INDICE. Production Part Approval Process 1- POLICY AND QUALITY VISION 2- QUALITY SYSTEM REQUIREMENTS 3- FIRST SAMPLES VALIDATION

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1 GAMESA QUALITY REQUIREMENTS FOR SUPPLIERS

2 INDICE POLICY AND QUALITY VISION 2- QUALITY SYSTEM REQUIREMENTS 3- FIRST SAMPLES VALIDATION 4- QUALITY PERFORMANCE Prductin Part Apprval Prcess 5 5- EXTERNAL ACESS TO DOCUMENTATION 2

3 1.- POLICY AND QUALITY VISION The visin f Gamesa Crpración Tecnlógica is being EXCELLENT in all ur Technlgy and Operatins activities Excellence means perfectin in all that we d: planning, executin, cmmunicatins perfrmance and parts. This is demnstrated thrugh cnsistent delivery f quality prducts t ur Custmers. Our cmmitment with excellence means t deliver ZERO DEFECTS prducts t ur custmers. The achievement f this gal clearly implies the same level f cmmitment frm ur suppliers Suppliers must have a cmmitment f ttal quality, by the implementatin f a rbust Quality Management System, accrding t prevent Gamesa Crpración Tecnlógica f defective parts thrugh preventin, mnitring and cntinuus imprvement Gamesa Crpración Tecnlógica wants its suppliers t be certificated accrding t ISO 9001:2008. Certificatin accrding ISO is required fr certain suppliers accrding its CNAE/NACE cde. OHSAS are strngly recmmended. We expect ur suppliers exceeding ur expectatins and the requirements f the GCT Supplier Quality Manual.(GSQM). This means: Right the first time: Means that business partners shall plan, prepare, and be trained t supply quality prducts and services. Right Every Time: Means t cntrl the prcess r systems fr assurance f cnsistent quality and t pr-actively address all issues. Cntinuus Imprvement: Means that business partners are encuraged t implement the cntinuus imprvement in the prduct quality, prcesses and supply chain management. 3

4 2.- QUALITY SYSTEM REQUIREMENTS FASE 1 ISO 9001:2008 Gamesa s gal fr all suppliers f materials and services affecting prductin material is t demnstrate cmpliance t ISO Unless therwise specified, cnfrmity must be demnstrated by third party certificatin. Alternatively QS-9000, VDA certificatin, ISO/TS r EAQF can be accepted. ISO 14001:2004 In rder t ensure the envirnmental plicy applicatin thrughut its supply chain, Gamesa expects frm its suppliers an active engagement in envirnmental cncerns. This includes the establishment, and adherence t, an envirnmental management as per ISO 14001, r ther equivalent standard. Suppliers active in sectrs as listed in PBE-1-00-R14 CNAE Cdes, are bligated t have implemented this certificate r alternatively present a plan t achieve ISO certificatin within 36 mnths, in rder t be qualified. OHSAS 18001: Gamesa strngly advises suppliers t certify accrding t OHSAS 18001, a system fr managing health and safety prmtes safe wrk envirnments by prviding a framewrk that allws the rganizatin t cnsistently identify and cntrl risks t health and safety, reduce ptential accidents, supprt enfrcement and imprve verall perfrmance. Qualificatin audit: During supplier selectin and assessment, Gamesa will perfrm varius audits t cnfirm supplier capability, beynd the certificatin level. Suppliers that initially d nt scre acceptably will be allwed t develp actin plans and timelines t crrect any deficiencies and then request a re-audit t verify implementatin f these actins SUPPLIER QUALIFIED: T btain the status f QUALIFIED is mandatry prir t launch any PPAP Prcedure, being nt allwed t launch purchasing rders fr first samples t a nn qualified supplier. 4

5 3.- FIRST SAMPLES VALIDATION All initial samples submissins f prductin parts must be submitted in accrdance with GAMESA prcedure fr Initial Samples Validatin (PPAP: Prductin Part Apprval Prcess) plus any ther additinal requirement agreed. GAMESA reserves the right t cnduct Initial Samples Validatin and inspectin f sample parts nsite at the supplying lcatin. Discrepant items uncvered during a GAMESA review f initial sample submissins will be cnsidered a failed submissin and dcumented as a rejectin f the Initial Samples Validatin. NOTE: In situatins that invlve prduct/cmpnents designated as safety/critical, n deviatins r cncessins shall be permitted n features that affect the functinality/reliability f the prduct withut the apprpriate validatin by the GAMESA Engineering department and/r custmer apprvals. Reasns fr First Sample Validatin submissin: NC = NEW COMPONENT NS = NEW SUPPLIER MD = DRAWING MODIFICATION MM = MATERIAL CHANGE PC = PROCESS CHANGE CT = CHANGE OF TOOLS, REPAIRS, TOOLING TRANSFER RV = RE-HOMOLOGATION Prttypes are prduced with a prcess that may nt include all final tls r prcess steps but has t simulate the final prductin prcess as clsely as pssible. These are nt t be cnfused with Initial Samples, which have the purpse t validate the prductin prcess and therefre must t be prduced with final prductin tls and prcess. (See Chapter 3.1.4) 5

6 3.- FIRST SAMPLES VALIDATION (FASE 2) FEASIBILITY SIGN OFF: Manufacturing Feasibility is a cmmitment by a supplier that a prpsed design can be manufactured, assembled, packaged, and shipped at a level that cnfrms t all GAMESA requirements at specified vlumes. It includes the frmal cnfirmatin f the fulfillment f all the requirements and is a prerequisite fr any activity related t the First Samples Validatin. It must be cnfirmed during the hmlgatin prject with every change f specificatins, prviding that the change cncerns the critical Characteristics f prduct (KPC s). During this stage the supplier cnfirms knwing and accepting this dcument; the Gamesa Supplier Quality Manual. Certificate f avidance f frbidden chemical substances fr related prduct & prcess: There are sme substances that cannt be used legally in Gamesa s prducts aswell as substances f which its use is nt desired and/r limited by Gamesa. These substances are defined in the respective instructins issued by the Envirnmental Area and distributed t the supplier within the applicable dcumentatin. The supplier must present a signed declaratin f cmpliance with the nn use f these frbidden and/r limited substances. (PCA R04) 6

7 3.- FIRST SAMPLES VALIDATION (Key Prduct Characteristics) KPCs are thse characteristics which particularly affect the functin f the prduct, its safety and custmer satisfactin. -Critical Characteristics<CC>:Magnitude, cnditin, prduct feature r prcess parameter whse nn-achievement culd affect (directly r via the sensitivity f respnse f the assciated feature) cmpliance with gvernm ent standards, regulatins r prduct functining which falls in the area f safety. -Significant Characteristics <SC> : All prduct requirements r prcess parameters whse achievement is regarded as essential fr the functin f the cmpnent, and whse assciated failure wuld imply the lss f a basic functin. -Fit Characteristics <FC> : All prduct requirements r prcess parameters whse nnachievement culd impede the assembly f the cmpnent itself with its interfaces, giving rise t dissatisfactin n the part f the end custmer r a majr distrtin in prcesses and whse assciated failure wuld imply a lss f settings, prblems with interchangeability, munting and/r appearance. SPECIFIC MANAGEMENT REQUIRED IN RELATION TO CCs, SCs and FCs 7

8 3.- FIRST PARTS VALIDATION (Manufacturing Prcess Verificatin: Fases 4-5) Manufacturing Prcess Verificatin: T guarantee that the supplier designs and implements a rbust and capable manufacturing prcess. The Prcess Audit is a methd t evaluate the supplier in his quality and lgistic prcesses, in his Quality Management System and perfrmance f GAMESA parts. The result f a Prcess Audit shws GAMESA the effectiveness f the supplier's perfrmance. The applicatin f a Prcess Audit must be made fr an actual prcess and n site. The Prcess Audit is als a tl fr the imprvement f the supplier s prcesses in rder t eliminate and prevent that defective cmpnents are either prduced at the supplier r shipped t GAMESA. Reasns t perfrm a Prcess Audit: intrductin f a new supplier intrductin f new parts/prcesses r majr changes in the prcesses f knwn suppliers unsatisfactry perfrmance in quality, lgistic f knwn suppliers: quality cncerns, custmer cncerns, warranty cncerns, repetitive prblems in quality and lgistics, etc. frequent review f perfrmance (yearly fr instance): accrding the GAMESA criteria. Sectins f the Prcess Audit: The Prcess Audit is divided in 6 sectins. A = Quality planning B = Custmer Cncern Management C = Incming Material-Strage D = Manufacturing Prcess E = Final Inspectin and prduct parts identificatin F = Organizatin and systems. 8

9 3.- FIRST SAMPLES VALIDATION (Final Assessment: Fase 6) CLOSE OF THE HOMOLOGATION PROCESS. Frmal cnfirmatin f all the hmlgatin requirements. 2 Pssible cases: VALIDATED: 100% Fulfilment f all requirements It is pssible t g t serial prductin. NOT VALIDATED: REQUIREMENTS ARE NOT FULFILLED: and it is nt pssible t be fulfilled Serial prductin is REJECTED. Prttypes can nt be sent t the custmer. 9

10 4.- QUALITY PERFORMANCE (part 1) The Quality Rating f prductin suppliers will be dne fur times a year, based n: 1. Envirnmental friendliness and Health and Safety 2. Deviatins 3. Incident Reslutin Supplier Q-Rating = 100 (Sum f penalty ints) Data Envirnment Health & Safety Deviatins Incident Reslutin & Management Quarterly Perfrmance Q Q Q Q Envirnmental Friendliness [0-10] ISO Implementatin N Planned Planned Yes Weighted Average (ISO = 25%) 6 7,25 5,75 8,5 Penalty [Pints] OHSAS Implementatin N N Planned Yes Penalty [Pints] Minr Deviatins [#] Severe Deviatins [#] Penalty [Pints] Reactin Time [0-10] Reactin Quality [0-10] Penalty [Pints] Ttal Penalty [Pints] Perfrmance [0-100] Cmments: After meeting with David n Dec. 12th 2010, agreed upn urgent reslutin f QIP and intrductin f quality cntact in lgistics department. Overall gd imprvement last 6 mnths. Average 12 Mnths 70 Pints B A Gd Supplier, n incidents B Rm fr Imprvement, plan t be presented <50 C Supplier in urgent need f Imprvement, n new prjects can be nminated C-Rated supplier Suppliers will be mnitred clsely, cnsidering pssible disqualificatin. 10

11 4.- QUALITY PERFORMANCE (part 2) Supplier Perfrmance Example 11

12 5.- GENERAL ISSUES The supplier will define its wrk team fr the fllw up and reslutin f incidents in Serial Prductin. Regarding quality he will identify the functin Client Quality, that will be the respnsible fr the cntinuus imprvement in the Quality perfrmance and the reslutin f all the Quality incidents, being its cntact with the Supplier Quality Assurance Engineer. Suppliers are respnsible fr all csts and expenses created by any deviatin r defect f the material supplied and Gamesa will recver these csts frm the respnsible supplier. 8D prcedure is the Key fr prblems slutin The suppliers shall ffer cmplete unlimited supprt t reslve the rt cause and the eradicatin f the incident. 12

13 5.- GENERAL ISSUES Cmmunicatin channels with Gamesa during Serial Prductin are defined as fllws: ID Respnsible in Gamesa Issues 1 SQA Pint f cntact fr all quality incidences and its technical discussins Technical implementatin f changes in prcess r prduct, bth initiated by the Supplier as well as nes initiated by Gamesa Everything related t cmpliance f prduct specificatins Imprvement f the quality perfrmance f the supplier Any event that has implicatins in the Quality f the prduct supplied 2 Purchasing Cntract negtiatin Financial issues regarding f Cst f Nn-quality Everything regarding the supply cnditins, including the re-negtiatin because f prduct changes. 3 Technlgy Feedback during prduct develpment (prduct changes in Series life) s as t ensure the ability f manufacturing the prduct in accrdance with the specificatins Interventin in changes in special manufacturing prcesses 13

14 5.- EXTERNAL ACESS TO DOCUMENTATION All this infrmatin and related prcedures are available thrugh the fllwing external link. LOGIN: PASSWORD: GAMESA (CAPITAL LETTERS) (Click n General in the Dcument tray) 14

15 THANK YOU FOR YOUR ATTENTION

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