ASD-STAN PREN 9255-2018 Aerospace series - Acceptance of supplier s design capabilities and management of Design Organisation authorisations (Edition P 1).pdf

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1、 ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM ASD-STAN prEN 9255 Edition P1 April 2018 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer 10 - 1000 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 775 8131 - www.asd-stan.orgICS: Descriptors: ENGLISH

2、 VERSION Aerospace series Acceptance of suppliers design capabilities and management of Design Organisation authorisations Luft- und Raumfahrt Abnahme der Entwicklungsfhigkeiten des Lieferanten und Steuerung der Autorisierungen des Entwicklungsbetriebes Srie arospatiale Agrment de capabilit de conce

3、ption et gestion des autorisation de lorganisme de conception dun forunisseur This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It is published for the needs of the European Aeros

4、pace Industry. It has been technically approved by the experts of the concerned Domain following member comments. Subsequent to the publication of this Prestandard, the technical content shall not be changed to an extent that interchangeability is affected, physically or functionally, without re-ide

5、ntification of the standard. After examination and review by users and formal agreement of ASD-STAN, the ASD-STAN prEN will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European Standard (EN). The CEN nati

6、onal members have then to implement the EN at national level by giving the EN the status of a national standard and by withdrawing any national standards conflicting with the EN. ASD-STAN Technical Committee approves that: “This document is published by ASD-STAN for the needs of the European Aerospa

7、ce Industry. The use of this standard is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising therefrom, is the sole responsibility of the user.” ASD-STAN reviews each standard and technical report at least every five years at wh

8、ich time it may be revised, reaffirmed, stabilized or cancelled. ASD-STAN invites you to send your written comments or any suggestions that may arise. All rights reserved. No parts of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electr

9、onic, mechanical, photocopying, recording, or otherwise, without prior written permission of ASD-STAN. Order details: E-mail: salesasd-stan.org Web address: http:/www.asd-stan.org/ Edition approved for publication 1stApril 2018 Comments should be sent within six months after the date of publication

10、to ASD-STAN Quality Domain prEN 9255:2018 (E) 2 Contents Page Introduction 3 1 Scope 4 2 Normative references 6 3 Terms, definitions and abbreviations . 6 4 Signatory authorisation per level . 9 5 Applicable DOA Requirements 11 6 Requirements for the management and cascade of design organisation aut

11、hority and signatory to supplier . 11 7 Process . 14 (informative) Typical DOID Table of content 21 Annex A(informative) Deliverables family . 22 Annex B(informative) Relationship between surveillance topics (prEN 9253 vs. prEN 9255) . 24 Annex C(informative) Relationship between prEN 9250 and prEN

12、9251 deliverables and Annex Dsignature levels . 25 prEN 9255:2018 (E) 3 Introduction This DOA Standard is part of a series developed by a joint effort of European Industry through the ASD DOA Working Group in order to: provide guidance related to the assessment of capabilities and surveillance of or

13、ganisations managing and/or performing design activities and associated tasks (e.g. tests) on behalf of organisation holding a Part 21 DOA (DOAH); share and take benefit of best practices among European Aerospace and Defence Industry. This European standard is focusing on the clauses and processes l

14、inked to the acceptance of Suppliers design capabilities and management of design organisation authorisations to subcontractors and design work-sharing partners. NOTE 1 The assessment of the suppliers capabilities might have been already performed or not by the DOA Holder and/or applicant. NOTE 2 Su

15、bcontractors or design work-sharing partners of the DOA holders or design approval holder, as intended in Part 21.A.239(c), are referred to as “design suppliers” or generically as “suppliers” in the remaining part of this standard, see also clause 3 for terms definition. Reminder: Per 21.A.239 Desig

16、n assurance system (c) The design organisation shall specify the manner in which the design assurance system accounts for the acceptability of the parts or appliances designed or the tasks performed by partners or subcontractors according to methods which are the subject of written procedures. And,

17、per 21.A.243 Data (b) Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to give, for all parts and appliances, the assurance of compliance required by poi

18、nt 21.A.239(b), and shall contain, directly or by cross-reference, descriptions and information on the design activities and organisation of those partners or subcontractors, as necessary to establish this statement. prEN 9255:2018 (E) 4 1 Scope 1.1 Deliverables and tasks The purpose of this DOA sta

19、ndard is to define generic requirements and methods for the acceptance of suppliers design capabilities and management of Design Organisation authorisations to suppliers performing design activities and/or tasks on behalf of DOAH. This European standard covers all suppliers as soon as they produce d

20、eliverables related to the design of parts or appliances (e.g. design data, compliance documents for certification activities, etc.) and/or perform the associated tasks (e.g. classification of changes to TC, execution of laboratory tests for development or compliance demonstration and associated tes

21、t data results collection and documentation). Any designing of parts or appliances or any execution of associated tasks performed by persons not directly employed by the DOAH should be considered as work being subcontracted, and therefore could be eligible to the cascade of authorisation as defined

22、in this European standard (refer to Table 1 in 1.2). Examples of tasks which can be subcontracted are: laboratory testing, test set-up and/or inspection; design data and drawings; stress analysis; qualification of software/equipment; instructions for continued airworthiness. Examples of tasks which

23、can be delegated are: technical endorsement of laboratory testing, test set-up and/or inspection; technical endorsement of design data and drawings; technical endorsement of stress analysis; technical endorsement of qualification of software/equipment; classification of changes and approval of minor

24、 changes at product level; classification of repairs and approval of minor repairs at product level; technical endorsement of Instructions for continued airworthiness. This European standard is applicable for: initial design during product development (type certificate/STC/RTC process): subcontracto

25、rs contribution to the preparation of compliance documents to be used by TC/STC applicant in the frame of the certification activities; changes to the type certificate/STC/RTC; repairs; engineering decision over unintentional manufacturing deviations. prEN 9255:2018 (E) 5 1.2 Signature rules 1.2.1 G

26、eneral Deliverables to be produced by a supplier might require up to three levels of signatures. 1.2.2 Level 1 Signature This is a signature for technical endorsement of the deliverable (e.g. design data might require only a Level 1 signature, when not used as compliance documents as intended in Par

27、t 21), see 4.1 for more details. 1.2.3 Level 2 Signature This is the signature by a compliance verification engineer, as defined in Part 21.A.239(b) (e.g. a compliance document requires at least a Level 1 and a Level 2 signatures), see 4.2 for more details. NOTE Per AMC 21.A.239(b)(1) The independen

28、t checking function of the demonstration of compliance should consist of the verification by a person not creating the compliance data. Such person may work in conjunction with the individuals who prepare compliance data. 1.2.4 Level 3 Signature This is a signature by an authorised signatory of a DO

29、AH for the exercise of its Part 21.A.263 privileges (e.g. classification of changes to TC, approval of minor changes to TC), see 4.3 for more details. Three levels of signature authorisations can be granted by the DOA holder to its suppliers. The granting of signatory authorisations to suppliers doe

30、s not relieve the DOAH of its DOA obligations as per Part 21 requirements. The Table 1 below provides a synthesis of the scope covered by this standard with the associated deliverable/signatory level. Table 1 Deliverable scope versus applicable signatory level Deliverables are non-product related De

31、liverables are product relatedaLevel 1 DesignbLevel 2 Independent Check Level 3 Release N/A Preparation Validation Acceptance Verification Airworthiness release The activity is not relevant for this European standard. The activity is relevant for this European standard. aThe use of this standard has

32、 been developed for deliverables directly linked to aeroplanes and rotorcrafts, engine or propeller certification without any credit from ETSO/TSO approval if any. This standard needs to be adapted if credit from ETSO/TSO approval is sought. bThe number of required signatures and the associated allo

33、cation of responsibilities within Level 1 are defined by the DOAH applicable procedure and associated deliverable template. prEN 9255:2018 (E) 6 A Level 1 signature authorisation is a an authorisation to a supplier to sign a deliverable requiring at least a Level 1 signature, Level 2 and Level 3 sig

34、nature authorisations are for the signature of a deliverable requiring Level 2 and/or Level 3 signatures. Level 2 authorisation implies a Level 1 authorisation has been already granted. NOTE External CVE acting on behalf of the DOAH and not pertaining to DOAH or Suppliers organisation is allowed but

35、 not covered by the general rules of the current version of the standard. A Level 3 authorisation implies that: a Level 2 authorisation has been already granted, except when authorised scope covers only deliverables without additional work to demonstrate compliance; a Level 1 authorisation has been

36、already granted. The minimum requirements being: one signature for each applicable level; independence is needed between the individual holding a Level 1 signature used to demonstrate the compliance and the individual holding the Level 2 signature performing the verification of the demonstration of

37、compliance. 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 documen

38、t (including any amendments) applies. When there is a conflict between this European Standard and any other normative reference (with the exception of European law), the present European Standard, developed to support compliance to European aviation safety regulation, prevails except when the suppli

39、er elects to comply with more restrictive/stringent requirements. EN 9130, Aerospace series Qualitiy systems Record retention EMAR 21 (or other equivalent European Military Requirements), Certification of military aircraft and related products, parts and appliances and design and production organisa

40、tions prEN 9253, Aerospace series Surveillance of Design Suppliers 3 Terms, definitions and abbreviations For the purposes of this document, the following terms, definitions and abbreviations apply. 3.1 Terms, definitions 3.1.1 Design Organisation DO organisation requesting or holding a design appro

41、val issued by EASA or under Part 21 DOA privileges, or to its design supplier. Design approvals can be (supplemental/restricted) type certificates (TC), European technical standard orders authorisations (ETSOA), design changes to TC/repair designs prEN 9255:2018 (E) 7 Note 1 to entry: For the case o

42、f design suppliers, they act on behalf of their company and their company has received a delegation/authorisation from the DOAH. Therefore, an agreement should be set up in order to clarify the roles and responsibilities of each one within the design and certification activities. 3.1.2 design suppli

43、er third party person or organisation contracted by the DOAH to design parts or appliances and/or execute associated tasks, see 1.1 for a definition of associated tasks Note 1 to entry: In this European standard, the term “supplier” is used for “design supplier”. 3.1.3 deliverable document (or data

44、set and/or record of activities) which is required to be produced by the design organisation for its design approval or continued airworthiness processes 3.1.4 delegation of nomination authority delegation to a supplier to: nominate individuals authorised to sign deliverables; grant signature author

45、isations 3.1.5 work package set of activities for the design of parts or appliances and/or associated tasks contracted to a supplier; a work-package may require the production of deliverables 3.1.6 DOA holder TC/STC holder, ETSOA holder, or change/repair design approval holder organisation Note 1 to

46、 entry: Per Part 21.A.2 “Undertaking by another person than the applicant for, or holder of, a certificate”. The actions and obligations required to be undertaken by the holder of, or applicant for, a certificate for a product, part or appliance under this section may be undertaken on its behalf by

47、any other natural or legal person, provided the holder of, or applicant for, that certificate can show that it has made an agreement with the other person such as to ensure that the holders obligations are and will be properly discharged. 3.1.7 product aircraft, engine or propeller Note 1 to entry:

48、The term “aircraft” is defined in the European regulation (EC 216/2008) and includes aeroplanes and rotorcrafts. SOURCE: Regulation (EC) No. 2016/2008 3.1.8 parts and appliances any instrument, equipment, mechanism, part, apparatus, appurtenance, software or accessory, including communications equip

49、ment, that is used or intended to be used in operating or controlling an prEN 9255:2018 (E) 8 aircraft in flight; it shall include parts of an airframe, engine or propeller, or equipment used to manoeuvre the aircraft from the ground SOURCE: Regulation (EC) No. 2016/2008 3.1.9 aircraft machine that can derive support in the atmosphere from the reactions of the air other than the reactions of the air against the earths surface (per CS-Definition) 3.1.10 engine engine used or intended to be used for air