The role of the Notified Body in the European rail industry

Railway Interoperability Directives (96/48/EC, on the interoperability of the Trans-European High-speed network, and 2001/16/EC, on the interoperability of the Trans-European Conventional network, both as amended by 2004/50/EC) are changing the way that railway fixed infrastructure, the rolling stock that runs on it and certain key components are designed, assessed and accepted into service. These changes are happening across Europe. Notified Bodies have a key role in these new, common European, processes.

I am often asked; “What is a Notified Body?” Perhaps I should not be so surprised because of the very small but key role that Notified Bodies play in the day to day issues that affect railway undertakings.

With this article, I give a brief overview of Notified Bodies, what they are and what they do and a brief overview on NB Rail, their coordination body.

Notified Bodies… What are they?

In simple terms, Notified Bodies are organisations that are appointed by Member States and notified to the European Commission to undertake a defined scope of verification activities against one or more European Directives.

Notified Bodies are not new. They have been required since 1985 and are the development of New Approach Directives. In general, Notified Bodies are required for pre-market conformity assessment of products against essential requirements of Directives, in particular, where there is high risk.

Notified bodies must meet certain criteria. They are subject to scrutiny by the Member States that appoint them. Notified Bodies must meet criteria for:

• Independence
• Impartiality
• Freedom from incentive and pressures
• Access to resources
• Competence
• Insurance
• Confidentiality
• Participation in their coordination group

Rail Interoperability?

The Interoperability Directives aim to promote a network of technically compatible railway structural subsystems to enable the safe and uninterrupted movement of trains across the Trans-European Rail Network. This also has benefits in enabling harmonised railway equipment to be traded across the European market without national restrictions.

The Interoperability Directives define ‘essential requirements’ for railway sub-systems (trains, signalling, infrastructure, etc). These must be met before new, upgraded or renewed works are placed into service and before key components, necessary for Interoperability (Interoperability Constituents) are placed on the market. Technical Specifications for Interoperability (TSIs) support the Directives by setting mandatory specifications that satisfy these essential requirements. Notified Bodies independently check, on behalf of the body responsible for developing a structural subsystem with the intent to bring it into service (the Contracting Entity) or the Manufacturer of an Interoperability Constituent, that these technical specifications have been met.

What do Notified Bodies do?

For Rail Interoperability, they

• Verify conformity of structural subsystems, (generally, before bringing into service)
• Compile Structural Subsystem Technical files (This is a departure from most directives where it is normal for the Notified Body to base its assessments on the basis of a technical file compiled by the manufacturer of the product under assessment)
• Assess Conformity and Suitability for use of some Interoperability Constituents, (generally, before they are placed on the market)

Contracting Entities must employ a Notified Body to carry out Verification of new, upgraded and major renewals of Structural Subsystems, before they seek authority to bring them into service. This authority must be obtained from the Member State where the subsystem is to be used.

A necessary evil?

Once employed, a Notified Body:

• Will scrutinise the design, manufacture, assembly, testing, commissioning and, sometimes, in service performance
• May make surprise visits
• May be critical
• May delay introduction
• May even refuse to issue a certificate and, to make things worse, they will tell the world (Notified Bodies have a duty to inform all other Notified Bodies of certificates requested, issued and refused)
• Finally, they have to be paid for causing all of this bother

It is not surprising that Manufacturers and Contracting Entities are reluctant to employ Notified Bodies. Prospective clients may perceive Notified Bodies as an unnecessary burden, which add little value. However, a principle aim for Interoperability is to reduce costs.

Notified Bodies must satisfy both their clients and their appointing Member State in order to stay in business.
A Notified Body is governed by a fine balance. On one side, there is government regulation. Member State appointment involves rigorous and regular reassessment against the appointment criteria. If a Notified Body fails to meet the defined criteria, its Member State can withdraw its appointment without appeal. This side of the balance tends towards a rigorous, high cost approach.

On the other side there is commercial pressure. Once appointed a Notified Body can operate in any Member State. There are currently, in excess of, thirty Railway Interoperability Notified Bodies with various scopes of appointment. Notified Bodies are commercial organisations. They must compete with their peers to win work. This side of the balance tends towards less rigour and reduced costs.

Details of all Notified Bodies are published on the EC’s Nando website₁.

Can Notified Bodies add value?

Where Contracting Entities and Manufacturers work closely with their Notified Body, they have demonstrated conclusively that Notified Bodies can add value.

Notified Bodies are on the side of the Contracting Entity or Manufacturer – they have to be or they will not win future work. They provide competent, independent and impartial assessments, which can lead to a smooth entry into service or placing on the market. They also give ensured independent, competent assurance that a product is indeed compliant with the essential requirements of the Interoperability Directives, including safety. They are fair but firm, ensured through monitoring by Member States and competition.

Notified Bodies look for evidence of compliance not fault. Where deficiencies are present, the Notified Body can provide constructive criticism and help their client meet its obligations under the Directives. As a side affect of their close involvement, Notified Bodies can provide their client with an insight to help identify emerging project risks and assist effective project management.

These positive experiences occur only where clients work closely and cooperate with their Notified Bodies. This involves agreeing what is necessary in advance and making the required evidence available in a form that the Notified Body can use directly when the Notified Body needs it. By working in this way, the cost of assessment and level of intrusion can be minimised.

NB Rail

With conflicting pressures on Notified Bodies, one can see that it is important that they act consistently with consistent results. NB Rail’s purpose is to promote this consistency.

The High-Speed Interoperability Directive originally set up NB Rail under a loose requirement. The amended Interoperability Directives now mandate a coordination group (NB Rail) to discuss any matter regarding Notified Body duties. The European Commission has a duty to propose measures needed to remedy problems raised by NB Rail.

All Notified bodies have an obligation to participate in NB Rail activities. It is one of the criteria set by the Directive. NB Rail also has representatives from the European Commission, Member State observers, the European Rail Agency (ERA) and Standards Organisations.

Some of the NB Rail guidance and answered questions to the European Commission are published on the NB Rail website₂.

In the early days, AEIF, the organisation that drafted the original TSIs, had no formal relationship with NB Rail. NB Rail was excluded from Development of TSIs until the last moment of drafting the first revision of the high-speed TSIs. As a result, many early issues raised by NB Rail have not been resolved.

Recently, things have improved greatly. The mandate for next suite of TSIs is with ERA. ERA has also recently gained a flexible mandate to fix errors in TSIs. NB Rail’s early influence has proved valuable to all parties. There have been close links forged between ERA and NB Rail. ERA has representation on all NB Rail subgroups.

There is one remaining limitation on the relationship between ERA and NB Rail. The European Regulations that set up ERA exclude NB Rail from participating in TSI working groups. NB Rail, however, has a key role in ERA conformity support groups, which should overcome this weakness.

How should Contracting Entities/Manufacturers use Notified Bodies?

If required to do so by the Interoperability Directives, Contracting Entities and Manufacturers must employ a Notified Body. So, they may as well employ them effectively and efficiently. Notified Bodies have a defined duty but that duty must fit within the requirements of their Contracting Entity/Manufacturer client. The client is in charge and has a great deal of power over what the Notified Body can and must do.

The client must determine the physical scope and the method of assessment that the Notified Body must use. The available methods are set in the TSIs as assessment modules, based on Council Decision 93/465/EEC. The TSIs limit the modules that can be used in certain conditions and product type. The modules do not determine what needs to be assessed but only the type of evidence that can be accepted to demonstrate conformity. Modules address either, the design phase, the production phase or both phases of a project. There is also a module that addresses in service experience of Interoperability Constituents. Modules involve either:

• Self assessment by the manufacturer (in this case no Notified Body is employed, this module is available only for low risk products)
• Inspection based assessment
• Quality assurance based assessment

The Contracting Entity/Manufacturer may choose any permitted combination of modules. The most effective choice is that which would result in the lowest cost of assessment. Often, the cost of implementing and assessing a quality assurance system for a simple project or small production run of Interoperability Constituents would be much greater than an inspection based approach. For larger or more complex projects, the sampling permitted by a quality assurance approach may prove the lower cost option. The Notified Body can provide advice on the choice of modules, but the final decision remains that of the Contracting Entity/Manufacturer.

A Notified Body must be employed from the earliest stages of a project. A sure way through the assessment process is to agree jointly what the Notified Body is going to assess and what evidence it will need at the various stages of the project. While the Contracting Entity can define the physical scope of the assessment, the Notified Body must find evidence of compliance with all of the applicable interoperability requirements that apply within that scope before it can issue a certificate. If both parties fully understand what is required and when, surprises can be avoided and costs can be kept to a minimum.

Contracting Entities and Manufacturers need to be fully open, honest and frank about the works under assessment. Often, a Notified Body can help if difficulties arise, for example, where errors or omissions in the TSI affect a project.

Notified Bodies need to be controlled, as does any contractor assigned to a project. Regular exchange of information affecting the assessment process is vital to success.

The future

The harmonised specifications and common assessment process will, in time deliver cost savings for the rail industry. However, it is early days for Interoperability and there are some hurdles to overcome, for example some TSIs have known errors, some are incomplete and some have yet to be drafted. While gaps exist in the TSIs, there will remain a need for National specific requirements and National specific assessments.

The common assessment process and the Notified Body certificates are recognised throughout the European market. Methods are developing, such as the use of Interim Statements of Verification that reduce the need for repeated assessment of identical work. Instead, the Interim statement and the associated content of the technical file can, in theory, be passed on and used by subsequent Notified Bodies.

The common assessment process, in itself should lead to cost savings. Much bigger savings, however, should stem from Interoperability through the economies of scale and greater market brought about by technical harmonisation of railway equipment.

References

1. http://ec.europa.eu/enterprise/ newapproach/nando
2. http://circa.europa.eu/irc/nbg/nbrail/ info/data/en/information/nbrail/ 00nb%20rail%

About the author

Stephen Gaskill is President of NB Rail. He is technical manager for two Railway Interoperability Notified Bodies within the Lloyd’s Register Group, Lloyd’s Register Verification Ltd and Lloyd’s Register NL BV. Prior to joining Lloyd’s Register Stephen was a Principal Inspector with Her Majesty’s Railway Inspectorate.