Copying of this document, giving it to others, using it, or communicating of the contents thereof, are forbidden without expressed authority. Offenders are liable to the payment of damages. All rights are reserved in the event of the grant of a patent or the registration of a utility model or design. Project: Euclid PLM Title: PLM-PA-02. Quality Assurance requirements for Euclid PLM Ground System Equipment Doc. No.: Issue: Date: EUCL-ASFT-RS-3-027 1.0 06/06/2013 Name Function Date Signature Prepared by: Isabelle Fournier PLM PA/QA 06.06.2013 Checked by: Ludovic Vaillon PLM System Engineer 06.06.2013 Approved by: André Sobeczko PLM PA Manager 06.06.2013 Released by: Vincent Cazaubiel PLM Project Manager 06.06.2013
Transcript
Copying of this document, giving it to others, using it, or communicating of the contents thereof, are forbidden without expressed authority. Offenders are liable to the payment of damages. All rights are reserved in the event of the grant of a patent or the registration of a utility model or design.
Project: Euclid PLM
Title: PLM-PA-02. Quality Assurance requirements for Euclid PLM Ground System Equipment
The aim of this document is to provide QUALITY REQUIREMENTS for GROUND SUPPORT EQUIPMENTS used in Assembly, Integration and test of EUCLID PLM.
These requirements are based on European standard specification completed with Astrium specific requirements from return of experience. This document is adapted for Euclid PLM from Astrium Reference documentation: ADS.E.1078 i1rev1 dated 12/06/12.
1.2 APPLICABILITY
These requirements are applicable for any GSE entering any Astr ium entities/sites, whether procured by AIT or delivered to AIT (such as Customer/Partners furnished equipments or hardware from other sites).
In some specific cases – such as for Customer and Prime furnished GSE this document will be provided to ESA/Prime as early as possible for explaining our needs and facilitate the Handover to AIT.
2 REFERENCES
2.1 RELATED DOCUMENTS
The following documents are referred to in the current procedure and shall be applied for the implementation of the processes described herein :
Applicable documents : None - this document is self-contained.
Templates/Forms :
[F 1] ADS.E.1078.Template HANDOVER TO AIT template
[F 2] ADS.E.1078.Matrix COMPLIANCE MATRIX
The actual issue of these templates and forms can be found in ADS on-line.
2.2 BACKGROUND DOCUMENTS
The following documents contain background information relating to the subjects addressed and facilitate the implementation of the principles and processes here detailed (if no version is indicated, latest versions shall be used) :
[1] ECSS-Q-ST-20C Space product Assurance – Quality assurance
[2] CAIT.08861.ASTR C-AIT Requirements for POWER test
[3] CAIT.08347.ASTR C-AIT HANDLING specification
[4] CAIT.02762.ASTR CAIT Electrical test configurations PRODUCT LIABILITY
[5] ADS.E.0422 PRODUCT SAFETY ASSESSMENT GUIDE
[6] ADS.E.0037 PRODUCT LIABILITY AND SAFETY HANDBOOK
[7] ADS.E.1015 TRANSPORT SPECIFICATION
[8] ADS.E.0975 PROCESS FME(C)A related to a Process
Supplier: the one who delivers GSE (case of CFE/PFI) or from whom GSE is procured.
2.3.2 Abbreviations
The following abbreviations are used in this document.
AIT Assembly, Integration and Test CAIT Central AIT CDR Critical Design Review CFE Customer Furnished Equipment CFI Customer Furnished Item COTS Commercial Off The Shelf DML Declared Materials List DRB Delivery Review Board ECSS European Cooperation for Space Standardization EGSE Electrical Ground Support Equipment FAT Factory Acceptance Tests FMEA Failure Mode and Effect Analysis FMECA Failure Mode, Effect and Criticality Analysis GSE Ground Support Equipment MGSE Mechanical Ground Support Equipment NA Not Applicable NCR Non Conformance Report PDR Preliminary Design Review PFI Partner Furnished Item QA Quality Assurance RFD Request For Deviation SAR Safety Assesment Report SAT Site Acceptance Tests SOW Statement Of Work TRR Tests Readiness Review
As the level of complexity depends of the GSE itself – it may vary from a new spacecraft container to a simple recurrent handling device, or from an electrical bench with many newly developed equipment to a single rack of recurrent software – requirements (including ECSS) have been separated in generic requirements applicable to all GSE (this chapter §3), and specific requirements that may be tailored, depending on GSE, as defined in GSE technical specification.
Only the specific requirements in next chapter should be tailored, each requirement of the present chapter §3 should be fulfilled – or the reason of non-compliance should be explained.
3.1 ECSS-Q-ST-20 REQUIREMENTS – PART 1: APPLICABLE TO ALL GSE
The present requirements are extracted from ‘pre-tailoring matrix for ground products’, ECSS-Q-ST-20C Rev1 draft3.1 annex K (background document [1]).
They include all chapters from this ECSS applicable to GSE ( all 5.8.xx chapters + some other applicable chapters).
ECSS clauses have been inserted with their numbering in the appropriate paragraph and have been organized to fit GSE development without cross-reference to other chapters.
ECSS
Clause
ECSS Requirement Text
QUALITY ASSURANCE principles and management requirements (ECSS §4 and §5.1)
Quality assurance principles (ECSS §4)
ECSS 4.1. Quality assurance management principles
4.1. The prime objective of Quality Assurance (QA) management is to ensure that a QA programme for projects covering mission definition, design, development and production of space systems is established, maintained and implemented. All QA requirements are specified through definition and implementation of adequate methods and procedures. Personnel whose performance determines or affects product quality are trained and certified in accordance with their skills and the activities performed.
ECSS 4.2. General principles
4.2. The implementation of the following phase-independent activities is ensured by the QA function throughout the lead-time of projects:
- nonconformance control
- stamp control
- traceability
- metrology and calibration
- handling, storage and preservation
- statistical quality control (if required by the business agreement).
ECSS 4.3. Design and verification principles
4.3. The objective of the QA function is to ensure that: a. a set of design rules and methods has been set up and is consistent with the project techniques and technologies; b. methods, procedures and tools have been defined and are implemented in order to prove that each applicable requirement is verified through one or more of the following methods: analysis, inspection, test, review of design, audits; c. the design is producible and repeatable and that the resulting product can be verified and operated within the required operating limits;
d. design and verification activities are planned in a consistent and logical way; e. the verification process is complete and includes clear test, test model and verification logic; f. a defined qualification approach is implemented to demonstrate that the item performs satisfactorily in the intended environment.
ECSS 4.4. Procurement principles
4.4. All procurement activities including selection of procurement sources, procurement documents, procurement source surveillance and receiving inspection are controlled to ensure that all procured items and services conform to requirements.
ECSS 4.5. Manufacturing, assembly and integration principles
4.5. All manufacturing, assembly and integration operations are planned and performed in coordination with inspections and tests to ensure that the deliverables are built, assembled and integrated to the approved configuration baseline. Special processes and new technologies are identified in a timely manner and adequate evaluation or qualification activities should be implemented in line with the overall schedule.
ECSS 4.6. Testing principles
4.6. Test facilities and test equipment are validated prior to their use to ensure conformance to project requirements. All tests are performed in accordance with documented and released procedures and results are comprehensively recorded.
ECSS 4.7. Acceptance and delivery principles
4.7. The objective is to ensure that an acceptance and delivery process is implemented which allows demonstrating and documenting the conformance of the delivered item.
ECSS 4.8. GSE principles
4.8. Design, production, delivery and maintenance requirements for GSE are defined and implemented allowing for testability, availability, safety, life duration, operability and ability to interface as necessary with space segment in a safe way
QA management requirements (ECSS §5.1.)
ECSS 5.1.1 Quality assurance plan
5.1.1 a. The supplier shall prepare, maintain and implement a QA plan, except for suppliers of catalogue COTS items such as standard laboratory equipment, work stations,... , from whom a dedicated QA plan is not required
5.1.1 b. The QA plan may be submitted to Astrium if required.
ECSS 5.1.2 Personnel training and certification
5.1.2 a. The supplier shall establish a documented training programme for the personnel whose performance determines or affects product quality.
5.1.2 b. Personnel performing special processes shall be trained and certified by internal or external training programmes.
5.1.2 c. Personnel inspecting or controlling special processes, or performing non-destructive testing and evaluation, shall be trained and certified according to training programmes and standards.
5.1.2 d. The supplier shall maintain records of the training.
GSE Development (ECSS §5.8.1.)
ECSS 5.8.1.1 Design quality requirements for GSE
ECSS 5.8.1.1.1 Design and verification
5.8.1.1.1 a. The supplier shall ensure that internal design and verification standards are used or developed corresponding with the techniques to be used and fitting with the level of complexity of the items to be developed.
5.8.1.1.1 b. The supplier shall ensure that development risks are identified and appropriate back-up solutions are identified.
5.8.1.1.1 c. The supplier shall ensure that the verification method and process are tailored to the:
13. 14. 15. none (initial ECSS requirement suppressed in the present document)
16. List of the loose items and not installed items supplied with the product.
17. Any additional useful information or data relevant to the product. NOTE For example, cleanliness certification when cleanliness is a requirement.
GSE Acceptance (ECSS §5.8.5) 5.8.5 a. Acceptance shall be achieved through a formal review process
5.8.5 b. The acceptance process shall include:
1. acceptance plan,
2. inspection and test procedures, and
3. inspection and test reports.
GSE Delivery board (ECSS §5.8.6) 5.8.6 a. The supplier shall propose GSE elements for which acceptance is granted by a delivery board and agree these with his customer.
5.8.6 b. The delivery board shall include QA representatives from the supplier and the customer.
GSE Acceptance and Delivery (ECSS §5.8.7., 5.7.4 and 5.7.5)
QA requirements for GSE delivery (ECSS §5.8.7.) Included in chapter 5.7.4, 5.7.5 and 5.2.7herafter
QA requirements for acceptance and delivery (ECSS §5.7.4 and §5.7.5)
ECSS 5.7.4 Preparation for delivery
ECSS 5.7.4.1 Packaging
5.7.4.1 a. The supplier shall ensure that packaging materials, methods, procedures and instructions provide for protection of items while at the supplier’s plant, during transportation, and after their arrival at destination.
ECSS 5.7.4.2 Marking and labeling
5.7.4.2 a. The supplier shall ensure that appropriate marking and labelling for packaging, storage, transportation and shipping of items are performed in accordance with the applicable specifications.
ECSS 5.7.5 Delivery
ECSS 5.7.5.1 Shipping control
5.7.5.1 a. The supplier shall ensure that the items to be shipped from his plant are inspected before release and found to be complete, adequately preserved and packaged, correctly marked and accompanied by all the required documentation.
5.7.5.1 b. Accompanying documentation shall include the EIDP and, attached to the outside of the shipping container, the handling and packing or unpacking procedure and any relevant safety procedures.
ECSS 5.7.5.2 Transportation
5.7.5.2 a. The supplier shall make provisions for the prevention of damage to items during transportation.
GSE General requirements (ECSS §5.8.8 and 5.2)
QA general requirements for GSE (ECSS §5.8.8)
Included in chapter 5.2.5 and 5.2.6. herafter
QA general requirements (ECSS §5.2)
ECSS 5.2.5 Traceability
5.2.5 a. The supplier shall ensure that a bidirectional and unequivocal relationship between parts, materials or products and associated documentation or records is established and maintained Note: Traceability is limited to product level, not to parts and material.
5.2.5 e. The supplier shall establish controls to ensure that:
1. identification numbers are assigned in a systematic and consecutive manner,
2. identification numbers of scrapped or destroyed items are not used again,
ECSS 5.2.6 Metrology and calibration
5.2.6 a. The supplier shall control, calibrate and maintain inspection, measuring and test equipment, whether owned by the supplier, on loan, or provided by the customer to demonstrate the conformance of product to the specified requirements.
5.2.6 b. The supplier shall use equipment in a manner which ensures that measurement uncertainty is known and is consistent with the specified measurement capability.
5.2.6 e. The supplier shall select inspection, measuring and test equipment in conformance with the required measurement accuracy and precision.
5.2.6 f. The supplier shall identify, calibrate and adjust all inspection, measuring and test equipment and devices that can affect product quality at prescribed intervals, or prior to use, against certified equipment.
5.2.6 h. The supplier shall ensure that the inspection, measuring and test equipment is capable of the specified accuracy and precision.
5.2.6 j. The supplier shall maintain calibration records for inspection, measuring and test equipment.
5.2.6 k. The supplier shall assess and document the validity of previous inspection and test results when inspection, measuring or test equipment is found to be out of calibration.
5.2.6 l. The supplier shall ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out.
5.2.6 m. The supplier shall ensure that inspection, measuring and test facilities, including both test hardware and test software are protected against adjustments, which can invalidate the calibration setting.
5.2.6 n. The supplier shall ensure that the inspection, measuring and test equipment is handled, preserved and stored such that the accuracy and fitness for use is maintained.
ECSS 5.2.7 Handling, storage and preservation
ECSS 5.2.7.1 Handling
5.2.7.1 a. The supplier shall prevent handling damage during all phases of manufacturing, assembly, integration, testing, storage, transportation and operation.
5.2.7.2 a. The supplier shall place the following items in storage areas:
1. incoming materials,
2. intermediate items needing temporary storage, and
3. end items before shipping.
5.2.7.2 b. The supplier shall place the following items in designated segregated areas:
1. 2. 3. none (initial ECSS requirement suppressed in the present document)
4. scraped items,
5. items designated to be stored separately for health or safety reasons.
6. Limited and suspended limited life materials shall be clearly identified with end of validity date
5.2.7.2 c. Each segregated area shall be identified and labelled for its intended use.
5.2.7.2 e. The supplier shall maintain records to ensure that all stored items are within the usable life limits, controlled and retested, and to provide traceability within the storage or segregated area.
ECSS 5.2.7.3 Preservation
5.2.7.3 a. The supplier shall ensure that items subject to deterioration, corrosion or contamination through exposure to any environmental elements are preserved by methods that ensure maximum protection consistent with life and usage.
GSE Maintenance (ECSS §5.8.9.)
5.8.9 a. The supplier shall ensure that information is given for planning maintenance activities.
5.8.9 b. The supplier shall ensure that maintenance demonstration is performed in order to prove that maintainability requirements are satisfied in the real operational environment.
GEN-001 Astrium GENERIC MGSE, EGSE or OGSE requirements shall be part of GSE specification, and the corresponding compliance matrix shall be provided.
GEN-002 When complex software is part of a new MGSE, Astrium EGSE generic specification shall be tailored to the product and included in the requirements.
GEN-003 The development of a complex GSE will follow the sequence:
- GSE Specification - Request for proposals and responses - Kick Off - Preliminary Design and its Review (PDR) - Detailed Design and its Review (CDR) - Production: procurement, manufacturing, integration - Tests after their Readiness Review (TRR) - Acceptance of the product (DRB), after tests at factory (FAT) and/or at site (SAT) - Transport – shipment - delivery - Handover to AIT (can be part of DRB)
For a simple or recurrent GSE, the sequence may be simplified to:
- Kick Off - Production with progress meetings - Acceptance checks (Factory or/and Site) and transport - Handover to AIT (can be part of Acceptance checks).
For COTS or CFE/CFI, the sequence will be :
- Order, transport - Handover to AIT
Note: Handover to AIT is necessary in every case.
GEN-004 Quality aspects shall be systematically on the agenda of the progress meetings. They will include:
- Achievements & Schedule for Quality related milestones and activities
- Details of major Non conformances / compliances
- Lower tier supplier problems GEN-005 The supplier shall implement a treatment for non-conformances and assure their traceability :
Corrective actions are determined to eliminate the causes of the non-conformances. Preventive actions are identified to avoid the occurrence of the non-conformance on similar items. The supplier’s reporting and processing of non-conformances is open and visible to customer reviews. The supplier shall provide the non-conformance status list to the customer, upon request, for the review of the correct application of classification criteria and appropriate processing.
GEN-006 The supplier shall ensure that GSE is configuration controlled : A document will show the breakdown of hardware into elements of decreasing complexity, through a structured hierarchical organisation.
All cables and loose items shall also be identified and correspond to the configuration supplied.
Configuration control shall be initialised at the CDR. GEN-007 The choice of materials depends on design, manufacturing, health requirements and environment of use.
Great care will be paid on mechanical characteristics, stress, temperature behavior, climatic environment, corrosion, fire resistance, compatibility between different materials, out-gazing, etc... especially for items exposed in thermal vacuum with space hardware
For items under particular environment or interfacing with flight hardware, a material list must be declared to ASTRIUM before manufacturing for agreement.
GEN-008 When the GSE includes software,
- a treatment for software non-conformances shall be implemented,
- software configuration control files shall be supplied,
- backup files shall be provided on a common media (CD, DVD,...),
- a virus free certificate shall be delivered.
GEN-009 The ITAR status of the GSE shall be provided. GEN-010 Management of alerts for GSE:
In case of multiple applications, the supplier shall notify its customer of failures or problems detected on one item that may have implications for the others.
GEN-011 Contamination requirements: GSE which are dedicated to operate under vacuum in the direct vicinity of optical spare hardware.shall comply with the following:
- Bake out of hardware either at part level (preferred) or at assembly level: bake out shall be done during 72h under vacuum at maximum possible temperature ( 60°C if possible)
- Material selection shall be done in accordance with ECSS-S-ST-70-71 with TML<1%, CVCM<0.05 and RML<0.1%. Materials which do not comply with these requirements shall be submitted to RFD with justification. Bake out could be proposed as a matter of justification in accordance with ECSS-Q-ST-70.
3.2.2 REVIEWS
REV-001 The KICK-OFF objectives are to verify & assess: - Compliance matrix with the applicable requirements - Quality assurance handbook of the contracting company - Management plans: development, quality, integration and validation - Project organisation, planning
• Confirm the requirements, interfaces and applicable documentation
• Review Functional analysis or description
• Verify & assess the chosen design concept, standards, safety
• Review technological choices, analysis of the components and processes
• Review risk analysis (FMECA and SAR)
• Approve the list of materials (DML) and associated surface treatment
• Check the list of the non-metallic materials used and off-gassing tests, when needed
• Review of software requirements and development
• Identify and agree any critical tooling or processes
REV-003 The CDR objectives are to
- validate lists of materials (DML, refer to GEN-007) and surface treatment
- validate list of processes (DPL) when needed
- review software documentation - check manufacturing file, procurements - follow non-conformities - review and approve plans, procedures and reliability files - Validate acceptance test procedures
REV-004 The ACCEPTANCE TESTS objectives are to
- Verify that the test equipment design, its hardware and associated software meet all the performance requirements
- Detect defects in material or workmanship. (long duration test in worst condition for Power equipment).
- Discover unexpected interference between assemblies - Verify the compatibility to interfacing equipment and in particular to spacecraft equipment. - Verify that the test equipment is within the normal calibration period. - Verify the EGSE safety (test of protection circuits) - Check markings Under specified condition operation (ex: under thermal vacuum conditions)
REV-005 Any non-conformance raised or still open after acceptance tests is classified as MAJOR
For Major NCRs, the supplier shall inform the ASTRIUM project office via telephone and supported in writing (e-mail) within 24 hours of the occurrence.
EADS Astrium analysis and acceptance is required for major NCR.
REV-006 Major repair done during fabrication or tests before acceptance shall be identified in the documentation (Individual Control Register).
REV-007 DELIVERY REVIEW BOARD (DRB) The DRB shall certify the acceptance of the GSE and authorize its shipment.
REV-008 If not otherwise specified in the SOW, the GSE deliverable documentation shall include (in addition to EIDP) :
- the CE Declaration of Conformity (DoC) - the GSE design definition - the EGSE manufacturing file (or industrial file), - the acceptance test plan, - the FMECA [as stated in GSE-E01 herunder] - the Safety assessment report - the acceptance test report - A Certificate of Compliance (CoC) with the specifications - the User's manual, Maintenance manual, - calibration and maintenance procedures - consumable references
and, if applicable:
- the HW/SW partitioning - the firmware description (if any), - the software description of the acceptance test plan, and its listing - the virus free certificate - the ITAR status
REV-009 TRANSPORT READINESS REVIEW
In the case of a critical item that need specific care during transport, a transport readiness review is to be held as mentioned in DR7 (transport specification)
REV-010 The HANDOVER TO AIT objectives are to:
• check the compliance of the GSE towards its requirements
• verify the presence of the needed documentation • ensure safety of the product entering AIT • ensure operational readiness of the GSE • Agree use of the product in AIT.
REV-011 OPERATIONAL ACCEPTANCE For some items, a period of use may be necessary for Astrium to declare the GSE fully operational. When this is the case (specified in the SOW), an operational acceptance shall close this period and declare the final acceptance of the GSE.
These requirements are extracted from C-AIT Requirements for POWER (background document [2]), §EGSE REQUIREMENTS, extended from EGSE to all GSE.
GSE-E01 An GSE FMECA shall be performed at interfaces with flight hardware
Design modifications shall be implemented when any risk of damage to flight hardware is identified.
GSE-E02 A Process FMEA shall also be performed to review the overall test process :
ƒ configuration (flight hardware + harnesses + GSE + site) errors or in-test anomalies ƒ test execution including operator errors (wrong command for example).
GSE-E03 User interfaces (GUI or front panel buttons) shall be such as to prevent unintentional modification of settings (including safety protection settings)
GSE-E04 Included in GSE-M08
GSE-E05 GSE SW, if any, shall prevent the users to trigger commands which could damage flight hardware.
3.2.4 HANDLING REQUIREMENTS
These requirements are extracted from C-AIT HANDLING specification background document [3]), §MGSE REQUIREMENTS, extended from MGSE to all GSE. GSE-M01 Each MGSE that transport, move, tilt or lift the flight hardware shall permit the verification of the correct
attachment of the hardware concerned by direct visual inspection.
All bolts and attachment parts necessary to secure the flight hardware shall be clearly visible. GSE-M02 All GSE with hazardous/unsafe configuration shall be well identified and adequate
automatism/alert/warning defined and implemented.
MGSE-M03 Process to adapt generic designed GSE to a project specific use must be clearly formalised with proper documentation mentioned when relevant.
GSE-M04 Loose items (bolts, shackles, cables, ...) shall be part of the GSE, duly specified in the GSE description and user manual, and unambiguously associated with it (colour code, marking, accountability box…..).
GSE-M05 For each GSE, the necessary criterion in order to be considered as "ready for use" shall be defined. Appropriate procedure for verification/inspection/preparation (including functional check if relevant) shall be developed.
GSE-M08 From delivery, a log book (including maintenance, modification, refurbishment, records, user manual and NCR……) shall go along each individual GSE (easily accessible) and be duly filled.
GSE-M10 A maintenance process shall be established, including an associated plan with dedicated responsibilities.
GSE-M11 MGSE involved in a lifting chain must be submitted to a formal check.
Nota: GSE-M6, 7 and 9 are not in the frame of the present document
These requirements are extracted from CAIT Electrical test configurations PRODUCT LIABILITY, PRODUCT SAFETY ASSESSMENT GUIDE and PRODUCT LIABILITY AND SAFETY HANDBOOK (background document [4] [5] and [6]).
SAPL-01 GSE are externally or internally supplied items. They are either subcontracted equipments, Commercial Off The Shelf (COTS) items or Customer Furnished Equipments (CFE). For all of them, it is required that they are in accordance with European legislation and CE marked when applicable. It must be ensured that the building blocks comply with all applicable laws and are:
• Safe • Fit for purpose • Accompanied by all the relevant paperwork, the credibility of which is not in doubt • Meet any other specific requirements, such as EMC performance or PRESSURE requirements.
Hazards lead to undesirable consequences either, through a single event, or through a chain of events A fundamental goal of engineering a product, or preparing an operation for safety, is to endeavour, as far as possible, to eliminate all these consequences as early as possible in the event chain, preferably through changes to design. This is achieved through the Hazard reduction process. Hazard Analysis is the qualitative assessment of hazards, while Safety Risk Assessment is the systematic identification, evaluation and classification of all hazards and potential accident scenarios relevant to a product. The main objective is to ensure that potential hazards do not subject personnel or property to avoidable risk of injury or damage at any stage during the life cycle. The analysis covers the product life cycle from the point where the product design concept is established, through manufacture, inspection, test, delivery installation, use, maintenance, modification, repair and final end-of-life disposal. Hazard Analysis is an iterative process throughout the lifetime of a project. It should commence at the concept phase of the project otherwise major redesigns later in the project can lead to delays and increased costs.
SAPL-02 Action taken to reduce hazards will be conducted in the following order of precedence: 1- Design for Minimum Hazard
The major goal throughout the design phase is to ensure inherent safety through the selection of appropriate design features Damage control, containment, and isolationn of potential hazards are included in design considerations together with the inclusion of inhibits where appropriate.
2- Safety Devices Where hazards cannot be eliminated through design, consideration is given to reducing or controlling them through the use of automatic safety devices as part of the system, subsystem, or equipment.
3- Warning Devices When it is not practical to preclude the existence or occurrence of known hazards or to use automatic safety devices, consideration is given to employing means for the timely detection of the condition and the generation of an adequate warning signal, coupled with emergency controls or corrective action, for operating personnel to make safe or shut down the affected subsystem. Warning signals and their application are designed to minimise the probability of wrong signals or of improper personnel reaction to the signal.
4- Special Procedures Where it is not possible to reduce the magnitude of an existing or potential hazard through design or the use of safety and warning devices, special procedures are developed to counter hazardous conditions for the enhancement of personnel safety.
5- Use of Labels
SAPL-03 Safety risk assessment shall be carried out and actions taken to remove the risk of undesirable events resulting from a hazard event chain. This shall be recorded in the Safety Assessment Report (SAR)
SAPL-04 The SAR should be initiated as soon as the proposed design has reached sufficient maturity to enable an initial hazard analysis and safety risk assessment to be performed. The SAR and associated Hazard Report sheets and/or Hazard Log shall be available for the Preliminary Design Review. The SAR shall be reviewed, and updated at various stages during the development of a system or a product. This should occur at least at intervals corresponding to the Safety Reviews and major Design Reviews, in order to support the design and development control philosophy. The final, fully completed SAR shall be issued prior to completion of the Final Design/acceptance Review meeting. The Final design/acceptance review cannot be completed until the final issue of the SAR, showing that al product liability and safety compliance requirements have been met, Hazard Report sheets ‘closed’ and all safety hazard reduction exercises have been completed and approved by Astrium.
SAPL-05 A safety check is done at the handover to AIT of the equipment (Subcontracted equipment, COTS or CFE). The necessary entry documents for this check are: - The Declaration of Conformity (DoC, may be included in the user manual). - A user manual describing all the safety-related limitations and recommendations - Statements of compliance to all other applicable directives/ Regulations typically including WEEE, RoHS, batteries and REACH If the equipment is not certified, a justification should be mentioned in the handover to AIT.
SAPL-06 The function of warning labels is to warn any person handling or approaching the equipment, before the exposure of the person to the hazard. Warning labels must meet the requirements of the most appropriate EN standard (eg EN 60417, EN 61010 etc) and should only be fitted if required by an EN standard or as a result of the safety risk assessment. They shall be fitted to the equipment in the positions that offer the best level of warning to potential users.
SAPL-07 EGSE safety requirements include - Stability - No sharp edges and corners - Rear door may be easily open/close, even with cabling - indication of Mass and Center of gravity - Wheel with brakes - Hoisting devices in conformance with CE and, when EGSE requires the use of a container: - indication of Mass and Center of gravity on the container - No danger identified when opening and taking EGSE out of the container
SAPL-08 Lifting or fasten parts shall be CE marked, which means the following marking: • CE sign • SWL • Clear identification of the product (type + serial number)
3.2.6 HANDOVER to AIT
HDV-001 The handover to AIT is the formal meeting that authorizes the use of the GSE in AIT.
HDV-002 This Handover to AIT shall take place for every GSE entering AIT. This includes GSE procured by AIT and GSE delivered to AIT such as COTS, CFE/CFI or PFI.
HDV-003 Compliance to AIT standards shall be reviewed to ensure operational readiness of GSE, such as Safety and Product liability aspects or Power and Handling operation requirements.
HDV-004 For GSE procured by AIT, Handover to AIT may be part of DRB or of Acceptance checks.
HDV-005 Handover to AIT shall address the following: • Check the compliance of the GSE towards its requirements:
• Final as-Built configuration
• Certificate of Conformity to the specification
• Test reports
• List of open NCRs • Verify that the product is safe for users, via:
• Safety assessment report
• Declaration of Conformity (DoC, for CE requirements)
• Visual inspection of the product (check of safety labels,...)
• Verify that the product is safe for materials interfacing with it, via: • Review of remaining open items (actions, deviations, waivers, NCR,...) and their impact on
product acceptability
• Visual inspection of the product (check of markings,...)
• Product FMECA when necessary
• Check compatibility with all materials that may interface with it (design verification and workmanship validation)
• Ensure operational readiness of the GSE • User manual provided
• Loose items well identified
• Readiness of operational procedures, in conformance with AIT requirements
• FMECA of operations when necessary
HDV-006 A template of Handover to AIT is given in annex for guidance.
4 PROJECT SPECIFIC REQUIREMENTS: TAILORED in GSE technical specification (if
any)
4.1 ECSS-Q-ST-20 REQUIREMENTS – PART 2
Requirements from ‘pre-tailoring matrix for ground products’, ECSS-Q-ST-20C Rev1 draft3.1 annex K (Background document [1]) are included in two chapters in this document:
- The ones applicable to all GSE, listed in chapter 3.1.
- All other ones, listed hereafter.
Most of the time, requirements from chapter 3.1 should be sufficient for GSE and the requirements of the present chapter will NOT be applicable. It will then be mentioned in GSE technical specification.
In case of specific need, these ECSS requirements will be tailored depending on GSE, and their applicability mentioned in the compliance matrix.
ECSS
Clause
ECSS Requirement Text
Applicability
QA requirements for design and verification (ECSS §5.3)
ECSS 5.3.1 Design rules ECSS 5.3.1.1 Produceability 5.3.1.1 a. The supplier shall ensure that the product is designed such that it can be produced with the specified level of
quality.
ECSS 5.3.1.2 Repeatability 5.3.1.2 a. The supplier shall ensure that the product is designed such that its performances and characteristics can be
reproduced over different models and serial production.
ECSS 5.3.1.3 Inspectability and testability 5.3.1.3 a. The supplier shall ensure that the product is designed such that it can be inspected and tested under
representative conditions, for production, AIV and operational environment.
ECSS 5.3.1.4 Operability 5.3.1.4 a. The supplier shall ensure that the product is designed such that it can be operated in accordance with
programme constraints and requirements, throughout its whole life cycle including handling, storage, transportation, integration and operations.
ECSS 5.3.2 Verification ECSS 5.3.2.1 General 5.3.2.1 a. The supplier shall ensure that requirement verification is performed progressively, as each stage of the project is
completed, and provides the organized base of data upon which qualification and acceptance is incrementally declared.
5.3.2.1 b. The supplier shall ensure that top-down requirement allocations and bottom-up requirement verifications are complete and consistent.
5.3.2.1 c. The supplier shall ensure that a system for tracking requirements and verification of results is established and maintained during the whole project life cycle.
5.3.2.1 d. The supplier shall ensure that verification methods are adequate and consistent with the type and criticality of the requirements.
5.3.2.1 e. The supplier shall ensure that appropriate reference to the verification documentation is recorded and status updated at project reviews up to final acceptance.
5.3.2.2 a. The supplier shall ensure that the objectives of the analysis are defined in relation with the development logic defined in the verification plan.
5.3.2.2 b. The following items shall be identified: 1. reference of the configuration item definition under analysis; 2. environmental constraints considered in the analysis; 3. Basic assumptions, analysis methods, mathematical models.
ECSS 5.3.2.4 Qualification process
ECSS 5.3.2.4.1 Qualification 5.3.2.4.1 a. The supplier shall ensure that all configuration items and their constituent items, either off-the-shelf or specifically
designed, are properly qualified with margins commensurate with the application and use environment.
5.3.2.4.1 b. The supplier QA shall review and approve the qualification plan.
5.3.2.4.1 c. The supplier QA shall review and approve the qualification results.
ECSS 5.3.2.4.2 Qualification by similarity 5.3.2.4.2 a. Qualification by similarity with an identical or similar product shall be justified by providing evidence that the new
application is within the limits of the previously qualified design.
5.3.2.4.2 b. Any difference in definition with respect to the reference product and any difference in the required qualification tests shall be identified.
5.3.2.4.2 c. The need for complementary qualification tests shall be analysed and the decision justified and submitted to the customer for approval.
5.3.2.4.2 d. For this purpose the supplier shall: 1. evaluate the as-designed or as-built configuration and related non conformances, 2. ensure that qualification requirements and qualification ranges are compatible with project requirements,
3. ensure that qualification test results meet the requirements and any non conformances are available for evaluation, and
4. ensure that information of the selected model is available for review. ECSS 5.3.2.4.3 Qualification testing 5.3.2.4.3 a. The product used for qualification testing shall be produced in accordance with a full and clearly identified
manufacturing and inspection file.
b. The item shall be qualified under all environmental conditions
5.3.2.4.3 c. To obtain authorization to initiate qualification tests the supplier shall demonstrate that:
1. the qualification model is fully representative of the operational model and any differences have been analysed to evaluate their effect on the qualification status;
2. inspection and test requirements are expressed in an unambiguous and quantified manner including:
(a) test sequence; (b) test conditions; (c) test standards, if any; (d) applicable test levels, durations and tolerances; (e) accuracy in measurement.
3. the qualification test procedures and facilities are defined, available and conforming to requirements of clause 5.6.
ECSS 5.3.2.4.4 Qualification status 5.3.2.4.4 a. The supplier shall report the qualification status
ECSS 5.3.2.4.5 Maintenance of qualification 5.3.2.4.5 a. Once the design is qualified, the supplier shall assess all subsequent changes, deviations and anomalies for their
impact on the qualification status and shall perform requalification as necessary.
ECSS 5.3.2.5 Design changes 5.3.2.5 a. The supplier shall ensure that all design changes and modifications are identified, documented, reviewed and
approved before their implementation.
QA requirements for procurement (ECSS §5.4)
ECSS 5.4.1 Selection of procurement sources ECSS 5.4.1.1 General 5.4.1.1 a. The supplier QA shall participate in the approval and the selection of procurement sources. ECSS 5.4.1.2 Selection criteria 5.4.1.2 a. The supplier shall select its suppliers on the basis of one of the following criteria:
1. The supplier has been certified by the final customer, and has a current approval to furnish items or services of the type and quality level being procured.
NOTE Third party certification (for instance against ISO 9001) can be also considered.
2. The supplier is furnishing, or has furnished within the past two years, items or services of the type and quality level being procured under other contracts with the final customer.
3. The supplier has demonstrated continuous capability to furnish items or services of the type and quality level being procured, supported by objective documentation. NOTE This criterion does not apply if the supplier has not furnished items or services of the type being procured for more than two years.
4. Supplier’s capability of satisfying business agreement requirements is demonstrated by a pre-award audit by the relevant customer.
5.4.1.2 b. The supplier shall document and maintain on file results of supplier selection process.
ECSS 5.4.1.3 Record and list of procurement sources 5.4.1.3 a. The supplier shall establish and maintain records of all procurement sources involved in business agreement
performance.
5.4.1.3 b. The supplier shall submit to the customer, upon request, the list of procurement sources, including all the information in the records 5.4.1.3a, for information.
ECSS 5.4.2 Procurement documents 5.4.2 a. The supplier shall ensure that supplies are identified and that all applicable requirements are defined in the
procurement documents.
5.4.2 b. The supplier shall ensure that requirements to those contained in lower tier procurement documents are traceable.
5.4.2 c. The procurement documents shall contain, by statement or reference: 1. comprehensive technical descriptions of the items and services to be procured,
2. details of the applicable requirements, such as requirements for preservation, packaging, marking, shipping, accompanying documentation and provisions for limited-life items,
3. details of QA activities to be performed, such as inspection and test characteristics, records and reports,
4. details of supplier’s QA activities at source, and 5. special acceptance conditions.
5.4.2 d. The supplier’s quality assurance organization shall review procurement documents prior to release, to verify the correct selection of procurement sources and appropriateness of their content.
ECSS 5.4.3 Surveillance of procurement sources 5.4.3 a. The supplier shall exercise surveillance over all the activities carried out by lower level suppliers during business
agreement performance.
5.4.3 b. The surveillance programme shall include audits, reviews, mandatory inspection points, as well as direct supervision by supplier’s resident personnel at his suppliers’ facilities and source inspection.
5.4.3 c. The supplier shall select among the following criteria to define the type and extent of surveillance:
1. Testing or inspections cannot be accomplished by the supplier. NOTE For example, environments or test equipment not available at supplier’s facility.
2. Verification tests are destructive in nature and the quality cannot be verified solely by inspection or test at supplier’s facility.
3. Supplies are designated for direct shipment from source to a customer site or the using site.
4. Manufacturing and AIV of complex equipment or subsystems. NOTE For example, payloads.
5. Past performance or quality history of the lower level supplier is marginal. 6. Functional criticality and technical complexity of the supplies. 7. The degree of responsibility placed on the procurement source.
5.4.3 d. The supplier shall ensure that each of his suppliers implements surveillance on their lower level suppliers, in accordance with the same criteria.
ECSS 5.4.4 Receiving inspection ECSS 5.4.4.1 General 5.4.4.1 a. The supplier shall ensure that all incoming supplies, including documentation and packaging, whether delivered
on his own premises or elsewhere, conform to the requirements of the procurement documents.
5.4.4.1 b. The supplier shall perform inspections in accordance with established procedures and instructions, to ensure that quality level is properly determined.
5.4.4.1 c. Receiving inspectors shall have available the procurement documents, specifications, drawings and any other document relevant to incoming supplies as required in the procurement documents.
1. verification of the packaging conditions and of the status of environmental sensors, 2. visual inspection of the delivered items, 3. verification of correct identification and, where appropriate, configuration identification for conformance to the ordering data,
4. verification of the evidence of inspection and tests performed by the supplier and associated documentation,
5. verification of the performance of supplier’s source inspection, when required, 6. performance of inspections and tests on selected characteristics of incoming supplies or test specimens submitted with the supplies,
7. identification of the shelf life of limited-life items, 8. identification of the inspection status and physical separation of the supplies in the receiving inspection area according to the following categories:
(a) items for which the receiving inspection has not been completed; (b) conforming items; (c) nonconforming items. 9. prevention of unauthorized use of uninspected items, 10. identification of the items to be released for production with conformance status and traceability data to be recorded in manufacturing documents,
11. maintenance of receiving inspection records in conformance with 5.4.4.4. ECSS 5.4.4.3 Customer furnished items 5.4.4.3 a. Receiving inspection of items supplied by the customer shall include the verification of identity and integrity after
transportation.
ECSS 5.4.4.4 Receiving inspection records 5.4.4.4 a. The supplier shall maintain receiving inspection records to ensure traceability and the availability of historical data
to monitor supplier performance and quality trends.
QA requirements for manufacturing, assembly and integration (ECSS §5.5)
ECSS 5.5.1 Planning of manufacturing, assembly and integration activities and associated documents
5.5.1 a. The supplier shall document the planning of manufacturing, assembly and integration operations and inspections in the manufacturing plan or flow chart for the product, including the sequence of operations and associated inspections and tests.
5.5.1 c. Instructions shall direct the actual performance of manufacturing, assembly and integration operations and inspections, to ensure that the activities proceed in an orderly manner and according to the planned sequence.
5.5.1 d. The supplier shall issue and maintain manufacturing, assembly and integration documents in accordance with established and formal procedures.
5.5.1 g. The supplier shall also provide for detail support documents and instructions, such as drawings, procedure and instruction sheets, to enable operations to be correctly performed.
ECSS 5.5.2 Manufacturing readiness reviews 5.5.2 a. The supplier shall perform an internal review of the readiness for manufacturing, prior to starting the manufacture
of the first flight-standard product.
5.5.2 b. The manufacturing readiness review shall evaluate the following aspects: 1. status of product definition and requirements, differences with the status of the qualification model, and impacts of these differences;
2. status of manufacturing, assembly, inspection and test documentation, differences with the status of the qualification model, and impacts of these differences;
3. validation status of manufacturing processes, with particular emphasis on critical processes;
4. implementation of dispositions for risk reduction, as defined by risk assessment, into the manufacturing, assembly, integration, inspection and test procedures;
5. availability of specified production, measuring and inspection equipment, and calibration status, when relevant;
6. cleanliness of facilities, with respect to the specified cleanliness levels;
7. facility temperature and humidity with respect to requirements. ECSS 5.5.4 Workmanship standards 5.5.4 a. The supplier shall employ workmanship standards throughout all phases of manufacturing, assembly and
integration, to ensure acceptable and consistent workmanship quality levels.
5.5.4 b. Workmanship standards shall identify acceptance or rejection criteria. 5.5.4 c. Physical samples or visual aids shall be reviewed and agreed by the customer when they are used for the
purpose of acceptance or rejection of items.
ECSS 5.5.5 Materials and parts control 5.5.5 a. The supplier shall ensure that only conforming items are released and used, and that those not required for the
operation involved are removed from work operation areas.
5.5.5 b. Items having limited-life or definite characteristics of quality degradation or drift with age or use shall be marked to indicate the dates, test times or cycles at which life was initiated and at which the useful life expires.
5.5.5 c. Sensitive items shall be processed or manufactured, inspected and tested in a controlled environment to prevent any degradation.
ECSS 5.5.6 Equipment control ECSS 5.5.6.1 Tooling
5.5.6.1 a. The supplier shall make provisions for accountability, identification and maintenance of manufacture, assembly and integration tooling.
5.5.6.1 b. Manufacture, assembly and integration tooling shall be checked for its dimensional accuracy, regarding the product drawings, and correct function.
5.5.6.1 e. Tools shall be checked for accuracy during the production life at adequate intervals. 5.5.6.1 f. Tools shall be submitted to re-approval following modification. 5.5.6.1 g. Tools shall be properly stored to prevent misuse, damage and deterioration. 5.5.6.1 h. Unnecessary tools shall be removed from working areas. ECSS 5.5.6.2 Equipment for computer-aided manufacturing 5.5.6.2 a. The supplier shall ensure that computer-aided techniques and data for processing and machining are validated
prior to use and controlled during their use in manufacturing.
5.5.6.2 b. The supplier shall ensure that provisions are made for the testing, approval and configuration control of the software involved and prevention of its being tampered with.
ECSS 5.5.7.5 Cleanliness of facilities 5.5.7.5 a. Fabrication, assembly and integration of contamination sensitive items shall be conducted in facilities that provide
cleanliness levels compatible with the specified product cleanliness.
ECSS 5.5.8 Inspection 5.5.8 a. Inspection and tests shall be planned at the points of the manufacturing, assembly and integration flow where
maximum assurance for correct processing and prevention of unrecoverable or costly nonconformances can be obtained.
5.5.8 b. All identified critical characteristics shall be inspected as defined in the critical-item control programme.
5.5.8 c. Self-inspection by the operators performing the associated manufacturing, assembly and integration activities shall not be considered sufficient for critical characteristics.
ECSS 5.5.9 Specific requirements for assembly and integration ECSS 5.5.9.2 Logbooks 5.5.9.2 a. A system shall be established to ensure configuration control of deliverable ground equipment.
5.6.1 a. The supplier shall ensure that test facilities, either internal or external, conform to specified requirements.
ECSS 5.6.2 Test equipment
5.6.2 a. The supplier shall ensure that computer-aided testing techniques and data are validated prior to use and controlled during their use in testing.
5.6.2 b. The supplier shall ensure that provisions are made for testing, approval and configuration control of the software
involved and prevention of its being tampered with.
5.6.3.1
ECSS 5.6.3 Test documentation ECSS 5.6.3.1 Test procedures a. The supplier shall ensure that tests are performed in accordance with documented procedures, which shall include, as a minimum:
1. scope of the test, including the identification of the requirement being verified,
2. identification of the test object,
3. applicable documents, with their revision status,
4. test flow,
5. test organization,
6. test conditions,
7. test equipment and set-up,
8. step-by-step procedure, including definition of specific steps to be witnessed by QA personnel,
9. recording of data,
10. pass or fail criteria and test data evaluation requirements, and
11. guidelines or criteria for deviation from test procedure and for retest.
5.6.3.1 b. The QA organization shall review and approve test procedures.
5.6.3.2
ECSS 5.6.3.2 Test reports a. The supplier shall ensure that all tests are comprehensively documented in test reports, and that they include, as a minimum:
1. reference to the applicable test procedure, and description of the deviations from it during the actual testing,
2. test data records and evaluation, and
3. summary of test results.
5.6.3.2 b. The QA organization shall review and approve test reports.
ECSS 5.6.4 Test performance monitoring
5.6.4 a. On the basis of an analysis of the test plan, the QA organization shall define within the test plan the most
appropriate way to monitor the performance of test activities, to ensure the adherence to the test procedures, and that any deviations are properly documented and treated.
5.6.4 c. All testing activities related to critical characteristics as identified in the critical-items control programme shall be certified.
5.6.4 d. Self-certification by the operators performing the test activities shall not be considered sufficient for critical
characteristics.
5.6.4 e. Testing activities or results to be subject to QA certification shall be identified as such in the relevant test procedure.
5.6.4 f. Testing shall be subject to the requirements for the control of hazardous operations.
5.6.4 g. Where safety of personnel or damage to items or associated test equipment is possible, QA personnel shall have the authority to stop the test.
ECSS 5.6.5 Test reviews 5.6.5 a. The supplier shall ensure that formal reviews are performed before and after major portions of qualification or
acceptance tests.
QA requirements for acceptance and delivery (ECSS §5.7)
ECSS 5.7.1 Acceptance and delivery process 5.7.1 a. The supplier shall establish a formal acceptance process for all deliverable items, at any contractual level, to
ensure that conformance of the items to be delivered is fully assessed and documented.
5.7.1 b. The supplier shall ensure that the preparation of the items for delivery and the physical delivery itself are performed in such a way that quality degradation is prevented.
ECSS 5.7.2 End item data package 5.7.2 a. The supplier shall provide an EIDP for each deliverable end item in conformance with §5.8.4.1.
5.7.2 b. The EIDP shall constitute the basis for formal acceptance reviews. 5.7.2 c. EIDPs shall be maintained and integrated into higher level EIDPs during subsystem or system integration and
testing.
ECSS 5.7.3 Delivery review board (DRB) 5.7.3 a. The supplier shall ensure that a DRB is convened prior to the delivery of equipment, separately assembled
subsystems, test equipment or handling equipment for higher level activities.
5.7.3 b. The DRB functions at system level shall be fulfilled by the final acceptance review and chaired by the customer.
5.7.3 c. The DRB shall be composed, at least, of the following members: 1. Representatives of the receiving organization: 2. Submitting supplier’s representatives:
5.7.3 d. If the final customer reserves the right to attend DRBs at any lower level as an observer, he shall be given due notice of such a DRB meeting.
5.7.3 e. The DRB shall be responsible for authorising the shipment of the items under acceptance, and certifying in writing that:
1. the items conform to the contractual requirements and to an approved design configuration;
2. the items are free from material and workmanship deficiencies; 3. all nonconformances are closed-out, or corresponding plans, compatible with the delivery, are accepted;
4. the relevant EIDP is complete and accurate. 5.7.3 f. Delivery shall only be authorized by the unanimous agreement of the DRB members. 5.7.3 g. For the delivery a certificate of conformity shall be made available and signed by the supplier.
