中文版品质控制标准QualityControlStandard(Ver7)(1)
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For Supplier
Established on Apr. 2007
Jan 2009 Rev.7
Toko, Inc.
Coil Material Design Section Purchasing Section
Index
索引
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
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. Audit by TOKO
TOKO审核
5. Additional
附件
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
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
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.
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.
(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。
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。
流程评定measures such as evaluating
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 record
不一致产品的记录Take record concretely about the non-conformity of quality which is caused by design or
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
process method when go through design/ pre-launch and production preparation activity, and
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Concrete example
具体案例
Prior examination of the non-conformity
预先检查不一致・Examine the method of prediction of
actualization
检查预报实现的方法和潜在不一致的
因素以
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
Check previous trouble
record.
核查以前的问题记录
Evaluation based on
评估建立在试验基础上experiment ・Confirm that it satisfy the required
specifications.
确定它符合必需的规格。
Measurement
测量可靠性测试
Reliability test
(4) Production preparation stage
预备生产阶段
Quality assurance activities at production preparation stage
品质保证行动在预备生产阶段
Subject 项目Content内容Concrete example
具体案例
Setting up target 设定目标・Set up quality target
设定品质目标
Process NG
制程NG 供应NG
Supply NG
Method of quality 品质保证方法assurance ・Method of quality assurance
based on required condition and
quality target.
品质保证方法基于必需的条件和品
质目标
Process Control Chart
流程管制图
Prior examination of the non-conformity
不一致前的预先检查・Prediction of non-conformity factor
and it’s
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.
Check previous trouble
record
检查以前的问题记录
Evaluation test 评估测试・Supplied parts manufactured
using prepared
用于预产流程的部品要满足必须的
条件
production process satisfy the
required condition
Measurement
测量法可靠性测试
Reliability Test
Preparation of standard documents
标准文件的预备・Standard documents needed in
ensuring continuing quality even at
mass production stage
标准文件确保持续的品质在量产阶
段
Standard Operation
Procedure
标准操作程序
Process Control Chart
流程管制图
Inspection Standard
检验标准
Education/Training and Process Capability
教育/训练
制程能力・Provide education and training to
the worker
提供教育或训练给员工
・Implement production trial and
process
贯彻教育考核和制程能力教育
确保符合
capability study, and confirm that
meet product
生产质量目标
quality target
Standard Operation
Procedure
Process Control Chart
Process Capability Chart
标准操作程序
制程管制图
制程能力图
(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
满足基本需要
Document name
文件名
Submission
period提交日
期
Applicable product (Content)
可应用的产品(内容)
Format
格式
Applica
ble
可应用
性
Supplied Part Specification or Drawing
提供产品规格和图纸During
approval
在审核的时候
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
Possible to
use supplier
format
可以使用供
应商的表格
■
items into
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
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
Possible to
use supplier
format
可以用供应
商的表格
■
Reliability test data 可靠性测试资料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
Appointed test items and
contents by us
我们指定测试项目和内容
Possible to
use supplier
format
可以使用供
应商的表格
■
Cpk data
制程能力资料Every lot
每批
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
可以使用供
应商的表格
■
Approval sample 样品审核Molding die
approval
冲模审核
Final sample
最终样品
■
Limit Sample 限度样品During
approval
在审核的时候
When requested by us
我们提出要求
□
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
Our format
我们的格式
■
Process control chart
制程管制图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
Possible to
use supplier
format
可以使用商
的表格
■
Process FMEA FEMA流程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
Format
appointed
by us
我们指定格
■
式
Periodical reliability test
定期的可靠性测试During
approval
在审核的时候
Periodical reliability test
frequency, test items
定期的可靠性测试周期测试项目
Possible to
use supplier
format
可以使用供
应商的表格
□
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
Possible to
use supplier
format
可以使用供
应商的表格
■
Quality assurance system chart
品质保证系统框架图During
approval
在审核的时候
TOKO
东光
Possible to
use supplier
format
可以使用供
应商的表格
■
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
Format
appointed by
us
我们指定表
格
■
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.
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
方法和期限Define the control items, method and dissolution condition 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
预备标准文件documents Prepare the process control chart, inspection specification and standard operation procedure
准备工程管制图,检查基准书和作业指导书。
Education and training
教育和培训及支撑能
and process ① Implement production trial, worker education and training
贯彻产品试验,工人教育和训导
② Define control items and control method based on process capability check result
capability
力核查
check
详细管制项目和基于制程能力核查结果的管制方法。
Inspection
检查Implementation 执行Implement initial lot inspection and implement initial lot delivery procedure that supplied to us
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
Audit implementation 审核执行Representative for production is to confirm and evaluate that there is no problem from the audit
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
预备标准文件documents ①Maintaining the standard documents and making observance to the
production related
维持这个标准文件和有使之遵守相关生产的职员。
personnels
②Control base on process control chart
控制基于流程管制图
Education and training
教育和培训①Compliance with the standard operation procedure and implement the
self check to all the operators.
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
控制制程管制水平level ①Use process control flow chart for key process
将制程管制流程图用在关键流程上
②Grasp and control the secured process capability (Cpk) index
控制安全的制程能力指数
Process change 制程改变管理management Change of process (Worker, equipment, method, parts, inspection apparatus, etc) is to be carried out
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)
according to our standard specified by us (Refer to the Attachment -6)
Treatment when 当不一致发生时的处理方式
non-conformity ①Treat the problems according to our standard (Refer to the Attachment 7)
按照我们的标准处理这些问题(查阅附件7)
②Take measures thoroughly so the opperator get to understand the
occurred communication route when they
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。
discovered non-conformity product ,process and etc.
Identification and 鉴定和可追溯traceability 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)
Record control 记录控制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
Monitoring and 监控和测量设施控制
measuring devices control 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)
Inspection/Test 检查/测试Implement inspections/tests according to inspection standard, etc.按照检查标准去贯彻检查/测试等。
(4)Process improvement
制程改善
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 Su-SL
Cp= 6 x standard deviation = 6σ
规格的上限值—规格的下限值 Su-SL
Cp= 6 x 标准偏差= 6σ
<Specification upper limit>
规格上限值
Specification upper limit – mean Su-X
Cpk= 3 x standard deviation = 3σ
规格上限值—中间值 Su-X
Cpk= 3 x标准偏差 = 3σ
<Specification lower limit>
规格下限值
Mean ― Specification lower limit X-SL
Cpk= 3 x standard deviation = 3σ
中间值—规格下限值 X-SL
Cpk= 3 x 标准偏差 = 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.
(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。
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
标识首批产品① Indicate identically at the box, for the initial lot indication.
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
⑤from 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.
(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:
①Change 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 changed parts 涉及到部品改变的行动①Prepare the documents as per stipulated in “Details of purchase
part change classification”
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交
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
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。