PROGRAM: AIRBUS - quality.demaspa.itquality.demaspa.it/.../uploads/2016/11/QFRA_01P.281_A9_Ed2.pdf · IAE G 01 Engineering Off-Load Activity ... AP 2190 General Requirements for Aerostructure

Doc. QFRA/01P.281/A9 Ed. 2 Date: October 2015

PROGRAM: AIRBUS

QUALITY REQUIREMENTS

FOR

ALENIA SUPPLIERS Prepared by: V. Toscano (Supply Chain Quality Assurance) Approved by: F. De Marino (Head of Supply Chain Quality Assurance)

Concurrence by: G. Giordano (Airbus Programs Quality Manager)

THE CONTENT OF THIS DOCUMENT IS THE PROPERTY OF ALENIA AERMACCHI S.p.A. THIS DOCUMENT IS SUPPLIED IN CONFIDENCE AND COMMERCIAL SECURITY ON ITS CONTENTS MUST BE MAINTAINED. IT MUST NOT BE USED FOR ANY PURPOSE OTHER THAN THAT FOR WHICH IT IS SUPPLIED NOR THE INFORMATION CONTAINED IN IT MAY BE DISCLOSED TO UNAUTHORIZED PERSONS. IT MAY NOT BE REPRODUCED IN WHOLE OR IN PART WITHOUT PERMISSION IN WRITING FROM ALENIA AERMACCHI S.p.A

.

Doc. QFRA/01P.281/A9 Ed. 2 Date: Oct 2015

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Ed. 2 October 2015

Completely revised. Added §7.1, §7.5.2.1, §8.1, §8.2.3 ATT. 4, ATT. 5, ATT. 6, ATT. 7.

F. De Marino


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This Document report only those paragraphs of IAY G05 which need additional instructions and/or special emphasis.

INDEX

1 SCOPE 1 2 APPLICATION 1 3 NORMATIVE REFERENCE/GENERAL 1

3.1 Normative reference ............................................................................................. 1

3.2 General ................................................................................................................. 2

3.2.1 General Principles .......................................................................................... 2

4 QUALITY MANAGEMENT SYSTEM 3 4.1 General Requirements .......................................................................................... 3

4.2 Documentation Requirements .............................................................................. 3

4.2.1 General .......................................................................................................... 3

4.2.2 Quality Manual ............................................................................................... 3

4.2.3 Control of documents ..................................................................................... 3

4.2.4 Control of records ........................................................................................... 3

5 MANAGEMENT RESPONSIBILITY 4 6 RESOURCE MANAGEMENT 4 7 PRODUCT REALIZATION 4

7.1 Planning of Product Realization ............................................................................ 4

7.1.1 Project Management ...................................................................................... 4

7.1.2 Risk Management .......................................................................................... 4

7.1.3 Configuration Management ............................................................................ 7

7.1.4 Control of Work Transfers .............................................................................. 8

7.2 Customer related Processes................................................................................. 8

7.3 Design and development ...................................................................................... 8

7.4 Purchasing ............................................................................................................ 9

7.5 Production and service provision ........................................................................ 10

7.5.1 Control of production and service provision ................................................. 10

7.5.2 Validation of processes for production and service provision ....................... 11

7.5.3 Identification and traceability ........................................................................ 13

7.5.4 Customer property ....................................................................................... 13

7.5.5 Preservation of product ................................................................................ 13

7.6 Control of monitoring and measuring devices ..................................................... 13


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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 14 8.1 General ......................................................................................................................... 14

8.1.1 Product and Process Key Characteristics .............................................................. 14

8.1.2 Control Plan ........................................................................................................... 15

8.2 Monitoring and Measurement ............................................................................. 15

8.2.1 Custumer Satisfaction .................................................................................. 15

8.2.2 Internal audit ................................................................................................ 15

8.2.3 Monitoring and measurement of processes ................................................. 16

8.2.4 Monitoring and measurement of product ...................................................... 16

8.3 Control of non-conforming product ..................................................................... 17

8.4 Data analysis ...................................................................................................... 18

8.5 Improvement ....................................................................................................... 18

8.5.1 Continuous improvement ............................................................................. 18

8.5.2 Corrective Actions ........................................................................................ 18

ATTACHMENTS ATTACHMENT 1 – Assembly Transfer Report Sections ATTACHMENT 2 – Filling instruction for Airbus programs

ATTACHMENT 3 – Example of form to be used for Quality Gate ATTACHMENT 4 – GAP Analysis Form ATTACHMENT 5 – Non Compliant Form ATTACHMENT 6 – Change Notification Form ATTACHMNET 7 – Transfer Notification Form

Doc. QFRA/01P.281/A9 Ed. 2 Date : Oct 2015

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1 SCOPE This document defines the general quality system requirements for Alenia Suppliers involved in Airbus programs. These requirements are to be regarded as additional to quality system requirements stated in Alenia Procedure IAY G05. Further others product quality requirements shall be included into Work Package technical specifications.

2 APPLICATION This document is applicable for all aircrafts work package’s activities subcontracted by Alenia. Therefore, this document is applicable to Suppliers, involved in the Airbus programs, classified as one of the Alenia Qualification Classes according to IAY G05: (For the paragraph applicability refer to paragraph 3.2.2 of IAY G05).

3 NORMATIVE REFERENCE/GENERAL

3.1 Normative reference The applicable documents are the followings: INTERNATIONAL STANDARDS - AEROSPACE SERIES EN 9100/AS 9100 Aerospace series – Quality management systems – Requirements (based on ISO 9001) and Quality systems – Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001) EN 9102/AS 9102 Aerospace series – Quality systems – First Article Inspection EN 9103/AS 9103 Aerospace series – Quality systems – Variation Management of key characteristics EN 9130/AS 9130 Aerospace series – Quality System – Record retention EN 9131/AS 9131 Aerospace series – Quality System – Non Conformance documentation INTERNATIONAL STANDARDS - QUALITY MANAGEMENT SYSTEMS ISO 9001 Quality Management Systems - Requirements ISO 9000 Quality Management Systems – Fundamentals and Vocabulary ALENIA DOCUMENTS IAY G05 Quality Management System Requirements for Suppliers IAE G 01 Engineering Off-Load Activity QFRA/06P.021 Guide line for subcontractors use of Incoming Inspection Delegation/Reduced Purchaser Testing released/implemented by Alenia for raw materials and standards suppliers


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AIRBUS DOCUMENTS AP 2190 General Requirements for Aerostructure & Material Suppliers (GRAMS) AP 2190 Amendment Issue C1: General Requirements for Aerostructures & Material

Suppliers – Amendment of Issue C AP 5270 Qualification Process of Couples <Special Processes / External Shop> AP 5262 Qualification Process of Couples <Test Method/Test Facility> AP 5374 Qualify and Standardize Products and Processes AP 5353 Qualification Process of Couples <Specified Item and Blank/Manufacturer Site> AP 2253 Validation and Technical Qualification of Manufacturing Processes AP 2003 Document Retention Requirements for Airbus Suppliers AP 2185 Significant Events, Events and Warnings Management AP 2196 Quality Gates Supply Chain A 1101 Requirements for Airbus Supply Chain Supplier Driven Transfers

A 1074 First Article Inspection Requirements for Suppliers A 1057 Foreign Object Prevention and Management

3.2 General

3.2.1 General Principles In addition: The program activities are subjected to Alenia, Airbus and Airworthiness Authority surveillance. The Supplier shall assure right of access for:

- Alenia personnel - Airbus representative - Airworthiness Authority representative

The Supplier and its sub-tiers shall be available to be submitted to the scheduled and/or unscheduled Alenia/Airbus/Authority audit activities, and/or to provide all quality records and technical information relating to the orders in progress necessary to exercising their surveillance actions within a reasonable time from the request.

Airbus has the complete responsibility of the Supplier’s qualification process

The Supplier shall be able to meet Contract requirements, including quality system and any quality assurance requirements before starting production activities. The Supplier Quality System must be in according to Airbus requirements AP2190, GRAMS. In case of non-compliance with contract requirements, an improvement/qualification plan will be issued by Supplier and agreed with Alenia and Airbus. Note: the surveillance exercised by Alenia (audit, inspection, etc.) do not waive the Supplier’s responsibility as far as the products are concerned.

3.2.1.1 Glossary NADCAP-PRI: National Aerospace and Defense Contractors Accreditation Program – Performance Review Institute


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4 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements No additional requirements

4.2 Documentation Requirements No additional requirements

4.2.1 General Special emphasis: The Supplier shall prepare a Quality Assurance Plan (QAP) in accordance with Alenia form (IAY G05 attachment 1), with the objective to define and document how the requirements for quality will be met. The Quality Assurance Plan shall cover all products and processes. CAD/CAM/CAI applied management system shall be described (if applicable to the work package).

4.2.2 Quality Manual No additional requirements

4.2.3 Control of documents In addition: When Alenia/Airbus provide digital data used for design, production and/or inspection the Supplier shall establish a data management system in accordance with Alenia/Airbus requirements. Identification, collection, filing, maintenance and disposition of all documents shall be provided for all the elements of Quality System by the Supplier in accordance with Airbus procedure AP 2003. Special emphasis: Documents and data can be in the form of any type of media, such as hard copy or electronic media.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.

4.2.4 Control of records In addition: All quality records shall be available for review by Alenia/Airbus/Regulatory Authorities as required.


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5 MANAGEMENT RESPONSIBILITY Special emphasis: The program organization chart 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 defined authority and organizational freedom to resolve matter pertaining to quality.

6 RESOURCE MANAGEMENT No additional requirements

7 PRODUCT REALIZATION

7.1 Planning of Product Realization No additional requirements

7.1.1 Project Management No additional requirements

7.1.2 Risk Management In addition: In accordance with Airbus Procedure AP2190 Module 1, for new WP and/or new process qualification, the Supplier shall define and deliver a procedure describing the systematic approach used to perform risk analysis and formalize the mental discipline to list and quote all risks. There are different kinds of risk analysis:

- Product risk analysis (i.e. Design Failure Mode & Effects Analysis (DFMEA)), see AP2190.2,

- Process risk analysis (i.e. Process Failure Mode & Effects Analysis (PFMEA)), see AP2190.5,

- Procurement and subcontractor risks analysis including all supply chain risks, see AP2190.4


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The Risk analysis shall cover the following activities:

- Project Management, planning and resources, - Concept and Design process, technical and innovative solutions, - Validation and Verification process, - Maturity, - Information Systems Management, IT infrastructure and people qualification, - Data Management (Space Allocation Mock-up (SAM), Geometrical Reference

Mockup (GRM), Design Mock Up (DMU), data exchanges, stress sheets, etc.), - Design, Industrial and supply chain change process, - Quality Assurance, - Industrial activities, - Product Risk Analysis (DFMEA), see AP2190.2, - Process Risk analysis (PFMEA), see AP2190.5, - Procurement and suppliers risks including all supply chain risks (see AP2190.4), - Attestation, - Certification, - Product Support, - Intellectual properties, - Export licensing or embargo, - Etc.

7.1.2.1 Process Risk Analysis Procedure The procedure shall contain:

the process to build the PFMEA cross functional team and responsible,

the PFMEA template (including revision history),

the PFMEA methodology including following data (PFMEA template):

- manufacturing domain applicability. All manufacturing steps shall be listed and analyzed,

- potential process/product-related failure modes, - effects of the potential failure on the customer, - severity of the potential failure, - potential manufacturing or assembly process causes or mechanism of failure, - occurrence quantification, - process/product variables on which to focus process controls (prevention or

detection) and detection quantification, - ranked list of potential failure modes, thus establishing a priority system (Risk

priority Number - RPN), - preventive/corrective action, implementation date and Risk Priority Number new

scoring,

the scoring table (i.e. Severity, Occurrence, Detection) to quantify the risk,

the Risk Priority Number RPN = (S)*(O)*(D) level which requires a corrective action to mitigate the risks.

FMEA technique is an endless iterative process that builds upon the knowledge provided by experience. The main input comes from actual performances and industrial changes. FMEA shall be updated in a timely manner in a preventive mode rather than corrective based upon actual experiences.


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The PFMEA shall be updated regularly with a maximum time period between two consecutive updates and whenever at least one of the following occurs:

- New component or part* - New, changed or improved process/sub-process - New, changed or improved subcontracting activity - Customer requirements - Customer claims - Manufacturing yield data and failure mode occurrence changes - New failure mode

*E.g. PFMEA could encompass several product families with same technology, by including all manufacturing steps. The PFMEA has three major outputs:

- corrective action plan resulting from the identification of high risks, - Control Plan, the process risk analysis control listing will serve as a base to create

these document, - Key Characteristics, in this case the Process risk analysis can highlight those

aspects of the design/process which have a major potential impact into final performances.

The PFMEA shall always reflect the latest design level as well as the latest relevant actions. Old corrective actions that have been implemented shall be captured in the PFMEA revision history.

7.1.2.2 Product Risk Analysis Procedure The Supplier shall define and deliver their procedure describing the systematic approach used to perform a product risk analysis using the Design Failure Mode & Effects Analysis methodology (DFMEA). The procedure shall contain:

the process to build the DFMEA cross functional team and responsible concurrently

with Purchaser and Supplier,

the Process to gather inputs (design intent, Purchaser wants and needs, etc.),

the DFMEA template (including revision history),

the DFMEA methodology including following data (DFMEA template):

- product domain applicability (block diagram for end items, along with every - related system, sub-system and components), - potential product/Design-related failure modes, - effects of the potential failure on the customer, - severity quantification of the potential failure, - potential causes or mechanism of failure, - occurrence quantification, - product/design variables on which to focus process controls (prevention or - detection) and detection quantification, - ranked list of potential failure modes, thus establishing a priority system (Risk

Priority Number - RPN), - preventive/corrective action, implementation date and Risk Priority Number new

scoring,

the scoring table (i.e. Severity, Occurrence, Detection) to quantify the risk,

the Risk Priority Number RPN = (S)*(O)*(D) level which requires a recommended action,


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DFMEA updates criteria including:

- new product, - development reviews, - changes (specification, design, integration in new environment or application, ...), - design non-conformance (whenever the design is the root cause), - frequency (regular reviews).

Note: The DFMEA may include the following activities: Concept and Design process, technical and innovative solutions

- Design methodology - Design verification methodology - Design tools - Packaging - Process steps and types - Specification errors - Testing - Other elements as required by Purchaser

The Supplier shall define in the DFMEA procedure how the old corrective actions that have been implemented shall be captured in the DFMEA revision history. The Supplier shall formalize the Product risk analysis in a Design Failure Mode & Effects Analysis (DFMEA) document in accordance with the procedure defined in § "Product Risk Analysis Procedure". Note: The DFMEA is a living document.

7.1.3 Configuration Management In addition Industrial Change Management Any industrial change has to be performed in accordance with AP2190 Module 4 “Industrial Change Management” The Supplier that shall be notify to Alenia with a dedicate form Chance Notification Form (The Template in ATTACHMENT 6) and update the Quality Plan for Approval Type of the change:

- Plant location or layout - Transportation mode - Enterprise Resource Planning (ERP) system - Top level organisation and personal at key position - Process (manufacturing, assembly, tests, inspection, main tools) - Major suppliers (including subcontractors) - Other (precise) Off-load from internal production to strategic supplier


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7.1.4 Control of Work Transfers In addition In case of Transfer of Work in accordance of AP 2190 Module 4 and A1101. Moreover has to provide the following documentation Prior to the initiation of any transfer, submit a copy of the work transfer procedure for acceptance to Airbus. The procedure shall include project management, gate review (where decisions are made on the transfer viability) and risk management aspects. Prior to any work transfer:

- Inform Airbus by using a Change Notification Form (GRAMS) - Submit a transfer plan (Project Plan) in compliance with:

the Work Transfer Procedure as accepted by Airbus

Project Management requirements from AP2190: Module 1

- Validate the transfer via the results obtained (in particular the Supplier shall perform an article review before transfer (Last Article Review) versus the article review after transfer (First Article Review), deviations, management of deviations).

The additional information refer to A1101 Transfer of Work documental needs:

- Transfer Notification Form fulfilled (Template in ATTACHMENT 7) - Manufacturing Flow Chart - Master Phase Plan - Transfer of Work Risk Analysis

7.2 Customer related Processes No additional requirements

7.3 Design and development Special emphasis: The Supplier shall issue a Design Quality Plan identifying the personnel responsible to approve design data. All activities will be controlled by Alenia Design Office as per IAE G 01 Alenia Operative Procedure; 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. Supplier shall manage the configuration of its hardware and software used in CAE/CAD process, shall demonstrate and shown them on Alenia request.


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7.4 Purchasing In addition: The Off-Load of design and development activities by Alenia Supplier is allowed, providing that:

- The sub-tier has been evaluated and approved by Alenia; - All Alenia/Airbus technical/quality requirements has been transferred to subtier; - The activities will be controlled by Alenia Design Office as per IAE G 01 Alenia

Operative Procedure; - The sub-tier suppliers cannot subcontract the design work package or part of it.

The Supplier authorized to purchase materials, shall be qualified by Alenia according to AP 2190 on the basis of a program preventively agreed with Airbus. Through the Quality Assurance Plan approval and after an audit, Alenia will release this qualification. The Supplier shall use only qualified material products from Airbus approved sources listed in the Airbus Qualified Parts List (QPL). The QPL is available at Airbus web site (www.airbus.com). The Supplier shall request credentials to access to QPL via Alenia Procurement. Note: Airbus founds a QPL also for some auxiliaries. The Supplier authorized to perform special processes, shall be qualified by Airbus. The Alenia Supplier cannot subcontract the work package or part of it without prior agreement and approval by Alenia. Off Load of manufacturing phase by Alenia Supplier is allowed, providing that: the off load that includes special processes, shall be allocated to sub-tier qualified by Airbus. Note: Supplier shall perform tests only in Airbus’ qualified laboratories. Special emphasis: In accordance with Airbus Procedure AP5353 all subcontractors using qualified couples <Specified Item & Blank/manufacturer site> from the Airbus QPL remain responsible of the quality of their products. All distributors/stockists shall procure only fully qualified couples <Specified Item & Blank/ manufacturer site> registered in QPL with P3 status and shall deliver to subcontractors/Airbus plants the products with original declaration of conformance (refer GRAMS AP2190.5 § 3.1.1.2) from manufacturer plus FAI report in case of 1st delivery.” In addition: The Alenia Supplier shall maintain active lists of:

Material purchased (when authorized), with the following indication: - Material (raw/standard) - Type and specification - Supplier (manufacturer/distributor)

Subcontracted manufacturing phase (off - load), with the following indication : - P/N(s) - Manufacturing phase - Special processes - Supplier name and address

http://www.airbus.com/


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The above lists will be indicated in the Quality Assurance Plan. Any changes and/or addition to the list, will be submitted to Alenia for approval before implementation. The Supplier can ask Alenia the possibility for use Alenia supplier authorized for Incoming Inspection Delegation (DCA) or Service Provider. For this purpose the Supplier shall provide to Alenia for approval a procedure issued according to guide lines described in document QFRA/06P021.

7.5 Production and service provision

7.5.1 Control of production and service provision In addition: the inspection and testing shall be performed according to documented procedure, this procedure shall specify the resources and methods to be implemented and methods of recording the results. In addition: For assemblies, the Assembly Transfer Report (attachment 2 of IAY G05) shall contain the following additional sections:

ATTACHMENT 1: Section M1 added column NOTE for any “partially performed” or “not applied” TSA and or deviation of revision level applied from Alenia released data; Section T “Assembly Transfer Report - Section T – Not Installed Standards”.

ATTACHMENT 2: Added Filling Instruction

The modified section is in attachment 1 of this document. If requested by Alenia, the Supplier shall sign a Quality Gate agreement with Alenia per AP2190 and AP2196. The reference form in Attachment 3 shall be considered as "live" form that will evolve as necessary and adapted case by case on yearly basis. In addition:

When Statistical Process Techniques are applicable the Supplier establish and maintain documented procedure for this activity management (see § 8.1).

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 approval.


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7.5.1.1 First Article Inspection (F.A.I.) Special emphasis: A F.A.I. plan and schedule will be prepared by the Supplier and agreed with Alenia for possible Alenia / Airbus France participation. The F.A.I. shall be performed in compliance with EN/AS 9102 and A1074 requirements. F.A.I forms and their filling instructions are enclosed to IAY G05. If Suppliers intend to use their internal form in accordance with EN/AS 9102, they have to formally ask to Alenia Suppliers Quality Department for this deviation.

7.5.2 Validation of processes for production and service provision In addition: The list of applicable special processes is given in the Mastelist ME0721033. Qualification procedure and requirements for the processes subjected to qualification are given in the AP5270. When Airbus Supplier applies Processes covered by one of the PRI Nadcap families (See PRI Nadcap families in www.pri.sae.org and Airbus Specification/Nadcap commodity Cross Table http://www.airbus.com/tools/airbusfor/suppliers/) of Special Processes. The Supplier shall have them certified by PRI Nadcap according to Airbus mandating plan. This plan also covers Suppliers having already a couple Supplier- Special Process certificate or a letter of approval (Through the appropriate scope of approval) granted by Airbus. A special process supplier is qualified only when is enclosed in Airbus’ QPL or when is enclosed in a special list, maintained by Alenia, of suppliers involved in Alenia’s WPs.

http://www.pri.sae.org/

http://www.airbus.com/tools/airbusfor/suppliers/


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7.5.2.1 Special Process qualification documental needs: In addition

1. Gap analysis between process instruction (Alenia or subcontractor actual process) and IPDA or AIPI requirement shall be done. Each requirement included in IPDA or AIPI (including KPP) shall be explained (line by line).

If any gap: - Recovery action plan shall be implemented to be compliant - In exceptional cases gap could be covered by NCF and motivated.

This gap analysis shall be done and provided to airbus at beginning of qualification: this is the first step of qualification. One of this document is to be filled in for each qualification NCF (Non Compliance Form) have to be provided for each gap identified and not possible to recover. A justification shall be joined with each NCF sent and accepted before the audit

2. Evidences: Work instructions and KPP (AIPI requirement) evidences (proofs of compliance of KPP) shall be provided for each Qualification

The reference form for Gap Analysis is in ATTACHMENT 4 The reference form for Non Compliance Form is in ATTACHMENT 5

Special emphasis: All Test Methods and Inspection Processes shall be considered as Special Processes and shall be qualified in order to ensure reliable data and confidence in the facility with comparability of test results. Each Facility using a test method/inspection process has to be qualified and continuously controlled by Airbus separately by each method/process. The Test Methods and Inspection Process Qualification is under responsibility of Airbus Engineering and follows rules described in AP 5374 and AP 5262. The supplier has to individuate the Test Methods applicable and notify to Alenia the request of qualification or the Qualified Independent Laboratory listed in QTML (http://www.airbus.com/tools/airbusfor/suppliers/). In case of qualification request, the Airbus Engineering will ask to the supplier to complete a pre-qualification questionnaire. Once the analysis regarding the tests and product criticism is performed, the Airbus Engineering will decide if this file could comply with our quality requirements, otherwise we can ask for complementary information or a more elaborated audit on site.



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7.5.3 Identification and traceability In addition: Requirements concerning identification/marking are in accordance with applicable specification called out by drawings and the Airbus document AP 2190.

7.5.4 Customer property No additional requirements

7.5.5 Preservation of product In addition: The supplier shall ensure that all materials/parts are properly protected during their fabrication process to avoid unintentional damage. In addition specific requirements per A 1057 shall be assigned to work areas to prevent damage and deterioration of materials, with particular attention to the time/temperature sensitive materials, and provisions for detection and removal of foreign object during manufacturing and before parts delivery to Alenia.

7.6 Control of monitoring and measuring devices In addition: 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 which ensure that the measurement uncertainty is known and is consistent with the required measurement capability. Special emphasis:

- 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.


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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General In addition In particular the process “Key Characteristics” for the A380 program shall be identified and controlled using, where possible, statistical techniques (SPC) according to the Quality Assurance Plan approved by Alenia. Special emphasis: 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

8.1.1 Product and Process Key Characteristics The Supplier shall comply with IAQG standard 9103 and AP 2190 Module 2

The Supplier shall define a methodology to determine Product Key Characteristics and Process Key Characteristics (i.e. Key process characteristic and Key process parameter):

- Applied Purchaser defined Key Characteristics (if any): specifications, drawings, definition dossier, etc.

- Applied Regulatory requirements - Output from Product risk analysis (DFMEA) and Process Risk analysis (PFMEA) - Design Of Experiment - Lessons learnt, Quality records - Etc.

The Supplier shall list the Product and Process Key Characteristics. Key Characteristics shall be highlighted by a specific symbol in the Control Plan (see § 8.1.2 "Control Plan").

The Supplier shall establish a robust measurement system for Key Characteristics by performing a Measurement System Analysis (MSA) and determine the capability of the measurement by evaluating the stability, discrimination, accuracy, linearity and precision (Gage Repeatability and Reproducibility).

The Supplier shall monitor the Product and Process Key Characteristics by Statistical Process Control and provide evidence. If other variation control methods are used, measurable evidence must demonstrate that the controls are efficient.


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8.1.2 Control Plan The Supplier shall provide a written summary description of the system used to minimize process and product variation and to control parts and processes. A multi-functional team shall develop the Control Plan by utilizing all the available information, such as:

- Manufacturing Flow Chart and Supply Chain Flow Chart, - Product Risk Analysis (DFMEA) and Process Risk Analysis (PFMEA), - Product and Process Key Characteristics, - Lessons Learnt, Team's Knowledge, - Testing and inspection strategy, - Optimization Methodologies (e.g. Quality Function deployment, Design Of - experiment, etc.).

The Control Plan form shall contain the list of actions (e.g. measurements, controls, tests, inspections, etc.) that are required at each phase of the process including receiving, inprocess, out-going requirements to assure that all process outputs will be in a state of control. The Control Plan form shall also precise for each action these information (or document reference):

- Product/process specification tolerance, - Evaluation/Measurement technique, - Sample size and Frequency, - Control method (e.g. inspection gate ref. No., SPC Chart ref No., etc.), - Reaction plan which describes the activities performed in case of Out of Control

(Out of Control Action Plan).

The Control Plan shall be continuously maintained up-to-date and reflect the current system.

8.2 Monitoring and Measurement

8.2.1 Custumer Satisfaction No additional requirements

8.2.2 Internal audit In addition: The Supplier shall conduct internal quality audits that assess compliance to their system and to the requirements of this document. Special emphasis on:

- Audit planning - Records of audit results - Follow-up audit activities


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8.2.3 Monitoring and measurement of processes In addition: The supplier has responsibility of the serial production control and the Test Methods shall be qualified. The supplier shall preform the Test methods in internal Captive Qualified Laboratory or in an External Qualified Independent Laboratory listed in QTML (http://www.airbus.com/tools/airbusfor/suppliers/).

8.2.4 Monitoring and measurement of product

8.2.4.1 Inspection documentation Special emphasis: About outstanding work and retrofits the Alenia Supplier must comply with the Alenia quality operative procedure IAY G05.

8.2.4.2 First article inspection (F.A.I.) Special emphasis: A F.A.I. plan and schedule will be prepared by the Supplier and agreed with Alenia for possible Alenia / Airbus France participation. The F.A.I. shall be performed in compliance with EN/AS 9102 and A1074 requirements. F.A.I forms and their filling instructions are enclosed to IAY G05. If Suppliers intend to use their internal form in accordance with EN/AS 9102, they have to formally ask to Alenia Suppliers Quality Department for this deviation.



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8.3 Control of non-conforming product Special emphasis:

Form to be used for MRR is enclosed with IAY G05

The supplier that has the responsibility of the design of the work package shall propose a technical disposition filling in the box #36 with date and the designer signature. A technical justification of the disposition shall be presented when requested by Alenia.

Supplier, although it has design authority, must be authorized by Alenia to perform MRB activity on their work packages. Any non-conformance management is prohibited without Alenia authorization.

The MRR's shall be numbered by Suppliers in the box #38, using the following “temporary number” (on the continuation sheets use the box #5).

SF/zzzzz/yy/xxxx zzzzz is the Alenia Code for the Supplier yy is Alenia Code for the program xxxx is a progressive number (from 0001 to 9999)

Alenia will assign a progressive number when insert the MRR in the Alenia SAP system.

Supplier shall ensure through a dedicated book, the traceability and the correspondence between the temporary number and the official SAP number of the MRR assigned by Alenia when the MRR come back with Alenia technical disposition.

Supplier shall verify that on all parts (if applicable) and on all work and accompanying documents shall be reported the official number of the MRR generated by SAP.

Suppliers Quality Control shall attach a copy of the MRR to the Conformity Certificate of the part for of shipping and shall file the original in the own archives.

The Supplier shall raise an MRR only:

1. On an elementary part/sub-assembly (non-constituent assembly), in exceptional cases of a temporary supply chain disruption on the program for Alenia Aermacchi or when repair is a more economical solution rather than reject or scrap.

2. Following a joint evaluation of previous point 1. with Alenia Aermacchi representative.

In case of an MRR is to be disposed as Concession, based on current Alenia Aermacchi level of Authority formalized by Airbus, the supplier shall provide an RCA using 5WHY and /or 8D methodology, pending the final disposition of noted concession by Alenia authorized MRB personnel.


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8.4 Data analysis No additional requirements

8.5 Improvement

8.5.1 Continuous improvement No additional requirements

8.5.2 Corrective Actions In addition

The Supplier shall ensure a Quality Product is delivered to Alenia Aermacchi in compliance with all applicable requirements defined under the Contract.

The Supplier shall remain fully responsible and accountable for all Quality aspects of its work package.

Supplier's Quality organization shall be responsible for the coordination of the corrective and preventive action process including coordination of all investigations related to Quality issues (Audit findings, Non-conformances, Airworthiness/Safety issues, etc), in accordance with AP 2185.

Preferred methods in root cause and corrective action identification process followed by the Supplier shall be an “8D & 5-WHY Problem Solving”. Alenia Quality will provide support to Supplier Quality for this topic, on request.

The Supplier shall identify root cause and corrective action (when applicable) within five (5) working days.

The Supplier shall implement corrective action within sixty (60) working days.


ATTACHMENT 1 – Assembly Transfer Report Section M1 for Airbus programs (1/2)


ATTACHMENT 1 – Assembly Transfer Report Section T for Airbus programs (2/2)


ATTACHMENT 2 – Filling instruction for Airbus programs Assembly Transfer Report is a document composed by sections, each ones dedicated to a specific subject.

Contents of the Assembly Transfer Report Contents of each section of the Assembly Transfer Report defined are below:

Cover Page The cover of the report must indicate the following information:

- Supplier’s name - Purchase order - N°. of the report - Date - Program - Assy P/N - Effectivity - N° of the Certificate of Conformity - Issue - Name of the assembly - Assembly number - Reference of Alenia authorization to (when necessary).

Section A - Index In this section shall be reported the index of the Assembly Transfer Report which shall contain:

- Document sections with their description - The amount of pages for each section - Drawing number - Drawing revision level - Outside Product Specification Plan /Aircraft Conf. List and its revision level - Design Standard and its revision level - Certificate of conformity.

Section B – Base document revision In this section shall be reported the data concerning the changes of the Assembly Transfer Report, particularly:

- Issue of document and date of the modification - Section and page modified - Additional notes

The issue of this section is the issue index of the whole document to be reported on the cover page.


Section C – Document revision after delivery In this section shall be reported the data concerning the revision of the Assembly Transfer Report occurred after delivery of the product, particularly:

- Changed pages of the report - Issued of the section - Date of the modification - Description of introduced changes related to the modified section/page.

Section D – List of the pages added after the delivery of the Assembly In this section shall be reported the list of the added pages that could be included in the report after the delivery of the assembly, particularly shall be pointed out:

- Section affected - Description of the added page included - Number of the added pages.

Section E – Inspection performed In this section shall be reported all inspection/controls with their related sketches, notes and measurements values performed on the assembly to be delivered. The inspection shall be carried out according with the Inspection Plan. The first page of this section shall report the list of the inspections carried out on the assembly to be delivered. Data format, sketches, measurements and tables related to this section can be defined by the Supplier.

Section F – List of serialized parts In this section shall be reported all the serialized parts, according with the requirements of drawings/specifications, for which the traceability is required. Particularly three types of serialized parts are identified:

- Identified parts - Major components - Equipment (it shall be specified if the equipment have the Log Card).

Log Card shall be enclosed.

Section G – Interchangeability Class I In this section shall be certified the interchangeability (class I) for the involved parts of the assembly. If this requirement is not satisfied, for each P/N a specific waiver/deviation shall be submitted to Alenia Aeronautica Design Department.

Section H – List and completion status of test procedures In this section shall be reported the list of all test procedures applicable to the in subject assembly stage. Particularly, for each functional test, the status (completed, partially completed, not done) and any problem occurred shall be indicated. Section I – List of non-conformity In this section shall be listed all waivers/deviations of category I and II concerning all the non conformity that have completed their iter. The waivers/deviations of category III shall be pointed out only if it is required or the flow is not completed.


The waivers/deviations which have not yet completed their flow (technical disposition not available or closure not yet performed) shall be listed. In this case, Sub-Contractor shall indicate the open activity, in the G, P, Q sections. Copy of all waivers/deviations of category I, II and III issued, shall be attached to the Assembly Transfer Report.

Section L – Weight In this section shall be reported the weight of the manufactured assembly in the delivery configuration (required by program).

Section M1 – List and completion status of applicable TSA In this section shall be indicated and certified the configuration “As Built” related to the applicable configuration “As Designed” defined by “Design Configuration Document” or equivalent document for the specific program. For each modification shall be clearly reported status of introduction of the delivery assembly (embodied, partially embodied, not embodied). added column NOTE for any “partially performed” or “not applied” TSA and or deviation of revision level applied from Alenia released data, record information/number of corresponding line item n° of Section “N” – list of missed parts, and Section “P” – List of supply outstanding works.

Section N – List of missed parts In this section shall be reported the list of all parts not installed on the assy (shortages) and/or dummy parts installed, compared with the Configuration List .

Section O – List of missed loose parts required by the Aircraft Configuration list In this section shall be listed all missing loose parts (parts not delivered) but required by specification.

Section P – List of supply outstanding works In this section shall be listed and described the works not performed on the assembly.

Section Q – List of not performed inspections In this section shall be listed and described the inspections/checks/tests that are not performed or partially performed.

Section R1 – Loose parts In this section must be listed all the parts not installed on the assembly but are enclosed to it, according to the Configuration List requirements.

Section S – Additional notes In this section must be listed possible additional notes considered useful for the works performed in Alenia Aeronautica plants.

Section T – Not Installed Standards In this section must be listed Not Installed Standards, a sketch of Not Installed Standards and/or Substitute Standards is required to be enclosed to this form.


ATTACHMENT 3 – Example of form to be used for Quality Gate

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