Guideline 6:

SPECIAL PROCESSES

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.
© 2020. All rights reserved
Table of Contents

1 Introduction ...................................................................................................................... 4
2 Normative references ......................................................................................................... 5
3 Terms and definitions ......................................................................................................... 5
3.1 Terms and definitions for the rail sector.............................................................................. 5
3.2 Abbreviations.................................................................................................................. 5
4 Criticality level of the output................................................................................................ 6
5 Operating method.............................................................................................................. 8
5.1 Management .................................................................................................................. 8
5.1.1 Roles and responsibilities in special process management................................................... 9
5.1.2 Risk Management ........................................................................................................10
5.1.3 Process qualification.....................................................................................................10
5.1.4 Process validation ........................................................................................................11
5.1.5 Process control and monitoring (Indicators).....................................................................11
5.1.6 Nonconformity management.........................................................................................12
5.1.7 Change management....................................................................................................12
5.1.8 Transfer management ..................................................................................................12
5.1.9 Supply chain management ............................................................................................12
5.1.10 Special process audits and inspections ..........................................................................12
5.1.11 Knowledge management.............................................................................................13
5.1.12 Special processes performed by External providers .........................................................14
5.2 Manpower.....................................................................................................................15
5.2.1 Special process coordinator...........................................................................................15
5.2.1.1 Coordinator qualification............................................................................................15
5.2.2 Special process operator ...............................................................................................15
5.2.2.1 Operator qualification ................................................................................................15
5.2.2.2 Operator skill matrix ..................................................................................................16
5.2.3 Other special processes personnel..................................................................................16
5.3 Machines.......................................................................................................................16
5.4 Methods .......................................................................................................................16
5.5 Materials .......................................................................................................................17
5.5.1 Inspection...................................................................................................................17

@ 2020. All rights reserved 2 / 21

5.5.2 Storage and handling conditions ....................................................................................18
5.5.3 Check at the workstation ..............................................................................................18
5.6 Mother nature (Environment) ..........................................................................................18
Bibliography........................................................................................................................19

3 / 21 @ 2020. All rights reserved

1 Introduction

The aim of this guideline is to define the specificities for compliance with the requirements of the
IRIS Certification® rev. 03 system regarding special processes. It guides and supports the user in
preparatory work for the implementation of the ISO/TS 22163 requirements related to special
processes.
Furthermore, it defines and describes the special processes that are relevant to the rail sector and
supports the management of those processes in accordance with the ISO/TS 22163 and IRIS
Certification® Conformity assessment.
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.
Compared to other processes, special processes require special attention as the conformity of the
output is not readily, technically or economically validated. See definition in clause 3. The following
processes are generally considered special processes.
• bonding and sealing,
• casting,
• crimping,
• force fitting or shrink fitting,
• forging,
• heat treatment,
• laminating (composites,…),
• moulding,
• potting (e.g. electronics),
• riveting,
• stress relief treatment,
• surface treatment (painting, coating, chemical and electro-chemical treatment),
• torque tightening/bolt tensioning (for preload application),
• welding (including soldering and brazing),
• 3D printing.
Other processes may be considered.
For the use of this guideline the following three aspects should be considered:
1) Is the process a special process? See clause 3,
2) What is the criticality level of the process output in terms of safety and quality? See clause 4,
3) Is the process carried out internally or externally (external providers)? For external providers
see clause 5.1.12.
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.

@ 2020. All rights reserved 4 / 21

2 Normative references

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”

IRIS Certification® Rules for achieving and maintaining IRIS Certification® recognition
Conformity
assessment

3 Terms and definitions

3.1 Terms and definitions for the rail sector

Special process A process used in manufacturing, construction of infrastructure or

maintenance where the conformity of the resulting product cannot be
readily, technically or economically determined without destructive
analysis prior to use is referred to as a “Special Process”.
NOTE According to ISO 9000:2015, “a process where the conformity of the resulting
output cannot be readily or economically validated is frequently referred to as a
“special process”.

Special process The person who coordinates the special process, see clauses 5.1.1 and 5.2.1.
coordinator

Special process The person who executes the special process, see clause 5.2.2.
operator

Special process A procedure for use in the workstation that describes how to carry out the
instruction special process.

3.2 Abbreviations
The abbreviations given in ISO/TS 22163 apply for the purpose of this document
FAI First Article Inspection

FAT Factory Acceptance Test

FMEA Failure Mode and Effects Analysis

HSE Health, Safety and Environment

IRIS International Railway Industry Standard

5 / 21 @ 2020. All rights reserved

 IRQB The International Rail Quality Board

Mock-up A scale or full-size model of a design

RACI Responsibility assignment matrix, which contemplates the following

participation roles
Responsible, Accountable, Consulted/Contribute, be Informed.

REACH Regulation for registration, Evaluation, Authorization and restriction of

CHemicals

RoHS Restriction of Hazardous Substances in electrical and electronic equipment

TPM Total Productive Maintenance

4 Criticality level of the output

In special processes the following six input elements (6M) need to be rigorously managed to achieve
a consistent output:

• Management,
• Manpower,
• Machines,
• Methods,
• Materials,
• Mother nature (Environment).

Process input elements and output can be represented using an Ishikawa diagram [1]. Ishikawa
diagrams are causal diagrams that show the potential causes resulting in a specific event.

Fig.1: Special process Ishikawa diagram

@ 2020. All rights reserved 6 / 21

The criticality of the output of the special process should be determined considering the impact on
safety and quality (see clause 5.1.2). The criticality level obtained should be considered to determine
the extent of application of this guideline (see Table 1).

Table 1: Special process implementation matrix according to the criticality level of the special process
output

Criticality level of the special process output

Item HIGH MEDIUM LOW 6M Clause
Requirements
review (contractual Review required Management 5.1.1
and internal)
Review required

Design review Coordinator Coordinator Coordinator Management 5.1.1

involvement involvement may involvement not
required be required required

Production
Required Management 5.1.1
planning
Inspection planning Required Recommended Management 5.1.1

Identification & No specific

Required Recommended Management 5.1.1
traceability requirement
No specific
Quality records Required Recommended Management 5.1.1
requirement

No specific
FMEA Required Recommended Management 5.1.2
requirement

Qualification &
validation of special Required Recommended Management 5.1.3
process
Process control &
Required Recommended Management 5.1.5
monitoring
Nonconformity and Required
corrective action Management 5.1.6
management Procedures for rework required Recommended

7 / 21 @ 2020. All rights reserved

 Criticality level of the special process output
Item HIGH MEDIUM LOW 6M Clause
Approval of
Approval of Approval of
special process
special process special process
may be required
required by the required by the
by the
organization or its organization or its
organization or
customer customer
Special process its customer
Management 5.1.12
external provider
Communication
Communication Communication
of requirements
of requirements of requirements
related to special
related to special related to special
process may be
process required process required
required
Special process
Required Manpower 5.2.1
coordinator(s)
Qualification is required
Special process
Skill matrix Manpower 5.2.2
operator(s) Skill matrix recommended
required
Production and
Required Machines 5.3
testing equipment
Preventive
Equipment
(Predictive Preventive Corrective Machines 5.3
maintenance
recommended)
Special process
Required Recommended Method 5.4
instruction(s)
Inspection of base
materials and Control plan required in accordance with risk analysis Materials 5.5.1
consumables
Materials and
consumables
In accordance with manufacturer recommendations Materials 5.5.2
storage and
handling conditions
Environmental
Mother
conditions of the Control plan required in accordance with risk analysis 5.6
nature
workstation

5 Operating method
The management of the special process is key to the output and is therefore described in detail before
the other 5M input elements: Manpower, Machine, Methods, Material and Mother nature.

5.1 Management
The management of the special process influences all of the input elements (see Fig. 1) as well as the
output. Special process management encompasses:
• roles and responsibilities in special process management,
• risk management,

@ 2020. All rights reserved 8 / 21

 • process qualification,
• process validation,
• process control and monitoring (indicators),
• nonconformity management,
• change management,
• transfer management,
• supply chain management,
• special process audits/inspections,
• knowledge management,
• special processes performed by external providers.

If there are special requirements regulated by international or national standards or legal

regulations, these requirements should be fulfilled, when applicable.

5.1.1 Roles and responsibilities in special process management

Within the organization, roles and responsibilities for managing special processes should be defined.
The organization should designate a special process coordinator and this designation should be
communicated to the organization. If the special process coordinator is external (subcontracted), an
internal deputy should also be included to the designation.
NOTE In the rest of the guideline where coordinator is mentioned, the activity may be carried out by the
coordinator’s deputy.

The relationship between the special process coordinator and the organization should be defined
and communicated.
The special process coordinator should be integrated into the organization in a way that allows the
execution of the tasks in the areas of responsibility without any restrictions; the coordinator should
have the required authority to instruct and make decisions, independent from production.
The areas of responsibility of the special process coordinator within the organization should be
documented. These areas of responsibility may include:

• internal guidelines, specifications, procedures and instructions,

• requirement review and feasibility confirmation in tender management,
• validation of special processes content/items in design review phase (if applicable),
• material specifications (including base and consumables materials),
• supply chain management,
• external providers of special processes,
• equipment and tools, including inspection/testing,
• qualification of personnel,
• production planning and start up, especially for new products,
• inspection planning,
• process qualification and validation,
• process and product audits,
• non conformities and corrective actions,
• identification and traceability,
• quality records,
• knowledge management.

9 / 21 @ 2020. All rights reserved

These areas of responsibility may be managed in different ways, for example, via specification,
participation, inspection, approval, control, act of presence, etc. and may be documented using a
responsibility assignment matrix, e.g. RACI.
Complementary roles and responsibilities can be defined according to the relevant applicable special
process standards (e.g. EN 15085, DIN 6701, etc.)

The relationship among locations within the same organization that share the same special
processes should be defined.

5.1.2 Risk Management

When no guidance or standard on the special process is available (e.g. EN 15085, DIN 6701, etc.), the
organization should consider how the input elements (see Fig. 2) and changes in these input
elements impact the output of the special process. The criticality of the input elements should be
determined in this analysis and approved by the special process coordinator.
A typical sequence for a process FMEA analysis is shown in the figure below:

Fig. 2: Sequence for a process FMEA analysis

5.1.3 Process qualification

A special process instruction should be established and include the definition of the input elements
required (5M in Fig.1) to produce a specific output.
Process qualification should fulfil the requirements established in the relevant national/
international special process standard and contract. If such standard does not exist, the special
process coordinator defines the qualification process and criteria.
The organization should issue a process qualification plan, approved by the special process
coordinator, which describes how to qualify a special process.
The qualification is carried out, as a general rule, on a mock-up and/or test pieces and under
industrial conditions to represent the performance of the product/process couple.
The qualification plan should include:

• required qualification documents (e.g. preliminary special process instruction, evaluation

sheet, qualification record),

@ 2020. All rights reserved 10 / 21

 • relevant standards (if applicable),
• identification and storage of mock-ups/test pieces and test records,
• inspection, non-destructive and/or destructive testing methods, including acceptability
criteria,
• range of validity (input elements) of the qualification,
• renewal criteria.

A standard qualification record form should be established. If a standard qualification form exists,
for example, in international or national standards, that form may be used directly.
Qualification tests are to be supervised by the special process coordinator. Qualification approval
needs to be given by the special process coordinator or by an external accredited examination body,
if applicable.

To assist in the determination of range of validity (if none exists), the risk management tools
specified in clause 5.1.2 should be used.

5.1.4 Process validation

The process validation is carried out when the first representative product is manufactured, installed
or maintained, before or as a part of the FAI. Depending on the results of the risk management (see
clause 5.1.2.) further process validations during series production, construction or maintenance may
be required.

During this validation the correct application of the qualified special process(es) should be checked,
as well as the ability to produce the expected results. These checks are performed throughout the
entire process (before, during and after).

5.1.5 Process control and monitoring (Indicators)

The organization should establish appropriate controls of the input elements and special process
considering the output of the risk analysis (see clause 5.1.2), e.g. control sheets, inspection plans, …
In addition, the organization should define and implement indicators to monitor the special process.
Performance indicators (KPIs) are based on quality, time and/or cost performance (IRQB Guideline 1:
KPIs). Because the performance cannot be readily or economically measured in a special process
during series production, the following KPIs are recommended:

• results of product inspection (partial conformity),

• results of destructive testing on series production witness samples,
• feedback from warranty period.

It may be useful to create additional indicators to measure the correct application of the special
process for example:

• results of workstation (5M) inspection,

• results of internal or external audits.
If there are significant deviations in these process indicators the organization should analyze the root
causes, even if the product characteristics are within the required limits. The indicators should be
used for continuous improvement purposes.

11 / 21 @ 2020. All rights reserved

5.1.6 Nonconformity management
The special process coordinator needs to be involved in nonconformity management in the special
process. The degree of involvement required should be documented and take into account the
severity of the nonconformity (e.g. rework, repair, reject, etc.), product criticality and contract
requirements.
Re-qualification, validation and traceability requirements should be defined.

5.1.7 Change management

This chapter describes the aspects of change management of released (qualified and validated)
special processes under the following conditions:

• same location (factory),

• same product technical specification.

The special process coordinator will determine when a change in the input elements (see Fig. 1)
requires a new or revised qualification (see clause 5.1.3) and process validation (see clause 5.1.4).
A revised qualification may include complete or partial inspection or testing that justifies the change.
If no further testing is carried out, the justification for not testing should be recorded.

When a qualified special process is substituted by another one, a new process validation (see clause
5.1.4) needs to be carried out.

5.1.8 Transfer management

This chapter describes aspects of change management of released (qualified and validated) special
processes under the following conditions:

• different location (factory),

• same product technical specification.

The special process coordinator at the original location should be informed of the location change.
All released documentation corresponding to the qualified special process should be transferred to
the new location.
The special process coordinator at the new location should review the documentation to ensure it
can be correctly applied at the new location. If not, new special process qualification(s) should be
carried out.

A new process validation (see clause 5.1.4) needs to be carried out at the new location.

5.1.9 Supply chain management

The organization should ensure that the requirements for material and services used in special
processes (including base materials and consumables) are fully described in the purchase order or
associated specification. The organization should ensure that these requirements are acknowledged
by the external provider.
These requirements should be communicated and verified through the supply chain.

5.1.10 Special process audits and inspections

Special process audits and/or inspections should be performed internally. Two cases are given in the
following table:

@ 2020. All rights reserved 12 / 21

 Name Special process quality audit Special process workstation
inspection
Aim Evaluate whether the special process has Evaluate the correct application of the
been designed, qualified and validated special process at the workstation
correctly prior to launching series
production
Scope Special processes as they apply to: Special process inputs (5M methodology):
- product design planning - input documentation / data
- process design planning - operators competence and
- product design qualification
- process design - inspection of materials and
- risk analysis for process design consumables
- special Process design (5M - machines maintenance
methodology) - control and measuring
- roles and mandates resources
- design reviews - storage and handling
- special Process qualification conditions
- special process validation - environment
- FAI Special process outputs
- change management Quality records
- knowledge management
- performance evaluation
- continuous improvement
Reference ISO/TS 22163 Special process instruction
documentation IRQB Guideline 6: Special processes (Manufacturing or Construction or
Organization Quality Management System Maintenance)
When In accordance with risk analysis and/or Periodic inspection based on risk analysis
applicable requirements and/or indicators and/or indicators

Who One or more persons able to identify Special process coordinator

what kind of deviations and failures may
occur and with the following
competences:
- auditor (ISO 19011)
- ISO/TS 22163
- IRQB Guideline 6: Special
processes
- organization quality
management system
(related party)
Record According to the quality management Record required
system

5.1.11 Knowledge management

The knowledge about the special process, its characteristics and the prevention of process and
product failures should be documented in an adequate way.
Recommended knowledge management tools are process FMEAs and knowledge data bases. The
organization should choose the best way to manage its knowledge.

Special process deviations and internal and external feedback are triggers for review. New
knowledge should be incorporated into the knowledge management tools.

13 / 21 @ 2020. All rights reserved

Results of knowledge management should be incorporated into special process instructions, control
sheets and/or inspection plans, and are the basis for special process training and personnel
qualification.

5.1.12 Special processes performed by External providers

In case external providers that carry out special processes, the organization should communicate all
the necessary requirements related to the product and the process including, when required, the
approval of the special process by the organization or by the customer.
Audits and/or inspections may be necessary to ensure the proper execution and control of the
special processes. Two cases are given in the following table:

Name Special process audit Process inspection for FAI or non-

conforming products
Aim Evaluate if the external provider is able to - authorize the launch of the
correctly manage and execute the special series production
process: - promote corrective action(s)
- first evaluation
- periodical assessment Applicable to specific products
Scope Special processes as they apply to: Special process inputs (5M methodology):
- product design planning - input documentation / data
- process design planning - operators competence and
- product design qualification
- process design - inspection of materials and
- risk analysis for process design consumables
- special process design (5M - machines maintenance
methodology) - control and measuring
- roles and mandates resources
- design reviews - storage and handling
- special Process qualification conditions
- special process validation - environment
- FAI Special process outputs
- change management Quality records
- knowledge management Special process qualification
- performance evaluation Special process validation
- continuous improvement
Reference ISO/TS 22163 External provider quality management
documentation IRQB Guideline 6: Special processes system, including special process
External provider quality management instructions
system Customer requirements
Customer requirements
Who One or more persons able to identify what Special process coordinator
kind of deviations and failures may occur
and with the following competences:
- auditor (ISO 19011)
- ISO/TS 22163
- IRQB Guideline 6: Special
processes
Record According to the quality management Record required
system

If the organization designs a product involving an outsourced special process but has no internal
expertise in process execution, the external provider should be involved in the design phase.

@ 2020. All rights reserved 14 / 21

In case no internal expertise, it is recommended that the audit/inspection is performed by an
external expert.
If both the design and manufacturing are outsourced to the same external provider, the organization
should provide the complete set of requirements for design, manufacturing and quality/safety.

5.2 Manpower
The input element “Manpower” refers to the personnel involved with the special process.

5.2.1 Special process coordinator

For definition see clause 3 Terms and definitions.

5.2.1.1 Coordinator qualification

If there are no requirements from international or national special process standards, the
organization should document the minimum academic and professional pre-requisites. These pre-
requisites should ensure that the special process coordinator is able to fulfill the roles and
responsibilities described in clause 5.1.1. The coordinator should be an “expert” in the special
process: a person with special skill or knowledge derived from training or experience.
The special process coordinator should continuously renew his/her knowledge in the special process,
for example by participating in exhibitions, benchmarking, workshops, professional training,
technical meetings and conferences, etc. Evidence should be documented.

These requirements apply for internal and external coordinators.

5.2.2 Special process operator

For definition see clause 3 Terms and definitions.

5.2.2.1 Operator qualification

Operator qualification is a minimum requirement for every special process. The required number of
qualified operators should be defined by the organization, considering the type of work, production
capacity and schedule (minimum two qualified operators).

Qualification should fulfill the requirements established in the relevant national/international special
process standard and contract. If such standard does not exist, the special process coordinator
defines the qualification procedure and criteria (see clause 5.1.1 for the roles and responsibilities for
special process coordinator).

The organization should issue an operator qualification procedure, defined by the special process
coordinator, which describes how to qualify an operator. This document should include:

• required qualification documents (e.g. applicable special process instruction, evaluation

sheet, qualification record),
• relevant standards (if applicable),
• identification and storage of test pieces and test records, including operator traceability (if
relevant),
• inspection method and acceptability criteria (if relevant),
• range of validity of the qualification,
• qualification renewal criteria.

15 / 21 @ 2020. All rights reserved

A standard qualification record form should be established by the organization. If a standard
qualification form exists, for example, in international or national standards, that form may be used
directly.
Qualification tests are supervised by the special process coordinator. Qualification approval should
be given by the special process coordinator or by an external accredited examination body, if
applicable.
The same requirements apply for internal and external personnel.

5.2.2.2 Operator skill matrix

The special process skill matrix should include all relevant special processes operators. The matrix
criteria should include:
• academic qualification,
• professional experience,
• participation in coaching and training programs,
• manual dexterity,
• process or task assessment level.
This matrix should reflect the minimum requirements for a given task or workstation as well as other
criteria considered relevant by the organization.

5.2.3 Other special processes personnel

Other personnel involved in the special process such as designers, auditors and inspectors should be
trained and their competences should be documented (e.g. skill matrix).

5.3 Machines
The input element “Machines” refers to all equipment and tools that affect the special process.
The equipment and tools that are required to perform the special processes should be qualified
according to clause 5.1.3 and regularly maintained (corrective, preventive and predictive
maintenance) to ensure the same performance.
Calibration and/or verification requirements should be considered when defining equipment and tools
in order to ensure a consistent special process output with the expected quality level.
Handling, capacity, ergonomic and HSE aspects should be considered during validation (see clause
5.1.4).
A capability analysis is recommended to ensure that the equipment and tools can deliver the
parameters that are required by the process, in a reproducible and repeatable manner.
Equipment and tools that are critical (see clause 5.1.2) to the special process output should be
traceable, so that affected products can be identified in case of nonconformity.
Special process operators should be trained (e.g. user manual) to use the relevant equipment and
tools.

5.4 Methods
The input element “Methods” refers to how the special process is performed:

• specification of relevant 4M (Manpower, Machine, Material and Mother nature),

• sequence of operations,
• parameters,

@ 2020. All rights reserved 16 / 21

 • etc.
The methods used in the special process should be qualified according to clause 5.1.3 and
documented. The methods should be revised and maintained as necessary.
Parameters that may be considered are:
• distance,
• energy (current, voltage, method of transfer, arc length),
• flow rate,
• pressure or force,
• position (operator, machine, tooling, workpiece, etc.),
• quantity (weight/volume),
• rate or speed,
• temperature,
• time,
• torque,
• etc.
A suitable range of parameters should be established. Means should be provided to control the
parameters within the established range and ensure the proper execution of the instructions.
The method should also describe, when necessary:
• material preparation,
• cleaning (initial, intermediate and final),
• execution sequence,
• inspections (initial, intermediate and final) and/or hold points,
• preservation,
• etc.

Parameters and/or instructions that are critical (see clause 5.1.2) to the special process output should
be traceable, so that affected products can be identified in case of nonconformity.

5.5 Materials
The input element “Materials” refers to the materials that go into the product (base materials) and
auxiliary materials (consumables).

The materials used in the special process should be qualified according to chapter 4.1.3. The
materials should also:
• fulfil the applicable regulations and laws (e.g. REACH, RoHS, etc.),
• fulfil the applicable technical specifications and standards,
• fulfil the requirements defined in the organization’s special process documentation,

Materials that are critical (see clause 5.1.2) to the special process output should also be traceable, so
that affected products can be identified in case of nonconformity.

5.5.1 Inspection
A control plan should be established, taking into account the risk management aspects considered in
clause 5.1.2. The inspection may be performed at the external provider’s premises (e.g. FAI, FAT) or
during reception.
Declaration of Conformity, test reports and inspection certificates should be considered.
Perishable materials should be managed appropriately.

17 / 21 @ 2020. All rights reserved

5.5.2 Storage and handling conditions
Material storage and handling conditions for special processes should be defined and managed.

• The transport and storage conditions (e.g. temperature and humidity) required by the special
process should be defined and respected,
• A stock inventory system e.g. "first-in/first-out" (FIFO) or “first-expiry/first-out” (FEFO) should
be used to optimize the warehouse response time and to secure the turnover,
• Material in stock should be checked for deviations with an adequate frequency,
• Expired products should be handled in the same way as defective products.
5.5.3 Check at the workstation
The material should be checked for:

• Identification, usability and damage,

• Deviations from expected behaviour or characteristics e.g. appearance, smell and consistency.

5.6 Mother nature (Environment)

The input element “Mother nature” refers to the environmental conditions of the workstation
where the special process is carried out.

The specific environmental conditions that affect the output of the special process should be
qualified according to clause 5.1.3.

Conditions that may be considered are:

• air currents,
• air quality,
• cleanliness,
• contamination sources,
• electrostatic discharge,
• humidity,
• illumination,
• magnetic fields,
• noise,
• radiation,
• temperature and temperature gradients,
• vibration,
• etc.

A suitable operational range should be established for the entire special process (before, during and
after execution). Means should be provided to control the environmental conditions within the
established range based on risk assessment.
Environmental conditions that are critical (see clause 5.1.2) to the special process output should be
traceable, so that affected products can be identified in case of nonconformity.

@ 2020. All rights reserved 18 / 21

Bibliography
[1] Guide to Quality Control, 1972 – Kaoru Ishikawa
[2] EN 15085 Series Railway applications – Welding of railway vehicles and components
[3] DIN 6701 Series Adhesive bonding of railway vehicles and parts

[4] ISO 19011:2018-07 Guidelines for auditing management systems

[5] IRQB Guideline 1: Key Performance Indicators
[6] IRQB Guideline 2: First Article Inspection
[7] IRQB Guideline 3: Maintenance

[8] IRQB Guideline 4: RAMS/LCC

[9] IRQB Guideline 5: Obsolescence
[10] IRQB Guideline 7: Problem solving

[11] IRQB Guideline 8: Configuration and change management

19 / 21 @ 2020. All rights reserved

 THIS PAGE LEFT BLANK INTENTIONALLY

@ 2019. All rights reserved 29 / 34

•

www.irqb.org | [email protected]