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Safety regulations

About this topic


Railway safety has improved along the years through different steps. First, the focus was on technical reliability, then on the formalisation of processes (Safety Management Systems or SMS) but for several years, it has become of prime importance to integrate human and organisational factors (HOF) in order to continue to maintain and improve safety performance.

Relevance to rail

With the aim of developing and continuously improving railway safety, when practicable, the EU 4th Railway package reinforced the obligation to take HOF into account. This approach includes elements for railway undertakings and infrastructure managers:

(a) the development of a strategy and the use of expertise and recognised methods from the field of HOF;

(b) identifying and analysing all operational, organisational and technical risks relevant to the type, extent and area of operations carried out by the organisation. Such risks shall include those arising from HOF such as workload, job design, fatigue or suitability of procedures, and the activities of other interested parties;

(c) addressing risks associated with the design and use of equipment, tasks, working conditions and organisational arrangements, taking into account human capabilities as well as limitations, and the influences on human performance;

(d) managing the safety risks associated with physical assets throughout their lifecycle, from design to disposal, and fulfil the human factors requirements in all phases of the life cycle;

Moreover, the Railway Undertakings and Infrastructure Manager shall, where appropriate, contractually oblige the other actors (as referred to in Article 4.4 of Directive 2016/798) having a potential impact on the safe operation of the Union rail system to implement risk control measures, and ensure that their contractors implement risk control measures.

Approaches and models

Concerning the railways, the main EU legislation that specifically refers to HOF is composed of:

– Directive 89/391 on the introduction of measures to encourage improvements in the safety and health of workers at work;

– Directive 2016/798 on railway safety that imposes to railway undertakings and infrastructure managers to integrate HOF in their safety management system (and ensure that their contractors implement risk control measures);

– Regulation 2018/761 establishing common safety methods for supervision by national safety authorities after the issue of a single safety certificate or a safety authorisation which indicates that the NSA shall identify in the supervision strategy risk areas for targeted supervision activities, including those emerging from the integration and management of HOF;

– Regulation 2018/762 establishing common safety methods on safety management system requirements that has reinforced this latter obligation by imposing to include HOF in risk assessment and mandating the demonstration from the organisation to have a systematic approach to integrating HOF within their SMS.

– Regulation 2020/572 on the reporting structure to be followed for railway accident and incident investigation reports that includes HOF.

Other requirements linked to HOF are included in the EU regulatory framework such as in the technical specifications for interoperability, the train driver directive and the regulation on certification of ECM.

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