Verification & Testing for Conformity Assessment / EC Verification. NB-Rail (ERTMS Group)

Transcription

1 Co-ordination group of Notified Bodies for railway products and systems. Verification & Testing for Conformity Assessment / EC Verification NB-Rail (ERTMS Group)

2 Overview Co-ordination group of Notified Bodies for railway products and systems. 1. Obligations 2. Requirements 3. Test Specifications 4. Use of Test Results 5. Acceptance of Safety Cases 6. Inspection - General Criteria 7. Inspection - Verification & Validation Methods (V&V) 8. Conclusions

3 Obligations Ref. TSI CCS 2006/860/EC, 2006/679/EC Co-ordination group of Notified Bodies for railway products and systems. Fulfilment of essential requirements by the applicant! Ensured by compliance with the applicable mandatory specifications, as demonstrated by a positive result of the assessment of conformity and/or verification of the subsystem. The mandate of NoBo s is defined by specific procedures* Ensured by the assessment of conformity of interoperability constituents and/or the EC verification of subsystems. (*ref. TSI CCS Annex E; based on modules as defined in Directive 93/465/EEC)

4 Obligations Ref. TSI CCS 2006/860/EC, 2006/679/EC Co-ordination group of Notified Bodies for railway products and systems. The Notified Body shall verify: - that all mandatory (M) functions are implemented; - which optional (O) functions are implemented; - that additional functions do not conflict with M or O functions. Note: EC verification of the assembly includes the verification of the integration* of the ICs that are notified as part of the assembly! (*ref. TSI CCS, Section / )

5 Co-ordination group of Notified Bodies for railway products and systems. Obligations Ref. TSI CCS 2008/386/EC Questions: Where in the TSI are tests specified that must be carried out in lab and/or real configuration? What tests are at minimum required by the TSI to be performed in lab and/or real configuration? What is meant by final testing of the subsystem? What provisions are to be made by the applicant for tests in lab and/or full operational conditions? Does the NoBo have permanent access for testing and verification activities? What, if not?

6 Requirements Ref. TSI CCS 2006/860/EC, 2006/679/EC Co-ordination group of Notified Bodies for railway products and systems. The applicable requirements originate from requirements: - imposed by the applicable procedure/module; - imposed by the TSI CCS independent of the module; - imposed by reference to chapter 4 of the TSI CCS that characterize the IC and/or assembly. Note: EC verification of the assembly includes the verification of the integration* of the ICs that are notified as part of the assembly!

7 Requirements Ref. TSI CCS 2006/860/EC, 2006/679/EC Characteristics EIRENE functions (data communication only) ETCS and EIRENE air gap interfaces TSI section Index Standard Version 22 intent. deleted 32 EIRENE FRS 7 33 EIRENE SRS reserved 9 Subset Subset ECC/DC(02)05 39 Subset Subset Subset Interfaces - STM Subset (excl. Interface K) 8 Subset [H] Subset Subset Subset [H] Subset [H] Subset GSM-R Subset Key management system 7 15 [H] Subset Subset intent. deleted 34 A11T reserved 56 [H] reserved 05E538 s. B35 - Key Management [C] -- intent, deleted - ETCS-ID Management Subset reserved - ETCS Driver Machine reserved s. Bxx Interf. - Data Interface Subset EIRENE SRS 15 - Environmental A4 EN conditions - EMC A6 EN Subset [H] Subset Co-ordination group of Notified Bodies for railway products and systems. Characteristics TSI section Safety ETCS on-board functionality (excl. radio in-fill, Euroloop, train integrity, level 3, data recording for regulatory purposes) Sample listing of identified mandatory specification applicable to a Group of Interoperability Constituents (GoICs): ERTMS/ETCS on-board; Safety Platform on-board; Odometry; ERTMS/GSM-R on-board Index Standard Version 27 Subset reserved s. B1 47 reserved s. B43 1 ERA/ERTMS/ E Subset Subset Subset Subset Subset Subset reserved 05E 537 s. B6 12 Subset Subset Subset [H] Subset Subset [C] intent. deleted Subset Subset [H] Subset Subset Subset Subset Subset Subset Subset Subset Subset [H] Subset reserved s. B34 52 Subset reserved --

8 Test Specifications Ref. Annex A 2010/79/EC ETCS test specifications listed in Annex A Co-ordination group of Notified Bodies for railway products and systems. TITLE SUBSET Scope of the test specifications(obu testing) Subset v102 (scope) Test Cases related to features Subset v231 Test Sequences Subset v231 Functional Requirements for an On-board Reference Test Facility Subset-094 v202 (test facilities) Test specification for Interface k Subset-102 v100 FFFIS STM Test Cases document Subset v100 ERTMS EuroRadio Test Cases Safety Layer Subset v230 JRU Test Specification Subset-028 (reserved) Test Specification for Eurobalise FFFIS Subset-085 v222 Test specification for EUROLOOP Subset-103 v100 RBC-RBC Test specification for Safe Communication Interface Subset-099 (reserved) GSM-R tests specifications listed in Annex A TITLE Test specification for mobile equipment GSM-R ERTMS GSM-R QoS Test Specification SUBSET Index 48/ reserved Index B5/ O2475 informative

9 Use of Test Results.. Ref. RFU-STR-022 (Modules B, SB, F, H2, SF, SG, SH2) Co-ordination group of Notified Bodies for railway products and systems. USE OF TEST RESULTS FROM TESTING BODIES OTHER THAN NOTIFIED BODIES a. Accreditation of testing body - accredited against EN or(at least) - independent, competent and procedures/facilities subject to a quality system for product inspection and testing. b. Competence - knowledge, training and practical experience. c. Acceptance of test results -documented tests and documented testing method

10 Co-ordination group of Notified Bodies for railway products and systems. Acceptance of Safety Cases Ref. RFU (CCS SUBSYSTEM CERTIFICATION ) CRITERIA FOR CROSS ACCEPTANCE OF SAFETY CASE ASSESSMENTS a. Acceptance of the ISA competency competence with regard to the product or subsystem and the standards and methods b. Acceptance of the ISA entity Notified Body, other accreditation or notification by member state c. Acceptance of the safety assessment results (Cross -) Acceptance criteria as stipulated guideline in the RFU

11 Co-ordination group of Notified Bodies for railway products and systems. Inspection - General Criteria Ref. DIN EN ISO/IEC Inspection methods and procedures 10.1 The Inspection body shall use the methods and procedures for inspection which are defined in the requirements, against which conformity is to be determined. Observation: (1) The basic notified procedures for conformity assessments are documented in the TSI CCS, Annex E (Modules). (2) More detailed procedures may be found in notified test specifications Ref. TSI CCS, Annex A, e.g. Subset -085, -094, -076, -102, -074, -092.

12 Co-ordination group of Notified Bodies for railway products and systems. Inspection - General Criteria Ref. DIN EN ISO/IEC Inspection methods and procedures 10.3 When the inspection body has to use inspection methods or procedures which are non-standard, such methods and procedures shall be appropriate and fully documented. Observation: (3) Application of non-standard methods or procedures are neither considered nor advised by the TSIs.

13 Co-ordination group of Notified Bodies for railway products and systems. Inspection - General Criteria Ref. DIN EN ISO/IEC Conclusion: Measures, methods and procedures to be applied for conformity assessments by Notified Bodies are: - not defined for all mandatory technical specifications - not defined to an adequate extent in the mandatory requirements baseline, against which conformity is to be assessed. Whenever methods or procedures are not specified, the Notified Body may use inspection methods or procedures which are non-standard!

14 Co-ordination group of Notified Bodies for railway products and systems. Inspection V&V Methods Ref. DIN EN ISO/IEC General Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the client. NOTE: International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal procedure if these standards are written in a way that they can be used as published by the operating staff in the laboratory. (* V&V := Verification and Validation)

15 Co-ordination group of Notified Bodies for railway products and systems. Inspection V&V Methods Ref. DIN EN ISO/IEC Selection of methods The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so. Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated.... The laboratory shall inform the client when the method proposed by the client is considered to be inappropriate or out of date.

16 Co-ordination group of Notified Bodies for railway products and systems. Inspection V&V Methods Ref. DIN EN ISO/IEC Non-standard methods The method developed shall have been validated appropriately before use. NOTE: For new test and calibration methods, procedures should be developed prior to the tests and/or calibrations being performed and should at least contain the following information: h) description of the procedure, including - identification, handling, transport, storing and preparation - checks to be made (for preparation, execution, calibration, adjustment etc.) - methods of recording observations and results - any safety measures to be observed i) criteria and/or requirements for approval/rejection;

17 Co-ordination group of Notified Bodies for railway products and systems. Inspection V&V Methods Ref. DIN EN ISO/IEC Non-standard methods The laboratory shall validate non-standard methods, The validation shall be as extensive as necessary to meet the needs of the given application or field of application.. NOTE 2: The techniques used for the determination of the performance of a method should be one of, or a combination of, the following: - Calibration using reference standards or reference materials; - Comparison of results achieved with other methods; - Interlaboratory comparisons; - Systematic assessment of the factors influencing the results; - Assessment of the uncertainty of the results based on scientific understanding of the theoretical principles of the method and practical experience.

18 Inspection V&V Methods Ref. DIN EN ISO/IEC Co-ordination group of Notified Bodies for railway products and systems. Conclusion: Verification methods to be applied for conformity assessments by Notified Bodies are for numerous mandatory specifications: - not harmonised or validated for their adequacy/applicability (before use) - neither agreed, authorized and/or technically justified -do not enclose information on how to perform verification/tests Criteria or requirements for the approval/rejection of verification, e.g. by test results, are often missing. Besides, findings concerning the methods are not communicated (extensive as necessary).

19 Conclusions Co-ordination group of Notified Bodies for railway products and systems. Most of the mandatory technical specifications leave room for interpretations and may thus lead to divergent verification results. Therefore they are considered immature for inspection and certification! The techniques used for determining the performance of measures and methods are not applied (extensive as necessary) on the standards against which conformity is to be determined.

20 Questions? Co-ordination group of Notified Bodies for railway products and systems. NB-Rail - Subgroup ERTMS rail homepage.htm