Professional Documents
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IRIS
International Railway
Industry Standard
GUIDELINE 6 : 2014
SPECIAL PROCESSES
English
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We would like to thank the following people for the excellent cooperation and contribution, without which this Guideline would not have been
possible:
Special Processes
SWG members Technical Forum for IRIS Management Centre
Improvement representatives
Laurent Dastas
Alstom Transport Angela de Heymer (Leader) Hans van Mulekom Bernard Kaufmann
Marco Vannucchi UNIFE Nedtrain IRIS General Manager
AnsaldoBreda David Martinez Andrea Anfosso Angela de Heymer
Dr.-Ing. Gerald Holst AENOR RINA IRIS Senior Manager
Bombardier Transportation Anne Pouyanne Ekaterina Bochkareva Kujtesa Hajredini
Nicole Harlan AFNOR Russian Register IRIS Manager
CAF Jean-Christophe Coulaud Susanne Schaub Maxime Schaub-Crouan
Francis Alliot Alstom Transport SBB/CFF/FFS IRIS Technical Coordinator
Faiveley Transport Dario Montefusco Bernd Diekmann Marcos Mendez
Wolfgang Emgen AnsaldoBreda Siemens Transportation & UNIFE Operations Manager
Gutehoffnungshütte Radsatz Giuseppe Greco Logistics
GmbH Bombardier Transportation Ludivine Francart
Andreas Glastetter Mikael Lindstrom SNCF
Knorr-Bremse Bureau Veritas Kay Jürgensen
Ekaterina Bochkareva Wolfgang Domke TÜV NORD
Russian Register DEKRA Riccardo Lasagna
Angela de Heymer Hans Jahn TÜV Rheinland
UNIFE DQS Alexander Rathiens
Bernard Kaufmann Thomas Beck TÜV SÜD
UNIFE DNV GL Bernard Kaufmann
Benoit Guillon UNIFE
Faiveley Marcus Schmid
Rüdiger Mesterheide VOITH TURBO
Hanning & Kahl
Oliver Stein
Knorr-Bremse
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Guideline 6 : 2014
SPECIAL PROCESSES
1 INTRODUCTION • Riveting
• Surface treatment (painting, shot peening, coating,
The aim of this guideline is to achieve a common
corrosion protection)
understanding and support the management of special
• Torque tightening
processes in our sector. It explains the specificities
• Welding (including soldering and brazing)
of special processes required to comply with the IRIS
requirements.
If there are special requirements regulated by
international or national standards or legal regulations,
2 PURPOSE
these requirements need to be fulfilled.
The purpose of this guideline is to give guidance and
examples for the implementation of IRIS requirements This guideline focusses on the fundamentals of all
and recommendations concerning special processes. special processes. Annexes for specific special processes
will amend this guideline.
Special processes play a key role in the rail sector
regarding e.g. safety, quality. Therefore their
appropriate management through all projects phases
and the whole value chain is necessary.
3 TERMS, DEFINITIONS, ABBREVIATIONS qualification and the related records are assessed
through the verification of a K.O. question (IRIS, ANNEX
For the purposes of this guideline in general, the terms,
4 and IRIS Questionnaire #7.5.2-3).
definitions and abbreviations given in ISO 9000 and IRIS
apply.
In addition, IRIS requires a Process (IRIS Questionnaire
Terms in this guideline beginning with capital letters are
#7.5.2-4) to be established within the Organization’s
listed and defined in ANNEX 5 of the IRIS booklet.
BMS in order to control special processes, including
qualification, approval prior to use and any subsequent
According to the rail sector’s understanding of special
changes to ensure proper outcome of the process.
processes, the following definition applies:
using an Ishikawa diagram. (Ishikawa, Kaoru (1956). coordinator is external (subcontracted), an internal
Guide to Quality Control. Tokyo: JUSE). Ishikawa deputy should also be included in the designation.
diagrams are causal diagrams that show the potential
The relationship between the special process
causes resulting in a specific event.
coordinator and the management representative
(IRIS chapter 3, clause 5.5.2) should be defined and
communicated. The relationship among locations
within the same organization that may share the same
special processes should be defined.
During this validation the correct application of the change in the input elements (see clause 6) mandates
qualified special process(es) should be checked as well a new or revised qualification (see clause 6.1.3) and
as the ability to produce the expected results. These process validation (see clause 6.1.4).
checks are performed throughout the entire process
A revised qualification may include complete or partial
(before, during and after).
testing that justifies the change. If no further testing
If the product is considered critical (see risk is carried out, the justification for no testing should be
management) during the process, destructive test may recorded.
be necessary to complete validation.
When a qualified special process is substituted by
another in the manufacturing or maintenance of a
6.1.5 PROCESS CONTROL AND MONITORING
product, a new process validation (see clause 6.1.4)
The organization should ensure constant monitoring of needs to be carried out.
the input elements and the special process, considering
the outcome of the risk analysis (see clause 6.1.2), e.g. 6.1.8 TRANSFER MANAGEMENT
control sheets, inspection plans…
This clause describes aspects of change management
In addition to the outcome of the process (product of released (qualified and validated) special processes
characteristics) the organization should choose key under the following conditions:
process indicators for the monitoring of a stable
• Different location (factory)
process. If there are significant deviations in these key
• Same product technical specification
process indicators the organization should analyze
the reasons, even if product characteristics are in the The special process coordinator at the original location
limits. The results of this investigation may be used for should be informed of the location change. All released
continuous improvement purposes. documentation corresponding to the qualified special
process should be transferred to the new location.
6.1.6 NONCONFORMITY MANAGEMENT
The special process coordinator at the new location
The special process coordinator needs to be involved in should review the documentation to ensure it can
nonconformity management in the special process. The be correctly applied at the new location. If not, new
degree of involvement required should be documented, special process qualification(s) should be carried out.
and take into account the severity of the nonconformity
A new process validation (see clause 6.1.4) needs to be
(e.g. rework, repair, reject, …), product criticality and
carried out at the new location.
contract requirements.
Qualification tests are supervised or approved against a These requirements apply for internal and external
recognized standard by the special process coordinator personnel.
or authorized delegate. Qualification approval may
be given by the special process coordinator or by an 6.3 MACHINES
external accredited examination body, if applicable.
The input element “Machine” refers to all equipment
The same requirements apply for internal and external and tools that affect the special process.
personnel.
The equipment and tools, which are required to
6.2.1.2 Operator skill matrix perform the special processes, are to be defined and
regularly maintained.
Organizations with a more mature level of special
process control consider additional criteria when Handling, capability, capacity, ergonomic and HSE
assigning operators to tasks or workstations. These aspects, TPM (autonomous and planned preventive
criteria may include: maintenance), calibration or verification requirements
and cost should be considered when defining
• Professional experience,
equipment and tools in order to ensure a consistent
• Participation in coaching and training programs,
special process output with the expected quality level.
• Manual dexterity.
A capability study is recommended to ensure that the
For this purpose, an operator skill matrix is
equipment and tools can deliver the parameters which
recommended. This matrix may reflect minimum
are required by the process, in a reproducible and
qualification requirements for a given task or work
repeatable manner.
station as well as other criteria considered relevant by
the organization. Equipment and tools critical to special process output
should be traceable, so that affected products can be
6.2.2 SPECIAL PROCESS COORDINATOR identified in case of non-conformity.
• Air currents
• Air quality
• Cleanliness
• Contamination sources
• Humidity
• Lighting
• Noise
• Radiation
• Temperature and temperature gradients
• Vibration
• etc.
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