indice : all-i-003...p6: « to purchase /-acheter » all-i-003.f01 : « acknowledgement of reception...

39
HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION / INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE ALL-I-003 SUPPLIERS GENERAL REQUIREMENTS EXIGENCES GENERALES APPLICABLES AUX FOURNISSEURS Issue / Indice : 4 Date: 27 May 2020 Date: 27/05/20 Page : 1 / 39 This document is in full ownership of High Performance Alloys division and It must not be, either fully or partly, copied or forwarded to any third party in any form, unless High Performance Alloys division authorizes it in written form. © ERAMET High Performance Alloys division – 2019 Ce document est la propriété de la Division Alliages Haute Performance et ne peut être reproduit ou transmis à une tierce partie, même partiellement et sous quelque forme que ce soit, sans autorisation écrite de notre part. © ERAMET Division Alliages Haute Performance– 2019 All printed copies of this document are for information only and must be verified as being current before use. Tous les exemplaires imprimés de ce document sont à titre indicatif et doivent être vérifiées comme étant valides avant utilisation. ALL-P-001.F03-Ind3 The 1 st part of this instruction is the English version. It starts on page 3. The 2 nd part is the French version. It starts on page 19. La 1 ère section de cette instruction est la version anglaise. Elle début page 3. La 2 nde section est la version française. Elle débute page 19. ASSOCIATED PROCESSES / PROCESSUS ASSOCIES RELATED DOCUMENTS / DOCUMENTS LIES P6: « To purchase /- Acheter » ALL-I-003.F01 : « Acknowledgement of reception of suppliers general requirements - Demande d’accusé de réception des « exigences générales applicables aux fournisseurs » ALL-I-003.F02 : « Major change notification form - formulaire de Déclaration de changement majeur » ALL-I-003.F03: « Acknowledgement of receipt “nuclear safety culture” leaflet - AR brochure « culture sûrete nucleaire » ALL-I-003.F04 : « Realization quality plan (RQP) - Plan qualité de réalisation : PQR » HISTORY / HISTORIQUE Issue Indice Date Date Main modifications Principales modifications 1 23 May 2016 23/05/16 Cancels and replaces the AD/DHA-P074 ind. 1 dated 11 March 2013 Annule et remplace-la AD/DHA-P074 ind. 1 du 11/03/13 2 15 Dec 2017 15/12/17 Update of the procedure following the new version of the EN9100 standard Mise à jour de la procédure suite à la nouvelle version de la norme EN9100 3 18 Dec 2019 18/12/19 Update of the procedure: • Integration of Airbus Application: Major Change notification • Integration of fool proofing levels Mise à jour de la procédure : Intégration de la demande d’Airbus : Déclaration de changement majeur Intégration du principe de détrompage 4 27 May 2020 27/05/20 Update of the procedure following a non-compliance during the BV 2020 audit: Clarification of the rules for managing customer qualifications Clarification of the management rules for 2nd tier subcontracting Mise à jour de la procédure suite à une non-conformité lors de l’audit BV 2020 : Clarification des règles de gestion des qualifications clients Clarification des règles de gestion de la sous-traitance de 2 ème rang SCOPE OF APPLICATION / DOMAINE D’APPLICATION This instruction applies to the following plants / Cette instruction s’applique aux sites suivants: AUBERT & DUVAL ERASTEEL Firminy Pamiers Champagnole Chalon Heyrieux INTERFORGE Commentry Bolingbrook Imphy Paris Kloster Paris Issoire Les Ancizes Aubière Stubs Booton

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  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

    Issue / Indice : 4

    Date: 27 May 2020 Date: 27/05/20

    Page : 1 / 39

    This document is in full ownership of High Performance Alloys division and It must not be, either fully or partly, copied or forwarded to any third party in any form, unless

    High Performance Alloys division authorizes it in written form. © ERAMET High Performance Alloys division – 2019 Ce document est la propriété de la Division Alliages Haute Performance et ne peut être reproduit ou transmis à une tierce partie, même partiellement et sous quelque forme

    que ce soit, sans autorisation écrite de notre part. © ERAMET Division Alliages Haute Performance– 2019

    All printed copies of this document are for information only and must be verified as being current before use.

    Tous les exemplaires imprimés de ce document sont à titre indicatif et doivent être vérifiées comme étant valides avant utilisation. ALL-P-001.F03-Ind3

    The 1st part of this instruction is the English version. It starts on page 3. The 2nd part is the French version. It starts on page 19. La 1ère section de cette instruction est la version anglaise. Elle début page 3. La 2nde section est la version française. Elle débute page 19.

    ASSOCIATED PROCESSES / PROCESSUS ASSOCIES

    RELATED DOCUMENTS / DOCUMENTS LIES

    P6: « To purchase /- Acheter » ALL-I-003.F01 : « Acknowledgement of reception of suppliers general requirements - Demande d’accusé de réception des « exigences générales applicables aux fournisseurs »

    ALL-I-003.F02 : « Major change notification form - formulaire de Déclaration de changement majeur »

    ALL-I-003.F03: « Acknowledgement of receipt “nuclear safety culture” leaflet - AR brochure « culture sûrete nucleaire »

    ALL-I-003.F04 : « Realization quality plan (RQP) - Plan qualité de réalisation : PQR »

    HISTORY / HISTORIQUE

    Issue Indice

    Date Date

    Main modifications Principales modifications

    1 23 May 2016

    23/05/16 Cancels and replaces the AD/DHA-P074 ind. 1 dated 11 March 2013 Annule et remplace-la AD/DHA-P074 ind. 1 du 11/03/13

    2 15 Dec 2017

    15/12/17 Update of the procedure following the new version of the EN9100 standard Mise à jour de la procédure suite à la nouvelle version de la norme EN9100

    3 18 Dec 2019

    18/12/19

    Update of the procedure: • Integration of Airbus Application: Major Change notification • Integration of fool proofing levels Mise à jour de la procédure : • Intégration de la demande d’Airbus : Déclaration de changement majeur • Intégration du principe de détrompage

    4 27 May 2020

    27/05/20

    Update of the procedure following a non-compliance during the BV 2020 audit: • Clarification of the rules for managing customer qualifications • Clarification of the management rules for 2nd tier subcontracting

    Mise à jour de la procédure suite à une non-conformité lors de l’audit BV 2020 : • Clarification des règles de gestion des qualifications clients • Clarification des règles de gestion de la sous-traitance de 2ème rang

    SCOPE OF APPLICATION / DOMAINE D’APPLICATION

    This instruction applies to the following plants / Cette instruction s’applique aux sites suivants:

    AUBERT & DUVAL ERASTEEL ☒ Firminy ☒ Pamiers ☒ Champagnole ☐ Chalon

    ☒ Heyrieux ☒ INTERFORGE ☒ Commentry ☐ Bolingbrook

    ☒ Imphy ☐ Paris ☐ Kloster ☐ Paris

    ☒ Issoire

    ☒ Les Ancizes

    ☐ Aubière

    ☐ Stubs

    ☐ Booton

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

    Issue / Indice : 4

    Date: 27 May 2020 Date: 27/05/20

    Page : 2 / 39

    SIGNATURES / SIGNATURES

    Written by / Rédacteur(s)

    Mariyam BENHAMOU

    Verified by / Vérificateur(s)

    Julien THERME

    Approved by / Approbateur(s)

    Bernard DELSUPEXHE

    Signature :

    Signature : Signature :

    DISTRIBUTION LIST / LISTE DE DIFFUSION

    Management / Encadrement

    Supplier Quality/ Qualité Fournisseur

    Fréderic COYARD Jawad MEBARKI, Julien SOUCHE, Valérie COPIER, Laurent FRIC, Emilie MADELEINE, Sophie

    GIRAULT, Eric PUJADE, Nathalie PAVLUS, Frederic FIBLA, Xavier WARBURTON, Lavinia NICOLAE, Christophe

    ROUGIER, Nelly ORO-LEBRETON, Cécile LANNAREIX

    Environnement : Olivier Luce

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

    Issue / Indice : 4

    Date: 27 May 2020 Date: 27/05/20

    Page : 3 / 39

    CONTENT

    PURPOSE ........................................................................................................... 4

    REFERENCE DOCUMENTS ................................................................................... 4

    INSTRUCTION CONTENTS ................................................................................. 4

    3.1 SUPPLIER COMMITMENT TO COMPLY WITH THIS SPECIFICATION ............................. 4 3.2 APPROVAL ........................................................................................................ 5 3.3 REVIEW OF AD/ES REQUIREMENTS ...................................................................... 5 3.4 VERIFICATION OF APPLICATION AND RIGHT OF ACCES ........................................... 5 3.5 PRIOR CONSENT FOR MAJOR MODIFICATION ........................................................ 6 3.6 CONTROL OF PRODUCT PROVIDED BY AD ............................................................. 7 3.7 PRODUCT TRACEABILITY .................................................................................... 7 3.8 SPECIAL PROCESS ............................................................................................ 7 3.9 PROCESS CONTROL ........................................................................................... 7 3.10 PRODUCT PRESERVATION / FOREIGN OBJECT PREVENTION ................................... 7 3.11 CONTROL OF PRODUCTION EQUIPMENT .............................................................. 8 3.12 CONTROL OF INSPECTION, MEASUREMENT AND TEST EQUIPMENT .......................... 8 3.13 DIMENSIONAL INSPECTION .............................................................................. 8 3.14 RISK ANALYSIS ............................................................................................... 9 3.15 CONTROL OF SOFTWARE AND COMPUTER PROGRAMS ........................................... 9 3.16 REQUIRED DOCUMENTS FOR AUTHORIZING DELIVERY OF PRODUCTS ................... 10 3.17 QUALITY DOCUMENTS .................................................................................... 10 3.18 CONTROL OF DOCUMENTS .............................................................................. 12 3.19 PACKAGING AND PACKAGE DESIGN OF PRODUCTS - DELIVERY ............................ 12 3.20 ORGANIZING TRANSPORT FOR PROUCTS DELIVERY TO AD / ES ........................... 12 3.21 TREATMENT OF NONCONFORMANCES ............................................................... 12 3.22 APPLICATION OF 10CFR21 (NUCLEAR MARKET ONLY) ......................................... 14 3.23 PROCESSING CORRECTIVE ACTIONS RESULTING FROM AUDIT (DAC/CORRECTIVE

    ACTION REQUEST)................................................................................................ 14 3.24 CORRECTIVE ACTIONS: PRINCIPLE OF FOOL PROOFING LEVELS ........................... 15 3.25 ENVIRONMENTAL MANAGEMENT SYSTEM .......................................................... 15 3.26 SECURITY AND SAFETY .................................................................................. 16 3.27 NUCLEAR SECURITY CULTURE (NUCLEAR MARKET ONLY) ..................................... 16 3.28 PRODUCTS PROTECTION AND COUNTERFEIT PARTS PREVENTIONErreur ! Signet non défini. 3.29 ARCHIVING .................................................................................................. 18 3.30 MATRIX OF COMPLIANCE WITH AD REQUIREMENTS ............................................ 18 3.31 CESSATION OF ACTIVITY OR LIQUIDATION ....................................................... 18 TERMS AND ABBREVIATIONS .......................................................................... 19

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

    Issue / Indice : 4

    Date: 27 May 2020 Date: 27/05/20

    Page : 4 / 39

    PURPOSE

    In addition to AD/ES General Purchasing Terms in effect, available on websites www.aubertduval.com and

    www.erasteel.com, this specification defines the general requirements for AD/ES suppliers.

    Unless specified otherwise in the purchase order EN 9100 standards apply.

    Special provisions stated in the order, such as AQAP 2110/2120 may complete this specification

    REFERENCE DOCUMENTS

    ❖ ISO 9001: Quality Management Systems

    ❖ ISO 14001: Environmental management systems.

    ❖ ISO 10012: Measurement Management System. Requirements for processes and measuring

    equipment.

    ❖ AQAP 2110: NATO quality requirements for design...

    ❖ ISO 17025: General requirements for the competence of calibration and testing laboratories.

    ❖ EN 9100: Aerospace series Quality system. Quality assurance model for design, development,

    production, installation and operation.

    ❖ EN 9120: Aerospace series Quality Management Systems. Requirements for stockist distributors.

    ❖ EN 9130: Aerospace series Quality system. Archiving documents.

    ❖ EN 10204: Metal products. Inspection document types.

    ❖ NF L 00-015: Management and quality assurance. Declaration of conformity

    ❖ Brochure « Nuclear Safety Objective »

    ❖ General conditions of Purchase AD /ES

    ❖ EN 9146: "Foreign Body Damage Prevention Program (FOD) - Requirements for Aeronautics, Space

    and Defense Organizations"

    ❖ MQN.AD-EN " Nuclear Quality Manual ”

    INSTRUCTION CONTENTS

    3.1 SUPPLIER COMMITMENT TO COMPLY WITH THIS SPECIFICATION

    In absence of any remark or comment within 30 days after the SPEC has been sent to Supplier, the latter

    undertakes to comply with. Only a deviation permit validated by AD / ES Quality department can authorize

    deviation.

    Suppliers must return a copy of the Acknowledgment of Receipt ALL-I-003.F01 « ACKNOWLEDGEMENT OF

    RECEIPT ”SUPPLIERS GENERAL REQUIREMENTS” » signed and with initials, attached to this specification to

    the Purchasing and Supplier Quality departments of the relevant site.

    This form also includes a table for the supplier to clearly explain exceptions to this instruction and each

    deviation must refer to the relevant paragraph.

    Restrictions must be approved by AD/ES before application.

    http://www.aubertduval.com/http://www.erasteel.com/

    ALL-I-003.F01

    ACKNOWLEDGEMENT OF RECEIPT ”SUPPLIERS GENERAL REQUIREMENTS”

    DEMANDE D’ACCUSE DE RECEPTION DES « EXIGENCES GENERALES APPLICABLES AUX FOURNISSEURS »

    Issue / Indice : 1

    Date: 18 Dec 2019

    Date : 18/12/19

    Page : 1 / 1

    HIGH PERFORMANCE ALLOYS DIVISION APPENDIX /

    ANNEXE BRANCHE DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003.F01

    ACKNOWLEDGEMENT OF RECEIPT ”SUPPLIERS GENERAL REQUIREMENTS”

    DEMANDE D’ACCUSE DE RECEPTION DES « EXIGENCES GENERALES APPLICABLES AUX FOURNISSEURS »

    Issue / Indice : 1

    Date: 25 nov 2019

    Date : 25/11/19

    Page : 2 / 2

    Le présent document fait foi d’accusé de réception de la procédure ALL-I-003 indice…..

    This document is an acknowledgement of receipt of the procedure ALL-I-003 issue…..

    Le tableau suivant permet de noter d’éventuels commentaires sur des exigences spécifiées dans la procédure susmentionnée.

    The following table allows you to make comments on the requirements specified in the above procedure.

    Paragraphe

    Paragraph

    Commentaires

    Comments

    Décision DAHP

    DAHP Decision

    Veuillez nous retourner un exemplaire de ce document dûment daté, validé et signé.

    Sans retour de votre part sous 30 jours, nous considérerons que les exigences sont validées. 

    Please return a copy of this document duly dated, signed and validated. Without receipt of this document by 30 days, we consider that the requirements are validated.

    Fournisseur

    SUPPLIER

    Nom + Fonction

    Name + Title

    Date + Signature

    Date + Signature

    Achats/Purchasing Department Qualité fournisseurs DAHP/DAHP Supplier Quality

    Document à retourner au Service Achats et à la Qualité fournisseur.

    Document to return to the supplier Department and supplier Quality

    mariyam.benhamouPièce jointeALL-I-003.F01-ind1 Acknowledgement of reception of suppliers general requirements.docx

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

    Issue / Indice : 4

    Date: 27 May 2020 Date: 27/05/20

    Page : 5 / 39

    3.2 APPROVAL

    3.2.1 CONDITIONS

    Approval of a couple product / supplier is issued by AD / ES based on a satisfactory assessment record whose

    contents are determined by AD / ES.

    The supplier must ensure that its third party and customer certificates are up to date in the Supplier

    Quality Portal. Automatic reminders inform the supplier of expiring certificates.

    The supplier is required to inform AD / ES of any evolution of its third party and client certifications, in

    particular, in case of loss or suspension of third party and/or client certifications, for which the supplier

    must alert AD / ES within 48 hours.

    3.2.2 Qualification

    The supplier must set up a 1st article file in the cases below:

    • Creation of the first article

    • Plan changes which can affect the shape and function of the room

    • Change of process, control method, manufacturing site, tooling or machine which may affect the shape or

    function of the part

    • Change of the digital control program or transfer of the control program to another operating system.

    • Substantial replacement of production and control personnel

    • Production stop over 2 years or on specific request from AD.

    • Before any transfer to another manufacturing site (internal or external), an LAI must be carried out in the

    site which “sends” and an FAI must be carried out in the site which “receives”.

    3.2.3 SUSPENSION OF APPROVAL

    Suspension of an approval is decided by the Quality department, based on:

    Case 1: Supplier’s certification has been withdrawn by the certifying body. Case 2: recurrent non-achievement of objectives by supplier or insufficient performance

    Case 3: period of interruption in the supply of a product exceeds the maximum period agreed upon by the

    customer.

    Case 4: Unless required otherwise by the customer, the period is 5 years for all segments except production

    subcontracting for which it is 5 years

    Re-approval process is initiated by AD / ES according to conditions specified to suppliers.

    3.3 REVIEW OF AD/ES REQUIREMENTS

    The supplier must take into account the requirements of this instruction, the order and the specifications.

    For each new case the supplier will have to carry out a review of the applicable requirements.

    The purpose of this review is to ensure that the product requirements have been understood and accepted

    and that any discrepancies have been removed.

    3.4 VERIFICATION OF APPLICATION AND RIGHT OF ACCES

    AD / ES reserves the right to check with the 1st and 2nd tier Suppliers (and with the agreement of the Tier

    1 supplier in this case), alone or in the presence of its Clients, or a Third Party, or the Regulatory Authorities

    compliance with these requirements.

    To this end, the Supplier undertakes to allow free access to the documentation and locations where all

    activities relating to the execution of the AD / ES order take place.

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

    Issue / Indice : 4

    Date: 27 May 2020 Date: 27/05/20

    Page : 6 / 39

    The supplier agrees to notify AD / ES of any direct requests for visits / documentation / audit by one of its

    customers. The supplier will not respond to these requests without the prior written consent of AD / ES.

    3.5 PRIOR CONSENT FOR MAJOR MODIFICATION

    Any major modification:

    ▪ Transfer of activity (change of manufacturing site, change of subcontractor or supplier,

    possible subcontracting to a third party of all or part of manufacturing or inspection/test

    operations).

    ▪ Change of ERP.

    ▪ Reorganization of site (change in top level management and key positions such as directors,

    quality manager ...).

    ▪ Change in contract manufacturing process

    ▪ Change in means of production and control

    ▪ Other changes related to supply chain aspects ( capacity, Lead time, Order entry)

    Must be formalizee via our ALL-I-003.F02 « Declaration of major change » Form, and submit it through the

    Supplier Quality Portal (documentation section ➔ conformity document ➔Declaration of major change)

    AD/ES may or not give its approval to the Supplier for initiating the change and the terms of implementation

    of this modification.

    3.6 SECOND RANK SUBCONTRACTING (applicable to production and

    test subcontracting suppliers)

    Before engaging any 2nd tier subcontracting, the 1st tier subcontractor must send a request to DAHP. This

    request must be accompanied by a Quality Assurance Plan which must be accepted by DAHP before starting

    any operation.

    The Quality Assurance Plan must include at least the following elements:

    - Flow-chart or clear description of the sequence of operations with the company or companies where they

    can be carried out.

    - Products covered by the QAP

    - The subcontractor(s) concerned

    - Contract review: brief description of how the review of the DAHP requirements between the 1st and

    2nd tier sub-contractors is conducted.

    - The ISP or DVI file, if applicable: brief description of how the creation and validation of the ISP /

    DVI file between the 1st and 2nd tier subcontractor is managed.

    - Management of anomalies: brief description of how the handling of anomalies is managed between

    the first-tier subcontractor and the second-tier subcontractor, including sharing information with

    DAHP, waiting for DAHP's decision and implementing the actions requested by DAHP.

    - Management of third party and client qualifications, including feedback to DAHP in case of

    modification or loss of qualifications

    - The Declaration of Compliance and Product Release: a brief description of how product release is

    carried out to assure AD that the full benefit has been achieved in accordance with the DAHP

    requirements.

    ALL-I-003.F02

    MAJOR CHANGE NOTIFICATION

    DÉCLARATION DE CHANGEMENT MAJEUR

    Issue / Indice : 2

    Date: 27 May 2020

    Date : 27/05/20

    Page : 1 / 2

    ALL-I-003.F02

    MAJOR CHANGE NOTIFICATION

    DÉCLARATION DE CHANGEMENT MAJEUR

    Issue / Indice : 2

    Date: 27 May 2020

    Date : 27/05/20

    Page : 2 / 2

    1 – PRODUCT IDENTIFICATION / IDENTIFICATION DU PRODUIT

    Company Name /nom de la compagnie

    Plant location /emplacement de l'usine

    Product description /description du produit

    2 – DESCRIPTION OF THE CHANGE /DESCRIPTION DU CHANGEMENT

    2.1 - Type of the change / Type de changement

    DAHP agreement required before setting up / Accord DAHP requis avant la mise en place

    DAHP must be informed / DAHP doit être informé

    Transfer of activity (change of manufacturing site, change of subcontractor or supplier, possible subcontracting to a third party of all or part of manufacturing or inspection/test operations) /Transfert d’activité (changement de site de fabrication, changement de sous-traitant ou de fournisseur, sous-traitance éventuelle à un tiers de tout ou partie des opérations de fabrication ou de contrôle).

    Change of ERP / Changement d’ERP.

    Change in contract manufacturing process/Changement dans le process de fabrication contractuel.

    Reorganization of site (change in top level management and key positions such as directors,quality manager...)/Réorganisation du site (changement dans le Top level management et postes clés tels que directeurs, responsable qualité…).

    Change in means of production and control (unless changed by identical means and machine requalified by the subcontractor) /Changement du moyen de production ou de contrôle (sauf si changé par des moyens identiques et machine requalifiée par le sous-traitant)

    Change in means of production and control (if change by identical means and machine requalified by the STT) /Changement du moyen de production ou de contrôle (si changement par des moyens identiques et machine requalifiée par le STT)

    Other changes related to supply chain aspects ( capacity, Lead time, Order entry)/ Autre changement relatif à des thématiques supply-chain (capacité, Lead time, Order entry)

    Other (precise) / autre (à préciser)

    Other (precise) / autre (à préciser)

    2.2 – Change description / Changer la description

    |_|Temporary / provisoire

    |_|Definitive / Définitif

    2.3 – Reason for change / Raison du changement

    2.4 – Benefit for DAHP / Avantage pour DAHP

    2.5 – Product change implementation start /Début de la mise en œuvre du changement de produit

    3 – RISK IDENTIFICATION AND MITIGATION ACTION/ IDENTIFICATION DES RISQUES ET ACTION D'ATTÉNUATION

    4 – ASSOCIATED SCHEDULE / PLANNING

    5 – IMPACT OF THE CHANGE / IMPACT DU CHANGEMENT

    Impact on costs / impact sur les coûts

    Impact on production lead time / impact sur les délais de production

    Other impact / autre impact

    6 – ADDITIONAL INFORMATION / INFORMATION COMPLEMENTAIRE

    Impact on DAHP proprietary tooling / Impact sur les outillages DAHP /

    |_|YES / OUI

    |_|NO / NON

    7 – DECISION (DAHP) /DECISION (DAHP)

    |_|Accepted / accepté

    |_| Accepted after setting up the actions requested by DAHP / accepté après la mise en place des actions demandées par DAHP

    |_|Refused / refusé

    Title: Supplier Quality Development Manager /Responsable Développement Qualité Fournisseurs

    Name

    Date

    Signature

    Title: Purchasing Manager / Responsable Achats

    Name

    Date

    Signature

    Title: Special Process Manager (if applicable) /Responsable procédés spéciaux (si applicable)

    Name

    Date

    Signature

    8- DECISION JUSTIFICATION AND-OR WAY FORWARD (DAHP) /

    JUSTIFICATION DE LA DÉCISION ET - OU VOIE À SUIVRE (DAHP)

    mariyam.benhamouPièce jointeALL-I-003.F02-Ind2 Major change notification form.docx

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

    Issue / Indice : 4

    Date: 27 May 2020 Date: 27/05/20

    Page : 7 / 39

    The 1st Tier Subcontractor must cascade all of DAHP's requirements and specific customer requirements

    cascaded by DAHP to its subcontractor.

    DAHP will evaluate the mastery of the second-tier subcontractor through audits.

    Note: If 2nd rank subcontracting is not foreseen when the range is submitted to the DAHP, please refer to

    the chapter PREVAILABLE MAJOR AMENDMENT AGREEMENT

    3.7 CONTROL OF PRODUCT PROVIDED BY AD

    Upon receipt of AD/ES products, based on the AD/ES order documents and the AD/ES delivery order, the

    external service provider must proceed to :

    · A quantitative verification,

    · A verification of the identification of the articles,

    · A visual check of the condition of uncollected items and parcels,

    · A check between the documentation and the product.

    Any anomaly must be reported to the outsourced technician AD/ES who controls the order.

    After completion of the service, the Supplier must return the shavings and drops with the product

    accompanied by their specific form, unless different arrangements to the order or contract have been

    provided. (Applicable only to subcontractors)

    3.8 PRODUCT TRACEABILITY

    Supplier must:

    • Take actions to ensure traceability of products and samples for testing during and between manufacturing operations (transfer of marking...) and the associated documentation. These actions

    must include, if required, software versions used for completing the services.

    • Ensure traceability of means that guarantee conformity of parts and compliance with customer requirements communicated by AD / ES.

    3.9 SPECIAL PROCESS

    Special processes must be subject to qualification decided by AD/ES according to appropriate methods.

    Supplier’s staff conducting non-destructive testing must be qualified according to NAS410 and or EN4179

    standards for aeronautics or according to EN ISO 9712 for other fields.

    3.10 PROCESS CONTROL

    As part of process control, AD / ES may request the Supplier to implement appropriate and approved

    monitoring of key characteristics / critical elements.

    3.11 PRODUCT PRESERVATION / FOREIGN OBJECT PREVENTION

    The Supplier must give the assurance that the handling, storage, production, packaging, transport, cleaning

    and protection of the products are carried out correctly with suitable means and competent personnel, in compliance with safety rules, so as to avoid any damage to the products. The supplier must ensure that no foreign substance or article has been left on a part so that the product

    manufactured and delivered is free from any foreign object (Foreign Object Prevention).

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

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    Issue / Indice : 4

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    3.12 CONTROL OF PRODUCTION EQUIPMENT

    Supplier must maintain his production resources, particularly through a preventive maintenance plan based

    on analysis of breakdowns or recommendations of manufacturers.

    3.13 CONTROL OF INSPECTION, MEASUREMENT AND TEST EQUIPMENT

    All inspection and testing equipment (dimensional measuring devices, thermocouple, recorder...) and tools

    that are used must be periodically checked according to the provisions specifying attachments to references,

    frequency, methods and acceptance criteria required by ISO 10012.

    3.14 DIMENSIONAL INSPECTION

    3.14.1 CHOICE OF MEANS OF MEASUREMENT

    The choice of a Means of Measurement must be done according to the tolerance interval to be guaranteed on

    the measurement / product / process.

    Tolerance interval = Upper Tolerance limit – Lower Tolerance limit

    IT = Ts – Ti

    The Means of Measurement must have a Maximum Permissible Deviation (Ecart Maximal Toléré - EMT) less than

    a quarter of the tolerance to be guaranteed.

    In case of centered tolerance, EMT is calculated from tolerance: EMT < IT/4

    In case of decentered tolerance, EMT is calculated from IT : EMT < IT/8

    Ex. 1 : dimensional measurement to be guaranteed 25 ± 0.2mm EMT < +/- 0.05 (50μm) (0.2/4)

    Ex. 2 : dimensional measurement to be guaranteed 25 +0 +0.4mm EMT < +/- 0.05 (50μm) (0.4/8)

    3.14.2 ENVIRONMENT

    For inspections carried out with a measuring arm or a three-dimensional measuring device (CMM), the Supplier

    must ensure that the environment has no impact on the measurement performed. Parameters that can influence

    measurement include:

    - Drafts

    - Room temperature

    - Temperature of the measured part

    - Vibrations

    - Stability of the part (equilibrium) and the means of control.

    Verification of these parameters must take into account the tolerance to be guaranteed on the parts.

    For parts having tolerances of 0.15 mm or less, temperature must not vary by more than 5°C throughout the

    duration of the inspection and must be comprised between 20 and 26°C.

    The parts must be in the inspection room at least 24h before measurement is carried out.

    3.14.3 CALIBRATION / STANDARDIZATION

    Dimensional control equipment used for AD/ES orders must be calibrated. The calibration certificate must indicate

    the link between the means used for calibrating the device and national standards.

    If the results are not in conformity, the sub-contractor must verify if there is or not an impact on the parts

    already delivered to AD/ES. Any substantiated impact must be reported immediately to AD/ES.

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

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    AUX FOURNISSEURS

    Issue / Indice : 4

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    The Supplier must adapt the intermediary calibration verifications to be performed on these control devices,

    based on the risks he has identified (tolerances to be guaranteed, parts to be checked, environment…). These

    verifications must be recorded.

    The Supplier must have control over the potential consequences of interventions carried out on the 3D means of

    control that may have an influence on the inspection and maintain traceability of these.

    3.14.4 CARRYING OUT INSPECTIONS

    The inspection programs and reports shall be validated in the FAI / Industrial process validation files.

    Requests for reduced inspections must be validated by AD and AD’s customer, based on a file containing, in

    particular, control charts and R&R study of the process and process capability. The elements to be provided shall

    be specified on a case-by-case basis according to requirements of AD’s customer.

    The inspections carried out by the sub-contractor must be sufficient to guarantee the conformity of 100% of the

    measurements requested on 100% of the parts.

    3.14.5 INSPECTION REPORT

    The Supplier must carry out and maintain a report of the dimensional inspection including at least:

    - Traceability of inspected parts (Process, Manufacturing Order number, individual number of parts)

    - Reference of the measuring device used

    - Report number and its revision number

    - Identification / name of the inspector who performed the inspection + signature

    - Date of inspection

    - Compliance status

    - Detailed results of the inspection

    - Plan or CAD model reference of the end-customer or AD/ES.

    This certificate shall be archived by the Supplier and made available to AD/ES.

    In the event of an anomaly, an inspection report is prepared including a descriptive sketch, out-of-tolerance

    points, photos of the defect, solution proposals, deviations from the customer’s finished part and a complete

    report on the part.

    3.15 RISK ANALYSIS

    On request of AD / ES, the subcontractor may have to provide or take part in risk analyses of product,

    process or system (transfer of activity, new business, and specific request from customer...)

    Supplier shall follow risk analysis methodology or FMEA of AD / ES, or follow his own methodology provided

    that it is approved by AD / ES.

    3.16 CONTROL OF SOFTWARE AND COMPUTER PROGRAMS

    Software and programs used by the Supplier to provide services must be identified: name, issue, creation

    and modification dates.

    Supplier must:

    • Carry out and document validation tests for his software and programs, for being used, at each installation, creation, modification,

    • Ensure traceability of software and programs (record, changes, interventions, installations, change versions, anomalies...),

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

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    Issue / Indice : 4

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    • Backup and restore data,

    • Establish rules for software management : property agreements, rules of access, passwords management, storage, version change management, new versions testing, transfer to operating

    environment, training

    3.17 REQUIRED DOCUMENTS FOR AUTHORIZING DELIVERY OF

    PRODUCTS

    Before or at the latest on delivery of product, the Supplier must deliver the documents as required in the

    purchase order; they must include all references of the completed operation.

    3.18 QUALITY DOCUMENTS

    3.18.1 DECLARATION OF CONFORMITY

    For each purchase order, Supplier must deliver a Declaration of Conformity (preferable) according to NF L

    00-015 and/or NF EN 10204 standards.

    Declaration of Conformity and associated documents:

    • Must refer to all specifications and their issue imposed in the purchase order ,

    • Must bear full identification of products including markings, (only valid for subcontractors and

    suppliers of semi products)

    • Are approved by authorized persons.

    • Must be drawn up and filled in permanently and legibly: use of correction fluid and pencil/lead pencil

    is strictly forbidden.

    3.18.2 MATERIAL CERTIFICATE

    In case metal is supplied by a stockist, Declaration of Conformity or the associated documentation must

    include the material certificate of the Supplier who is the producer.

    3.18.3 PRODUCT DATA SHEET / SAFETY DATA SHEET

    Supplied product must be defined by a data sheet with date or issue number, specifying the reference and

    main characteristics of the product and its use, if applicable, such as:

    • Analysis (composition),

    • Physical and chemical properties,

    • Dimensional characteristics,

    • Field of use,

    • Particle size,

    • REACH compliance,

    • Goods origin, if possible,

    • Expiration date,

    • Recommendations and / or requirements for storage conditions. In addition, each product must be accompanied by a SDS compliant with REACH and CLP or GHS and it must

    not be older than 5 years.

    Any change of technical / safety / environmental data of a product must result in systematic update of the

    corresponding documents, particularly the SDS, and must be communicated as early as possible to AD / ES

    : HSE department of the relevant site.

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    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

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    3.18.4 MANUFACTURING PROCESS PLAN (PTF)

    In the case of purchase order for nuclear purposes, if required in the order or specifications, the supplier

    shall provide a Manufacturing Process Plan for approval by AD. This document shall include at the least:

    • Information relating to the purchase order ( customer name, part description, AD/ES brand and grade, specifications and their revision index, applicable code and its revision index if required,

    signatures of writer, reviewer and approver and approval of customer if required)

    • History, date and reasons for changes

    • All detailed steps required for manufacturing

    3.18.5 REALIZATION QUALITY PLAN (RQP)

    If required by the AD/ES specifications, a Quality realization Plan (PQR) is established for each product of

    the order and is submitted for acceptance. It must incorporate the points of convocation provided by AD/ES

    through the specifications AD/ES.

    This document is used as a follow-up and is updated according to the execution of the operations. At the

    final status, this document will be included in the final documentation required by AD/ES.

    This document will include at least:

    • The chronological list of operations, manufacturing and control,

    • The contractual documents required,

    • The list of meeting and stopping points for customer inspection,

    • If required, the list of Important Activities for Protection and if applicable their technical inspection.

    A system of letters is introduced to categorize the surveillance operation:

    ➢ "A" : Breakpoint

    Call AD/ES and wait for his answer before taking the corresponding action.

    The letter «H» («Hold Point») or any other acronym whose meaning is identical after agreement with

    AD/ES sometimes replaces this letter.

    Unless otherwise indicated in the order file, the contractual period allowed will be 15 calendar days

    ➢ « C » : Meeting Point

    To convene AD/ES and without answer from him within a contractually foreseen time, to carry out the

    corresponding operation.

    This letter is sometimes replaced by the letter "W" ("Witness Point") or any other acronym whose meaning

    is identical after agreement with AD/ES.

    ➢ « R » : Delivery of documents

    Transmit or prepare an interim control certificate or certificates to inform AD/ES of the results obtained

    during the controls or intermediate operations.

    Any other acronym whose meaning is identical may be used in agreement with AD/ES.

    This information does not give rise to convocation.

    A blank PQR frame is available in appendix ALL-I-003.F04 "PLAN QUALITY OF REALIZATION: P.Q.R" of this

    instruction.

    ALL-I-003.F04

    PLAN QUALITE DE REALISATION (PQR)

    REALIZATION QUALITY PLAN (RQP)

    Issue / Indice : 1

    Date: 18 Dec 2019

    Date : 18/12/19

    Page : 2 / 2

    Client

    (Customer)

    Client

    Commande :

    (Order)

    N° cde

    Commande Interne :

    (Internal order)

    Fourniture :

    (Supply)

    Plan + indice

    Lot :

    (Batch)

    Lot ou OF

    Produit :

    (Product)

    Coulée :

    (Heat number)

    N° Spéc. et indice :

    (Spec. Nb and rev.)

    Spec matière + code (avec indice selon exigence client)

    Nuance :

    (grade)

    Programme de fabrication :

    (Manufacturing program)

    Commentaires (Comments) :

    Suivi des modifications (Modification follow-up) :

    Evolution des indices

    Emargement

    Rédaction

    (Written by)

    Vérification

    (Checked by)

    Nom (Name)

    Date (Date)

    Visa (Sign)

    Ce document vous est transmis pour

    (This document is sent you for)

    |_|

    Approbation

    (Approval)

    Approbation client

    (Approved by customer)

    Statut du document

    (Document status)

    |_|

    Information (Information)

    ALL-I-003.F04

    PLAN QUALITE DE REALISATION (PQR)

    REALIZATION QUALITY PLAN (RQP)

    Issue / Indice : 1

    Date: 18 Dec 2019

    Date : 18/12/19

    Page : 1 / 2

    HIGH PERFORMANCE ALLOYS DIVISION APPENDIX /

    ANNEXE BRANCHE DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003.F04

    PLAN QUALITE DE REALISATION : P.Q.R. N°

    Realization Quality Plan (R.Q.P.)

    Issue / Indice : 1

    Date: 25 NOV 2019

    Date : 25/11/19

    Page : 2 / 3

    Client :

    (Customer)

     

    Commande:

    (order)

     

    A / H : Point d’Arrêt / Hold Point

    C / W : Convocation / Witness Point

    R / R : Remise de document / Certificate

    Produit :

    (Product)

     

    Lot :

    (Batch)

     

    Visa DAHP :

    (DAHP Visa)

     

    Visa SST :

    (Sub-contractor. Visa)

     

    Commentaires :

    (Comments)

     

    Opérations de fabrication et de contrôle

    (Manufacturing and control operations)

    Spécifications utilisées

    (Used specifications)

    Interventions, dates, visas

    (Interventions, dates, visas)

    Opérations sous-traitées

    (Subcontracted operations)

    Réf. FAI

    (Nonconformance ref.)

    Réf. Certificat

    (Certificate ref.)

    Sous-Traitant

    Sub-contractor

     

     

    O/N

    Y/N

    Sous-traitant

    Sub-contractor

    mariyam.benhamouPièce jointeALL-I-003.F04-ind1 Realization quality plan (RQP).docx

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    For an order that does not require a PQR but is subject to notice points, the final documentation of the

    external service provider must contain the actual dates of completion of the operation (s). For an extended

    operation over several days, the end date is the date of completion.

    3.19 CONTROL OF DOCUMENTS

    If requested with the purchase order, the Supplier shall submit the pre-production documents for AD / ES

    approval: manufacturing programs, PQR, technical instructions or procedures,

    Contents of these documents shall be agreed upon with AD / ES.

    Supplier must control language skills of writers and approvers of bilingual and foreign language documents

    and provide proof.

    Supplier must define a document control process (writing, reviewing, approving and changing)

    Nuclear market only: if requested to the order the references of the documents must comprise 14

    characters maximum, without space nor special characters.

    3.20 PACKAGING AND PACKAGE DESIGN OF PRODUCTS - DELIVERY

    Packaging and package design requirements of products shall be specified in the purchase order.

    The delivered products must be located individually or by a whole batch according to contract requirements.

    The supplier must set up the means necessary to preserve the products as well as possible.

    The products will have to be stored, by work order under identical conditions (temperature, hygroscopy),

    safe from bad weather, in adapted places, delimited. In the case of outside storage, the supplier will take

    care to avoid the creation of water retention zones on the products. (Only valid for subcontractors and

    suppliers of semi products)

    3.21 ORGANIZING TRANSPORT FOR PROUCTS DELIVERY TO AD / ES

    3.21.1 TRANSPORT UNDER RESPONSIBILITY OF AD / ES

    Supplier must inform AD / ES (department or person named in purchase order) of the expected date

    of goods collection and name of his carrier to organize transport.

    He must provide the information necessary for organizing transport: Purchase order number, OF

    (manufacturing order) number, gross weight, product identification, number, size and package type.

    Partial deliveries are not accepted without prior written consent of AD / ES.

    3.21.2 TRANSPORT ORGANIZED BY SUPPLIER

    Documents as required in the purchase order must be sent to AD / ES (department or person named

    in purchase order) products must be accompanied by a copy of these documents.

    In the case of subcontracting the supplier undertakes to complete and return to the transport service

    the form which will be sent to him.

    3.22 TREATMENT OF NONCONFORMANCES

    o If waiver :

    Supplier must :

    • Create a DAF within 24h in AD / ES Supplier Quality Portal by filling in all required fields

    • Submit the DAF to AD / ES via Supplier Quality Portal

    • The supplier shall follow the process for treating non conformance and its consequences described

    via Supplier Quality Portal (correction actions, analyze causes, corrective actions...)

    • Compensation for non conformance and its consequences shall also be treated via the portal.

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

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    When the DAF lead to requests for exemption to the customers of the High Performance Alloys

    Division then these must remain exceptional and the anomalies must be the subject of immediate

    corrective actions with the help of tools and / or methods (tools statistics, 8D,…).

    If the cause or corrective action cannot be defined at the time of issuance of the DAF, the supplier

    must open an 8D and regularly communicate the progress to its quality correspondent. This updated

    8D must be attached to any new DAF on the same subject.

    An eradication plan presenting all the anomalies treated as an exception must be presented every

    month to the quality correspondent

    o If claim :

    Supplier must:

    • Acknowledged the DAF under 48h in the portal providers Quality, including confirmation that the

    correction / securing / containment actions are implemented by integrating them into the Supplier

    Quality portal

    • The supplier shall follow the process for treating non-conformance and its consequences described

    via Supplier Quality Portal (correction actions, analyze causes, corrective actions...)

    • Compensation for non-conformance and its consequences shall also be treated via the portal.

    In both cases AD must notify Supplier of the actual cost justified by the consequences of the Supplier-related

    non-conformance and inform him of the business consequences.

    In any case, the cost charged to the supplier shall not be less than:

    Creation of a nonconformance record 200 €

    Waiver (AD / ES to customer) 280 €

    Waiver (supplier to AD / ES) 200 €

    Customer claim 550 €

    Internal rework

    Re-machining 240 €

    Re-grinding 60 €

    Re-marking 40 €

    Additional 3D inspection 80 €

    Additional tracing 60 €

    US method 50 €

    Scan specific plan 220 €

    Supplementary metal analysis 90 €

    Scrap Value of workpiece at transformation stage

    Transport 550 €

    Note: This grid is not applicable to semi-finished product suppliers.

    REMINDER: No welding operation is authorized and any other repair must be the subject of prior approval by

    AD/ES.

    o If anomaly exported

    Supplier must:

    • Open a DAF within 24 hours in the AD / ES Supplier Quality Portal by completing all required fields.

    • Submit the DAF to AD / ES via the Supplier Quality Portal

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

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    AUX FOURNISSEURS

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    • AD / ES will provide the supplier with the details to follow.

    The supplier can not send the parts without written agreement via the DAF. In all of the above cases (waiver, Claim, exported anomaly), Products affected by an anomaly may be delivered to the relevant site of AD / ES or to its customer in the case of direct delivery only, only when a

    authorization will have been transmitted through the DAF.

    o In the event of an Escape The supplier must:

    • Open a DAF within 24 hours in the AD / ES Supplier Quality Portal by completing all the required

    fields.

    • Submit the DAF to AD / ES via the Supplier Quality portal

    • Set up actions to secure the outstanding amount

    • AD / ES will analyze the impact of non-compliance in relation to customer

    3.23 Application of 10CFR21 (nuclear market only)

    If required to order or specification, the requirements of 10CFR21 are applicable.

    The detection of the potential existence of non-compliance on materials already delivered as part of an order

    will be notified by the external service provider to AD/ES, within 5 days. This information will refer to the

    order, with the mention "Application of 10CFR21".

    If a deviation or deviation is found, this detection would be automatically recorded according to this procedure

    through the AD/ES Suppliers Portal.

    3.24 PROCESSING CORRECTIVE ACTIONS RESULTING FROM AUDIT

    (DAC/Corrective Action Request)

    After a supplier audit, DACs (corrective action request resulting from audit) will be opened in Supplier Quality

    Portal by AD/ES.

    Supplier must communicate responses to nonconformities detected, within the agreed time limits as below.

    Non conformity types Response time

    Search causes Correction Corrective actions

    Minor: non-fulfilment of a requirement

    of the reference document which does

    not entail significant risk of

    nonconformity to a specified product

    requirement or that does not undermine

    effectiveness of the QMS.

    5 days 7 days 10 days

    Major: non-fulfilment of a requirement

    of the reference document and which

    entails significant risk of nonconformity

    to a specified product requirement or

    undermines effectiveness of the QMS.

    3 days 5 days 7 days

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

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    ALL-I-003

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    Critical: nonconformity to a specified

    product requirement of a product

    already delivered or under delivery.

    48h 48h 5 days

    Note: A minor recurring NC becomes major.

    3.25 CORRECTIVE ACTIONS: PRINCIPLE OF FOOL PROOFING LEVELS

    For all corrective actions ensuing DAF or DAC, the Supplier shall assess the fool proofing level of the action

    implemented (I, II or III) according to the following scale and shall update this level in the Supplier Portal.

    The Supplier shall implement Level 1 actions in priority. A response to a deviation that comprises only Level

    III actions shall not be accepted.

    3.26 ENVIRONMENTAL MANAGEMENT SYSTEM

    Supplier must be ISO 14001 certified or at least follow a dynamic policy to Reduce impacts on environment.

    Supplier commits to:

    • Inform AD/ES of any event likely to impact human health or environment.

    • Implement a policy to reduce environmental impact over the entire life cycle of product.

    • Special measures relating to pollution and transport conditions may be, if necessary, notified in

    purchase orders and they must be implemented by the supplier.

    The problem can never occur due to the implementation of an active

    solution (e.g. a physical or electronic device). - One-way assemblies

    - Automatic computation

    - Computer form preventing any processing carried out with missing

    data.

    Error becomes impossible

    An active alert of the existence of a problem when it occurs during a

    process. To be effective, it requires a reaction from a human being.

    For example: - Alarms

    - Lamps

    - Synoptics

    - Prompts on the screen when using the "delete" key: "Are you sure?" question is displayed

    Also, solutions triggered by either an active or passive alert are

    paused to reduce the risk of an error.

    The coding solution may not be 100% effective.

    Passive warning devices that alert you to the need to do something

    right, as well as solutions that detect a problem after a process has

    been completed but before the customer is exposed to the effects. - Standardized work documents/ work instructions

    - Inspections carried out before the next operation

    - Warning labels / signs

    The coding solution may not be 100% effective.

    1 ULTIMATE

    2

    BETTER

    3

    GOOD

    Eff

    icacit

    é

    GUIDE TO CODING METHODS

    Description Keying

    level Examples

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

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    3.27 SECURITY AND SAFETY

    Supplier commits to take in his internal organization appropriate measures to ensure security and safety

    of operations entrusted.

    Supplier commits to:

    • Implement continuously appropriate security and safety measures compatible with the nature of

    operations done on behalf of AD / ES,

    • Apply all instructions and restrictions provided by AD / ES, particularly in respect to conditions of

    intervention in AD / ES sites,

    • Adequately protect its information system and particularly the information entrusted by AD / ES,

    against any attempt to fraudulent or unauthorized intrusion.

    These security and safety measures include:

    • Training and regular information of all its staff, including temporary staff, on security and safety

    issues and risks related to their mission and confidentiality obligations associated,

    • Strict and controlled management of access devices entrusted by AD / ES such as keys, badges

    and access codes,

    • Regular inspection of safety devices and procedures.

    • Implementation of an effective process to inform and take actions when a non-conformance in

    security and safety is detected.

    3.28 NUCLEAR SECURITY CULTURE (nuclear market only)

    In the context of orders whose products are intended for the nuclear market, the requirements described

    in the brochure "Culture Nuclear Safety" must be applied. The acknowledgment of receipt of this must be

    returned to us according to the instructions provided in the Appendices ALL-I-003.F03 "

    ACKNOWLEDGEMENT OF RECEIPT “NUCLEAR SAFETY CULTURE” LEAFLET.

    The external service provider must ensure that the elements of our "Nuclear Safety Culture" brochure

    (below) are appropriated by all of its employees involved in AD/ES orders.

    The external provider must:

    • Ensure a common understanding of the key aspects of the safety culture in the company through

    awareness raising for all employees, including temporary workers. This awareness should be

    recorded and periodically verified for effectiveness,

    • provide the means by which the company supports individuals and teams in carrying out their

    tasks safely and successfully, taking into account the interaction between individuals, technology

    and organization,

    • reinforce learning and the attitude of questioning at all levels of

    • provide the means by which the organization is continually seeking to develop and improve its

    safety culture.

    In the case of an order governed by the decree of February 7, 2012 setting the general rules for basic nuclear

    facilities, AD/ES will provide in its Terms of Reference the list of Important Activities for Protection, the

    required registrations, and than the essential parameters. Important Activities for Protection will be subject

    to a technical control.

    The external service provider will ensure the qualification of the personnel carrying out these AIPs.

    If required by AD/ES specifications additional provisions may be required under RCC-M or ASME order.

    ALL-I-003.F03

    ACKNOWLEDGEMENT OF RECEIPT “NUCLEAR SAFETY CULTURE” LEAFLET

    AR BROCHURE « CULTURE SÛRETE NUCLEAIRE »

    Issue / Indice : 1

    Date: 18 dec 2019

    Date : 18/12/19

    Page : 1 / 2

    HIGH PERFORMANCE ALLOYS DIVISION APPENDIX /

    ANNEXE BRANCHE DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003.F03

    ACKNOWLEDGEMENT OF RECEIPT “NUCLEAR SAFETY CULTURE” LEAFLET

    AR BROCHURE « CULTURE SÛRETE NUCLEAIRE »

    Issue / Indice : 1

    Date: 25 NOV 2019

    Date : 25/11/19

    Page : 2 / 2

    Veuillez retourner, sous trente jours, cette lettre au Service Achats et à la Qualité fournisseur.

    Please return, within thirty days, this letter completed to the supplier Department and supplier Quality.

    Accusé de réception de la Brochure « Culture Sûreté Nucléaire »Acknowledgement of receipt «Nuclear Safey Culture» Leaflet

    Version / Issue

    Nous avons bien reçu le document précité - We have received the contractual document

    Nous avons détruit le document périmé - We have destroyed the expired document

    Remarques / Remarks

    Société / Company

    Nom / Name

    Fonction / Title

    Date

    Signature

    mariyam.benhamouPièce jointeALL-I-003.F03-Ind1 Acknowledgement of receipt “nuclear safety culture” leaflet.docx

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

    Issue / Indice : 4

    Date: 27 May 2020 Date: 27/05/20

    Page : 17 / 39

    Safety culture is the set of

    characteristics and attitudes in organizations and individuals

    that ensures that issues related

    to the safety of nuclear power

    plants receive the priority attention they deserve because

    of their importance.

    It refers to the commitment and

    sense of personal responsibility of all those involved in the

    production of parts for the

    nuclear industry.

    Constantly thinking about safety implies an attitude of systematic

    questioning, a refusal to be

    satisfied with the results

    achieved, a constant concern for

    perfection, and an effort of personal responsibility and

    group self-discipline in matters

    of safety.

    What is nuclear safety culture?

    Nuclear

    safety

    culture

    The human factor is of fundamental importance in

    ensuring safety in nuclear

    facilities.

    Being involved in the production of parts for the nuclear industry, I

    am aware of the impact of my

    activity on safety.

    This is why all the links in the

    chain must comply with the requirements of the

    manufacturing documents and be

    aware that their actions can have

    consequences on nuclear safety and the safety of everyone.

    All those involved

    in nuclear safety

    What is nuclear safety culture?

    * The main Quality standards for the Nuclear industry are : ISO9001, NCA3800 (ASME), RCC-M, RCC-MRx, 10CFR21, GS-R-3

    (AIEA), HAF604 as well as customer references.

    The Quality and Nuclear Safety approach: the same fight

    These two approaches are based on the same two pillars

    Safety culture is the set of characteristics and attitudes in organizations and individuals that ensures that issues related to the safety of nuclear power plants receive the priority attention they deserve because of their importance. It refers to the commitment and sense of personal responsibility of all those involved in the production of parts for the nuclear industry. Constantly thinking about safety implies an attitude of systematic questioning, a refusal to be satisfied with the results achieved, a constant concern for perfection, and an effort of personal responsibility and group self-discipline in matters of safety.

    Human: responsibilities are clearly defined, and staff are trained for the tasks they perform with all the necessary rigor. Involved, the personnel are proactive and alert in case of doubt.

    Organisational: based on Quality and nuclear* guidelines, the company's organisation, quality manual, procedures and operating methods incorporate their requirements for the implementation of all our actions.

    know-how

    priority

    responsability

    reflection

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

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    3.29 PREVENTION OF FRAUDULENT AND SUSPICIOUS COUNTERFEIT

    PARTS

    Supplier shall take all necessary measures to control protection of products especially by identifying and

    managing risks throughout their manufacture.

    Supplier must prevent and detect counterfeit or suspect products and block their delivery to an Alloys

    Division site.

    He must describe and put in place the necessary measures to ensure that products / parts manufactured

    and delivered to an Alloys Division site are not counterfeit.

    In the case of detection of a counterfeit product or suspected to be, the supplier must imperatively

    quarantine the product and must alert AD by declaring a DAF in the supplier quality portal within 24

    hours.

    3.30 ARCHIVING

    Filed documents must be preserved in a room: • Locked

    • Protected against fire, water, rodents and excess light

    • With controlled access

    3.30.1 AEROSPACE / NUCLEAR / DEFENSE / MEDICAL SEGMENT PRODUCTS

    Documents used during the various manufacturing and inspection operations, calibration reports must

    be archived for a minimum of 50 years and cannot be destroyed without the authorization of AD / ES.

    Documents relating to our purchase orders must be available on our request. Time allowed to reconstitute

    traceability of a purchase order must not exceed 2 working days and 24 hours if safety against thefts is

    questioned.

    3.30.2 OTHER FIELDS

    Documents relating to purchase orders must be available on our request. Time allowed to reconstitute

    traceability of a purchase order must not exceed 5 working days.

    Documents used through the various operations of manufacturing and inspection and calibration reports

    must be filed at least for 10 years and cannot be destroyed without AD / ES consent.

    3.31 MATRIX OF COMPLIANCE WITH AD REQUIREMENTS

    The Supplier must set up a matrix highlighting how he meets each of AD/ES’ requirements including this

    specification.

    3.32 CESSATION OF ACTIVITY OR LIQUIDATION

    In this case Supplier must inform AD / ES so that it can take back all its products, tools and relevant

    documents.

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

    EXIGENCES GENERALES APPLICABLES

    AUX FOURNISSEURS

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    TERMS AND ABBREVIATIONS

    Term or abbreviation Definition

    AD AD

    Correcting action = Curative action Action to eliminate the detected non-conformity.

    Critical items Those items (e.g., functions, parts, software,

    characteristics, processes) having significant effect on

    the product manufacturing and use , including safety,

    performance, size, interchangeability and function,

    producibility, service life cycle, etc.., that

    requirespecific actions to ensure they are adequately

    managed. Examples of critical items include safety

    critical items, fracture critical items, mission critical

    items, key characteristics ...,

    DAF Supplier Non-conformance Declaration

    DAC corrective action request following audit

    Deviation permit Written authorization to deviate from the

    requirements specified in the order for a supply

    ES Erasteel

    FDS Safety Data Sheet

    Key characteristics

    a property or a characteristic whose variation has a

    significant effect on size, interchangeability and

    function of product, its performance, service life, or

    its producibility that require specific actions to control

    this variation

    Major change

    change in Manufacturing Process, production or

    control means, manufacturing site or supplier.

    Possible outsourcing of all or part of manufacturing

    and control operations that have been assigned

    Nonconformance Deviation from an order, a reference (standard,

    specification or a procedure ...)

    PQR Quality Plan of Realization

    Product In this specification, where the word product is used,

    it can also mean service.

    PTF Manufacturing Process Plan

    QAP Quality Assurance Plan

    Repair Modification by heat treatment, welding, grinding,

    dimensional change.

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

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    AUX FOURNISSEURS

    Issue / Indice : 4

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    Term or abbreviation Definition

    Requalification

    Test and inspection program for process and product,

    validated by the customer; support documents prove

    quality of product and compliance with significant

    process parameters

    SMQ Quality Management System

    Supplier Quality Portal It's a Web application availability of suppliers and

    their corresponding AD/ES

    Special process

    Production process and service preparation where the

    resulting output cannot be verified by subsequent

    monitoring or measurement. This includes any

    process where deficiencies become apparent only

    after the product is in use or the service provided

    (NDT, Heat treatment, test Laboratory ...)

    Special services

    Hot processing operations (forging, rolling, extrusion,

    bending, Heat Treatment, Surface treatment,

    moulding), machining for usability, Test and

    inspection, direct delivery

    Specification Technical Specification of Supply Chain or

    Subcontracting

    Stockist distributor Provider carrying out purchase, storage and sale of

    product without altering the state

    Traceability

    Necessary actions to ensure reconstitution of the

    manufacture of products under process or already

    shipped to AD/ES (documents used, human resources

    and materials)

    Escape

    Export non-conformity not reported during processing

    of the AD order and after delivery of parts.

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

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    Issue / Indice : 4

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    SOMMAIRE

    OBJET.............................................................................................................. 22

    DOCUMENTS DE REFERENCE ........................................................................... 22

    CONTENU DE L’INSTRUCTION ......................................................................... 22

    3.1 ENGAGEMENT DU FOURNISSEUR AU RESPECT DE CETTE SPECIFICATION ................ 22 3.2 AGREMENT ..................................................................................................... 23 3.3 REVUE DES EXIGENCES AD/ES .......................................................................... 23 3.4 VERIFICATION D’APPLICATION ET DROIT D’ACCES ............................................... 23 3.5 ACCORD PREALABLE DE MODIFICATION MAJEURE ................................................ 24 3.6 MAITRISE DU PRODUIT FOURNI PAR AD / ES ....................................................... 25 3.7 TRACABILITE DU PRODUIT ............................................................................... 25 3.8 PROCEDES SPECIAUX ...................................................................................... 25 3.9 MAITRISE DES PROCEDES ................................................................................ 25 3.10 PRESERVATION DU PRODUIT/ FOREIGN OBJECT PREVENTION .............................. 25 3.11 MAITRISE DES MOYENS DE PRODUCTION ......................................................... 26 3.12 MAITRISE DE MOYENS DE CONTRÔLE, DE MESURE ET D'ESSAIS .......................... 26 3.13 CONTROLE DIMENSIONNEL ............................................................................. 26 3.14 ANALYSE DE RISQUES .................................................................................... 27 3.15 MAITRISE DES LOGICIELS ET PROGRAMMES INFORMATIQUES ............................. 27 3.16 DOCUMENTATION NECESSAIRE POUR L’AUTORISATION DE LIVRAISON DES PRODUITS ......................................................................................................................... 28 3.17 DOCUMENTATION QUALITE ............................................................................. 28 3.18 MAITRISE DES DOCUMENTS ............................................................................ 30 3.19 EMBALLAGE ET CONDITIONNEMENT DES PRODUITS – LIVRAISON ........................ 30 3.20 ORGANISATION DU TRANSPORT POUR LA LIVRAISON DES PRODUITS CHEZ AD / ES 30 3.21 TRAITEMENT DES ANOMALIES (DAF) ................................................................ 30 3.22 APPLICATION DU 10CFR21 (MARCHE NUCLEAIRE UNIQUEMENT) .......................... 32 3.23 TRAITEMENT DES ACTIONS CORRECTIVES SUITE A AUDIT (DAC) ......................... 32 3.24 ACTIONS CORRECTIVES : PRINCIPE DES NIVEAUX DE DETROMPAGE ..................... 33 3.25 SYSTEME DE MANAGEMENT DE L'ENVIRONNEMENT ............................................ 34 3.26 SURETE ET SECURITE .................................................................................... 34 3.27 CULTURE SURETE NUCLEAIRE (MARCHE NUCLEAIRE UNIQUEMENT) ...................... 34 3.28 SECURITE DES PRODUITS ET PREVENTION DES PIECES CONTREFAITES ................ 36 3.29 ARCHIVAGE .................................................................................................. 36 3.30 MATRICE DE CONFORMITE AUX EXIGENCES DE CETTE INSTRUCTION .................... 37 3.31 CESSATION D'ACTIVITE OU DEPÔT DE BILAN .................................................... 37 TERMES ET ABREVIATIONS ............................................................................. 38

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

    SUPPLIERS GENERAL REQUIREMENTS

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    AUX FOURNISSEURS

    Issue / Indice : 4

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    OBJET

    En complément des Conditions Générales d’Achats AD/ES en vigueur disponibles sur les sites web

    www.aubertduval.com et www.erasteel.com , cette spécification définit les exigences générales applicables aux

    Fournisseurs de AD/ES.

    Sauf indication contraire à la commande les exigences des normes EN 9100 sont applicables.

    Des dispositions particulières stipulées à la commande, telles que AQAP 2110/2120, peuvent compléter la

    présente spécification.

    DOCUMENTS DE REFERENCE

    ❖ ISO 9001 : Systèmes de management de la qualité.

    ❖ ISO 14001 Systèmes de management environnemental

    ❖ ISO 10012 : Système de management de la mesure Exigences pour les processus et les équipements

    de mesure.

    ❖ AQAP 2110 : OTAN exigences qualité pour la conception …

    ❖ ISO 17025 : Prescriptions générales concernant la compétence des laboratoires d'étalonnages et

    d'essais.

    ❖ EN 9100 : Série aérospatiale. Système qualité. Modèle pour l'assurance qualité en conception,

    développement, production, installation et exploitation.

    ❖ EN 9120 : Série aérospatiale. Systèmes de management de la qualité. Exigences pour les distributeurs

    stockistes.

    ❖ EN 9130 : Série aérospatiale. Système qualité. Archivage de documents.

    ❖ EN 10204 : Produits métalliques. Types de documents de contrôle.

    ❖ NF L 00-015 : Management et assurance de la qualité. Déclaration de conformité

    ❖ Brochure « Objectif Sûreté nucléaire »

    ❖ Conditions Générales d'Achats AD / ES

    ❖ EN 9146 : “Programme de prévention des dommages causés par un corps étranger (FOD) - Exigences

    pour les Organismes de l'Aéronautique, l'Espace et la Défense”

    ❖ MQN.AD-FR « Manuel Qualité Nucléaire »

    CONTENU DE L’INSTRUCTION

    3.1 ENGAGEMENT DU FOURNISSEUR AU RESPECT DE CETTE SPECIFICATION

    Sans remarque ou commentaire sous 30 jours à partir de l’envoi de l’instruction au Fournisseur, ce dernier

    s'engage au respect de cette dernière. Seule une dérogation validée par le service Qualité AD / ES, peut

    autoriser un écart.

    Les fournisseurs doivent retourner une copie signée et visée de l’Accusé de Réception ALL-I-003.F01-ind1

    ”DEMANDE D’ACCUSE DE RECEPTION DES « EXIGENCES GENERALES APPLICABLES AUX FOURNISSEURS »

    joint à cette spécification au service Achats et Qualité fournisseurs du site concerné.

    Ce formulaire comporte également un tableau afin que le fournisseur puisse expliciter clairement les

    exceptions à cette instruction, chaque écart devra faire référence au paragraphe concerné.

    Les réserves seront validées par AD/ES avant application.

    http://www.aubertduval.com/http://www.erasteel.com/

    ALL-I-003.F01

    ACKNOWLEDGEMENT OF RECEIPT ”SUPPLIERS GENERAL REQUIREMENTS”

    DEMANDE D’ACCUSE DE RECEPTION DES « EXIGENCES GENERALES APPLICABLES AUX FOURNISSEURS »

    Issue / Indice : 1

    Date: 18 Dec 2019

    Date : 18/12/19

    Page : 1 / 1

    HIGH PERFORMANCE ALLOYS DIVISION APPENDIX /

    ANNEXE BRANCHE DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003.F01

    ACKNOWLEDGEMENT OF RECEIPT ”SUPPLIERS GENERAL REQUIREMENTS”

    DEMANDE D’ACCUSE DE RECEPTION DES « EXIGENCES GENERALES APPLICABLES AUX FOURNISSEURS »

    Issue / Indice : 1

    Date: 25 nov 2019

    Date : 25/11/19

    Page : 2 / 2

    Le présent document fait foi d’accusé de réception de la procédure ALL-I-003 indice…..

    This document is an acknowledgement of receipt of the procedure ALL-I-003 issue…..

    Le tableau suivant permet de noter d’éventuels commentaires sur des exigences spécifiées dans la procédure susmentionnée.

    The following table allows you to make comments on the requirements specified in the above procedure.

    Paragraphe

    Paragraph

    Commentaires

    Comments

    Décision DAHP

    DAHP Decision

    Veuillez nous retourner un exemplaire de ce document dûment daté, validé et signé.

    Sans retour de votre part sous 30 jours, nous considérerons que les exigences sont validées. 

    Please return a copy of this document duly dated, signed and validated. Without receipt of this document by 30 days, we consider that the requirements are validated.

    Fournisseur

    SUPPLIER

    Nom + Fonction

    Name + Title

    Date + Signature

    Date + Signature

    Achats/Purchasing Department Qualité fournisseurs DAHP/DAHP Supplier Quality

    Document à retourner au Service Achats et à la Qualité fournisseur.

    Document to return to the supplier Department and supplier Quality

    mariyam.benhamouPièce jointeALL-I-003.F01-ind1 Acknowledgement of reception of suppliers general requirements.docx

  • HIGH PERFORMANCE ALLOYS DIVISION INSTRUCTION /

    INSTRUCTION DIVISION ALLIAGES HAUTE PERFORMANCE

    ALL-I-003

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    AUX FOURNISSEURS

    Issue / Indice : 4

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    3.2 AGREMENT

    3.2.1 CONDITIONS DE DELIVRANCE

    L’agrément du couple produit / fournisseur est délivré par AD / ES après la constitution satisfaisante d’un

    dossier dont le contenu est fixé par AD / ES.

    Le fournisseur doit s’assurer que ses certificats tierce partie et client sont à jour dans le portail Qualité

    fournisseurs. Des relances automatiques informent le fournisseur des certificats arrivant à expiration.

    Le fournisseur est tenu d’informer AD / ES de toute évolution de ses certifications tierce partie et clients, en

    particulier, en cas de perte ou de suspension de certification tierce partie et/ou clients, pour lequel le

    fournisseur doit alerter AD / ES sous 48h.

    3.2.2 Qualification

    Le fournisseur doit mettre en place un dossier 1er article dans les cas ci-dessous :

    • Réalisation du 1er article

    • Évolution de plan qui peut affecter la forme et la fonction de la pièce

    • Changement de process, de méthode de contrôle, de site de fabrication, d’outillage ou de machine qui

    peut affecter la forme ou la fonction de la pièce

    • Changement du programme numérique de contrôle ou transfert du programme de contrôle sur un autre

    système d’exploitation.

    • Remplacement important de personnel de production et de contrôle

    • Arrêt de production supérieure à 2 ans ou sur demande spécifique d’AD.

    • Avant tout transfert vers un autre site de fabrication (interne ou externe) une LAI doit être effectuée

    dans le site qui « envoi » et une FAI doit être réalisée dans le site qui « reçoit ».

    3.2.3 SUSPENSION DE L’AGREMENT

    La suspension d’un agrément est prononcée par le service Qualité, elle est motivée par :

    Cas 1 : L’organisme certificateur à retirer la certification au fournisseur

    Cas 2 : les objectifs fixés au fournisseur ne sont pas atteints de manière récurrente ou la performance est

    jugée insuffisante

    Cas 3 : la durée de l’arrêt de fourniture d’un produit dépasse la durée maximale fixée par le client.

    Cas 4 : Sans exigence client sur la durée celle-ci est fixée à 5 ans pour tous lorsqu’il dépasse 5 ans pour

    tous les segments sauf la sous-traitance de production pour laquelle la durée est fixée à 2 ans

    Le processus de ré-agrément est initialisé par AD / ES suivant des conditions qui seront précisées aux

    fournisseurs.

    3.3 REVUE DES EXIGENCES AD/ES

    Le fournisseur doit prendre en compte les exigences de la présente instruction, de la commande et du

    cahier des charges.

    Pour chaque nouvelle affaire le fournisseur devra mener une revue des exigences applicables.

    L’objectif de cette revue est de s’assurer que les exigences relatives au produit ont été comprises et acceptées

    et que les écarts éventuels ont été formellement levés.

    3.4 VERIFICATION D’APPLICATION ET DROIT D’ACCES

    AD / ES se réserve le droit de vérifier chez le Fournisseur de 1er et 2ème rang (et avec accord du fournisseur

    de rang 1 dans ce cas), seul ou en présence de ses Clients, ou d’une Tierce Partie, ou des Autorités

    réglementaires le respect de ces exigences.

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    Pour ce faire le Fournisseur s’engage à laisser le libre accès à la documentation et aux emplacements où se

    déroulent toutes les activités relatives à l'exécution de la commande AD / ES.

    Le fournisseur s’engage à prévenir AD/ES de toutes demandes directes de visites/documentation/audit de la part d’un de

    ses clients. Le fournisseur ne donnera pas suite à ces demandes sans accord préalable et écrit d’AD/ES.

    3.5 ACCORD PREALABLE DE MODIFICATION MAJEURE

    Toute modification majeure :

    • Transfert d’activité (changement de site de fabrication, changement de fournisseur ou de fournisseur, sous-

    traitance éventuelle à un tiers de tout ou partie des opérations de fabrication ou de contrôle).

    • Changement d’ERP.

    • Réorganisation du site (changement dans le Top level management et postes clés tels que directeurs,

    responsable qualité…).

    • Changement dans le process de fabrication contractuel.

    • Changement du moyen de production ou de contrôle

    • Autre changement relatif à des thématiques supply-chain (capacité, Lead time, Order entry)

    Doit être formalisée via notre formulaire ALL-I-003.F02 « Déclaration de changement majeur », et nous le

    communiquer via le portail qualité fournisseur (rubrique documentation ➔document de conformité ➔ Déclaration de

    changement majeur)

    AD/ES donnera ou non son accord au fournisseur pour engager la modification et les conditions de mise en œuvre

    de cette modification.

    3.6 SOUS-TRAITANCE DE DEUXIEME RANG (applicable aux fournisseurs de sous-traitance de production et d’essais)

    Avant d’engager toute sous-traitance de 2ème rang, le sous-traitant de 1er rang doit adresser une demande à DAHP. Cette demande doit être accompagnée d’un Plan d’Assurance Qualité qui doit être accepté par la DAHP avant de commencer toute opération. Le Plan d’Assurance Qualité doit comporter a minima les éléments suivants :

    • Le Flow-chart ou descriptif clair de l’enchainement des opérations avec la/les sociétés où elles peuvent être réalisées

    • Les produits concernés par le PAQ • Le(s) sous-traitant(s) concerné(s)

    • La revue de contrat : description brève de la façon dont est pilotée la revue des exigences de DAHP entre le

    sous-traitant de 1er rang et celui de 2ème rang • Le dossier de FAI ou DVI le cas échéant : description brève de la façon dont est pilotée la constitution et la

    validation du dossier FAI / DVI entre le sous-traitant de 1er rang et celui de 2ème rang • La gestion des anomalies : description brève de la façon dont est pilotée le traitement des anomalies entre

    le sous-traitant de 1er rang celui de 2ème rang, incluant le partage de l’information avec DAHP, l’attente de la décision de DAHP et la mise en place des actions demandées par DAHP

    • La gestion des qualifications tierce partie et clients et notamment la remontée de l’information vers DAHP en cas de modification ou perte

    • La déclaration de conformité et la libération du produit : description brève de la façon dont est réalisée la libération du produit pour garantir à AD que la totalité de la prestation a été réalisée conformément aux exigences DAHP

    Le sous-traitant de 1er rang doit cascader l’ensemble des exigences de la DAHP et les exigences spécifiques des

    clients qui lui ont été cascadées par DAHP à son sous-traitant.

    ALL-I-003.F02

    MAJOR CHANGE NOTIFICATION

    DÉCLARATION DE CHANGEMENT MAJEUR

    Issue / Indice : 2

    Date: 27 May 2020

    Date : 27/05/20

    Page : 1 / 2

    ALL-I-003.F02

    MAJOR CHANGE NOTIFICATION

    DÉCLARATION DE CHANGEMENT MAJEUR

    Issue / Indice : 2

    Date: 27 May 2020

    Date : 27/05/20

    Page : 2 / 2

    1 – PRODUCT IDENTIFICATION / IDENTIFICATION DU PRODUIT

    Company Name /nom de la compagnie

    Plant location /emplacement de l'usine

    Product description /description du produit

    2 – DESCRIPTION OF THE CHANGE /DESCRIPTION DU CHANGEMENT

    2.1 - Type of the change / Type de changement

    DAHP agreement required before setting up / Accord DAHP requis avant la mise en place

    DAHP must be informed / DAHP doit être informé

    Transfer of activity (change of manufacturing site, change of subcontractor or supplier, possible subcontracting to a third party of all or part of manufacturing or inspection/test operations) /Transfert d’activité (changement de site de fabrication, changement de sous-traitant ou de fournisseur, sous-traitance éventuelle à un tiers de tout ou partie des opérations de fabrication ou de contrôle).

    Change of ERP / Changement d’ERP.

    Change in contract manufacturing process/Changement dans le process de fabrication contractuel.

    Reorganization of site (change in top level management and key positions such as directors,quality manager...)/Réorganisation du site (changement dans le Top level management et postes clés tels que directeurs, responsable qualité…).

    Change in means of production and control (unless changed by identical means and machine requalified by the subcontractor) /Changement du moyen de production ou de contrôle (sauf si changé par des moyens identiques et machine requalifiée par le sous-traitant)

    Change in means of production and control (if change by identical means and machine requalified by the STT) /Changement du moyen de production ou de contrôle (si changement par des moyens identiques et machine requalifiée par le STT)

    Other changes related to supply chain aspects ( capacity, Lead time, Order entry)/ Autre changement relatif à des thématiques supply-chain (capacité, Lead time, Order entry)

    Other (precise) / autre (à préciser)

    Other (precise) / autre (à préciser)

    2.2 – Change description / Changer la description

    |_|Temporary / provisoire