SIST EN 9116:2016

SLOVENSKI STANDARD
SIST EN 9116:2016
01-marec-2016
$HURQDYWLND=DKWHYH]DVSRURþLORRVSUHPHPEDK
Aerospace series - Notice of Change (NOC) Requirements
Luft- und Raumfahrt - Anforderungen an eine Änderungsmitteilung
Série aérospatiale - Avis de modification
Ta slovenski standard je istoveten z: EN 9116:2015
ICS:
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
SIST EN 9116:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 9116:2016

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SIST EN 9116:2016


EN 9116
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2015
EUROPÄISCHE NORM
ICS 49.020
English Version

Aerospace series - Notice of Change (NOC) Requirements
Série aérospatiale - Avis de modification Luft- und Raumfahrt - Anforderungen an eine
Änderungsmitteilung
This European Standard was approved by CEN on 26 September 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9116:2015 E
worldwide for CEN national Members.

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EN 9116:2015 (E)
Contents Page
European foreword . 3
RATIONALE . 4
1 Scope . 5
1.1 General . 5
1.2 Application . 5
2 Normative references . 6
3 Terms and definitions . 7
4 Configuration change definitions . 8
4.1 Changes to baseline configuration . 8
4.2 Change types . 12
4.2.1 Changes that require customer acceptance prior to implementation . 12
4.2.2 Changes that may require customer acceptance prior to implementation . 12
4.2.3 Changes implemented concurrent with notification for customer acceptance . 13
4.2.4 Changes – non-configuration . 13
4.3 Change impact analysis tool . 14
5 Requirements for organizations to obtain authorization to analyze changes on
behalf of customer . 15
5.1 Quality management system requirements . 15
5.2 Customer agreements . 15
5.3 Approval of design activity to perform change impact assessments . 16
5.3.1 Prerequisites for design activities to perform change impact assessments . 16
5.3.2 Requesting and maintaining design change impact assessment approval . 16
5.3.3 Design change impact assessment processes and procedures . 17
5.4 Requirements for data submission of notice of change . 17
5.5 Record retention . 18
6 NOTES . 18
Annex A (informative) Acronym log . 19
Annex B (informative) Supplier Notification of Change (NOC) – Change Impact Analysis
(CIA) logic tree . 20
Annex C (informative) List of Notice of Change (NOC) data . 26
Annex D (informative) Sample Notice of Change (NOC) form . 33


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EN 9116:2015 (E)
European foreword
This document (EN 9116:2015) has been prepared by the Aerospace and Defence Industries
Association of Europe - Standardization (ASD-STAN).
After enquiries and votes carried out in accordance with the rules of this Association, this European
Standard has received the approval of the National Associations and the Official Services of the member
countries of ASD, prior to its presentation to CEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
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RATIONALE
This European Standard was created to define the process requirements and data expectations for the
submission of proposed changes in design information that requires concurrent approval of the design
authority, when the design authority is different from the design activity. This European Standard
provides for the organizational requirements, definitions, and data submission, including suggested
data descriptions and format (paper or electronic submission).
This European Standard was created to provide for the uniform submittal of change notifications
and/or approval when contractually invoked at any level or as guidance within the aviation, space, and
defence industries. This European Standard can be invoked as a stand-alone requirement or used in
conjunction with 9100-series standards (i.e., 9100, 9110, 9120).
To assure customer satisfaction, aviation, space, and defence industry organizations must produce and
continually improve safe, reliable products that meet or exceed customer and regulatory authority
requirements. The globalization of the industry and the resulting diversity of regional/national
requirements and expectations have complicated this objective. End-product organizations face the
challenge of assuring the quality and integration of product purchased from suppliers throughout the
world and at all levels within the supply chain. Industry suppliers and processors face the challenge of
delivering product to multiple customers having varying quality expectations and requirements.
The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG)
for the purpose of achieving significant improvements in quality and safety, and reductions in cost
throughout the value stream. This organization includes representation from companies in the
Americas, Asia/Pacific, and Europe. This international standard has been prepared by the IAQG.
A change process consists of design change management and/or manufacturing process change to a
previously approved design (baseline configuration) of the product. This document standardizes
requirements for Notice of Change (NOC) data definition and documentation for the aviation, space, and
defence industries. The establishment of common requirements for use at all levels of the supply-chain
is intended to improve quality, safety, and decrease costs by the elimination or reduction of
organization-unique requirements and the resultant variation inherent in these multiple expectations.
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1 Scope
1.1 General
The aviation, space, and defence industries rely on the development and manufacture of complex
products comprised of multiple systems, subsystems, and components each designed by individual
designers (design activities) at various levels within the supply chain. Each design activity controls
various aspects of the configuration and specifications related to the product. When a change to design
information is requested or required, the change has to be evaluated against the impacts to the higher-
level system.
Proposed changes to design information that the design activity identifies to be minor and have no
effect on their product requirements or specifications have the potential to be concurrently
implemented and approved, where authorized to do so. Changes that affect customer mandated
requirements or specifications shall be approved prior to implementation. In many cases, the design
activity is not the design approver or authority; ultimate approval may be several layers above the
design activity. The typical flow of design requirements to the supplier, from the design authority, and
the change notification flow is presented in Figure 1.
REQUIREMENTS
Supplier Integrator Design Holder Design Authority

SUPPLIER CHANGE NOTIFICATION
Design Activity Change Evaluator (Customer) Design Authority
Figure 1 — Typical design requirements and change notification flow
Submitting NOC data either electronically or conventionally on paper is subject to the terms and
conditions of the customer’s contract. This also includes, where applicable, data access under the
regulations of export control.
The process of exchanging, coordinating, and approving NOC data varies with the multiple relationships
and agreements among all organizations concerned. The information provided by this European
Standard forms the architecture for submitting and managing data that allows for concise and accurate
communication using various methods. One objective of this European Standard is to provide the
definition of a data set that can be integrated into any form of communication (e.g., electronic data
interchange, submission of conventional paper forms).
If all or part of this European Standard is invoked in the contract, design activities and design holders
(i.e., the organization responsible for the design) that have responsibility for change management of
products used on other higher-level designs shall use the information and processes defined in this
European Standard, and in accordance with the contract, for submitting change notifications to
customers.
1.2 Application
This European Standard defines the common NOC requirements for aviation, space, and defence
organizations. Included are the requirements that an internal/external supplier or subcontractor shall
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use when submitting a NOC to the customer for either change authorization or notification. A NOC
informs the customer of physical or functional (including software) changes to an established baseline
configuration. Retention of the NOC establishes a means of configuration control and captures the
evolution of the part. This requirement is of utmost importance in commercial/civil aviation products
where changes to type certificated products are mandated by regulations. However, these same
concepts are also required to some degree in defence and space applications per contractual
requirements.
This European Standard is not applicable to products that are manufactured by a supplier to their
customer's designs and processing requirements (also known as build-to-print). Change requests to
this type of product shall be formally submitted to the customer and approved via the customer’s
change request process. Additionally, this European Standard is not applicable to commercial parts (off-
the-shelf items not specifically designed for aviation, space, or defence products) for which changes in
product definition is not affected or known, but change to commercial parts that are known (i.e., change
in definition from one commercial part number to a different commercial part number) shall be
processed in accordance with this European Standard.
When this European Standard is applied to an organization that distributes product, then this European
Standard shall be a requirement from the distribution organization to the organization from which the
product is procured. The distribution organization may act as a conduit for the NOC or the design
activity (supplier) may work directly with the design authority (customer). The distributor should be
compliant with the 9120 standard, as defined by customer requirements.
Application or implementation of this European Standard in any form, either expressed or implied, is
not allowed for product which has escaped the supplier’s quality system.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies. When a
conflict in requirements between this document and referenced standards exists, the requirements of
this document shall take precedence. Nothing in this document, however, supersedes applicable laws
and regulations, unless a specific exemption has been obtained.
EN 9100, Quality Management Systems — Requirements for Aviation, Space and Defence Organizations
EN 9110, Quality Management Systems — Requirements for Aviation Maintenance Organizations
EN 9120, Quality Management Systems — Requirements for Aviation, Space, and Defence Distributors
NOTE Equivalent versions (e.g., AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published
internationally in each sector.
ANSI/ASME Y14.24, Types and Applications of Engineering Drawings [document available from
American National Standards Institute (ANSI); www.ansi.org]
ARP9034, A Process Standard for the Storage, Retrieval and Use of Three-Dimensional Type Design Data
EIA – 649, National Consensus Standard for Configuration Management [document available from
Electronic Industries Alliance (EIA) Publications; www.eia.org]
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
RTCA/DO-254 (EUROCAE ED-80), Design Assurance Guide for Airborne Electronic Hardware [document
available from Radio Technical Commission for Aeronautics Inc.; www.rtca.org]
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3 Terms and definitions
Definitions for general terms can be found in ISO 9000 and the IAQG Dictionary, which is located on
the IAQG website. An acronym log for this European Standard is presented in Annex A. For the
purpose of this European Standard, the following shall apply:
3.1
baseline configuration
the design definition for the physical product and its performance requirements from which design
change control can then take place. This is determined jointly by the customer and the design activity
3.2
change evaluator
the person authorized on behalf of the design authority to assess the potential impact of the change(s),
evaluates changes for the potential impact on the fit, form, or functionality of the part, system, or
assembly and failure to meet the customer requirements. The change evaluator could also be the
customer or the producer of the end item and/or the design authority.
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 are adequately managed.
Examples of critical items include safety critical items, fracture critical items, mission critical items, key
characteristics, etc.
3.4
deliverable
any design data provided to the customer which represents the product provided
3.5
design activities
the supplier design activity or subcontractor that owns the design and provides a deliverable to the
customer
3.6
design authority
an organization with formal authority for the design, validation, and service support of a product
Note 1 to entry: In civil aviation, this is the organization responsible for the design of articles or for changes
thereto that is the holder of a design approval granted by a regulatory authority [i.e., Type Certificate (TC);
Supplemental Type Certificate (STC); Parts Manufacturer Approval (PMA); Technical Standard Order
(TSO)/European Technical Standard Order (ETSO); European Part Approval (EPA); European Aviation Safety
Agency (EASA) Part 21 - “Design Organization Approval Holder”, or equivalent].
3.7
end item
the item that is ultimately delivered to the end user (e.g., vehicle, propulsion system)
3.8
key characteristics
an attribute or feature whose variation has a significant effect on product fit, form, function,
performance, service life, or producibility that requires specific actions for the purpose of controlling
variation (refer to section 3.3)
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3.9
mandatory
a requirement that shall be fulfilled or common transferable data that shall be provided and
systematically recorded
3.10
optional
any data field that is not defined as mandatory by this European Standard, including any special data
fields requested by the customer or the originator
3.11
product
any aviation, space, and defence vehicle, engine, propeller, airframe part or equipment (within that
vehicle) to be used in operating or controlling a vehicle in flight. The result of a process, which in the
context of this European Standard, includes finished detailed parts, assemblies, forgings, and castings.
Note 1 to entry: Product may include software that is embedded or field loadable in the end item.
3.12
Source Control Drawing (SOCD)
provides an engineering description, qualification requirements, and acceptance criteria for items
procurable from a specialized segment of industry, that provide the performance, installation,
interchangeability, or other characteristics required for critical applications. Furthermore, it may
provide a list of approved sources of supply and the vendor's item identification that have been
qualified and approved for use in the critical application(s).
Note 1 to entry: Adapted from ANSI/ASME Y14.24.
3.13
special process
a process where the resulting output cannot be verified by subsequent monitoring or measurement and
as a consequence, deficiencies become apparent only after the product is in use or has been delivered
4 Configuration change definitions
4.1 Changes to baseline configuration
A baseline configuration is an agreed configuration definition against which compliance was shown
(e.g., certification baseline). Baseline configuration is captured by design data and is typically retained
by the design activity. The baseline configuration shall clearly define the design characteristics and
performance requirements of the product, including acceptance conditions of the products to the lowest
level of detail necessary to produce the product and ensure compliance with all applicable
requirements of the customer.
All changes to previously customer accepted baseline configurations shall be evaluated and approved.
Until the requirements of section 5 are satisfied, each change (from the lowest level in the supply chain)
shall be submitted to the customer and ultimately to the design authority for concurrence to implement.
Figure 2 depicts the process when customer delegated change evaluation is not obtained and Figure 3 is
for organization’s with customer delegated change evaluation approval.
The product baseline configuration from which changes will be evaluated may include:
a. SOCD.
b. Product specifications and drawings, including electronic data sets and supersession.
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c. Bill of Materials (BOM), including definition of spare or substitute parts which may be used in
repair, but have different definition than those of baseline configuration parts.
d. Process specifications in accordance with contractual requirements.
e. Manufacturing methods, as shown on engineering drawings.
f. Product usage/function/systems application, which may include:
• Effect of product failure on system application.
• Identification of key components, processes, and/or characteristics, as applicable.
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Figure 2 — Flow chart for Notice of Change (NOC) submittal
(Design Activity is NOT Authorized to Analyze Changes on Behalf of Customer)
NOTE Design activity does NOT meet criteria of section 5.
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Figure 3 — Flow chart for Notice of Change (NOC) submittal
(Design Activity is Authorized to Analyze Changes on Behalf of Customer)
NOTE Design activity meets criteria of section 5.
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4.2 Change types
Change types are controlled by the customer and/or design authority. The following are default
categories that shall apply, unless modified or changed by the customer/design authority.
4.2.1 Changes that require customer acceptance prior to implementation
These are changes in design or design information that will always require prior acceptance from the
customer, unless otherwise stated in the contract:
a. Any change that affects product airworthiness or safety.
b. Any change to product function.
c. Any change affecting a SOCD or top-level drawing.
d. Any change to product performance tolerances specified by customer or product definition.
e. Weight, balance, or moment of inertia change outside of specification requirements.
f. Change affecting interchangeability, compatibility, maintainability, or repairability at customer
serviceable level.
g. Electromagnetic characteristics or signature change.
h. Change in product technical data, including Qualification Test Plan (QTP) or Acceptance Test Plan
(ATP); see section 4.2.1.q.
i. Any change in installed software/firmware that changes the software identity or functionality.
j. Change affecting environmental interactions (e.g., use of hazardous/prohibited materials).
k. Change affecting traceability of a required traceable item.
l. Any change to a ‘frozen’ design or process.
m. Change to customer identified ‘critical items’ or ‘key characteristics’.
n. Change that negatively impacts contractual prices, schedules, or deliveries to the customer.
o. Change that positively or negatively impact Failure Modes and Effects Analysis (FMEA) or Failure
Review and Corrective Action System (FRACAS) information originally approved.
p. Any change of electronic or specific component.
q. Any change to tooling or gages used for product acceptance.
4.2.2 Changes that may require customer acceptance prior to implementation
Depending on product definition or customer requirements, these types of changes to design
information may also require prior acceptance from the customer. The customer agreement shall
determine prior acceptance requirements.
a. Change to the BOM.
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b. Any change of a special process (type or process).
c. Change of special process sources.
d. Change in sources of supply of sub-components, may include obsolescence.
e. Change in manufacturing methods, including changes to specified tolerances.
f. Change in location of manufacture for the end item.
g. Change to manuals or instructional material which has been provided to the customer (e.g.,
component maintenance manuals, shop manuals).
h. Revision to a repair/modification drawing that changes the baseline configuration, which had been
previously approved by the design holder/design authority.
4.2.3 Changes implemented concurrent with notification for customer acceptance
Changes other than those described in sections 4.2.1, and potentially 4.2.2, may be implemented and
delivered prior to customer acceptance, if the authority to proceed is granted in accordance with
section 5 requirements. Any change to design information that does not require prior customer
acceptance is considered eligible for implementation and requires a NOC record to be created.
Submittal of the NOC record to the customer concurrently for any change is necessary, when required
by the customer/design authority.
If authority for change implementation is not granted from the customer, then changes other than those
defined in sections 4.2.1, and potentially 4.2.2, may be implemented at the risk of the design and
manufacturing activities, but shall not be delivered to the customer pending acceptance.
4.2.4 Changes – non-configuration
Changes to design information that are clerical in nature or are to correct errors in previously approved
design information, and do not effect items listed in sections 4.2.1, 4.2.2, and 4.2.3, do not have to be
reported or documented via the NOC process defined in this European Standard. However, these types
of changes do have to be recorded and documented within the design activities’ configuration
management system and records retained per section 5.5. In addition, the design authority/customer
may negotiate with the design holder/supplier a schedule for notification of non-configuration changes
for information purposes.
Examples of non-configuration changes include:
a. Drawing corrections; bringing records in line with manufacturing practices.
b. Drawing corrections; elimination of clerical/typing/drafting drawing errors.
c. Addition of instructional information and/or inspection requirements to a drawing, but shall not
remove or modify without prior approval.
d. Alteration of non-functional features, as long as, no formal qualification testing is required,
providing that any change does not increase the envelope of the unit or affect unit performance.
e. Addition of dash number to catalogue component drawings; does not affect existing configurations.
f. Supplier order office name and address changes/additions for industry standard catalogue
...