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Company Confidential

EASA Other Party Supplier Control" Workshop10 May 2011 Cologne

Presented byGuy DIONEAQG Leader

ZODIAC Aerospace

9100 Requirements

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Company Confidential 2

IAQG &9100

-Background

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IAQG Organization

International Aerospace Quality GroupInternational Aerospace Quality Group

IAQG Council

IAQG started in 1998

EAQG(Europe)

AAQG(Americas)

APAQG(Asia & Pacific)

67 Major OEMs worldwide

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IAQG Mission

Achieve significant performance improvements inQuality, Delivery, and consequently Cost, on allproducts and services throughout the value stream

Through the establishment of effective preventionoriented practices and processes

By standardising Requirements, providing Process

Guidelines and spreading Best Practices By introducing a Culture of Quality as early as

possible in the value stream thus reducing the costof poor quality

Through establishing and maintaining dynamiccooperation between international Aviation, Spaceand Defense companies

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IAQG Objectives

Establish commonality of aviation, space and defensequality systems, as documented and as applied

Establish and implement a process of continualimprovement to bring initiatives to life

Establish methods to share best practices in theaviation, space and defense industry

Coordinate initiatives and activities withregulatory/government agencies and other industryStakeholders

Only 1 management systemthroughout the whole Supply Chain

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IAQG Vision Goals

Product and Services Quality & Delivery will have

improved 20% per year throughout the productlifecycle

Robust processes achieved throughout the Supply

Chain (SCMH supplier maturity assessment level 3or better)

90% of the industry Supply Chain certified to IAQG

Quality Management System Standards

IAQG Quality management system certification(ICOP) program robust, recognized and valued

5 years IAQG Vision

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IAQG Enlarged Strategy

Enlarged IAQG Strategy defined in 2010 withaddition of topics within the 4 ImprovementStrategy streams

Definition of 2011 priorities within Enlarged

Strategy

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IAQG Initiative - QMS

Before IAQG implementation:

1 set of QMS (Quality Management System)requirements per OEM for their Aviation, Space &

Defense Suppliers

After IAQG implementation:

Only 1 set of QMS requirements fully harmonized

worldwide through the 9100 standard and usedwithin the Aviation, Space & Defense Supply Chain

Only 1 Certification scheme for organizationcompliant with 9100 standard controlled by theICOP scheme

About 70 % of Industry Supply Chain (Eligiblesuppliers) 9100 certified (IAQG goal to reach 90 %

certification rate in less than 5 years)

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9100 Principle

9100 based on ISO 9001 QualityManagement Systems Requirements

9100 with ISO 9001 structure with addition

of specific requirements for Aviation, Space &Defense Industry

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Company Confidential 11

IAQG 9100:2009

Revision Overview

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9100 Revision Objectives

Incorporate ISO 9001:2008 changes

Expand scope to include land and sea based

systems for defense applications Ensure alignment with IAQG strategy

(on-time, on-quality performance)

Adopt new requirements based onstakeholder needs

Improve existing requirements where

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

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9100:2009 Key Changes

New Definitions

Clause 3.1 Risk An undesirable situation or circumstance that has

both a likelihood of occurring and a potentiallynegative consequence.

Clause 3.2 - Special Requirements Those requirements which have high risks to

being achieved thus, requiring their inclusion inthe risk management process.

Clause 3.3 - Critical Items Those items (e.g., functions, parts, software,

characteristics, processes) having significant effect

on the product realization and use of the product;including safety, performance, form, fit, function,

producibility, service life, etc.that require specific actions to ensure they areadequately managed.

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7.1 Planning of Product Realization


7.4Purchasing -

Vendor/SupplierProvidedProducts

Statutory,Regulatory, and

Other

Requirements

CustomerRequirements

includingRequirementsidentified as

special by the

customer

7.2Determinationand Review ofRequirementsRelated to the

ProductSpecial

Requirementsas determinedby customer or

organization

7.3 Design &Development

7.3.3.e criticalitems,

including KeyCharacteristics

7.5 Production& serviceprovision

(Drawings,Instructions,

Plans. etc.)

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

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

DesignInputs

DesignOutputs

7.1.2 Risk Management

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

7.5.1appropriate

processes tomanage

critical items

7.4.2 flowdown reqtto suppliers

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Clauses 5.2/8.2.1 Customer Focus/Satisfaction

Addition:

Top management shall ensure that product conformityand on-time delivery performance are measured and

that appropriate action is taken if planned results arenot, or will not be, achieved. (5.2)

Information to be monitored and used for the evaluationof customer satisfaction shall include, but is not limited

to: product conformity

on-time delivery performance

customer complaints

corrective action requests. Organizations shall develop and implement plans for

customer satisfaction improvement that addressdeficiencies identified by these evaluations, and assessthe effectiveness of the results. (8.2.1)

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Clauses 5.2/8.2.1 Customer Focus/Satisfaction (Continued)

Rationale:

Establish clear relationship between the QMS andorganizational performance, in line with IAQGstrategy

To promote continuous improvement of customersatisfaction

Implementation/Audit Considerations:

Review of management focus and organizationalprocess to measure customer satisfaction and planimprovements

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7.1.1 - Project Management Addition:

New requirement for planning and managingproduct realization in a structured and controlled

way to meet requirements at acceptable risk,within resource and schedule constraints. Rationale:

Most aviation, space and defense products arecomplex and involve multi-tier partners and

suppliers This clause provides additional focus on upfront

planning and the management of project plansthroughout product realization


Does the organization have a process to manageproduct realization planning to ensure quality andschedule are not compromised?

How are project plans used to manage the

successful completion of projects?17

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7.1.2 - Risk Management Addition:

New requirement to implement a risk managementprocess applicable to the product and organizationcovering: responsibility, criteria, mitigation andacceptance.

The concept of risk is integrated within the revised9100.

Rationale:

Risk Management was placed in clause 7.1.2 toprovide additional focus on product risk duringproduct realization.

Implementation/Audit Considerations: Does the organization have a risk management

process that addresses all of the applicablerequirements? Is the definition of risk appropriately understood

and applied in that process? Are risks successfully managed in the

organization?


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7.1.3 - Configuration Management Revision/Relocation:

Moved from Clause 4.3 to 7.1.3.

Structured in line with ISO 10007 requirements

Rationale: Focuses configuration management on the product

and how it is sustained throughout productrealization

Implementation/Audit Considerations: Some level of configuration management is

expected for all products at all levels of the supplychain in compliance with exclusion criteria (seeclause 1.2).

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7.1.4 Work Transfer Revision/Relocation:

Moved from clause 7.5.1.4 (Production) to clause7.1.4

The organization must have a process to plan andcontrol the transfer activities

Expanded to cover permanent transfer (e.g. fromone organization to another, from one organizationto supplier, from one supplier to another).

Rationale:

Work transfer can occur at anytime during productrealization

Addresses problems that often occur during work

transfers Implementation/Audit Considerations:

A process must exist to control the transfer of workincluding planning and subsequent control of the

transfer.

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Clause 7.4.1 Recognition of Supplier Quality Data

Revision:

Added note to recognize that one factor that maybe used during supplier selection and evaluation is

objective and reliable data from external sources

Rationale:

Recognition that the industry trend is to useexternally provided supplier performance data (e.g.

Online Aerospace Supplier Information System OASIS, Nadcap)


Even though this is only a Note, IAQG encourages

use of external sources to understand supplierrisks.

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Clause 7.4.1 Approval status for suppliers

Revision:

Added and provided examples of approval status(e.g. approved, conditional, disapproved) and

examples of scope of approval (e.g. producttype, process family).

The organization must define the process forsuppliers approval status decisions or changes.

Rationale: Clarify that the conditions for using a supplier

depends on its approval status


The process, responsibilities and authority must bedefined for this process


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Clause 7.5.1.1 Production Process Verification Revision/Relocation:

Moved from 8.2 (measurement) to 7.5 (production) Requirement to verify the production processes,

documentation and tooling are capable of producing

parts and assemblies that meet requirements. Thisprocess shall be repeated when changes occur thatinvalidate the original results (e.g. engineering ormanufacturing processes changes, tooling changes).

Rationale:

Movement to clause 7 acknowledges that thisrequirement (previously called first article inspection -FAI) is not primarily a measuring and monitoringprocess, but a process that will be used to assureproduct realization capability under controlled

conditions. Allows justifiable exclusion for unique and individualproducts

Implementation/Audit Considerations: Validation of requests for exclusion (unique and

individual products vs. production run).

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In Closing

The 9100 Team goals and objectives were to:

Emphasis on product and process improvement(e.g. risk management, critical items, project management)

Expand the 9100 scope to include Aviation, Space &Defense

Provide additional focus on IAQG objective of on-time andon-quality deliveries

Ensure 9100 standard is compatible for use by allstakeholder segments and by organizations of all typesand sizes

Ensure 9100 stays recognized by authorities

Ensure extensive stakeholder involvement in revisioneffort by the use of a project management approach tosolicit input and manage the revision

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Questions

04 - 9100 requirements

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