how human and organizational factors are addressed in railway … · 2020. 12. 10. · roberto...
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How Human and Organizational factors are addressed in railway safety standards
Roberto SEMPRINI
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How Human and Organizational factors are
addressed in railway safety standards
Roberto SEMPRINI
ALSTOM
![Page 3: How Human and Organizational factors are addressed in railway … · 2020. 12. 10. · Roberto SEMPRINI, Safety Assessment Director, ALSTOM Master Degree in Electronic Engineering](https://reader031.vdocuments.us/reader031/viewer/2022012006/60f8ec83d2241b036e4bcd3f/html5/thumbnails/3.jpg)
Roberto SEMPRINI, Safety Assessment Director, ALSTOM
Master Degree in Electronic Engineering and Professional Engineer. Working in
ALSTOM since 25 years in railway safety domain, covering product development
and manufacturing, signalling subsystems, overall system integration, vehicles
authorization. Contributor to dissemination of safety culture inside the company and
in the railway sector.
Currently Safety Assessment Director of the in-house assessment body accredited
ISO/IEC 17020. Participated to development of CENELEC safety standards since
2000, and currently Convenor of CENELEC EN 50126 and IEC 62278.
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Roberto SEMPRINI
How Human and
Organizational factors are
addressed in railway safety
standards
3 December, 2020
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© ALSTOM SA, 2019. All rights reserved. Information contained in this document is indicative only. No representation or warranty is given or should be relied on that it is complete or correct or will apply to any particular project. This will depend on the technical and commercial circumstances. It is
provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited. 5
A system comprises not only its technical components but also the interaction with the humansdeveloping, operating, and maintaining it
Railway system perspective
Human
And
Organisational
factors
Sottosistema strutturale
tecnologico limitrofo
(della stessa natura)Same nature
neighbouring subsystems
Other nature
structural subsystems
Operation
Maintenance
Users (passengers, …)
Structural subsystem
Environment
Technology
Human and
Organisational
factors
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© ALSTOM SA, 2019. All rights reserved. Information contained in this document is indicative only. No representation or warranty is given or should be relied on that it is complete or correct or will apply to any particular project. This will depend on the technical and commercial circumstances. It is
provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited. 6
Safety standards applied since years in the railway industry
Standardization is a key support to address complexity
European and
international
standardization
bodies
with dedicated
Technical
Committees
focussing on
railways needs
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© ALSTOM SA, 2019. All rights reserved. Information contained in this document is indicative only. No representation or warranty is given or should be relied on that it is complete or correct or will apply to any particular project. This will depend on the technical and commercial circumstances. It is
provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
What is a “human error” ?
Human and Organisational Factors
7
[source: IEV 60050: 192-03-14]
human error:
discrepancy between the human action taken or omitted, and that intended or required
EXAMPLE: Performing an incorrect action; omitting a required action; miscalculation; misreading a value.
Need to specify which human actions are needed
Need to identify how human actions could fail
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© ALSTOM SA, 2019. All rights reserved. Information contained in this document is indicative only. No representation or warranty is given or should be relied on that it is complete or correct or will apply to any particular project. This will depend on the technical and commercial circumstances. It is
provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
CSM-Monitoring
8
Risks shall be managed all along the system lifecycle
How to manage human factors and related risks for a railway system
Apportionment of System Requirements
Design and Implementation
5
6
Manufacture 7
Installation
System Validation (including Safety Acceptance and Commissioning)
8
9
System Acceptance 10 1114
Operation and Maintenance
De-commissioning and Disposal
Performance Monitoring
12
Modification and Retrofit
13
Concept
System Definition & Application Conditions
Risk Analysis
System Requirements
2
3
4
Safety Requirements
1
Definition
of a
structured
lifecycle
model
CSM-RA: Risk Assessment
CSM –RA: Preliminary definition of the system
CSM-RA: Hazard Control
Re-application of the CSM-RA
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited. 9
Safety requirements specification and allocation based on Risk Assessment
Consideration of human factors at System Definition
● During “System Definition” phase, the operational context shall be considered, defining:- functions to be performed by the technical system, - relevant interfaces considering interactions with human operators and their behavior,
● Requirements shall include the different modes of operation (i.e. normal, abnormal/degraded, maintenance mode), states and transitions and their interactions, if they could have an impact on the systems functionality and safety;
● Both the maintenance process (described in the maintenance manuals) and the operation are specified.- Not considered parts of the technical system itself -> restricted by “application conditions”.
● Human factors can be defined as the impact of human characteristics, expectations and behaviour upon a system. These factors include the anatomical, physiological and psychological aspects of humans.
● The precise influence of human factors on RAMS is specific to the application under consideration.
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
● All humans are subject to occasional lapses in performance.
● When these occur in the operational and maintenance phases of the system life cycle they tend to result in random failures;
● When they occur in earlier phases of the life cycle they can result in systematic failures in the operational phase.
10
Human influence can be regarded as having both random and systematic aspects
Analysis of the causes
Causes
Effects
Analysis and evaluationmostly based on
qualitative methods(Organisation,
process,techniques)
Analysis and evaluation also possible by means of
quantitative methods
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
Human influencing factors – Example of checklist
11
Requirements on the system arising from:• human competence;
• human motivation and aspiration support;
• mitigating the effects of human behavioural
changes;
• operational safeguards;
• human reaction time and space.
Requirements for the system arising from
human information processing
capabilities, including:• human/machine communications;
• density of information transfer;
• rate of information transfer;
• the quality of information;
• human reaction to abnormal situations;
• human training;
• supporting human decision making processes;
• other factors contributing to human strain.
the effect on human performance
within the system of:• the human/system interface;
• the environment, including the
physical environment and ergonomic
requirements;
• human working patterns;
• human competence;
• the design of human tasks;
• human interworking;
• human feedback process;
• railway organisational structure;
• railway culture;
• professional railway vocabulary;
• problems arising from the introduction
of new technology
the allocation of system functions
between human and machine;
the effect on the system of human/system
interface factors, including:• the design and operation of the human/system
interface; the provision of user manuals etc.;
• the effect of human error;
• the effect of deliberate human rule violation
(e.g. where an operator ignores a rule in order
to save time);
• human involvement and intervention in the
system;
• human system monitoring and override;
• human perception of risk;
• human involvement in critical areas of the
system;
• human ability to anticipate system problems;
• human reaction under different operating
modes (e.g. normal, degraded or emergency).
human factors in all phases of the system
lifecycle, including:• human competency;
• human independence during design,
verification and validation;
• human involvement in verification and
validation;
• interface between human and automated tools;
• systematic failure prevention processes (e.g.
measures to assure safety integrity)..
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
● Systematic faults are caused by human errors in the various stages of the system, subsystem or equipment life cycle.
● EXAMPLE:- specification errors;- design errors;- manufacturing errors;- installation errors;- operation errors;- maintenance errors;- modification errors.
● Systematic failure integrity is achieved by means of the quality management system (QMS), safety management system (SMS) and technical defences.
● In addition to the quality and safety management techniques, technical defence measures are taken such that in the event of a hazardous systematic fault it would, as far as reasonably practicable, be prevented from creating an unacceptable risk.
Quality and Safety Management System
12
Organisation: Roles, Responsibilities, Competencies, Independence, Impartiality
Policy, Processes and management
Procedures, Methods, Techniques
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
Systematic integrity: Verification and Validation in the lifecycle
13
G.D.
Architecture & apportionment
of system requirements 5
Manufacture 7Design and
implementation6
Concept 1
System acceptance 10
Operation, maintenance,
performance monitoring11 Decommissioning 12
Validation
Feedback on
RAMS into
risk analysis
Control of
RAMS
requirements
System definition and
operational context2
Specification of
system requirements4
Verification task:
Risk analysis
and evaluation 3
System validation 9
Integration 8
Key:
Risk Assessment
Implementation and
demonstration of
compliance
with RAMS requirements
Operation, maintenance and
decommissioning
Validation task:
To: Operation, maintenance and decommissioning
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
● Verification and validation tasks performed along system lifecycle have the aim to detect systematic errors/failures.
● Verification:- confirmation, through the provision of objective evidence, that specified requirements have been fulfilled- Verification is conducted at various life cycle phases of development, examining the system and its constituents to
determine conformity to the requirements specified at the beginning of that life cycle phase
● Validation:- confirmation, through the provision of objective evidence, that the requirements for a specific intended use or
application have been fulfilled
Systematic integrity: Verification and Validation in the lifecycle
14
Includes confirmation that process and lifecycle activities
have been properly performed
Appropriate conditions of use defined and exported
Not only correctness, but also completness
● Verification and Validation are tasks/activities of the lifecyle
● They are based on methods (analysis, checks, inspection, testing, …)
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited. 15
Safety Assessment is different from Conformity Assessment
Independent Safety Assessment
● Process to determine whether the system/product meets the specified safety requirements and to form a judgement as to whether the system/product is fit for its intended purpose in relation to safety
● It’s a means to provide additional confidence about the avoidance of systematic failures of the system under consideration which can adversely influence safety
● The role of Independent Safety Assessor (ISA) is in addition to Verification and Validation
● Also the legal framework (CSM-RA) more recently has defined the activity of SafetyAssessment to be performed either by accredited internal or external organisationidentified as AsBo, fulfilling requirements of inspection bodies according to ISO/IEC 17020 standard.
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
● Safety shall be:- Planned- Specified on the basis of risk assessemnt- Controlled on the basis of causal analysis- Demonstrated on the basis of appropriate Verification and Validation activities
Key activities of the Safety management
16
Safety
Plan
Risk
Analysis
Safety
Case
Causal
Analysis
Verification
& Validation
Safety
Requirements
Hazard Log
Safety Related
Item ListSafety Related
Application ConditionsManufacturing,
Maintenance
Configuration/Installation,
Boundary systems,
Operation, Maintenance, …
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Lot of back-and-forth information between analysis of the technical system design
and analysis of related design/operation/maintenance processes
Human Factors in causal analysis
● Hazard control process requires to perform causal analysis identifying events leading to hazardous conditions and defining mitigations to keep the risk at an acceptable level.
● The causal analysis techniques aim to identify the logic sequence of the events developing into a hazard. The maybe top-down or bottom-up techniques or mixed bottom-up and top-down techniques. Typical examples of techniques includes Fault Tree Analysis (FTA), FailureMode Effects and Criticality Analysis (FMECA), …
● The list of causes shall consider technical as well as all credible human errors
● Causal analysis shall be applied to all lifecycle phases:- Development (specification, design, …)- Deployment (manufacturing, installation)- Operation, Maintenance
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Causes shall be tuned to the specific process under consideration
Human Factors in causal analysis
● Example of FMECA
● FMECA applied to Design (also called DFMECA) and to process (also called PFMECA) are based on same method.
● When applied to processes:- Structured definition of the process with all the functions and
input/output relationships
- Function is specified action or activity which can be performed by technical means and/or human beings and has a defined output in response to a defined input
- Causes shall includes Organisation and human factors, i.e. procedures, roles, human errors, … .
causes
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited. 19
Independence of failure modes
Human Factors in causal analysis
● The acceptable level of risk associated to the hazardous event may be achieved by combination of two functions (technical or process tasks).
● Independence is a pre-condition to allow use of “AND” combination in the risk evaluationHazardous event
Failure of
function A
Failure of
detection
means B
AND
Failure of function
A
Failure of
detection means B
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No process-related causes shall prevent the identification of flaws
inheriting the potential for common cause failures
Human Factors in causal analysis
● Organisational independence and diversity in human resource and life-cycle processes are deemed to contribute to higher overall safety integrity
● Any common process activities in the design, manufacturing, installation and maintenance phases (e.g. same human resource, common modelling, etc.) can be a cause of common mistakes during the development phase of the two functions.
Hazardous event
Failure of
function A
Failure of
detection
means B
AND
Common
Cause
Failure
OR
Failure of function
A
Failure of
detection means B
Common Cause Failures
(CCF)
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
● Tools can perform or support activities in any of the life cycle phases (design, construction, testing, operation, maintenance, … ) helping to minimize the possibility of introducing human errors
● The more the level of automation, the less will be the contribution of human operators. Tools can:- directly affect safety: those tools which generate outputs that contribute to the design or
implementation of a safety-related function, and whose errors could directly lead to a systematic hazardous fault
- indirectly affect safety: those tools which support the safety verification of the design or implementation of a safety-related function, and whose errors do not directly lead to a systematic hazardous fault in the product or application, but rather might affect the detection of other errors from other sources.
● Importance to control potential systematic errors becoming the main source of risk: - Hazard identification and hazard analysis shall be applied to the tools and the processes- Validation of the tool and related processes with methods and techniques commensurate to the
required safety integrity
Use of Tools for safety related functions
21
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provided without liability and is subject to change without notice. Reproduction, use or disclosure to third parties, without express written authorisation, is strictly prohibited.
● Whenever needs for modifications are identified, risk assessment and lifecycle shall be re-iterated.
● A Modification management process with related Risk Assessment, including: - analysis of the change (technical, organizational, operational)- configuration management- application of the modification (retrofit/upgrade)
Modifications management
22
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Thank you for your attention
23
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