Management of Change
The regulatory regime on the GB mainline railway system
The three principal railway-specific regulations governing the management of change on the GB mainline railway system are listed below. However there are other, general regulations that are applicable (for example, the Construction (Design and Management) Regulations 2015). These regulations and other regulations relating to the legislative framework for the GB mainline railway system can be found on the webpage 'Complying with Legislation'.
The Common Safety Method for Risk Evaluation and Assessment
An important addition to the regulatory regime is the introduction of the common safety method for risk evaluation and assessment (CSM RA). Use of CSM RA is a legal requirement when making any significant change to the mainline railway system.
The CSM RA defines a common European risk management process, and its use is mandatory for all significant changes, whether they are ‘technical’ (engineering), operational or organisational.
The original Commission Regulation (EC) No 352/2009 of 24 April 2009 introduced the requirement for CSM RA and was replaced by Regulation 402/2013 of 30 April 2013. This was in turn amended with Regulation 2015/1136 of 13 July 2015.
The following RSSB Guidance Note on CSM RA is aimed at those who need to undertake an application of CSM RA and steps through the relevant risk management processes.
Related guidance on how companies in the rail industry take decisions that affect safety can be found in the RSSB document Taking Safe Decisions.
Legislation requires the application of the CSM RA process for ‘significant change’ to the mainline railway system. However, even if its use is not required by law, the CSM RA represents good practice for assessing and managing risk, and as such the processes are suitable for building into a company’s safety management system more generally.
The diagram below (click on image to enlarge) shows the scope the CSM RA risk management process mapped to the appropriate parts of the Guidance Note GEGN8646.
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 (available from the Resources section below).
The Railway and Other Guided Transport Systems (Safety) Regulations(as amended) 2006
The 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).
The 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 Railways (Interoperability) Regulations 2011
The 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 interoperability helpnotes to provide guidance on the regulations.
The 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
Guidance on the management of engineering change
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.
- A 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.
What has happened to the Yellow Book?
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.