ERA guide for application of the Common Safety Methods ... - Europa

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INDEPENDENT ASSESSMENTSystem Definition Review in functionof the identified Safety RequirementsHAZARD IDENTIFICATIONAND CLASSIFICATIONHAZARD MANAGEMENTEuropean Railway AgencyGuide for the application of the CSM Regulation PRELIMINARY SYSTEMDEFINITIONSignificantChange?YESSYSTEM DEFINITION(Scope, Functions, Interfaces, etc.)RISK ASSESSMENTHAZARD IDENTIFICATION(What can happen? When?Where? How? Etc.RISK ANALYSISHAZARD CLASSIFICATION(How critical?)BroadlyAcceptableRisk?NOYESSelection ofRisk AcceptancePrincipleCODES OF PRACTICEApplication ofCodes of PracticeSIMILAR REFERENCESYSTEM(S)Similarity Analysiswith ReferenceSystem(s)EXPLICIT RISK ESTIMATIONIdentification of Scenarios &associated Safety MeasuresQualitativeSafetyCriteria?QuantitativeEstimateFrequencyEstimateSeverityEstimateRiskImplicit Risk Acceptance Criteria (RAC)(Conditions to fulfil by CoP & Ref. Syst.)Comparisonwith CriteriaComparisonwith CriteriaExplicit Quantitative orQualitative RAC requiredCriteria requiredRISK EVALUATIONComparisonwith CriteriaNOAcceptableRisk?NOAcceptableRisk?NOAcceptableRisk?YESYESYESSafety Requirements(i.e. the Safety Measuresto be implemented)Demonstration ofCompliance with theSafety RequirementsFigure 3: Risk management framework in the CSM Regulation {Ref. 2}. Reference: ERA/GUI/01-2008/SAF Version: 1.1 Page 26 of 54File Name: Guide_for_Application_of_CSM_V1.1.docEuropean Railway Agency ● Boulevard Harpignies, 160 ● BP 20392 ● F-59307 Valenciennes Cedex ● France ● Tel. +33 (0)3 27 09 65 00 ● Fax +33 (0)3 27 33 40 65 ● http://www.era.europa.eu
European Railway AgencyGuide for the application of the CSM Regulation 1.1.2. This iterative risk management process:(a) shall include appropriate quality assurance activities and be carried out bycompetent staff;(b) shall be independently assessed by one or more assessment bodies.[G 1] The application of the risk assessment process is triggered by a change that is categorisedas significant (see Figure 3). The iterative risk management process finishes with theacceptance by the proposer of the significant change based on the safety assessment reportprovided by the assessment body for the system under assessment (see Article 7 (1)). Afterthat, if during the system operation and maintenance another change appears necessary,the significance of the change needs to be considered. If the change is deemed significant,the CSM needs to be applied for that new change.[G 2] A definition for "staff competence" is given in point [G 2](b) in the explanation of Article 3.1.1.3. The proposer in charge of the risk management process required by this Regulationshall maintain a hazard record according to section 4.[G 1] Additional explanation is not judged necessary.1.1.4. The actors who already have in place methods or tools for risk assessment maycontinue to apply them as far as they are compatible with the provisions of thisRegulation and subject to the following conditions:(a) the risk assessment methods or tools are described in a safety managementsystem which has been accepted by a national safety authority in accordance withArticle 10(2)(a) or Article 11(1)(a) of Directive 2004/49/EC, or;(b) the risk assessment methods or tools are required by a TSI or comply with publiclyavailable recognised standards specified in notified national rules.[G 1] According to recital (4) in the Railway Safety Directive {Ref. 1}, "safety levels in theCommunity Rail System are generally high … It is important that safety is at the very leastmaintained during the current restructuring phase… ". Actors who already have methods inplace for risk assessment can continue to apply them as long as they are compatible with theprovisions laid down in the CSM Regulation. Any risk assessment process already in placeand not compliant with the CSM will need to be revised to ensure that it meets therequirements of the CSM.[G 2] The terms "methods or tools" refers to "processes, techniques or tools" (e.g. HAZOP, PHA,Event Trees, Fault Trees, FMECA, etc.) which can be applied for meeting the requirementsdefined by the common process of the CSM. Therefore, as long as those processes,techniques and tools already in place are compatible with the provisions of the CSM they cancontinue to be used. Human factor analysis or human reliability analysis techniques andtools need also to be considered in this way. Reference: ERA/GUI/01-2008/SAF Version: 1.1 Page 27 of 54File Name: Guide_for_Application_of_CSM_V1.1.docEuropean Railway Agency ● Boulevard Harpignies, 160 ● BP 20392 ● F-59307 Valenciennes Cedex ● France ● Tel. +33 (0)3 27 09 65 00 ● Fax +33 (0)3 27 33 40 65 ● http://www.era.europa.eu
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ERA guide for application of the Common Safety Methods ... - Europa

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