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New CENELEC StandardS & CSM-RA

New CENELEC StandardS & CSM-RA. Agenda. New EN 501xx Standards What is new/changed/improved The use of CENELEC in CSM-RA process. And an example. CENELEC & CSM-RA Timeline. EN61508. EN61508. ENV50126. EN50126. EN50128. EN50129. EN50128. EN50126. EN50129. 2018. 1995. 1999. 2000.

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New CENELEC StandardS & CSM-RA

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  1. New CENELEC StandardS& CSM-RA

  2. Agenda • New EN 501xx Standards • What is new/changed/improved • The use of CENELEC inCSM-RA process And an example

  3. CENELEC & CSM-RA Timeline EN61508 EN61508 ENV50126 EN50126 EN50128 EN50129 EN50128 EN50126 EN50129 2018 1995 1999 2000 2001 2003 2010 2011 2017 TR50126-3 TR50126-2 2006 2007 TSI 2010 2012 2015 CSM-RA 352/2009 CSM-RA 402/2013 CSM-RA 1136/2015

  4. Overview of current Railway safety standards 2007 TR 50126-2 Guide to the application of EN 50126 for safety 1999 EN 50126 The Specification and Demonstration of Reliablity, Availablity, Maintainability and Safety (RAMS) Guidance System Level 2006 TR 50126-3 Guide to the application of EN 50126 for rolling stock 2003 2007 EN 50129 Communication, signalling and processing systems – Safety related electronic systems for signalling TR 50506-1 Guide to the application of EN 50129 – Part 1: Cross Acceptance SubSystem (Product) Guidance 2011 2008 EN 50128 Communications, signalling and processing systems - Software for railway control and protection systems TR 50506-2 Guide to the application of EN 50129 – Part 2: Safety Assurance 2001

  5. Overview of New Railway safety standards 2017 2017 EN 50126-2 Systems Approach to Safety EN 50126 The Specification and Demonstration of Reliablity, Availablity, Maintainability and Safety (RAMS) System Level Guidance 2018 2007 EN 50129 Communication, signalling and processing systems – Safety related electronic systems for signalling TR 50506-1 Guide to the application of EN 50129 – Part 1: Cross Acceptance SubSystem (Product) Guidance 2011 2008 EN 50128 Communications, signalling and processing systems - Software for railway control and protection systems TR 50506-2 Guide to the application of EN 50129 – Part 2: Safety Assurance

  6. Safety standards relationships EN 50126 Entire Railway system EN 61508 ”FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS” General standard (generic) EN 50129 System HW+SW IEC 61551 Process Sector Safety System Standard for Safety Instrumented Systems Designers, Integrators and Users IEC 62061, Safety of machinery ­Functional safety of electrical/ electronic/ programmable control systems Railway sub-system / Product Where no other sector/ application exists Specific sector / application EN 50128 SW Other sectors (e.g. machinery / process control) Other Railway signalling Railway Applications Adapted after EN 50129 / IEC WG group

  7. Railway safety standards - subsystem 2017 EN 50126-1 & 2 Railway Applications - The Specification and Demonstration of Reliability, Availability, Maintainability and Safety (RAMS) SC9X / S-509 SC9XA SC9XB SC9XC 2017 2018 2018 EN 50155 Electronic equipment used on rolling stock EN 50562 Process, measures and demonstration of safety for electric traction systems EN 50129 Communication, signalling and processing systems – Safety related electronic systems for signalling 2017 2011 EN 50657 Rolling stock applications - Software on board ofrolling stock, excluding railway control and protection applications EN 50128 Communications, signalling and processing systems - Software for railway control and protection systems Rolling Stock Fixed Installation Signalling

  8. EN 50126 old & New IN comparison Improved/detailed • Clear hazard identification and classification • Classification of safety requirements • Method to derive THR from statistics • Safety Case structure • Modularity • Handling of product/Generic / specific Application • Safety Apportionment methods • Key system safety roles & responsibilities Similarities • System approach for RAMS • Risk based approach • RAMS lifecycle • Safety demonstration principles New/changed • More mature and consistent • CSM-RA approach • Multilevel system approach (hierarchies) • Aligned risk evaluation • Safety demonstration • Safety requirements Spec. • Guidance integrated part • Clear linkage to TSI

  9. EN 50126-1 New General 1: Scope 2: Normative reference 3: Terms & Definition 4: Abbreviation 7: RAMS Life cycle 8: Safety Case 6: Management of Railway RAMS – general requirements 5: Railway RAMS Normative New New Annex B Examples of parameters for railway Annex D Guidance on system definition Annex C Risk Management Calibration and risk acceptance categories Annex A RAMS Plan Informative Bibliography

  10. EN 50126-2 General 1: Scope 2: Normative reference 3: Terms & Definition 4: Abbreviation 8: Risk Assessment 7: Organisation and independence of roles 5: Safety Process Normative 10: Apportionment of functional safety integrity requirements 9: Specification of system safety requirements 11: Design & Implementation 6: Safety Demonstration Bibliography Annex A ALARP, GAME, MEM Annex D Safety Target Apportionment methods Annex B Using failure and accident statistics to derive a THR Annex C Guidance on SIL Allocation Informative

  11. Products in CENELEC process EN 50126 • Provide the overall process for development of products • Lifecycle • Hazard identification and management • Safety requirements identification and apportionment • Safety target (THR, TFFR, SIL) • Implementation evidence • Documentation 50129/50128 • Provide the process for development of products • Tailored system/hardware/software development process • Detailed analysis of failure and hazard control • SIL demonstration • Product specific implementation evidence • Product specific documentation

  12. EN 50129 General 1: Scope 2: Normative reference 3:Definition 4: Overview 8: Acceptance and subsequent phases 6: Requirements for external elements 7: Safety Case 5: Requirements for Developing electronic systems Annex C HW component failure modes Normative Annex B Management of faults Annex E SIL-based techniques Annex A Safety Integrity Level (SIL) Annex F Programmable Components Bibliography Informative

  13. CSM-RA versus EN50126 CSM-RA • Focus on a change • Significance • Emphasis on hazard identification & control • Hazard normally controlled by well known measures • Independent safety assessor as NSA proxy EN 50126 • Can be applied for changes and products • Always applicable • Life cycle approach in hazard identification and control • Generic control of hazards • Verification and validation process • Independent safety assessor to ensure process • Functional Safety & Safety Integrity • RAM (dependability)

  14. CSM-RA in short Significance evaluation CSM-RA relevant ? Concept Design Imple-mentation EN50126 System Definition The Change in short System definition EN50126 Hazard identification What is the risk? Risk evaluation How to control risk EN50126 Hazard Record EN50126 EN50126 Risk Acceptance Control risk EN50129/EN50128 EN50126 Safety documentation Risk was in control EN50129/EN50128 Safety Documentation

  15. CSM-RA supported by EN50126 The Good Process CSM-RA • The Legal framework • System definition • Risk Management process • Require systematic process • Require documentation for hazard control EN 50126 • Hierarchical system definition model • Detailed risk management process & evaluation principles • The systematic process • Standard lifecycle to be tailored to project • Detailed risk management process • Engineering process requirements • Provide the principles for safety documentation • Safety Case structure • Verification & Validation process

  16. Significant ? Prelim. System Definition EN 50126 lifecycle compared to CSM-RA process 1 Concept Risk Assessment System Definition 2 System definition and Operational Context Risk Analysis Hazard Identification and classification 8 7 4 6 5 9 11 12 3 10 CSM-RA Integration System Acceptance Operation and Maintenance Manufacture Risk Analysis and Evaluation Design and Implementation Architecture and Apportionment of System Requirements Specification of System Requirements De-commissioning and Disposal System Validation Code of Practice Similar Reference System Explicit Risk Estimation Hazard Management Independent Safety Assessment Risk Evaluation vs risk acceptance criteria Safety Requirements Demonstration of Compliance with Safety Requirement

  17. System Definition Risk analysis Risk evaluation Railway Duty Holder’s responsibility CSM-RA Proposer • System requirements • Safety Measures & Safety requirements • Code Of practice • Reference system • Functional/technical/context Legal framework Contractual Arrangement Additional Hazards Application Conditions Hazard Hazard CENELEC System Actor Sub System Supplier’s Responsibility Hazard analysis Demonstration of compliance Products

  18. System definition Contextual Requirements The operational environment Functional Requirements What the system shall do Technical Requirements Ensure the system function

  19. HazardIdentification & acceptance Code Of Practice Interface Hazards Lack of Hazards Reference system HZ Explicit Risk Evaluation Hazard HZ HZ HZ Reference HZ Code of Practice (3) Hazard CENELEC HZ Hazard Hazard HZ Hazard Code of Practice (2) Hazard HZ Code of Practice (1) Hazard HZ HZ Reference System definition Interface Hazards Interface Hazards

  20. Example Hazards CSM-RA Hazard related to Specific Appl. Trains too close - > separate EN50126 Specific Appl. Block sections Indicate free/occupied Axle counter Specific indicate free while occupied Generic ApplicationSC Hazard related to Generic Appl. EN50129 EN50128 Generic Product SC Failures/Hazards in Product

  21. Proposer’sHazard Record Safety Demonstration CSM-RA System Defintion CSM-RA Safety Dcoumentation CLOSE CENELEC CENELEC Register EN50126 Allocation of hazards Specific Appl. Safety Case(s) Log Specifc log CENELEC EN50126 System Defintion Implementation Generic Appl. Safety Case(s) EN50129 EN50129 Register Generic Product Safety Case(s) Supplier Hazard Log EN50128

  22. Application of Cenelec standards on system/Subsystem level Hazards identified in CSM-RA Hazard Hazard Hazard EN 50126 systematicprocess System SUb SystemIntegration EN 50129 System Integration Hardware Software EN 50128 Software developmentprocess SIL requirement EN 50129 Hardware developmentprocess

  23. HazardRates & SIL - principle Safety functionality Hazardrate Hazards Hazard not controlled by system Hazard not fullymitigated Functional Hazardrate System Failure Safety Integrity (SIL) Functional Safety System

  24. Safety Integrity SIL Qualitative Measures SIL Quantitative Target (TFFR) Quality Management Conditions Safety Management Conditions Technical Safety Measures Demonstration of Quantitative Targets Compliance to the Safety Integrity measures Compliance to Basic Integrity measures

  25. CSM-RA & Safety Case CSM-RA CENELEC What is done Executive summary System description System definition Introduction 1 Definition of System QA System description 2 Quality Management Report QA Audit Safety Plan 3 Safety Management Report Risk Management Safety Management Audit 4 Technical Safety Report Hazard Log (activities) 5 Hazard Record Hazard Log (register) Related Safety Cases Evidence of implementation 6 Conclusion Safety requirements Safety Analysis

  26. Feedback on RAMS into risk analysis Operation, Maintenance Performance Monitoring 11 Concept 1 Concept 1 2 System Definition and Operational Concept 2 System Definition and Operational Concept 10 System Acceptance Safety Case Decommissioning Risk Analysis and evaluation 3 Risk Analysis and evaluation 3 12 Specification of System Requirements 4 System Validation 9 Specification of System Requirements 4 System Validation 9 5 8 Architecture & Apportionment of Sys. Req Integration 5 8 Architecture & Apportionment of Sys. Req Integration Control of RAMS Requirements Design and Implementation 6 Manufacture 7 Design and Implementation 6 Manufacture 7

  27. V & V independence arrangements Project Management Independent of project Independent Safety Assessor Validator Design Verifier SIL 4 / SIL 3 (Vital) OR Independent Safety Assessor Project Management Independent of project Verifier Design Validator Independent Safety Assessor SIL 2 / SIL 1 Basic Integrity Project Management Validator Design Verifier

  28. CENELEC & CSM-RA New EN 50126 & EN 50129 • No Contradiction with CSM-RA – but a good Code of Practice for the process • CENELEC -> provide the good practice • Fill-in on products

  29. Thank You Questions ? Stig Munck SGM@ramboll.dk +45 5161 6375 End slide

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