EN 9102:2024
(Main)Aerospace series - Quality systems - First article inspection requirements
Aerospace series - Quality systems - First article inspection requirements
1.1 General
This document establishes the requirements for performing and documenting FAI. It is emphasized the requirements specified in this document are complementary (not alternative) to customer and applicable statutory and regulatory requirements.
1.2 Purpose
The primary purpose of FAI is to verify and validate product realization processes are capable of producing characteristics that meet engineering and design requirements. A well-planned and executed FAI by a multi-disciplinary team (e.g. members from responsible functions) provides objective evidence the manufacturer’s processes can produce compliant product; having effectively understood and incorporated the associated requirements.
NOTE A FAI is not a product acceptance document. While interrelated, FAI and product acceptance are separate activities. The focus of FAI is verification of production processes via assessment of product. FAI and supporting documentation do not provide assurance regarding conformance for product acceptance purposes; neither does the lack of a FAI necessarily imply product is nonconforming to engineering and design requirements.
FAI will:
- provide confidence, through objective evidence, the product realization processes are capable of producing conforming product;
- demonstrate the manufacturers and processors of the product have an understanding of the associated requirements;
- provide assurance of product conformance at the start of production and after changes, as outlined in this document.
A FAI is intended to:
- mitigate risks associated with production startup and process changes;
- reduce future escapes;
- help ensure product safety;
- improve quality, delivery, and customer satisfaction;
- reduce costs and production delays associated with product nonconformances;
- identify product realization processes not capable of producing conforming characteristics and initiate and/or validate associated corrective actions.
-
1.3 Application
This document applies to organizations and their suppliers responsible for product realization processes that produce the design characteristics of the product. The organization shall flow down the requirements of this document to suppliers who produce design characteristics.
This document also applies to suppliers performing special process(es). A certificate of conformance (CoC) provided by processors attests to satisfying the requirements. External suppliers providing special process(es) can satisfy this document's requirements by either:
- documenting the design characteristics and associated results on a first article inspection report (FAIR); or
- documenting the design characteristics and associated results on a detailed CoC.
This document applies to assemblies, sub-assemblies, and detail parts including castings, forgings, and modifications to standard catalogue or commercial-off-the-shelf (COTS) items. Each of these items have a separate FAI.
Unless contractually required, this document does not apply to:
- development and prototype parts that are not considered as part of the first production run;
- procured standard catalogue item, COTS, or deliverable software. When these items are included in an assembly, they shall be documented in the index of part numbers in an assembly FAIR.
1.4 Informative
If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence.
In this document, the following verbal forms are used:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permission;
- "can" indicates a possibility or a capability.
Information marked as "NOTE" is for guidance in understanding or clarifying the associated requirement .
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Anforderungen an die Erstmusterprüfung
Série aérospatiale - Systèmes qualité - Exigences pour la revue premier article
1.1 Généralités
Le présent document établit les exigences pour réaliser et documenter la FAI. Il est à souligner que les exigences spécifiées dans le présent document viennent compléter (sans les remplacer) les exigences du client et les exigences légales et réglementaires applicables.
1.2 Objet
L'objet principal de la FAI est de vérifier et de valider que les procédés de réalisation du produit sont à même de produire des caractéristiques qui satisfont aux exigences d'ingénierie et de conception. Une FAI bien planifiée et effectuée par une équipe pluridisciplinaire (par exemple : dont les membres occupent des fonctions à responsabilité) apporte les preuves objectives que les procédés du fabricant permettent de produire des produits conformes, pour autant que les exigences associées aient été bien comprises et incluses à la FAI.
NOTE Une FAI n'est pas un document d'acceptation d'un produit. Si elles sont interdépendantes, la FAI et l'acceptation d'un produit sont toutefois des activités distinctes. L’objectif de la FAI est de vérifier les procédés de production via l'évaluation du produit. La FAI et la documentation associée ne fournissent aucune garantie quant à la conformité en vue de l'acceptation d'un produit. L'absence de FAI n'implique pas que le produit n'est pas conforme aux exigences d'ingénierie et de conception.
La FAI :
- donne confiance, grâce aux preuves objectives, dans la capacité des procédés de réalisation du produit à fournir un produit conforme ;
- démontre que les fabricants et les transformateurs du produit comprennent les exigences associées ;
- garantit la conformité du produit au début de la production et après les changements, comme décrit dans le présent document.
Une FAI est destinée à :
- réduire les risques associés au lancement de la production et aux modifications de procédé ;
- réduire les futures dérives ;
- garantir la sécurité du produit ;
- améliorer la qualité, la livraison et la satisfaction client ;
- réduire les coûts et les délais de production associés aux non-conformités du produit ;
- identifier les procédés de réalisation du produit ne permettant pas de produire des caractéristiques conformes, et lancer et/ou valider les actions correctives associées.
1.3 Application
Le présent document s'applique aux organismes et à leurs fournisseurs responsables des procédés de réalisation du produit qui élaborent les caractéristiques de conception du produit. L'organisme doit transmettre les exigences du présent document aux fournisseurs qui élaborent les caractéristiques de conception.
Le présent document s’applique également aux fournisseurs en charge d’un ou plusieurs procédés spéciaux. Un certificat de conformité (CC) fourni par les transformateurs atteste que les exigences sont satisfaites. Les fournisseurs externes chargés d’un ou plusieurs procédés spéciaux peuvent satisfaire aux exigences du présent document :
- en documentant les caractéristiques de conception et les résultats associés dans un rapport de revue premier article (FAIR) ; ou
- en documentant les caractéristiques de conception et les résultats associés dans un CC détaillé.
Le présent document s'applique aux ensembles, aux sous-ensembles et aux pièces élémentaires, y compris aux pièces forgées ou moulées et aux modifications des articles catalogue standards ou des produits sur étagère (COTS). Chacun de ces articles dispose d’une FAI distincte.
Sauf exigence contractuelle, le présent document ne s'applique pas :
- aux pièces prototypes et de développement qui ne sont pas considérées comme faisant partie de la première production de série ;
- aux articles catalogue standards, aux COTS ou aux logiciels livrables achetés. Lorsque ces articles sont inclus dans un ensemble, ils doivent être documentés dans l'index des références articles d'un FAIR de l’ensemble.
[...]
Aeronavtika - Sistem vodenja kakovosti - Zahteve za prvi pregled vzorcev
1.1 Ta dokument postavlja zahteve za izvedbo in dokumentiranje za prvi pregled vzorcev (FAI). Poudariti je treba, da zahteve iz tega standarda dopolnjujejo (niso alternativna možnost) zahteve odjemalcev in ustrezne zakonske ter regulativne zahteve.
V primeru neskladnosti med zahtevami iz tega dokumenta in zahtevami odjemalcev ali ustreznimi zakonskimi ali regulativnimi zahtevami, imajo prednost ustrezne zakonske ali regulativne zahteve.
V tem dokumentu so uporabljene naslednje glagolske oblike:
– »treba je« ali »mora« označuje zahtevo;
– »naj« označuje priporočilo;
– »sme« označuje dovoljenje;
– »lahko« označuje možnost ali sposobnost.
Informacije, označene kot »OPOMBA«, so namenjene usmerjanju pri razumevanju ali pojasnjevanju pripadajoče zahteve.
1.2 Namen
Primarni namen prvega pregleda vzorcev je preveriti in potrditi, da procesi realizacije izdelka omogočajo ustvarjanje lastnosti, ki izpolnjujejo zahteve inženiringa in projektiranja. Prvi pregled vzorcev ni dokument o sprejemljivosti proizvoda. Dobro načrtovan in izveden prvi pregled vzorcev, ki ga izvede večdisciplinarna skupina (npr. člani z odgovornih funkcij), zagotovi objektivne dokaze, da proizvajalčevi procesi lahko proizvedejo skladen izdelek ob razumevanju in upoštevanju povezanih zahtev.
OPOMBA: Čeprav sta med seboj povezani, sta prvi pregled vzorcev in sprejemljivost izdelka ločeni dejavnosti. Prvi pregled vzorcev se osredotoča na preverjanje proizvodnih procesov z ocenjevanjem izdelka. Prvi pregled vzorcev in spremni dokumenti ne dajejo zagotovila glede skladnosti za namene sprejemljivosti izdelka; prav tako odsotnost prvega pregleda vzorcev ne pomeni nujno, da je izdelek neskladen z inženirskimi in projektantskimi zahtevami.
Prvi pregled vzorcev bo:
– zagotovil zaupanje, da procesi realizacije izdelka omogočajo proizvodnjo skladnega izdelka;
– pokazal, da proizvajalci in obdelovalci izdelka razumejo z izdelkom povezane zahteve;
– zagotovil objektivne dokaze o zmožnosti procesa;
– zmanjšal tveganja, povezana z začetkom proizvodnje in/ali spremembami procesa;
– zagotovil skladnost izdelka ob začetku proizvodnje in po spremembah, opredeljenih v tem dokumentu.
Prvi pregled vzorcev je namenjen:
– zmanjšanju prihodnjih napak, tveganj in skupnih stroškov;
– v pomoč pri zagotavljanju varnosti izdelka;
– izboljšanju kakovosti, dobave in zadovoljstva strank;
– zmanjšanju stroškov in zastojev proizvodnje, povezanih z neskladnostjo izdelka;
– ugotavljanju procesov realizacije izdelka, ki ne omogočajo proizvodnje skladnega izdelka, in sprejemanju in/ali potrjevanju povezanih korektivnih ukrepov.
1.3 Uporaba
Ta dokument se uporablja za organizacije in podrejene entitete, ki so odgovorne za proizvodnjo projektnih lastnosti izdelka (tj. za realizacijo izdelka). Organizacija bo zahteve tega dokumenta posredovala dobaviteljem, ki proizvajajo konstrukcijske lastnosti.
Ta dokument se uporablja za zunanje dobavitelje, ki izvajajo posebne procese. Potrdilo o skladnosti, ki ga zagotovijo obdelovalci, dokazuje skladnost z zahtevami specifikacij pristojnega organa za projektiranje. Zunanji dobavitelji, ki zagotavljajo posebne procese, lahko izpolnijo zahteve iz tega dokumenta:
– z dokumentiranjem konstrukcijskih lastnosti in povezanih rezultatov pri prvem pregledu vzorcev;
– z dokumentiranjem konstrukcijskih lastnosti in povezanih rezultatov na potrdilu o skladnosti, ki ga določi stranka.
Ta dokument se uporablja za sestave, podsestave in posamezne dele, vključno z ulitki, izkovki, in spremembami izdelkov iz kataloga dokumenta ali standardnih izdelkov (COTS). Za vsakega od teh elementov je treba izvesti ločen prvi pregled vzorcev.
Če ni pogodbeno dogovorjeno drugače, se ta dokument ne uporablja za:
– razvijanje delov in prototipov, ki ne spadajo v prvo proizvodno serijo;
– izdelke, dobavljene iz standardnega kataloga, standardne izdelke ali dobavljivo programsko opremo. Te elemente je treba dokumentirati v kazalu številk delov pri pripravi poročila o prv
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2024
Aeronavtika - Sistem vodenja kakovosti - Zahteve za prvi pregled vzorcev
Aerospace series - Quality systems - First Article Inspection Requirement
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Anforderungen an die
Erstmusterprüfung
Série aérospatiale - Systèmes qualité - Exigences pour la revue premier article
Ta slovenski standard je istoveten z: EN 9102:2024
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 9102
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2024
EUROPÄISCHE NORM
ICS 03.120.10; 49.020 Supersedes EN 9102:2015
English Version
Aerospace series - Quality systems - First article inspection
requirements
Série aérospatiale - Systèmes qualité - Exigences pour Luft- und Raumfahrt - Qualitätsmanagementsysteme -
la revue premier article Anforderungen an die Erstmusterprüfung
This European Standard was approved by CEN on 29 January 2024.
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, 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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9102:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
1.1 General. 5
1.2 Purpose . 5
1.3 Application . 6
1.4 Convention . 6
2 Normative references . 7
3 Terms and definitions . 7
4 Requirements . 10
4.1 First article inspection planning . 10
4.2 Part requirements . 11
4.3 Digital product definition requirements . 11
4.4 Evaluation activities . 12
4.5 Nonconformance handling . 12
4.6 Partial or re-accomplishment of first article inspection . 13
4.7 Documentation . 14
4.8 Retained documented information . 15
Annex A (informative) Acronym log . 16
Annex B (normative) EN 9102 forms and supporting form instructions . 17
B.1 General. 17
B.2 Form 1: Part number accountability . 18
B.3 Form 2: Product accountability — materials, special processes and functional testing . 22
B.4 Form 3: Characteristic accountability, verification and compatibility evaluation . 25
Bibliography . 28
European foreword
This document (EN 9102:2024) has been prepared by 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-STAN, 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 September 2024, and conflicting national standards shall be
withdrawn at the latest by September 2024.
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.
This document supersedes EN 9102:2015.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this document: 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, Türkiye and the United
Kingdom.
Introduction
This document was revised to emphasize and enhance the first article inspection (FAI) planning,
evaluation, and re-accomplishment activities; aligning requirements to EN 9100. Additional changes to
the document requirements, definitions, and associated notes were incorporated in response to
stakeholder needs.
To ensure customer satisfaction, the aviation, space, and defence industry organizations must produce
and continually improve safe, reliable products that meet or exceed customer and regulatory
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 products purchased from suppliers throughout the
world and at all levels of the supply chain. Industry suppliers face the challenge of delivering products
to multiple customers having varying quality requirements and expectations.
The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG)
for the purpose of achieving significant improvements in quality, delivery, safety, and reductions in cost
throughout the value stream. This organization includes representation from companies in the
Americas, Asia/Pacific, and Europe.
This document standardizes FAI process requirements to the greatest extent possible. While primarily
developed for the aviation, space, and defence industry, this document can also be used in other
industry sectors where a standardized FAI process is needed.
1 Scope
1.1 General
This document establishes the requirements for performing and documenting FAI. It is emphasized the
requirements specified in this document are complementary (not alternative) to customer and
applicable statutory and regulatory requirements.
1.2 Purpose
The primary purpose of FAI is to verify and validate product realization processes are capable of
producing characteristics that meet engineering and design requirements. A well-planned and executed
FAI by a multi-disciplinary team (e.g. members from responsible functions) provides objective evidence
the manufacturer’s processes can produce compliant product; having effectively understood and
incorporated the associated requirements.
NOTE A FAI is not a product acceptance document. While interrelated, FAI and product acceptance are separate
activities. The focus of FAI is verification of production processes via assessment of product. FAI and supporting
documentation do not provide assurance regarding conformance for product acceptance purposes; neither does
the lack of a FAI necessarily imply product is nonconforming to engineering and design requirements.
FAI will:
— provide confidence, through objective evidence, the product realization processes are capable of
producing conforming product;
— demonstrate the manufacturers and processors of the product have an understanding of the
associated requirements;
— provide assurance of product conformance at the start of production and after changes, as outlined
in this document.
A FAI is intended to:
— mitigate risks associated with production startup and process changes;
— reduce future escapes;
— help ensure product safety;
— improve quality, delivery, and customer satisfaction;
— reduce costs and production delays associated with product nonconformances;
— identify product realization processes not capable of producing conforming characteristics and
initiate and/or validate associated corrective actions.
1.3 Application
This document applies to organizations and their suppliers responsible for product realization
processes that produce the design characteristics of the product. The organization shall flow down the
requirements of this document to suppliers who produce design characteristics.
This document also applies to suppliers performing special process(es). A certificate of conformance
(CoC) provided by processors attests to satisfying the requirements. External suppliers providing
special process(es) can satisfy this document's requirements by either:
— documenting the design characteristics and associated results on a first article inspection report
(FAIR); or
— documenting the design characteristics and associated results on a detailed CoC.
This document applies to assemblies, sub-assemblies, and detail parts including castings, forgings, and
modifications to standard catalogue or commercial-off-the-shelf (COTS) items. Each of these items have
a separate FAI.
Unless contractually required, this document does not apply to:
— development and prototype parts that are not considered as part of the first production run;
— procured standard catalogue item, COTS, or deliverable software. When these items are included in
an assembly, they shall be documented in the index of part numbers in an assembly FAIR.
1.4 Convention
If there is a conflict between the requirements of this document, and customer or applicable
statutory/regulatory requirements, the latter takes precedence.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement .
Notes to entry used in definitions, however, are considered normative and will provide additional information
that supplements the terminological data such as statements, instructions, recommendations, or requirements
relating to the use of a term.
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.
ISO 9000, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, the IAQG Internal
Dictionary and the following apply.
An acronym log for this document is presented in Annex A.
ISO and IEC maintain
...
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