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

European Railway AgencyGuide for the application of the CSM Regulation 5. EVIDENCES FROM THE APPLICATION OF THE RISKMANAGEMENT PROCESS5.1. The risk management process used to assess the safety levels and compliance withsafety requirements shall be documented by the proposer in such a way that all thenecessary evidence showing the correct application of the risk management process isaccessible to an assessment body. The assessment body shall establish its conclusionin a safety assessment report.[G 1] The number of documents the proposer may produce for documenting the risk managementprocess is not imposed by the CSM. It is up to the proposer to decide how to structure thisdocumentary evidence: see point [G 1] in section 5.2. The purpose of the evidence from therisk management and risk assessment activities is to enable:(a) the development of the change under assessment;(b) independent assessment by assessment bodies;(c) in case of any problem during the system life-cycle, to be able to go back into theassociated safety analyses and safety records for understanding the reasons havinglead to decisions: see point [G 4] in section 5.2;(d) the reuse of the system under assessment as a reference system for other applications.5.2. The document produced by the proposer under point 5.1. shall at least include:(a) description of the organisation and the experts appointed to carry out the riskassessment process,(b) results of the different phases of the risk assessment and a list of all the necessarysafety requirements to be fulfilled in order to control the risk to an acceptable level.[G 1] The term "document" in section 5.2 of the CSM is to be read as the documentary evidenceproduced by the application of the risk management process in the CSM rather than a "singlephysical document". Section 5.2 tells what the minimum documentary evidence is necessaryto enable the assessment body (-ies) to check the correct application of the CSM. How tofulfil this requirement is not imposed. Freedom is left to each actor involved in the systemunder assessment to use its own structure for the documentation, specified by their internalquality management and safety management system/process (where relevant), provided thatat least:(a) the organisation put in place to carry out the risk assessment process is clearly set outbeforehand;(b) the experts involved in the risk assessment process have the proper competence. Adefinition for "staff competence" and "expert judgement" is given in points [G 2](b) and[G 2](c) in Article 3;(c) the results of the different phases of the risk assessment process are clearlydocumented;(d) the list of all the necessary safety requirements to be fulfilled, in order to control the riskat an acceptable level, is established.[G 2] When evidence is not available, justifications need to be provided to and assessed by theassessment body.[G 3] Once a project is completed, the outcomes of the risk management and risk assessmentprocess will either be incorporated into the system or, if necessary, will become part of therisk control system for the RU and IM under their safety management system. Reference: ERA/GUI/01-2008/SAF Version: 1.1 Page 52 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