Professional Documents
Culture Documents
Irqb Guideline 3 Maintenance Rev01
Irqb Guideline 3 Maintenance Rev01
MAINTENANCE
2020 / rev. 01
English
This document and its contents are protected. This document contains confidential proprietary
information. The reproduction, distribution or communication of this document or any part thereof,
without express authorization is strictly prohibited. Offenders will be held liable for the payment of
damages.
1 Introduction ...................................................................................................................... 6
2 Normative references ......................................................................................................... 7
3 Terms and definitions ......................................................................................................... 7
3.1 Terms and definitions for the rail sector.............................................................................. 7
3.2 Abbreviations.................................................................................................................. 9
4 Context of the organization ................................................................................................. 9
4.1 Understanding the organization and its context ................................................................... 9
4.2 Understanding the needs and expectation of interested parties ............................................. 9
5 Leadership .......................................................................................................................10
5.1 Leadership and commitment ............................................................................................10
5.1.1 General ......................................................................................................................10
5.1.2 Customer focus............................................................................................................10
5.3 Organizational roles, responsibilities and authorities ...........................................................10
5.3.1 Organizational roles, responsibilities and authorities – Supplemental ..................................11
6 Planning...........................................................................................................................11
6.1 Actions to address risks and opportunities .........................................................................11
6.1.3 Actions to address risks and opportunities – Supplemental ................................................11
6.1.4 Contingency planning ...................................................................................................11
6.2.3 Safety objectives ..........................................................................................................12
6.3 Planning of changes ........................................................................................................12
7 Support ...........................................................................................................................12
7.1 Resources......................................................................................................................12
7.1.1.1 General - Supplemental ..............................................................................................12
7.1.2 People........................................................................................................................13
7.1.3 Infrastructure..............................................................................................................13
7.1.4 Environment for the operation of processes ....................................................................13
7.1.5 Monitoring and measuring resources ..............................................................................13
7.1.5.2 Measurement traceability...........................................................................................13
7.1.5.3 Monitoring and measuring resources - Supplemental .....................................................13
7.1.6 Organizational knowledge - Supplemental .......................................................................14
7.2 Competence ..................................................................................................................14
The aim of this guideline is to define the specificities of the maintenance business required to
comply with the requirements of IRIS Certification® rev. 03 system. It guides and supports the user in
preparatory work for the implementation of the ISO/TS 22163 requirements with a focus on
maintenance.
The guideline describes all key topics or names their references, which might be worked on for a
successful implementation of the IRIS Certification® rev. 03 system in a maintenance organization.
The focus is on the ISO/TS 22163 requirements and the assessment methodology with key elements
like knock-out criteria as well as the activities declared as mandatory, which are to be prepared in
advance.
The details on
• the technical requirements can be found in the ISO/TS 22163 “Railway applications – Quality
management system – Business management system requirements for rail organizations:
ISO 9001:2015 and particular requirements for application in the rail sector”.
• the certification process and the assessment methodology can be found in the IRIS
Certification® Conformity assessment.
The guideline structure is following the ISO high level structure to support and enhance the
understanding of the user. It can be used in conjunction with the ISO/TS 22163. The content
concentrates on the ISO/TS 22163 clauses, where rail maintenance specifics are identified, or where
explanation is needed.
In the annex, the user finds a comparison of existing regional maintenance regulations, such as
Regulation (EU) 2019/779 [4] for the European system of certification for Entities in Charge of
Maintenance (ECMs) with the IRIS Certification® rev. 03 system.
To emphasize the key areas a maintenance organization may focus on, the related mandatory
requirements on Knock-out, process, Key Performance Indicators and retained documented
information, which are assessed every year during a third-party audit, and in this document
highlighted with following symbols for better visualization:
Maintenance in the rail sector is necessary in order to guarantee the safety, availability and comfort
of the customer. It also enhances the products during their lifetime.
Maintenance activities are performed either by railway operators, system integrators, equipment
manufacturers or by private maintainers.
Maintenance within the IRIS Certification® rev. 03 system, is an IRIS activity, which covers fleet
maintenance, refurbishment and component overhaul/repairs. It may include maintenance (for new
built: manufacturing) and/or design activities on track (infrastructure) and on board (rolling stock)
systems.
The guideline content is a recommendation based on good practices from the rail sector experts and
methods and is not subject to be audited by any third-party audit as a mandatory requirement.
2 Normative references
IRIS Certification® Rules for achieving and maintaining IRIS Certification® recognition
Conformity
assessment
Corrective maintenance carried out after fault recognition and intended to put an item
Maintenance into a state in which it can perform a required function
[SOURCE: EN 13306:2010, 7.5]
Keeper natural or legal person that, being the owner of a vehicle or having the
right to use it, exploits the vehicle as a means of transport and is
registered as such in a vehicle register.
[SOURCE: Interoperability Directive (EU) 2016/797, 2 (21)]
Repair physical action taken to restore the required function of a faulty item.
[SOURCE: EN 13306:2010, 8.10]
Supplemental: Measures taken to restore the original operational state of
components and systems.
Turtle the Turtle diagram is a tool to visually display process characteristics and
other high-level information to assist in the effective execution and
improvement of business processes.
[SOURCE: IRIS Certification® Conformity assessment:2020, Appendix 5]
As per ISO/TS 22163 requirement, management reviews (see clause 9.3) have to take place regularly
to ensure the understanding of issues influencing the organization and its context.
5 Leadership
5.1 Leadership and commitment
5.1.1 General
Main focus of this area is the commitment and leadership of the top management in respect to the
quality management system towards planned and unplanned maintenance activities. Top
management should include in their planning human resources, infrastructure, logistics, materials
for a certain percentage of additional works and/or deferred work.
Customer’s requirements should also be understood in terms of the product life cycle. For example:
mileage expectations of a wheel set.
Customer focus can be demonstrated at different levels (e.g. ranging from operational maintenance
activities to account management at executive level).
5.2 Policy
The maintenance activity should be integrated in the company policy. Safety targets should be in
correlation with the policy.
The different actors and their duties in the maintenance process are:
• The keeper of the fleet is responsible for ensuring that the vehicle is in a safe state for
operation,
• The operator is responsible for the safe operation of the product and ensures the availability
of the product for maintenance,
- - - - Mandatory
6 Planning
6.1 Actions to address risks and opportunities
Risks and opportunities may be understood at different levels, e.g. business and technical. At business
level a SWOT analysis may be used and at technical level an FMEA or FMECA may be used to identify
risks. It is recommended to link the FMEA and FMECA as an input to the FAI to determine criteria and
to use a multi-disciplinary approach when assessing risks and when feasible involve customers.
One risk assessment method can be the process FMEA as a minimum per product family. Relevant to
the scope of maintenance and agreements with customer (e.g. administration, packaging,
transportation, cleaning, disassembly, etc.).
• information technology,
• infrastructure interruptions,
• labour shortage,
• key production equipment,
• transportation
Due to potential localization of equipment, the organization may implement actions to ensure the
continuity of the maintenance at own location or at any maintenance workshop.
More details can be found in ISO 22301 [3] Business continuity management.
The organization should have a risk management approach to manage changes in the maintenance
file including maintenance plans, equipment, processes, organization staffing or interfaces. The
decision for change is taken by knowing all consequences for the customer and the maintainer. The
full supply chain is generally involved when a design change is validated.
Depending on the type of change, e.g. obsolescence, system upgrade, the applicable as built and
validation file is the basis for analysis of a change request. It is key that the file is up to date.
The change should be validated according to the defined process in the business management system
to keep the safe operational state of the product / system.
7 Support
7.1 Resources
Resources form a key cornerstone in a maintenance organization , including people and
infrastructure. Top management commitment and leadership as specified in clause 5 of the ISO/TS
22163 need to be ensured especially for maintenance resources.
- Mandatory - - Mandatory
Key roles for continuous operations and business critical activities are to be identified and included in
the contingency planning.
7.1.3 Infrastructure
The meaning of infrastructure in this clause also include the facility at which maintenance activities
are performed - or in case of mobile teams - the equipment and tools needed to perform the
maintenance activities. There is also an option where external maintenance staff is using the
customer’s infrastructure or facilities.
The driver for selecting maintenance location and the infrastructure of the facility to be used is the
content of the maintenance plan.
All infrastructure, including facilities and equipment, are adapted, qualified, validated and maintained
in order to be in line with the requirements of the maintenance plan.
If equipment is found unfit for its purpose, then a risk assessment should be carried out.
More details about requirements for measurement systems can be found in the ISO 10012 [1].
- Mandatory - - Mandatory
- Recommended - - -
Intellectual property should be protected. In case intellectual property is owned by other parties (e.g.
contractor developed training materials), some sharing restrictions should be considered.
This organizational knowledge specific to products should be communicated and shared with the OEM
respectively (see clause 8.3.3).
This knowledge may permit greater availability of the products, costs efficiency and optimization of
the maintenance tasks.
7.2 Competence
Maintenance activities requiring special/specific qualifications and competences are identified by the
organization. The execution of maintenance activities needs the allocation of staff with the
appropriate competence(s), e.g. skills matrix.
Competence management should be supported by a training plan to ensure the updates of
skills/qualifications as required. Refresher training (especially for safety-related tasks) or practical
exam could be ways to keep awareness and up to date skills, especially for operators managing special
processes to keep up to date knowledge and sufficient level of awareness of risks identified.
A focus is put on qualifications on special processes and activities with expiry dates (e.g. welding,
bonding, non-destructive testing). These qualifications are to be followed up and recurring trainings
are to be organized before authorizations expire.
The IRQB Guideline 6: Special processes [10] contains further details regarding required
competences.
Authorizations are necessary to carry out some tasks after specific trainings are provided (e.g.
electrical, lifting, special processes, etc.). Therefore, qualification/authorisation could be visualized
using skill matrices, or adequate electronic tools.
The organization ensures that the teams have the needed competences on maintenance activities as
such. Shared knowledge in a team should be fostered to avoid unique knowledge.
Therefore, competence management should apply to all staff (including to temporary workers or in
case of delegation of tasks/outsourcing) within the organization.
7.3 Awareness
Raising awareness within the organization requires the implementation of soft skills and tools.
Examples of
• tools could be 8D training, quality circle and employee town hall meeting
Field service, customer complaint, accidents, internal failure information, audit result should be used
as training inputs to raise awareness of employees.
7.4 Communication
Knock-out Process Mandatory process Key Performance Retained documented
requirement for performance Indicators information
evaluation
- Recommended - - -
The organization should put in place communication strategies with all relevant stakeholders.
Efficient maintenance management requires good communication and a reliable exchange of
information between all involved parties. An exchange of information should be organized in a regular
basis and as required for the status update of the maintenance activities between the maintenance
manager within the maintenance organization. This would focus on the exchange of information about
operational, organizational and technical topics of maintenance, such as
The heads of the maintenance are responsible for providing their respective organizations with
maintenance-related information in a reliable, timely, comprehensible and easily accessible form
before the application. It is suggested to implement a communication matrix.
An external exchange of information with owners, railway operators and railway infrastructure
operators about the status of the maintenance should take place on a regular basis.
The responsibilities for managing documented information is defined, including clear interfaces, based
on the contractual requirements e.g. technical library.
7.5.3.2
Knock-out Process Mandatory process Key Performance Retained documented
requirement for performance Indicators information
evaluation
- - - - Mandatory
- Mandatory - - Mandatory
- Mandatory - - Mandatory
The process considers what controls are necessary to ensure that its requirements are met, e.g. risk
assessment, possibly jointly with the outsourcing company, passing down relevant customer
requirements, defining roles and responsibilities, whether a FAI is to take place, how the outsourced
work will be supervised and monitored, defining maintenance documented information to be
produced and retained. Activities that may be outsourced could include cleaning, special testing
services and overhaul of OEM systems.
Even when outsourcing the organization is still responsible for quality and product safety.
The requirements defined in the clause 8.1.2 Tender management from the ISO/TS 22163 and the
related parts of the IRIS Certification® Conformity assessment are applicable for maintenance
organizations.
The requirements defined in the clause 8.1.3 Project management from the ISO/TS 22163 and the
related parts of the IRIS Certification® Conformity assessment are applicable to maintenance
organizations.
The organization defines and documents which maintenance activities have to be handled as projects
with milestones and stage gates (e.g. refurbishment). When using a gate review process, the criteria
for passing to the next stage should be pre-defined.
More details about guidance for project management can be found in the ISO 21500 [2].
- - - Mandatory -
- - - - Mandatory
A proper configuration management allows an organization to have control over the status and
version of hardware (e.g. bill of materials, spare parts, drawings) and software that are required to be
• the vehicle configuration is handed over by the manufacturer to the maintenance provider
• a configuration list is created from the system at the time of delivery of a new vehicle
• this vehicle-related configuration list is archived in the vehicle file for each vehicle in the
configuration folder
• the configuration of the vehicle should be maintained from the start of operations.
Additionally, the software configuration of the vehicle and subsystems is included and maintained in
the vehicle configuration list e.g.:
In this configuration list, the vehicle configuration as well as the software versions of the vehicle and
the subsystems are requested.
The procurement and archiving of the vehicle configuration is the responsibility of the maintenance
organization.
A risk assessment is required to assess the implications of installing any alternative hardware or
software.
The configuration management process helps to keep situations under control where different
versions of similar material/software are installed.
A typical maintenance requirement may be updating and maintaining the technical configuration and
technical library and software during the life cycle of the material and rolling stock. This requires a
process to be in place to ensure that all updates and changes are captured in the technical library.
Detailed information can be found in the IRQB Guideline 8: Configuration and change management
[12].
Where there is a related contract, the change process is closely aligned so that the implications on
maintenance of the products/systems changes can be fully assessed.
The impact of the change on maintenance activities (and OEM production if applicable) should be
analysed (risk assessment) and the implementation organized adequately. Triggers for change might
be technical, organizational and operational.
Detailed information can be found in the IRQB Guideline 8: Configuration and change management
[12].
- - - Recommended -
For all maintenance contracts, a communication plan should be defined including the definition of
responsible persons for communicating with the customer and who are the customer contacts in
certain situations.
There may be different points of contact for different situations, e.g. for operational matters,
engineering matters and for formal correspondence. SPOC may be a good practice. The
communication may include an escalation process for the resolution of problems. Such a
communication plan will help prevent misinformation and delays.
For maintenance contracts, it is recommended to have a 24 hour “on-call” plan for the communication
and resolution of urgent issues that may affect customer operations e.g. concessions.
• Mandatory standards,
• Specific customer requirements,
• Customer’s operational requirements,
Customer requirements may also include RAMS and LCC commitments and, for example, managing
obsolescence.
- - - - Mandatory
The organization ensures that the requirements for its maintenance products or services are clearly
defined and understood, that risks are assessed, and it has the ability to comply when either:
It may also be appropriate to include all the confirmed contract requirements in a contract
management plan/database, which will include the descriptions of the requirements, timescales and
the person responsible for the fulfilment of the requirements. This can then be reviewed on a regular
basis with deviations recorded and correction action planned.
If appropriate, maintenance requirements can be defined in a maintenance plan, which may include
the following information:
The organization defines and documents, which maintenance activities should be handled as design
and development activities.
Note that maintenance engineering is not considered as a design and development activity even
though modernisation usually does include some design and development activity.
Within the IRIS Certification® rev. 03 system, Design and development is an IRIS activity, which could
be certified stand alone. Therefore, the maintenance organization defines if it is within its scope.
When designing and developing a maintenance product or service, the organization takes the
following factors into account as early as possible in the design and development process
• obsolescence issues,
Additionally, the design authority should be clearly defined at an early stage for safety related
decisions.
If the organization is introducing new technologies such as a new maintenance technique or process
— e.g. automated inspection — the organization should perform a process FMEA before the
implementation.
In case a maintenance organization has only the IRIS activity maintenance (not Design and
development) the interfaces (remote functions, manufacturer) should be considered and
documented.
- Mandatory - - Mandatory
In case of corporations, where certain activities are performed by internal functions (e.g. qualification
of sub-suppliers may be done by the central department) not belonging to the maintenance
organization, these activities have to be considered by the maintenance organization and documented
respectively, including all interfaces.
The full EPPPS process is reflected and fulfilling the respective requirements of the ISO/TS 22163.
When making use of contractors or external providers for safety related products and services, the
organization has processes in place to verify at the time of selection that contractors, subcontractors
and external providers are competent.
The organization has processes to monitor the awareness of external providers and contractors of
risks they may introduce to the organization´s operation.
As a minimum, the basic principles for this process is clearly defined, known and allocated in the
contract between the contracting parties: responsibilities and tasks relating to railway safety issues,
obligations relating to the transfer of relevant information between both parties and the tracea bility
of safety related documents.
Examples of safety related products and services can include maintenance, upgrade, overhaul,
refurbishment and spares supply for the following parts:
• bogies,
• braking systems,
• coupling systems,
• signalling systems,
• components installed in freight wagons used for the transportation of dangerous goods.
to ensure that relevant maintenance requirements from its customer are passed down to the
subcontractor.
Relevant maintenance requirements could include overhaul specifications, drawings, technical library
obligations, LCC and RAMS, obsolescence management, protection and segregation of customer
material and/or tooling.
For a maintenance organization, the process might reflect that the product or service provision may
take place at facilities owned by the customer or third parties and that it may need to control property
(e.g. trains, systems, components) owned by the customer or operator.
- Mandatory Mandatory - -
Special processes are often used in maintenance activities. Therefore, the special process itself and
also the qualification of the respective personnel needs to be managed. See clause 7.2 Competence.
- - - - Mandatory
The organization should have suitable methods/systems for identification (e.g. QR code, RFID) and
traceability (avoid mixing up different components within a batch).
8.5.4 Preservation
The organization should have documented specifications for the preservation of its materials and
components. Preservation may include for example holding parts for inspection after repair or
overhaul, preserving accident damaged components for investigation, overhaul of sensitive
components or systems in a clean air room.
- Mandatory - - -
In a maintenance setting, examples of these activities may include ongoing requirements to maintain
a technical library, warranty commitments, ongoing spare parts supply, FRACAS, accident repairs,
technical support, asset disposal and archive of maintenance records.
It is recommended that clear points of contact are communicated for these activities.
- - - - Mandatory
In a maintenance environment, the control of changes is important for many reasons (e.g. change of
equipment, procedures, organization, staffing, interfaces and configuration to ensure clear
traceability of change) and it is therefore recommended that the organization demonstrates it has a
process to document the review, approval and implementation of changes (see clause 8.1.5).
It should be ensured that certain changes (e.g. safety relevant products, operationally/technically
critical changes) might be approved with the FAI also by the manufacturer of the system being
maintained, upgraded or refurbished.
Based on the maintenance plan materials, resources, competences and facilities ' requirements are
defined.
Due to the nature of maintenance activities, unplanned corrective maintenance may be required and
there should be consideration of this aspect in the plan.
The organization should review its schedule constantly for possible bottlenecks and other risks that
may affect the ability to meet customer requirements, e.g. lack of spare parts, equipment, resources.
Stakeholders may expect a KPI for monitoring production capacity utilization that should be
implemented according to the clause 9.1.1.1.
Application software or planning tool may be helpful in improving this process by identifying the
critical path and to implement changes in customer requirements as they may occur in time.
- - - - Mandatory
The organization should have a method/system to check, that the performed maintenance tasks are
in accordance with the maintenance orders and to issue a documented notice (including any possible
faults or defects regarding safety) to the customer. The handover of the product/system after
maintenance and the verification that the product/system is able to re-enter into service should be
agreed with the customer.
Responsibility for validating that the maintenance work has satisfactorily been completed is clearly
defined.
- - - Mandatory Mandatory
The organization controls the identification and resolution of non-conforming outputs in the provision
of its maintenance activities.
In such cases the organization may have a documented process (see clause 8.7.3) for identifying and
communicating the requirements for a concession as well as recording the decision and when the
concession expires.
The organization also ensures that it plans the correction of the non-conformance in cooperation with
the customer.
The organization should use an application software to record all non-conformities and concessions
to ensure that follow-up actions are completed on time and there is a record of return of experience.
Where the organization is not responsible for maintaining the product, then it can plan for the
collection and reporting of actual RAMS/LCC data from operations.
People responsible for RAMS/LCC have competences in failure reporting system such as FRACAS.
The organization should consider using its FAI process during its maintenance activities in case of:
- Mandatory - - -
The risk of obsolescence is high during a long lifetime of a maintained product/system. Therefore,
obsolescence needs to be managed.
The organization identifies, as early as possible, the potential sources of obsolescence of the product
to be maintained, develop mitigation actions, assign responsibility and define the budget.
The organization can obtain commitments from its external provider to adopt the same approach and
includes a review of their obsolescence plan in the regular external provider meetings. This is to be
included within an obsolescence management plan as part of an overall obsolescence strategy.
The maintenance organization should also ensure that it reviews and understands any obsolescence
requirements contained in the contract.
- Recommended - - -
The process describes how and when the organization systematically reviews its own external
environment and the external environment of its customers and stakeholders, how it identifies ideas
to address any identified opportunities and threats, how the ideas are prioritized and developed, who
are the key stakeholders and how they will be involved in the innovation process.
In case certain aspects of innovations are not carried out by the maintenance organization, interfaces
(remote functions, manufacturer) are considered and documented.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
Reliability and availability should to be tracked, if applicable. This applies to new or refurbished
product/systems.
Maintenance-related empirical data from operations can be generated from the information of
railway operators and infrastructure operations and empirical data from maintenance is derived from
reports of internal maintenance providers.
The performance evaluation is set up in line with the maintenance contract and tuned with business
processes such as budgeting.
- - - Mandatory -
Goals, targets and KPIs are defined and deployed in the organization.
There should be a good mix of KPIs that are used to prove compliance and to steer the organization.
The collector of customer satisfaction data should ensure the transfer of information to departments
or organizations involved in maintenance.
The organization should have methods/systems to collect and share field experience data, especially
with the manufacturer.
When defining the necessary skills of auditors (see clause 7.2), in addition to the basic requirements,
the country specific regulatory requirements, maintenance specifics (products, services) and special
processes (see also IRQB Guideline 6: Special Processes [10]) should also be considered.
- - - - Mandatory
The management of the organization is to be informed about maintenance activities and the results
of those activities in the management review.
10 Improvements
10.1 General
Potential sources of improvement and methods for a maintenance organization could be based on:
• use of information about investigations and causes of accidents, faults, near-accidents and
other hazardous events, as required by other standards,
• reports/information from other relevant sources, such as general and specialist media, are
consulted and considered,
- Mandatory - - Mandatory
[4] Regulation (EU) 2019/779 Laying down detailed provisions on a system of certification of
entities in charge of maintenance of vehicles pursuant to Directive (EU) 2016/798 of the
European Parliament and of the Council and repealing Commission Regulation (EU) No
445/2011
Predictive condition based maintenance carried out following a forecast derived from
Maintenance repeated analysis or known characteristics and evaluation of the significant
parameters of the degradation of the item [5] 7.4
Deferred corrective maintenance which is not immediately carried out after a fault
Corrective detection but is delayed in accordance with given rules [5] 7.6
Maintenance
Immediate corrective maintenance that is carried out without delay after a fault has
Corrective been detected to avoid unacceptable consequences [5] 7.7
Maintenance In IRIS sometimes called as “Containment Maintenance”
Temporary Repair physical action taken to allow a faulty item to perform its required function
for a limited time interval and until a repair is carried out [5] 8.11
Accidental Repair Repair of an item that has been damaged in case of an accident
Rebuilding / Rebuilding: action following the dismantling of an item and the repair or
Refurbishment replacement of those sub-items, that are approaching the end of their
useful life and/or should be regularly replaced [5] 8.14
Supplementary: Refurbishment: Quality-assured renovation and repair of
items (components and vehicles) to an as-built state so that they can be put
to further use – without changing function.
Each of the stakeholders now bears it share of responsibility for rail transport safety.
Maintenance provider Responsible for the safe operational state of the vehicle
www.irqb.org | [email protected]