An important addition to the regulatory regime is the introduction of the
Common Safety Method on risk evaluation and assessment (the CSM RA). The CSM RA has applied since 01 July 2012 to all significant changes to the mainline railway system – ‘technical’ (engineering), operational and organisational.
The CSM RA defines a common European risk management process. Its use is mandatory for all significant changes to the mainline railway system.
Commission Regulation (EC) No 352/2009 of 24 April 2009 on the adoption of a common safety method on risk evaluation and assessment was replaced by
Regulation 402/2013 of 30 April 2013. This was in turn amended with
Regulation 2015/1136 of 13 July 2015, which introduces design targets (CSM-DT). Guidance on applying the CSM RA has been produced by both ORR and RSSB (see below). More general guidance on how companies in the rail industry take decisions that affect safety can be found in
Taking Safe Decisions.
The following Rail Industry Guidance Notes have been published, aimed at those who are required to undertake an application of the CSM RA process in their work.
There are six complementary Rail Industry Guidance Notes (GNs):
The ORR has also produced
guidance on the application of the CSM RA and a 'policy statement on the relationship between the CSM REA and other risk assessment requirements'
(Rail Guidance Document RGD-2013-06
The diagram below (click on image to enlarge) shows the scope of each GN mapped to the diagram of the CSM RA risk management process.
CSM RA risk management process
It should be noted that:
- The CSM RA applies to all significant changes to the mainline railway system – ‘technical’ (engineering), operational and organisational. The GNs are equally appropriate for engineering changes and operational changes. Guidance on organisational changes is provided at Annex 4 of the
ORR guidance on the application of the CSM RA. More guidance on organisational changes will be developed in due course.
- Commission Regulation No 352/2009 requires the application of the process in the CSM RA for ‘significant change’ to the mainline railway system. However, even if its use is not required by law, it represents a good process for assessing and managing risk, and as such the processes are suitable for building into a company’s safety management system more generally.
revised CSM RA (Commission Implementing Regulation No 402/2013) was published in the Official Journal of the European Union on 03 May 2013 and came into force on 23 May 2013. Therefore, a proposer may use the revised CSM RA if they wish.
The revised CSM RA will apply from 21 May 2015; this is the date on which the revised CSM RA must be used.
The principal amendments in the revised CSM RA relate to the recognition and accreditation of Assessment Bodies. The ORR guidance will be amended in due course.
Design Targets for the Common Safety Method for Risk Evaluation and Assessment
The Common Safety Methods for Risk Evaluation and Assessment (CSM RA) regulation has been amended to introduce the concept of mutually recognised safety design targets for technical systems.
If the proposer of a change to a technical system can demonstrate that functional failures of the technical system are no greater than the design targets, then the acceptability of the failure rate of these functions is, by definition, mutually recognised in all EU member states. There are two classes of quantified design targets described in the amendment:
- Class (a) design target; this is for functional failures that have the potential to lead to catastrophic accidents. In this case, the risk associated with a technical system does not have to be reduced further if the frequency of the failures of the associated function is demonstrated to be less than or equal to 10-9
per operating hour.
- Class (b) design target; this is for functional failures that might lead to critical accidents affecting a small number of people and resulting in at least one fatality. For these failures the risk does not have to be reduced further if the frequency of the failures of the associated function is demonstrated to be less than or equal to 10-7 per operating hour.
Design targets are intended to be used for the design of Electrical, Electronic and Programmable Electronic (E/E/PE) technical systems. They are not intended for the design of purely mechanical systems.
The new amendment came into force on 3 August 2015. When introducing a new technical system or implementing a change to a technical system, the proposer now has the option to use the design targets, provided that the system has the potential to lead to either catastrophic or critical accidents. Using the design targets is mandatory if the proposer is using the CSM risk acceptance principle of “explicit risk estimation” and wants to have the acceptance of the change mutually recognised in other member states.
We have produced a short guidance note on Design Targets for the Common Safety Method for Risk Evaluation and Assessment.
The Railway and Other Guided Transport Systems (Safety) Regulations(as amended) 2006
Railway and Other Guided Transport Systems (Safety) Regulations 2006 (ROGS) came into force on 01 October 2006. ROGS place a duty on railway undertakings (RUs) and infrastructure managers (IMs) to:
- Develop safety management systems that must meet certain requirements
- Have a safety certificate (for RUs) or a safety authorisation (for IMs)
- Show that they have procedures in place to introduce new or altered vehicles or infrastructure safely
- Carry out risk assessments and put in place the measures they have identified as necessary to make sure that the transport system is run safely
- Work together to make sure the transport system is run safely (ROGS regulation 22).
ROGS (Miscellaneous Amendments) Regulations 2013 came into force on
21 May 2013. The 2013 amendments include:
- The requirement for entities in charge of maintenance (ECMs) of freight wagons to have an ECM certificate
- The removal of the requirement for mainline operators to carry out safety verification under ROGS (this requirement has been superseded by the equivalent requirement in the CSM REA)
- The requirement for controllers of safety critical work to have suitable and sufficient monitoring arrangements in place.
The ORR has published an
unofficial consolidated version of ROGS , showing the amendments from 2006 to 2013.
The ORR has issued a
guide to ROGS and RSSB has issued a
duty of cooperation guide relating to ROGS regulation 22.
The Railways (Interoperability) Regulations 2011
Railways (Interoperability) Regulations 2011 came into force on 16 January 2012. They supersede the earlier Railways (Interoperability) Regulations 2006.
The Railway (Interoperability) Regulations (RIR) 2011 require new, upgraded or renewed structural subsystems or vehicles to be authorised to be placed into service on railway network in the UK. The design has to comply with the relevant Technical Specifications for Interoperability (TSIs) in order to meet the 'essential requirements'. The essential requirements cover health, safety, environment, technical compatibility and reliability.
The DfT has produced a number of
helpnotes to provide guidance on the regulations.
Railways (Interoperability) (Amendment) Regulations 2013 came into force on 01 January 2014. The Amendment Regulations:
- List the amendments to the Railways Interoperability Directive(2008/57/EC)
- Amend the essential requirements to include accessibility
On behalf of the
Industry Standards Coordination Committee (ISCC), RSSB has produced some guidance on the management of engineering change:
Guidance on the principles of the safe management of engineering change. This provides a good foundation for understanding the safe management of engineering change. The guidance is written to be independent of any specific legislative environment.
process map allowing organisations to navigate their way through the relevant legislation and available guidance. The process map provides links to guidance specific to each regulation (for example, ORR's guidance on the CSM on risk evaluation and assessment, and the DfT helpnotes on the Railways (Interoperability) Regulations). The process map is written primarily for organisations involved in the GB mainline railway system and can be used when the proposer (the organisation introducing the change) has decided to make an engineering change.
Guidance to the rail industry on the safe management of engineering change, commonly referred to as Engineering Safety Management (ESM), was provided by a handbook known as the Yellow Book. The Yellow Book was written for people involved in introducing engineering change to the railway.
When need for large-scale revision to the Yellow Book became evident in 2010, ISCC set up a sub-group to consider what guidance existed, and what guidance was needed, related to the safe management of engineering change.
Acting on the recommendations of the sub-group, ISCC decided to withdraw YB4 because it no longer represented up-to-date guidance for the GB mainline railway system. YB4 has been replaced by the guidance on the application of the CSM REA and the management of engineering change, which can be found above.
However, YB4 continues to be available for organisations to use if they wish and can be downloaded via the links in the Standards catalogue. All organisations should note that the guidance contained within it no longer aligns with the current regulatory regime that exists in the GB mainline railway system.