PROGRAM: C27J QUALITY REQUIREMENTS FOR ALENIA SUB-CONTRACTORS

Transcription

1 PROGRAM: C27J QUALITY REQUIREMENTS FOR ALENIA SUB-CONTRACTORS PREPARED BY Suppliers Quality APPROVED BY Suppliers Quality This document is property of Alenia Aeronautica S.p.A. it shall not be copied or its content shall not be communicated to third parties without written authorisation of Alenia Aeronautica S.p.A. 1/17

2 MODIFICATION DESCRIPTION ISSUE DATE MODIFIED PAGES APPROVAL / September 02 First Release C. Scafa, R. del Pezzo, V. Ruggeri 1 April 2006 The quality requirements have been aligned with current issue of IAY G05 C and Military Standards (AQAP, AER-Q) See cover page 2 June 2006 Updated the Attachment 1 and related RFW/RFD fill in instruction (para 8.3) See cover page 2/17

3 INDEX 1. Scope 2. Application 3. Normative reference / General 3.1 Normative reference 3.2 General Definitions and glossary General Principles 4. Quality management system 4.1 General Requirements 4.2 Documentation Management General Control of documents Control of Quality Records 5. Management responsibility 6. Resource management 6.8. Product Identification and Traceability 7. Product realization Control of design and development changes 7.4. Purchasing Control of production and service provision Control of Production Equipment, tools and numerical control (N.C.) machine programs Validation of processes for production and service provision 7.6. Control of monitoring and measuring devices 8. Measurement, Analysis and Improvement Internal audit Monitoring and measurement of product 8.3. Control of non conforming product Attachment 1 RFW/RFD FORM In this document, there are reported only IAY G05 C paragraphs for which additional or special emphasized requirements are present. 3/17

4 1. SCOPE This document defines the Alenia Aeronautica subcontractor general quality system requirements for C27J program. These requirements are additional to quality system requirements stated in Alenia Aeronautica External Procedure IAY G05 C. Any others product quality requirements may be included into Work Package technical specifications. 2. APPLICATION This document is applicable for the following aircraft work package activities typology subcontracted by Alenia Aeronautica: - design and manufacturing - design - manufacturing with material purchasing - manufacturing without material purchasing - industrialization. Therefore, this document is applicable to Suppliers, involved in the C27J program, classified as one of the following Alenia Aeronautica Qualification Levels according to IAY G05 C: C1 C2 C3 D1 H1 H2. NOTE 1: For the paragraph applicability, refer to paragraph of IAY G05 C. NOTE 2: In this document, only those paragraphs of IAY G05 C which present additional or special emphasized requirements are reported. 3. NORMATIVE REFERENCE / GENERAL 3.1 Normative reference The applicable documents are the followings: INTERNATIONAL STANDARDS - AEROSPACE SERIES EN 9100/AS 9100 EN 9102/AS 9102 Aerospace series Quality management systems Requirements (based on ISO 9001:2000) and Quality systems Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001:1994) Aerospace series Quality systems First Article Inspection 4/17

5 EN 9103/AS 9103 Aerospace series Quality systems Variation Management of key characteristics INTERNATIONAL STANDARDS - QUALITY MANAGEMENT SYSTEMS ISO 9001:2000 ISO 9000 Quality Management Systems - Requirements Quality Management Systems Fundamentals and Vocabulary MILITARY STANDARDS AQAP 2110 AQAP 2070 AER-Q 2110 NATO Quality Assurance Requirements for Design, Development and Production NATO Mutual Government Quality Assurance (GQA) Process Requisiti di Assicurazione Qualità della D.G.A.A. concernenti la Progettazione, lo Sviluppo e la Produzione AIRWORTHINESS AUTHORITIES DOCUMENTS EASA Part 21 G Certification Procedures for Aircraft and Related Products and Parts ALENIA DOCUMENTS IAY G05 C Quality Management System Requirements for Suppliers (at last issue) IAE G 01 Engineering Off-Load Activity M Alenia Tooling Manual QFRA/06P.021 Guide line for subcontractors use of Incoming Inspection Delegation/Reduced Purchaser Testing released by Alenia to raw materials suppliers and standard suppliers All the above documents have to be considered at last/current revision. 3.2 General Definitions and glossary CAD CAI CAM D.O.E. ENAC FAI MDD Computer Aided Design Computer Aided Inspection Computer Aided Manufacturing Design of Experiments Ente Nazionale per l Aviazione Civile (Italian Airworthiness Authority) First Article Inspection Master Dimension Data 5/17

6 NDT OASIS P/N Q.P.L. S/N W/D Non Destructive Testing On-line Aerospace Supplier Information System Part Number Qualified Product List Serial Number Waiver/Deviation General Principles The Supplier quality management system shall be in accordance to AS/EN 9100 international standard and it is expected to gain Other Party Scheme certification issued by accredited Certification Bodies and OASIS registration. Moreover the Supplier shall undergo to Alenia Aeronautica qualification. The Supplier shall be able to meet Contract requirements, including quality requirements before starting production activities. In case of non compliance with contract requirements, the Supplier shall put in place all the improvement initiatives required by Alenia Aeronautica (e.g. Quality Improvement Plan, etc.). Note: The Alenia Aeronautica qualification and surveillance (audit, inspection, etc.) do not affect the Supplier s responsibility for the provided product. The program activities are subjected to Alenia Aeronautica and to Airworthiness Authority surveillance The Supplier shall assure right of access for: Alenia Aeronautica Alenia Aeronautica Customer representative Airworthiness Authority representative. The Supplier and its sub-tiers shall be available to be submitted to the scheduled and/or unscheduled Alenia Aeronautica/Alenia Aeronautica Customer representative/authority audit activity, and/or provide all quality records and technical information relating to the orders in progress necessary to exercise their surveillance actions within reasonable time from the request. 6/17

7 4. QUALITY MANAGEMENT SYSTEM 4.1 General Requirements The Supplier shall prepare a Quality Assurance Plan in accordance with Alenia Aeronautica form (IAY G05 C Attachment 1), to define and demonstrate fulfilment of quality requirements. The Quality Assurance Plan shall cover all products and processes and in particular CAD/CAM/CAI implemented management system shall be described (if applicable to the work package). The Supplier Quality System Procedures shall be readily accessible to personnel who are responsible for performing works. Changes in Quality System Procedures shall be notified to Alenia Aeronautica. 4.2 Documentation Management General The Supplier Quality System Procedures shall be readily accessible to personnel who are responsible for performing works. Changes in Quality System Procedures shall be notified to Alenia Aeronautica Control of documents - Documents and data can be in the form of any type of media, such as hard copy or electronic media. - When Alenia Aeronautica provide digital data to be used for design, production and/or inspection, the Supplier shall establish system controls in accordance with Alenia Aeronautica requirements. Documentation changes Supplier shall establish a process to ensure the timely review, distribution, implementation and maintenance of all authorized and released drawings, standards, specifications, planning and changes. The Supplier shall maintain a record of changes. Documentation changes shall be coordinated with Alenia Aeronautica. 7/17

8 As soon as the Supplier receives a revision to process technical specification, the Supplier shall provide Alenia Aeronautica the evidence of the change evaluation and the identification of possible impacts on production Control of Quality Records All quality records shall be made available for review by Alenia Aeronautica/Alenia Aeronautica Customer representative/regulatory Authority at least for ten (10) years. 5. MANAGEMENT RESPONSIBILITY Supplier organization dedicated to C27J program shall be included in the Quality Assurance Plan and the responsibility of each function shall be indicated. In particular, the Program Quality Manager shall be indicated and shall have authority for solving any quality problem. The Supplier shall immediately inform Alenia Aeronautica in writing of any changes in manufacturing facility location and in the management representative for the quality system. 6. RESOURCE MANAGEMENT - Training/Qualification/Certification of personnel performing NDT, special processes and MDD extraction for inspection shall be in accordance with the requirements included in Alenia Aeronautica operative procedure. - The evidence of each training session includes examinations results shall be maintained as quality records. If Supplier NDT personnel training and tests are performed by Alenia Aeronautica III level, the evidence of this training and tests will be recorded by Alenia Aeronautica. 6.8 Product Identification and Traceability 8/17

9 The S/N of all identifiable parts assembled shall be listed in the Assembly Inspection Report form attached to IAY G05 C. 7. PRODUCT REALIZATION Control of design and development changes Design and development activities shall be planned to assure that all the design and technical requirements are taken into account including constrains and performance/environmental conditions. All the above shall be included in a Quality Assurance Plan identifying the personnel responsible to approve design data; it shall be submitted to Alenia Aeronautica Design Assurance for approval. 7.4 Purchasing The Off-Load of design and development activities by Alenia Aeronautica Supplier is allowed, with the following requirements: - the sub-tier has been evaluated and approved by Alenia Aeronautica; - all the Alenia Aeronautica technical/quality requirements has been transferred to sub-tier; - the sub-tier Suppliers cannot subcontract the design work package or part of it. The Alenia Aeronautica Supplier cannot subcontract the work package or part of it without prior agreement and approval by Alenia Aeronautica. Off-Load of manufacturing phase by Alenia Aeronautica Supplier is allowed with the following requirement: - if the Off-Load includes special processes, it shall be allocated to sub-tier qualified by Alenia Aeronautica. The Alenia Aeronautica Supplier shall maintain active lists of: Material purchased (when the Supplier is authorized to purchase raw material and/or standard), with the following indication: Type of product and specification Manufacturer/Distributor. Subcontracted manufacturing phase (Off-Load), with the following indication : 9/17

10 P/N(s) Manufacturing phase Special processes Sub-tier name and address The above lists will be indicated in the Quality Assurance Plan. Any changes and/or addition to the list, will be previously submitted to Alenia Aeronautica for approval before implementation. The Supplier in order to purchase raw materials and standards, shall be qualified by Alenia Aeronautica, through the Quality Assurance Plan approval and audit. The Supplier shall purchase raw materials/chemical materials and standards only from qualified manufactures (Q.P.L. Source). Raw material/chemical material and standards purchased by Supplier must be received with Certificate of Conformance and Test Report issued by Manufacturer. The Alenia Aeronautica Supplier shall periodically validate test reports for raw materials. For this activity if an external laboratory is used it shall be accepted by Alenia Aeronautica. The method used to perform the above inspections shall be described in an internal procedure or in the Quality Assurance Plan that shall be submitted to Alenia Aeronautica Suppliers Quality for approval and shall include for each material class at least the following: - Incoming Inspection Plans - frequency of inspection. The Supplier may obtain the possibility to use a Manufacturer/Distributor approved by Alenia Aeronautica for Incoming Inspection Delegation or Service Provider according to IAY G05 C par For this purpose the Supplier shall provide to Alenia Aeronautica for approval a procedure issued according to guide lines described in documents QFRA/06P Control of Production and Service Provision The inspection and testing shall be performed according to documented procedure, this procedure shall specify the resources/instruments to be used, and the methods to be implemented and the way of recording the results Control of Production Equipment, tools and numerical control (N.C.) machine programs Control and Management of Coordinate Measurement System (CMS) shall be performed in accordance with Supplier documented procedures (that shall be submitted 10/17

11 to Alenia Aeronautica for approval) as specified in the Alenia Aeronautica Operative Procedure IAY G05 C Validation of processes for production and service provision Process/plant qualification must be obtained by Alenia Aeronautica before the FAI is closed. All the changes in the process, after the qualification phase, shall be promptly notified to Alenia Aeronautica in order to evaluate any impact on process qualification. 7.6 Control of monitoring and measuring devices The Supplier shall establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment, including test software, used by the Supplier to demonstrate the conformance of product to the specified requirements. The Inspection, measuring and test equipment shall be used in a manner that the measurement uncertainty is known and it is consistent with the required measurement capability. - Accuracy required - Inspection, measuring and test equipment identification - Process employed for the calibration - Records of calibration status - Action taken when inspection, measuring or test equipment is found out of calibration. - Environmental condition of metrological laboratory. - Methods for recall of measuring devices that require calibration. 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT Internal audit The Supplier shall conduct annual internal quality audits that assess compliance to their system and the requirements of this document. 11/17

12 Special emphasis on: - audit planning - records of audit results - follow-up audit activities Monitoring and measurement of product According to the nature of the product subcontracted and depending on its criticality and the specified requirements, these techniques may be used to support: - design verification - selection and inspection of key characteristics - process capability measurements - statistical process control - Design of Experiments (D.O.E.) - inspection - Quality Management When Statistical Process Techniques are applicable the Supplier establish and maintain documented procedure for this activity. When the Supplier uses sampling inspection as a means of product acceptance, the plan shall be statistically valid and appropriate for use. The plan shall preclude the acceptance of know defectives in the lot. The plan shall be submitted for Alenia Aeronautica approval. 8.3 Control of non conforming product - for the C27J program all non conformities detected during production phase or on final product have to be reported on RFW/RFD form and sent to Alenia Aeronautica, in compliance with Attachment 1and shall be prepared containing all information required in the table below: 12/17

13 Section RFW/RFD fill in instruction 1 This section is signed by Customer (Quality Control) 2 Delete the word Deviation if it is a Request for Waiver (RFW) or delete the word waiver if it is a Request for Deviation (RFD) 3 Drawing Number and relevant issue of the Part/Assembly subject of the W/D or Part Number 4 This section is signed by Customer (Quality Control) 5 Issuing date of the RFW/D 6 Number code assigned to the aircraft where the item is installed (if applicable) 7 This section is signed by Customer (Quality Control) 8 This section is signed by Customer (Quality Control) 9 RFW/RFD Number assigned by Supplier (if applicable) 10 This section is signed by Customer (Engineering) 11 This section is signed by Customer (Quality Control) 12 Purchase order number 13 Name/Code of the manufacturer/supplier 14 This section is signed by Customer (Quality Control) 15 Part/Assembly name as appropriate (as it appears in the drawing or in the specification) 16 This section is signed by Customer (Quality Control) 17 Serial Number of the item when applicable 18 Batch Number 19 This section is signed by Customer (Quality Control) 20 This section is signed by Customer (Quality Control) 21 Material description 22 This section is signed by Customer (Engineering) 23* In case of recurring W/D, check Yes and specify the quantity 24 This section is signed by Customer (Quality Control) 25 Factory work order number 26 This section is signed by Customer (Quality Control) 27 This section is signed by Customer (Quality Control) 28 This section is signed by Customer (Quality Control) 29 Quantity of the held parts because of the W/D, indicating the relevant position (Lh=left side, Rh=right side, N=neural side) 30 This section is signed by Customer (Engineering) 13/17

14 31 This section is signed by Customer (Engineering) 32 This section is signed by Customer (Engineering) 33* Quantity of the found out defects, indicating the relevant position (Lh=left side, Rh=right side, N=neural side) 34 Number of next higher Assembly (if applicable) 35* Symmetrical Assembly (Yes/No) 36 Text and sketches to explain the non conformance, and the reason for the application and effect on any previous demonstration of conformance 37 Recommended technical disposition, with date and signature by Supplier Engineering responsible for the item 38 Work shop stamp, date and signature of the responsible of the productive Unit or their deputy after repair to assert that the operation has been performed in accordance with the Work Cycle and the Technical disposition 39 Stamp, date and signature of the Inspector quality Control after repair to assert that the operation has been performed in accordance with the Work Cycle 40 This section is signed by Customer (Quality Control) 41 Closure date of the RFW/RFD in the System Management Center by the Inspector Quality Control that has the management responsibility of the RFW/RFD and signature 42 Cause description of the non conformance 43 Signature of the Responsible, or his deputy, of the productive Unit entrusted to perform the activity subject of the Technical Disposition 44 Stamp and signature of the Control Quality Inspector that issues the document 45 Full details of every corrective action proposed/taken to prevent recurrence 46 This section is signed by Customer (other Units) 47* Space used, from different Department, to report explaining notes signed by the relevant Department Responsible. Moreover this space is utilized by the Responsible of the productive Unit to report the Work Cycle number when the Technical disposition prescribes an operation 48 This section is signed by Customer (Engineering) 49 This section is signed by Customer (Quality Control) 50 This section is signed by Customer representative at the MRB (when request) 51 This section is signed by Airworthiness responsible of the C27J Program for RFW/RFD of the Class I and II with airworthiness impacts, if in DOA (*) Not mandatory 14/17

15 DEFINITIONS Critical (Class I) RFW/RFD Non conformities which affect any of the following factors: safety, performance, strength, service life, physical and functional interchangeability, reliability, maintainability, testability and that, after the corrective action has been taken, limit the technical/operational functions of the final product. Major (Class II) RFW/RFD Non conformities which affect any of the following factors: safety, performance, strength, service life, physical and functional interchangeability, reliability, maintainability, testability and that, after the corrective action has been taken, do not limit the technical/operational functions of the final product. Minor (Class III) RFW/RFD In all other cases. - When defect/non conformity is suspected/detected to the Alenia Aeronautica delivered product, the Supplier shall notify it to Alenia in writing within twelve (12) hours in accordance with Alenia document Alert requirements. - Scrap material shall be permanently marked and shall be unusable when the material leaves the segregated area. 15/17

16 ATTACHMENT 1 RFW/RFD FORM (first page) PLANT STAB. TO Receive note no. N. bolla d'entrata Drawing No./Part No. - N. Disegno Simmetrical Date - Data Aircraft RFW/RFD No. Rev ATR 42 MP REQUEST FOR Simmetrico Velivolo C27J 1 WAIVER / DEVIATION Application No. Page Of 4 9 Pag. 10 di Purchase order No. N. ordine d'acquisto Supplier - Fornitore Restore code - Codice reintegro Part name - Denomin. Contract Commessa Serial No N. di serie Material - Materiale Classification - Classificazione Q.ty - Q.tà Recurring Specification / Test plan No. Work order Resp. dept. Resp. step. Reject. code Minor - Minore Ricorrente N. specifica / Piano di prova Ord. di lav. Rep. resp. Rep. resp. Cod. scarto 21 Major - Maggiore Critical - Critico Yes - Sì No Held q.ty - Q.tà sospesa Accepted q.ty - Q.tà accettata Q.ty to be repaired - Q.tà da rip. Rejected q.ty - Q.tà scartata Defects - Difetti Assembly No. Simm. Assemb. Lh - Sx N. Rh - Dx Lh - Sx N. Rh - Dx Lh - Sx N. Rh - Dx Lh - Sx N. Rh - Dx Lh - Sx N. Rh - Dx N. complessivo Compl. Simm DEFECT DESCRIPTION - DESCRIZIONE DEL DIFETTO MRB INSTRUCTIONS - DISPOSIZIONE TECNICA MRB Work shop stamp after repair / Timbro lav. dopo riparazione Batch Lotto Defect Difetto Cause Causa 38 Inspection stamp after repair / Timbro C.Q. dopo riparazione 39 Q.C. cust. stamp after repair / Timbro C.Q. cliente dopo riparazione 40 Closure date Data di chiusura 41 Cause description - Descrizione della causa 42 Working chief Capo lavoraz. 43 Q.C. Inspector Controllore Action - Provvedimento Consultant Consulente 46 NOTES - NOTE Technical Dept. Progettazione MATERIAL REVIEW BOARD - APPROVAL Quality Control Controllo Qualità Customer Quality Control Controllo Qualità Cliente Airworthiness Aeronavigabilità /17

17 ATTACHMENT 1 RFW/RFD FORM (following page) PLANT STAB. TO Drawing No./Part No. - N. Disegno Date - Data Aircraft RFW/RFD No. Rev Velivolo C-27J REQUEST FOR 1 WAIVER / DEVIATION Application No. Page Of 9 10 Pag. di DEFECT DESCRIPTION - DESCRIZIONE DEL DIFETTO MRB INSTRUCTIONS - DISPOS. TECNICA MRB Assembly No. N. complessivo /17