1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM prEN 9114 Edition P 2 March 2014 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.org ICS: 49.060 Supersedes edition P 1 of
2、 August 2005 Descriptors: ENGLISH VERSION Aerospace series Quality systems Direct Ship Guidance for Aerospace Companies Srie arospatiale Systme qualit Expdition Directe Recommandations pour compagnies arospatiales Luft- und Raumfahrt Qualittsmanagement Direkt Anlieferungen Richtlinie fr die Luft- un
3、d Raumfahrtindustrie 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 Aerospace Industry. It has been technically approved by the ex
4、perts 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-identification of the standard. After examination and review
5、 by users and formal agreement of ASD-STAN, it 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 national members have then to implement the EN at national level by giving t
6、he EN the status of a national standard and by withdrawing any national standards conflicting with the EN. Edition approved for publication 1st March 2014 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2014 by ASD-STAN prEN 9114:2014 (E)
7、2 Contents Page Foreword 2 Rationale 3 Foreword 3 1 Scope 4 2 Applicable documents 4 3 Terms and definitions . 5 4 Direct ship requirements 6 5 Notes . 9 Appendix A (informative) ACRONYM LOG .10 FIGURES Figure 1 Direct ship overview . 4 Figure 2 Direct ship flow . 7 Foreword This standard was review
8、ed by the Domain Technical Coordinator of ASD-STANs Quality Domain. After inquiries and votes carried out in accordance with the rules of ASD-STAN defined in ASD-STANs General Process Manual, this standard has received approval for Publication. prEN 9114:2014 (E) 3 Rationale This document was revise
9、d to coincide with the 14 Code of Federal Regulations (CFR) Part 21, “Certification Procedures for Products, Articles, and Parts”, re-write published October 16, 2009 under Docket No. FAA-2006-25877 and associated policy and guidance material made by the Federal Aviation Administration (FAA). All ot
10、her 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 requirement
11、s. The globalisation 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
12、 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 p
13、urpose 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 standardises requirements for the direct shipment of articles fro
14、m a supplier of an approved manufacturer to a customer of an approved manufacturer and was originally produced as a cooperative effort between the FAA and the IAQG. The establishment of common expectations, for use at all levels of the supply-chain by organisations, should result in improved quality
15、 and safety, and decreased costs, due to the elimination or reduction of organisation-unique requirements and the resultant variation inherent in these multiple expectations. prEN 9114:2014 (E) 4 1 Scope 1.1 General Limited to the aerospace industry, where an approved manufacturer requests a supplie
16、r to ship an article against the approved manufacturers quality system directly to a customer. The direct ship process is not required or applicable to standard parts or military parts. In this process the approved manufacturer is responsible for assurance that the article conforms to type design in
17、formation. 1.2 Purpose This document provides guidance to approved manufacturers, their suppliers, and customers when an approved manufacturer requests a supplier to ship an article against the approved manufacturers purchase document directly to a customer, commonly known as “Direct Ship” (see Figu
18、re 1). Figure 1 Direct ship overview 2 Applicable documents These include, but are not limited to: 2.1 European aviation safety agency publications: a. Commission Regulation (EC) No 748/2012 Annex l (also called Part 21) b. European Aviation Safety Agency (EASA) Annex l to Executive Director (ED) De
19、cision 2102/020R also called Acceptable Means of Compliance (AMC) and Guidance Material (GM) to Part 21 prEN 9114:2014 (E) 5 2.2 Federal aviation administration publications: a. FAA Advisory Circular (AC) 20-62, “Eligibility, Quality, and Identification of Aeronautical Replacement Parts” b. FAA AC 2
20、1-29, “Detecting and Reporting Suspected Unapproved Parts” c. FAA AC 21-43, “Production Under 14 CFR Part 21, Subparts F, G, K, and O” d. 14 CFR Part 21, “Certification Procedures for Products, Articles, and Parts” 3 Terms and definitions An acronym log for this standard is presented in Appendix A.
21、For the purpose of this standard, the following definitions are used: 3.1 Approved manufacturer also known as Production Approval Holder (PAH) A manufacturer that is responsible for the quality of an article and has obtained the right to use a design from the design approval holder (may be the same
22、entity). This is the holder of a Production Certificate (PC), Parts Manufacturer Approval (PMA), Technical Standard Order (TSO) authorisation, Production Organisation Approval (POA), European Technical Standard Order (ETSO) authorisation, or other production approval issued by any National Aviation
23、Authority (NAA). 3.2 Article Material, part, product, component, assembly, or appliance which is listed by the approved manufacturer as eligible for installation in a type certificated product or included in the design data approved by the regulatory authority, not inclusive of standard parts. 3.3 C
24、ustomer The recipient of a direct ship article (e.g., owner/operator, repair station, distributor). 3.4 Delegated inspection The delegation of inspection authority to a supplier on behalf of the approved manufacturer. 3.5 Direct ship authorisation The written authorisation granted by an approved man
25、ufacturer to a supplier to ship articles directly to a customer, without the articles being processed through the approved manufacturers own facility. The direct ship authorisation may be limited in scope. Some examples of limitations include part number(s), time period, and customer(s). 3.6 Direct
26、ship declaration A written statement from the supplier that accompanies a direct ship article stating the article was produced under the terms of the approved manufacturers production approval. 3.7 Product An aircraft, aircraft engine, or propeller. prEN 9114:2014 (E) 6 3.8 Standard part A part manu
27、factured in compliance with an established government or industry-accepted specification that contains design, manufacturing, and uniform identification requirements. The specification must include all information necessary to produce and conform the part, and must be published so that any person/or
28、ganisation may manufacture the part. 3.9 Statement of Conformance (SOC) Evidence provided by the supplier certifying the article conforms to approved data. 3.10 Supplier The furnisher of articles or related services, at any tier, to an approved manufacturer. 4 Direct ship requirements 4.1 General Th
29、e direct ship process involves an approved manufacturer, a supplier, and a customer. In a chronological flow, the customer requests an approved manufacturer to provide an article and delineates any special requirements. The approved manufacturer determines that the article is to be ordered/produced/
30、delivered from a supplier and requests the supplier to ship the article directly to the customer. The contracts are between the customer and the approved manufacturer, and again between the approved manufacturer and the supplier (see Figure 2). In some cases, the approved manufacturer allows the cus
31、tomer to buy directly from the supplier. In those cases, the supplier should obtain permission from the approved manufacturer for this arrangement. 4.2 Approved manufacturer 4.2.1 Procedures An approved manufacturer that intends to issue direct ship authorisation to a supplier must have approved qua
32、lity procedures that will compensate for the absence of inspections normally conducted at the approved manufacturers facility. Compensating factors shall include onsite evaluations of the supplier and the inspection of the article as either: a. Source inspection performed by the approved manufacture
33、r; or b. Inspection by the supplier under a delegated inspection authority from the approved manufacturer. 4.2.2 Direct ship authorisation The approved manufacturer shall provide direct ship authorisation to a supplier. 4.2.3 Records The approved manufacturer shall issue and maintain records of dire
34、ct ship authorisation and make them available to regulatory authorities, upon request. prEN 9114:2014 (E) 7 Figure 2 Direct ship flow 4.2.4 Flow down of direct ship requirements to suppliers The approved manufacturer shall obligate the supplier to: a. Direct ship the article. b. Meet any special cus
35、tomer requirements accepted by the approved manufacturer. c. Maintain evidence of direct ship authorisations granted by the approved manufacturer. d. Maintain evidence of direct shipments made on behalf of the approved manufacturer. e. Provide with the shipment a signed direct ship declaration. f. P
36、rovide with the shipment a signed/stamped SOC certifying that the article conforms to approved data. g. Provide with the shipment traceability to the customer purchase request. prEN 9114:2014 (E) 8 h. Provide evidence with the shipment that acceptance or inspection has been accomplished by the appro
37、ved manufacturer or through a delegated inspection authority. i. When delegated inspection is used, provide with the shipment a statement that delegation of inspection authority has been granted by the approved manufacturer, and that the inspection was performed on behalf of the approved manufacture
38、r. 4.2.5 Special considerations for foreign customers An approved manufacturer must ensure the requirements of the importing country will be met, prior to authorising direct shipment to a customer located in a foreign country. 4.3 Supplier 4.3.1 Records The supplier shall maintain records of and mak
39、e them available, upon request: a. Direct ship authorisation by the approved manufacturer. b. Direct shipments made on the behalf of the approved manufacturer. 4.3.2 Compliance The supplier shall adhere to all approved manufacturer flow down requirements, including: a. Direct ship the article. b. Pr
40、ovide a signed direct ship declaration with the shipment. c. Provide a signed/stamped SOC certifying that the article conforms to approved data with the shipment. d. Provide evidence with the shipment that acceptance or inspection has been accomplished by the approved manufacturer or through a deleg
41、ated inspection authority. When delegated inspection is used, also provide with the shipment a statement that delegation of inspection authority has been granted by the approved manufacturer and that the inspection was performed on behalf of the approved manufacturer. e. Show traceability with the s
42、hipment to the customer purchase request. f. The requirements of the importing country will be met prior to shipment to a customer located in a foreign country. 4.4 Customer 4.4.1 Examination of direct ship articles Customers who receive articles shipped under an approved manufacturers direct ship a
43、uthority shall examine the articles and the accompanying documentation to ensure the airworthiness condition of the articles is adequately established. prEN 9114:2014 (E) 9 4.4.2 Documentation required with direct ship articles Direct ship articles shall be received with one or more documents contai
44、ning: a. A signed direct ship declaration. b. A signed/stamped SOC certifying that the article conforms to approved data. c. Evidence that acceptance or inspection has been accomplished by the approved manufacturer or through a delegated inspection authority. When delegated inspection is used, also
45、provide with the shipment a statement that delegation of inspection authority has been granted by the approved manufacturer, and that the inspection was performed on behalf of the approved manufacturer. d. Traceability to the customer purchase request. 4.4.3 Notification of Discrepancies Any identif
46、ied non-conformance or noncompliance is to be coordinated and resolved through the approved manufacturer. In those cases in which the approved manufacturer allows the customer to buy directly from the supplier, these issues should be resolved through the supplier. 5 Notes A change bar (|) located in
47、 the left margin is for the convenience of the user in locating areas where technical revisions, not editorial changes, have been made to the previous issue of this document. An (R) symbol to the left of the document title indicates a complete revision of the document, including technical revisions.
48、 Change bars and (R) are not used in original publications, nor in documents that contain editorial changes only. prEN 9114:2014 (E) 10 Appendix A (informative) ACRONYM LOG AC Advisory Circular AMC Acceptable Means of Compliance EASA European Aviation Safety Agency ED Executive Director ETSO Europea
49、n Technical Standard Order FAA Federal Aviation Administration GM Guidance Material NAA National Aviation Authority PAH Production Approval Holder PC Production Certificate PMA Parts Manufacturer Approval POA Production Organisation Approval SOC Statement of Conformance TSO Technical Standard Order
