oSIST prEN 9116:2022
(Main)Aerospace Series - Supplier Notice of Change (NOC)
Aerospace Series - Supplier Notice of Change (NOC)
Série aérospatiale - Avis de modification (NOC) du fournisseur
1.1 Généralités
Les industries aéronautique, spatiale et de la défense reposent sur le développement et la fabrication de produits complexes constitués de nombreux systèmes, sous-systèmes, et composants, chacun issu de concepteurs individuels (activités de conception) à plusieurs niveaux de la chaîne d'approvisionnement. Chaque activité de conception ou de fabrication maîtrise plusieurs aspects de la configuration et des spécifications liées au produit. Quand une modification de conception ou de processus est demandée ou exigée, la modification doit généralement être évaluée en fonction de ses impacts sur la totalité du système.
Les demandes de modifications des informations de conception que l’activité de conception identifie comme mineures et sans effet sur les exigences ou spécifications de leur produit peuvent être mises en œuvre et approuvées, lorsque cela est autorisé, mais requièrent une notification. Les modifications qui affectent les exigences ou les spécifications client doivent être approuvées avant leur mise en œuvre. Dans de nombreux cas, l'activité de conception n'est pas conduite par le DAH ou l'autorité de conception. L'activité de conception peut parfois se trouver plusieurs niveaux au-dessous de l'agrément de conception. Quel que soit le fournisseur au sein de la chaîne d'approvisionnement, la notification est obligatoire. Le flux de notification type est présenté à la Figure 1.
[Figure 1]
1.2 Objet [...]
1.3 Conventions [...]
Aeronavtika - Sporočilo dobavitelja o spremembi
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 9116:2022
01-junij-2022
Aeronavtika - Sporočilo dobavitelja o spremembi
Aerospace Series - Supplier Notice of Change (NOC)
Ta slovenski standard je istoveten z: prEN 9116
ICS:
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
oSIST prEN 9116:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN 9116:2022
---------------------- Page: 2 ----------------------
oSIST prEN 9116:2022
DRAFT
EUROPEAN STANDARD
prEN 9116
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2022
ICS Will supersede EN 9116:2015
English Version
Aerospace Series - Supplier Notice of Change (NOC)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee ASD-
STAN.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 9116:2022 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
Contents Page
European foreword . 3
0 Introduction . 4
0.1 Rationale . 4
0.2 Introduction . 4
1 Scope . 5
1.1 General. 5
1.2 Purpose . 6
1.3 Convention . 6
2 Normative references . 7
3 Terms and definitions . 7
4 Configuration change requirements . 9
4.1 Changes to baseline configuration. 9
4.2 Change types . 12
4.2.1 General. 12
4.2.2 Approval prior to implementation . 12
4.2.3 Customer acceptance prior to implementation . 13
4.2.4 Concurrent with Notification . 13
4.2.5 Non-configuration. 13
4.3 Change impact analysis tool . 14
5 Requirements for change analysis on behalf of the design holder . 15
5.1 General requirements . 15
5.2 Quality management system requirements . 15
5.3 Customer agreements . 15
5.4 Approval of Design Activity to Perform Change Impact Assessments . 16
5.4.1 General. 16
5.4.2 Prerequisites for change impact assessments . 16
5.4.3 Requesting and maintaining design change impact assessment approval . 16
5.4.4 Design change impact assessment processes . 17
5.5 Requirements for submission of notice of change . 17
5.6 Retained documented information . 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 . 28
Annex D (informative) Sample notice of change (NOC) form . 35
Bibliography . 40
2
---------------------- Page: 4 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
European foreword
This document (prEN 9116:2022) has been prepared by the Aerospace and Defence Industries
Association of Europe — Standardization (ASD-STAN).
This document is currently submitted to the CEN Enquiry.
After enquiries and votes carried out in accordance with the rules of this Association, this document has
received the approval of the National Associations and the Official Services of the member countries of
ASD-STAN, prior to its presentation to CEN.
This document will supersede EN 9116:2015.
3
---------------------- Page: 5 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
0 Introduction
0.1 Rationale
This document was created to define the process requirements and data expectations for the
submission of proposed changes in design and manufacturing information that requires approval of the
Design Approval Holder (DAH), when the DAH is different from the design activity. This document
provides for the organisational requirements, definitions, and data submission, including suggested
data descriptions and format (paper or electronic submission).
This revision to the document provides updated information and improves the writing clarity to
facilitate uniform submittal of supplier change notifications and/or approval when contractually
invoked at any level, including sub-tier suppliers, or as guidance within the aviation, space, and defence
industries. This document can be invoked as a stand-alone requirement or used in conjunction with
9100-series standards (i.e. 9100, 9110, 9120).
0.2 Introduction
To ensure customer satisfaction, aviation, space, and defence industry organisations needs to provide
and continually improve, safe and reliable products and services that meet or exceed customer and
applicable statutory and regulatory authority requirements. The globalization of the industry and the
resulting diversity of regional and national requirements and expectations have complicated this
objective. Organisations have the challenge of purchasing products and services from external
providers throughout the world and at all levels within the supply chain. External providers have the
challenge of delivering products and services to multiple customers with varying quality expectations
and requirements.
Industry established the International Aerospace Quality Group (IAQG), with representatives from
aviation, space and defence companies in the Americas, Asia/Pacific, and Europe, to implement
initiatives that make significant improvement in quality and reductions in cost throughout the value
stream. This international standard has been prepared by the IAQG.
This document identifies requirements for design change management and/or manufacturing process
change to a previously approved product design (baseline configuration) of the product. This includes
requirements for supplier 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. This document can be invoked as a stand-alone requirement or used in conjunction with
IAQG 9100-series standards (i.e. 9100, 9110, 9120).
4
---------------------- Page: 6 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
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 or manufacturing
activity controls various aspects of the configuration and specifications related to the product. When a
change to design or process is requested or required, the change is typically required to be evaluated
against the impacts to the entire 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 implemented and
approved, where authorized to do so, but require notification. Changes that affect customer mandated
requirements or specifications shall be approved prior to implementation. In many cases, the design
activity is not conducted by the DAH or design authority. The design activity may be several layers
below the design approval. Irrespective of the supplier is in the supply chain, notification is required.
The typical change notification flow is presented in Figure 1.
Figure 1 — Requirements for 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 organisations concerned. An objective of this document 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). A sample form can be found in the Supply Chain
Management Handbook (SCMH).
If all or part of this document is contractually invoked, design organisations and design holders (i.e. the
organization responsible for the product end item design) that have responsibility for change
management of products used on other higher-level designs need to use the information and processes
defined in this document for submitting change notifications.
5
---------------------- Page: 7 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
1.2 Purpose
This document defines the common NOC requirements for aviation, space, and defence organisations.
Included are the requirements that an internal/external supplier or subcontractor need to use when
submitting a NOC to the customer for either change authorization or notification. A NOC informs the
customer of physical or functional (e.g. design, material, software) changes or any associated process
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 in defence and space applications per contractual requirements.
Where there are changes to items which the organization does not have design input or is not permitted
to make any changes to the design [e.g. build to print, Technical Standard Order (TSO) articles]. Change
requests need to be formally submitted to the customer and approved via the customer’s change
request process.
This document is not applicable to commercial parts [off-the-shelf items not specifically designed for
aviation, space, or defence products; aka Commercial off-the-Shelf (COTS)] for which changes in
product definition is not affected or known. COTS items that are modified or altered are subject to the
requirements herein. When this document is applied to an organization that distributes product, then
this document need to be a requirement from the distribution organization to the organization from
which the product is procured.
1.3 Convention
In this document, the following terms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission; and
— “can” indicates a possibility or capability.
Words “example” or “e.g.” indicate suggestions given for guidance. Information marked “NOTE” is for
guidance in understanding or clarifying the associated requirement.
6
---------------------- Page: 8 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 9100:2018, Quality Management Systems - Requirements for Aviation, Space and Defence
1
Organizations
2
EIA – 649, National Consensus Standard for Configuration Management
SUPPLY CHAIN MANAGEMENT HANDBOOK I.A.Q.G. (SCMH) — (see IAQG website —
https://iaqg.org/tools/scmh/)
3
RTCA/DO-254, Design Assurance Guide for Airborne Electronic Hardware (EUROCAE ED-80)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in the IAQG International
4
Dictionary and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp
• IEC Electropedia: available at https://www.electropedia.org/
3.1
baseline configuration
product definition that is established by agreeing to the definition of the attributes for a product at a
point in time; identifies a known configuration to which changes are addressed
Note 1 to entry: this definition is sometimes determined jointly by the customer and the design activity (supplier)
and may require consultation with the DAH and/or design authority, if different than the customer.
3.2
change evaluator
person(s) authorized on behalf of the DAH 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
Note 1 to entry: the change evaluator could also be the customer or the producer of the end item.
1
As developed under the auspice of the IAQG and published by various standards bodies [e.g., ASD-STAN, SAE
International, European Committee for Standardization (CEN), Japanese Standards Association (JSA)/Society of
Japanese Aerospace Companies (SJAC), Brazilian Association for Technical Norms (ABNT)].
2
Published by: Electronic Industries Alliance (EIA) Publications; https://www.eia.org.
3
Published by: Radio Technical Commission for Aeronautics Inc.; https://www.rtca.org.
4)
Located on the IAQG website: https://iaqg.org/tools/dictionary/.
7
---------------------- Page: 9 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
3.3
critical item
items (e.g., functions, parts, software, characteristics, processes) having significant effect on the
provision and use of the products and services; including safety, performance, form, fit, function,
producibility, service life, etc.; that require specific actions to ensure they are adequately managed
EXAMPLE Examples of critical items include safety critical items, fracture critical items, mission critical
items, and key characteristics.
3.4
design activity
organisation that transforms customer supplied information and/or design specifications into product
attributes to establish the configuration of the product
3.5
design approval holder
(DAH)
organisation with formal approval 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 product 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); TSO/European Technical Standard
Order (ETSO); European Part Approval (EPA); European Aviation Safety Agency (EASA) Part 21 - “Design
Organisation Approval Holder”, or equivalent].
3.6
end item
item that is ultimately delivered to the end user
EXAMPLE Aircraft, vehicle, propulsion system.
3.7
key characteristics
(KC)
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
Note 1 to entry: refer to 3.3.
3.8
product
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
Note 1 to entry: the result of a process, which in the context of this standard includes any item, part, or
component used in the end item (see 3.6).
Note 2 to entry: product may include software that is embedded or field loadable in the end item.
8
---------------------- Page: 10 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
3.9
source control drawing
(SCD)
engineering description, qualification requirements, and acceptance criteria for items procurable from a
specialised segment of industry, that provides the performance, installation, interchangeability, or other
characteristics required for critical applications
Note 1 to entry: an SCD also provides visibility of approved sources and the vendor's item identification that is
qualified and approved for use in the critical application(s).
[SOURCE: adapted from ANSI/ASME Y14.24.]
3.10
special process
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 requirements
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.
Any changes in the product configuration shall be submitted to the customer and DAH if different from
the customer's. Figure 2 depicts the process when customer-delegated change evaluation is not
obtained, and Figure 3 is for organization with customer-delegated change evaluation approval.
The product baseline configuration from which changes will be evaluated may include:
a. SCD;
b. product specifications and drawings, including electronic data sets and supersession;
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 or supporting process specifications;
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.
9
---------------------- Page: 11 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
NOTE Design activity does not meet criteria of Clause 5.
Figure 2 — Flow chart for notice of change (NOC) submittal (design activity is not authorized to
analyse changes on behalf of customer)
10
---------------------- Page: 12 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
NOTE Design activity meets criteria of Clause 5.
Figure 3 — Flow chart for notice of change (NOC) submittal (design activity is authorized to
analyse changes on behalf of customer)
11
---------------------- Page: 13 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
4.2 Change types
4.2.1 General
Change types are controlled by the customer contract terms and conditions, and/or DAH. The following
apply, unless modified or changed by the customer and/or DAH.
4.2.2 Approval prior to implementation
Changes in design or design information that shall 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 SCD 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 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.
12
---------------------- Page: 14 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
4.2.3 Customer acceptance prior to implementation
The customer agreement shall determine prior acceptance requirements. Depending on product
definition or customer requirements, these types of changes to design, product manufacturing, or
product maintenance information may also require prior acceptance from the customer:
a. change to the BOM;
b. any change of a special process (type or actual process);
c. change in special process sources;
d. change in sources of supply of sub-components, including 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;
h. revision to a repair/modification drawing that changes the baseline configuration, which had been
previously approved by the DAH/design activity;
i. any change driving the need for a First Article Inspection (FAI) or partial FAI (as defined in
EN 9102).
4.2.4 Concurrent with Notification
Changes other than those described in 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 Clause 5
requirements. Any change to design information that does not require prior customer acceptance is
considered eligible for implementation and requires a NOC form to be created. Submittal of the NOC
form to the customer concurrently for any change is necessary, when required by the customer and/or
DAH.
If authority for change implementation is not granted from the customer, then changes other than those
defined in 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.
4.2.5 Non-configuration
Changes to design information that are clerical in nature or are to correct errors in previously approved
design information, and do not affect items listed in 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 document. However, these types of changes shall be
recorded and documented within the design activity’s configuration management system and records
retained per 5.5. In addition, the customer and/or DAH may negotiate with the design activity a
schedule for notification of non-configuration changes for information purposes.
Non-configuration changes may include:
a. drawing corrections; bringing documented information in line with manufacturing practices;
b. drawing corrections; elimination of clerical/typing/drafting drawing errors;
c. alteration of non-functional features, if no formal qualification testing is required, providing that
any change does not increase the envelope or weight of the unit or affect unit performance;
13
---------------------- Page: 15 ----------------------
oSIST prEN 9116:2022
prEN 9116:2022 (E)
d. addition of dash number to catalogue component drawings; does not affect existing configurations;
e. supplier order office name and address changes/additions for industry standard catalogue
components and detail parts;
f. revision of notes to incorporate latest revision of industry standards and supplier company
specifications where there is no impact on configuration or product characteristics or change to
contractual requirements;
g. addition, selection, or amendment of data/information on drawings not delivered to the customer
where there is no impact on configuration or product characteristics or change to contractual
requirements;
h. changes to the format of draw
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.