SIST EN 16602-20:2020
(Main)Space product assurance - Quality assurance
Space product assurance - Quality assurance
This Standard defines the quality assurance (QA) requirements for the establishment and implementation of a Quality Assurance
programme for products of space projects. Discipline related qualification activities are complemented in standards specific to those
disciplines (e.g. ECSS-E-ST-32-01 for fracture control).
For software quality assurance, the software product assurance standard, ECSS-Q-ST-80 is applicable.
This Standard is applicable to all space projects.
This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.
For the tailoring of this standard the following information is provided:
- A table providing the pre-tailoring per "Product types" in clause 6
- A table providing the pre-tailoring per "Project phase" in Annex J
Raumfahrtproduktsicherung - Qualitätssicherung
Assurance produit des projets spatiaux - Assurance qualité
La présente norme définit les exigences d'assurance qualité (AQ) applicables à l'établissement et à la mise en oeuvre d'un programme d'assurance qualité pour les produits des projets spatiaux.
Les activités de qualification liées à chaque discipline sont traitées dans des normes spécifiques à chacune (par exemple, l'ECSS-E-ST-32-01 pour le contrôle de rupture).
Pour l'assurance qualité logicielle, la norme ECSS-Q-ST-80, assurance produit logiciel, s'applique.
La présente norme s'applique à tous les projets spatiaux.
La présente norme peut être adaptée aux caractéristiques et contraintes spécifiques d'un projet spatial conformément à l'ECSS-S-ST-00.
Les informations suivantes sont fournies pour adapter la présente norme :
- un tableau fournissant la préadaptation par « Types de produits » dans l'Article 6 ;
- un tableau fournissant la préadaptation par « Phase de projet » dans l'Annexe J.
Zagotavljanje kakovosti proizvodov v vesoljski tehniki - Zagotavljanje kakovosti
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 16602-20:2020
01-junij-2020
Nadomešča:
SIST EN 16602-20:2014
Zagotavljanje kakovosti proizvodov v vesoljski tehniki - Zagotavljanje kakovosti
Space product assurance - Quality assurance
Raumfahrtproduktsicherung - Qualitätssicherung
Assurance produit des projets spatiaux - Assurance qualité
Ta slovenski standard je istoveten z: EN 16602-20:2020
ICS:
03.120.99 Drugi standardi v zvezi s Other standards related to
kakovostjo quality
49.140 Vesoljski sistemi in operacije Space systems and
operations
SIST EN 16602-20:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 16602-20:2020
---------------------- Page: 2 ----------------------
SIST EN 16602-20:2020
EUROPEAN STANDARD
EN 16602-20
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2020
ICS 49.140
English version
Space product assurance - Quality assurance
Assurance produit des projets spatiaux - Assurance Raumfahrtproduktsicherung - Qualitätssicherung
qualité
This European Standard was approved by CEN on 15 July 2019.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2020 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN 16602-20:2020 E
reserved worldwide for CEN national Members and for
CENELEC Members.
---------------------- Page: 3 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
Table of contents
European Foreword . 5
1 Scope . 7
2 Normative references . 8
3 Terms, definitions and abbreviated terms . 9
3.1 Terms from other standards . 9
3.2 Terms specific to the present standard . 9
3.3 Abbreviated terms and symbols . 11
3.4 Nomenclature . 12
4 Quality assurance principles . 13
4.1 QA management principles . 13
4.2 General principles . 13
4.3 Design and verification principles . 13
4.4 Procurement principles . 14
4.5 Manufacturing, assembly and integration principles . 14
4.6 Testing principles . 14
4.7 Acceptance and delivery principles . 14
4.8 GSE principles . 14
5 Quality assurance requirements . 15
5.1 QA management requirements . 15
5.1.1 Quality assurance plan . 15
5.1.2 Personnel training and certification . 15
5.2 QA general requirements . 15
5.2.1 Critical-items control . 15
5.2.2 Nonconformance control system . 15
5.2.3 Management of alerts . 16
5.2.4 Acceptance authority media . 16
5.2.5 Traceability . 16
5.2.6 Metrology and calibration . 17
5.2.7 Handling, storage, transportation and preservation . 18
2
---------------------- Page: 4 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
5.2.8 Statistical quality control and analysis . 19
5.3 QA requirements for design and verification . 20
5.3.1 Design rules . 20
5.3.2 Verification . 20
5.4 QA requirements for procurement . 23
5.4.1 Selection of procurement sources . 23
5.4.2 Procurement documents . 24
5.4.3 Surveillance of procurement sources . 24
5.4.4 Receiving inspection . 25
5.5 QA requirements for manufacturing, assembly and integration . 27
5.5.1 Planning of manufacturing, assembly and integration activities and
associated documents . 27
5.5.2 Manufacturing readiness reviews . 28
5.5.3 Control of processes . 28
5.5.4 Workmanship standards. 29
5.5.5 Materials and parts control . 29
5.5.6 Equipment control . 30
5.5.7 Cleanliness and contamination control . 30
5.5.8 Inspection . 31
5.5.9 Specific requirements for assembly and integration . 33
5.5.10 Manufacturing, assembly and integration records . 33
5.5.11 Electrostatic discharge control (ESD) . 33
5.6 QA requirements for testing . 34
5.6.1 Test facilities . 34
5.6.2 Test equipment . 34
5.6.3 Test documentation . 34
5.6.4 Test performance monitoring . 35
5.6.5 Test reviews . 35
5.7 QA requirements for acceptance and delivery . 35
5.7.1 Acceptance and delivery process . 35
5.7.2 End item data package . 36
5.7.3 Delivery review board (DRB) . 36
5.7.4 Preparation for delivery . 37
5.7.5 Delivery . 37
5.8 QA requirements for ground support equipment (GSE) . 37
5.8.1 Design, development and verification . 37
5.8.2 Configuration control . 38
5.8.3 Production . 38
3
---------------------- Page: 5 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
5.8.4 Acceptance and delivery . 39
5.8.5 <> . 39
5.8.6 <> . 40
5.8.7 <> . 40
5.8.8 General requirements . 40
5.8.9 Maintenance . 40
6 Pre-tailoring matrix per space product types . 41
Annex A (normative) QA plan - DRD . 53
Annex B (normative) End item data package (EIDP) - DRD . 55
Annex C (normative) Logbook - DRD . 57
Annex D (normative) Certificate of conformity (CoC) - DRD . 59
Annex E (informative) Example of a logbook cover page . 61
Annex F (informative) Example of EIDP cover page . 62
Annex G (informative) Example of EIDP contents . 63
Annex H (informative) Example of Certificate of conformity . 64
Annex I (informative) Deliverable QA documents per review . 65
Annex J (informative) <> . 67
Bibliography . 70
Tables
Table I-1 : QA document requirement list with respect to milestones . 65
4
---------------------- Page: 6 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
European Foreword
This document (EN 16602-20:2020) has been prepared by Technical Committee
CEN-CENELEC/TC 5 “Space”, the secretariat of which is held by DIN.
This standard (EN 16602-20:2020) originates from ECSS-Q-ST-20C Rev.2.
This European Standard shall be given the status of a national standard, either
by publication of an identical text or by endorsement, at the latest by September
2020, and conflicting national standards shall be withdrawn at the latest by
September 2020.
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. CEN [and/or CENELEC] shall not be held
responsible for identifying any or all such patent rights.
This document will supersedes EN 16602-20:2014.
The main changes with respect to EN 16602-20:2014 are listed below:
• Clause 3: Title of clause corrected. Term "acceptance authority media"
added. References to ECSS-S-ST-00-01 made for terms "ground segment
sub-system", "ground support equipment" and "repeatability"
• Term "stamp control" replaced by "acceptance authority media control
• Titles of clauses 5.2.7 and 5.2.7.1, 5.8.3.2, A2.1<3>, Annex I modified
• Pre-Tailoring matrix updated using the TA agreed symbols as stated in
Table 6 1 "Definitions of the columns of Table 6 2"
• Informative Annex I "Deliverable QA documents per review" updated
• Informative Annex J "ECSS-Q-ST-20 applicability according to programme
phases " deleted
• Update of issue of EN 9100 standard in Bibliography
This document has been prepared under a standardization request given to
CEN by the European Commission and the European Free Trade Association.
This document has been developed to cover specifically space systems and has
therefore precedence over any EN covering the same scope but with a wider
domain of applicability (e.g. : aerospace).
5
---------------------- Page: 7 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
According to the CEN-CENELEC Internal Regulations, the national standards
organizations of the following countries are bound to implement this European
Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
6
---------------------- Page: 8 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
1
Scope
This Standard defines the quality assurance (QA) requirements for the
establishment and implementation of a Quality Assurance programme for
products of space projects.
Discipline related qualification activities are complemented in standards
specific to those disciplines (e.g. ECSS-E-ST-32-01 for fracture control).
For software quality assurance, the software product assurance standard, ECSS-
Q-ST-80 is applicable.
This Standard is applicable to all space projects.
This standard may be tailored for the specific characteristic and constraints of a
space project in conformance with ECSS-S-ST-00.
For the tailoring of this standard the following information is provided:
A table providing the pre-tailoring per “Product types” in clause 6
A table providing the pre-tailoring per “Project phase” in Annex J
7
---------------------- Page: 9 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
2
Normative references
The following normative documents contain provisions which, through
reference in this text, constitute provisions of this ECSS Standard. For dated
references, subsequent amendments to, or revision of any of these publications
do not apply. However, parties to agreements based on this ECSS Standard are
encouraged to investigate the possibility of applying the more recent editions of
the normative documents indicated below. For undated references, the latest
edition of the publication referred to applies.
EN reference Reference in text Title
EN 16601-00-01 ECSS-S-ST-00-01 ECSS system - Glossary of terms
EN 16602-10 ECSS-Q-ST-10 Space product assurance - Product assurance
management
EN 16602-10-04 ECSS-Q-ST-10-04 Space product assurance - Critical-item control
EN 16602-10-09 ECSS-Q-ST-10-09 Space product assurance - Nonconformance control
system
EN 61340-5-1 (2007) Electrostatics - Part 5-1: Protection of electronic
devices from electrostatic phenomena - General
requirements
ANSI-ESD S20.20- Development of an Electrostatic Discharge Control
2007 Program for Protection of Electrical and Electronic
Parts, Assemblies and Equipment
8
---------------------- Page: 10 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
3
Terms, definitions and abbreviated terms
3.1 Terms from other standards
a. For the purpose of this Standard, the terms and definitions from ECSS-
ST-00-01 apply, in particular for the following terms:
1. nonconformance
2. process
3. product assurance
4. quality assurance
5. space system
6. space segment element
7. space segment sub-system
8. launch segment element
9. launch segment sub-system
10. ground segment element
11. ground segment sub-system
12. ground segment sub-system
13. ground support equipment
14. space segment equipment
15. launch segment equipment
16. ground segment equipment
17. repeatability
3.2 Terms specific to the present standard
3.2.1 acceptance authority media
devices or media to confirm and document acceptance
NOTE 1 Examples of acceptance authority media are
stamps, electronic signatures, passwords
NOTE 2 Wording adopted from EN 9100.
9
---------------------- Page: 11 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
3.2.2 inspectability
ability of an item of being inspected
NOTE Inspectability includes provisions for the
followings aspects:
Definition of inspection including
acceptance or rejection criteria, expressed in
an unambiguous and quantified manner.
Part and component accessibility for
inspection
Definition of tolerance methods for
dimensional inspection performance (e.g.
functional tolerances).
3.2.3 producibility
ability of an item of being producible
NOTE Producibility includes provisions for the
following aspects:
Design simplification and standardization,
reduction in part types and part number.
Guidelines for selection of preferred parts,
materials and processes.
Unambiguous definitions of the
requirements and limits to be used.
Definition of tolerance build-up methods, in
order to simplify manufacturing, assembly,
inspection.
Standardization of interfaces.
Part accessibility for assembly and
inspection.
Definition of design criteria consistent with
the capability of manufacturing processes.
Definition of design methods to ensure that
the cleanliness requirements are compatible
with the capability of related cleanliness
procedures and facilities.
3.2.4 testability
ability of an item of being tested
NOTE Testability includes provisions for the
followings aspects:
Definition of test requirements, including
acceptance or rejection criteria, expressed in
an unambiguous and quantified manner.
Part and component accessibility for test.
10
---------------------- Page: 12 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
Definition of recommended design
techniques to facilitate fault detection,
identification and location (e.g. test points,
modularity, built-in test software, and
feedback loops).
3.3 Abbreviated terms and symbols
For the purpose of this Standard, the abbreviated terms and symbols from
ECSS-S-ST-00-01 and the following apply:
Abbreviation Meaning
AIV
assembly, integration, verification
BB breadboard
CI configuration item
CoC certificate of confirmity
DRB
delivery review board
NOTE: DRB is synonymous to “Acceptance Review
Board” (ARB) in ECSS-M-ST-10
DRD document requirements definition
EEE
electrical, electronic, electromechanical
EGSE electrical ground support equipment
EIDP end item data package
FGSE fluidic ground support equipment
FM
flight model
GSE ground support equipment
MGSE mechanical ground support equipment
MIP mandatory inspection point
NCR nonconformance report
NRB nonconformance review board
OGSE optical ground support equipment
PA product assurance
PM project manager
QA quality assurance
QM
qualification model
RFD request for deviation
RFW request for waiver
TRB test review board
TRR test readiness review
VCB verification control board
VCD verification control document
11
---------------------- Page: 13 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
3.4 Nomenclature
The following nomenclature apply throughout this document:
a. The word “shall” is used in this standard to express requirements. All the
requirements are expressed with the word “shall”.
b. The word “should” is used in this standard to express recommendations.
All the recommendations are expressed with the word “should”.
NOTE It is expected that, during tailoring, all the
recommendations in this document are either
converted into requirements or tailored out.
c. The words “may” and “need not” are used in this standard to express
positive and negative permissions respectively. All the positive
permissions are expressed with the word “may”. All the negative
permissions are expressed with the words “need not”.
d. The word “can” is used in this standard to express capabilities or
possibilities, and therefore, if not accompanied by one of the previous
words, it implies descriptive text.
NOTE In ECSS “may” and “can” have a complete
different meaning: “may” is normative
(permission) and “can” is descriptive.
e. The present and past tense are used in this standard to express statement
of fact, and therefore they imply descriptive text.
12
---------------------- Page: 14 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
4
Quality assurance principles
4.1 QA management principles
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 project needs.
4.2 General principles
The implementation of the following phase-independent activities is ensured by
the QA function throughout the lead-time of projects:
critical-items control
nonconformance control
alert management
acceptance authority media control
traceability
metrology and calibration
handling, storage and preservation
statistical quality control (if required by the business agreement).
4.3 Design and verification principles
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
c. the design is producible and repeatable and that the resulting product
can be verified and operated within the required operating limits;
13
---------------------- Page: 15 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
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.
4.4 Procurement principles
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.
4.5 Manufacturing, assembly and integration principles
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.
4.6 Testing principles
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.
4.7 Acceptance and delivery principles
The objective is to ensure that an acceptance and delivery process is
implemented which allows demonstrating and documenting the conformance
of the delivered item.
4.8 GSE principles
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.
14
---------------------- Page: 16 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
5
Quality assurance requirements
5.1 QA management requirements
5.1.1 Quality assurance plan
a. The supplier shall prepare, maintain and implement a QA plan in
conformance with the DRD in Annex A.
b. The QA plan shall be submitted to the customer for approval.
NOTE Information on the schedule for delivery of the
QA plan is given in Annex I.
5.1.2 Personnel training and certification
a. The supplier shall establish a documented training programme for the
personnel whose performance determines or affects product quality.
b. Personnel performing or evaluating special processes shall be trained and
certified according to standards accepted by the customer.
NOTE The term “special process” is defined in ECSS-
S-ST-00-01.
c. Personnel performing non-destructive testing and evaluation shall be
trained and certified according to standards accepted by the customer.
d. The supplier shall maintain records of the training.
5.2 QA general requirements
5.2.1 Critical-items control
a. The supplier shall implement Critical-items control in conformance with
ECSS-Q-ST-10-04.
5.2.2 Nonconformance control system
a. The supplier shall implement a nonconformance control system in
conformance with ECSS-Q-ST-10-09.
15
---------------------- Page: 17 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
5.2.3 Management of alerts
a. The supplier shall manage alerts in conformance with ECSS-Q-ST-10,
clause 5.2.9.
5.2.4 Acceptance authority media
a. The supplier shall establish and maintain a documented acceptance
authority media control system to ensure the correct and legitimate use
of all fabrication and inspection authority media.
b. Acceptance authority media shall be used to:
1. signify the completion of operations and processes, and
2. indicate inspection performance at source and incoming
inspection, in process inspection and tests, final inspection, end
point testing, storage and shipment.
c. The use of acceptance authority media shall be restricted to authorized
personnel as identified in the acceptance authority media control system.
d. Acceptance authority media shall be traceable to individuals responsible
for their use.
e. Acceptance authority media shall be applied directly to parts and
materials, when specified by engineering drawings and specifications,
and associated documents, records, labels.
f. Acceptance authority media materials and methods shall be compatible
with the articles and their use.
g. <>
5.2.5 Traceability
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.
b. The supplier shall be capable to trace data, personnel and equipment
related to procurement, manufacturing, inspection, test, assembly,
integration and operations activities.
c. The supplier shall be capable to trace backward the locations of materials,
parts, sub-assemblies.
d. The supplier shall be capable to trace forward the locations of materials
from raw stock.
e. The supplier shall establish controls to ensure that:
1. identification numbers are assigned in a systematic manner,
2. identification numbers of scrapped or destroyed items are not used
again,
3. identification numbers, once allocated, are not changed, unless the
change is authorized by the customer.
NOTE Requirements for identification are addressed
in ECSS-M-ST-40.
16
---------------------- Page: 18 ----------------------
SIST EN 16602-20:2020
EN 16602-20:2020 (E)
5.2.6 Metrology and calibration
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
...
SLOVENSKI STANDARD
oSIST prEN 16602-20:2018
01-september-2018
Zagotavljanje varnih proizvodov v vesoljski tehniki - Zagotavljanje kakovosti
Space product assurance - Quality assurance
Raumfahrtproduktsicherung - Qualitätssicherung
Assurance produit des projets spatiaux - Assurance qualité
Ta slovenski standard je istoveten z: prEN 16602-20
ICS:
03.120.99 Drugi standardi v zvezi s Other standards related to
kakovostjo quality
49.140 Vesoljski sistemi in operacije Space systems and
operations
oSIST prEN 16602-20:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN 16602-20:2018
---------------------- Page: 2 ----------------------
oSIST prEN 16602-20:2018
EUROPEAN STANDARD
DRAFT
prEN 16602-20
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2018
ICS 49.140
Will supersede EN 16602-20:2014
English version
Space product assurance - Quality assurance
Assurance produit des projets spatiaux - Assurance Raumfahrtproduktsicherung - Qualitätssicherung
qualité
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/CLC/JTC 5.
If this draft becomes a European Standard, CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal
Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any
alteration.
This draft European Standard was established by CEN and CENELEC in three official versions (English, French, German). A
version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own
language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.Recipients of this draft are invited to submit, with their comments, notification
of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2018 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. prEN 16602-20:2018 E
reserved worldwide for CEN national Members and for
CENELEC Members.
---------------------- Page: 3 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
Table of contents
European Foreword . 5
1 Scope . 6
2 Normative references . 7
3 Terms, definitions and abbreviated terms . 8
3.1 Terms from other standards . 8
3.2 Terms specific to the present standard . 8
3.3 Abbreviated terms and symbols . 10
3.4 Nomenclature . 11
4 Quality assurance principles . 12
4.1 QA management principles . 12
4.2 General principles . 12
4.3 Design and verification principles . 12
4.4 Procurement principles . 13
4.5 Manufacturing, assembly and integration principles . 13
4.6 Testing principles . 13
4.7 Acceptance and delivery principles . 13
4.8 GSE principles . 13
5 Quality assurance requirements . 14
5.1 QA management requirements . 14
5.1.1 Quality assurance plan . 14
5.1.2 Personnel training and certification . 14
5.2 QA general requirements . 14
5.2.1 Critical-items control . 14
5.2.2 Nonconformance control system . 14
5.2.3 Management of alerts . 15
5.2.4 Acceptance authority media . 15
5.2.5 Traceability . 15
5.2.6 Metrology and calibration . 16
5.2.7 Handling, storage, transportation and preservation . 17
2
---------------------- Page: 4 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
5.2.8 Statistical quality control and analysis . 18
5.3 QA requirements for design and verification . 19
5.3.1 Design rules . 19
5.3.2 Verification . 19
5.4 QA requirements for procurement . 22
5.4.1 Selection of procurement sources . 22
5.4.2 Procurement documents . 23
5.4.3 Surveillance of procurement sources . 23
5.4.4 Receiving inspection . 24
5.5 QA requirements for manufacturing, assembly and integration . 26
5.5.1 Planning of manufacturing, assembly and integration activities and
associated documents . 26
5.5.2 Manufacturing readiness reviews . 27
5.5.3 Control of processes . 27
5.5.4 Workmanship standards. 28
5.5.5 Materials and parts control . 28
5.5.6 Equipment control . 29
5.5.7 Cleanliness and contamination control . 29
5.5.8 Inspection . 30
5.5.9 Specific requirements for assembly and integration . 32
5.5.10 Manufacturing, assembly and integration records . 32
5.5.11 Electrostatic discharge control (ESD) . 32
5.6 QA requirements for testing . 33
5.6.1 Test facilities . 33
5.6.2 Test equipment . 33
5.6.3 Test documentation . 33
5.6.4 Test performance monitoring . 34
5.6.5 Test reviews . 34
5.7 QA requirements for acceptance and delivery . 34
5.7.1 Acceptance and delivery process . 34
5.7.2 End item data package . 35
5.7.3 Delivery review board (DRB) . 35
5.7.4 Preparation for delivery . 36
5.7.5 Delivery . 36
5.8 QA requirements for ground support equipment (GSE) . 36
5.8.1 Design, development and verification . 36
5.8.2 Configuration control . 37
5.8.3 Production . 37
3
---------------------- Page: 5 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
5.8.4 Acceptance and delivery . 38
5.8.5 <> . 38
5.8.6 <> . 39
5.8.7 <> . 39
5.8.8 General requirements . 39
5.8.9 Maintenance . 39
6 Pre-tailoring matrix per space product types . 40
Annex A (normative) QA plan - DRD . 52
Annex B (normative) End item data package (EIDP) - DRD . 54
Annex C (normative) Logbook - DRD . 56
Annex D (normative) Certificate of conformity (CoC) - DRD . 58
Annex E (informative) Example of a logbook cover page . 60
Annex F (informative) Example of EIDP cover page . 61
Annex G (informative) Example of EIDP contents . 62
Annex H (informative) Example of Certificate of conformity . 63
Annex I (informative) Deliverable QA documents per review . 64
Annex J (informative) <> . 66
Bibliography . 69
Tables
Table I-1 : QA document requirement list with respect to milestones . 64
4
---------------------- Page: 6 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
European Foreword
This document (EN16602-20:2018) has been prepared by Technical Committee
CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN (Germany).
This document (EN16602-20:2018) originates from ECSS-Q-ST-20C Rev.2.
This document is currently submitted to the CEN ENQUIRY.
This document will supersede EN 16602-20:2014.
The main changes with respect to EN 16602-20:2014 are listed below:
• Clause 3: Title of clause corrected. Term "acceptance authority media" added.
References to ECSS-S-ST-00-01 made for terms "ground segment sub-system",
"ground support equipment" and "repeatability"
• Term "stamp control" replaced by "acceptance authority media control
• Titles of clauses 5.2.7 and 5.2.7.1, 5.8.3.2, A2.1<3>, Annex I modified
• Pre-Tailoring matrix updated using the TA agreed symbols as stated in Table
6 1 "Definitions of the columns of Table 6 2"
• Informative Annex I "Deliverable QA documents per review" updated
• Informative Annex J "ECSS-Q-ST-20 applicability according to programme
phases " deleted
• Update of issue of EN 9100 standard in Bibliography
This document has been developed to cover specifically space systems and will
the-refore have precedence over any EN covering the same scope but with a
wider do-main of applicability (e.g.: aerospace).
5
---------------------- Page: 7 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
1
Scope
This Standard defines the quality assurance (QA) requirements for the
establishment and implementation of a Quality Assurance programme for
products of space projects.
Discipline related qualification activities are complemented in standards
specific to those disciplines (e.g. ECSS-E-ST-32-01 for fracture control).
For software quality assurance, the software product assurance standard, ECSS-
Q-ST-80 is applicable.
This Standard is applicable to all space projects.
This standard may be tailored for the specific characteristic and constraints of a
space project in conformance with ECSS-S-ST-00.
For the tailoring of this standard the following information is provided:
• A table providing the pre-tailoring per “Product types” in clause 6
• A table providing the pre-tailoring per “Project phase” in Annex J
6
---------------------- Page: 8 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
2
Normative references
The following normative documents contain provisions which, through
reference in this text, constitute provisions of this ECSS Standard. For dated
references, subsequent amendments to, or revision of any of these publications
do not apply. However, parties to agreements based on this ECSS Standard are
encouraged to investigate the possibility of applying the more recent editions of
the normative documents indicated below. For undated references, the latest
edition of the publication referred to applies.
EN reference Reference in text Title
EN 16601-00-01 ECSS-S-ST-00-01 ECSS system - Glossary of terms
EN 16602-10 ECSS-Q-ST-10 Space product assurance - Product assurance
management
EN 16602-10-04 ECSS-Q-ST-10-04 Space product assurance - Critical-item control
EN 16602-10-09 ECSS-Q-ST-10-09 Space product assurance - Nonconformance control
system
EN 61340-5-1 (2007) Electrostatics - Part 5-1: Protection of electronic
devices from electrostatic phenomena - General
requirements
ANSI-ESD S20.20- Development of an Electrostatic Discharge Control
2007 Program for Protection of Electrical and Electronic
Parts, Assemblies and Equipment
7
---------------------- Page: 9 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
3
Terms, definitions and abbreviated terms
3.1 Terms from other standards
a. For the purpose of this Standard, the terms and definitions from ECSS-
ST-00-01 apply, in particular for the following terms:
1. nonconformance
2. process
3. product assurance
4. quality assurance
5. space system
6. space segment element
7. space segment sub-system
8. launch segment element
9. launch segment sub-system
10. ground segment element
11. ground segment sub-system
12. ground segment sub-system
13. ground support equipment
14. space segment equipment
15. launch segment equipment
16. ground segment equipment
17. repeatability
3.2 Terms specific to the present standard
3.2.1 acceptance authority media
devices or media to confirm and document acceptance
NOTE 1 Examples of acceptance authority media are
stamps, electronic signatures, passwords
NOTE 2 Wording adopted from EN 9100.
8
---------------------- Page: 10 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
3.2.2 inspectability
ability of an item of being inspected
NOTE Inspectability includes provisions for the
followings aspects:
• Definition of inspection including
acceptance or rejection criteria, expressed in
an unambiguous and quantified manner.
• Part and component accessibility for
inspection
• Definition of tolerance methods for
dimensional inspection performance (e.g.
functional tolerances).
3.2.3 producibility
ability of an item of being producible
NOTE Producibility includes provisions for the
following aspects:
• Design simplification and standardization,
reduction in part types and part number.
• Guidelines for selection of preferred parts,
materials and processes.
• Unambiguous definitions of the
requirements and limits to be used.
• Definition of tolerance build-up methods, in
order to simplify manufacturing, assembly,
inspection.
• Standardization of interfaces.
• Part accessibility for assembly and
inspection.
• Definition of design criteria consistent with
the capability of manufacturing processes.
• Definition of design methods to ensure that
the cleanliness requirements are compatible
with the capability of related cleanliness
procedures and facilities.
3.2.4 testability
ability of an item of being tested
NOTE Testability includes provisions for the
followings aspects:
• Definition of test requirements, including
acceptance or rejection criteria, expressed in
an unambiguous and quantified manner.
• Part and component accessibility for test.
9
---------------------- Page: 11 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
• Definition of recommended design
techniques to facilitate fault detection,
identification and location (e.g. test points,
modularity, built-in test software, and
feedback loops).
3.3 Abbreviated terms and symbols
For the purpose of this Standard, the abbreviated terms and symbols from
ECSS-S-ST-00-01 and the following apply:
Abbreviation Meaning
AIV
assembly, integration, verification
BB breadboard
CI
configuration item
CoC certificate of confirmity
DRB delivery review board
NOTE: DRB is synonymous to “Acceptance Review
Board” (ARB) in ECSS-M-ST-10
DRD document requirements definition
EEE electrical, electronic, electromechanical
EGSE electrical ground support equipment
EIDP end item data package
FGSE fluidic ground support equipment
FM flight model
GSE ground support equipment
MGSE mechanical ground support equipment
MIP mandatory inspection point
NCR nonconformance report
NRB nonconformance review board
OGSE optical ground support equipment
PA product assurance
PM project manager
QA quality assurance
QM qualification model
RFD request for deviation
RFW request for waiver
TRB test review board
TRR test readiness review
VCB verification control board
VCD verification control document
10
---------------------- Page: 12 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
3.4 Nomenclature
The following nomenclature apply throughout this document:
a. The word “shall” is used in this standard to express requirements. All the
requirements are expressed with the word “shall”.
b. The word “should” is used in this standard to express recommendations.
All the recommendations are expressed with the word “should”.
NOTE It is expected that, during tailoring, all the
recommendations in this document are either
converted into requirements or tailored out.
c. The words “may” and “need not” are used in this standard to express
positive and negative permissions respectively. All the positive
permissions are expressed with the word “may”. All the negative
permissions are expressed with the words “need not”.
d. The word “can” is used in this standard to express capabilities or
possibilities, and therefore, if not accompanied by one of the previous
words, it implies descriptive text.
NOTE In ECSS “may” and “can” have a complete
different meaning: “may” is normative
(permission) and “can” is descriptive.
e. The present and past tense are used in this standard to express statement
of fact, and therefore they imply descriptive text.
11
---------------------- Page: 13 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
4
Quality assurance principles
4.1 QA management principles
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 project needs.
4.2 General principles
The implementation of the following phase-independent activities is ensured by
the QA function throughout the lead-time of projects:
• critical-items control
• nonconformance control
• alert management
• acceptance authority media control
• traceability
• metrology and calibration
• handling, storage and preservation
• statistical quality control (if required by the business agreement).
4.3 Design and verification principles
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
c. the design is producible and repeatable and that the resulting product
can be verified and operated within the required operating limits;
12
---------------------- Page: 14 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
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.
4.4 Procurement principles
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.
4.5 Manufacturing, assembly and integration principles
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.
4.6 Testing principles
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.
4.7 Acceptance and delivery principles
The objective is to ensure that an acceptance and delivery process is
implemented which allows demonstrating and documenting the conformance
of the delivered item.
4.8 GSE principles
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.
13
---------------------- Page: 15 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
5
Quality assurance requirements
5.1 QA management requirements
5.1.1 Quality assurance plan
a. The supplier shall prepare, maintain and implement a QA plan in
conformance with the DRD in Annex A.
b. The QA plan shall be submitted to the customer for approval.
NOTE Information on the schedule for delivery of the
QA plan is given in Annex I.
5.1.2 Personnel training and certification
a. The supplier shall establish a documented training programme for the
personnel whose performance determines or affects product quality.
b. Personnel performing or evaluating special processes shall be trained and
certified according to standards accepted by the customer.
NOTE The term “special process” is defined in ECSS-
S-ST-00-01.
c. Personnel performing non-destructive testing and evaluation shall be
trained and certified according to standards accepted by the customer.
d. The supplier shall maintain records of the training.
5.2 QA general requirements
5.2.1 Critical-items control
a. The supplier shall implement Critical-items control in conformance with
ECSS-Q-ST-10-04.
5.2.2 Nonconformance control system
a. The supplier shall implement a nonconformance control system in
conformance with ECSS-Q-ST-10-09.
14
---------------------- Page: 16 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
5.2.3 Management of alerts
a. The supplier shall manage alerts in conformance with ECSS-Q-ST-10,
clause 5.2.9.
5.2.4 Acceptance authority media
a. The supplier shall establish and maintain a documented acceptance
authority media control system to ensure the correct and legitimate use
of all fabrication and inspection authority media.
b. Acceptance authority media shall be used to:
signify the completion of operations and processes, and
indicate inspection performance at source and incoming
inspection, in process inspection and tests, final inspection, end
point testing, storage and shipment.
c. The use of acceptance authority media shall be restricted to authorized
personnel as identified in the acceptance authority media control system.
d. Acceptance authority media shall be traceable to individuals responsible
for their use.
e. Acceptance authority media shall be applied directly to parts and
materials, when specified by engineering drawings and specifications,
and associated documents, records, labels.
f. Acceptance authority media materials and methods shall be compatible
with the articles and their use.
g. <>
5.2.5 Traceability
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.
b. The supplier shall be capable to trace data, personnel and equipment
related to procurement, manufacturing, inspection, test, assembly,
integration and operations activities.
c. The supplier shall be capable to trace backward the locations of materials,
parts, sub-assemblies.
d. The supplier shall be capable to trace forward the locations of materials
from raw stock.
e. The supplier shall establish controls to ensure that:
identification numbers are assigned in a systematic manner,
identification numbers of scrapped or destroyed items are not used
again,
identification numbers, once allocated, are not changed, unless the
change is authorized by the customer.
NOTE Requirements for identification are addressed
in ECSS-M-ST-40.
15
---------------------- Page: 17 ----------------------
oSIST prEN 16602-20:2018
EN16602-20:2018 (E)
5.2.6 Metrology and calibration
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.
b. The supplier shall use equipment in a manner which ensures that
measurement uncertainty is known and is consistent with the specified
measurement capability.
c. The supplier shall include in the calculations of all measurements the
total error in the measurement process attributable to the cumulative
error from the calibration chain, measuring equipment and those
contributed by personnel, procedures and the environment.
d. The supplier shall record the basis for the calculation of the cumulative
errors as specified in requirement 5.2.6c.
e. The supplier shall select inspection, measuring and
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.