1 of 59september 9, 2004civil aviation safety symposium aerospace quality management systems eugene...
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September 9, 2004 Civil Aviation Safety Symposium 1 of 59
AEROSPACEAEROSPACEQUALITY MANAGEMENT QUALITY MANAGEMENT
SYSTEMSSYSTEMS
Eugene M. BarkerEugene M. Barker..
Past ChairmanPast ChairmanAmericas Aerospace Quality GroupAmericas Aerospace Quality Group
September 9, 2004 Civil Aviation Safety Symposium 2 of 59
Tier 4Tier 4 - Make to Print / Machine Shops/ - Make to Print / Machine Shops/ ProcessorsProcessors
Tier 2Tier 2Integrators /Integrators /
Source Control/Source Control/Software Dev./Software Dev./
Major AssembliesMajor Assemblies
Tier 5Tier 5 - Distributors (Fasteners, Raw Materials, - Distributors (Fasteners, Raw Materials, Commodities, Adhesives, Special Materials) Commodities, Adhesives, Special Materials)
Tier 3Tier 3 - Integrators / - Integrators /Source Control / SpecialtySource Control / Specialty
Electronics / Wiring / Compnts Electronics / Wiring / Compnts
Tier 6Tier 6 - Raw Materials (Castings, Forgings, Sheet, etc) - Raw Materials (Castings, Forgings, Sheet, etc)
Aerospace Supply ChainAerospace Supply Chain
Tier 1Tier 1
Special P
rocesses
Special P
rocesses
91009100
91209120
90039003
Tier 1Tier 1Vehicle / Airframe /Vehicle / Airframe /Propulsion ManufacturePropulsion Manufacture Variation Reduction
Variation Reduction
910291029103
9103
91109110MR&OMR&O
September 9, 2004 Civil Aviation Safety Symposium 3 of 59
Aerospace Quality System Aerospace Quality System ModelModel
Company
Reqmnts
AS/EN/JIS Q9100
Int’l Reqmnts
& CompanyReqmnts
Internationally Agreed Implementation Processes
Risk Mgnt
Prgrm Mgnt
Special Process
Process Rqmts
Deliverable
Non-Deliver
MRO 9110
Dist. 9120
Service Specific
Requirements
Quality System Requirements - International Standard ISO 9001
Common Aerospace Quality System Requirements - International Requirements 9100
Program Specific
Requirements
Hardware Specific
Requirements
Software Specific
Requirements
September 9, 2004 Civil Aviation Safety Symposium 4 of 59
Aerospace Quality StandardsAerospace Quality StandardsNumbering SystemNumbering System
• International Standards - 91xxInternational Standards - 91xx– Are planned for harmonization across all 3 aerospace Are planned for harmonization across all 3 aerospace
sectors and are recognized globallysectors and are recognized globally
• Americas Standards - 90xxAmericas Standards - 90xx– Are published for use by AAQG, may become an 91XX Are published for use by AAQG, may become an 91XX
standard at a later datestandard at a later date
• ““AS” Standards - AmericasAS” Standards - Americas– Published by Society of Automotive EngineersPublished by Society of Automotive Engineers
• ““EN” Standards - EuropeEN” Standards - Europe– published in Europe by AECMApublished in Europe by AECMA
• ““JIS Q”or “SJAC” is the Japan / Asia EquivalentJIS Q”or “SJAC” is the Japan / Asia Equivalent
September 9, 2004 Civil Aviation Safety Symposium 5 of 59
Aerospace Quality SystemAerospace Quality System Standards Standards
• INTERNATIONAL STANDARDSINTERNATIONAL STANDARDS– 9100 - Quality System for Aerospace 9100 - Quality System for Aerospace ManufacturersManufacturers– 9102 - First Article Inspection9102 - First Article Inspection– 9103 - Management of Key Characteristics9103 - Management of Key Characteristics– 9104 – Requirements for Registration of AQMS9104 – Requirements for Registration of AQMS– 9110 - Quality System for Aerospace Repair Stations 9110 - Quality System for Aerospace Repair Stations – 9120 - Quality System for “Pass-Through” 9120 - Quality System for “Pass-Through”
DistributorsDistributors– Special Process ApprovalSpecial Process Approval
September 9, 2004 Civil Aviation Safety Symposium 6 of 59
Why 9100?Why 9100?
• To standardize Aerospace quality To standardize Aerospace quality expectations on a expectations on a globalglobal level level
• To achieve improvements in quality and To achieve improvements in quality and reducereduce costscosts throughout the value stream throughout the value stream
• ISO 9000 model for quality does not ISO 9000 model for quality does not capture capture regulatory requirements or regulatory requirements or importance of safety, reliability or importance of safety, reliability or maintainabilitymaintainability
• Captures aerospace Captures aerospace supplementssupplements agreed agreed to at an international levelto at an international level
September 9, 2004 Civil Aviation Safety Symposium 7 of 59
9100:2001 conforms to 9001:20009100:2001 conforms to 9001:2000Model of a process based quality Model of a process based quality management systemmanagement system
CUSTOMERCUSTOMERCUSTOMERCUSTOMER
Continual Improvement of the Quality Management System
ManagementResponsibility
ManagementResponsibility
ManagementResponsibility
ProductRealization
CUSTOMERCUSTOMER
ProductRequirements
Satisfaction
input output
Value added activities
Information Flow
September 9, 2004 Civil Aviation Safety Symposium 8 of 59
9100 Specifics 9100 Specifics (where ISO 9001 (where ISO 9001 implies – 9100 requires)implies – 9100 requires)
ISO 9001:ISO 9001:• Generic quality management system standard - applicable Generic quality management system standard - applicable
to anvils to airplanesto anvils to airplanes
9100:9100: (9100:2001)(9100:2001)• Includes all ISO 9001 requirementsIncludes all ISO 9001 requirements• Adds the expectations of the aerospace industry for a robust quality Adds the expectations of the aerospace industry for a robust quality
management system for aerospace productsmanagement system for aerospace products
Continuous Improvement:Continuous Improvement:• Continuous improvement processes shall include provision for using the Continuous improvement processes shall include provision for using the
quality policy, quality objectives, audit results, measurement and analysis of quality policy, quality objectives, audit results, measurement and analysis of data, data, variability reductionvariability reduction, corrective and preventive action, and management , corrective and preventive action, and management review review (all but variability reduction are part of 9001:2000 requirements)(all but variability reduction are part of 9001:2000 requirements)
September 9, 2004 Civil Aviation Safety Symposium 9 of 59
ISO9001 versus 9100ISO9001 versus 9100
• 9100 version is formatted to match ISO 9001:2000 and 9100 version is formatted to match ISO 9001:2000 and added “requirements” that provide for - added “requirements” that provide for -
• Regulatory organizations interfacesRegulatory organizations interfaces• Configuration ManagementConfiguration Management• Design and Development V& V., & V&V testingDesign and Development V& V., & V&V testing• Control of changes in Production ProcessControl of changes in Production Process• Control of production equipment, tools, NC machinesControl of production equipment, tools, NC machines• Control of work in outside facilitiesControl of work in outside facilities• Control of service operationsControl of service operations• First Article InspectionFirst Article Inspection• Inspection documentationInspection documentation
• These added requirements enables a standardized These added requirements enables a standardized approach to supplier flow down requirementsapproach to supplier flow down requirements
September 9, 2004 Civil Aviation Safety Symposium 10 of 59
9100: Quality Management 9100: Quality Management Systems (ISO Clause 4)Systems (ISO Clause 4)
• Requirements of regulatory authorities must be Requirements of regulatory authorities must be included in documentationincluded in documentation– Including access by authorities to the records, Including access by authorities to the records,
documentation and change approval (as req’d)documentation and change approval (as req’d)
• Must show relationship of 9100 standard to Must show relationship of 9100 standard to lower level procedureslower level procedures
• Documented procedure for records controlDocumented procedure for records control• Requires Configuration Management for the Requires Configuration Management for the
product / processproduct / process
September 9, 2004 Civil Aviation Safety Symposium 11 of 59
• Design and Development output includes:Design and Development output includes:– Identification of Key Characteristics (FMECA)Identification of Key Characteristics (FMECA)– All necessary data to manufacture the productAll necessary data to manufacture the product– Gated Design ReviewsGated Design Reviews– Documentation of both Design Verification and Documentation of both Design Verification and
Design Validation (reports / calculations / etc.)Design Validation (reports / calculations / etc.)– Design Verification and Validation testingDesign Verification and Validation testing
• Design Change ControlDesign Change Control– Includes customer and regulatory approval as Includes customer and regulatory approval as
necessarynecessary
9100:9100:Product Realization (ISO Clause 7)Product Realization (ISO Clause 7)
September 9, 2004 Civil Aviation Safety Symposium 12 of 59
• PurchasingPurchasing– Responsible for all suppliers (incl. customer designated Responsible for all suppliers (incl. customer designated
ones)ones)
– Must have a list of suppliersMust have a list of suppliers
– Supplier performance review processSupplier performance review process
– Control of special process sourcesControl of special process sources
– Whoever approves a supplier, can disapprove them as Whoever approves a supplier, can disapprove them as wellwell
– Stringent flow down requirements - sub-tierStringent flow down requirements - sub-tier
– Notification of nonconformance / process changeNotification of nonconformance / process change
– Right of access by customer and regulatory personnelRight of access by customer and regulatory personnel
9100:9100:Product Realization (ISO Clause 7)Product Realization (ISO Clause 7)
September 9, 2004 Civil Aviation Safety Symposium 13 of 59
• Planning for Production and Service:Planning for Production and Service:– Control plans and process controlsControl plans and process controls
– In-process verification for hidden featuresIn-process verification for hidden features
– Design of tooling for variable measurementsDesign of tooling for variable measurements
• Controlled ProductionControlled Production– accountability of product during manufactureaccountability of product during manufacture
– evidence all operations are completeevidence all operations are complete
– FOD controlFOD control
– monitoring of environmental influencesmonitoring of environmental influences
– criteria for workmanshipcriteria for workmanship
– Use of approved data and specified tooling with Use of approved data and specified tooling with instructionsinstructions
9100:9100:Product Realization (ISO Clause 7)Product Realization (ISO Clause 7)
September 9, 2004 Civil Aviation Safety Symposium 14 of 59
Tier 4Tier 4 - Make to Print / Machine Shops/ - Make to Print / Machine Shops/ ProcessorsProcessors
Tier 2Tier 2Integrators /Integrators /
Source Control/Source Control/Software Dev./Software Dev./
Major AssembliesMajor Assemblies
Tier 5Tier 5 - Distributors (Fasteners, Raw Materials, - Distributors (Fasteners, Raw Materials, Commodities, Adhesives, Special Materials) Commodities, Adhesives, Special Materials)
Tier 3Tier 3 - Integrators / - Integrators /Source Control / SpecialtySource Control / Specialty
Electronics / Wiring / Compnts Electronics / Wiring / Compnts
Tier 6Tier 6 - Raw Materials (Castings, Forgings, Sheet, etc) - Raw Materials (Castings, Forgings, Sheet, etc)
Aerospace Supply ChainAerospace Supply Chain
Tier 1Tier 1
Special P
rocesses
Special P
rocesses
91009100
91209120
90039003
Tier 1Tier 1Vehicle / Airframe /Vehicle / Airframe /Propulsion ManufacturePropulsion Manufacture Variation Reduction
Variation Reduction
910291029103
9103
91109110MR&OMR&O
September 9, 2004 Civil Aviation Safety Symposium 15 of 59
9100 Introduces Two important 9100 Introduces Two important Concepts for AerospaceConcepts for Aerospace
• First Article InspectionsFirst Article Inspections– Always requiredAlways required– 9102 is mentioned for Guidance9102 is mentioned for Guidance– 9102 is only mandatory when specifically required 9102 is only mandatory when specifically required
in contractsin contracts
• Key CharacteristicsKey Characteristics– When specifiedWhen specified– 9103 is referenced for guidance9103 is referenced for guidance– 9103 is only mandatory when specifically required 9103 is only mandatory when specifically required
in contracts and key characteristics are identifiedin contracts and key characteristics are identified
September 9, 2004 Civil Aviation Safety Symposium 16 of 59
9102 First Article Inspection9102 First Article Inspection
• FAIs apply:FAIs apply:– to assemblies and all levels of parts within to assemblies and all levels of parts within
an assembly, including castings and an assembly, including castings and forgingsforgings
– Suppliers responsible for ensuring that Suppliers responsible for ensuring that characteristics conform to Customer characteristics conform to Customer requirementsrequirements
– Sub-tier suppliers and processors of parts Sub-tier suppliers and processors of parts and materials for suppliersand materials for suppliers
September 9, 2004 Civil Aviation Safety Symposium 17 of 59
What is Included in First Article What is Included in First Article Inspection?Inspection?
• Verification of All Design Characteristics:Verification of All Design Characteristics:– Dimensional Verification via Marked-up (or “Ballooned”) Drawings that Correlate Dimensional Verification via Marked-up (or “Ballooned”) Drawings that Correlate
Characteristic Number from FAI to the Drawing.Characteristic Number from FAI to the Drawing.– Part MarkingPart Marking
•Material and Special Process CertificationsMaterial and Special Process Certifications
Including Operator Certs (e.g. NDT, Welding)Including Operator Certs (e.g. NDT, Welding)
• Manufacturing Process VerificationsManufacturing Process Verifications– Manufacturing Routing Sheets.Manufacturing Routing Sheets.– Referenced Exhibits Supporting the FAI (e.g. CMM Data Printouts, Test Data, Referenced Exhibits Supporting the FAI (e.g. CMM Data Printouts, Test Data,
Acceptance Test Procedures, Process Certifications, etc.). Acceptance Test Procedures, Process Certifications, etc.). – Process Capability Studies, As Applicable.Process Capability Studies, As Applicable.– Gauge Correlation, As Applicable.Gauge Correlation, As Applicable.– Tooling Traceability, If Tooling Is Used to Verify Design CharacteristicsTooling Traceability, If Tooling Is Used to Verify Design Characteristics
• Nonconformance ResolutionsNonconformance Resolutions
September 9, 2004 Civil Aviation Safety Symposium 18 of 59
9102 First Article Inspection9102 First Article Inspection
• Any 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 thereto.
• New part means – Parts, sub-assemblies and assemblies, however FAI’s are progressive
September 9, 2004 Civil Aviation Safety Symposium 19 of 59
9103 Key Characteristics9103 Key Characteristics
• Variation Management of Key Characteristics will provide a common standard for expectations for KC’s within the aerospace industry.
• Key Characteristic (9100): The features of a material or part whose variation has a significant influence on the fit, performance, service life, or manufacturability.
– Dimensional features - thickness, diameter, length, etc.– Chemical concentrations– Time, Pressure, speed, rates, temperature, etc.
September 9, 2004 Civil Aviation Safety Symposium 20 of 59
Variation Management of Key Variation Management of Key Characteristics Purpose (9103)Characteristics Purpose (9103)
Intent to drive the improvement of the manufacturing processes through adequate planning and effective management of Key Characteristic variation.
• Methodology for component/process proving focused on Key Characteristics.
Understanding processes
Using appropriate tools
Demonstrating acceptable process capabilities
Guidelines for reporting process capability data to primes.
September 9, 2004 Civil Aviation Safety Symposium 21 of 59
Take action from study
Take action from study
Analyze data
Analyze data
Process Based Variation Management Process Based Variation Management of Key Characteristics (9103)of Key Characteristics (9103)
Operate the process
Operate the process
Yes
Output for each stage. Report to a common form.
Plan a manufacturing
process
Plan a manufacturing
process
UnderstandKey
Characteristics
UnderstandKey
Characteristics
Is a process change
required ?
Continue to monitor
performances
Continue to monitor
performances
No
September 9, 2004 Civil Aviation Safety Symposium 22 of 59
4 Quality management system4.1 General requirements4.2 Documentation requirements
4.2.1 General4.2.2 Quality manual4.2.3 Control of documents4.2.4 Control of records4.3 Configuration management
9100 Model -Implementation Standards / 9100 Model -Implementation Standards / RequirementsRequirements
9130 - Record RetentionARP 9034 – Digital Data Retention
Area of Discussion
September 9, 2004 Civil Aviation Safety Symposium 23 of 59
9100 Model -Implementation Standards / 9100 Model -Implementation Standards / RequirementsRequirements
5 Management responsibility5.1 Management commitment5.2 Customer focus5.3 Quality policy5.4 Planning
5.4.1 Quality objectives5.4.2 Quality management system planning
5.5Responsibility, authority and communication
5.5.1 Responsibility and authority5.5.2 Management representative5.5.3 Internal communication5.6 Management review
5.6.1 General5.6.2 Review input5.6.3 Review output
September 9, 2004 Civil Aviation Safety Symposium 24 of 59
9100 Model -Implementation Standards / 9100 Model -Implementation Standards / RequirementsRequirements
6 Resource management6.1 Provision of resources6.2 Human resources
6.2.1 General6.2.2 Competence, awareness and training6.3 Infrastructure6.4 Work environment
September 9, 2004 Civil Aviation Safety Symposium 25 of 59
9100 Model -Implementation Standards / 9100 Model -Implementation Standards / RequirementsRequirements
7 Product realization7.1 Planning of product realization7.2 Customer-related processes
7.2.1Determination of requirements related to the product
7.2.2Review of requirements related to the product
7.2.3 Customer communication7.3 Design and development
7.3.1 Design and development planning7.3.2 Design and development inputs7.3.3 Design and development outputs7.3.4 Design and development review7.3.5 Design and development verification7.3.6 Design and development validation
7.3.6.1Documentation of design and/or development verification and validation
7.3.6.2Design and/or development verification and validation testing
7.3.7Control of design and development changes
9103 - Management of Key Characteristics
September 9, 2004 Civil Aviation Safety Symposium 26 of 59
9100 Model -Implementation Standards / 9100 Model -Implementation Standards / RequirementsRequirements
7.4 Purchasing7.4.1 Purchasing process7.4.2 Purchasing information7.4.3 Verification of purchased product7.5 Production and service provision
7.5.1Control of production and service provision
7.5.1.1 Production documentation7.5.1.2 Control of production process changes
7.5.1.3Control of production equipment, tools and numerical control (N.C.) machine programs
7.5.1.4Control of work occasionally performed by the organization’s personnel outside the organization’s facilities
7.5.1.5 Control of service operations
7.5.2Validation of processes for production and service provision
7.5.3 Identification and traceability7.5.4 Customer property7.5.5 Preservation of product
7.6Control of monitoring and measuring devices
NADCAP
9103 - Management of Key Characteristics
9132 - Direct Part Marking
ARP 9005 Product Acceptance Software
ARP 9113 – Supplier Risk Management
ARP 9009 – Contract Clauses
September 9, 2004 Civil Aviation Safety Symposium 27 of 59
9100 Model -Implementation Standards / 9100 Model -Implementation Standards / RequirementsRequirements
8 Measurement, analysis and improvement8.1 General8.2 Monitoring and measurement
8.2.1 Customer satisfaction8.2.2 Internal audit8.2.3 Monitoring and measurement of processes8.2.4 Monitoring and measurement of product
8.2.4.1 Inspection documentation8.2.4.2 First article inspection
9103 - Management of Key
Characterisitics
9102 - First Article Inspection
ISO 19011 - Audit Req’mts
ARP 9008 Sampling Plan requirements
September 9, 2004 Civil Aviation Safety Symposium 28 of 59
9100 Model -Implementation Standards / 9100 Model -Implementation Standards / RequirementsRequirements
8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement
8.5.1 Continual improvement8.5.2 Corrective action8.5.3 Preventive action
9131 - NonconformanceDocumentation
September 9, 2004 Civil Aviation Safety Symposium 29 of 59
9100 Model -Implementation Standards / 9100 Model -Implementation Standards / RequirementsRequirements
• Quality System Approval ProcessQuality System Approval Process• International Operating Procedure (9104)International Operating Procedure (9104)
– Sharing of Audits by Prime ContractorsSharing of Audits by Prime Contractors• AIR5359B (Americas) AECMA - EASE (Europe)AIR5359B (Americas) AECMA - EASE (Europe)
– Registration / Certification of Quality SystemsRegistration / Certification of Quality Systems• AIR5359B (Americas) SJAC 9010 & 9013 (Japan)AIR5359B (Americas) SJAC 9010 & 9013 (Japan)
– Training RequirementsTraining Requirements• AIR 5493A (Americas) SJAC 9011 (Japan)AIR 5493A (Americas) SJAC 9011 (Japan)
– Audit Documentation -Audit Documentation - 9101 checklist9101 checklist
September 9, 2004 Civil Aviation Safety Symposium 30 of 59
Tier 4Tier 4 - Make to Print / Machine Shops/ - Make to Print / Machine Shops/ ProcessorsProcessors
Tier 2Tier 2Integrators /Integrators /
Source Control/Source Control/Software Dev./Software Dev./
Major AssembliesMajor Assemblies
Tier 5Tier 5 - Distributors (Fasteners, Raw Materials, - Distributors (Fasteners, Raw Materials, Commodities, Adhesives, Special Materials) Commodities, Adhesives, Special Materials)
Tier 3Tier 3 - Integrators / - Integrators /Source Control / SpecialtySource Control / Specialty
Electronics / Wiring / Compnts Electronics / Wiring / Compnts
Tier 6Tier 6 - Raw Materials (Castings, Forgings, Sheet, etc) - Raw Materials (Castings, Forgings, Sheet, etc)
Aerospace Supply ChainAerospace Supply Chain
Tier 1Tier 1
Special P
rocesses
Special P
rocesses
91009100
91209120
90039003
Tier 1Tier 1Vehicle / Airframe /Vehicle / Airframe /Propulsion ManufacturePropulsion Manufacture Variation Reduction
Variation Reduction
910291029103
9103
91109110MR&OMR&O
September 9, 2004 Civil Aviation Safety Symposium 31 of 59
9120 9120 Distributor Quality SystemDistributor Quality System
• 9120 developed and implemented for “pass 9120 developed and implemented for “pass through” stockists / distributors that handle through” stockists / distributors that handle parts and supplies that are used in aerospace parts and supplies that are used in aerospace productsproducts– Checklist 9121 is also availableChecklist 9121 is also available– Based on 9100, but only appliesBased on 9100, but only applies
necessary system requirementsnecessary system requirements..– Expected flow-down requirementExpected flow-down requirement– Registration plans are available (just begun)Registration plans are available (just begun)
September 9, 2004 Civil Aviation Safety Symposium 32 of 59
Tier 4Tier 4 - Make to Print / Machine Shops/ - Make to Print / Machine Shops/ ProcessorsProcessors
Tier 2Tier 2Integrators /Integrators /
Source Control/Source Control/Software Dev./Software Dev./
Major AssembliesMajor Assemblies
Tier 5Tier 5 - Distributors (Fasteners, Raw Materials, - Distributors (Fasteners, Raw Materials, Commodities, Adhesives, Special Materials) Commodities, Adhesives, Special Materials)
Tier 3Tier 3 - Integrators / - Integrators /Source Control / SpecialtySource Control / Specialty
Electronics / Wiring / Compnts Electronics / Wiring / Compnts
Tier 6Tier 6 - Raw Materials (Castings, Forgings, Sheet, etc) - Raw Materials (Castings, Forgings, Sheet, etc)
Aerospace Supply ChainAerospace Supply Chain
Tier 1Tier 1
Special P
rocesses
Special P
rocesses
91009100
91209120
90039003
Tier 1Tier 1Vehicle / Airframe /Vehicle / Airframe /Propulsion ManufacturePropulsion Manufacture Variation Reduction
Variation Reduction
910291029103
9103
91109110MR&OMR&O
September 9, 2004 Civil Aviation Safety Symposium 33 of 59
9110 9110 Repair Station QualityRepair Station Quality System System
• Why 9110?Why 9110?– Manufacturers want a Quality Management System Manufacturers want a Quality Management System
flow-down requirement for their MR&O activityflow-down requirement for their MR&O activity– Manufacturers want reputable suppliers that have Manufacturers want reputable suppliers that have
repair station approvals and a defined quality systemrepair station approvals and a defined quality system– There is a need to put all of the expectations in one There is a need to put all of the expectations in one
document for Maintenance, Repair and Overhaul document for Maintenance, Repair and Overhaul organizationsorganizations
– Military is very interested in having defined Quality Military is very interested in having defined Quality System requirements for MR&OSystem requirements for MR&O
September 9, 2004 Civil Aviation Safety Symposium 34 of 59
9110 9110 Repair Station QualityRepair Station Quality System System
• 9110 developed and implemented in for 9110 developed and implemented in for facilities that perform maintenance & facilities that perform maintenance & repair of aerospace productsrepair of aerospace products– Based on 9100 requirements and FAA / Based on 9100 requirements and FAA /
JAA - 145 requirements (new version)JAA - 145 requirements (new version)
• Corresponding 9111 checklist has also been developed
• Registration plans are in development and expect full implementation in 2004
September 9, 2004 Civil Aviation Safety Symposium 35 of 59
Tier 4Tier 4 - Make to Print / Machine Shops/ - Make to Print / Machine Shops/ ProcessorsProcessors
Tier 2Tier 2Integrators /Integrators /
Source Control/Source Control/Software Dev./Software Dev./
Major AssembliesMajor Assemblies
Tier 5Tier 5 - Distributors (Fasteners, Raw Materials, - Distributors (Fasteners, Raw Materials, Commodities, Adhesives, Special Materials) Commodities, Adhesives, Special Materials)
Tier 3Tier 3 - Integrators / - Integrators /Source Control / SpecialtySource Control / Specialty
Electronics / Wiring / Compnts Electronics / Wiring / Compnts
Tier 6Tier 6 - Raw Materials (Castings, Forgings, Sheet, etc) - Raw Materials (Castings, Forgings, Sheet, etc)
Aerospace Supply ChainAerospace Supply Chain
Tier 1Tier 1
Special P
rocesses
Special P
rocesses
91009100
91209120
90039003
Tier 1Tier 1Vehicle / Airframe /Vehicle / Airframe /Propulsion ManufacturePropulsion Manufacture Variation Reduction
Variation Reduction
910291029103
9103
91109110MR&OMR&O
September 9, 2004 Civil Aviation Safety Symposium 36 of 59
9100 Special Process 9100 Special Process RequirementsRequirements
• 7.5.2 Validation of processes for production and service7.5.2 Validation of processes for production and service• ……processes …where the resulting output cannot be verified by processes …where the resulting output cannot be verified by
subsequent monitoring or measurement. subsequent monitoring or measurement. NOTE: NOTE: These processes are frequently referred to as special processes.These processes are frequently referred to as special processes.
• ……demonstrate the ability of these processes to achieve planned results.demonstrate the ability of these processes to achieve planned results.
• ……establish arrangements for these processes including, as applicableestablish arrangements for these processes including, as applicable
• a) defined criteria for review and approval of the processes,a) defined criteria for review and approval of the processes,
qualification and approval of special processes prior to use,qualification and approval of special processes prior to use,
• b) approval of equipment and qualification of personnel,b) approval of equipment and qualification of personnel,
• c) use of specific methods and procedures,c) use of specific methods and procedures,
control of the significant operations and parameters of special control of the significant operations and parameters of special processes in accordance with documented process specifications processes in accordance with documented process specifications and changes thereto,and changes thereto,
• d) requirements for records (see 4.2.4), andd) requirements for records (see 4.2.4), and
• e) revalidation.e) revalidation.
September 9, 2004 Civil Aviation Safety Symposium 37 of 59
Special Process Approval Special Process Approval ObjectivesObjectives
• To put in place industry controlled process for To put in place industry controlled process for meeting requirements of 9100 clause 7.5.2meeting requirements of 9100 clause 7.5.2– Supplier processes are an extension of the OEM processesSupplier processes are an extension of the OEM processes
• To reduce redundant audits for the special To reduce redundant audits for the special process at suppliers and improve the global process at suppliers and improve the global quality levelquality level– Common requirements (auditors and audit questionnaires)Common requirements (auditors and audit questionnaires)– Harmonized assessment processHarmonized assessment process– Data exchangeData exchange– Demonstrated industry managed processDemonstrated industry managed process– Process oversightProcess oversight– Mutual system recognitionMutual system recognition
September 9, 2004 Civil Aviation Safety Symposium 38 of 59
The Road AheadThe Road Ahead
• Obtain Sector Commitment
• Develop Areas of Focus: • Assign Strategy Team members to each area of focus• Further Develop Definition and Strategic Objective• Develop initiatives against areas of focus • Seek Champions for the initiatives
• Enhance the IAQG Operating Management System:• Revise Charter – Don Buehler• Revise procedure 101 – J. Addey, G. Baker, S. Shepherd • Validate Current Initiatives for Alignment to Areas of Focus
Next Steps for the Strategy Development
September 9, 2004 Civil Aviation Safety Symposium 39 of 59
International Aerospace Sector International Aerospace Sector Certification SchemeCertification Scheme
Each geographic region or area is establishingEach geographic region or area is establishinga system, based on a set of agreed criteria, a system, based on a set of agreed criteria,
which defines how 9100 will be implementedwhich defines how 9100 will be implemented
The IAQG will have agreed and compatible systemsThe IAQG will have agreed and compatible systemsacceptable to all, which allows sharing of audit results acceptable to all, which allows sharing of audit results
and approvals resulting in multiple assessment reductionand approvals resulting in multiple assessment reductionand process improvementand process improvement
September 9, 2004 Civil Aviation Safety Symposium 40 of 59
What is the Goal of the System?
The goal of the system is for a supplier to receive oneaerospace quality systems approval that will be acceptable to all aerospace OEMs throughout the world.
The key element in this is confidence. The aerospace OEMs must have confidence in the approvals being performed on a global basis
All Aerospace organizations will be able to take advantage of the system for supplier control purposes
September 9, 2004 Civil Aviation Safety Symposium 41 of 59
International Requirements for International Requirements for Certification / RegistrationCertification / Registration
International AerospaceInternational AerospaceSupplier Quality SystemSupplier Quality SystemEvaluation/CertificationEvaluation/Certification
Active IndustryActive Industryparticipationparticipation
ApprovedApprovedAerospaceAerospaceAuditorsAuditors
Oversight/control Oversight/control by IAQGby IAQG
and Sectorsand Sectors
Inter-NationalInter-NationalAviation AuthorityAviation Authority
endorsementendorsement
One audit One audit accepted byaccepted byall Primesall Primes
ApprovedApprovedCert. Bodies&Cert. Bodies&
RegistrarsRegistrars
SingleSingle global standards global standards
91009100
Inter-NationalInter-National AccreditationAccreditation
controlcontrol
Harmonised systemsHarmonised systemsof applicationof application
Data easily Data easily available to allavailable to all
participantsparticipants
GlobalGlobalacceptance byacceptance bysupplier basesupplier base
September 9, 2004 Civil Aviation Safety Symposium 42 of 59
Important Considerations about Important Considerations about Certification / RegistrationCertification / Registration
• Industry Controlled ProcessIndustry Controlled Process– Includes requirements for AB’s and CRB’sIncludes requirements for AB’s and CRB’s– Includes requirements for auditorsIncludes requirements for auditors
• Training requirements are statedTraining requirements are stated– Includes requirements for reporting results of Includes requirements for reporting results of
auditsaudits– Includes minimum audit times and guidelinesIncludes minimum audit times and guidelines
• Industry involvementIndustry involvement– Must require suppliers to notify OEM’s of status of Must require suppliers to notify OEM’s of status of
Registration and any changes theretoRegistration and any changes thereto– Must report problems with RegistrarsMust report problems with Registrars– Track suppliers vs. Registrars vs performanceTrack suppliers vs. Registrars vs performance
September 9, 2004 Civil Aviation Safety Symposium 43 of 59
O.A.S.I.S. - DatabaseO.A.S.I.S. - Database
• On-line Aerospace Supplier Information On-line Aerospace Supplier Information SystemSystem
• Went “Live” 1 July 2003Went “Live” 1 July 2003– Assessments are entered by CRB’sAssessments are entered by CRB’s
• Assessment results are to be entered when Assessment results are to be entered when performed or can be entered now for performed or can be entered now for assessments prior to 1 Jul 03assessments prior to 1 Jul 03
• Organizations can access information nowOrganizations can access information now• Restricted access to dataRestricted access to data
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Why OASIS?Why OASIS?
The database is The database is essentialessential to provide independent to provide independent verification of the status of certification, thereby verification of the status of certification, thereby validating the entire other party process to stakeholdersvalidating the entire other party process to stakeholders
Enables the acceptance of a Enables the acceptance of a single assessmentsingle assessment globally globally thus preventing multiple visits / audits by multiple thus preventing multiple visits / audits by multiple stakeholdersstakeholders
Without the database OEMs would have to Without the database OEMs would have to independently verifyindependently verify each auditor, CRB and assessment each auditor, CRB and assessment resultsresults
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OASIS BenefitsOASIS Benefits
• Customers / OEM’s / SuppliersCustomers / OEM’s / Suppliers– Provides Up-to- date and complete information on Provides Up-to- date and complete information on
Aerospace QMS approvals, with data on Who, How, Aerospace QMS approvals, with data on Who, How,
When and What is Approved, including results. When and What is Approved, including results.
• AB’s / CRB’s / AuditorsAB’s / CRB’s / Auditors– Current information on Who is Approved and for What by Current information on Who is Approved and for What by
the Aerospace Industrythe Aerospace Industry
• NAAs / DoD’s and Space AgenciesNAAs / DoD’s and Space Agencies– Complete oversight information available in one source Complete oversight information available in one source
with no conflicting information (i.e. multiple data entries)with no conflicting information (i.e. multiple data entries)
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OASIS BenefitsOASIS Benefits
• OASIS should be part of the OEM / Supplier’s OASIS should be part of the OEM / Supplier’s process of supplier managementprocess of supplier management
– The database should allow a supplier to be added to an ASL The database should allow a supplier to be added to an ASL without additional showing of QMS approvalwithout additional showing of QMS approval
– OEMs need to insist that suppliers be listed in OASISOEMs need to insist that suppliers be listed in OASIS– Available to entire Aerospace Supply ChainAvailable to entire Aerospace Supply Chain
• Fee for every Fee for every INITIAL INITIAL certification/registration into the certification/registration into the IAQG-OASIS database – invoiced via the CRB.IAQG-OASIS database – invoiced via the CRB.
– The recurring fee for reassessment (normally in 3 years) – The recurring fee for reassessment (normally in 3 years) – WILL BE LESSWILL BE LESS
““If a database entry saves 1 Day of an OEM / If a database entry saves 1 Day of an OEM / supplier’s time in a QMS audit it will be worth supplier’s time in a QMS audit it will be worth the fee”the fee”
Agreed to improve the overall approach to qualityAgreed to improve the overall approach to quality
Major Aerospace Companies have agreed upon Major Aerospace Companies have agreed upon Quality Management System approval approachesQuality Management System approval approaches
A key objective is to improve performance and A key objective is to improve performance and reduce the number of auditsreduce the number of audits
There are significant benefits to the entire There are significant benefits to the entire Aerospace Industry supply chainAerospace Industry supply chain
International approach is based on agreed International approach is based on agreed standards, standards, harmonizationharmonization of system application of system application and shared informationand shared information
Industry Leaders are ListeningIndustry Leaders are Listening
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QUESTIONSQUESTIONS