1、April 2014I 1April 2014Change ManagementTraining MaterialPPT File?id : pncsoftAgendaApril 2014I 21. Group 4M change material集团4M变更材料2. SZ site 4M change procedure / checklist深圳4M变更程序和检 查清单1.Change Flow chart变更流程图2.PCR from initiation to closure follow upPCR技术从开始到结束跟进3. Real case study真实的案例研究4. Speci
2、fic requirements from customer : VW, SVW , FAW-VW , FORD , Nissan etc.客户的特殊要求5. Quiz测试1. Group 4M change material1243April 2014I 3Case study - scenario 1案例研究 - 方案1Basics - 4M rules基础知识 - 4M规则Case study -scenario 2 (using 4M Matrix)案 例研究 - 方案2（使用4M矩阵） Annex附件1April 2014I 4Case study - scenario 1Case
3、studyFew weeks ago, my friend was putting a plaster (elastoplasts) on his arm几个星期前，我的朋友是在他的胳膊上打上了石膏带（弹性绷带）The day after, he starts to have allergy at the location where he put the elastoplasts第二天，在他打绷带的位置开始过敏I started to make a FTA with him, in order to understand from wherethe issue comes为了了解问题的来源，
4、我开始给他做一个问题分析树，Same producer, same reference of elastoplasts, no visual differencebad part, good part统一生产商，同样的参考标准，没有外观上的好坏 差异，The analysis and investigation, shows the following 分析和调查，由以下内容April 2014I 5Case studyafter investigations :经过调查后The Elasto Cie doing Elastoplasts, purchases the glue for the
5、 plaster, from another company, Tier1 Glue该弹性体的绷带，所需要的一级石膏胶，从另一家公司采购。This Tier1 Glue modified a component in the glue without informing Elasto (cost reduction)一级石 膏胶 降成本 没通知Then, no full validation tests on end-users was made by neither Elasto, nor Tier1 Glue最终没有进行测试 无法达到一级的标准Within a couple of week
6、 Elasto receives many complaints from their customers about allergies.收 到客户的投诉关于过敏At the end the Elasto has to recall the products. 召回When you make a change做做出改变出改变 导致风险导致风险 造成灾难造成灾难You take a RISKA risk can lead to a disasterApril 2014I 62April 2014I 7Basics - 4M rulesCome back to basics : What is
7、the good attitude to have ?有哪些良好的心态？What kind of risk do I take when I make a change ?当我做出改变时，我会有什么样的风险？Which communication is needed with the customer ?我们需要和客户做哪些沟通？What are the validation needed?我们需要做哪些验证？Is there any Customer procedure specific to changes that need to be applied ?是否有特定的客户程序需要被应用？
8、April 2014I 8Quality Standard : ISO/TS 16949:2009(E)7.1.4 Change ControlThe organization shall have a process to control and react to changes that impact product realization. 组织应当建立一个过程，对影响产品 实现的更改进行控制和反应。The effects of any change, including those changes caused by any supplier, shall be assessed, a
9、nd verification and validation activities shall be defined, to ensure compliance with customer requirements. 任何更改的影响，包括由任何新供应商所引起的更改，都应进行评估， 并且验证和确认活动应得以规定，以确保与顾客要求相一致。更改应在实施前April 2014I 9Changes shall be validated before implementation.予以确认。Quality Standard : ISO/TS 16949:2009(E)7.1.4 Change Contro
10、lFor proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated.具有专利权的设计，影响 外形、配合和功能（包括性能，和/或耐久性）的更改，应与顾客一同评 审，以适当地评价所有影响。When required by the customer, additional verification/iden
11、tification requirements, such as those required for new product introduction, shall be met.当顾客要求时，额外的验证/标识要求应被满足，例如新产品导 入的那些要求。April 2014I 10Quality Standard : ISO/TS 16949:2009(E)7.1.4 Change ControlNOTE 1 Any product realization change affecting customerrequirements requires notification to, and a
12、greement from the customer.注1：任何将影响顾客产品的更改，需要通知并征得顾客的同意。NOTE 2 The above requirement applies to product and manufacturing process changes.注2： 以上要求适用于产品和制造过程的更改。April 2014I 11To be compliant with ISO standards, Valeo developed an internal tool called 4 M Matrix. Valeo has developed a 4Mchange matrix
13、which is the standard for you and yoursuppliers. The 4M change matrix explains :How to Communicate the change如何沟通改变How to Validate the change如何验证变更Who validates the change谁验证了变化April 2014I 12Quality StandardWhy is it important to manage 4M changes?It can stop us from putting business at risk 它可以降低来
14、自业务的风险It can save us all a lot of time and money, if we can manage 4M changes right the first time 如果我们可以在 第一时间对4M变更进行管理，它可以节省我们很多时间 和金钱It is a requirement of our industry 它是行业要求It is a requirement of working in Valeo也是来自VALEO的要求April 2014I 134M matrix rulesAll changes at Valeo (Tier 1) at our Suppl
15、iers (Tier 2) and their Suppliers (Tier 3) need to be logged on a Single List of Changes. The change then needs to be assessed against the matrix for either Tier 1, 2 or 3 (different matrix dependant on Tier)Supplier doesnt use the MATRIX it self ; the Matrix is used by ValeoEach change will have a
16、level created for validation 1,2 or 3(different from Tier 1,2,3 above)Each change will have a level for customer communication A,B or CApril 2014I 144M matrix rules Change ManagementChanges are managed by the Technical Committee orModification Committee :Communicate changes per the 4M Change Matrix
17、to the Technical Committee or Modification Committee.Obtain confirmation of the change level; A1, C3 etc. Obtain approval to go ahead with the proposed changeApril 2014I 15What are 4M changes?April 2014I 16Material:材料Changes that are made to what is used in the components or raw materials or who sup
18、plies the components or raw materials. 所使用的部件或原材料，或供应部件或原材料的变化Method:作业方法Changes that are made in how we produce or test or control parts.我们如何生产或测试或控制部件的变化。Machine:机械Changes that are made in the machines, gauges or tools used to produce or test or control parts.用于生产或测试或控制部件的 机器、仪表或工具的变化。Man:人Changes
19、 to who produces the parts.对谁生产零件的变化。Design changes 设计变更Product identificationRaw material specificationHexavalent Chrome plating Chrome 3 platingSpecification changesTolerancesFunctional performance changesPackaging changesPackaging material (3 ply cardboard 2 ply) Shape of packagingLabelSuppliersA
20、dd a second sourceChange supplier or sub-supplierApril 2014I 17Examples of 4M changes: MaterialExamples of 4M changes: MethodChange process flowPackaging done at end of line packaging done in warehouseChange in technologyAutomatic process manual process Single part processing batch processingChange
21、in process parameterPress cycle time change to allow longer/shorter cooling timeChecking frequency change from 100% 5 at start of production, or vice versaChange transport methodApril 2014I 18Change internal material handlingInternal packaging change from plastic box cardboard boxChange in technolog
22、yScrewdriver with torque control no torque controlChange in control parameterTest cycle duration change from 2 seconds 1 secondAir pressure change from 6 bar 8 barProcess with poka yoke no poka yokeChange preventive maintenance frequencyApril 2014I 19Examples of 4M changes: MethodExamples of 4M chan
23、ges: MachineMovement of a machineChange layout of production work station, machine or line, but no change in equipmentProduction change from one press to a different pressChange of locationStop supplying from a production site in France, and start supplying from a production site in ChinaSupplier st
24、arts to deliver same part from another plantNew or renovated machine or mouldPurchase new press in order to increase capacity Renovation of an old mouldEquipment improvements Purchase new test equipmentApril 2014I 20Examples of 4M changes: ManSignificant change in workforceStrike in place, and intro
25、duce temporary replacement workers Add a new production shiftAn Operator certified I for this workstation starts at the workstation (may be experienced on other workstations, but not this workstation)April 2014I 213April 2014I 22Case study -scenario 2 (using 4M Matrix)Case study scenario 2 (applying
26、 4M matrix)The company doing Elastoplasts, (called Elasto) supplies the glue for the plaster from another company, Tier1 GlueThis Tier1 Glue modified a component in the glueTier1 Glue used the 4 M matrix before implementing this modification in productionThe use of the 4 M matrix shows the following
27、 April 2014I 23What has changed ?The process is described using 6M analysis3 - Material4 - Man2 - Method1- MachineEnvironnementMeasurementsExperienceApril 2014I 244M MatrixIF THE CUSTOMERS REQUIREMENTS ARE MORE SEVERE THAN OUR 4M MATRIX, THEN WE DO AS THE CUSTOMER REQUIRESOES DOES NOT MEAN THAT WE C
28、AN DO WHAT WE WANT.WE MUST RESPECT THE CUSTOMER PROCEDURES!Let us go trough the Matrix and review the 4 area of application :V A L E O M a t r i x f or 4 M c h a n g e m a n a g e m e n t V 3 . 1N o t e 1 : If a g r e e d c u s t o m e r s r e q u i r e m e n t s ( c h a n g e c o m m u n i c a t i
29、o n , v a l i d a t i o n etc.) a r e m o r e s e v e r e t h a n t h i s 4 M M a t r i x , t h e n t h o s e r e q u i r e m e n t s a g r e e d w i t h t h e c u s t o m e r m u s t b e r e s p e c t e d a n d n o t t h i s 4 M M a t r i xN o t e 2 : F o r O E S p a r t s o u t o f o r i g i n a l
30、 O E M p r o d u c t i o n o r s p e c i f i c O E S d e v e l o p m e n t s , t h e O E S c u s t o m e r p r o c e d u r e m u s t b e a p p l i e d( E x : O E M 4 M m a t r i x r u l e s r e s p e c t e d if t h e a f t e r m a r k e t c h a n g e m u s t b e m a n a g e d a s O E M ) . If n o c
31、u s t o m e r p r o c e d u r e / r u l e s t h e I A M 4 M m a t r i x r u l e s a r e a p p l i e d .Note 2 : Specific After market criteriaApril 2014I 254M Matrix : 2 criterias to monitorImpact onCommunicationImpact onValidationApril 2014I 26Communication levelValidation documentationValidation l
32、evelValidation planProcess auditCapabilty dataInternalI.S.External I.S.Decision of Development process and governance is made by the Technical Committee according to CIP V2.0 (Extract below)Notification to customer not requiredLevel 1YESYESYESYESYESChange has to be notified to the Customer latest 4
33、-6weeks before changeLevel 2YESYESYESYESUnderCustom er requestChange has to be released by customerLevel 3Under quality decisionUnder quality decisionUnder quality decisionUnder quality decisionUnderCustom er request4M change management in serial productionABC* Special notification process : Notific
34、ation 6 weeks before introduction. At least, 4 weeks before introduction, Customer may ask for if necessary further validations. This change type (with or without further validation) must be confirmed in Customer meeting or confcall and confirmation mail of Customer 4 weeks before introduction.tothe
35、4MMatrixSpecific After market criteria4M change at VALEO (Tier 1 supplier)4M Change Matrix4 M c h a n g e m a n a g e m e n t i n s e r i a l p r o d u c t i o nABCS p e c i f i c A f t e r m a r k e t c r i t e r i a4 M c h a n g e a t V A L E O ( T i e r 1 s u p p l i e r )1.M A C H I N E1 .1M o v
36、 e m e n t o f m a c h i n e / e q u i p m e n t1 .1 .1W i t h i n s a m e p l a n t1 .1 .1 .1N o c h a n g e of p r o c e s s f l o wB2C21 .1 .1 .2C h a n g e of p r o c e s s f l o w(ie: c h a n g e in p r o c e s s w i t h o u t c h a n g e for t h e e q u i p m e n t s )B2C2C o m m u n i c a t i
37、 o n l e v e lN o t i f i c a t i o n t o c u s t o m e r n o t r e q u i r e dC h a n g e h a s t o b e n o t i f i e d t o t h e C u s t o m e r l a t e s t 4 - 6 w e e k s b e f o r e c h a n g eC h a n g e h a s t o b e r e l e a s e d b y c u s t o m e rO E MO E S ( s a m e p r o d u c t i o n
38、t h a n O E M )IA M3 communication levelsA. 4M change must be released by the customerB. 4M change must be communicated to the customer 4 6 weeks before the change is implementedC. No customer notification requiredApril 2014I 274M Change MatrixValidation d o c u m e n t a t i o nValidation levelVali
39、dation planProcess auditCapabilty dataInternal I.S. External I.S.Decision of D e v e l o p m e n t p ro c e s sLevel 1Y E SYESYESY E SY E Sa n d g o v e r n a n c e is m a d e b y the Technical C o m m i t t e e according to C I P V2.0 (Extract below)Level 2Y E SYESYESY E SU n d e r Customer request
40、Level 3U n d e r quality decisionU n d e r quality decisionU n d e r quality decisionU n d e r quality decisionU n d e r Customer request3 levels of validation documentation:Level 1 Complete validationLevel 2 Complete internal validation Customer may request initial samplesLevel 3 Internal validatio
41、n defined by Quality ManagerApril 2014I 28April 2014I 294M Change Matrix 1- The MachineAftermarketOE / OESplanauditdataInternal I.S. External I.S.1.1.1.2 Change of process flow(ie: change in process without change for the equipments)B2C21.1.2Change of production location within Valeo GroupA11.1.2.1
42、Change of production location within Valeo Group WITH Made InChange for the finished goodA11.1.2.2 Change of production location within Valeo Group WITHOUT Made InChange for the finished goodB21.1.3Outsourcing of processA11.1.3.1 WITH impact on Made In of finished goodA11.1.3.2 WITHOUT any impact on
43、 Made In of finished goodC21.2Increase of capacity1.2.1Duplication of machine/equipmentB2C21.2.2New manufaturing machine / equipment = Influence on occurrence factor1.2.2.1 New machine / mould with design changes(ie: change of injection point)A11.2.2.1a Design change visible / noticeable for the end
44、-user or functionalitychangeA11.2.2.1b Design change NOT visible / noticeable for the end-user and NOfunctionality changeC21.2.2.2 New machine / mould, changing of an old machine / mouldB2C21.2.3New check / testing machine / equipment = Influence on non- detection factor1.2.3.1 Bringing check / test
45、ing more preciseB3C31.2.3.2 Bringing check / testing less preciseB2B21.3No use of production equipment (inactive production equipment) 6 monthsC3C31.4Change of manufacturing process / machine1.4.1W I T H O U T impact on capacity, leadtime or final product SpecsC3CIP V2.0 (Extract below)C o m m u n i
46、 c a t i o n leveland confirmation mail of Customer 4 weeks before introduction.Validation d o c u m e n t a t i o nValidation levelValidationProcessCapabiltyDecision of Development processNotification to c u s t o m e r not r equi r edLevel 1Y E SY E SY E SY E SY E Sand governance is made by theCha
47、nge h a s to b e notified to t he C u s t o m e r latest 4 -6 w e e k s bef or e c h a n g eLevel 2Y E SY E SY E SY E SU n d e r C u s t o m e r Technical Committee according torequestC h a n g e h a s to b e r el eased b y c u s t o m e rLevel 3U n d e r qualityU n d e r qualityU n d e r qualityU n
48、 d e r qualityU n d e r C u s t o m e r decisiondecisiondec is iondec is ionrequest4 M c h a n g e m a n a g e m e n t in serial pr oduct i onABC* Special notification process : Notification 6 weeks beforeSpecific After m a r k e t criteriaintroduction. At least, 4 weeks before introduction, Custome
49、r may ask4M change aOEMO E S ( s a m et VALEO (Tier 1 supplier)p r o d u c t i o n t h a nOEM)for if necessary further validations. This change type (with or withoutI A Mfurther validation) must be confirmed in Customer meeting or confcall1.M A C H I N E1.1Movement of machine / equipment1.1.1Within
50、same plantExtract of CIP for selecting development process and governance1.1.1.1 No change of process flowB2C21.4.2W I T H i m p a c t o n capacity, leadtime or final p ro d u c t S p e c sB3After analysis of this case, the machine has not been identified as a factor2-The MethodAfter analysis of thi
