我们发行通告审核是 在样品评估测试之后 Process control chart 制程管制图

Molding die approval 冲模审核 During approval 在审核的时候 During approval 在审核的时候

Final sample 最终样品 When requested by us 我们提出要求 All parts supplied with purchase specification were issued 所有的购买品的产品供应规格都要发 行



□ Our format 我们的格式 ■

During approval 在审核的时候

All parts supplied with purchase specification were issued 所有的购买品的产品供应 规格都要发行 All parts supplied with purchase specification were issued 所有的购买品的产品供应 规格都要发行 Periodical reliability test frequency, test items 定期的可靠性测试周期 测试项目

Process FMEA FEMA 流程 Periodical reliability test 定期的可靠性测试

During approval 在审核的时候 During approval 在审核的时候

Final inspection standard 对产品进行最终检查

During approval 在审核的时候

Inspection items, frequency, judgment standard 检查项目、频率、判定标准 TOKO 东光

Quality assurance system chart 品质保证系统框架图 Environmental Hazardous 危险环境物质报告 Substances documents

During approval 在审核的时候

All parts supplied with purchase specification ■ were issued 所有的购买品的产品供应规格都要发 行 In addition, even without instruction from our procurement or part engineering division, should the supplier deemed that it is 除此之外,即使没有从我们那里获得或是从工程处得到指令,供应商也应该相信他们有必须的详细资料 necessity to have particular documents to be prepared and utilized. Submit the particular approval documents for supplier’s each 去准备和利用。递交特别审核的文件给供应商去关注每个工厂的特殊产品。 factory concerned that particular part. 9

During approval 在 审核的时候

Possible to use supplier format 可以使用商的 表格 Format appointed by us 我们指定格式 Possible to use supplier format 可以使用供应 商的表格 Possible to use supplier format 可以使用供应 商的表格 Possible to use supplier format 可以使用供应 商的表格 Format appointed by us 我们指定表格











3.2 Production control 生产控制 (1) Initial production flow control 最初生产流程控制 Implement the following activities during mass production start up for new part supply and part applicable for change control 在量产启动后为新品供应和产品能够适应变化请贯彻如下行动。 procedure. Method and duration Define the control items, method and dissolution condition 方法和期限 控制方法详细说明,方法和分解条件。 As a general rules, the period to be set as 3 months 按照一般规定,至少制订 3 个月的期限。 Preparation of standard Prepare the process control chart, inspection specification and standard operation procedure 预备标准文件 准备工程管制图,检查基准书和作业指导书。 documents Education and training ① Implement production trial, worker education and training 教育和培训及支撑能 贯彻产品试验,工人教育和训导 and process capability ② Define control items and control method based on process capability check result 力核查 详细管制项目和基于制程能力核查结果的管制方法。 check Inspection Implement initial lot inspection and implement initial lot delivery procedure that supplied to us 检查 贯彻最初的货物检查和交货程序使之能够向我们供应产品 Implementation 执行 Audit implementation Representative for production is to confirm and evaluate that there is no problem from the audit 审核执行 生产代表去确认和评估在最初的生产流程管制情形和发行中没有问题, 按我们的 implemented on initial production flow control situations and its release. Submit the audit 要求递交审核文件 document upon our request. (3) Mass production control 量产控制 Implement the following activities during mass production stage in order to maintain process stability. 为维持制程稳定,在量产过程中请贯彻如下的行动 Preparation of standard ① Maintaining the standard documents and making observance to the production related 预备标准文件 维持这个标准文件和有使之遵守相关生产的职员。 documents personnels ② Control base on process control chart 控制基于流程管制图 Education and training ① Compliance with the standard operation procedure and implement the self check to all the operators. 教育和培训 所有与员工能够遵照作业指导书和实行自检 ②Provide the education and training let all the new operators comply with the standard operation 提供教育和培训给所有的新员工让他们遵守作业指导书和有足够的能力去操作 procedure and have adequate skill for the operation. Grasp process control ①Use process control flow chart for key process 控制制程管制水平 将制程管制流程图用在关键流程上 level ② Grasp and control the secured process capability (Cpk) index 控制安全的制程能力指数 Process change Change of process (Worker, equipment, method, parts, inspection apparatus, etc) is to be carried out 制程改变管理 按照我们(查阅附件 6)的说明标准而去改变制程(员工,设备,方法,部件,检查设备) management according to our standard specified by us (Refer to the Attachment -6) Treatment when ① Treat the problems according to our standard (Refer to the Attachment 7) 当不一致发生时的处 按照我们的标准处理这些问题(查阅附件 7) 理方式 ② Take measures thoroughly so the opperator get to understand the communication route when they non-conformity occurred 采取尽可能的办法让操作员明白通过怎样的沟通渠道去反应当他们发现不一致的产品 和制程等时。 10

Identification and 鉴定和可追溯 traceability Record control 记录控制 Monitoring and 监控和测量设施控制 measuring devices control Inspection/Test 检查/测试 (4) Process improvement 制程改善

discovered non-conformity product ,process and etc. The supplier shall provide a trace code for every lot (e.g. test lot, material lot) and implement FIFO. 供应商应提供一个可追索的编号给每一个批次和落实 FIFO.(举例来说: 测试批次和材料批 次) Keep record for more than three (3) years for general parts inspection, test result records, non-conformity 为一般部品的检查,测试结果记录,不一致记录等保持 3 年以上的记录。 records, etc Establish and implement control system for measuring equipment, molding die, jigs, etc (Maintenance 建立和贯彻控制系统为测量设备,模具,夹具等(维持和修理工具,储存和技术维护计 and repair facility, storage and maintenance plan), (Maintenance to be included with inspection and 划) (维持包括检查和校准) calibration) Implement inspections/tests according to inspection standard, etc. 按照检查标准去贯彻检查/测试等。

In order to improve and control the supplied parts quality, grasp that particular process control level using process capability index 为了去提高和控制供应产品的品质,用制程能力指数紧抓制程,控制水准和促进制程改善。 and promote process improvement. Process capability index (Cp, Cpk) / process capability measurement value of the important characteristic item 制程能力指数/制程能力 测量尺度用于重要和有代表性的项目上 a) Control limit level decision 坚决控制限度水准 Plot the X-R control chart of five (5) samples/day for twenty (20) days and calculate the control limit level. 绘制 X-R 管制图为(5)样品/日在 20 天内和计算控制范围水平。 In this case, confirm that all the plot points are within the control limit level. 既然这样,确定所有的绘图都在管理范围水准内 Keep using the same control limit level calculated unless there are change of process occurred (changes of equipment, production 一直用同样的管理范围水平来计算除非制程发生了改变。 (设备改变,生产场所改变等) location, etc) b) Normal distribution study 正态分布研究 Study normal distribution by using frequency table 用频率表来研究正态分布 c) Calculation of Cp, Cpk value 计算 CP,CPK 价值 <Two sides specification> 上下限的说明书 Specification upper limit- specification lower limit Cp= 6 x standard deviation = Su-SL 6σ

规格的上限值—规格的下限值 Cp= 6 x 标准偏差 =

Su-SL 6σ

11

<Specification upper limit> 规格上限值 Specification upper limit – mean Cpk= Cpk= <Specification lower limit> 规格下限值 Mean ― Specification lower limit Cpk= Cpk= 3 x standard deviation 中间值—规格下限值 3 x 标准偏差 = = X-SL 3σ X-SL 3σ 3 x standard deviation 规格上限值—中间值 3 x 标准偏差 = = Su-X 3σ Su-X 3σ

In case of two sides specification, make comparison between specification upper limit and lower limit, take lower figure as Cpk. 假设这 2 种规格,上限值和下限值相比较,取较低的作为 CPK In case the specification itself is kind of one sided specification ,i.e.)Specification lower and upper limit then, Cp=Cpk 假设这种规格本身就是一种有边的规格,也就是说低的规格和高的规格,那么 CP=CPK d) Judgment 判定 Cp or Cpk must be more than 1.67 CP 和 CPK 必须要大于 1.67 However, the part specified with a specified material in the drawing etc. secures Cpk≧1.67. 无论如何,这个产品详细列在图纸上的规格至少 CPK≧1.67 Contact our company when you do not fill the acceptability criterion. Execute the decrease activity of the difference continuously 当你不能履行这些协议的时候,请联系我们公司。减少这些连续的差异直到 CPK≧1.67,得到我们的认可。 until Cpk≧1.67 is achieved, and our approval is obtained. 3.3 Control of important characteristics 管制重要特征 The supplier, in order to ensure the quality of important characteristics, performs the control and management of the important 供应商为确保重要特征的质量。执行控制和管理重要特征。 characteristics that tucked in the following; There are two (2) criteria of product deems as important characteristics, characteristics justified as important by us and special 这里有 2 个产品的重要的特征标准,特征的重要是由我们判定和由我们的客户所要求。 characteristics requested by our customer. (1) Identification of the important characteristics 鉴定重要特征 For the selected important characteristics, define it clearly as important characteristics in the specification or process control chart 为了挑选这些重要的特征,请清晰的定义这些重要特征在说明书和管制流程图书或成列出来用同样的标记。 and display it with identical symbol. 12

(2) Ensure and maintain the process capability 确保和维持制程能力 As for control of important characteristics, ensure at least the following process control level 为了控制重要特征,确保最低的制程控制水平, Process capability index 制程能力指数 Cpk≧1.67 ※ For molding die with multiple cavities, as general rules, Cpk need to be calculated for each cavity, but due to molding die 成型冲模有很多穴号,按一般规则,CPK 需要去适合每一个腔号,但是由于成型冲模结构,管理这些差量 structure, manage the point (molding die) where the dispersion is the biggest cavity as a representative figure. 在最大的腔号里作为典型的数据。 (3) Handling of reworked product 返工操作 Get approval from supplier’s quality assurance representative, should rework is unavoidable to the important characteristics and 从供应商处品质保证代表处获得批准,有影响的产品和重要特征的产品必须要返工。同时,100%执行返工 influence part is needed. At the same time, implement 100% inspection to reworked important characteristics and indicate it at the 在重要特征上并标识出来,这样能够识别并最好保持返工记录。 part itself so it can be identified and keep rework record as well. (4) Record retention 记录保持力 Record retention for important characteristics related inspection, record of test result and non-conformity record is three (3) years. 记录保持力是为了拿些重要特征相关的检查和测试记录结果及不一致记录等必要保持 3 年以上,然而,指定的 However, a specified parts is keeping over 15 years. 产品要保持记录 15 年以上。 (5) Operator’s education and training 员工教育和培训 Engage only operator who had finished the education and training course based on internal rules for all the work process of 只雇佣那些已经完成对所有工作流程中重要特征要点培训课程的操作员。 important characteristics. (6) Implementation of self audit 执行自检 The audit enforcement representative, as general rule, to carry out audit more than one (1) time in a year to the implementation 有代表性的强制审核,按一般的规定,控制关键部品的执行情况,在一年之内至少要执行 1 次以上的自检。 situation of key parts control with. (7) Reporting to us 向我们报告 In case of being requested to submit report of audit result by our part engineering division manager, submit it quickly. 假如我们的生产工程部门要求提供审核结果报告,要迅速提交。 3.4 Delivery control 纳期控制 Supplier, in order to progress smooth delivery, plan and run the implementation requirement tucked in the following “delivery control”, 供应商为了顺畅的交货,计划和执行需要吃透理解如下的“纳期管理” ,并有目标要 100%的遵守纳期。 13

and aims at the observance of the delivery date 100%. (1) Applicable range 使用范围 Applicable for new supply parts, modified parts, and mass production supplied part. 应用于新品,改良品和量产品。 However, these applicable ranges can be excluded, for reworked parts, and malfunction measured parts as per modified part, in 但是,应用范围应把返工品,有故障后修理品排除在外。 case if the non-conformity contents are minor, with the consent of our part engineering division head. (3) Control during delivery of new supply part and modified part 管制在纳期间的新品和修理品 Indication of initial lot ① Indicate identically at the box, for the initial lot indication. 标识首批产品 在所有的箱子上统一标识为首批产品。 As general rules, identification period is from 1st supply lot until 5th supply lot, but 按一般规定,鉴定期间为第一批到第五批 ,但是考虑到提供产品的储存量和 considering supplied part storage and work in progress quantity, follow instruction from our 工作进行,可以按我们生产工程部门的指示来确定。 part engineering division, should there are. (4) Control during delivery for mass production part 管制纳期内的量产品 Quality check Control of quality records 品质检查 管制品质记录 ① Keep the inspection report by each lot (submit it upon our request.) 保留每一批产品的检查报告(应我们的需求递交) The inspection report must contain Cpk value of important characteristics and the statistic 检查必须包含 CPK 值等重要特征最好是一些统计性的资料。 data as well. ② Cpk value must be more than 1.67. CPK 值必须大于 1.67 ③ Execute the 100% inspection when the Cpk value doesn't satisfy 1.67. 当 CPK 小于 1.67 的时候要 100%检查。 ④ Frequency of inspection record submission to us can be changed after getting the approval 在我们审核后来决定递交检查记录的频率是否修改 ⑤ from quality assurance division head at our each factory concerned. It depends upon 从品质保证来区分来看我们每一个工厂所关注的,它取决于稳定的品质状况 stability of the quality status, improvement of Cpk and so on for the supplied part. CPK 的改善等。 ⑥ Supplier must deliver the one that the quality assurance of one year or more after the 在产品地交付给我们公司后,供应商必须递交一份或者更多的品质保证。 product is delivered to our company is done. However, the product with a short period that can be used applies separately to provided 然而,产品在一段短时间内要隔离并提供规章。 regulations.

3.5 Change control 管制改变 Supplier shall establish and implement “Change control” procedure for supplied products which is fulfilled all the items mentioned 供应商应该建立和执行“管制改变”程序去履行所有的项目条款,包括但不限于如下的条款 1 和 2,是为了 include but not limited to the following clause 1 and 2 in order to guarantee the quality with permanent stable after making and change 永久的保证产品的质量为那些在生产和改变的产品。 for supplied parts. 14

(1) Part material change control 产品材料改变管制 Applicable range 应用范围 The following parts and materials change applicable for this control 如下的产品和材料改变应用于如下的管控: ① Change based on our “Details of purchase part change classification” 改变是基于我们的“购买产品分级改变的详细资料” ② Others; change justified by supplier as important Activity related to the ① Prepare the documents as per stipulated in “Details of purchase part change classification” changed parts 按照购买产品分级改变的详细资料和改变通告的规定来准备资料和预先提 涉及到部品改变的行 交 动 and “Change Notification” and submit them beforehand. However, propose alternative goods about the supply end before 24 months. 但是,建议选择性的供应品在 24 个月以前要结束 ② Follow above 3.4 (2) for production start and it’s delivery 按照如上 3.4(2)给初始生产和交货 (2) Confirmation of change content 确认改变内容 We are entitled to extraordinary audit supplier’s premises when we conclude the nesessity of the on-site audit to confirm the change 当我们判断有必要在生产点去确认改变的内容和结果的前提下,我们有权利去进行特殊的审核。 content and the result. (3) Approval of change and supply end parts 改变审核和提供最终产品 Supplier shall supplied continuous current parts until approval of change and supply end parts. 供应商应该连续不断的提供产品直到改变被批准和提供最终产品。 3.6 Identification and traceability 标识和可追溯性 The supplier shall establish and implement the lot control procedure include but not limit to the items mentioned the clause 1 to 3 in 供应商应建立和执行产品批次管理程序包括但是不限定于项目谈及到的条款 1 和 3 是为了确保这些产品记录和 order to ensure the production record and FIFO delivery. FIFO 的交付。 (1) Applicable parts and materials 可适用的产品和材料 Implement lot control to each parts and materials supplied to us. 执行产品批次管控在每一个产品和材料供应。 (2) Implementation of lot number 执行批号 a) Setting up lot number as identification 设定批号来作为证明 The supplier is to set lot number in order to be able to trace and search for the parts and materials record. 供应商去设定批次号是为了追溯和搜索产品和材料记录。 b) Lot number indication 批号标识 The supplier, as rules, need to indicate lot number at the box according to supply lot unit in order to ensure the traceability. 供应商按照规定,需要去标识批号在箱子上为了确保产品的可追溯性。 c) Record of lot control 15

批号管控记录 The supplier is to prepare and keep record of “Lot control record” so in order to have faster traceability back with our order number 供应商应该准备和保持“批号管控记录“是为了在我们有需求是更快的追溯和搜索处该产品 when parts and materials tracing and searching. (3) Other 其他 Control the formation of lot with considering the following contents 管控批次的表格应考虑到如下的内容 ? By the characteristics of part materials, form lot base on key process and manage it. ? 产品材料的特性,批号形式是基于关键流程并管理它。 ? Scale down lot size to the size controllable by supplier ? 供应商可以按批量大小来按比例减小来进行管理

3.7 Corrective action 纠正措施 The supplier, in case non-conformance were found at the product supplied to us, is to grasp the situation accurately, and in order to 供应商一旦发现有不一致的产品供应给我们,要紧抓现场改善是为了采取迅速和有效的行动(包括预防再发生) , take immediate appropriate action (including re-occurrence prevention), establish and carry out implementation requirement as tucked 如建立和执行命令和行动,请吃透理解如下的改善措施。 in the followings “Corrective action”. (1) Non-conforming product measure 不一致产品的测量 Information flow 数据流程 Clearly define the system flow such as information flow to related department, non-conforming 清晰的定义系统流程如相关部门的信息流程, 不一致的测量程序详细定义反馈给 我们的各家供应商的质量保证代表(包括从我方处的信息) 除此之外,品质代 , 表要判定不一致产品的重要程度和执行品质改善措施。 measured procedure as defined by information route to us by person who found the non-conforming (including information from us) to quality assurance representative at the supplier. In addition, justification of important level of non-conforming product and its corrective action have to be carried out by representative of quality assurance department at the supplier. In order to continuously support our production maintaining, get co-operation with our 为了持续不断的提供给我们稳定的产品, 与我们的调度部门合作并试着让我们对 此产品放心,不管怎样,供应商还是我们的库存产品质量的测量和内容,与我们 的工程部门合作通过调度部门并尝试保护产品并递交给我们。 procurement division and try to secure the part and supply it to us. However, about the content of supply part quality as measure of stock level at supplier and us, get co-operation from engineering department via procurement division and try to secure the part and supply to us. Clearly define the root cause of non-conformity and carry out appropriate corrective action. 清晰的定义不一致的根本原因和执行适当的改善措施

Continuous support to our production maintaining 连续提供稳定的产品

Corrective action 执行改善措施 implementation (2) Implementation of re-occurrence prevention 预防不良再发生 Individual re-occurrence Prevention 预防单个的再发生

Investigate the non-conformance root cause 4M (man, machine, method and material) and 调查不一致的根本原因(通过 4M 人、机、物、法) ,紧抓发生的原因和执行永 久改善措施和预防措施,在同一时间采取简单的测量给同样的产品 grasp the occurrence and cause of issue and implement permanent corrective and preventive 16

Systemize re-occurrence Prevention 预防系统性的再发生

Implementation of audit 执行审核

Procedure for initial product delivery after the corrective action taken for the non-conformity 试产缴纳后 (3) Procedure taken for us Procedure when non-conformance occurred 当不一致发生时的程序

action. At the same time, take similar measures for similar product/part. In order not to generate non-conformity due to the same root cause, implement the corrective 为了不让同样的根本原因再次不一致,对工作组织执行改善和永久措施(包括程 序、技术标准、控制标准和组织等) and permanent action toward work structure (procedure, technical standard, control standard, organization, etc) Our part engineering department, based on necessity, to implement the audit about 我们的工程部门基于必须的去执行关于不一致改善措施和足够去预防再发生和 non-conforming corrective action and its adequacy of such as the prevention of recurrence and 遵守维持测量的项目 the observance of the maintenance measures item. Follow the above 3.4 (2) for control of new supplies, change product supply. 按照如上的 3.4(2)去控制新产品、改变的产品。

Supplier, when non-conformance occurred regardless in-house or at customer side, is to 当不一致发生时,不管是在内部还是在客户处,供应商都要迅速报告情况、内 immediately report the situation, content and the corrective action to procurement division 容和改善措施给调度部门并等待指示,当不一致发生的时候,第一次报告要在 and waits for the instructions. 24 小时之内。
The supplier reports on the first report within 24 hours when the abnormal quality was accepted.

Submission of root cause and corrective action report 递交根本原因和改善措 施报告

Submit the corrective action report and chart-7 and including request items as per stipulated 递交改善措施报告和 chart-7 和包括在 chart-7 中规定要求的项目在最终期限之内 in the chart-7 to our procurement division on/ before deadline given by us. 递交给我们,当原因发生的时候供应商要在 5 天之内递交报告给我们,如果递
The supplier submits it within five days when the cause of generation of

交报告延期,同样也要递交延期报告。
abnormal parts is in suppliers. When submitting is delayed, it reports so.

3.8 Nomination of quality assurance representative 任命品质保证代表 The supplier shall nominate the quality assurance representative in order to ensure the quality assurance system and supplied 供应商要任命品质保证代表去确保品质保证系统和产品供应 product. (1) Qualification and nomination of quality assurance representative. 赋予资格和任命品质保证代表 The supplier shall nominate the quality assurance representative who has the following qualification. 供应商任命的品质保证代表有如下的资格: Quality assurance The person who has the responsibility and authorization for the quality assurance. representative 这个认有职责和权限为品质保证 品质保证代表 Deputy quality assurance The person at supplier’s each facilitiy who take action whenever the quality problem occurs. representative (2) Nominate of quality assurance liaison officer 任命质量保证联络员 Establish the quality assurance liaison officer as a communication window with us. 确定品质保证联络员作为一个与我们信息沟通的窗口 17

(3) Procedures needed to us 对应我们的程序 a) Submit the list of the quality assurance representative, deputy representative at supplier’s each facility and quality assurance liaison 递交品质保证代表的名单,以附件的形式“任命品质保证代表通告”来告知没个工厂的品质保证代表和品质 officer to us using “Notification of quality assurance representative nomination/change” (Attachment-1) 联络员。 b) Submit it to our procurement division 递交给我们的调度部门。 4. Audit by TOKO 东光审核 We, along with this standard, in order to confirm the structure of supplier’s quality assurance system, shall implement audit with planning 我们随同这个标准,是为了确认供应商的品质保证系统的构架,贯彻计划或基于需要。 or based on necessity. (1) Audit types 审核类型 Audit is classified in the following base on audit contents. 基于以下审核内容进行分类审核 New audit In case of approving supplier for important parts and materials. 新审核 假设对供应商的重要产品和材料满意 Periodical audit Supplier of important parts and materials are to conduct periodical self audit (every 2years) and (Self audit) report the result to us. 定期查账(自我审核) 供应商对于重要部品和材料要进行定期查账(每 2 年)和报告结果给我们 Extraordinary audit In case justified as necessity by us to conduct audit beside periodical audit. (Visit audit) (Non-conformance occurred, change, customer request, etc) 特殊审核(监查审核) 证明进行在审核方进行定期审核是有必要 不一致发生,改变,和客户需求等。 (2) Conduct of audit 进行审核 Self audit implementation 自我进行审核 Quality assurance representative at supplier is to implement self audit. 品质保证代表在供应商处要执行自我审核, Items of audit is based on the prescribed audit check list by us. 项目审核是基于我们指定进行的审核来检查 The quality assurance representative of supplier shall prepare the self audit report fill-in the 供应商处的品质保证代表要准备自我审核的报告, 履行不一致发生时候的改善措 施。 corrective action for the non-conformance item if any. Our procurement division submits the audit plan to the supplier which is made based on the 我们的调度部门会基于供应商的改善措施递交审核计划给供应商 supplier’s corrective action by us. Our auditor is to conduct audit base on prescribed audit check list. 我们的核算人员将会基于规定的核算表进行审核,对于不一致发生的特殊审核, For extraordinary audit for non-conformance occurrences, follow our non-conformance 按照我们不一致的通告出来。 notification. There is possibility that we will issue stop delivery instruction, should we found major and 有可能我们会发布停止交货的指令, 当我们发现大多数的或者严重的不良在审核 serious defect during the audit. In this case, implement corrective action until instructed due 期间,执行改善直到约定时间和报告给我们。 date and report it to us.

Self audit report preparation 准备自我审核报告 Audit plan 审计计划 Audit implementation 执行审核

Audit result 审核结果

18

Audit flow 审核流程 Supplier 供应商 Self Audit 自我审核 Self Audit Report 自我审核报告
Implement Self Audit 执行自我审核 Self Audit Report 自我审核报告

TOKO 东光
Audit Request 要求审核 Confirm Self Audit Report 确认自我审核报告

Audit Planning 审核计划

Audit plan 审 核计划

Audit Implementation 执行审核
Corrective Report 改善报告 Action

Audit Checklist 审核清单

Non-conformance Notification 不一致通告

Audit Result 审核结果

Audit Report 审核报告

5.

Additional 另外 Document to be submitted to our company 文件要递交给我们公司 Appendix -1 “Quality Assurance Representative?Contact person of quality assurance 附录 1:质量保证代表,质量保证联络员 election and change report” 挑选和改变报告 Appendix -2 “Process control chart” 附录 2:流程管制图 Appendix -3 “Process FMEA” 附录 3:FMEA 流程 Appendix -4 “Process FMEA”< Manual for filling in> 附录 4:FMEA 流程(手工填写) Appendix -5 “Parts and Material change report” 附录 5:产品和材料变更报告 Appendix -6 “Details of part material change division” 附录 6:产品材料和变更的详细资料 Appendix -7 “Quality failure notice for Parts” 附录 7:产品的品质不良布告

19

Revision Record 修订记录 Date of issue: Sep 1, 2008 Rev.Data (M/Y) 修订日期 Reason and position for change 变化的地方和原因 Established 已确定的 ?Clause 3.1(5) 条款 3.1(5) The object goods (content) in process FMEA in the recognition 在 FMEA 流程中的目标物标出的材料和递交的样品表格当我们提 material and the submission of the sample table were changed to 出需要求都要变更 " When requested by us ". ?Clause 3.2(3) c) 条款 3.2(3)c The content of the standard of the calculation value of the Cp CP 和 cpk 指数的计算值的标准的内容要变成较低限度。 value and the Cpk value is changed to "lower limit". ?Clause 3.7(3) 条款 3.7(3) Root cause and corrective action report: It changes to the style of 根本原因和改善措施报告要改变成客户的样式 supplier. ?Revision Record is added. 增加修订记录 ?Clause 3.1(5) 条款 3.1(5) The content of the format in the Supplied Part Specification or 供应产品的规格书的内容形式和递交的图纸表格和批准的材料和 Drawing of Submitting table of Approval materials and sample is 样品变更 changed. ?Clause 3.1(5) 条款 3.1(5) The part applicable (content) in process FMEA of Submitting table 发行日期 2008 9. 1 Approved by 核准 Checked by 审核 Draft By 制作

REV 修订


04.2007 05.2007

Sotome Koga takahashi Arai

Noguch



Sotome Arai takahash i

Noguchi



07.2007

Sotome Arai takahash i

Noguchi

产品可应用于 FMEA 流程中和递交材料和样品批准的变 更 of Approval materials and sample are changed.
?Clause 3.2(2) 条款 3.2(2) The content of the Monitoring and measuring devices control is 监测和测量设备控制内容的变更 changed. ?Clause 3.7(3) 条款 3.7(3) The content of submitting of root cause and corrective action report 递交的根本原因和改善措施报告内容的变更 was changed.

20



12.2007

?Clause 1.2 条款 1.2 The scope of an important parts was clarified. 重要产品范围要阐明 ?Clause 2.2 条款 2.2 Quality Assurance Agreement for purchased parts changed to a 购买产品的质量保证协议改编成质量保证协议 Quality Assurance Agreement. ?Clause 3 条款 3 "The following matter contained???" is deleted. 接下来的问题包括…被删除 " In addition, establish quality system for???" added to the end of 此外,为…建立品质系统,增加到最后的句子上。 sentence. ?Clause 1.2 条款 1.2 The scope of a key parts is changed. 关键产品范围的变更 ?Clause 1.3(3) 条款 1.3(3) Addition. Definition clarification of general parts, key parts, and 增加定义来说明一般产品,关键产品和指定产品 specified parts. ?Clause 3.7(3) Procedure taken to us 条款 3.7(3)程序适应于我们 ① The following are added to " Procedure when

Nakao

Arai

Noguchi



19.05.2008

Nakao

Sotome

Arai



1.09.2008

Nakao

Nakamic Arai hi

如下增加的不一致发生时的程序。 non-conformance occurred ".
供应商要递交报在 5 天之内当在供应商处产生不一致时。 The supplier submits it within five days when the cause of generation of abnormal parts is in suppliers. ② The following are added to " Submission of root cause and

如下要增加递交根本原因和改善措施报告 corrective action report ".
供应商递交在报告在 5 天之内,当反常产品出现在供应商处时。 ? The supplier submits it within five days when the cause of generation of abnormal parts is in suppliers. 当递交报告拖延时,也要报告拖延原因。 ?When submitting is delayed, it reports so.

REV

Rev.Data (M/Y) 修订日期

Reason and position for change 原因和位置变更

Approved by

Checked by

Draft by

21



30.1.2009

?Clause 3.2(3)d) The cpk value since clause 3.2(3)d) is changed Koga to 1.67 or more. 条款 3.2(3)d cpk 值自条款 3.2(3)d 变更要在 1.67 或以上。 The following contents of a letters are added. 如下的内容被增加, However, the part specified with a specified material in the 可是,指定的产品有指定材料在图纸中等,可靠的 cpk 要大于或等 drawing etc. secures Cpk≧1.67. Contact our company when you 于 1.67,当你不能购履行这些可接受性的标准时候要通知我们。 do not fill the acceptability criterion. 采取措施减少差异发生直到 Cpk≧1.67 才能接和获得我们的承认, Execute the decrease activity of the difference continuously until Cpk≧1.67 is achieved, and our approval is obtained. ? Clause 3.3(4) The following are added. 条款 3.3.(4)如下的内容被增加 However, a specified parts is keeping of 15 years or more. 指定的产品要保持 15 或以上的记录 ?Clause 3.4 The following are added. 条款 3.4 如下的内容被增加 …, and aims at the observance of the delivery date 100%. … 目标是遵守规定 100%按时交货。 3)③ English translation omission. Addition. 英文翻译冗长, ⑤ A postscript is added as clause ⑤ as follows. 如下的附言⑤是增加条款 Supplier must deliver the one that the quality assurance of 供应商必须保证产品品质在产品交付给我们一年以后或者更长 one year or more after the product is delivered to our 时间, company is done. However, the product with a short period that can be used 不管怎样,产品必须有一个简短的时期能购适应于个别提供的 applies separately to provided regulations. 规则 ?3.5(1) A postscript is added to clause ① of “Activity related to the ?3.5(1)附言是增加的条款 changed parts” as follows. 涉及到产品变更的行为 However, propose alternative goods about the supply end before 不管怎样,建议这些 2 选 1 的货物要在 24 个月之前要提供 24 months. ?4(1) Extraordinary audit (revaluation) is changed to Extraordinary ?4(1)特别审核(再评价)改成特别审核(拜访审核) audit (Visit audit). ?4(3) Deleted. ?4(3)删除 ?Appendix -6 A postscript the following is added to the “Details of 附录-6A 附言增加了详细的产品材料改变要在 24 月之前要提供。 part material change division” Supply end (alternative proposal indispensability before 24 months)

Nakao

Inoue

22

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