2 Audience Check-InHow Many Companies Certified to AS9100/AS9120/ISO 9001?How Many Companies have Contractual Flow Downs for AS5553 or AS 6081?Or Other CPP Requirements?How Many Organization’s Currently Have A CPP Program?And are Auditing within their AS9100/AS9120/ISO9001 Certification?
3 Presentation Focus Who is NQA Update on Accreditation Update of 5553/6081Revision ImpactsUpdate on 9100 & 9120 Revision ImpactsIndustry Information Resources
4 Introductions- Who Is NQA Company ProfileStandardsLeading International Accredited Certification BodyLeading Aerospace Industry RegistrarServing Customers for Industry SuccessMore than 30,000 Customers WorldwideLocal audit resources world-wideAS9100AS9110AS9120AS5553AS6081CustomersCommitteesBoeingNASAESALockheed MartinRaytheonL-3 CommunicationsBall AerospaceUnited Launch AllianceAerospaceAAQSC Voting MemberAAQG/IAQG – Numerous Working GroupsSAE G-19 Counterfeit Part Prevention WGTelecomQuEST Forum MemberOtherAutomotive – IATF/SMMTDept. of Homeland Security – Business ContinuityISO 9001ISO 14001TS 16949TL9000ISO 13485ISO 27001ISO 20000ISO 28000OHSAS 18001ESD S20.20
5 Update On Accreditation & Certification Accredited Certification has Been Around for DecadesAccredited Certification Schemes Are Understood and Used by Government, Industry and Associated Supply ChainsAlso Understood by Many Members of SAE G-19Initial Focus has Been on Requirements Standards for Manufacturers, Distributors and Test OrganizationsAwaiting Efforts on Certification Integrity FocusIn the Mean Time, …….…….NQA is Progressing Accredited Certification
6 Counterfeit Parts & The Industry Model Industry Supply ChainMOD, ESA/NASA, Civil Aviation, Etc.PrimesPrimesPrimesDesign RespAS 9100 & AS 5553Sub-SystemEmerging Certification SchemesNot Design RespComponentSub-ComponentDiscuss the industry Supply Chain ModelDiscuss the Needs of the IndustryDiscuss the Roles ofSystem IntegratorDesign Responsible Middle Tier OrganizationsNon Design Responsible Middle Tier OrganizationsDistributorsHistoricallyFastenersRaw MaterialsNow with outsourcing, moving to more complex Procurements at Lower Points in the Supply ChainParts OCMs & AftermarketFranchised DistributorOther Type DistributorStockingBrokerIndependentOther SourcesSurplusOpen MarketRecyclersEtc.AS 9120, AS 5553, AS 6081Counterfeit Parts Entering the Supply Chain
9 NQA Focus for Accredited Certification Services Alignment to IAQG (& Sector) ModelFocus on End User/Government Control ModelFocus on ISO 17021/17025 Based ModelContinue with G-19 Supplement/Augmentation ApproachAreas of FocusStandards, Competencies, Tools, Formants, Oversight Alignment, etc.Why is this ImportantNeed Regulatory Compliance Aligned ApproachIndustry, End User, Authority/Government RecognitionSupply Chain Efficiency & Cost ControlAvoid Developing an Additional Industry Controlled Model (IAQG, NADCAP, Etc.)Awaiting G-19 to Address & Achieve AlignmentNQA Aligning Certification with Using IAQG & ANAB Recognized Approaches
11 Update AS 5553/AS 6081 AS6081 AS5553 Key Changes Test Requirements Removed (Pointer to AS6171 Added)Modified Competency Needs (Removed Reference to NAS 410)Strengthened Government Reporting (GIDEP, Etc.)Strengthened Supplier Selection (Risk Characterization)Ballot Deferred Until Completion of AS6171 SeriesAS5553Key Change - Appendices RemovedAS5553b Ballot FailedBallot Comments Being Worked
12 Update ISO 9001/AS 9100/AS 9120 - Foundations for AS5553/AS6081 - Support From Other Standards & Upcoming RevisionsISO 9001:2008Currently Very General and Non CPP SpecificStatutory/RegulatoryCustomer Requirementsetc.ISO 9001:2015 DraftsStep Forward With Foundational WordingBut Still No CPP SpecificRiskMitigation/PreventionPlanning & Control
14 Current & Future Wording AS 9100/AS 9120 - Foundations for AS5553/AS6081 - Current AS9100Stronger Wording More Aligned to CPP ProcessesRisk, Special Requirements/Critical Items/Key CharacteristicsSupplier Risk ManagementAugmented Traceability & Inspection WordingFuture AS9100 (draft)Requirements for Counterfeit Prevention ProcessesTraining, Obsolescence, Traceability, Inspection, Reporting, QuarantineEnhanced Wording on Key QMS Processes Supporting CPPRisk Based Purchasing ControlsSupplier & Sub-Tier Supplier ControlsRisk Based Inspection & TestScrap of Validated Counterfeit items
15 Emerging Areas of Focus Update AS 9100/AS 9120Addressing Emergent Supply Chain ChallengesExpanded Expectations & Needs in the Supply ChainDriving the Need For More Controls Deeper in the Supply ChainIAQG Development of New Quality/Process Control MethodsChanges to QMS Standards (AS9100, etc.)Risk & Escape PreventionCounterfeit PartsSub-tier Supplier ControlRaw Material TestingObsolescence ManagementNotification of ChangeCompliance, Ethics, Safety Impacting ProductEmerging Areas of Focus
16 Risk Associated Wording 9100 WD1 SubjectDIS Ref.TopicRiskComplexImpactLikelihoodConseqnceSeverityPreventMitigateControlQMS Plan/Change6.1/6.1.2/6.3QMS Plan, Control & ChangesX+XCustomer188.8.131.52.2.2.dCust, Stat, Reg RequirementsCustomer FocusDetermination of Requirements+Design8.3.2/8.3.3/184.108.40.206.4Planning, Input & ChangesD&D Control (review)External Providers220.127.116.11.28.4.3Ext. Providers GeneralType & Extent of ControlDoc Info For Ext. ProvidersOps Plan/Control18.104.22.168.22.214.171.124.126.96.36.199.188.8.131.52.184.108.40.206.7Ops Planning & ControlOperation Risk ManagementConfiguration ManagementProduct SafetyCounterfeit PartsControl Production ProvisionID & TraceabilityPreservationPost Delivery Plan/ContControl of ChangesNC ControlQMS Processes220.127.116.11/18.104.22.168.22.214.171.124.2.1Documented InformationAnalysis & EvaluationInternal AuditsManagement ReviewImprovementNC & CA
17 Information & Guidance for Supply Chain IAQG Supply Chain Management HandbookInternational Information Sharing by OEM/PrimesWide Variety of Aerospace/Defense Business & Quality Management System Practices
18 New SCMH structure and content 3Market & SellMake (incl. Assemble & test)CustomerSupport9103 Material for Key Characteristics9102 Material for First Article InspectionCounterfeit & Suspect Unapproved PartsControl of non conformitiesForeign Object Debris (FOD)Human factors for new manufacturingStatistical Process Acceptance61TBDMaster Scheduling5Deliver2Design & DevelopDelivery Metrics DefinitionCertificate of ConformanceDelegated Product Release verificationSpecial Requirements & Critical ItemsQuality Aspects of New Product DevelopmentNotification of ChangeSoftware Guidance (9115)CUSTOMERCUSTOMERCUSTOMERAppendices4Buy9100 Rev C Deployment SupportPeople Capability PCAP 001Link to ICOP Overview9100/SSCA/PPDAC ComparisonIAQG dictionarySupplier Selection and Capability AssessmentProduct Performance Detailed Assessment ChecklistsSupplier Quality Mgt BasicsSub-tier Supplier Control Management7Plan & ManageWork TransferRoot Cause Analysis & Problem SolvingProcess Mapping (VSM Based)Advanced Product Quality Planning (APQP)Risk ManagementConfiguration managementCapacity Management, Ordering and Logistics8Stakeholders relationship and communicationRequirements & Flow Down TemplatesContractual Requirements Review & Management GuidanceSections already in progress Future sections
19 In Closing Counterfeit Part Avoidance Significant Challenges Need Broad-based SolutionsIndustry Focus Ramping Up.Educational Information Available to Supply ChainNumerous Committees Are Working Towards SolutionsStandards Are EvolvingAccredited Certification is AvailableWhat Part will We Play in Solving this Industry Problem?Accredited Certification is a Key Component of Building Industry Trust!
20 Questions? Counterfeit Part Prevention AS 9100 & AS 5553 DOD, NASA, Civil Aviation, Etc.PrimesPrimesPrimesAS 9100 & AS 5553Counterfeit Part PreventionSub-SystemComponentSub-ComponentParts OEMs & AftermarketFranchised DistributorOther Type DistributorStockingBrokerIndependentOther SourcesSurplusOpen MarketRecyclersEtc.AS 9120, AS 5553, AS 6081
21 Overview 8.1.4 Prevention of counterfeit parts The organization shall establish, implement and maintain a process, appropriate to the product, that prevents the use of counterfeit or suspect counterfeit parts and their inclusion in product(s) delivered to the customer.NOTE Counterfeit parts prevention processes should consider:training of appropriate personnel in the awareness and prevention of counterfeit parts;application of a parts obsolescence monitoring program;procurement requirements for assuring traceability of parts and components to their original authorized manufacturers;inspection processes to detect counterfeit parts;monitoring of counterfeit parts reporting services;quarantine and reporting of suspect or detected counterfeit parts.8.4.2 Type and extent of control of external provisionVerification of externally provided products and services shall be performed according to the risks identified.Verification activities shall include inspection of products or periodic testing, as applicable, where there is high risk of counterfeit or nonconforming product.8.4.3 Documented information for external providersThe organization shall communicate to external providers applicable requirements for the following:j) requirements regarding the need for the external provider to:prevent the use of counterfeit products;8.7 Control of nonconforming process outputs, products and servicesProduct identified as counterfeit shall not be returned to the external provider and shall be controlled and disposed of as scrap.X