Aerospace series - Quality systems - Direct Delivery Authorization - Guidance for Aerospace Companies

1.1   General
Limited to the commercial aerospace industry where a request is made for a PO to have Direct Delivery Authorization (DDA), which includes an Appropriate Arrangement (AA) between the PO and the Design Organisation (DO). In this process the DO is responsible for ensuring the continuous updating of design and airworthiness data to the PO, whilst the PO is responsible for assurance that the manufactured article conforms to approved design and airworthiness data. The PO is responsible to provide airworthiness release documentation.
1.2   Purpose
This document provides guidance to a PO and DO on how to comply with the DDA, including AA requirements per the applicable documents referenced in Clause 2 (see Figure 1).
(...)

Luft- und Raumfahrt - Qualitätsmanagement - Genehmigung der Direktlieferung - Leitlinie für die Luft- und Raumfahrtindustrie

Série Aérospatiale - Systèmes qualité - Autorisation de livraison directe - Recommandations pour les compagnies aérospatiales

Aeronavtika - Sistemi vodenja kakovosti - Dovoljenje za neposredno dostavo - Navodilo za letalsko in vesoljsko industrijo

1.1   Splošno
Standard je omejen na komercialno letalsko in vesoljsko industrijo, kjer se zahteva, da ima proizvajalec (PO) dovoljenje za neposredno dostavo (DDA), ki vključuje ustrezen dogovor (AA) med proizvajalcem in projektno organizacijo (DO). V tem procesu mora projektna organizacija (DO) zagotavljati proizvajalcu stalno posodobljene podatke o projektiranju in plovnosti, medtem ko mora proizvajalec zagotavljati, da je proizvedeni izdelek skladen z odobrenimi podatki o projektiranju in plovnosti. Proizvajalec je dolžen zagotoviti dokumentacijo o potrditvi plovnosti.
1.2   Namen
Ta dokument proizvajalcu in projektni organizaciji zagotavlja smernice, kako ravnati v skladu z dovoljenjem za neposredno dostavo, vključno z zahtevami ustrezne ureditve glede na veljavne dokumente iz točke 2 (glej sliko 1).
(...)

General Information

Status
Published
Publication Date
11-Dec-2018
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
12-Dec-2018
Completion Date
12-Dec-2018

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SLOVENSKI STANDARD
SIST EN 9107:2019
01-marec-2019
Aeronavtika - Sistemi vodenja kakovosti - Dovoljenje za neposredno dostavo -
Navodilo za letalsko in vesoljsko industrijo

Aerospace series - Quality systems - Direct Delivery Authorization - Guidance for

Aerospace Companies

Luft- und Raumfahrt - Qualitätsmanagement - Autorisierung für Direktanlieferungen -

Richtlinie für die Luft- und Raumfahrtindustrie
Série Aérospatiale - Systèmes qualité - Autorisation de livraison directe -
Recommandations pour les compagnies aérospatiales
Ta slovenski standard je istoveten z: EN 9107:2018
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
SIST EN 9107:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 9107:2019
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SIST EN 9107:2019
EN 9107
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 03.120.10; 49.020
English Version
Aerospace series - Quality systems - Direct Delivery
Authorization - Guidance for Aerospace Companies

Série Aérospatiale - Systèmes qualité - Autorisation de Luft- und Raumfahrt - Qualitätsmanagement -

livraison directe - Recommandations pour les Autorisierung für Direktanlieferungen - Richtlinie für

compagnies aérospatiales die Luft- und Raumfahrtindustrie
This European Standard was approved by CEN on 11 June 2018.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9107:2018 E

worldwide for CEN national Members.
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SIST EN 9107:2019
EN 9107:2018 (E)
Contents
Page

European foreword ....................................................................................................................................................... 3

Rationale ........................................................................................................................................................................... 4

Foreword .......................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Applicable documents ................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 6

4 Direct delivery authorization requirements......................................................................................... 8

(informative) Acronym log ................................................................................................................... 11

(informative) Appropriate arrangement ........................................................................................ 12

(informative) Direct delivery authorization template ............................................................... 16

(informative) Article listing ................................................................................................................. 18

Figures

Figure 1 — Direct delivery overview...................................................................................................................... 5

Figure 2 — Direct delivery authorization process flow .................................................................................. 8

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SIST EN 9107:2019
EN 9107:2018 (E)
European foreword

This document (EN 9107:2018) 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 document 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 document shall be given the status of a national standard, either by publication of an identical text

or by endorsement, at the latest by June 2019, and conflicting national standards shall be withdrawn at

the latest by June 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
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SIST EN 9107:2019
EN 9107:2018 (E)
Rationale

This document was revised to coincide with European Union (EU) Commission Regulation

No. 748/2012 of 3 August 2012 as amended by EU Commission Regulations No. 7/2013 of

th th

8 January 2013 and No. 69/2014 of 27 January 2014, and the associated Acceptable Means of

Compliance (AMC) and Guidance Material (GM) to Part 21 of EU Commission Regulation No. 748/2012.

All other changes made to the document presented herein were editorial in nature.

Foreword

To assure customer satisfaction, the aviation, space, and defence industry organisations 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, has complicated this objective. End-product organisations face the

challenge of assuring the quality of, and integrating, 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 organisation includes representation from companies in the

Americas, Asia/Pacific, and Europe.

This document standardizes requirements for the “direct delivery” of articles from a Production

Organisation (PO); it was originally produced as a cooperative effort between the European Aviation

Safety Agency (EASA) and the IAQG. The establishment of common expectations, for use at all levels of

the supply-chain by organisations, should result in improved quality and safety, and decreased costs,

due to the elimination or reduction of organisation-unique requirements and the resultant variation

inherent in these multiple expectations.
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SIST EN 9107:2019
EN 9107:2018 (E)
1 Scope
1.1 General

Limited to the commercial aerospace industry where a request is made for a PO to have Direct Delivery

Authorization (DDA), which includes an Appropriate Arrangement (AA) between the PO and the Design

Organisation (DO). In this process the DO is responsible for ensuring the continuous updating of design

and airworthiness data to the PO, whilst the PO is responsible for assurance that the manufactured

article conforms to approved design and airworthiness data. The PO is responsible to provide

airworthiness release documentation.
1.2 Purpose

This document provides guidance to a PO and DO on how to comply with the DDA, including AA

requirements per the applicable documents referenced in Clause 2 (see Figure 1).
Key
A/W Airworthiness release documentation
Figure 1 — Direct delivery overview
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SIST EN 9107:2019
EN 9107:2018 (E)
2 Applicable documents
These include, but are not limited to.
2.1 European Aviation Safety Agency publications

a) EU Commission Regulation No. 748/2012, Annex I, Subpart G — Production Organisation Approval,

Part 21.A.133, Eligibility, paragraph (c)

b) EU Commission Regulation No. 748/2012, Annex I, Subpart G — Production Organisation Approval,

Part 21.A.165, Obligations of the holder

c) Acceptable Means of Compliance (AMC) 21.A.4, Transferring of information on eligibility and

approval status from the design holder to production organisations

d) AMC No. 1 to 21.A.133(b) and (c), Eligibility — Link between design and production organisations

e) AMC No. 2 to 21.A.133(b) and (c), Eligibility — Link between design and production organisations

2.2 Federal Aviation Administration publications

a) 14 Code of Federal Regulations (CFR) Part 21, Certification Procedures for Products, Articles, Parts

2.3 Transport Canada publications
a) Canadian Aviation Regulations (CARs) Part V — Airworthiness
3 Terms and definitions

For the purposes of this document, the following terms and definitions given in Annex A and the

following apply.
3.1
Appropriate Arrangement

documented link between a DO and PO that describes the required coordination necessary to ensure

airworthiness data and continuing airworthiness matters is satisfactory, and meets regulatory authority

requirements
3.2
approved application

designation of the product, part, appliance, etc. having design and airworthiness data approval by a

regulatory authority for which an article is eligible for installation
3.3
approved design and airworthiness data

after issuance of the Type Certificate (TC), Supplemental Type Certificate (STC), Parts Manufacturer

Approval (PMA), Technical Standard Order (TSO)/Joint Technical Standard Order (JTSO)/European

Technical Standard Order (ETSO) Authorization or equivalent by the regulatory authority, design and

airworthiness data is defined as “approved”; Items manufactured in conformity to this data are eligible

to be released using Authorised/Authorized Release Certificates (ARCs) certifying airworthiness

Note 1 to entry: The approved design and airworthiness data typically consists of drawings, material

specifications, dimensional data, processes, surface treatments, shipping conditions, quality requirements, etc.

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SIST EN 9107:2019
EN 9107:2018 (E)
3.4
article

material, part, product, component, assembly, or appliance which is listed by the DO as eligible for

installation in a type-certificated product or included in the design and airworthiness data approved by

the regulatory authority; not inclusive of standard parts
3.5
Authorised/Authorized Release Certificate
ARC

document whose purpose is to detail an aeronautical product which has been manufactured or

maintained, the data to which it conforms or was maintained to, and who manufactured or performed

the maintenance on it; in Canada, this document is known as the Transport Canada Authorized Release

Certificate – Form One; in the EASA system, it is known as the EASA Form 1; and the Federal Aviation

Administration (FAA) equivalent is the FAA Form 8130-3
3.6
constituent
part, component, or element of a larger unit/installation/assembly
3.7
Design Organisation

organisation 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., TC, STC, PMA, TSO/JTSO/ETSO Authorization, or

equivalent)
3.8
Direct Delivery Authorization
DDA

written endorsement granted by a DO to a PO that allows the PO to deliver articles to end-users,

installers, or customers; and for this purpose to use the DO’s approved design and airworthiness data to

declare an article in conformance to the regulatory approved data in order to guarantee continued

airworthiness control of the released articles
3.9
product
aircraft, aircraft engine, or propeller
3.10
Production Organisation

organisation, approved by an applicable regulatory authority, which is responsible for the manufacture

of aeronautical articles
3.11
standard part

parts for which the design, manufacturing, inspection data, and marking requirements necessary to

demonstrate conformity of the part are in the public domain, and published or established as part of

officially recognized standards
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EN 9107:2018 (E)
4 Direct delivery authorization requirements
4.1 General

The DDA process involves a DO and a PO. In a logical flow, a request for DDA is generated, an AA is

verified to have been established between the DO and PO, the DO validates airworthiness eligibility

(approved design), and the DO informs the PO of DDA approval or denial status (see Figure 2).

Figure 2 — Direct delivery authorization process flow
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EN 9107:2018 (E)
4.2 Design organisation
4.2.1 Procedures

A DO that intends to issue DDA to a PO shall develop internal procedures that, as a minimum, address:

a) the decision whether to grant or deny the PO DDA;

b) the determination of whether an AA (see Annex B) already exists with the PO, and if one does not

exist, the DO initiates the process to establish an AA that is agreed to by the PO;

c) the process used to determine an article is suitable for ultimate airworthiness certification by

ensuring the article is a constituent of a regulatory approved design (e.g., TC, STC, PMA, TSO, JTSO,

ETSO);

d) the process used and the type of documentation to transmit DDA approval or denial status to the

PO;

e) the process used to modify an existing DDA in whole or in part, and when required by the DO’s

regulatory authority to notify the DO’s regulatory authority of such modification;

f) transmission of DDA approval or denial status to the PO.
4.2.2 Direct delivery authorization

The DO shall provide DDA (see Annex C), for article(s) described in accordance with Annex D, to a PO

when:
a) a DO receives a DDA application.

b) the decision has been made by the DO to grant aftermarket rights to the PO for the article(s).

c) an AA in accordance with Annex B has been agreed to by the DO and the PO.

d) determination has been made that the article(s) is a constituent of a regulatory approved design

and is eligible for airworthiness certification.
4.2.3 Records

The DO shall issue and maintain records of DDAs, and make them available to regulatory authorities,

upon request.
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SIST EN 9107:2019
EN 9107:2018 (E)
4.3 Production organisation
4.3.1 Procedures

A PO that intends to apply for DDA to a DO shall develop internal procedures that, as a minimum,

address:
a) the process to establish an AA is in existence between the DO and the PO;
b) the process to apply to the DO for DDA;

c) the process to receive the approved design and airworthiness data and plan appropriate

manufacturing, assembly, and inspection processes sufficient to establish and declare that the

produced article is complete, conforms to the approved design and airworthiness data, and is in

condition for safe operation;
d) the process to implement granted DDAs;
e) the process to act upon modified DDAs.
4.3.2 Direct delivery authorization
The PO shall make application for DDA to a DO in accordance with Annex C.
4.3.3 Records
The PO shall maintain records and make the following available, upon request:
a) AAs between the DO and PO (see Annex B);
b) DDAs granted by the DO (see Annex C);
c) Article listings reflecting granted DDA (see Annex D).
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EN 9107:2018 (E)
(informative)
Acronym log
AA Appropriate Arrangement
AMC Acceptable Means of Compliance
ARC Authorised/Authorized Release Certificate
CARs Canadian Aviation Regulations
CFR Code of Federal Regulations
DDA Direct Delivery Authorization
DO Design Organisation
EASA European Aviation Safety Agency
ETSO European Technical Standard Order
FAA Federal Aviation Administration
GM Guidance Material
IAQG International Aerospace Quality Group
JTSO Joint Technical Standard Order
NAA National Aviation Authority
PMA Parts Manufacturer Approval
PO Production Organisation
STC Supplemental Type Certificate
TC Type Certificate
TSO Technical Standard Order
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SIST EN 9107:2019
EN 9107:2018 (E)
(informative)
Appropriate arrangement
Annex B is comprised of:

— European Aviation Safety Agency (EASA) regulatory requirements in order to comply with

European Union (EU) Commission Regulation No. 748/2012, Annex I, Subpart G — Production

Organisation Approval, Part 21.A.133 and associated Acceptable Means of Compliance

(AMC)/Guidance Material (GM) requirements, when achieved via a contractual agreement; and

— two versions of an Appropriate Arrangement (AA) template, when the arrangement is not achieved

via a contractual agreement.
B.1 European aviation safety agency regulatory requirements

B.1.1 In compliance with EU Commission Regulation No. 748/2012, Annex I, Subpart G — Production

Organisation Approval, Part 21.A.133 requirements and associated AMC/GM requirements, the Design

Organisation and the Production Organisation must ensure, through an AA satisfactory coordination

between production and design.

B.1.2 When the design organisation and the production organisation are part of the same legal entity,

the AA or interfaces may be demonstrated by company procedures accepted by the National Aviation

Authority (NAA).

B.1.3 The AA is achieved by contractual agreement or a separate agreement, see attached template.

B.1.4 The AA must satisfy the intent and the spirit of the referenced regulations.

B.1.5 An arrangement is considered “appropriate”, if it is documented and satisfies the NAA that

coordination is satisfactory.

B.1.6 To achieve satisfactory coordination, the documented arrangements must at least define the

following aspects irrespective of whether the two organisations are separate legal entities or not:

a) the responsibilities of a design organisation, which assure correct and timely transfer of up-to-date

...

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