Safety Management System
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Common safety methods for Risk assessment  
 
Differences in the assessment and acceptance of changes in the railway system have been an obstacle to cross border operations and approval of railway products in different Member States. A risk based approach with a harmonisation of assessment methodologies will contribute to improving mutual recognition.
 
This CSM gives a harmonised framework for the risk assessment process through the prescription of Hazard Identification, Risk Analysis and Risk Evaluation. The regulation gives a broad framework for the use of risk assessment methodologies to assess changes to the railway system. It allows the proposer, without prescribing any order of priority, to use interchangeably among three risk acceptance principles already in place such as acknowledged codes of practice and reference systems, or explicit risk estimation for the acceptance of the risks related to the change.
 
The revision of the first Regulation (EC) N°352/2009 on the CSM for risk assessment clarifies the requirements for the independent assessment body referred to in Article 6 of that Regulation. The Commission Implementing Regulation (EU) N°402/2013 repeals Regulation (EC) N°352/2009 from 21st May 2015. It defines the criteria to be fulfilled by the assessment body and the necessary requirements for the accreditation or recognition of its competence in order to achieve a similar quality of independent assessment regardless on whether the assessment body is accredited or recognised.
 
The Commission Implementing Regulation (EU) N°2015/1136 amends the earlier Commission Implementing Regulation (EU) N°402/2013 and completes the revision of the CSM for risk evaluation and assessment initiated by the Commission Decision of 12.10.2010 (the Mandate).
 
Regulation (EU) N°2015/1136 comes into force on Monday 3rd August 2015. It marks a significant step forward in creating a common approach to safety across the EU railway system. The Regulation sets out harmonised design targets for technical systems which should help with mutual recognition of those systems across the EU. The Regulation should foster the sustainability of EU railways and permit a safe railway competition with other modes of transport by making the development costs of technical systems proportionate to the risk associated with their failures.
 
The agency will now complete the guidelines for helping the railway actors to implement properly the CSM by adding a technical guide related to the Regulation  (EU) N°2015/1136 and additional Information regarding the Commission Implementing Regulation (EU) N°402/2013.

 

 Documents

 
Publication date Title
14-07-2015In accordance with Article 6(1) and (2) of Directive 2004/49/EC, the Commission has published the Regulation (EU) N°2015/1136. It amends the earlier implementing Regulation (EU) N°402/2013 on the CSM for risk evaluation and assessment, on the basis of the recommendation of the European Railway Agency. Regulation (EU) N°2015/1136 completes the revision of the CSM for risk evaluation and assessment initiated by the Commission Decision of 12.10.2010 (C(2010) 6931 final) (the Mandate).
12-05-2015This is an explanatory note on the main requirements to be fulfilled by the assessment body defined in Article 6 of the CSM for risk assessment. It does not contain any legally binding requirements.
19-03-2015In accordance with Article 6(2) of Directive 2004/49/EC and the Commission Decision of 12.10.2010 (C(2010) 6931 final) (the Mandate), the European Railway Agency has revised the common safety method on risk evaluation and assessment which is expected to amend the Commission Implementing Regulation (EU) N°402/2013. The revision of this CSM was based on the development and validation of further harmonised risk acceptance criteria that may be used to assess the acceptability of risks arising from failures of technical systems when the proposer chooses the explicit risk estimation principle. These criteria are intended to support the mutual recognition between Member States of TSI compliant structural sub-systems and vehicles in compliance with Article 15 of Regulation (EU) N°402/2013. To distinguish the acceptance of risks associated with technical systems from the acceptance of operational risks, and of the overall risk at the level of the railway system of either a Member State or the EU, the terminology ‘risk acceptance criteria’ with respect to technical systems is changed into ‘design targets’ for such technical systems’. The revision was led by the European Railway Agency with the support of Members of the working group which initially developed the Regulation (EC) N°352/2009 on the CSM for risk assessment, the NSA network members and all representative bodies (CER, EIM, UIP, UNIFE, i.e. railway undertakings, infrastructure managers, private wagon keepers and manufacturers).
29-10-2014This Agency draft recommendation falls in the scope of the Commission Decision of 12.10.2010 (C(2010) 6931 final) on a mandate to the European Railway Agency for the revision of Commission Regulation N°352/2009 on the common safety method (CSM) for risk evaluation and assessment. Although there was a consensus that harmonised risk acceptance criteria for technical systems are needed to support the mutual recognition of TSI compliant structural sub-systems and vehicles, in 2012 the majority of the stakeholders could not agree on the proposed RAC-TS. Based on the developments achieved on the roles and responsibilities of the CSM assessment body, referred to in Article 6 of Regulation N°352/2009, in 2012 the Agency submitted then to the Commission a recommendation for revising only the assessment body part of the CSM . This resulted in the adoption of Regulation N°402/2013 that repeals Regulation N°352/2009 with effect from 21 May 2015. Between 2012 and 2014, the Agency worked closely with all stakeholders who wanted to take part actively to the validation of the RAC-TS, including the members of the working group on the CSM for risk assessment, the NSA network members and all representative bodies (CER, EIM, UIP, UNIFE, i.e. railway undertakings, infrastructure managers, private wagon keepers, manufacturers). The scope of application of the RAC-TS and the working method for the validation were agreed with the stakeholders. To avoid confusion between RAC-TS and any other type of risk acceptance criteria (e.g. operational or organisational RAC) used in risk assessments, the terminology is changed into CSM design targets (CSM-DT) for technical systems. A summary of the development and of the validation of those harmonised CSM design targets (CSM-DT or former RAC-TS) is given in the related documents below. This Agency draft recommendation on the amendment of Regulation 402/2013 represents the view of the majority of the stakeholders and experts who took part to the validation of the harmonised CSM-DT (former RAC-TS). Please use the following e-mail address era-con-2014-04-saf@era.europa.eu to return your comments to the Agency by at latest 31/12/2014, using the form below for "Review Comments".
08-07-2014Invitation, Draft Agenda and Directions to the venue of the 2nd Workshop on Risk Evaluation and Assessment in the context of rail, road and inland waterways Transport of Dangerous Goods.
02-09-2013In accordance with Article 6(2) and 6(4) of Directive 2004/49/EC, and on the basis of the recommendation of the European Railway Agency, the Commission adopted the Regulation 402/2013 on the CSM for risk assessment that repeals Regulation 352/2009.
02-09-2013On 25th-26th June 2013 in Lille the "1st Workshop on the development of RAC-TS and the experience with the application of the CSM RA" took place. Here you can download the slides from the presentations given during the workshop.
05-02-2013The CSM for Risk Assessment needs further harmonised Risk Acceptance Criteria (RAC) than the one, which is already existing in point 2.5.4 of its Annex I. This present RAC refers only to failures of functions of technical systems, which have potential to lead directly to catastrophic consequences. To address also the point of the acceptance of risks related to human interactions within the railway system, the ERA has launched the "Study on the Assessment and the Acceptance of Risks Related to Human Interactions within the European Railways".
05-02-2013The CSM for Risk Assessment (from 2009) presently contains one explicit harmonised Risk Acceptance Criteria (RAC), which can be found in point 2.5.4 of its Annex I. In the years until 2012 the working groups of the Agency have been trying to make a suggestion for a recommendation of further RAC for technical systems to be included in the revision of the CSM for Risk Assessment (in 2013). In the end of this development process, no agreement could have been achieved between the National Safety Authorities and the Representative Bodies (CER, UNIFE, UIP, EPTTOLA, EIM). Consequently, no RAC could have been proposed for this revision. The underlying document is a first information note on this subject on the side of ERA. It explains the intention for the way forward with the development of explicit harmonised RAC for technical systems. It sets also a proposal for the regulatory text for a future revision of the Regulation. This proposal will have to be validated by the European railways in the near future. For questions, hesitations AND validation inputs, please do not hestiate to contact the responsible project officers of ERA at: rac@era.europa.eu .
06-07-2012In accordance with Article 6(4) of Directive 2004/49/EC and the Commission Decision of 12.10.2010 (C(2010) 6931 final) (the mandate), the European Railway Agency has revised the common safety method on risk evaluation and assessment which is expected to repeal the Commission Regulation N°352/2009. The revision of this CSM was based on the following inputs: • the experience gained with the application of Regulation N°352/2009 since its adoption; • developments of the taskforce on the roles and responsibilities of the CSM assessment body; • developments of the taskforce on risk acceptance criteria (RAC) to be required and mutually accepted for the design of technical systems. The revision was led by the Agency with the support of a dedicated "revision taskforce" and of the working group for CSM on risk evaluation and assessment, which initially developed the existing Regulation N°352/2009. As compared to the existing regulation, the current revision clarifies mainly the requirements for the independent assessment body referred to in Article 6 of Regulation N°352/2009. It defines the criteria to be fulfilled by the assessment body and the necessary requirements for accreditation or recognition of its competence in order to achieve a similar quality of independent assessment regardless on whether the assessment body is accredited or recognised.
08-03-2012This is a consultation of the revision by the European Railway Agency of the Commission Regulation N°352/2009 on the common safety method (CSM) on risk evaluation and assessment based on both the experience gained from the use of that regulation and further developments on roles and responsibilities of assessment bodies.
19-02-2010The objective is to summarise and highlight the main characteristics of the associated "Commission Regulation on a Common Safety Method on risk evaluation and assessment" (EC) N° 352/2009 published in the Official Journal on 29th of April 2009
04-02-2010Generic Presentation given during workshops on dissemination of the CSM on risk assessment. ERA examples are contained
22-01-2010The Agency has let a contract with Det Norske Veritas Limited (DNV), the purpose of which was to research and report on the usage of risk acceptance criteria in various industries.
26-06-2009Terms of reference for dissemination of EC regulation on risk assessment (2009/352/EC)
06-01-2009Guide for the application of the Commission Regulation on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of the Railway Safety Directive
06-01-2009Collection of examples of risk assessments and of some possible tools supporting the CSM Regulation on risk assessment
16-12-2005Mandate to the European Railway Agency for the development of the first set of Common Safety Methods
 
 

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  • Dragan Jovicic
    Project officer
    +33 (0) 32 70 96 558
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