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Page 1: Gaia Issue : 02 Rev. : 00emits.sso.esa.int/emits-doc/ASTRIUMLIM/GAIA_POWERSCOE/...Gaia Ref : GAIA.ASF.SP.SAT.00037 Issue : 02 Rev. : 00 Date : 14/04/2006 Page : iv DOCUMENT CHANGE
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EADS/Astrium

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SUMMARY

This document defines requirements applicable to Ground Support Equipment contractors, for the GAIA programme. GAIA is an European Space Agency (ESA) programme dedicated to Science.

Document controlled by

EADS/Astrium

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DOCUMENT CHANGE LOG

Issue/

Revision Date Modification Nb Modified pages Observations

01/00 14/09/05 Initial issue for GAIA B/C/D/E proposal and RFIs to subcos. This document is based on EADS Astrium document ref ADS.E.0675 titled: ENS generic PA requirements for Electrical Ground Support Equipment

02/00 14/04/06 Update accounting for recommendation 64 from ESA, see final negotiation meeting of 13/02/2006 Modification of section 8 for SW requirements, reference to specific PA SW reqts

EADS/Astrium

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CONTENTS

1 SCOPE .....................................................................................................................................................................1

2 APPLICABILITY ...................................................................................................................................................1

3 REFERENCES........................................................................................................................................................1

3.REQ: A. APPLICABLE DOCUMENTS.............................................................................................................................1 3.1. REFERENCE DOCUMENTS ......................................................................................................................................2 3.2. DEFINITIONS ..........................................................................................................................................................2 3.3. ACRONYMS............................................................................................................................................................3

4 SUPPLIER APPROVAL BY EADS ASTRIUM ..................................................................................................4

4.REQ: A. APPROVED SUPPLIER LIST.............................................................................................................................4 4.REQ: B. SUPPLIER QUALITY AUDIT .........................................................................................................................4 4.REQ: C. QUESTIONNAIRE AND A COMPLIANCE MATRIX..............................................................................................4

5 GENERAL...............................................................................................................................................................5

5.REQ: A. RIGHT OF ACCESS..........................................................................................................................................5 5.REQ: B. SECURITY DATA ............................................................................................................................................5 5.REQ: C. COMPLIANCE MATRIX ...................................................................................................................................5 5.REQ: D. COMPLIANCE CHANGES ................................................................................................................................5 5.REQ: E. SUPPLIER RESOURCES...................................................................................................................................5 5.REQ: F. PRODUCT ASSURANCE MANAGER ................................................................................................................5 5.REQ: G. QUALITY PLAN .............................................................................................................................................6 5.REQ: H. REPORTING ...................................................................................................................................................6

6 DESIGN MANAGEMENT AND VERIFICATION ............................................................................................7

6.REQ: A. DESIGN RELATED REQUIREMENTS................................................................................................................7 6.REQ: B. RAMS ANALYSES ........................................................................................................................................7 6.REQ: C. FMECA........................................................................................................................................................7 6.REQ: D. PRODUCT LIABILITY .....................................................................................................................................7 6.REQ: E. PRODUCT LIABILITY, MILITARY STANDARDS ...............................................................................................8 6.REQ: F. USE OF KNOWN DESIGNS ...............................................................................................................................8 6.REQ: G. COMMERCIAL OFF-THE-SHELF ITEMS (COTS) .............................................................................................8 6.REQ: H. COTS ITEMS EEE / M&P..............................................................................................................................8 6.REQ: I. CHANGES TO COTS ITEMS............................................................................................................................8 6.REQ: J. DESIGN COMPLIANCE ...................................................................................................................................8

7 DESIGN REVIEWS................................................................................................................................................9

7.REQ: A. REVIEWS, DESIGN.........................................................................................................................................9 7.REQ: B. REVIEWS, SCHEDULING AND SCOPE..............................................................................................................9

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7.REQ: C. REVIEWS, ATTENDANCE ...............................................................................................................................9 7.REQ: D. REVIEWS, MINUTES ......................................................................................................................................9 7.REQ: E. REVIEW TYPES..............................................................................................................................................9 7.REQ: F. PRELIMINARY DESIGN REVIEW (PDR)..........................................................................................................9 7.REQ: G. PDR DOCUMENTATION...............................................................................................................................10 7.REQ: H. CRITICAL DESIGN REVIEW (CDR) ..............................................................................................................10 7.REQ: I. CDR DOCUMENTATION ..............................................................................................................................10 7.REQ: J. POST CDR DOCUMENT FREEZE ..................................................................................................................11

8 SOFTWARE QUALITY ASSURANCE .............................................................................................................11

8.REQ: A. SOFTWARE ..................................................................................................................................................11

9 RISK MANAGEMENT........................................................................................................................................12

9.REQ: A. RISK MANAGEMENT ...................................................................................................................................12 9.REQ: B. RISK REGISTER ...........................................................................................................................................12

10 DOCUMENTATION AND CHANGE CONTROL.......................................................................................12

10.REQ: A. CADM SYSTEM REQUIRED ....................................................................................................................12 10.REQ: B. CHANGE CONTROL EXTENT ....................................................................................................................12 10.REQ: C. CHANGES TO THE BASELINE ...................................................................................................................13

11 RECORDS.........................................................................................................................................................13

11.REQ: A. RECORDS ................................................................................................................................................13 11.REQ: B. PHOTOGRAPHS........................................................................................................................................13

12 PROCUREMENT.............................................................................................................................................13

12.REQ: A. SUPPLIER CONTROL................................................................................................................................13 12.REQ: B. SUPPLIER CERTIFICATES.........................................................................................................................13 12.REQ: C. REQUIREMENTS ON SUPPLIERS ...............................................................................................................13 12.REQ: D. PROCUREMENT SPECIFICATIONS.............................................................................................................13 12.REQ: E. RECORDS OF PURCHASE ORDERS ...........................................................................................................14

13 PARTS AND MATERIALS.............................................................................................................................14

13.REQ: A. COMMERCIAL QUALITY..........................................................................................................................14 13.REQ: B. PARTS AND MATERIALS SELECTION ........................................................................................................14

14 INSPECTION AND TEST...............................................................................................................................14

14.REQ: A. ACCEPTANCE TESTING ...........................................................................................................................14 14.REQ: B. PRE-DELIVERY TESTING (FAT)..............................................................................................................15 14.REQ: C. SITE ACCEPTANCE TESTING (SAT) ........................................................................................................15 14.REQ: D. VALIDATION & CALIBRATION ................................................................................................................15 14.REQ: E. TRACEABILITY OF CALIBRATION............................................................................................................15 14.REQ: F. INSPECTION PLAN .......................................................................................................................................15 14.REQ: G. TESTED PRODUCT STATUS......................................................................................................................15

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14.REQ: H. QUALIFIED PERSONNEL ..........................................................................................................................16 14.REQ: I. TEST SCHEDULE..........................................................................................................................................16 14.REQ: J. NOTIFICATION OF TEST...............................................................................................................................16 14.REQ: K. TEST PROCEDURE ...................................................................................................................................16 14.REQ: L. TEST READINESS REVIEW (TRR)............................................................................................................16 14.REQ: M. TRR NOTIFICATION................................................................................................................................16 14.REQ: N. TEST FAILURES.......................................................................................................................................16 14.REQ: O. TEST REVIEW BOARD .............................................................................................................................17 14.REQ: P. INSTALLATION SPECIFICATION ...................................................................................................................17 14.REQ: Q. SUPPLIER SUPPORT TO COMMISSIONING.................................................................................................17

15 CONTROL OF NON-CONFORMING MATERIAL ...................................................................................17

15.REQ: A. NON CONFORMANCE MANAGEMENT SYSTEM........................................................................................17 15.REQ: B. MAJOR NC .............................................................................................................................................17 15.REQ: C. NOTIFICATION ........................................................................................................................................18 15.REQ: D. MINOR NC..............................................................................................................................................18 15.REQ: E. NC RECORDS..........................................................................................................................................18 15.REQ: F. NON CONFORMANCE REVIEW BOARD (NRB).............................................................................................18

16 DEVIATIONS AND WAIVERS......................................................................................................................19

16.REQ: A. DEVIATIONS AND WAIVERS....................................................................................................................19

17 PACKAGING SPECIFICATIONS.................................................................................................................19

17.REQ: A. ACCEPTABLE SPECIFICATIONS................................................................................................................19

18 END ITEM DATA PACK (EIDP)...................................................................................................................19

18.REQ: A. EIDP ......................................................................................................................................................19 18.REQ: B. COC DELIVERY ......................................................................................................................................20 18.REQ: C. CERTIFICATE OF CONFORMANCE............................................................................................................20 18.REQ: D. HANDBOOKS...........................................................................................................................................21

19 DELIVERY REVIEW......................................................................................................................................21

19.REQ: A. DELIVERY REVIEW BOARD LOCATION..................................................................................................21 19.REQ: B. DELIVERY REVIEW BOARD.....................................................................................................................21 19.REQ: C. DRB ATTENDEES ...................................................................................................................................21 19.REQ: D. DRB TASKS............................................................................................................................................21

20 COMPLIANCE MATRIX ...............................................................................................................................23

20.REQ: A. COMPLIANCE CODES ..............................................................................................................................23 20.REQ: B. MATRIX FORMAT....................................................................................................................................23

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1 SCOPE

These Quality Assurance requirements define the controls to be placed on companies under contract with EADS Astrium to provide Electrical Ground Support Equipment.

The controls described in these requirements will provide confidence to EADS Astrium that the product supplied is designed, developed, manufactured, installed and tested using well-established and effective quality control practices and methodologies.

This document has been produced to complement the contract and clarify or define Quality Assurance related requirements

In order to be cost effective, suppliers’ existing Quality systems should be used wherever possible, providing that the requirements of this document are met.

2 APPLICABILITY

These requirements are applicable to any company that has this specification imposed on them as part of a contract.

The requirements herein form part of that contract and must be read in conjunction with other applicable documents including those referenced in Para 3.Req: A.

Note: Items classified as test aids are specifically excluded from these requirements.

3 REFERENCES

3.REQ: A. APPLICABLE DOCUMENTS

The following publications form a part of this document to the extent specified herein. Unless an issue is quoted for a document, the current issue is deemed to apply. When an issue is quoted, that issue and no other must be used:

Ref Document Issue Description

AD A. EN ISO 9001 Model for Quality Assurance In Design, Development, Production, Installation And Servicing.

AD B. MIL HDBK 217 Reliability Prediction for Electronic Equipment

AD C. ECSS.Q.80B Software Quality Assurance Requirements

AD D. ECSS.M.0040 Configuration and Data Management

AD E. The Statement(s) of Work for the relevant contract.

AD F. GAIA.ASF.SP.SAT.0046 GAIA SW P. A. Requirements for EGSE/OGSE Software

AD G. The Technical Specification(s) for the relevant contract.

AD H. GAIA.ASF.SP.SAT.0007 GAIA EGSE General Design and Interface Requirements (GDIR)

AD I. GAIA.ASF.SP.SAT.0010 GAIA MGSE General Design and Interface Requirements (GDIR)

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3.1. REFERENCE DOCUMENTS

The publications listed below were used in the preparation of this document, and contain background information relating to the subjects addressed.

• 73/23/EEC Low Voltage Directive (LVD)

• EN 292 Machinery Directive

• EN 60950 European standard for electrical safety

• 89/336/EEC EMC Directive

• MIL STD 461 Requirements for the Control of Electromagnetic Interference

• DEF STAN 59-41 Electromagnetic Compatibility

• ECSS-M-00 Space Project Management, Policies and Principles

3.2. DEFINITIONS

customer (see ECSS-M-00) Company to which a supplier provides goods or services under a contract. EADS Astrium’s customer is referred to herein as the “level 0” customer and is normally the ‘first level’ customer.

deviation Written authorisation to depart from the specified customer requirements for an item prior to its production.

major NC A Major non-conformance is defined as a discrepancy which has, or may have, an operational impact on the deliverable product and/or could affect contract requirements. Classification of non conformances is not based on their consequences on cost and schedule.

minor NC Any NC that is not Major.

Product Anything that is supplied under the terms of the contract.

PA Manager The term PA Manager is synonymous with QA Manager for these requirements. The supplier shall use whichever term fits his organisation.

supplier (see ECSS-M-00) In this document, a supplier is any entity which provided a product or service to his customer. No difference is made between suppliers with and without design authority.

waiver Written authorisation to use or release a product which does not conform to the specified requirements and may affect one or more of the following: Function, Performance, Interchangeability, Mass, Reliability, Safety, Strength.

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3.3. ACRONYMS

CoC Certificate of Conformity

CDR Critical Design Review

CN Change Notice

COTS Commercial off the Shelf

D of C Declaration of Conformity

DRB Delivery Review Board

EGSE Electrical Ground Support Equipment. (The term equipment refers to any support product, even if it can be considered as a subsystem or system)

EIDP End Item Data Pack

EMC Electro-Magnetic Compatibility

FAT Factory Acceptance Test

M&P Materials and Processes

MRB Material Review Board

MRR Manufacturing Readiness Review

NC Non Conformance

PDR Preliminary Design Review

QA Quality Assurance

RFW Request for waiver

RMT Risk Management Team

RR Risk Register

SAT Site Acceptance Test

SPA Software Product Assurance

TRR Test Readiness Review

TRB Test Review Board

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4 SUPPLIER APPROVAL BY EADS ASTRIUM

4.REQ: A. APPROVED SUPPLIER LIST

Suppliers not selected from the EADS Astrium “approved vendor list” shall support a review process to ensure that they have the capability and resources available to meet the contract requirements placed upon them. The point below applies

• In the early stages of negotiation potential suppliers shall, at EADS Astrium request, supply details of their Quality Organisation together with proof of any internationally recognised quality system accreditation they may hold.

4.REQ: B. SUPPLIER QUALITY AUDIT

The supplier shall support Quality Assurance audits by EADS Astrium.

Suppliers holding internationally recognised quality system accreditation such as EN ISO 9001 or similar may still be required to be audited by EADS Astrium in the frame of the contract.

4.REQ: C. QUESTIONNAIRE AND A COMPLIANCE MATRIX

Suppliers may be sent a Quality audit questionnaire and a compliance matrix. This shall be completed and returned to EADS Astrium. The usage of these is given below:

The completed questionnaire &/or compliance matrix will then be evaluated to ascertain if audit action at the Supplier’s place of work is required. Following the review, the supplier will be contacted and informed whether a Quality audit is required.

This review will consider the following supplier attributes:

• Known supplier of Quality goods or services within the scope of the contract.

• Heritage of similar products, which have been delivered to EADS Astrium including supplier quality performance.

• Evaluation of the Questionnaire &/or compliance matrix content

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5 GENERAL

5.REQ: A. RIGHT OF ACCESS

EADS Astrium and ESA representatives shall be afforded right of access at any site used in conjunction with the supply of goods through the contract. Visits to lower tier suppliers shall be granted , they will not take place without prior agreement and attendance of the contractor. The following notes apply:

Following consultation, EADS Astrium reserves the right to perform Ad hoc audits at the supplier’s place of work if a major problem is identified and not resolved within a timescale commensurate with the contract delivery milestones.

Right of access applies to all documentation generated for, or applicable to, this contract. Exceptions shall be specifically identified to EADS Astrium as part of the contract definition process. Exceptions shall be referenced in the compliance matrix.

5.REQ: B. SECURITY DATA

Where specific security arrangements have to be met, the supplier shall give EADS Astrium reasonable notice to allow time to obtain the necessary agreement.

5.REQ: C. COMPLIANCE MATRIX

A compliance matrix shall be completed and returned to EADS Astrium for each new contract.

5.REQ: D. COMPLIANCE CHANGES

Suppliers must inform EADS Astrium if any of their circumstances change with respect to conditions indicated in previous compliance statements.

5.REQ: E. SUPPLIER RESOURCES

The supplier shall establish an organisation with sufficient resources to meet the conditions of these requirements for the duration of the contract.

5.REQ: F. PRODUCT ASSURANCE MANAGER

One person shall be nominated as the supplier PA Manager who shall be responsible for managing the tasks and shall have sufficient authority and organisational freedom to ensure completion of them. He shall be supported by personnel, including PA specialists, as necessary.

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5.REQ: G. QUALITY PLAN

The supplier shall provide a Quality Plan, as defined below:

The plan shall contain:

An organisational chart applicable to the contract showing key personnel and the interface with other line departments

A detailed description of the methods by which the requirements of this document shall be met.

It shall include, but not be limited to, all design, development, manufacturing, verification, validation, inspection, test and delivery activities of the programme

The supplier Quality Plan shall describe the controls to be implemented for the surveillance of all test activities.

Where a supplier holds an Internationally recognised Quality system accreditation similar to those described in AD. A, then the Quality Plan may be structured in accordance with that standard. The compliance matrix (Para 5.Req: C) shall include cross references between the internal Quality document paragraphs and the EADS Astrium requirement.

5.REQ: H. REPORTING

The supplier shall provide periodic quality assurance reporting to EADS Astrium, as a section of the overall progress reporting; the content is as defined below:

• Achievements & Schedule for Quality related milestones and activities

• Details of major Non conformances / compliances

• Problem areas and proposed way forward

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6 DESIGN MANAGEMENT AND VERIFICATION

6.REQ: A. DESIGN RELATED REQUIREMENTS

Where the contract includes a supplier design element then the supplier shall comply with the controls identified in this section. The note below applies:

Where there is no supplier design element, support information may be required from the supplier to permit EADS Astrium performance of its analyses.

6.REQ: B. RAMS ANALYSES

Reliability, Availability, Maintainability and Safety analysis shall be performed by the supplier to achieve and demonstrate the level of performance stated in the requirements specification.

6.REQ: C. FMECA

A Failure Mode Effect and Criticality Analysis shall be performed by the supplier to assess the consequences of a product failure on the interfaces with the equipment under test. It shall in particular be verified that there is no failure mode existing in the supply that could propagate to the EADS Astrium items that will be in interface with the supply (ex: Electrical Ground Support Equipment to satellite)

6.REQ: D. PRODUCT LIABILITY

All products supplied under an EADS Astrium contract, whether a single item or a system, shall comply with all applicable National and European Legislation related to Product Liability. This includes, but may not be limited to:

All products shall be accompanied by a copy of the ‘Declaration of Conformity’ (DoC) as required by National and European Law. The ‘Declaration of Conformity’ must reference all applicable European Directives and also the Standards applied in order to prove compliance.

Products shall have a CE certification and marking.

Note: This is NOT the same as the certificate of conformance to contract requirements.

All products and equipment(s) must be suitable for the appropriate environmental conditions in which they will be used, in particular, all external electrical equipment shall be suitably protected and of the appropriate IP (Ingress Protection) rating.

All products and equipment(s) containing voltages between 50V-1000V AC and 75V-1500V DC shall comply with the ‘essential requirements’ of the Low Voltage Directive (LVD) 73/23/EEC. The preferred standard to show compliance with the LVD is EN 60950 (latest issue).

All products and equipment(s), where applicable, shall as a minimum comply with the ‘essential requirements’ of the EMC Directive 89/336/EEC.

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6.REQ: E. PRODUCT LIABILITY, MILITARY STANDARDS

Where military EMC standards are quoted, such as MIL STD 461 E or DEF STAN 59-41, the supplier shall demonstrate the compliance of deliverable products to the quoted standards, by presentation of test results of the finished product. A test plan as noted below is required.

Before starting any such test work, the supplier shall provide a ‘test plan’ to demonstrate how EMC compliance will be demonstrated to EADS Astrium.

These guidelines are not exhaustive and it remains the responsibility of the supplier to ensure compliance against all applicable National and European Legislation.

6.REQ: F. USE OF KNOWN DESIGNS

Where practical, to aid risk reduction, use shall be made of existing designs and constructions.

6.REQ: G. COMMERCIAL OFF-THE-SHELF ITEMS (COTS)

The supplier shall provide documentary evidence to demonstrate that COTS products will operate to the required EADS Astrium performance specification.

6.REQ: H. COTS ITEMS EEE / M&P

Where COTS products are selected, the choice of components and material is the responsibility of the supplier, however they must comply with the EADS Astrium requirements, including reliability.

6.REQ: I. CHANGES TO COTS ITEMS

Proprietary items, which are modified to meet the EADS Astrium requirements shall be configuration controlled as detailed in Chapter 9.

6.REQ: J. DESIGN COMPLIANCE

Suppliers shall demonstrate compliance of the design against the specified requirements. This includes the following non exclusive list:

This shall include a statement of planned test criteria for all performance related attributes unless acceptable justification is provided and agreed with EADS Astrium that such tests are not necessary (Supplier issue of a Request For Deviation from the requirement specification may be necessary).

All design verification and acceptance test plans shall be submitted to EADS Astrium for agreement, prior to the commencement of any test activities.

Appropriate analyses and reports as specified in the contract shall be supplied.

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7 DESIGN REVIEWS

7.REQ: A. REVIEWS, DESIGN

Where specified in the contract, the supplier shall support formal reviews of the design. These reviews shall be supported by an agreed documentation to be provided by the contractor

These reviews may include a Preliminary Design Review (PDR), Critical Design Review (CDR) and Manufacturing Readiness Review (MRR).

The performance of these reviews shall not absolve the supplier from the need to ensure compliance to the applicable requirements.

7.REQ: B. REVIEWS, SCHEDULING AND SCOPE

The positioning, scheduling, documentation (deliverable and otherwise), and agenda of the reviews shall be agreed with EADS Astrium.

7.REQ: C. REVIEWS, ATTENDANCE

EADS Astrium shall be invited to attend all such reviews and notice must be given as specified in the contract. The EADS Astrium customer shall have the right to attend the reviews.

7.REQ: D. REVIEWS, MINUTES

Configured minutes of the meeting shall be taken by the supplier, supplied to attendees at the meeting and formally distributed to EADS Astrium within ten working days of the review.

7.REQ: E. REVIEW TYPES

The types of review applicable to the supplier’s product depend, among other things, on the type and complexity of the product. The supplier shall support the reviews as appropriate for the concerned product. The point below applies:

• Reviews may be at the supplier’s site, EADS Astrium’s site or other venue agreeable to both parties.

• Reviews may be one or more of the formal reviews mentioned below.

7.REQ: F. PRELIMINARY DESIGN REVIEW (PDR)

When required by the contract:

This review shall be held when the Design has matured to a point where the system or related equipment functional and architectural design is complete. Major interfaces between functional elements have been defined but no detailed design has yet commenced. The PDR establishes by analysis that the architectural design meets the requirements and that the functional partitioning is optimised. It gives the green light to detailed design definition.

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7.REQ: G. PDR DOCUMENTATION

The supplier shall present the design in a PDR data pack. It shall be supplied to EADS Astrium prior to the review. The general agenda and contents are as below:

The PDR package and agenda shall address the following and any other points specified in the contract with the supplier: -

• Design Report

• Confirm the requirements, interfaces and applicable documentation

• Review verification tests to be performed

• Review the status of reliability data

• Review of software requirements and development

• Review the status of any risk analysis

• Check that safety aspects including CE legislation are being addressed adequately

• Establish specification compliance status

• Identify and agree any critical tooling or processes

• Initiate the detailed design phase

• Agreement on successful completion of this review phase.

7.REQ: H. CRITICAL DESIGN REVIEW (CDR)

When required by the contract:

Following successful PDR and development, a CDR shall be held at the point where the detailed design is completed and it is established by analysis and possibly to a limited extent by test, that this design meets in full the requirements. The aim of the review is to confirm the design’s acceptability and authorisation for production

7.REQ: I. CDR DOCUMENTATION

The supplier shall present the design in a CDR data pack. It shall be supplied to EADS Astrium prior to the review. The general agenda and contents are as below:

The CDR shall address the following as a minimum: -

• Check that any PDR recommendations have been successfully embodied

• Review the results of any testing and the implications on deliverable hardware.

• Review the overall final design

• Check that the final design meets the technical specification requirements

• Check the adequacy of the acceptance and integration test procedures.

• Review all deliverable documentation including: -

- Specifications

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- Procedures & Plans

- Drawings

- Bills of Materials (BOM)

- Configuration Control Documentation (CCD)

- Interface documentation

• Review materials, processes and electronic part selection

• Review the reliability analyses (FMECA)

• Review of software development and module level testing

• Review the risk register and assess implications of risks

• Check that safety aspects including CE legislation have been addressed adequately

• Agreement on the success of the CDR and confirmation of agreement to commence deliverable product build.

7.REQ: J. POST CDR DOCUMENT FREEZE

Following successful completion of the review, the design and all related documentation shall be frozen. All design changes and changes to approved documents require EADS Astrium prior formal approval.

8 SOFTWARE QUALITY ASSURANCE

8.REQ: A. SOFTWARE

Software Product Assurance (SPA) shall comply with the specification GAIA Software Product Assurance Requirements for Subcontractors, referenced GAIA.ASF.SP.SAT.00046. This specification is a tailoring of the applicable ECSS-Q-80B.

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9 RISK MANAGEMENT

9.REQ: A. RISK MANAGEMENT

Unless otherwise specified in the contract, the supplier shall implement Risk Management (RM) procedures to identify the risks with respect to all aspects of the contract. The procedures shall ensure that appropriate actions are instigated to mitigate the identified risks by the most appropriate means. The RM and mitigation process shall consider the following: -

• Identification of sources of risk.

• Assessment of the individual risks for likelihood of occurrence and degree of impact

• Analysis (both qualitative and quantitative) of identified risks to identify the areas of highest risk and to estimate the overall impact.

• Planning of strategies, development paths, equipment selections and specific actions to reduce or eliminate the degree of risk.

• Implementation of an action plan for monitoring and mitigation of identified risks

9.REQ: B. RISK REGISTER

The supplier shall create and maintain a Risk Register (RR) which shall be periodically revised to include new risks, identify risks which have been eliminated or have changed in their assessment and identify the progress in risk reduction actions.

10 DOCUMENTATION AND CHANGE CONTROL

10.REQ: A. CADM SYSTEM REQUIRED

The supplier shall establish and maintain a Configuration Data Management system in accordance with AD D. ECSS.M.0040 Configuration and Data Management. The point below applies:

The CADM system shall be identified in either the supplier’s Quality Plan or a specific Configuration and Data Management Plan

10.REQ: B. CHANGE CONTROL EXTENT

All changes to Drawings, BOM, Specifications, Procedures etc, produced and issued in accordance with the contract, shall be controlled by the supplier’s documented change control procedures.

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10.REQ: C. CHANGES TO THE BASELINE

Any intended changes to the agreed contract baselines (e.g. contractual, design definition) shall be submitted to EADS Astrium in accordance with the change proposal procedure.

11 RECORDS

11.REQ: A. RECORDS

The Supplier shall maintain records relating to all activities within the scope of the contract. This shall enable demonstration of conformance to specified requirements, effective operation of the Quality system, traceability of operations performed and results of verification activities. Records shall be legible and shall be stored in a suitable environment to prevent damage or degradation and to facilitate ease of retrieval.

11.REQ: B. PHOTOGRAPHS

Records shall include photographic evidence where such is useful to understand configurations (e.g. test, delivery), confirm build (e.g. cable installation) or demonstrate test results (e.g. oscilloscope plots).

12 PROCUREMENT

12.REQ: A. SUPPLIER CONTROL

The supplier shall ensure that adequate controls are exercised over his suppliers to assure compliance to Quality conditions relevant to the item being purchased.

12.REQ: B. SUPPLIER CERTIFICATES

The supplier shall require delivery of a Certificate of Conformance from his suppliers confirming that the articles provided meet the specified criteria.

12.REQ: C. REQUIREMENTS ON SUPPLIERS

Suppliers shall impose the relevant parts of these requirements on their lower tier suppliers such that all products meet these EADS Astrium requirements.

12.REQ: D. PROCUREMENT SPECIFICATIONS

Any procurement shall be made against a documented and approved specification. For items (raw materials, off the shelf items) that would not be procured with a dedicated specification, the contractor shall provide evidence and records of the source inspection or incoming inspection enabling to verify the conformity of the procured item.

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12.REQ: E. RECORDS OF PURCHASE ORDERS

The Supplier shall maintain records of all purchase orders raised in conjunction with the EADS Astrium contract. EADS Astrium reserves the right to review these.

13 PARTS AND MATERIALS

13.REQ: A. COMMERCIAL QUALITY

Unless otherwise specified in the contract, the supplier shall ensure that commercial quality electronic parts and materials used in fulfilment of the EADS Astrium contract are selected according to known operational quality records or are screened and inspected for conformity to their data sheet or the applicable specification.

13.REQ: B. PARTS AND MATERIALS SELECTION

Selection of parts and materials shall ensure that they are non contaminants by proximity, and compatible with clean room environment (i.e. they shall not contaminate the clean room environment and flight hardware in clean room). If the ground equipment is used inside the thermal vacuum chamber for system environmental testing, then the materials shall be selected for their low outgassing properties. The same criteria than for flight hardware shall then apply: TML< 1%, CVCM< 1%.

PVC (PolyVynil Cloride) shall not be used, as it is considered to be potentially contaminant by proximity. Other materials such as zinc, cadmium, pure tin are also prohibited.

Use of oils/grease is not allowed, except if hermetically sealed. Materials shall be cleaned to remove traces of oils, in particular wires and cables.

Cleanliness/Contamination

Ground equipment shall be compatible with clean room, and not degrade the class 100 000 (ISO 8) environment. Cleaning shall be performed before delivery to reach a “visibly clean” level under white light illumination (outside and inside benches for example). Cleaning with solvent before delivery shall remove any traces of molecular contamination.

Refer also to documents referenced ADH and AD I that provide more details relative to parts and materials selection, and to cleanliness/contamination.

14 INSPECTION AND TEST

14.REQ: A. ACCEPTANCE TESTING

All products shall be subjected to acceptance testing on completion of manufacture and prior to delivery. The testing shall cover the points below:

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Testing may, if required by EADS Astrium, be performed in two parts; FAT and SAT, as covered in the following

paragraphs.

All of the performance requirements specified in the contract shall be verified by test unless acceptable justification is provided and agreed with EADS Astrium that such tests are not necessary.

Product liability requirements shall be met

Where it can be shown that it is impractical for required tests to be carried out on the deliverable product, compliance shall be demonstrated by one or more of the following:

- testing on a purpose specific model

- analysis supported by appropriate, supportive, data

14.REQ: B. PRE-DELIVERY TESTING (FAT)

All deliverable products shall be subjected to formal Factory Acceptance Testing (FAT) of the main functional parameters prior to shipment from the suppliers site to determine that: -

a) The product functions to a performance level within the technical performance requirements. b) The product is representative of the baseline Design

14.REQ: C. SITE ACCEPTANCE TESTING (SAT)

Where it is not possible to perform a full FAT at the suppliers site due, for example, to final assembly being undertaken after shipment then the supplier shall perform Site Acceptance Testing (SAT) in accordance with the contract and the points described below:

The SAT is a reduced version of the FAT. The extent of the SAT shall be agreed with EADS Astrium prior to formal testing.

14.REQ: D. VALIDATION & CALIBRATION

All inspection, measuring and test equipment used by the Supplier for verification and acceptance test purposes shall be validated and within its calibration period.

14.REQ: E. TRACEABILITY OF CALIBRATION

The calibration standards used shall be traceable back to National or International Standards.

14.REQ: F. INSPECTION PLAN

The supplier shall ensure that an appropriate in-process inspection plan is defined. Inspection activities shall be clearly identified as part of the production and test flow.

14.REQ: G. TESTED PRODUCT STATUS

The build standard of products subjected to formal testing shall be clearly defined and documented.

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14.REQ: H. QUALIFIED PERSONNEL

Testing shall only be undertaken by appropriately qualified staff.

14.REQ: I. TEST SCHEDULE

Acceptance testing shall be undertaken to a schedule previously agreed with EADS Astrium.

14.REQ: J. NOTIFICATION OF TEST

The supplier shall confirm the test date to EADS Astrium at least 1 week prior to test commencement. EADS Astrium reserves the right to witness all or parts of any formal testing.

14.REQ: K. TEST PROCEDURE

The supplier shall provide an acceptance test procedure to EADS Astrium for approval, prior commencement of any acceptance testing

Note 1: EADS Astrium will review and respond to each document within 2 weeks of receipt.

Note 2: Default procedure delivery timescale is at least 14 days prior to the scheduled commencement of the test.

14.REQ: L. TEST READINESS REVIEW (TRR)

Prior to any formal testing, a Test Readiness Review shall be organised by the supplier to obtain the formal authorisation to proceed with the acceptance testing. The TRR will review the status of the following:

• Declared build standard versus Design baseline.

• Status of any Non-conformance and open item status

• Test procedures/plans and status of approval.

• Validation status of test equipment / facility.

• Software Standard (Test and /or application).

14.REQ: M. TRR NOTIFICATION

A minimum of five working days prior to TRR, the supplier shall invite EADS Astrium attendance. EADS Astrium will chair the review.

14.REQ: N. TEST FAILURES

For any test activity that does not meet the relevant acceptance criteria, the supplier shall prepare and submit a NCR (or equivalent) detailing the anomaly/non conformance.

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14.REQ: O. TEST REVIEW BOARD

Following completion of acceptance testing (FAT and SAT) activities, the supplier shall convene a Test Review Board. EADS Astrium will chair the review.

The purpose of the review shall be to verify the effectiveness of the acceptance testing activities prior to formal delivery of the product. The TRB shall address the following: -

• Status and close-out of any actions placed at the TRR

• Review of the actual as run test procedure(s) to establish if any deviations/amendments to the test procedure agreed at the TRR were applied during test activities

• Test results

• Non conformances and anomalies encountered during testing, NCR reports issued.

• Test report status

• Conclusions (Agreement to completion of test)

Note 1: By prior agreement of all parties, this may be performed as part of the Delivery Review Board (see Para 18.Req: B).

14.REQ: P. INSTALLATION SPECIFICATION

The supplier shall provide an Installation Specification at least one month prior to shipment,

14.REQ: Q. SUPPLIER SUPPORT TO COMMISSIONING

The installation and commissioning of the product, following successful SAT, will take place at EADS Astrium premises or at the final destination (site) and shall be supported by the supplier.

15 CONTROL OF NON-CONFORMING MATERIAL

15.REQ: A. NON CONFORMANCE MANAGEMENT SYSTEM

The Supplier shall establish and maintain a procedure for controlling materiel that does not conform to drawing or specification requirements.

The procedure shall include controls for identification, documentation, classification, segregation of the non-conforming item and disposition of the non-conformance.

15.REQ: B. MAJOR NC

Non conformances shall be classified major as per definition of major given in section 3.2

Examples of this type of Non-conformance include: -

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• Any non compliance to the EADS Astrium requirements specifications

• Any non compliance affecting the safety aspects

• Acceptance test failures

15.REQ: C. NOTIFICATION

For Major non-conformances, the supplier will inform the EADS Astrium project office immediately via telephone and supported in writing (e-mail or fax ) within 24 hours of the occurrence.

15.REQ: D. MINOR NC

All non conformances that are not classified MAJOR shall be included in the class MINOR.

The Supplier can control minor non-conformances locally. Examples of such deficiencies:

• Non conformance that can be brought back to compliance by Rework to Drawing

• Back to compliance by Reset and Retest

• Minor superficial damage or minor test discrepancy not affecting the EADS Astrium requirements

15.REQ: E. NC RECORDS

Records of all non-conformances shall be maintained with suitable evidence of disposition by the Supplier Quality and Design authorities.

15.REQ: F. NON CONFORMANCE REVIEW BOARD (NRB)

Immediately after notification of a MAJOR NC the supplier shall convene a NRB either at the supplier’s premises or, with EADS Astrium agreement, by teleconference. NRB objectives and involved personnel are detailed below:

The objectives of the NRB will be to:

• Review the original non compliance in detail

• Determine the root cause of the problem

• Identify the actions required to remedy the problem and maintain the schedule

• Agree any retest programme which may be required

• Identify appropriate corrective and preventive actions to prevent re-occurrence

The NRB shall involve the following personnel:

• Supplier Quality Assurance Manager for the Product

• Supplier Project Manager (optional)

• Appropriate Supplier design &/or test engineers

• EADS Astrium Quality representative (Chairman)

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• EADS Astrium Design representative(s)

EADS Astrium customer representatives shall be allowed to participate to NRBs, as necessary.

16 DEVIATIONS AND WAIVERS

16.REQ: A. DEVIATIONS AND WAIVERS

The supplier shall issue a Request For Deviation (RFD) for any requested relaxation of requirement (before production) that is specified in EADS Astrium requirements specifications, or a Request For Waiver (RFW) for any departure from a requirement detected after production and affecting a limited number of models, that is proposed to be kept as is.

• All requests must contain sufficient information to clearly identify the item, the nature of the requested relaxation and the applicability.

• Each customer shall assess the potential impact of the RFD / RFW to his customer(s). Where there is a potential impact, the RFD / RFW shall be supplied to those customers for review and, if appropriate, approval.

• Evidence of review by the appropriate supplier Quality, Design, and Management personnel must be provided with each submission.

• Following review and subsequent approval or rejection, the original of the RFD / RFW will be returned to the Supplier.

17 PACKAGING SPECIFICATIONS

17.REQ: A. ACCEPTABLE SPECIFICATIONS

Where the contract requests a recognised and approved method of packing such as a Defence Standard or Military Standard then the supplier will comply with that standard or notify EADS Astrium immediately if this is not possible. Where no specific standard is defined the following applies:

The supplier shall use a standard acceptable to EADS Astrium for all packaging, special containers and handling jigs etc. The standard shall be such that no degradation to the product occurs in the specified production, transport and storage environments.

18 END ITEM DATA PACK (EIDP)

18.REQ: A. EIDP

Prior to the DRB and unless otherwise specified in the contract, the Supplier shall prepare an End Item Data pack (EIDP) as described below. It shall be forwarded to EADS Astrium to be available five working days prior to DRB commencement. The EIDP shall be updated after the DRB to include the DRB minutes and any other actions updates.

The EIDP shall contain the following information;

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Section No. Title Contents

0 Introduction & Contents A configured listing of all documentation items included with the delivery. Details required are: Front Page: item title, part number and batch number.

A list of the items being delivered. This covers cables, connector savers, data media (discs), tooling etc.

1 Configured Documents Top assembly drawings, diagrams and interface control documents

2 As-Built to As-Designed reconciliation.

Configured item data list (CIDL) or Configuration control Document (CCD)

3 Deviations and Waivers All applicable Deviations and Waivers

4 Major Non conformances. NCR copies and NRB minutes of meeting

5 Open Items. A list of any outstanding activities.

6 Test results, Reports, calibration data Certified test results and associated test reports.

7 Handbooks, Operation Manual, Integration specifications

All necessary documentation to properly operate and use the supply

8 Certificate of Conformance (CoC) Signed by the supplier QA authority. The CoC shall reference all EADS Astrium approved RFD & RFW.

9 Safety / Design Certificate Safety Certificate / Declaration of Conformance to legislative requirements.

10 Handling Packaging and transportation Procedures.

All necessary documentation relative to handling, packing and transporting the supply

11 Declaration of Conformity (DoC) Refer to Product Liability Requirements: CE certificate

12 Serialised Items details Lists of items with serial numbers. This would contain calibrated sensor details, removable rack modules, etc

18.REQ: B. COC DELIVERY

The CoC shall be despatched with the goods and a copy included in the End Item Data Pack (EIDP)

18.REQ: C. CERTIFICATE OF CONFORMANCE

Following successful FAT or SAT, whichever is appropriate, and prior to DRB the supplier shall prepare a CoC. The content shall contain the minimum information relevant to the system being formally released by the Supplier:

• Name and Address of Consignee

• Contract number

• Date of shipment or release

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• Clear description of the product being released

• Quantity

• Serial number or batch number of the released product

• Configuration Control number (CCD) and issue to which the product is being released

• Top assembly drawing or BOM to which the product is being released

• Any Deviations or Waivers

• Any other relevant information

18.REQ: D. HANDBOOKS

Handbook requirements will be specified in the Requirement Specification. When there is nothing specifically stated, the Supplier shall supply any deliverable handbooks to a good commercial standard.

19 DELIVERY REVIEW

The details of the review board, its tasks and members are given in the following paragraphs.

19.REQ: A. DELIVERY REVIEW BOARD LOCATION

The review shall be convened by the supplier at a location agreed with EADS Astrium and prior to final acceptance of the supplies.

19.REQ: B. DELIVERY REVIEW BOARD

The supplier shall support a DRB on his product. Support includes personnel, facilities, documentation and closure of resulting actions.

19.REQ: C. DRB ATTENDEES

The DRB shall as a minimum consist of the following personnel: -

• EADS Astrium Product Assurance Manager or his delegated representative. (Chairman)

• EADS Astrium Project Manager, or his delegated representative.

• Supplier representatives.

19.REQ: D. DRB TASKS

The DRB shall address the following: -

• If not performed separately, the DRB shall address the points required for a TRB.

• Review action status and impact of open actions on product acceptability

• Agree final acceptance of the product.

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• Final as-Built configuration versus baseline Design standard.

• Review any remaining applicable open items (e.g. open work).

• Review the status of RFD and RFW

• Review the End Item Data Pack contents. (Including Design, and Product release and Product Liability Certification)

• Review of the closure status of any related NC

• Undertake visual inspection of the product (if venue permits)

• Validation of test related data

EADS Astrium will provide written, configured, minutes of the DRB for inclusion in the EIDP.

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20 COMPLIANCE MATRIX

20.REQ: A. COMPLIANCE CODES

The following codes shall be used:

C = Fully compliant to the requirement.

NA = Not Applicable. Use where the requirement has no relevance to the product.

NC = Not Compliant. Explain why, and what alternative(s) are offered.

PC = Partially Compliant. (Where used, details of the differences shall be specified)

20.REQ: B. MATRIX FORMAT

The matrix shall be returned to EADS Astrium in Microsoft Excel™ electronic format as well as hard copy.

A copy of the matrix in Microsoft Excel™ format can be made available to the supplier. For a copy please contact EADS Astrium PA Manager.

Alternatively, it can be obtained by copy and paste into Microsoft Excel™.

Matrix for Compliance to document ref: Issue

Para

title Comp. Status Remarks

1 SCOPE

2 Applicability

3 References

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Para title Comp. Status Remarks

3.Req: A. Applicable Documents

4 Supplier Approval by EADS Astrium

4.Req: A. Approved Supplier list

4.Req: B. Supplier audit

4.Req: C. Questionnaire and a compliance matrix

5 General

5.Req: A. Right of access

5.Req: B. Security data

5.Req: C. Compliance matrix

5.Req: D. Compliance Changes

5.Req: E. Supplier Resources

5.Req: F. PA Manager

5.Req: G. Quality Plan

5.Req: H. Reporting

6 Design Management and Verification

6.Req: A. Design Related Requirements

6.Req: B. RAMS Analyses

6.Req: C. FMECA

6.Req: D. Product Liability

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Para title Comp. Status Remarks

6.Req: E. Product Liability, Military Standards

6.Req: F. Use of known designs

6.Req: G. Commercial Off-the-Shelf Items

6.Req: H. COTS items EEE / M&P

6.Req: I. Changes to COTS items

6.Req: J. Design Compliance

7 Design Reviews

7.Req: A. Reviews, Design

7.Req: B. Reviews, Scheduling and Scope

7.Req: C. Reviews, Attendance

7.Req: D. Reviews, Minutes

7.Req: E. Review Types

7.Req: F. Preliminary Design Review (PDR)

7.Req: G. PDR Documentation

7.Req: H. Critical Design Review (CDR)

7.Req: I. CDR Documentation

7.Req: J. Post CDR Document Freeze

7.Req: K. Final Design Review (FDR)

8 Software Quality Assurance

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Para title Comp. Status Remarks

8.Req: A. Software

9 Risk Management

9.Req: A. Risk Management

9.Req: B. Risk Register

10 Documentation and Change Control

10.Req: A. CADM System Required

10.Req: B. Change Control extent

10.Req: C. Changes to the Baseline

11 Records

11.Req: A. Records

11.Req: B. Photographs

12 Procurement

12.Req: A. Supplier Control

12.Req: B. Supplier Certificates

12.Req: C. Requirements on Suppliers

12.Req: D. Procurement Specifications

12.Req: E. Records of Purchase Orders

13 Parts and Materials

13.Req: A. Commercial Quality

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Para title Comp. Status Remarks

13.Req : B. Parts and Materials Selection

14 Inspection and Test

14.Req: A. Acceptance Testing

14.Req: B. Pre-Delivery Testing (FAT)

14.Req: C. Site Acceptance Testing (SAT)

14.Req: D. Validation & Calibration

14.Req: E. Traceability of Calibration

14.Req: F. Inspection Plan

14.Req: G. Tested Product Status

14.Req: H. Qualified Personnel

14.Req: I. Test Schedule

14.Req: J. Notification of Test

14.Req: K. Test Procedure

14.Req: L. Test Readiness Review (TRR)

14.Req: M. TRR Notification

14.Req: N. Test Failures

14.Req: O. Test Review Board

14.Req: P. Installation Specification

14.Req: Q. Supplier Support to Commissioning

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Para title Comp. Status Remarks

15 Control of non-conforming material

15.Req: A. NC Management System

15.Req: B. Major NC

15.Req: C. Notification

15.Req: D. Minor NC

15.Req: E. NC Records

15.Req: F. MRB

16 Deviations and Waivers

16.Req: A. Deviations and Waivers

17 Packaging Specifications

17.Req: A. Acceptable Specifications

18 End Item Data Pack (EIDP)

18.Req: A. EIDP

18.Req: B. C of C Delivery

18.Req: C. Certificate of Conformance

18.Req: D. Handbooks

19 Delivery review

19.Req: A. DRB Location

19.Req: B. Delivery Review Board

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Para title Comp. Status Remarks

19.Req: C. DRB Attendees

19.Req: D. DRB Tasks

20 Compliance Matrix

20.Req: A. Compliance Codes

20.Req: B. Matrix format

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DISTRIBUTION LIST

Overall document Summary Action Information ESA

M. COLANGELO

JP BALLEY

EADS Astrium Ltd

R. EMERY

S. KING

D. PERKINS

EADS Astrium GmbH

M. SCHELKLE

L. GESSLER

EADS Astrium SAS

F. FAYE

C. GABILAN

L. LOBO

A. SOBECZKO

P. LELONG

C. LEBRANCHU

D. HERBIN

P. CHARVET

A. LABORIE

P. POUNY

P.L BAZIN

D. MARCHAIS