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Guidance for Use of CSM Recommendation - ERA - Europa

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European Railway Agency<br />

Collection <strong>of</strong> examples <strong>of</strong> risk assessments and <strong>of</strong> some possible tools<br />

supporting the <strong>CSM</strong> Regulation<br />

<br />

(c) the design and the implementation <strong>of</strong> the technical system, including if applicable the<br />

configuration or parameterisation <strong>of</strong> a generic product to specific requirements <strong>of</strong> the<br />

specific application;<br />

(d) the supporting documentation necessary <strong>for</strong>:<br />

(1) the development <strong>of</strong> the technical system;<br />

(2) the operation and maintenance <strong>of</strong> the technical system;<br />

A.3.4.2.<br />

The notes associated to this definition specify further the scope <strong>of</strong> the technical system:<br />

(a) "The development <strong>of</strong> a technical system starts with its requirements specification and<br />

ends with its safety approval". It includes the phases 1 to 10 <strong>of</strong> the V-Cycle<br />

represented in Figure 10 <strong>of</strong> the CENELEC 50 126-1 Standard {Ref. 8};<br />

(b) "It shall consider the design <strong>of</strong> relevant interfaces with human behaviour. Human<br />

operators and their actions are however not included in a technical system."<br />

Although the human factor errors during the operation and the maintenance <strong>of</strong> the<br />

technical system are not part <strong>of</strong> the technical system itself, the design <strong>of</strong> the interfaces<br />

with the human operators needs to take them into account. The purpose is to minimise<br />

the probability <strong>of</strong> human errors due to a poor design <strong>of</strong> the relevant interfaces with the<br />

human operators;<br />

(c) "Maintenance is not included in the definition, but is included in maintenance<br />

manuals." This means that the RAC-TS needs not be applied to the operation and<br />

maintenance <strong>of</strong> the technical system; these rely strongly on processes and actions<br />

per<strong>for</strong>med by human personnel.<br />

However, in order to support the maintenance <strong>of</strong> technical systems, the technical<br />

system definition must include any relevant requirements (e.g. periodic preventive<br />

maintenance, or corrective maintenance in case <strong>of</strong> failures), with a sufficient level <strong>of</strong><br />

details. But how the maintenance needs to be organised and achieved on the related<br />

technical system is not part <strong>of</strong> the technical system definition but in the corresponding<br />

maintenance manuals.<br />

A.3.4.3. See also section A.3.1. in Appendix A.<br />

A.3.5.<br />

A.3.5.1.<br />

A.3.5.2.<br />

A.3.5.3.<br />

Functions <strong>of</strong> Technical Systems to which RAC-TS applies<br />

According to the definition <strong>of</strong> the RAC-TS, it applies to wrong side failures <strong>of</strong> the functions to<br />

be fulfilled by the technical system if they have "a credible direct potential <strong>for</strong> a<br />

catastrophic consequence": see section 2.5.4. in {Ref. 4}.<br />

The RAC-TS can also be applied to functions that involve technical systems but whose<br />

failures do not have a "direct potential <strong>for</strong> a catastrophic consequence". In this case, the<br />

RAC-TS needs to be applied as an overall target <strong>for</strong> the set <strong>of</strong> events that leads to the<br />

catastrophic consequence. Based on this overall target, the actual contribution <strong>of</strong> each<br />

event, and thus <strong>of</strong> the functional failures <strong>of</strong> the technical system that is involved in the<br />

considered scenario, need to be derived according to section A.3.6. in Appendix A.<br />

Such a use <strong>of</strong> the RAC-TS needs still to be discussed and agreed on with the <strong>CSM</strong> working<br />

group.<br />

To what functions <strong>of</strong> the technical system does the RAC-TS apply? According to the IEC<br />

61226:2005 standard:<br />

(a) a function is defined in this context as a "specific purpose or objective to be<br />

accomplished that can be specified or described without reference to the physical<br />

means <strong>of</strong> achieving it";<br />

<br />

Reference: <strong>ERA</strong>/GUI/02-2008/SAF Version: 1.1 Page 64 <strong>of</strong> 105<br />

File Name: Collection_<strong>of</strong>_RA_Ex_and_some_tools_<strong>for</strong>_<strong>CSM</strong>_V1.1.doc<br />

European 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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