SIST EN 16602-10:2017

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zagotavljanje kakovosti proizvodov v vesoljski tehniki - Ureditev zagotavljanja kakovosti proizvodovRaumfahrtproduktsicherung - Management der ProduktsicherungAssurance produit des projets spatiaux - Gestion de l'assurance produitSpace product assurance - Product assurance management49.140Vesoljski sistemi in operacijeSpace systems and operationsICS:Ta slovenski standard je istoveten z:EN 16602-10:2017SIST EN 16602-10:2017en,fr,de01-maj-2017SIST EN 16602-10:2017SLOVENSKI
STANDARDSIST EN 13291-1:20001DGRPHãþD



SIST EN 16602-10:2017



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16602-10
February
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English version
Space product assurance æ Product assurance management Assurance produit des projets spatiaux æ Gestion de l 5assurance produit
Raumfahrtproduktsicherung æ Management der Produktsicherung This European Standard was approved by CEN on
t t December
t r s xä
C Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN and CENELEC memberä
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels y any means reserved worldwide for CEN national Members and for CENELEC Membersä Refä Noä EN
s x x r tæ s rã t r s y ESIST EN 16602-10:2017



EN 16602-10:2017 (E) 2 Table of contents European foreword . 4 1 Scope . 5 2 Normative references . 6 3 Terms, definitions and abbreviated terms . 7 3.1 Terms and definitions from other standards . 7 3.2 Abbreviated terms. 8 4 Principles . 9 4.1 General principles . 9 4.2 PA programme planning . 9 4.3 PA programme implementation . 10 5 Requirements . 11 5.1 PA programme planning . 11 5.1.1 Product Assurance organization and responsibilities . 11 5.1.2 PA management interfaces . 12 5.1.3 PA plan . 12 5.2 PA programme implementation . 12 5.2.1 Product assurance management . 12 5.2.2 PA reporting . 14 5.2.3 Project PA audits . 14 5.2.4 Critical items control and PA interfaces to project risk management . 15 5.2.5 Documentation and data control. 15 5.2.6 Quality records . 15 5.2.7 PA contribution to configuration management . 15 5.2.8 Nonconformance control . 16 5.2.9 Management of alerts . 16 6 Pre-tailoring matrix per space product types and project phases . 18 Annex A (normative) Product Assurance Plan (PAP) - DRD . 24 Annex B (normative) Qualification Status List - DRD . 27 SIST EN 16602-10:2017



EN 16602-10:2017 (E) 3 Annex C (normative) Qualification Certificate for Launch Segment - DRD . 30 Annex D (informative) PA document delivery with respect to milestones . 33 Bibliography . 34
Figures Figure B-1 : Example of a Qualification status list (QSL) . 29
Tables Table D-1 : PA document requirement list with respect to milestones . 33
SIST EN 16602-10:2017



EN 16602-10:2017 (E) 4 European foreword This document (EN 16602-10:2017) has been prepared by Technical Committee CEN-CENELEC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-10:2017) originates from ECSS-Q-ST-10C Rev.1. 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 August 2017, and conflicting national standards shall be withdrawn at the latest by August 2017. 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 supersedes EN 13291-1:1999 Space products assurance - General requirements - Part 1: Policy and principles. The main changes with respect to EN 13291-1:1999 are listed below: • new EN number and modified title, • material common to the three ECSS branches (Space engineering, Space project management and Space product assurance moved to EN 16601-00 (EN version of ECSS-S-ST-00), material specific to product assurance to this standard,
• reorganization of the content of the document to separate descriptive text and requirements, including clarification, modification of requirements and implementation of change requests, • pre-tailoring matrix (Clause 6) added, • addition of new DRDs. This document has been prepared under a mandate 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). 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. SIST EN 16602-10:2017



EN 16602-10:2017 (E) 5 1 Scope The ECSS standards of the Q branch describe a set of requirements for a Product Assurance programme to be implemented throughout the phases of a space project.
This document defines the Product assurance management requirements for space projects.
This document is structured in two main parts, the first part presenting the principles of Product Assurance management and the second providing the detailed requirements. In addition, the expected content of the Product Assurance plan is specified in Annex A. Information on the expected delivery of ECSS PA management discipline documents per review is provided in Annex D.
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. SIST EN 16602-10:2017



EN 16602-10:2017 (E) 6 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 16602-10-04 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 SIST EN 16602-10:2017



EN 16602-10:2017 (E) 7 3 Terms, definitions and abbreviated terms 3.1 Terms and definitions from other standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01 apply, in particular for the following terms: acceptance alert approval assembly audit component configuration item conformance critical item customer dependability failure function nonconformance performance
planetary protection procedure process product product assurance project qualification quality assurance review risk SIST EN 16602-10:2017



EN 16602-10:2017 (E) 8 safety space mission supplier system traceability waiver 3.2 Abbreviated terms For the purpose of this Standard, the abbreviated terms from ECSS-S-ST-00-01 and the following apply:
Abbreviation Meaning EEE electrical, electronic, electromechanical MIP mandatory inspection point PA product assurance QA quality assurance QSL qualification status list SIST EN 16602-10:2017



EN 16602-10:2017 (E) 9 4 Principles 4.1 General principles The prime objective of Product Assurance is to ensure that space products accomplish their defined mission objectives in a safe, available and reliable way. Commitment to quality of the entire organization is key to the Quality of the product and success of the space mission. The management of Product Assurance is fully embedded in the management of the project and receives the highest priority from the organization management.
The early identification of aspects potentially detrimental for safety and mission success, and the cost-effective prevention of any adverse consequence of such aspects are the basic principles for the ECSS Product Assurance requirements. Product Assurance Management ensures the integration of activities from the Product Assurance disciplines defined in the other ECSS standards of the Q branch, namely: • Q-20 Quality assurance • Q-30 Dependability • Q-40 Safety • Q-60 Electrical, electronic, electromechanical (EEE) components • Q-70 Materials, mechanical parts and processes • Q-80 Software product assurance 4.2 PA programme planning The requirements for Product Assurance planning specified in clause 5.1 address the following aspects: • Definition of a Product Assurance organization with the allocation of adequate resources, personnel and facilities • Definition of Product Assurance requirements for lower tier suppliers • Definition of a Product Assurance Plan describing the Product Assurance programme and how it fulfils project objectives and requirements SIST EN 16602-10:2017



EN 16602-10:2017 (E) 10 4.3 PA programme implementation The requirements for Product Assurance programme implementation specified in clause 5.2 address the following aspects: • Management and control of the PA tasks performed by the PA disciplines • Progress reporting of all Product Assurance matters • Management of audits, critical items, nonconformances and alerts, • Support to the risk management, in coordination with the Project Management functions • Support to the documentation and data control , quality records and to configuration management. • Lower-tier supplier control for ensuring implementation of PA requirements by the suppliers SIST EN 16602-10:2017



EN 16602-10:2017 (E) 11 5 Requirements 5.1 PA programme planning 5.1.1 Product Assurance organization and responsibilities 5.1.1.1 Organization
a. The supplier shall identify the personnel responsible for implementing and performing PA management and other PA disciplines. b. The supplier shall assign a project PA manager reporting to the project manager and having unimpeded access to higher management. c. The appointed project PA manager, irrespective of other responsibilities, shall have organizational authority to establish and implement a product assurance programme in accordance with the project product assurance requirements. d. The project PA Manager shall act as the focal point of contact within the project concerning Product Assurance matters.
The project PA manager is referred to as “PA NOTE manager” in the rest of this document. 5.1.1.2 Responsibility and authority
a. The supplier shall define and document the responsibility, the authority and the interrelation of personnel who manage, perform and verify work affecting product assurance. b. The supplier shall define and document the responsibilities and the interfaces of the PA functions, either external or internal, involved in a project. c. When the supplier's PA organization delegates product assurance tasks to another organization it shall be done in a documented and controlled way monitored by the PA organization.
The supplier PA organization retains the NOTE responsibility towards the Customer SIST EN 16602-10:2017



EN 16602-10:2017 (E) 12 5.1.1.3 Resources
a. The supplier shall identify the PA resources needed to implement the PA programme. b. The supplier shall provide resources capable to perform the PA tasks identified in the PA programme. c. Reviews and audits of the product assurance programme, of processes or of product shall be carried out by personnel not directly involved in the work being performed. 5.1.2 PA management interfaces a. The PA manager shall interface with project management, ensuring that the contractual provision and schedule planning for the definition and phasing of PA activities are met. b. The PA manager shall interface with risk management, configuration management, engineering, procurement and AIV for the definition and execution of tasks in which PA activities are involved. c. The PA manager shall interface with the customer regarding all Product Assurance matters. d. The PA manager shall interface with lower-tier suppliers regarding all Product Assurance matters. 5.1.3 PA plan a. The supplier shall prepare, maintain and implement a plan of the PA activities in accordance with the customer PA requirements. b. The Product Assurance plan shall be prepared in conformance with DRD in Annex A. c. The Product Assurance plan shall be submitted to the customer for approval. NOTE 1 The Product Assurance plan can refer to Clauses of the Company Quality Manual and to in-house procedures. NOTE 2 Information on the schedule for delivery of PA management documents is given in Annex D. 5.2 PA programme implementation 5.2.1 Product assurance management a. The PA manager shall ensure that PA disciplines are organized at the beginning of the project according to customer contractual requirements. SIST EN 16602-10:2017



EN 16602-10:2017 (E) 13 b. The PA manager shall ensure that the inputs used by the PA disciplines are consistent and complete, and available in line with the project schedule. c. The PA manager shall ensure that the PA disciplines perform the tasks described in the PA Plan in line with the project schedule. d. The PA manager shall ensure that the outputs produced by the PA disciplines are consistent and complete, and delivered in line with the project schedule. e. The PA manager shall ensure the application of processes defined in applicable project plans and documents.
f. The PA manager shall control the quality of his supplier’s products by: 1. issuing product assurance requirements applicable to the supplier
2. ensuring the implementation of the PA requirements by the supplier. g. The PA manager shall ensure that PA contributions to verification are defined and provided. h. The PA manager shall ensure that a qualification programme is defined, approved and maintained by the relevant organization.
Requirement for the qualification programme NOTE are addressed in ECSS-Q-ST-20, ECSS-Q-ST-60, ECSS-Q-ST-70, ECSS-Q-ST-80, ECSS-E-ST-10-02 and ECSS-E-ST-10-03. i. The PA manager shall ensure that the qualification programme is implemented and the qualification results are recorded, evaluated and documented. j. The PA manager shall ensure that a Qualification Status List of the programme items is maintained in conformance with Annex B. k. The PA manager shall review and approve the achieved qualification status. l. The PA manager shall approve the product acceptance during the Acceptance or Delivery Review.
The PA manager approval is based on the NOTE outputs of the Acceptance or Delivery Review. m. For Launch Segment perimeter, the PA manager shall ensure that
Qualification Certificates, identifying the qualified configuration, are issued for all ground and flight programme items in accordance with DRD in Annex C. n. For Launch Segment perimeter, the PA manager shall sign and approve the certificates specified in req. 5.2.1m. before final programme manager acceptance. o. The PA manager shall ensure that a Technology Plan is defined, approved and maintained by the relevant organization. SIST EN 16602-10:2017



EN 16602-10:2017 (E) 14
The technology plan (TP) supports evaluation NOTE of a critical technology to meet the intended requirements, and ensure effective preparation of the technologies necessary for the relevant product. Technology Plan contents are defined in ECSS-E-ST-10 Annex E. p. The PA manager shall ensure that a Technology Readiness Status List (TRSL) is defined, approved and maintained by the relevant organization.
The contents of Technology Readiness Status NOTE List are defined in ECSS-E-ST-10 Annex E.2.1<5>. 5.2.2 PA reporting a. The supplier shall report on the status and progress of the product assurance program implementation. b. The PA report shall include at least the following items for the reporting period:  Progress and accomplishment of each major product assurance task including resolved and new problems, future planning of major activities and events  Status of PA reviews, Audits and MIPs, Waiver requests, Non conformances (minor and major), Critical items (including mitigation action plan status), Qualification status, EEE component status, Material and processes status, Alerts status. c. The PA progress report may be part of the project progress report.
The general contents of the project progress NOTE report are detailed in ECSS-M-ST-10 Annex E. 5.2.3 Project PA audits a. The supplier shall perform audits on his own performance to verify the implementation and effectiveness of the provisions defined in the PA plan. NOTE 1 Audits can be performed by sampling on various projects or by periodic audits of the supplier quality system. NOTE 2 The general contents of project audits are detailed in ECSS-M-ST-10 clause 5.2.3. b. The supplier shall establish and maintain an audit plan for procurement activities on the project, designating the lower tier suppliers to be audited, the current status and the schedule for auditing. c. In addition to the planned audits, extra audits shall be performed when necessary to overcome failure, consistent poor quality, or other problems.
SIST EN 16602-10:2017



EN 16602-10:2017 (E) 15 d. The supplier shall plan and perform audits using established and maintained procedures. 5.2.4 Critical items control and PA interfaces to project risk management a. The supplier shall establish a critical items control programme in conformance with ECSS-Q-ST-10-04. b. The PA manager shall identify and evaluate critical items in support of the overall project risk management activities. c. The PA manager shall ensure that a critical item control programme is implemented to eliminate or mitigate associated risks. 5.2.5 Documentation and data control a. The PA manager shall ensure that the applicable issues of all documents and data are available at all locations where activities required for the implementation of the PA programme are performed. b. The PA manager shall ensure that invalid or obsolete documents and data are removed from all points of issue or use, or assured against unintended use. c. The PA manager shall ensure that obsolete documents and data retained for legal or knowledge preservation purposes are identified as such. d. The PA manager shall identify the project documents requiring approval including those requiring approval by PA. 5.2.6 Quality records a. The supplier shall establish and maintain quality records to provide objective evidence of complete and successful performance of all PA discipline tasks and to demonstrate compliance with requirements.
Requirements for the storage, retrieval and NOTE archiving of quality records are addressed in ECSS-M-ST-40. 5.2.7 PA contribution to configuration management a. The PA manager shall verify during Configuration Control Boards the suitability for release of drawings, plans, specifications, procedures and changes thereto.
The operation of Configuration Control Boards NOTE is detailed in ECSS-M-ST-40 b. The PA manager shall ensure that: SIST EN 16602-10:2017



EN 16602-10:2017 (E) 16 1. the as designed status is defined and released prior to manufacturing; 2. the as-built documentation is properly defined, identified and maintained in order to reflect approved modifications; and 3. items delivered comply with the as-built documentation. 5.2.8 Nonconformance control a. The supplier shall establish and maintain a nonconformance control system in conformance with ECSS-Q-ST-10-09. 5.2.9 Management of alerts a. The supplier shall notify its customer of preliminary information on failures or problems that can result in an alert. NOTE 1 The above is applicable to failure or problems detected by the supplier or by one of his lower tier suppliers. NOTE 2 The above is only applicable to failures or problems meeting all of the following criteria: • The item with the observed failure or problem has multiple applications, which can have implications for more than one project, thus requiring prompt action. • The failure or problem has occurred in the application of an item within the specified design and usage limitations.
• Failures or problems due to usage within reasonably expected limits of performance, but where these limits were not specified precisely. • A preliminary investigation has provided evidence of the root cause of the failure or problem. • Failure or problems are confirmed not to be of a random nature. b. The supplier shall investigate in cooperation with the originator of the failure or problem to define the immediate measures to be taken, to identify the causes, and to recommend corrective actions for similar items. c. The PA manager shall ensure: 1. the assessment of any failure having the potential to lead to an alert by the customer, 2. the investigation, until disposition of the items subject of the potential alert, and SIST EN 16602-10:2017



EN 16602-10:2017 (E) 17 3. the assessment of incoming alerts for the definition, implementation and follow-up of necessary actions. d. The supplier shall participate in the alert system organized by the customer or other sources, by: 1. assessment of the impact of incoming alerts to project work, and definition, implementation and follow-up of necessary corrective actions at any contractual level. 2. distribution of incoming alerts to the possible affected users within the project.
The alert system is set up for the prompt NOTE interchange of information on failures or problems which can affect more than one user, or can recur in other projects or circumstances, if no preventive actions are taken. SIST EN 16602-10:2017



EN 16602-10:2017 (E) 18 6 Pre-tailoring matrix per space product types and project phases The Matrix of Table 6-1 presents the pre-tailoring of ECSS-Q-ST-10C Rev. 1 per space product type. For the terminology and definitions of the nine space product types see ECSS-S-ST-00-01. Attention of the reader is drawn to the importance of the precise meaning of these terms for an appropriate application of the present table.
The applicability of a requirement is specified as follows: • “A” when applicable, • “A#” when requirement is applicable with supplementary information in the “Comment” column • “X#” when the applicability is to be decided on a case by case basis, with explanation in the “Comment” column, or • “NA” when not applicable The number assigned for comments relating to each relevant column marked with A# or X# starts at 1 and increases incrementally left to right across the columns, and then starts afresh on the next row.
SIST EN 16602-10:2017



EN 16602-10:2017 (E) 19 Table 6-1: Pre-Tailoring matrix for ECSS-Q-ST-10C Rev.1 ECSS req. number Space product types Space system Space segment element and sub-system Space segment equipment Launch segment element and sub-system Launch segment equipment Ground segment element and sub-system Ground segment equipment Ground support equipment Software Comments 5.1.1.1a A A A A A A A NA NA For Software, covered by clause 5.1.4 of ECSS-Q-ST-80 5.1.1.1b A A A A A A A NA NA For Software, covered by clause 5.1.4 of ECSS-Q-ST-80 5.1.1.1c A A A A A A A NA NA For Software, covered by clause 5.1.4 of ECSS-Q-ST-80 5.1.1.1d A A A A A A A NA A
5.1.1.2a A A A A A A A NA NA For Software, covered by clause 5.1.2 of ECSS-Q-ST-80 5.1.1.2b A A A A A A A NA NA For Software, covered by clause 5.1.2.1 of ECSS-Q-ST-80 5.1.1.2c A A A A A A A NA NA For Software, covered by clause 5.1.2.3 of ECSS-Q-ST-80 5.1.1.3a A A A A A A A NA NA For Software, covered by clause 5.1.3 of ECSS-Q-ST-80 5.1.1.3b A A A A A A A NA NA For Software, covered by clause 5.1.3 of ECSS-Q-ST-80 5.1.1.3c A A A A A A A NA NA For Software, covered by clause 5.1.3 of ECSS-Q-ST-80 5.1.2a A A A A A A A NA A
5.1.2b A A A A A A A NA A
5.1.2c A A A A A A A NA A
5.1.2d A A A A A A A NA A
5.1.3a A A A A A A1 A1 NA NA 1 Except for suppliers of catalogue OFF-THE-SHELF items such as standard laboratory equipment, work stations, from whom a dedicated PA plan is not required
For Software, covered by clause 5.2.1 of ECSS-Q-ST-80 SIST EN 16602-10:2017



EN 16602-10:2017 (E) 20 ECSS req. number Space product types Space system Space segment element and sub-system Space segment equipment Launch segment element and sub-system Launch segment equipment Ground segment element and sub-system Ground segment equipment Ground support equipment Software Comments 5.1.3b A A A A A A A NA NA For Software, replaced by ECSS-Q-ST-80 Annex B which contains the Software PA Plan DRD 5.1.3c A A A A A A A NA A
5.2.1a A A A A A A A NA A
5.2.1b A A A A A A A NA A
5.2.1c A A A A A A A NA A
5.2.1d A A A A A A A NA A
5.2.1e A A A A A A A NA A1 1 For Software, processes are defined in clause 5.7 "Assessment and improvement process" and clause 6 "Software process assurance" of ECSS-Q-ST-80 5.2.1f A A A A A A A NA NA For Software, covered by clause 5.4.2 of ECSS-Q-ST-80 5.2.1g A A A A A A A NA A
5.2.1h A A A A2 A2 A1 A1 NA NA 1 Except for catalogue OFF-THE-SHELF. Qualification items related to catalogue OFF-THE-SHELF are covered at a higher level.
2 Except NOTE because Launchers have dedicated Qualification programmes
For Software, covered by clause 6.3.5 "Testing and validation" of ECSS-Q-ST-80 5.2.1i A A A A A A A NA NA For Software, covered by clause 6.3.5 "Testing and validation" of ECSS-Q-ST-80 5.2.1j A A A A1 A1 A1 A1 NA A12 1 For Launch Segment, Ground Segment and Software, the Annex B is Informative 2 Note: for Software, qualification is generally replaced by the word "Validation" 5.2.1k A A A A A A A NA A1 1 Note: for Software, qualification is generally replaced by the word "Validation" 5.2.1l A A A A A A A NA A
SIST EN 16602-10:2017



EN 16602-10:2017 (E) 21 ECSS req. number Space product types Space system Space segment element and sub-system Space segment equipment Launch segment element and sub-system Launch segment equipment Ground segment element and sub-system Ground segment equipment Ground support equipment Software Comments 5.2.1m NA NA NA A A NA NA NA NA
5.2.1n NA NA NA A A NA NA NA NA
5.2.1o A A A A A A A NA NA
5.2.1p A A A A A A A NA NA
5.2.2a A A A A A A A NA NA For Software, covered by clause 5.2.2 of ECSS-Q-ST-80 5.2.2b A A A A A A A NA NA For Software, covered by clause 5.2.2 of ECSS-Q-ST-80 5.2.2c A A A A A A A NA A1 1 For Software, see also clause 5.2.2.1 of ECSS-Q-ST-80 5.2.3a A A A A A A A NA A1 1 ECSS-Q-ST-10 requirement declared ap
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