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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
9100:2009 Key Changes
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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9100:2009 Key Changes
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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9100:2009 Key Changes
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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9100:2009 Key Changes
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
Implementation/Audit Considerations:
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?
9100:2009 Key Changes
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9100:2009 Key Changes
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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9100:2009 Key Changes
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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9100:2009 Key Changes
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)
Implementation/Audit Considerations:
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
Implementation/Audit Considerations:
The process, responsibilities and authority must bedefined for this process
9100:2009 Key Changes
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9100:2009 Key Changes
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