(精品)QC080000IntroductionEnglishVersion.ppt

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1、-ISO 9001:2000 QMS -ISO14001:2004 EMS-OHSAS18001-QC080000 HSPM-ISO 13485 MDD,CMDCAS-ISO22000(HACCP)-AS9000-TL9000-ISO/IEC 27000ISMS-ISO/IEC 20000ITSMS-SA8000 System Certification Overview ANAB:ISO 13485，ISO 9000,QS-9000,AS9000,AS9100,TL-9000&TE Supplement IATF:ISO/TS-16949 RvA:ISO 9000,QS9000,ISO270

2、00,ISO20000 UKAS:ISO 9000,ISO 13485，ISO14000 SCC:ISO 13485，ISO 9000,QS-9000,TE Supplement,ISO 14000,TL-9000 IECQ:QC080000 HSPM SAI:SA8000Accredited StatusIECQ-HSPM QC080000The DUTCH ministry of environment X-Ray Fluorescence (X光螢光分析儀)(NITON 700 XRF)What is RoHS?RoHSDirective 2002/95/EC of the Europe

3、an Parliament and of the Councilof 27 January 2003 on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipmentRoHS:Restriction of Hazardous SubstancesTo reduce waste harmfulness,bans the following six substances,above the noted concentration levels,in electri

4、cal and electronic equipmentSubstanceLead PbMercury HgCadmium CdHexavalent Chromium Cr(VI)Polybrominated biphenyls PBBPolybrominated diphenyl ethers-PBDEMax Concentration0.1%0.1%0.01%0.1%0.1%0.1%Key Date:Compliance by July 1,2006by Weight in Homogenous MaterialWhat is WEEE?什么是WEEE？Directive 2002/96/

5、EC of the European Parliament and of the Council of 27 January 2003 on Waste Electrical and Electronic EquipmentTrend of Bans/RestrictionsRequirementsRoHS,WEEE EUAsia PacificUnited StatesIndustry Green Process ProcurementMajor OEMs WorldwideUS&Global HSF LegislationMaineCalifornia10 US States with P

6、ending LegislationAnd growing every day!ChinaJapanAustraliaKoreaRecognized IssuesRequirements are still being developedUSA(State by State)SB-50,SB-20,Prop-65,AB2202JapanJGPSSIKoreaKorea RoHS,WEEEChinaChinas legal requirements on the restriction of TS/HS in EIP and WEEEOthers?Courtesy of PRTMSONY：SS-

7、00259 DELL：6T198、7X435 TI：QA-11284Microsoft：H00594、H00642MOTOROLA：12G02897W18 Pioneer Group：GGP-001-AHP：A-5951-1745-1 FUTURE：QES9401.RoHS DirectiveWEEE DirectiveWaste Package DirectiveCd-prohibition Ordinance Azo-prohibition Ordinance Battery DirectiveCalifornia USA SB 50China RoHS RegulationRegulat

8、ion and DirectiveIndustry Green Process ProcurementGreen Product RequirementsHow do you meet them all?RoHS?SB50?Green Process?China Article 11?Todays MessTesting capacity and expertise insufficientTesting product samples is proving problematicSelf-declarations proving questionable“Be a Manager,Go to

9、 Jail”emergingDevelopemnt of Restricted SubstanceRoHS Directive issuedSpecial Substance banned Requirement from special customer DeclarationRoHS compliance Factory Audit Green Regulation RoHS+Customer requirementsIECQ HSPM All involved RS 3rd part audit Technical Speciation Continual ImprovementIEC=

10、International Electrotechnique Commission IECQ=IEC Quality Assessment System for Electronic ComponentsHSPM=Electrical and Electronic Components and Products Hazardous Substance Process Management System Requirements(HSPM)QC 080000 IECQ HSPMWhat is QC 080000 IECQ HSPM?Based on belief that achievement

11、 of HSF products&production processes cannot be realized without effective integration of management disciplinesSolution must be process-basedCant“inspect in”quality;Cant“test out”HSF QC 080000 IECQ HSPMA Common Sense ApproachMoves from product to process focusMoves from self-declarations to third-p

12、arty assessment and certification to an internationally accepted StandardExpandable,adaptable framework for futureQC 080000 IECQ HSPMCompatible and complimentary to many existing standards and approachesMakes use of known conventions(ISO)already in widespread use Changes the currency in the supply c

13、hain from extensive,expensive testing and audits to a credible certificate indicating well understood,controlled processesQC 080000 and ISO 9001IECQ HPSM is an“add on”to the ISO 9001:2000 Quality Management System(QMS)ISO 9001 provides a blueprint for optimization of business and quality management

14、systems IECQ HSPM was written to fit into that blueprintIECQ HSPM strengthens adherence to the principles and practices prescribed by the International Organization of Standardization(ISO)and directs their application to the management of hazardous substances ISO 9001IECQ QC 080000Basic Process for

15、Achieving HSF OperationsContinued on nextBasic Process for Achieving HSF OperationsKey Elements of the StandardQC 080000 HSPMPurposeScopeReference DocumentsTerms and DefinitionsGeneral RequirementsManagement ResponsibilityPlanningManagement ReviewResource ManagementProduct RealizationDesign and Deve

16、lopmentPurchasingVerification of Purchased ProductProduction and Service Identification and TraceabilityHandling of Hazardous Substances PartsMeasurement,Analysis and ImprovementQC 080000 HSPMReference Documents(RoHS)Directive 2002/95/EC on Restriction of the Use of Certain Hazardous Substances in E

17、lectrical and Electronic Equipment(WEEE).Directive 2002/96/EC on Waste Electrical and Electronic EquipmentISO 9001:2000,Quality Management Systems RequirementsQC 080000 HSPMTerms and DefinitionsShall indicates a mandatory requirement to be followed in order to conform to this documentShould indicate

18、s that,among several possibilities,one is recommended as particularly suitable,without mentioning or excluding others;or that a certain course of action is preferred but not necessarily required;or that(in the negative form)a certain course of action is deprecated but not prohibited.May indicates a

19、course of action that is permissible within the limits of this document.QC 080000 HSPMTerms and DefinitionsHSF Hazardous Substances Free refers to the reduction or elimination of any material as listed in the WEEE or RoHS directives or other applicable standards or regulations.HS Hazardous Substance

20、 refers to any material as listed in the WEEE or RoHS as prohibited from usage and is interchangeable with Restricted Substances.Restricted Substance refers to any material as listed in the WEEE or RoHS as prohibited from usage and is interchangeable with HSQC 080000 HSPMGeneral RequirementsThe orga

21、nization shall:Identify and document all hazardous substances in use in the organization.Identify the specific processes to be managed relevant to its HSF goals.Implement actions to ensure continuous process improvement in achieving HSF.Have a process established to restrict and/or eliminate the use

22、 of hazardous substances from products and processes.QC 080000 HSPMGeneral RequirementsCompose a list of all hazardous substances used within the organization.Statements of HSF policy and objectives with inclusion of a timeline for elimination of use of all hazardous substances as appropriate.Establ

23、ish in the organizations quality manual a section on the HSF process management plan and objectives and reference to HSF documented proceduresQC 080000 HSPMManagement ResponsibilityEstablishing the HSF policyEnsuring that HSF objectives are established including HSF in management reviews,and providi

24、ng resources to ensure progress toward HSF products and production processes.Ensuring the list of hazardous substances is communicated throughout the organization QC 080000 HSPMPlanningHSF objectives shall include a timeline,as appropriate,for the elimination of hazardous substances identified and u

25、sed in processes or products including procured productsPractices required to achieve HSF are integrated into the quality management system planning and are elements in the quality objectives.QC 080000 HSPMManagement ReviewTop management shall include and report on,during the regular management revi

26、ews,activities related to the HSF plan with regards to identification of,use of hazardous substances,nonconformances and corrective actions.QC 080000 HSPMResource ManagementThe organization shall determine and provide the resources needed to implement and maintain HSF processes and productsProvide t

27、raining specific to the HSF plan for the identification,use,and elimination of hazardous substances.QC 080000 HSPMProduct RealizationIn planning HSF product realization,the organization shall determine the following,as appropriate:Quality objectives and requirements for the HSF productEstablish HSF

28、processes,documents,and provide resources specific to the HSF productDocumented procedures or work instructions for processes that include the use of restricted substances to include prevention where the possibility of contamination exists.QC 080000 HSPMProduct RealizationReview of HSF requirements

29、and definition of products HSF requirementsAny use of or possibility of contamination or mixing of processes or product that contain restricted substances shall be communicated to the customer.QC 080000 HSPMDesign and DevelopmentIn planning the design,the use of any restricted substance shall be ide

30、ntified in the documentation and a plan for control and eventual replacement/elimination of the part.When the design requires the use of a restricted substance a documented procedure shall be developed for the control,identification,monitoring and measurement of the process/product to include subcon

31、tracted product.QC 080000 HSPMPurchasingThe organization shall ensure that any HSF part/material is free from possible contamination with a restricted substance.Procurement of restricted substances shall be clearly identified on the purchase document and upon receipt of the material.QC 080000 HSPMVe

32、rification of Purchased ProductThe procurement route of purchased goods shall be fully understood and any process that has the possibility of contamination by restricted hazardous substances shall be fully identified.A documented procedure shall outline the procurement activities related to the HSF

33、process.QC 080000 HSPMVerification of Purchased ProductEstablish a documented procedure for the inspection and identification of Hazardous substances included in purchased goods.The hazardous substance shall be identified by the type in the inspection data.Included shall be a process to handle an ab

34、normality/nonconformance.If the processes are combined with each other a documented procedure shall be established to differentiate between parts.QC 080000 HSPMProduction and Service ProvisionProcesses that have the possibility of contamination are identified and documented.Operational procedures ar

35、e documented and define preventive measures to prevent possible contamination.QC 080000 HSPMIdentification&TraceabilityProcesses that include any restricted substance shall be uniquely identified and segregated to prevent combination with HSF product.QC 080000 HSPMHandling of Hazardous Substances Pa

36、rtsThere shall be a documented procedure for the handling and storage of hazardous substances This procedure shall include records of receiving and shipping;and records showing hazardous substances are segregated and managed separatelyQC 080000 HSPMMeasurement,Analysis and ImprovementThe organizatio

37、n shall conduct internal assessments at planned intervals to determine whether the organizations Hazardous Substance Free processes conform to the requirements of this standard and to customer specifications,and are effectively implemented and maintainedQC 080000 HSPMMeasurement,Analysis and Improve

38、mentThe organization shall establish a documented procedure to monitor and measure the Restricted Substances of the product to verify that product requirements have been met.This shall be carried out at appropriate stages of the product realization process in accordance with the HSF plan.QC 080000 H

39、SPMMeasurement,Analysis and ImprovementThere shall be a clear procedure to handle situations when nonconforming products that contain restricted substances are detectedTo prevent products that contain restricted substances from being shipped unless otherwise allowedRecords of the nature of nonconfor

40、mities and subsequent actions taken shall be maintained and clearly identified as to what restricted substance was detected.QC 080000 HSPMMeasurement,Analysis and ImprovementThe analysis of data shall provide information relating tocontinuous improvement efforts for the elimination of the all hazard

41、ous substances,as applicable.QC 080000 HSPMMeasurement,Analysis and ImprovementA HSF documented procedure shall be established to define requirements forReviewing HSF nonconformities(including customer complaints)Determining the causes of nonconformities,Evaluating the need for action to ensure that

42、 HSF nonconformities do not recurQC 080000 HSPMMeasurement,Analysis and ImprovementCorrective ActionDetermining and implementing action neededRecords of the results of action taken Reviewing corrective action takenReporting the status of all HSF corrective actions for management review.Certification

43、 Advantages Companies achieving IECQ HSPM Certification will;Improve operational resultsReduce compliance costsPreserve access to global marketsImprove supply chain managementPerhaps improve suppliersReduce legal liabilityGain competitive advantageAssure compliance with laws and highest industry sta

44、ndardsIndicate companys desire to be world-class and to do the right thing!Where to Start (1)Key executives and operations managers need to become aware of laws and HSPM Operations managers and key employees need to know more to become“Implementers”Selected employees need to be educated and certifie

45、d as“Internal Assessors”Where to Start(2)Get expert help to do a Gap AssessmentExecutive knowledge,Customer requirements,Design process,Supply chain,Material mgt.,Operations,Finished Goods Management,Internal Training.Develop Implementation Plan Prepare and assist suppliers to begin process toward I

46、ECQ HSPM certification Process of IECQ QC 080000 CertificationCustomer Information FormContract Gap Analysis(If need)ApplicationMaintenancesurveilianceDocument ReviewOn-site AuditCertificates证书证书Report ReportCustomer Information Form（CIF）Basic Information:Company (name,venue,licence,Contact,etc.)Num

47、ber of employeesAll production process (eg：Injection&Molding，Pressing，Painting,etc)Labor-intensive processRegulation,Directive,Customer requirementsQuotation for CertificationApplication fee to ECCB US$1200Document Review：US$680/man-dayAudit(manday):US$865/man-dayCertificate fee:US$80/yearAudit man-

48、day TableEmployeesInitial on-site AuditInitial Document ReviewMaintenance Surveillance1-501.50.5151-7520.5176-1002.50.51.5101-15030.52151-2003.512.5201-400412.5401-6004.513601-1000513.51001-20005242001-30006243001-4000725 Base on the QMS had been established in place.ServiceSystem CertificationGap AnalysisTrainingOverviewStandard InterpretImplementationInternal AuditorIECQ Recognized Lead Auditor Training courseQ&A