ISO 10794:2011
(Main)Space systems - Programme management - Material, mechanical parts and processes
Space systems - Programme management - Material, mechanical parts and processes
ISO 10794:2011 defines the programme management requirements for material, mechanical parts and processes for projects covering mission definition, design, development, production and operations of space systems, including disposal. ISO 10794:2011 covers the following: management, including organization, reviews, acceptance status and documentation control; selection criteria and rules; evaluation, validation and qualification, or verification testing; procurement and receiving inspection; utilization criteria and rules. ISO 10794:2011 applies to all space deliverable products and all programme phases.
Systèmes spatiaux — Management de programme — Matériaux, éléments mécaniques et procédés
General Information
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Frequently Asked Questions
ISO 10794:2011 is a standard published by the International Organization for Standardization (ISO). Its full title is "Space systems - Programme management - Material, mechanical parts and processes". This standard covers: ISO 10794:2011 defines the programme management requirements for material, mechanical parts and processes for projects covering mission definition, design, development, production and operations of space systems, including disposal. ISO 10794:2011 covers the following: management, including organization, reviews, acceptance status and documentation control; selection criteria and rules; evaluation, validation and qualification, or verification testing; procurement and receiving inspection; utilization criteria and rules. ISO 10794:2011 applies to all space deliverable products and all programme phases.
ISO 10794:2011 defines the programme management requirements for material, mechanical parts and processes for projects covering mission definition, design, development, production and operations of space systems, including disposal. ISO 10794:2011 covers the following: management, including organization, reviews, acceptance status and documentation control; selection criteria and rules; evaluation, validation and qualification, or verification testing; procurement and receiving inspection; utilization criteria and rules. ISO 10794:2011 applies to all space deliverable products and all programme phases.
ISO 10794:2011 is classified under the following ICS (International Classification for Standards) categories: 49.140 - Space systems and operations. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 10794:2011 has the following relationships with other standards: It is inter standard links to ISO 10794:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 10794:2011 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 10794
First edition
2011-08-01
Space systems — Programme
management — Material, mechanical
parts and processes
Systèmes spatiaux — Management de programme — Matériaux,
éléments mécaniques et procédés
Reference number
©
ISO 2011
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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Published in Switzerland
ii © ISO 2011 – All rights reserved
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Abbreviated terms .2
5 General requirements .4
5.1 Materials, mechanical parts and processes programme management.4
5.1.1 Materials, mechanical parts and processes activity diagram.4
5.1.2 Product assurance plan.4
5.1.3 Management.4
5.1.4 Customer reviews.4
5.2 Management and consolidation of the activities .7
5.2.1 Relationship .7
5.2.2 Establishing and processing of lists.7
5.2.3 Management of the lists.8
5.2.4 Supplier role and responsibilities.8
5.3 Technical constraints.9
5.4 Cleanliness and contamination control .9
5.5 Safety hazardous parts and materials.9
5.6 Optical, mechanical or electrical GSE hardware.9
6 Material control.10
6.1 Technical criteria for selection of materials .10
6.2 Selection.11
6.3 Declared materials list content .12
6.4 Criticality analysis .12
6.5 Evaluation and validation phases.13
6.5.1 General .13
6.5.2 Evaluation phase .13
6.5.3 Validation phase .13
6.5.4 Approval phase.13
6.5.5 Deviation request .14
6.6 Procurement of materials .14
6.6.1 Procurement specifications .14
6.6.2 Incoming inspection procedure.14
6.7 Use of materials.14
6.7.1 Validation status of materials .14
6.7.2 Traceability of materials .14
6.7.3 Packaging, storage, removal from storage.14
6.7.4 Limited-life materials before implementation.15
6.7.5 Limited-life materials after implementation.15
6.7.6 Materials' non-conformances and alerts.15
6.7.7 Health and safety.15
7 Mechanical parts control .15
7.1 Verification of mechanical parts .15
7.2 Use of mechanical parts .15
7.3 Declared mechanical parts list content.15
7.4 Criticality analysis .16
7.5 Evaluation and qualification phases.16
7.5.1 General.16
7.5.2 Evaluation phase .17
7.5.3 Qualification phase.17
7.5.4 Approval phase.17
7.5.5 Deviation request.17
7.6 Procurement of mechanical parts.17
7.6.1 General.17
7.6.2 Procurement specification.18
7.6.3 Source inspection.18
7.6.4 Incoming inspection procedure .18
7.7 Use of mechanical parts .18
7.7.1 Qualification status of parts .18
7.7.2 Traceability of parts.18
7.7.3 Packaging, storage, removal from storage.18
7.7.4 Limited-life parts or parts subject to wearout .18
7.7.5 Parts non-conformance and alerts .18
8 Process control.19
8.1 Specifications or procedures .19
8.2 Associated materials and mechanical parts.19
8.3 Selection .19
8.4 Declared processes list content.19
8.5 Criticality analysis .20
8.6 Evaluation and verification phase.20
8.6.1 General.20
8.6.2 Evaluation phase .20
8.6.3 Verification phase.21
8.6.4 Approval phase.21
8.6.5 Deviation request.21
8.7 Use of a process .21
8.7.1 Verification status of a process .21
8.7.2 Reverification of a process.21
8.7.3 Implementation of a process .22
8.7.4 Traceability of processes.22
8.7.5 Process non-conformances and alerts .22
8.7.6 Mandatory inspection points (MIPs).22
8.7.7 Packaging, storage, removal from storage.22
Annex A (informative) Relationship between materials, mechanical parts, processes activities and
programme phase.23
Annex B (informative) Declared materials list — Document requirements definition .25
Annex C (informative) Declared mechanical parts list — Document requirements definition.33
Annex D (informative) Declared processes list — Document requirements definition .40
Annex E (informative) Request for approval (RFA) — Document requirements definition.46
Bibliography .50
iv © ISO 2011 – All rights reserved
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
This ISO document is copyright-protected. While the reproduction by participants in the ISO standards
development process is permitted without prior permission from ISO, neither this document nor any extract
from it may be reproduced, stored or transmitted in any form for any other purpose without prior written
permission from ISO. In addition, some elements of the document may be the subject of patent rights. ISO
shall not be held responsible for identifying any or all such patent rights.
ISO 10794 was prepared by Technical Committee ISO/TC 20, Aircraft and space vehicles, Subcommittee
SC 14, Space systems and operations.
Introduction
This International Standard is intended for application by the management in space programmes and
applications.
The formation of this International Standard takes into account the existing International Standard prepared by
ISO/TC 176, notably ISO 9000, ISO 9001 and ISO 9004, and the content of ISO 14300-1 and ISO 14300-2.
The purpose of this International Standard is to define the requirements and statements applicable to
materials, mechanical parts and processes to satisfy the mission performance requirements.
This International Standard also defines the documentation requirements and the procedures relevant to
obtaining approval for the use of materials, mechanical parts and processes in the fabrication of space
systems and associated equipment.
vi © ISO 2011 – All rights reserved
INTERNATIONAL STANDARD ISO 10794:2011(E)
Space systems — Programme management — Material,
mechanical parts and processes
1 Scope
This International Standard defines the programme management requirements for material, mechanical parts
and processes for projects covering mission definition, design, development, production and operations of
space systems, including disposal.
This International Standard covers the following:
⎯ management, including organization, reviews, acceptance status and documentation control;
⎯ selection criteria and rules;
⎯ evaluation, validation and qualification, or verification testing;
⎯ procurement and receiving inspection;
⎯ utilization criteria and rules.
This International Standard applies to all space deliverable products and all programme phases.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 14300-2, Space systems — Programme management — Part 2: Product assurance
ISO 27025, Space systems — Programme management — Quality assurance requirements
ISO 23461, Space systems — Programme management — Non-conformance control system
ISO 9000, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.
3.1
critical material
material that is new to an individual company or non-validated for the particular application and environment
3.2
critical mechanical part
mechanical part that requires specific attention or control due to fracture mechanics aspects and limited-life
aspects, or with which the contractor has no previous experience of using the mechanical part in the specific
application and environment or are new or non-qualified
3.3
critical process
process that is declared critical when it is new to an individual company or non-verified for the application in
question or has caused problems during previous use that remain unresolved
3.4
material
raw, semi-finished or finished purchased item (gaseous, liquid, solid) of given characteristics from which
processing into a functional element of the product is undertaken
3.5
mechanical part
piece of hardware that is not electrical, electronic or electromechanical and that performs a simple
(elementary) function or part of a function in such a way that it can be evaluated as a whole against expected
performance requirements and cannot be disassembled without destroying this capability
NOTE Only standard parts are subject to the mechanical parts lists; non-standard parts are described through their
materials.
3.6
process
set of interrelated or interacting activities that transforms inputs into outputs
See ISO 9000.
NOTE In this International Standard, “process” means the manufacturing process of product, i.e. set of interrelated
resources and activities which transforms a material or semi-finished product into a semi-finished product or final product.
3.7
request for approval
document by which the supplier or user asks the competent body for permission to use a critical material, part
or process
3.8
special process
process where quality cannot be completely ensured by inspection of the end article only
4 Abbreviated terms
The following abbreviated terms are defined and used within this International Standard.
AA Aluminum Association
AOCS attitude and orbit control system
ATOX atomic oxygen
AISI American Iron and Steel Institute
CDA Copper Development Association
CDR critical design review
2 © ISO 2011 – All rights reserved
CFRP carbon fibre reinforced polymer
CI configuration item number (as per project definition)
DML declared materials list
DMPL declared mechanical parts list
DPL declared processes list
DRD document requirements definition
EEE electrical, electronic and electromechanical
ESA European Space Agency
GOX gaseous oxygen
GSE ground support equipment
LEO low earth orbit
LOX liquid oxygen
MIP mandatory inspection point
MMPP materials, mechanical parts and processes
NASA National Aeronautics and Space Administration
NCR non-conformance report
NRB non-conformance review board
PA product assurance
PDR preliminary design review
PID process identification document
PMP parts, materials, processes
QR qualification review
QRR qualification review report
RFA request for approval
SCC stress corrosion cracking
5 General requirements
5.1 Materials, mechanical parts and processes programme management
5.1.1 Materials, mechanical parts and processes activity diagram
The general activity within the framework of a project is summarized by the flow chart shown in Figures 1
and 2 and Table 1.
5.1.2 Product assurance plan
Suppliers shall provide a material, mechanical parts and processes plan in accordance with ISO 14300-2 and
this International Standard. This can form part of the overall project product assurance plan, or exist as a
separate document.
5.1.3 Management
The supplier shall appoint a materials, mechanical parts and processes manager who ensures that the
requirements laid out in this International Standard are satisfied. This manager shall be the customer's contact
as far as application of this International Standard is concerned within the overall PA reporting system. The
manager shall periodically inform the customer of the progress of tasks relating to its application. The
manager shall ensure conformance to technical and scheduling aspects of the various actions undertaken
(status of material validation, part qualification and process verification).
The manager shall ensure that all suppliers apply the requirements of this International Standard.
5.1.4 Customer reviews
To obtain the validation status for materials and qualification status for parts and verification status for
processes, the materials, mechanical parts and processes manager shall present to the customer those
activities that were performed in order to comply with this International Standard together with results obtained.
The materials, mechanical parts and processes manager shall organize technical review meetings with his or
her suppliers at all levels, as appropriate.
4 © ISO 2011 – All rights reserved
Functional and technical specification
Risk and contamination analysis
Project list and incident databank Results of previous uses
Criticality
Identification of needs Selection
Start
Preliminary
lists
Yes Yes
No Evaluation
Critical?
necessary
Yes
No
Conform to
requirements?
No
Evaluation and validation or
Validation or qualification
qualification or verification programm e
or verification programme
Test
Test
programme
programme
Deviation
RFA first issue RFA first issue
PDR
No
No
No Accept?
Accept?
Accept?
Yes
Yes Yes
Yes
Evaluation tests New test?
Validation or qualification
or verification programme
Test results
No
Test results
No New
Yes
Accept?
selection?
Yes Yes
RFA first issue New test?
No
No
Deviation
No
New
Yes
Accept?
selection?
No
Accept?
Yes
No
Yes
Validation or qualification
or verification programme
Deviation Yes
Test results
New test?
No
RFA final issue
No
Accept?
New Yes
selection?
Yes
No
No
Accept?
Deviation
Yes
No
Accept?
Yes
CDR
As-designed lists
To Figure 2
From Figure 2 (NBR decision)
Figure 1 — Materials, mechanical parts and processes flow chart (continued in Figure 2)
From Figure 1 To Figure 1
Procurement of materials Procurement of mechanical parts
Packing, storage
Removal from storage, conformity
check with requirements
No
Accept?
Yes
Implementation of processes
No
Accept?
Yes
Yes
No
NCR NRB
Use
Inspection
No
Accept?
Yes
Utilization
No
Accept?
Yes
As-designed lists (updated)
QR
End
Figure 2 — Materials, mechanical parts and processes flow chart (continued from Figure 1)
6 © ISO 2011 – All rights reserved
Table 1 — Steps to be taken to get approval for materials, mechanical parts and processes
Approval process for materials, mechanical parts and processes (MMPP)
Materials Mechanical parts Processes
Phase
Step Comments Step Comments Step Comments
Critical analysis 1 — 1 — 1 —
Critical processes are
evaluated by testing
Mechanical parts are
Evaluation (usually by Critical materials are “technology samples”
tested by, for example,
test methods defined tested, e.g. including all, for
2 2 vibration, thermal 2
by national agency outgassing, SCC, example, electrical
analysis, offgassing and
standards) flammability. interconnection
life test.
processes and painting,
adhesive bonding.
Verification/validation/
3 Validation 3 Qualification 3 Verification
qualification
By RFA (see Annex E) By RFA (see Annex E) By RFA (see Annex E)
Approval 4 4 4
or DML or DMPL/DPL or DPL
NOTE 1 Project approval is always by means of the request for approval (RFA) form and the project's declared materials list (DML),
declared mechanical parts list (DMPL) and declared processes list (DPL).
NOTE 2 The details for approvals of MMPP lists are contained in this International Standard.
NOTE 3 To summarize: Materials are validated.
Mechanical parts are qualified.
Processes are verified.
And in addition: Skills training schools are customer approved.
Outside test or evaluation laboratories are customer approved.
Operators and inspectors for critical processes are trained, certified and monitored.
5.2 Management and consolidation of the activities
5.2.1 Relationship
The relationship between materials and processes activities and programme phases is shown in Annex A.
5.2.2 Establishing and processing of lists
5.2.2.1 Each supplier and sub-tier supplier shall establish, collect, review and deliver the declared
materials, mechanical parts and processes lists including all the items intended for use in the flight equipment.
The lists shall reflect the current design at the time of issue. These lists shall contain the materials,
mechanical parts and processes used in the current design. The objectives are as follows:
⎯ compliance with all requirements of the programme;
⎯ verification of the results of equipment supplier activities;
⎯ control and monitoring the status of materials, mechanical parts and processes in accordance with
programme milestones. For additional information, see informative Annex A.
5.2.2.2 The following constraints should be taken into account:
⎯ requirements originating from the functional specifications;
⎯ requirements and conditions specific to the project;
⎯ maximum use of the materials and processes described in approved data sources, e.g. national agency
standards, and items already approved on similar projects;
⎯ use of project related preferred lists, if available.
5.2.2.3 An analysis of the criticality of these preliminary lists shall, after checking the conformity of the
materials, mechanical parts and processes against all the project requirements, allow them to be classified
into three categories:
⎯ critical items, subject to evaluation, validation, qualification, or verification programmes, for which a
request for approval should be drafted according to the method and the formats defined in the RFA DRD.
For additional information, see informative Annex E;
⎯ items that are not critical but which do not conform to one or more project requirements (a justified
deviation request should be drafted for this category);
⎯ non-critical items.
5.2.3 Management of the lists
The supplier shall document all the MMPP used in the project in accordance with the DRD. The MMPP lists
shall be provided in a form that is exchangeable, searchable, sortable and suitable for storage and retrieval (in
accordance with the contractual requirements).
The customer shall process the lists for suppliers as necessary to achieve the objectives of exchangeability,
searchability, sortability, storability and retrievability for that set of lists, before releasing it for use by the
higher-level customer.
These lists shall be updated during the course of the project. The preliminary lists shall include the items from
suppliers' preliminary requirements and are used to identify those that are critical (available for the PDR).
The as-designed lists shall include the items from the baseline's various design files (available for the CDR).
Any change after CDR or QR shall be reflected in the list and shall be in accordance with Figure 2.
The materials, mechanical parts and processes manager is responsible within the programme to ensure that
all the information required is given and that the approval status is consistent with technical and scheduling
objectives and that the data are exchangeable.
Where no project requirements exist for a separate DMPL, the mechanical parts can be entered into a
separate section of the DML.
The materials of, for example, bearings, heatermats, and gears that are made up of a few materials, can be
listed in the DMPL. The materials (metals and plastics) of complex parts can be listed in the DML with, for
example, outgassing, toxicity, flammability, corrosion and stress corrosion values and reference to the DMPL
item.
5.2.4 Supplier role and responsibilities
5.2.4.1 The supplier shall be responsible for the following tasks:
⎯ obtaining the correct and complete lists from lower-level suppliers;
⎯ providing provisional and, later, definitive approval for each list;
⎯ submitting the project declared lists for approval prior to initiation of the hardware phase (before critical
design review).
8 © ISO 2011 – All rights reserved
The lists established by the suppliers shall include all the information described in this International Standard.
Amendments to the lists shall be implemented only through established change procedures.
5.2.4.2 Any of the following documentation shall be made available to the final customer upon request:
⎯ RFA (reference and issue);
⎯ material, mechanical parts or processes justification files;
⎯ evaluation reports;
⎯ deviation requests.
5.3 Technical constraints
Parts and materials shall satisfy the mission's functional constraints. They shall also satisfy both ground
environment constraints (e.g. manufacture, tests, storage, maintenance, transport and integration) and flight
constraints (launch and orbit). The technical criteria from 6.1 shall be taken into account, according to the
mission.
The estimated availability of the parts and products obtained from materials and processes used shall be
compatible with the final system's life cycle (tests, storage and mission).
5.4 Cleanliness and contamination control
The supplier shall establish and maintain an effective contamination and cleanliness control programme
including, as a minimum, the following:
⎯ cleaning procedures; and
⎯ cleanliness monitoring procedures or methods.
The risks of chemical or particle pollution generated by parts, materials or processes used shall be identified
and reduced in accordance with mission requirements (cleanliness or contamination analysis).
For cleanliness- or contamination-critical applications, a specific cleanliness control plan and requirement
specification (chemical and particle) shall be established.
5.5 Safety hazardous parts and materials
Parts and materials with hazardous characteristics shall be identified, managed and processed according to
customer standards.
5.6 Optical, mechanical or electrical GSE hardware
When optical, mechanical or electrical GSE materials are used in thermal vacuum or interfacing with flight
hardware, possible degradation shall be taken into account (e.g. contamination, surface degradation,
flammability, electromechanical and chemical effects).
6 Material control
6.1 Technical criteria for selection of materials
The following requirements shall be taken into account only if the environmental conditions of the mission
require their application. The agency- or customer-specific requirements, test methods and accept or reject
criteria shall be applied.
a) Temperature: Material properties shall be compatible with the thermal environment to which they are
exposed.
b) Thermal cycling: Materials subject to thermal cycling shall be assessed for their ability to withstand
induced thermal stress and shall be tested according to approved procedures.
c) Vacuum:
⎯ Materials selection shall be made in accordance with approved data sources.
⎯ Outgassing tests shall be carried out according to approved procedures.
d) Offgassing, toxicity, bacterial and fungus growth: Spacecraft and associated equipment shall be
manufactured from materials and by processes that shall not cause an unacceptable hazard to personnel
or hardware, whether on the ground or in space.
e) Flammability: The materials flammability resistance shall be evaluated for the most hazardous
environment envisaged for their use.
f) Radiation: Materials used on the spacecraft external surfaces shall be assessed to determine their
resistance to the radiation dosage expected during the mission.
The genealogy of fluorine resin (PTFE) has weak resistance to the radiation dosage. Therefore, if the
material is used inside the spacecraft, it shall be assessed in terms of the resistance to the radiation
dosage.
g) Electrical charge and discharge: External surfaces of the spacecraft shall be sufficiently conductive,
interconnected and grounded to the spacecraft structure to avoid the build-up of differential charges.
h) Lightning strike: Provision shall be made in the design to ensure that the safety and functionality of the
vehicle are not compromised by the occurrence of a lightning strike during launch or return.
i) Corrosion: For all materials that come into contact with atmospheric gases, cleaning fluids or other
chemicals, it shall be demonstrated that the degradation of properties during their anticipated service life
is acceptable in terms of the performance and integrity requirements.
j) Stress corrosion:
⎯ Materials used for structural and load-bearing applications (subject to tensile stress) shall be chosen
in conformance with approved data sources.
⎯ Any material not covered by an approved standard shall be tested according to approved procedures.
k) Fluid compatibility:
⎯ Materials within the system exposed to liquid oxygen (LOX), gaseous oxygen (GOX) or other reactive
fluids, both directly and as a result of single-point failures, shall be compatible with that fluid in their
application.
10 © ISO 2011 – All rights reserved
⎯ The possibility of hydrogen embrittlement occurring during component manufacture or use shall be
assessed. An appropriate material evaluation shall be undertaken, including the assessment of
adequate protection and control.
l) Galvanic compatibility: When bimetallic contacts are used, the choice of the pair of metallic materials
used shall be taken into account. This also includes metal-to-conductive fibre-reinforced materials
contacts.
m) Atomic oxygen:
⎯ All materials considered for use on the external surfaces of spacecraft intended for use in low earth
orbit (LEO) altitudes (between 200 km and 700 km) shall be evaluated for their resistance to atomic
oxygen (ATOX).
⎯ Test procedures shall be subject to the approval of the customer.
n) Micrometeoroids and debris: The effect of impacts by micrometeoroids and debris on materials shall be
reviewed and assessed on a case-by-case basis and their use shall comply with safety evaluation and
assessment results concerning design and application criteria or details.
o) Moisture absorption and desorption: Precautions shall be taken to avoid moisture absorption during
manufacture and storage of CFRP-type materials.
p) Mechanical contact surface effects (cold welding, fretting, wear): For all solid surfaces in moving contact
with other solid surfaces, it shall be demonstrated that the degradation of surface properties over the
complete mission is acceptable from a performance point of view.
q) Life: materials shall be selected to ensure sufficient life with respect to the intended application.
r) Magnetic material: The use of the magnetic material should be kept to a minimum in consideration of
system requirements.
6.2 Selection
6.2.1 Materials shall be chosen giving preference to the following:
⎯ those successfully used for an identical application in other space programmes that are similar with
respect to environment constraints and lifetime to the proposed application;
⎯ those for which satisfactory evaluation results have been obtained on samples representative of the
application with a sufficient margin as regards conditions of use;
⎯ those included in approved data sources, for example ESA and NASA data banks.
6.2.2 Whether the materials are already validated or remain to be validated, their selection shall take into
account the following criteria:
⎯ continuity of supply;
⎯ reproducibility of characteristics;
⎯ approved supplier/distributor.
6.3 Declared materials list content
The declared materials list (DML) shall be broken down into clear categories to facilitate locating each item in
the documentation (an example of such a breakdown is given in the DML DRD). For additional information,
see informative Annex B. The DML shall include the following information:
⎯ issue status of DML;
⎯ unique item number (as the reference of the material in the DML) that shall be the same throughout the
duration of the project;
⎯ material designation (commercial identification);
⎯ material keys, e.g. AISI; AA; CDA, UNS, ASTM;
⎯ chemical nature and type of product;
⎯ manufacturer's name and procurement specifications or standards;
⎯ summary of processing parameters (e.g. finish, temper condition, mix ratio and curing);
⎯ use and location;
⎯ applicable process identifier from the DPL;
⎯ environmental code;
⎯ size code, test data (e.g. outgassing, stress corrosion cracking, corrosion and test data references);
⎯ approval status (with reference to the approval authority, to test report and similar previous applications).
Any coding or acronyms used within the list shall be defined within the document. An example of a suitable
completed DML format is given in Table B.4 in the DML DRD. For additional information, see informative
Annex B.
6.4 Criticality analysis
The objective of the analysis is to identify whether further data are required to conform to mission
requirements.
a) The supplier shall analyse all the materials contained in his or her preliminary lists with respect to
criticality and in correlation with the risk analysis performed.
b) Any material not meeting the project requirements shall be the subject of an RFA that is submitted to the
next customer.
c) The RFA shall include the reason and details of the subsequent evaluation and validation that it is
necessary to perform. For additional information, see informative Annex E and 5.2.2.
d) Any material when specifically required; marking inks can be excluded.
12 © ISO 2011 – All rights reserved
6.5 Evaluation and validation phases
6.5.1 General
Depending on the results of the criticality analysis, the supplier shall perform either evaluation and
qualification phases, or a qualification phase only for all critical parts. The choice between these two
approaches takes into account
⎯ knowledge of the part (e.g. new part, new use or change of configuration); and
⎯ extension of the application.
Procurement and validation results, together with associated documents, shall be available for review at the
contractor's premises before the start of evaluation or qualification phases.
6.5.2 Evaluation phase
The evaluation shall consider the following as a minimum for each material with unknown characteristics:
⎯ the limits of use;
⎯ the material's physical, chemical or functional characteristics along with their values and tolerances;
⎯ behavioural tendencies and degradation processes depending on environmental parameters (including
sensitivity to pollution);
⎯ acceptance criteria.
When evaluation is performed, an evaluation programme (available at PDR, in accordance with Figures 1 and
2) shall be drawn up, implemented and an evaluation report (available before CDR, in accordance with
Figures 1 and 2 and Table 1) shall be drawn up.
6.5.3 Validation phase
For all materials with unknown characteristics, a validation programme (available at PDR) shall be drawn up
by the supplier and then implemented to check or confirm that the materials satisfy the mission requirements
with appropriate margins as necessary to obtain validation status.
Validation status shall depend on the results obtained (validation report) and the review of corresponding
documentation (available at CDR).
6.5.4 Approval phase
Provided that the requirements in 6.5.2 and 6.5.3 are satisfied, the material then receives an approval
identification in the declared materials list for the project.
If approval is not granted, the supplier in charge of the item shall either
⎯ select another material;
⎯ propose a modified evaluation programme and resubmit for approval; or
⎯ initiate a deviation procedure if the above actions fail to achieve positive results.
6.5.5 Deviation request
All materials not conforming to project requirements, whether at the end of criticality analysis or of evaluation
and validation tests, shall form the subject of a duly justified deviation request in accordance with ISO 27025.
6.6 Procurement of materials
6.6.1 Procurement specifications
All materials shall be procured to an internationally or nationally recognized specification or an in-house fully
configured procurement specification that defines the material's properties, the materi
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