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

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
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
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

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

• 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

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

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

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

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

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 inspection, measuring or test equipment is found to be out of calibration. l. The supplier shall ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out. m. The supplier shall ensure that inspection, measuring and test facilities, including both test hardware and test software are protected against adjustments, which can invalidate the calibration setting. SIST EN 16602-20:2014

NOTE 1 Examples of test hardware are: jigs, fixtures, templates and patterns.
NOTE 2 Test aids such as test leads, break-out boxes, mains leads and similar items are not subject to the entire set of requirements defined in this clause, but are validated in a way appropriate to their usage. p. The supplier shall establish the extent and frequency of such checks and shall maintain records as evidence of control. q. The supplier shall make the measurement design data available to the customer upon request. 5.2.7 Handling, storage and preservation 5.2.7.1 Handling a. The supplier shall prevent handling damage during all phases of manufacturing, assembly, integration, testing, storage, transportation and operation. NOTE
Possible prevention measures are: • protection of items during handling, • handling devices, or • procedures and instructions. 5.2.7.2 Storage a. The supplier shall place the following items in secure storage areas: 1. incoming materials, 2. intermediate items needing temporary storage, and 3. end items before shipping. NOTE
Security of the storage is defined according to specific customer requirements. b. The supplier shall place the following items in designated segregated areas: 1. limited life materials, 2. suspended limited life materials, 3. nonconforming items awaiting NRB disposition, SIST EN 16602-20:2014

Examples of such environmental elements are: air and moisture. 5.2.8 Statistical quality control and analysis 5.2.8.1 General a. Statistical quality control and analysis methods shall be used to maintain or improve the specified control of quality, when statistically significant with respect to the product characteristics and to quantities produced. NOTE
Examples of statistical quality control and analysis methods are sample inspection plans, determination of quality levels, statistical process control and process capabilities studies. b. When employing statistical quality control and analysis methods, the supplier shall ensure that all the conditions for use are enforced. NOTE
Example of such conditions are sample significance, recording and elaboration of data, and formulation of clear decision rules. c. Statistical quality control applications, when used by the supplier for acceptance of materials, parts, processes and products, shall be submitted to the customer for approval.
5.2.8.2 Sampling plans a. When sampling plans are used the supplier shall define and justify the following: SIST EN 16602-20:2014

2. acceptance / rejection criteria, and
3. screening of rejected lots. b. The supplier shall maintain records of the sampling tests, together with the identification of the characteristics to which sampling is applied. 5.3 QA requirements for design and verification 5.3.1 Design rules 5.3.1.1 Producibility a. The supplier shall ensure that the product is designed such that it can be produced with the specified level of quality.
5.3.1.2 Repeatability a. The supplier shall ensure that the product is designed such that its performances and characteristics can be reproduced over different models and serial production.
5.3.1.3 Inspectability and testability a. The supplier shall ensure that the product is designed such that it can be inspected and tested under representative conditions, for production, AIV and operational environment.
5.3.1.4 Operability a. The supplier shall ensure that the product is designed such that it can be operated in accordance with programme constraints and requirements, throughout its whole life cycle including handling, storage, transportation, integration and operations. 5.3.2 Verification 5.3.2.1 General a. The supplier shall ensure that requirement verification is performed progressively, as each stage of the project is completed, and provides the organized base of data upon which qualification and acceptance is incrementally declared. b. The supplier shall ensure that top-down requirement allocations and bottom-up requirement verifications are complete and consistent. SIST EN 16602-20:2014

Design reviews address the following items: • Quality requirements and criteria for design, producibility, repeatability, testability and operability are adequately considered in design documentation. • Methods and data required for procurement, manufacturing, inspection and test are available and validated. • Risks of not achieving requirements are highlighted and adequately controlled. 5.3.2.4 Qualification process 5.3.2.4.1 Qualification a. The supplier shall ensure that all configuration items and their constituent items, either off-the-shelf or specifically designed, are properly qualified with margins commensurate with the application and use environment. NOTE
For equipment with heritage, an Equipment Qualification Status Review can be organised to assess qualification status. b. The supplier QA shall review and approve the qualification plan. NOTE
The qualification plan is a subset of the VCD as defined in ECSS-E-ST-10-02. SIST EN 16602-20:2014

Qualification results are a subset of Verification Control Document (VCD) as defined in ECSS-E-ST-10-02. d. The supplier QA manager shall ensure that a Verification Control Board (VCB) is established to monitor the qualification process. NOTE
Verification Control Board (VCB) is defined in ECSS-E-ST-10-02. 5.3.2.4.2 Qualification by similarity a. Qualification by similarity with an identical or similar product shall be justified by providing evidence that the new application is within the limits of the previously qualified design. b. Any difference in definition with respect to the reference product and any difference in the required qualification tests shall be identified. c. The need for complementary qualification tests shall be analysed and the decision justified and submitted to the customer for approval. d. For this purpose the supplier shall: 1. evaluate the as-designed or as-built configuration and related nonconformances, 2. ensure that qualification requirements and qualification ranges are compatible with project requirements, 3. ensure that qualification test results meet the requirements and any nonconformances are available for evaluation, and 4. ensure that a logbook of the selected model is available for review. 5.3.2.4.3 Qualification testing a. The product used for qualification testing shall be produced in accordance with a full and clearly identified manufacturing and inspection file.
b. To obtain authorization to initiate qualification tests the supplier shall demonstrate that: 1. the qualification model is fully representative of the flight model and any differences have been analysed to evaluate their effect on the qualification status; 2. inspection and test requirements are expressed in an unambiguous and quantified manner including: (a) test sequence; (b) test conditions; (c) test standards, if any; (d) applicable test levels, durations and tolerances; (e) accuracy in measurement. 3. the qualification test procedures and facilities are defined, available and conforming to requirements of clause 5.5.11b. SIST EN 16602-20:2014

The selection of procurement sources for EEE components is defined in ECSS-Q-ST-60. 5.4.1.2 Selection criteria a. The supplier shall select its suppliers on the basis of one of the following criteria: 1. The supplier has been certified by the final customer, and has a current approval to furnish items or services of the type and quality level being procured. 2. The supplier is furnishing, or has furnished within the past two years, items or services of the type and quality level being procured under other contracts with the final customer. 3. The supplier has demonstrated continuous capability to furnish items or services of the type and quality level being procured, supported by objective documentation. 4. Supplier’s capability of satisfying business agreement requirements is demonstrated by a pre-award audit by the relevant customer. NOTE 1 NOTE to item 1:Third party certification (for instance against ISO 9001) can be also considered. SIST EN 16602-20:2014

Example of review is the manufacturing readiness review. SIST EN 16602-20:2014
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