Emerging Aerospace Requirements for Quality Management Systems (Aerospace Standard 9100)

Jet Propulsion LaboratoryCalifornia Institute of Technology

Emerging Aerospace Requirements for Quality Management Systems (Aerospace Standard 9100)

Jack FletcherSr. Specialist, JPL/NASA Quality [email protected]

IAQGIAQG(International Aerospace(International Aerospace

Quality Group) Quality Group) --

IAQG Executive Briefing PackIAQG Executive Briefing PackMay 2008

IAQG Executive Briefing PackIAQG Executive Briefing Pack

… … a Global Teama Global TeamInternational Aerospace Quality GroupInternational Aerospace Quality Group

IAQGCouncil

General Assembly Forums

AAQG (Americas)

EAQG(Europe)

APAQG(Asia & Pacific)

20 AAQG

members32 EAQGmembers

12 APAQGmembers

Every Major Aerospace company in the World

IAQG MembershipIAQG Membership


AmericasAmericas• ATKATK• The Boeing CompanyThe Boeing Company• Bombardier AerospaceBombardier Aerospace• EmbraerEmbraer• GE AviationGE Aviation• Goodrich Corporation Goodrich Corporation • GulfstreamGulfstream• Honeywell AerospaceHoneywell Aerospace• L-3 Communications L-3 Communications • Lockheed Martin Lockheed Martin • Northrop GrummanNorthrop Grumman• OrbitalOrbital• Parker AerospaceParker Aerospace• RaytheonRaytheon• Rockwell CollinsRockwell Collins• Rolls-Royce North AmericaRolls-Royce North America• Spirit AerosystemsSpirit Aerosystems• Textron – Bell HelicopterTextron – Bell Helicopter• United Technologies Corp.United Technologies Corp.• VoughtVought• SAE *SAE *

AsiaAsia• AIDC (Aerospace IndustrialAIDC (Aerospace Industrial

Development Corp)Development Corp)• AVIC 1AVIC 1• AVIC 2AVIC 2• Fuji Heavy Industries Fuji Heavy Industries • Hawker de HavillandHawker de Havilland• Indonesian AerospaceIndonesian Aerospace• IHIIHI• Kawasaki Heavy IndKawasaki Heavy Ind• Korea Aerospace IndKorea Aerospace Ind• Korean Air AerospaceKorean Air Aerospace• Mitsubishi Heavy IndMitsubishi Heavy Ind• SMICSMIC• SJAC *SJAC *

*: Sponsor*: Sponsor

EuropeEurope• AgustaWestlandAgustaWestland• AirbusAirbus• ALENIAALENIA• AvioAvio• BAE SystemsBAE Systems• Dassault AviationDassault Aviation• EADSEADS• EADS – CASAEADS – CASA• EADS MilitaryEADS Military• EurocopterEurocopter• GE Aviation SystemsGE Aviation Systems• Hegan Hegan • Hispano-Suiza Hispano-Suiza • Israel Aerospace IndustriesIsrael Aerospace Industries• LiebherrLiebherr• MBDAMBDA• Messier-BugattiMessier-Bugatti• Messier-DowtyMessier-Dowty• MTU Aero engineMTU Aero engine• PFWPFW• RAFAELRAFAEL• Rolls-RoyceRolls-Royce• SAAB AerospaceSAAB Aerospace• SAFRANSAFRAN• SNECMASNECMA

Europe Europe – – ContinuedContinued

• SONACASONACA• Stork Fokker AerostructuresStork Fokker Aerostructures• SukhoiSukhoi• THALESTHALES• TurbomecaTurbomeca• Volvo – AeroVolvo – Aero• ZodiacZodiac• ASD * /ASD * / ASD-EASE * ASD-EASE *

IAQG PurposeIAQG Purpose Implement initiatives that make significant Implement initiatives that make significant

improvements in Quality and reductions in costimprovements in Quality and reductions in cost

throughout the value streamthroughout the value stream

by establishing and maintaining dynamicby establishing and maintaining dynamic cooperation between internationalcooperation between international aerospace and defense companiesaerospace and defense companies


Reducing costs andReducing costs and Improving Quality performanceImproving Quality performance

ObjectivesObjectives


Establish common Quality standards and requirementsEstablish common Quality standards and requirements Common aerospace basic quality systemsCommon aerospace basic quality systems Best practices in aerospace industryBest practices in aerospace industry Performance metricsPerformance metrics

Minimize risk and waste through shared oversightMinimize risk and waste through shared oversight AuditsAudits InspectionsInspections Sharing Supply Chain performance informationSharing Supply Chain performance information

Establish common process of continual improvementEstablish common process of continual improvement Bring initiative to life through pragmatic implementation plansBring initiative to life through pragmatic implementation plans and maximise benefit to the whole industryand maximise benefit to the whole industry

Obtain key stakeholders concurrence, Obtain key stakeholders concurrence, including Regulatory Authoritiesincluding Regulatory Authorities

Only 1 management systemOnly 1 management systemthroughout the whole Supply Chainthroughout the whole Supply Chain

64 members companies, all key OEM’s64 members companies, all key OEM’s

Dedicated working teamsDedicated working teamswith representation of 3 sectorswith representation of 3 sectors

Council & General Assembly ForumsCouncil & General Assembly ForumsTwice a yearTwice a year

Council:Council:Forum of IAQG members setting IAQG policy, purposeForum of IAQG members setting IAQG policy, purposeand objectives, review/approval of proposed initiatives,and objectives, review/approval of proposed initiatives,responsible of oversight and implementation activitiesresponsible of oversight and implementation activities

General Assembly:General Assembly:Communication Forum extended to the worldwideCommunication Forum extended to the worldwideAerospace community (OEMs & Suppliers)Aerospace community (OEMs & Suppliers)


OperationsOperations

An efficient way to operate globallyAn efficient way to operate globally

IAQG was launched

in 1998

IAQG StrategyIAQG StrategyFoundations - DefinitionsFoundations - Definitions

IAQG Strategy is to develop and promote IAQG Strategy is to develop and promote implementation of Common Standards, Shared implementation of Common Standards, Shared Auditing and Continual Improvement methods and Auditing and Continual Improvement methods and tools;tools;

• Assuring Customer Satisfaction through Assuring Customer Satisfaction through On-TimeOn-Time, , On-QualityOn-Quality Delivery of products and services, Delivery of products and services, through the through the lifecyclelifecycle

• Delivering exactly Delivering exactly whawhat the customer ordered, t the customer ordered, exactly exactly whenwhen we agreed to we agreed to

deliver itdeliver it


Assure safety & mission with no wasted costAssure safety & mission with no wasted cost

IAQG Strategic GoalIAQG Strategic Goal


Lifecycle On-Time, On-Quality Delivery (OTOQD)Lifecycle On-Time, On-Quality Delivery (OTOQD) Continual Improvements through Continual Improvements through PeoplePeople, , ProcessesProcesses and and ToolsTools

On Time On Quality

• Product Delivery

• Spares & Services Delivery

• Parts and Data at all levels in the chain

• Reduced inventory

• Continual Safety Improvement• Maturity, Reliability & Cost of Ownership• Freedom from Design & Manufacturing defects• Reduced Waste

• On-Time, On-Quality Delivery generates continual reduction of costs

On Cost

Step change inStep change inPerformancePerformance


Strategic FocusStrategic FocusAligned to Address ChallengesAligned to Address Challenges

Relationship Growth Strategy• Civil Authorities• Space• Defense• Trade Associations

ImprovementStrategy

• Requirements

• People Capability • Product & Supply

Chain Improvement

IAQG Operating Management SystemIAQG Other Party Management Team

IAQG Financial Budgeting & EstimatingIAQG Communications Team

3 Axes3 Axes

Improvement StrategyImprovement Strategy RequirementsRequirements

Establish, Develop, and Maintain Industry Qualityrequirements to improve product and process

integrity

People CapabilityDevelop the competency of, and support for,Those engaged in Supply Chain processes, in allfunctions, to deliver continual improvements inOTOQD

Product & Supply Chain improvementDevelop and deploy guidance material tocontinuously improve On Time On Quality Delivery throughout the entire value stream

IAQG Executive Briefing PackIAQG Executive Briefing Pack3 Improvement streams3 Improvement streams

Relationship Relationship Growth StrategyGrowth Strategy

Civil Airworthiness RelationshipCivil Airworthiness Relationship• Working together with the international airworthiness Working together with the international airworthiness

authorities to enable local design, production and certification authorities to enable local design, production and certification with global acceptancewith global acceptance

International Space ForumInternational Space Forum• Working towards global convergence to harmonised Working towards global convergence to harmonised

standards and certificationstandards and certification

Defense RelationshipDefense Relationship • Coordination with NATO and defense organizations to adopt Coordination with NATO and defense organizations to adopt

simpler, common standardssimpler, common standards

Trade Associations RelationshipTrade Associations Relationship • Establish relationships with other aviation industry Trade Establish relationships with other aviation industry Trade

Associations whose purpose and objectives overlap those of Associations whose purpose and objectives overlap those of the IAQGthe IAQG

IAQG Executive Briefing PackIAQG Executive Briefing PackWorking together to develop a Working together to develop a singlesingle voice voice

ActionsActionsSetting Common StandardsSetting Common Standards

Requirements to harmonise the Quality Requirements to harmonise the Quality Management SystemManagement System

• 9100 – Aerospace Quality Management System 9100 – Aerospace Quality Management System Standard cornerstone of our initial focusStandard cornerstone of our initial focus

• 9110 – Maintenance and Repair Stations9110 – Maintenance and Repair Stations• 9120 – Distributors/Stockists9120 – Distributors/Stockists


Improving quality performanceImproving quality performanceandand reducing costs reducing costs

ActionsActionsSetting Common StandardsSetting Common Standards

Requirements to raise product integrityRequirements to raise product integrity 9102 - First Article Inspection9102 - First Article Inspection 9103 - Variation Management of Key Characteristics9103 - Variation Management of Key Characteristics 9107 - Direct Delivery Authorization9107 - Direct Delivery Authorization 9114 - Direct Shipment9114 - Direct Shipment 9131 - Non-conformance Management9131 - Non-conformance Management 9132 - Data Matrix Quality Requirements for Parts 9132 - Data Matrix Quality Requirements for Parts

MarkingMarking NAS410 - Harmonized NDT Personnel QualificationNAS410 - Harmonized NDT Personnel Qualification 9134 - Global Supplier Risk Management9134 - Global Supplier Risk Management 9162 - Operator Self Verification9162 - Operator Self Verification

Other work in progress – Supply Chain Management Other work in progress – Supply Chain Management Handbook, People Competencies Management, Handbook, People Competencies Management, Software…Software…


Agenda for change, pursued with constancy of purposeAgenda for change, pursued with constancy of purpose

ActionsActionsShared Auditing and MeasuringShared Auditing and Measuring

ICOP (Industry Controlled Other Party)ICOP (Industry Controlled Other Party)


Accreditation Bodies

Certification Bodies

Suppliers

Industry

2nd party audits

accreditation

3rd partyCertificationfor ISO 9001

The ‘traditional’ scheme

Suppliers

Accreditation Bodies

Certification Bodies

Suppliers

Industry

Other partyCertificationfor 9100/9110/9120

The Aerospace ‘ICOP’ scheme

Auditors

Approval and

oversight

Surveillance based

on risk analysis

&product audit

certification

ActionsActionsShared Auditing and MeasuringShared Auditing and Measuring

Checklists for auditors – 9101 (QMS), - 9111 (Maintenance), - 9121 Checklists for auditors – 9101 (QMS), - 9111 (Maintenance), - 9121 (Stockists / Distributors)(Stockists / Distributors)

9104 – Industry Controlled Other-Party (ICOP) oversight program 9104 – Industry Controlled Other-Party (ICOP) oversight program for consistent implementationfor consistent implementation

Supported by a web hosted database, IAQG Online Aerospace Supported by a web hosted database, IAQG Online Aerospace Supplier Information System (OASIS)Supplier Information System (OASIS)

OASIS figures (April 2008):OASIS figures (April 2008):• 9100 + supplier sites (growing rate 2000 per year)9100 + supplier sites (growing rate 2000 per year)

[30 % coverage of aerospace suppliers (expected to become 35%)][30 % coverage of aerospace suppliers (expected to become 35%)]• 18000 + registered users18000 + registered users• 740 registered Aerospace Auditors740 registered Aerospace Auditors• 90 + approved Certification Bodies90 + approved Certification Bodies

IAQG Executive Briefing PackIAQG Executive Briefing PackA Global business requires Global solutionsA Global business requires Global solutions

AchievementsAchievements IAQG members agree standards to use internally IAQG members agree standards to use internally

and with suppliersand with suppliersOne voice, Minimize variation, Shared resources, Reduced One voice, Minimize variation, Shared resources, Reduced

duplication and wasteduplication and waste • Global Aerospace Quality StandardGlobal Aerospace Quality Standard• System for third party approvalSystem for third party approval• Shared supplier approval databaseShared supplier approval database• Recognition by the authorities FAA, EASA, NASA,…Recognition by the authorities FAA, EASA, NASA,…• Standard industry documentationStandard industry documentation• Open sharing of “Best Practices” Open sharing of “Best Practices” • Rapid consensus & deploymentRapid consensus & deployment

IAQG Executive Briefing PackIAQG Executive Briefing Pack… … Across Aviation, Space, and DefenseAcross Aviation, Space, and Defense

BenefitsBenefits IAQG members agree to use standards internally and IAQG members agree to use standards internally and

with supplierswith suppliersOne voice, Minimize variation, Shared resources, Reduced One voice, Minimize variation, Shared resources, Reduced

duplication and wasteduplication and waste Focus on the complete supply chain and stakeholdersFocus on the complete supply chain and stakeholders True global Aerospace cooperation and harmonizationTrue global Aerospace cooperation and harmonization Higher quality products at reduced costHigher quality products at reduced cost Fewer , customer-unique , documentsFewer , customer-unique , documents System for Third Party approvalSystem for Third Party approval Shared supplier approval databaseShared supplier approval database Recognition by Regulatory AuthoritiesRecognition by Regulatory Authorities Open sharing of “Best Practices”Open sharing of “Best Practices” Networking with Quality Directors / VPs in Primes and Networking with Quality Directors / VPs in Primes and

SuppliersSuppliers Rapid consensus & deploymentRapid consensus & deployment

IAQG Executive Briefing PackIAQG Executive Briefing Pack… … Across Aviation, Space, and DefenseAcross Aviation, Space, and Defense

BenefitsBenefits Benefits due to:Benefits due to:

• Reduction of duplicate auditing costsReduction of duplicate auditing costsFor OEM’s & for suppliersFor OEM’s & for suppliers

• Transfer of auditing & accreditation costs Transfer of auditing & accreditation costs downstream to suppliers (to be customised to downstream to suppliers (to be customised to audience)audience)

• Released previous auditing resources to higher Released previous auditing resources to higher value tasksvalue tasks

• Other IAQG effects (Sharing of better practices, useOther IAQG effects (Sharing of better practices, use of same techniques and methods) improving of same techniques and methods) improving

product quality product quality IAQG Executive Briefing PackIAQG Executive Briefing Pack

DeliveringDelivering

Reduced costReduced cost

Reduced riskReduced risk

Improved QualityImproved Quality


IAQG 9100:2008IAQG 9100:2008 Overview Overview

Prepared by IAQG 9100 TeamPrepared by IAQG 9100 Team

9100 Revision Objectives9100 Revision Objectives Incorporate ISO 9001:2008 changesIncorporate ISO 9001:2008 changes Expand scope to include space and land / sea Expand scope to include space and land / sea

based systems for defense applicationsbased systems for defense applications Ensure alignment with IAQG strategy (on-time, Ensure alignment with IAQG strategy (on-time,

on-quality performance)on-quality performance) Adopt new requirements based on stakeholder Adopt new requirements based on stakeholder

needsneeds Improve existing requirements where Improve existing requirements where

stakeholders identified need for clarification, stakeholders identified need for clarification, including when a documented procedure is including when a documented procedure is required.required.

Formal BallotFormal Ballot• May 2008May 2008Limit date for commentsLimit date for comments• August 2008August 2008IAQG MeetingIAQG Meeting• Oct 2008Oct 2008

• Preparation for Formal Sector Preparation for Formal Sector BallotBallot

• Development of deployment Development of deployment support materialsupport material

9100 Revision Process9100 Revision Process

New ISO 9001 scheduleNew ISO 9001 schedule(TC176 changed their estimated (TC176 changed their estimated release date from June 2009 to release date from June 2009 to October 2008)October 2008)

9100 9100 Formal Formal BallotBallotMay May 20082008

New ISO 9001 scheduleNew ISO 9001 schedule(TC176 changed their estimated (TC176 changed their estimated release date from June 2009 to October release date from June 2009 to October 2008)2008)Revision Effort Completion: Nov 2008Revision Effort Completion: Nov 2008

Structure of Key Changes SlidesStructure of Key Changes Slides• Revision/Relocation, Addition, or DeletionRevision/Relocation, Addition, or Deletion• RationaleRationale• Implementation/Audit ConsiderationsImplementation/Audit Considerations

9100 Revision Key Changes 9100 Revision Key Changes (Covered in this (Covered in this presentation)presentation)• 5 Additions5 Additions• 6 Revisions/Relocations6 Revisions/Relocations• 3 Deletions3 Deletions

9100 Change Overview9100 Change Overview

9100:2008 Key Changes9100:2008 Key Changes

Clause 1 - Clause 1 - 9100 Scope and Application9100 Scope and Application• Revision: Revision:

Scope extended to include Defense as well as Aviation and SpaceScope extended to include Defense as well as Aviation and Space Application guidance provided when 9100, 9110, and 9120 are Application guidance provided when 9100, 9110, and 9120 are

appropriate for useappropriate for use• Rationale:Rationale:

The 9100 based QMS is applicable to other complex systems and The 9100 based QMS is applicable to other complex systems and would receive benefit from implementation including land and sea would receive benefit from implementation including land and sea based applicationsbased applications

Possible additional recognition and synergies with NATO Allied Possible additional recognition and synergies with NATO Allied Quality Assurance Publications (AQAPs)Quality Assurance Publications (AQAPs)

• Implementation/Audit Considerations:Implementation/Audit Considerations: Increased use and improved understanding of when the various Increased use and improved understanding of when the various

aviation, space, and defense standards are applicable.aviation, space, and defense standards are applicable.


Clause 3.1 - Clause 3.1 - RiskRisk• Addition:Addition: Define new term “risk” Define new term “risk”

An undesirable situation or circumstance that has both a An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative likelihood of occurring and a potentially negative consequence. consequence.

• Rationale:Rationale: The understanding of risk is important The understanding of risk is important for an for an organization to develop a proactive quality organization to develop a proactive quality management system management system

• Implementation/Audit Considerations:Implementation/Audit Considerations: Understanding this term is important to implement a Understanding this term is important to implement a

risk management process in the applicable clauses.risk management process in the applicable clauses.

9100:2008 Key Changes9100:2008 Key Changes Clause 3.2 - Clause 3.2 - Special RequirementsSpecial Requirements

• Addition:Addition: Define new term “special requirements” Define new term “special requirements” Those requirements which have high risks to being Those requirements which have high risks to being

achieved thus, requiring their inclusion in the risk achieved thus, requiring their inclusion in the risk management process. management process.

Factors used to determine special requirements Factors used to determine special requirements include:include:

•product or process complexityproduct or process complexity•past experiencepast experience•product or process maturity. product or process maturity.

Examples include:Examples include:•performance requirements imposed by the customer performance requirements imposed by the customer that are at the limit of the state-of-the-artthat are at the limit of the state-of-the-art

•requirements determined by the organization to be at requirements determined by the organization to be at the limit of their technical or process capabilities.the limit of their technical or process capabilities.


Clause 3.2 - Clause 3.2 - Special Requirements Special Requirements (Continued)(Continued)• Rationale: Rationale:

Improve understanding of “Special Requirements” and Improve understanding of “Special Requirements” and the potential chain of flow to “Critical Items” and to “Key the potential chain of flow to “Critical Items” and to “Key Characteristics.” Characteristics.”

Ensure these important requirements are systemically Ensure these important requirements are systemically addressed and linked to risk management activities by addressed and linked to risk management activities by the organization. the organization.

• Implementation/Audit Considerations: Implementation/Audit Considerations: Understanding this term is important to implement Understanding this term is important to implement

special requirement processes in the applicable clauses.special requirement processes in the applicable clauses.


Clause 3.3 - Clause 3.3 - Critical ItemsCritical Items• Addition:Addition: Define new term “critical item” Define new term “critical item”

Those items (e.g., functions, parts, software, Those items (e.g., functions, parts, software, characteristics, processes) having significant effect characteristics, processes) having significant effect on the product realization and use of the product; on the product realization and use of the product; including safety, performance, form, fit, function, including safety, performance, form, fit, function, producibility, service life, etc.; that require specific producibility, service life, etc.; that require specific actions to ensure they are adequately managed. actions to ensure they are adequately managed.

Examples of critical items include:Examples of critical items include:•safety critical itemssafety critical items• fracture critical itemsfracture critical items•mission critical itemsmission critical items•key characteristicskey characteristics


Clause 3.3 - Clause 3.3 - Critical ItemsCritical Items (Continued) (Continued)• Rationale:Rationale:

Improve understanding of “Critical Items” coming from Improve understanding of “Critical Items” coming from Special Requirements. Special Requirements.

Ensure these important requirements are systemically Ensure these important requirements are systemically addressed and linked to risk management activities by addressed and linked to risk management activities by the organization.the organization.

• Implementation/Audit Considerations:Implementation/Audit Considerations: Understanding this term is important to implement Understanding this term is important to implement

critical items processes in the applicable clauses.critical items processes in the applicable clauses.

7.1 Planning of Product Realization


7.4Purchasing -

Vendor/ SupplierProvidedProductsStatutory,

Regulatory, and Other

Requirements

Customer Requirements

includingRequirements

flagged as special by the

customer

7.2 Determination and Review of Requirements Related to the

Product Special Requirements as determined

as by customer or organization

7.3 Design & Development

7.3.3.e Critical items,

including KCs

7.5 Production & service provision

(Drawings, Plans.

Instructions, Etc.)

8.2.3/8.2.4 - Monitoring & Measurement of Processes/Products8.4 Analysis of Data

8.5 Improvement (CI, C/A, P/A)

Design Inputs

Design Outputs

7.1.2 Risk Management

Interrelationship between Special Requirements, Critical Items, Key Characteristics, and Risk Management process


Clause 4.2.2 – Clause 4.2.2 – Quality Manual RelationshipsQuality Manual Relationships• Deletion:Deletion: Requirement to create a document Requirement to create a document

showing the relationship between 9100 showing the relationship between 9100 requirements and the organizations documented requirements and the organizations documented proceduresprocedures

• Rationale: Rationale: Requirement adds no value to assuring product Requirement adds no value to assuring product

qualityquality• Implementation/Audit Considerations:Implementation/Audit Considerations:

Auditors need to identify appropriate Auditors need to identify appropriate documented procedures as an inherent part of documented procedures as an inherent part of carrying out the auditcarrying out the audit

9100:2008 Key Changes9100:2008 Key Changes Clauses 5.2/8.2.1 – Clauses 5.2/8.2.1 – Customer Focus/SatisfactionCustomer Focus/Satisfaction

• Addition:Addition: Management responsibility for measuring “product Management responsibility for measuring “product

conformity” and “on-time delivery” and for taking conformity” and “on-time delivery” and for taking appropriate remedial actions (5.2)appropriate remedial actions (5.2)

Requirement to evaluate customer satisfaction using Requirement to evaluate customer satisfaction using specific QMS information, then develop plans that address specific QMS information, then develop plans that address deficiencies (8.2.1)deficiencies (8.2.1)

• Rationale:Rationale: Establish clear relationship between the QMS and Establish clear relationship between the QMS and

organizational performance, in line with IAQG strategy organizational performance, in line with IAQG strategy To promote continuous improvement of customer To promote continuous improvement of customer

satisfactionsatisfaction• Implementation/Audit Considerations:Implementation/Audit Considerations:

Review of management focus and organizational process Review of management focus and organizational process to measure customer satisfaction and plan improvementsto measure customer satisfaction and plan improvements

9100:2008 Key Changes9100:2008 Key Changes 7.1.1 - 7.1.1 - Project ManagementProject Management

• Addition:Addition: New requirement for planning and managing product New requirement for planning and managing product

realization in a structured and controlled way to meet realization in a structured and controlled way to meet requirements at acceptable risk, within resource and requirements at acceptable risk, within resource and schedule constraints.schedule constraints.

• Rationale:Rationale: Most aviation, space and defense products are complex Most aviation, space and defense products are complex

and involve multi-tier partners and suppliers and involve multi-tier partners and suppliers This clause provides additional focus on upfront planning This clause provides additional focus on upfront planning

and the management of project plans throughout product and the management of project plans throughout product realization realization

• Implementation/Audit Considerations:Implementation/Audit Considerations: Does the organization have a process to manage product Does the organization have a process to manage product

realization planning to ensure quality and schedule are not realization planning to ensure quality and schedule are not compromised?compromised?

How are project plans used to manage the successful How are project plans used to manage the successful completion of projects?completion of projects?

7.1.2 - 7.1.2 - Risk ManagementRisk Management• Addition:Addition:

New requirement to implement a risk management process New requirement to implement a risk management process applicable to the product and organization covering: applicable to the product and organization covering: responsibility, criteria, mitigation & acceptanceresponsibility, criteria, mitigation & acceptance

• Rationale:Rationale: Risk Management was placed in clause 7.1.2 to provide Risk Management was placed in clause 7.1.2 to provide

additional focus on product risk during product realization.additional focus on product risk during product realization.• Implementation/Audit Considerations:Implementation/Audit Considerations:

Does the organization have a risk management process Does the organization have a risk management process that addresses all of the applicable requirements?that addresses all of the applicable requirements?

Is the definition of risk appropriately understood and applied Is the definition of risk appropriately understood and applied in that process?in that process?

Are risks successfully managed in the organization? Are risks successfully managed in the organization? Concept of risk is intertwined within the revised 9100.Concept of risk is intertwined within the revised 9100.


7.1.3 - 7.1.3 - Configuration ManagementConfiguration Management• Revision/Relocation:Revision/Relocation:

Moved from Clause 4.3 to 7.1.3.Moved from Clause 4.3 to 7.1.3. Structured in line with ISO 10007 requirementsStructured in line with ISO 10007 requirements

• Rationale:Rationale: Focuses configuration management on the product Focuses configuration management on the product

and how it is sustained throughout product realizationand how it is sustained throughout product realization• Implementation/Audit Considerations:Implementation/Audit Considerations:

Some level of configuration management is expected Some level of configuration management is expected for all products at all levels of the supply chainfor all products at all levels of the supply chain


9100:2008 Key Changes9100:2008 Key Changes 7.1.4 – 7.1.4 – Work TransferWork Transfer

• Revision/Relocation:Revision/Relocation: Moved from clause 7.5.1.4 (Production) to clause Moved from clause 7.5.1.4 (Production) to clause

7.1.47.1.4 The organization must have a process to plan and The organization must have a process to plan and

control the transfer activitiescontrol the transfer activities Expanded to cover permanent transferExpanded to cover permanent transfer

• Rationale:Rationale: Work transfer can occur at anytime during product Work transfer can occur at anytime during product

realizationrealization Addresses problems that often occur during work Addresses problems that often occur during work

transferstransfers• Implementation/Audit Considerations:Implementation/Audit Considerations:

A process must exist to control the transfer of work A process must exist to control the transfer of work including planning and subsequent control of the including planning and subsequent control of the transfer.transfer.


Clause 7.4.1 – Clause 7.4.1 – Recognition of Supplier Quality DataRecognition of Supplier Quality Data• Revision:Revision:

Added note to recognize that one factor that may be Added note to recognize that one factor that may be used during supplier selection and evaluation is used during supplier selection and evaluation is objective and reliable data from external sourcesobjective and reliable data from external sources

• Rationale:Rationale: Recognition that the industry trend is to use Recognition that the industry trend is to use

externally provided supplier performance dataexternally provided supplier performance data• Implementation/Audit Considerations:Implementation/Audit Considerations:

Note onlyNote only


Clause 7.4.3 – Clause 7.4.3 – Validation of Test ReportsValidation of Test Reports• Deletion:Deletion: Where the organization utilizes test reports to Where the organization utilizes test reports to

verify purchased product, the data in those reports shall be verify purchased product, the data in those reports shall be acceptable per applicable specifications. The organization acceptable per applicable specifications. The organization shall periodically validate test reports for raw material.shall periodically validate test reports for raw material.

• Rationale:Rationale: Misunderstood concept that was frequently misappliedMisunderstood concept that was frequently misapplied Unable to develop a process applicable to all Unable to develop a process applicable to all

stakeholdersstakeholders• Implementation/Audit Considerations:Implementation/Audit Considerations:

If an organization is making critical items where the If an organization is making critical items where the material chemical/physical requirements are important, material chemical/physical requirements are important, are they verifying test reports as part of their risk are they verifying test reports as part of their risk management process.management process.


Clause 7.5.1.1 – Clause 7.5.1.1 – Production Process VerificationProduction Process Verification• Revision/Relocation:Revision/Relocation:

Moved from 8.2.4.2 (measurement) to 7.5.1.1 (production) Moved from 8.2.4.2 (measurement) to 7.5.1.1 (production) Requirement to verify the production processes, Requirement to verify the production processes,

documentation and tooling are capable of producing parts and documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original repeated when changes occur that invalidate the original results (e.g. engineering or manufacturing processes results (e.g. engineering or manufacturing processes changes). changes).

• Rationale:Rationale: Movement to clause 7 acknowledges that this requirement is Movement to clause 7 acknowledges that this requirement is

not primarily a measuring and monitoring process, but a not primarily a measuring and monitoring process, but a process that will be used to assure product realization under process that will be used to assure product realization under controlled conditions.controlled conditions.

Allows justifiable exclusion for unique and individual productsAllows justifiable exclusion for unique and individual products• Implementation/Audit Considerations:Implementation/Audit Considerations:

Validation of requests for exclusion (unique and individual Validation of requests for exclusion (unique and individual products vs. production run).products vs. production run).


Clause 8.2.2 – Clause 8.2.2 – Detailed Tools and TechniquesDetailed Tools and Techniques• Deletion: Deletion:

““Detailed tools and techniques shall be developed Detailed tools and techniques shall be developed such assuch as check sheets, process flowcharts, check sheets, process flowcharts, or any similar methodor any similar method to support audit of the quality management system to support audit of the quality management system requirements. The acceptability of the selected tools will requirements. The acceptability of the selected tools will be measured against the effectiveness of the internal audit be measured against the effectiveness of the internal audit process and overall organization performance.”process and overall organization performance.”

• Rationale:Rationale: RedundantRedundant to the ISO text and to the ISO text and too prescriptivetoo prescriptive. Reference . Reference

to specific tools in a “such as” statement is more to specific tools in a “such as” statement is more appropriate as guidance material.appropriate as guidance material.

• Implementation/Audit Considerations:Implementation/Audit Considerations: Methods and effectiveness measures remain intact in the Methods and effectiveness measures remain intact in the

ISO text. Tools and techniques may still be needed to ISO text. Tools and techniques may still be needed to support the audit process. support the audit process.


Clause 8.2.4 –Clause 8.2.4 –Sampling InspectionSampling Inspection• Revision:Revision:

When the organization uses sampling inspection as a means When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be of product acceptance, the sampling plan shall be justified on justified on the basis of recognized statistical principles and appropriate the basis of recognized statistical principles and appropriate for usefor use (i.e., matching the sampling plan to the criticality of the (i.e., matching the sampling plan to the criticality of the product and to the process capability).product and to the process capability).

• Rationale:Rationale: Numerous requests were received to improve clause 8.2.4. Numerous requests were received to improve clause 8.2.4.

The comments ranged from that it was The comments ranged from that it was statistically inaccuratestatistically inaccurate, , to that it was to that it was too prescriptivetoo prescriptive. .

• Implementation/Audit Considerations:Implementation/Audit Considerations: Validation of recognized statistical principles utilized.Validation of recognized statistical principles utilized. Process used to determine criticality of product.Process used to determine criticality of product.

Proposed 9100 Implementation Proposed 9100 Implementation ScheduleSchedule

PublicationDate

+ 6Months

+ 18Months

+ 30Months

6 Months 12 Months 12 Months

DevelopAuditorTraining

Train Certification Bodiesand Auditors

All Companies toUpgrade to New Std

At Next Surveillance AuditOr Re-Certification

Maximum 30 month Implementation from PublicationMaximum 30 month Implementation from Publication

Earliest Opportunityfor Certification to

New Standard(i.e. the early adopters)

MaximumAllowedTime toUpgrade

In ClosingIn Closing The 9100 Team goals and objectives were to:The 9100 Team goals and objectives were to:

• Expand the 9100 scope to include Aviation, Space & Expand the 9100 scope to include Aviation, Space & Defense Defense

• Provide additional focus on IAQG objective of on-time Provide additional focus on IAQG objective of on-time and on-quality deliveriesand on-quality deliveries

• Ensure 9100 standard is compatible for use by all Ensure 9100 standard is compatible for use by all stakeholder segments and by organizations of all types stakeholder segments and by organizations of all types and sizesand sizes

• Ensure 9100 stays recognized by authoritiesEnsure 9100 stays recognized by authorities• Ensure extensive stakeholder involvement in revision Ensure extensive stakeholder involvement in revision

efforteffort• Use a project management approach to solicit input and Use a project management approach to solicit input and

manage the revisionmanage the revision

The key changes are not inclusive of all the changes in the 9100 standard.


Questions????

.

www.sae.org/aaqg /

www.iaqg.org.


Thank You

Jack Fletcher

[email protected]

817-964-8116

mailto:[email protected]






Documents

Emerging Aerospace Requirements for Quality Management Systems (Aerospace Standard 9100)