SIST EN 16602-20:2014

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zagotavljanje varnih proizvodov v vesoljski tehniki - Zagotavljanje kakovostiRaumfahrtproduktsicherung - QualitätssicherungAssurance produit des projets spatiaux - Assurance qualitéSpace product assurance - Quality assurance49.140Vesoljski sistemi in operacijeSpace systems and operations03.120.99Drugi standardi v zvezi s kakovostjoOther standards related to qualityICS:Ta slovenski standard je istoveten z:EN 16602-20:2014SIST EN 16602-20:2014en,fr,de01-november-2014SIST EN 16602-20:2014SLOVENSKI
STANDARDSIST EN 13291-2:20041DGRPHãþD



SIST EN 16602-20:2014



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16602-20
September 2014 ICS 49.140
Supersedes EN 13291-2:2003
English version
Space product assurance - Quality assurance
Assurance produit des projets spatiaux - Assurance qualité
Raumfahrtproduktsicherung - Qualitätssicherung This European Standard was approved by CEN on 6 March 2014.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2014 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 16602-20:2014 E
SIST EN 16602-20:2014



EN 16602-20:2014 (E) 2 Table of contents Foreword . 5 1 Scope . 6 2 Normative references . 7 3 Terms and definitions . 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 and preservation . 17 SIST EN 16602-20:2014



EN 16602-20:2014 (E) 3 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 . 33 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 . 34 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 SIST EN 16602-20:2014



EN 16602-20:2014 (E) 4 5.8.4 Acceptance and delivery . 37 5.8.5 <> . 38 5.8.6 <> . 38 5.8.7 <> . 38 5.8.8 General requirements . 38 5.8.9 Maintenance . 39 6 Pre-tailoring matrix per space product types . 40 Annex A (normative) QA plan - DRD . 49 Annex B (normative) End item data package (EIDP) - DRD . 51 Annex C (normative) Logbook - DRD . 53 Annex D (normative) Certificate of conformity (CoC) - DRD . 55 Annex E (informative) Example of a logbook cover page . 57 Annex F (informative) Example of EIDP cover page . 58 Annex G (informative) Example of EIDP contents . 59 Annex H (informative) Example of Certificate of conformity . 60 Annex I (informative) QA document requirement list . 61 Annex J (informative) ECSS-Q-ST-20 applicability according to programme phases . 62 Bibliography . 65
Tables Table I-1 : QA document requirement list with respect to milestones . 61 Table J-1 : ECSS-Q-ST-20C Requirements per programme phase . 62
SIST EN 16602-20:2014



EN 16602-20:2014 (E) 5 Foreword This document (EN 16602-20:2014) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-20:2014) originates from ECSS-Q-ST-20C 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 March 2015, and conflicting national standards shall be withdrawn at the latest by March 2015. 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 13291-2:2003. 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 16602-20:2014



EN 16602-20:2014 (E) 6 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 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
SIST EN 16602-20:2014



EN 16602-20:2014 (E) 7 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 S20.20-2007 Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment SIST EN 16602-20:2014



EN 16602-20:2014 (E) 8 3 Terms and definitions
3.1 Terms from other standards For the purpose of this Standard, the terms and definitions from ECSS-ST-00-01 apply, in particular for the following terms: nonconformance process product assurance quality assurance space system space segment element space segment sub-system launch segment element
launch segment sub-system ground segment element
ground segment sub-system space segment equipment launch segment equipment ground segment equipment 3.2 Terms specific to the present standard 3.2.1 ground support equipment (GSE) optical, mechanical, fluidic, electrical and software support equipment or systems used for example for calibration, measurements, testing, simulation, transportation, and handling of space segment or of space segment elements 3.2.2 inspectability ability of an item of being inspected NOTE
Inspectability includes provisions for the followings aspects: SIST EN 16602-20:2014



EN 16602-20:2014 (E) 9 • 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 repeatability ability to reproduce the performance and characteristics of an item
NOTE
Repeatability includes provisions for the following aspects: • Definition of standard tolerances generally applicable. • Recommended design concepts and solutions to ensure repeatability. • Recommended manufacturing processes having proven repeatability. • Design criteria that optimize implementation of automated manufacturing methods, or computer-aided manufacturing SIST EN 16602-20:2014



EN 16602-20:2014 (E) 10 3.2.5 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. • 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 SIST EN 16602-20:2014



EN 16602-20:2014 (E) 11 RFD request for deviation RFW request for waiver TRB test review board TRR test readiness review VCB verification control board VCD verification control document
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. SIST EN 16602-20:2014



EN 16602-20:2014 (E) 12 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 • stamp 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 through one or more of the following methods: analysis, inspection, test, review of design, audits; c. the design is producible and repeatable and that the resulting product can be verified and operated within the required operating limits; SIST EN 16602-20:2014



EN 16602-20:2014 (E) 13 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. SIST EN 16602-20:2014



EN 16602-20:2014 (E) 14 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. SIST EN 16602-20:2014



EN 16602-20:2014 (E) 15 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. NOTE
Acceptance authority media include stamps and signatures as defined in EN9100. 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, SIST EN 16602-20:2014



EN 16602-20:2014 (E) 16 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. 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 test equipment in conformance with the required measurement accuracy and precision. f. The supplier shall identify, calibrate and adjust all inspection, measuring and test equipment and devices that can affect product quality at prescribed intervals, or prior to use, against certified equipment. g. The supplier shall establish, document and maintain calibration procedures, including details of equipment type, identification number, location, frequency of checks, check method, acceptance criteria and the action to be taken when results exceed the specified accuracy. h. The supplier shall ensure that the inspection, measuring and test equipment is capable of the specified accuracy and precision. i. The supplier shall identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status. j. The supplier shall maintain calibration records for inspection, measuring and test equipment. k. The supplier shall assess and document the validity of previous inspection and test results when ins
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