AEROSPACE QUALITY MANAGEMENT SYSTEM STANDARDS …

1 28/1 QUALITY AEROSPACE QUALITY MANAGEMENT SYSTEM MANAGEMENT SYSTEM STANDARDS STANDARDS --AS 9100 SERIESAS 9100 SERIES "" "" , , 28/1 OF 9100 HISTORY OF 910028/1 Background --Early to midEarly to mid--1990s1990sQuality Control ( Inspect In QUALITY at end of line)QualityAssurance( Inspect In QUALITY In Process)QualityAssuranceManagement( Manufacture In QUALITY )MIL-I-452081940 s-60 sMIL-Q-98581960 s-80 sISO 9001,2,3 1980 s-end 90 s Regulations(FAA, JAA, ESA, etc) Customers SpecificRequirements28/1 Background --Early to midEarly to mid--1990s1990szDOD (US Department of Defense) canceled QUALITY SYSTEM specifications (MIL-Q-9858)zFAA (Federal Aviation Administration) lacks a definitive description of a QUALITY SYSTEM (FAR 21 & FAR145)zDefense Customers and AEROSPACE Primes (mainly in Europe) began to flow ISO 9000 series plus unique requirements to supplierszSuppliers asked industry to standardize Needed to operate a single QUALITY SYSTEM Already adopting ISO 9000 series 28/1 Industry Response Industry Response --19951995 Supplier MANAGEMENT and QUALITY Assurance professionals from:AlliedSignalPratt & WhitneyBoeing Rockwell CollinsGE Engines Rolls-Royce AllisonLockheed Martin Sundstrand McDonnell DouglasNorthrop GrummanSponsors Aviation/Space & Defense Division ofAmerican Society for QUALITY SAE AEROSPACE Council28/1 Industry Agree: AEROSPACE Industry Agree.

2 Where AEROSPACE QUALITY and safety is is no competitive advantage 28/1 Req mtsNASAI nputsAS9100 AEROSPACE Standard birthAerospace Standard birth28/1 QUALITY Standard ActivityGlobal QUALITY Standard Activity28/1 Global OrganizationA Global OrganizationInternational AEROSPACE QUALITY GroupInternational AEROSPACE QUALITY GroupInternational AEROSPACE QUALITY GroupIAQGC ouncilGeneral Assembly ForumsAPAQG(Asia)AAQG (Americas)EAQG(Europe)Implement initiatives that make significant improvements in QualImplement initiatives that make significant improvements in QUALITY ity and reduction in cost, throughout the value stream, by establisand reduction in cost, throughout the value stream, by establishing hing and maintaining dynamic cooperation, based on trust, between and maintaining dynamic cooperation, based on trust, between international AEROSPACE companiesinternational AEROSPACE companiesWhose purpose is:Whose purpose is:28/1 Approach to Global Approach to ImprovementImprovementzOver 50 major AEROSPACE companies across three global sectors zImprovement through implementation of effective QUALITY MANAGEMENT systems and practiceszSystem and product integrity initiatives driven with constancy of purposezCo-operation, consultation and communication with.

3 Partners and suppliers airworthiness authorities customers across all sectors of business28/1 Organization of CoAn Organization of Co--operationoperationAmericasAmericas The Boeing CompanyThe Boeing Company BombardierBombardier CAECAE EmbraerEmbraer GE Aircraft EnginesGE Aircraft Engines Goodrich Corporation Goodrich Corporation GulfstreamGulfstream Honeywell AEROSPACE Honeywell AEROSPACE Lockheed Martin Lockheed Martin Northrop GrummanNorthrop Grumman OrbitalOrbital Parker AerospaceParker AEROSPACE RaytheonRaytheon Rockwell CollinsRockwell Collins RollsRolls--Royce CorporationRoyce Corporation TextronTextron United Technologies Technologies Corp. VoughtVought PRI PRI SAESAEAsiaAsia AEROSPACE Industrial AEROSPACE Industrial Development Corp. Aviation Industries of China Aviation Industries of China Fuji Heavy Industries Fuji Heavy Industries IshikawajimaIshikawajimaHarima Heavy Harima Heavy IndustriesIndustries Kawasaki Heavy Kawasaki Heavy IndInd Korea AEROSPACE Korea AEROSPACE IndInd Korean Air AerospaceKorean Air AEROSPACE Mitsubishi Heavy Mitsubishi Heavy IndInd Shin Shin MayawaMayawaIndInd SJACSJACE uropeEurope AirbusAirbus ALENIAALENIA BAE SystemsBAE Systems DassaultDassaultAviationAviation EADSEADS EADS EADS CASACASA EADS MilitaryEADS Military EurocopterEurocopter (Fiat) (Fiat)

4 AvioAvio Fokker Fokker AerostructuresAerostructures WestlandsWestlands HeganHegan HispanoHispano--SuizaSuiza Israel Aircraft IndustriesIsrael Aircraft Industries MessierMessier--BugattiBugatti MessierMessier--DowtyDowty MTU Aero engineMTU Aero engine RollsRolls--RoyceRoyce SAAB AerospaceSAAB AEROSPACE Smiths IndustriesSmiths Industries SNECMA SNECMA MoteursMoteurs SonacaSonaca SukhoiSukhoi ThalesThalesAvionicsAvionicsEurope Continued Turbomeca Volvo Aero Westland Helicopters Zodiac AECMAAECMA28/1 TC 20WG11AS9100EN 9100AS9000prEN 9000-1 AmericasStandardEuropeanStandardISO 90011994 World AEROSPACE QUALITY Standard ; AS/EN/JIS Q 9100 International QUALITY SystemInternational QUALITY SystemStandard Creation 1998 Standard Creation 199828/1 9100?Why 9100?zTo standardize AEROSPACE QUALITY expectations on a global levelzTo achieve improvements in QUALITY and reduce costs throughout the value streamzISO 9000 model for QUALITY does not capture regulatory requirements or importance of safety, reliability or maintainabilityzCaptures AEROSPACE supplements agreed to at an international level28/1 4- Make to Print / Machine Shops/ ProcessorsTier 2 Integrators /Source Control/Software AssembliesTier 5- Distributors (Fasteners, Raw Materials,Commodities, Adhesives, Special Materials)Tier 1 Vehicle / Airframe /Propulsion ManufactureTier 3- Integrators /Source Control / SpecialtyElectronics / Wiring / CompntsSpecial ProcessesTier 6- Raw Materials (Castings, Forgings, Sheet, etc)

5 91009120 Variation ReductionFAIP rocess ProvingCompany Specific or NADCAP9110 for Repair StationsAEROSPACE SUPPLY CHAINAEROSPACE SUPPLY CHAIN28/1 QUALITY StandardsAerospace QUALITY StandardsNumbering SystemNumbering SystemzInternational STANDARDS - 91xx Harmonized across all 3 AEROSPACE sectors and are recognized globallyz AS STANDARDS - Americas Published by Society of Automotive Engineersz EN STANDARDS - Europe published in Europe by ASD (former AECMA)z JIS Q or SJAC is the Japan / Asia Equivalent28/1 QUALITY SystemAerospace QUALITY SystemStandardsStandardszINTERNATIONAL STANDARDS 9100- QUALITY SYSTEM for AEROSPACE Manufacturers 9101- Check sheet for 9100 9110- QUALITY SYSTEM for AEROSPACE Repair Stations 9111- Check sheet for 9110 9120- QUALITY SYSTEM for Distributors 9121- Check sheet for 912028/1 QUALITY SYSTEM 9100 AEROSPACE QUALITY SYSTEM 9100 Standard versus ISO 9001 Standard versus ISO 9001z9100 added 83 additional and specific requirements to the 20 elements of ISO 9001 11 amplifications of ISO 9001 paragraphs are also insertedzEmphasis is placed on Design Control, Process Control, Purchasing, Inspection & Testing and Control of Non conformances All areas that have the greatest impact on safety and reliability for AEROSPACE products28/1 Specifics 9100 Specifics (where ISO (where ISO 9001 9001 impliesimplies 9100 9100 requiresrequires))ISO 9001.

6 ZGeneric QUALITY MANAGEMENT SYSTEM standard - applicable to shoes as well as to airplanes9100:zIncludes all ISO 9001 requirementszAdds the expectations of the AEROSPACE industry for a robust QUALITY MANAGEMENT SYSTEM for AEROSPACE productsContinuous Improvement:zContinuous improvement processes shall include provision for using the QUALITY policy, QUALITY objectives, audit results, measurement and analysis of data, variability reduction, corrective and preventive action, and MANAGEMENT review (all but variability reduction are part of 9001:2000 requirements)28/1 versus 9100 ISO9001 versus 9100z9100 version is formatted to match ISO 9001:2000 and added requirements that provide for - Regulatory organizations interfaces Configuration MANAGEMENT Design and Development V& V., & V&V testing Control of changes in Production Process Control of production equipment, tools, NC machines Control of work in outside facilities Control of service operations First Article Inspection Inspection documentationzThese added requirements enables a standardized approach to supplier flow down requirements28/1 : QUALITY MANAGEMENT 9100: QUALITY MANAGEMENT Systems (ISO Clause 4)Systems (ISO Clause 4)zRequirements of regulatory authorities must be included in documentation Including access by authorities to the records, documentation and change approval (as req d)zMust show relationship of 9100 standard to lower level procedureszDocumented procedure for records controlzRequires Configuration MANAGEMENT for the product / process28/1 and Development output includes.

7 Identification of Key Characteristics (FMECA) All necessary data to manufacture the product Gated Design Reviews Documentation of both Design Verification and Design Validation (reports / calculations / etc.) Design Verification and Validation testingzDesign Change Control Includes customer and regulatory approval as necessary9100:9100:Product Realization (ISO Clause 7)Product Realization (ISO Clause 7)28/1 Responsible for all suppliers (incl. customer designated ones) Must have a list of suppliers Supplier performance review process Control of special process sources Whoever approves a supplier, can disapprove them as well Stringent flow down requirements - sub-tier Notification of nonconformance / process change Right of access by customer and regulatory personnel9100:9100:Product Realization (ISO Clause 7)Product Realization (ISO Clause 7)28/1 for Production and Service: Control plans and process controls In-process verification for hidden features Design of tooling for variable measurementszControlled Production accountability of product during manufacture evidence all operations are complete FOD control monitoring of environmental influences criteria for workmanship Use of approved data and specified tooling with instructions9100:9100.

8 Product Realization (ISO Clause 7)Product Realization (ISO Clause 7)28/1 Special Process Requirements9100 Special Process Validation of processes for production and ..where the resulting output cannot be verified by subsequent monitoring or measurement. NOTE: These processes are frequently referred to as special the ability of these processes to achieve planned arrangements for these processes including, as applicablea) defined criteria for review and approval of the processes,qualification and approval of special processes prior to use,b) approval of equipment and qualification of personnel,c) use of specific methods and procedures,control of the significant operations and parameters of special processes in accordance with documented process specifications and changes thereto,d) requirements for records (see ), ande) Process Approval ObjectivesSpecial Process Approval ObjectiveszTo put in place industry controlled process for meeting requirements of 9100 clause Supplier processes are an extension of the OEMprocesseszTo reduce redundant audits for the special process at suppliers and improve the global QUALITY level Common requirements (auditors and audit questionnaires)

9 Harmonized assessment process Data exchange Demonstrated industry managed process Process oversight Mutual SYSTEM recognitionNADCAP/ASD PRO28/1 Introduces Two important 9100 Introduces Two important Concepts for AerospaceConcepts for AerospacezFirst Article Inspections Always required 9102 is mentioned for Guidance 9102 is only mandatory when specifically required in contractszKey Characteristics When specified 9103 is referenced for guidance 9103 is only mandatory when specifically required in contracts and key characteristics are identified28/1 First Article Inspection9102 First Article InspectionzFAIs apply: to assemblies and all levels of parts within an assembly, including castings and forgings Suppliers responsible for ensuring that characteristics conform to Customer requirements Sub-tier suppliers and processors of parts and materials for suppliers28/1 is Included in First Article What is Included in First Article Inspection?

10 Inspection?zVerification of All Design Characteristics: Dimensional Verification via Marked-up (or Ballooned ) Drawings that Correlate Characteristic Number from FAI to the Drawing. Part MarkingzMaterial and Special Process CertificationsIncluding Operator Certifications ( NDT, Welding)zManufacturing Process Verifications Manufacturing Routing Sheets. Referenced Exhibits Supporting the FAI ( CMM Data Printouts,Test Data, Acceptance Test Procedures, Process Certifications, etc.). Process Capability Studies, As Applicable. Gauge Correlation, As Applicable. Tooling Traceability, If Tooling Is Used to Verify Design CharacteristicszNonconformance Resolutions28/1 First Article Inspection9102 First Article InspectionzAny 9100 compliant organization in absence of a contractual requirement to use 9102 or other specific FAI customer requirement, can devise any methods and processes it chooses to meet the requirements of this clause and the "extent" of an FAI is also at the discretion of the organization as along as it is applied to each " new part" and subsequent changes part means Parts, sub-assemblies and assemblies, however FAI s are progressive28/1 Key Characteristics9103 Key CharacteristicszVariation MANAGEMENT of Key Characteristics will provide a common standard for expectations for KC s within the AEROSPACE Characteristic(9100): The features of a material or part whose variation has a significant influence on the fit, performance, service life, or manufacturability.