Lecture Notes: Introduction to Functional Safety and Safety Lifecycle
Day 1: Overview and Management of Functional Safety
Focus: General overview of ISO 26262 Volumes 1–12.
Topics:
o Introduction to functional safety and safety lifecycle.
o Safety management (project-independent and during
development/production).
o Safety planning and supporting processes (FMEA, FTA).
o Role-based certification and assessment process.
1. Introduction to Functional Safety
Functional safety is a critical aspect of the automotive industry, particularly as
systems become more complex and autonomous. ISO 26262 defines functional
safety as the absence of unreasonable risk due to hazards caused by
malfunctioning behavior of electrical or electronic (E/E) systems.
Key Concepts in Functional Safety:
Hazards: Potential sources of harm or danger, particularly those caused
by the malfunction of E/E systems.
Risk: The combination of the probability of a hazardous event and the
severity of its potential consequences.
Safety Goals: High-level requirements that specify the necessary
functional safety measures to mitigate identified risks.
Importance of ISO 26262 in Automotive Systems
ISO 26262 is the automotive industry's functional safety standard, ensuring that
safety-critical systems in vehicles operate correctly and reliably under both
normal and fault conditions. It covers:
Passenger cars up to 3.5 tons.
Systems that include E/E components such as braking systems, airbag
control units, and ADAS (Advanced Driver Assistance Systems).
Scope of ISO 26262:
Defines functional safety for all lifecycle stages, from concept to
decommissioning.
Provides guidance for OEMs, Tier 1, and Tier 2 suppliers, with specific roles
and responsibilities.
Why Functional Safety Matters:
Ensures that safety mechanisms are in place to mitigate risks.
Contributes to customer trust and compliance with legal safety
requirements.
Helps avoid costly recalls, accidents, and liability issues.
Safety Lifecycle: Overview
The Safety Lifecycle as defined by ISO 26262 is a structured, step-by-step
process that ensures that safety is considered at all stages of product
development, from concept through decommissioning.
Key Phases of the Safety Lifecycle:
Concept Phase (ISO 26262-3)
Define the item (system or sub-system) and its environment.
Perform Hazard and Risk Analysis (HARA) to identify potential
risks and safety goals.
Product Development at System Level (ISO 26262-4)
Development of the Functional Safety Concept, which defines
safety measures to mitigate risks.
Develop the Technical Safety Concept based on system
architecture, detailing the implementation of safety mechanisms.
Product Development at Hardware Level (ISO 26262-5)
Design and implement safety mechanisms at the hardware level.
Evaluate hardware against quantitative metrics such as fault
tolerance and diagnostic coverage.
Product Development at Software Level (ISO 26262-6)
Define and implement safety mechanisms within the software.
Perform software verification and validation, ensuring safety
measures are effective.
Production and Operation (ISO 26262-7)
Implement safety during production.
Ensure ongoing safety management throughout the vehicle's
operational life.
Supporting Processes (ISO 26262-8)
Cover supporting activities such as configuration management,
change control, and tool qualification.
ASIL (Automotive Safety Integrity Level) Determination (ISO 26262-
9)
Assign the ASIL rating (A to D) based on the severity, exposure, and
controllability of hazards identified during HARA.
Higher ASIL ratings (e.g., ASIL D) require more stringent safety
measures.
Verification, Validation, and Confirmation Reviews (ISO 26262-4, 5,
6)
Continuous verification and validation ensure that the system meets
its safety goals and functions as intended.
Confirmation reviews provide independent assessments of safety
processes.
Production, Operation, Service, and Decommissioning (ISO 26262-
7)
Implement processes to ensure that safety continues throughout
the system's lifecycle, including during servicing and
decommissioning.
Key Elements of Functional Safety Management
Functional safety management is the systematic approach to ensure that all
functional safety activities are planned, executed, and verified throughout the
safety lifecycle.
Core Aspects of Safety Management:
Project-Independent Safety Management: Includes organizational-
level activities such as safety culture, training, and establishing safety
management structures.
Development Safety Management: Ensures that safety is integrated
into product development, from concept to production. This includes
planning, managing, and documenting all safety-related activities.
Post-Production Safety Management: Deals with maintaining safety
once the product is in the market, ensuring effective field monitoring and
corrective actions if new risks arise.
Safety Planning:
A safety plan is a key document outlining all safety-related activities and
deliverables.
The plan ensures that all relevant safety standards are followed and risks
are systematically addressed.
Safety Culture:
Developing a safety-oriented culture in the organization is crucial for the
effective implementation of ISO 26262.
Ensures that every stakeholder (engineers, managers, suppliers)
understands the importance of safety.
Supporting Processes in Functional Safety
ISO 26262 emphasizes the need for supporting processes to manage and
control functional safety across the entire safety lifecycle. These processes are
covered in Volume 8 and include:
Configuration Management: Ensures traceability of safety work
products.
Change Management: Helps manage and track changes to safety-
related elements throughout the product lifecycle.
Documentation: Comprehensive documentation is essential for audits
and ensuring compliance with ISO 26262.
FMEA and FTA in the Safety Lifecycle:
Failure Modes and Effects Analysis (FMEA): Identifies potential failure
modes and their effects on the system. It is used to ensure that safety
mechanisms can mitigate risks.
Fault Tree Analysis (FTA): A top-down approach to identifying the
causes of system failures. FTA helps in evaluating the probability of
system-level failures due to component faults.
Role-Dependent Assessment and Certification
ISO 26262 assigns specific responsibilities to different roles within the
automotive supply chain:
OEM (Original Equipment Manufacturer): Primarily responsible for
ensuring that the entire vehicle meets safety standards.
Tier 1 Supplier: Typically responsible for delivering complete subsystems
that meet the safety requirements specified by the OEM.
Tier 2 Supplier: Supplies individual components or systems that must
conform to the safety requirements passed down from Tier 1 suppliers or
OEMs.
Certification Process:
Functional safety certification is often role-specific and requires that
individuals or teams demonstrate competence in managing and
implementing safety processes.
ISO 26262 defines various certification programs (Functional Safety
Engineer, Professional, Expert) that professionals can undertake after
completing training courses like this one.
Conclusion
The introduction to functional safety and the safety lifecycle on Day 1 is
foundational for understanding ISO 26262’s principles and the roles of OEMs,
suppliers, and engineers in managing safety-critical systems in automotive
environments. The standard outlines the requirements for ensuring that safety is
integrated into every step of product development, from concept through
decommissioning, with a strong focus on systematic risk reduction and lifecycle
management.
2. Safety Management (Project-Independent, During Development, and
Production)
Introduction to Safety Management
Safety management is a critical function in the ISO 26262 framework, ensuring
that all processes related to functional safety are systematically planned,
executed, and monitored. Effective safety management is necessary to ensure
that safety objectives are met throughout the lifecycle of an automotive system,
from concept to decommissioning.
In ISO 26262, safety management encompasses activities at the organizational
level (project-independent), during the development phase, and in production
and post-production phases.
Overview of Safety Management in ISO 26262
Safety management in the context of ISO 26262 involves implementing,
coordinating, and overseeing all functional safety activities required throughout
the vehicle or system lifecycle. It ensures that safety-related aspects are
addressed consistently and according to the required safety integrity levels
(ASIL).
Key Responsibilities in Safety Management:
Planning and coordinating safety activities.
Ensuring compliance with ISO 26262.
Defining safety roles and responsibilities.
Monitoring the progress of safety activities.
Continuous risk assessment and hazard analysis.
Project-Independent Safety Management
Organizational Safety Management
Project-independent safety management involves creating a functional safety
framework at an organizational level, which applies to all projects. It defines the
overall processes, structures, and responsibilities required to implement and
manage safety activities across multiple projects.
Key Activities:
Establishing a Safety Culture: Promoting safety awareness throughout
the organization and ensuring that safety is a priority in all stages of
development.
Defining Safety Policies and Procedures: Developing organizational-
level procedures that guide how safety is managed, verified, and validated
in various projects.
Safety Competence Management: Ensuring that the organization has
qualified personnel trained in functional safety. ISO 26262 emphasizes the
importance of developing the necessary skills and knowledge through
training and experience.
Safety Governance and Structure: Implementing governance
structures, such as safety steering committees and appointing safety
managers, to oversee functional safety activities.
Project-Independent Tools and Processes:
Configuration Management Systems: Ensure traceability and manage
changes across different projects.
Safety Case Templates: Develop templates for documenting safety
cases across all projects.
Supporting Tools: Use safety management tools to track and report on
safety-related activities across different projects.
Objective:
The main objective of project-independent safety management is to establish a
robust foundation for safety processes that can be applied consistently across
multiple projects, ensuring that all teams follow best practices in safety
management.
Safety Management During Development
Safety management during the development phase involves the systematic
integration of safety activities into product design and implementation, covering
hardware, software, and system development.
Development Phase Activities:
Safety Planning: At the beginning of the project, a detailed Safety Plan
is created to outline all the required safety activities, timelines, and
deliverables. It includes a plan for hazard and risk analysis, safety
validation, and verification.
Hazard and Risk Analysis (HARA): Conduct hazard analysis to identify
potential risks and assign ASIL (Automotive Safety Integrity Level) ratings,
which define the level of rigor required to mitigate those risks.
Development of Functional and Technical Safety Concepts: These
are high-level and system-level safety architectures developed based on
risk analysis. The functional safety concept outlines the general safety
measures, while the technical safety concept details how these measures
will be implemented.
Safety Requirements Derivation: Safety requirements are derived from
the HARA and functional/technical safety concepts. These requirements
must be incorporated into system design at the hardware, software, and
system levels.
Verification and Validation (V&V): Ongoing verification and validation
ensure that the system design meets the safety goals throughout the
development process. Testing methods such as FMEA (Failure Mode and
Effects Analysis), FTA (Fault Tree Analysis), and FMEDA (Failure Mode,
Effects, and Diagnostic Analysis) are applied.
Assessment and Auditing: Internal and external safety assessments are
conducted to evaluate whether the safety plan and activities align with
ISO 26262 requirements. Independent audits ensure objectivity in
evaluating compliance.
Key Roles During Development:
Safety Manager: Responsible for planning, tracking, and reporting safety
activities.
Development Engineers: Implement the functional safety measures in
the system design.
Test and Validation Engineers: Conduct verification and validation to
ensure safety requirements are met.
Objective:
The primary objective of safety management during development is to ensure
that all safety-related risks identified during the concept phase are mitigated
through design and implementation. The focus is on adhering to safety goals,
conducting continuous risk assessments, and ensuring compliance through
verification and validation activities.
Safety Management During Production
Safety management extends beyond development to cover production and post-
production activities. The ISO 26262 standard ensures that functional safety
continues to be monitored and controlled during production, maintenance, and
after the product has been released to the market.
Production Phase Activities:
Production Safety Plan: A dedicated safety plan for production is
developed, outlining how safety measures will be integrated into the
manufacturing process. This includes process control and safety
monitoring on the production line.
Manufacturing Process Design: The production process should
incorporate safety mechanisms to ensure that products are built and
tested according to the required functional safety standards.
Manufacturing should focus on maintaining product integrity by reducing
faults, defects, and failures.
Monitoring and Testing: Safety tests are conducted during production to
ensure that components and systems function correctly. For example, end-
of-line testing ensures that manufactured products meet the defined
safety goals.
Traceability and Documentation: Documentation plays a crucial role in
tracking the production of safety-critical systems, ensuring all parts can be
traced back to their source and development process. It also ensures that
any issues found post-production can be effectively traced and rectified.
Objective:
The objective of safety management during production is to ensure that the
safety integrity established during development is maintained during the
manufacturing process. Continuous monitoring and quality control measures are
essential to prevent the introduction of faults or safety-related failures.
Post-Production Safety Management
After the product is launched, ISO 26262 requires that functional safety is
maintained throughout the operational life of the product, including during
maintenance, updates, and eventual decommissioning.
Post-Production Phase Activities:
Field Monitoring: Once the product is released, field data must be
collected to monitor for any safety-related incidents or failures. Data from
vehicle recalls, maintenance records, and real-time diagnostics can be
used to assess whether safety issues arise after the product is in use.
Maintenance and Repair: Ensuring that repair and maintenance
activities do not introduce new safety risks is critical. Safety must be
maintained throughout the life of the vehicle.
Change Management: Modifications or updates to the system after
production should undergo the same rigorous safety assessments as
during development. Any changes must be validated to ensure that they
do not impact safety.
Decommissioning: Safe disposal of systems, especially those with
hazardous materials, must be planned and executed. The safety risks
associated with decommissioning should be assessed and mitigated.
Objective:
Post-production safety management ensures that the product continues to
function safely throughout its lifecycle, and any emerging risks are addressed
quickly through updates, repairs, or recalls. The aim is to maintain the functional
safety integrity even as the product ages or undergoes modifications.
Summary
Safety management in ISO 26262 is an ongoing process that spans across all
phases of the product lifecycle, from project-independent activities, through
development and production, to post-production. Effective safety management
ensures that functional safety is systematically integrated into every phase of
the product lifecycle, ensuring compliance with ISO 26262 and minimizing risks
associated with E/E systems in automotive applications.
By maintaining robust safety management processes, organizations can ensure
that they not only comply with functional safety standards but also provide safe,
reliable products that protect drivers, passengers, and other road users.
3. Safety Planning and Supporting Processes (FMEA, FTA)
Introduction to Safety Planning
Safety planning is an essential component of the ISO 26262 functional safety
lifecycle, involving the systematic organization and documentation of all
activities needed to achieve functional safety for automotive systems. The safety
plan outlines all tasks, resources, responsibilities, timelines, and dependencies
related to safety across the product development process.
Purpose of Safety Planning:
Ensure that safety activities are integrated into all stages of the product
lifecycle.
Provide a clear framework for identifying, assessing, mitigating, and
validating risks.
Ensure compliance with ISO 26262 by planning for verification, validation,
and testing at each phase.
Core Elements of a Safety Plan:
Scope and Objectives: Clearly define the scope of safety activities and
their alignment with the functional safety goals of the project.
Role and Responsibilities: Assign responsibilities for safety activities to
individuals and teams, including safety managers, engineers, testers, and
auditors.
Timeline and Milestones: Establish a timeline with key safety-related
milestones, such as hazard analysis, risk assessment, and validation.
Work Products and Documentation: Define the required safety work
products, such as the hazard and risk analysis (HARA), safety goals, safety
requirements, and technical safety concept.
Tools and Methods: Specify the tools and methodologies used for safety
analysis, verification, and validation, such as Failure Modes and Effects
Analysis (FMEA) and Fault Tree Analysis (FTA).
Supporting Processes in Functional Safety
ISO 26262 mandates a range of supporting processes to ensure that safety is
systematically managed throughout the safety lifecycle. These supporting
processes are vital for ensuring traceability, consistency, and compliance.
Key Supporting Processes:
Configuration Management: Ensures that safety-related artifacts (e.g.,
safety requirements, design documents) are managed, tracked, and
version-controlled throughout the project lifecycle. This ensures
traceability and helps in managing changes systematically.
Change Management: Addresses the impact of changes to the system,
ensuring that any updates or modifications are evaluated for their impact
on functional safety and re-validated as necessary.
Documentation: Comprehensive documentation is required to support all
safety activities. This includes documenting risk assessments, safety
cases, validation reports, and any deviations from the original plan.
ISO 26262 also emphasizes the importance of functional safety assessments
and confirmation reviews, where independent assessors validate that the
functional safety processes and activities conform to the safety plan.
Failure Modes and Effects Analysis (FMEA)
What is FMEA?
Failure Modes and Effects Analysis (FMEA) is a bottom-up, systematic
approach to identifying potential failure modes in a system, component, or
process and assessing the effects of those failures on system behavior. FMEA is
widely used in functional safety to analyze risks associated with component
failures and to ensure that mitigation measures are in place to prevent or reduce
risks.
Objectives of FMEA:
Identify all possible failure modes within a system.
Assess the impact of each failure mode on system performance and safety.
Prioritize failure modes based on their severity, occurrence, and detection
(using Risk Priority Number – RPN).
Recommend actions to mitigate risks associated with the failure modes.
Steps in Conducting FMEA:
Define the System or Item: Start by identifying the system, subsystem,
or component being analyzed.
Identify Failure Modes: For each element of the system, identify all
potential failure modes (i.e., ways in which the element could fail).
Analyze Effects: Determine the effects of each failure mode on the larger
system or its components.
Assess Severity: Assign a severity rating to each failure mode, reflecting
the potential impact on safety or system functionality.
Analyze Causes: Identify the root causes of each failure mode.
Assign Occurrence and Detection Ratings: Estimate the likelihood of
each failure occurring (occurrence) and the probability of detecting the
failure before it leads to a hazard (detection).
Calculate RPN: The Risk Priority Number is calculated as the product of
severity, occurrence, and detection scores. Higher RPNs indicate higher
risks and prioritize mitigation efforts.
Recommend Mitigations: Propose actions to reduce the severity,
occurrence, or improve detection of the failure modes.
Example of FMEA in Automotive Systems:
For an Electronic Brake Control Module:
Failure Mode: Loss of communication with the brake pedal sensor.
Effect: The vehicle's braking system might fail to respond correctly,
leading to loss of vehicle control.
Severity: High, as it could lead to a collision.
Occurrence: Medium, based on the system's reliability data.
Detection: High, as the system can detect loss of communication through
diagnostics.
RPN: Calculated based on severity, occurrence, and detection.
Fault Tree Analysis (FTA)
What is FTA?
Fault Tree Analysis (FTA) is a top-down deductive analysis method used to
determine the causes of system-level failures or hazards. In contrast to FMEA,
which analyzes failures at the component level, FTA begins with an undesirable
event (called the "top event") and works backward to identify the potential
causes of that event.
Objectives of FTA:
Identify the root causes of a specific hazard or system-level failure.
Provide a graphical representation of the logical relationships between
component failures that lead to the top event.
Help in developing mitigation strategies by understanding the contribution
of various failures to the top event.
Steps in Conducting FTA:
Define the Top Event: The top event is the system-level failure or hazard
that you want to analyze (e.g., "Brake system fails").
Develop the Fault Tree: Break down the top event into its immediate
causes, represented as branches of the tree. Each cause can be further
broken down into lower-level failures.
Use AND and OR gates to describe the relationships between
failures:
AND Gate: The top event occurs only if all input events
occur.
OR Gate: The top event occurs if any of the input events
occur.
Analyze the Tree: Identify minimal cut sets (smallest set of events that,
if they occur, will lead to the top event) and assess the probability of
occurrence.
Mitigate Risks: Identify safety mechanisms to prevent or mitigate the
top event by addressing the root causes.
Example of FTA in Automotive Systems:
For an Electronic Stability Control System:
Top Event: Loss of vehicle stability control.
Immediate Causes:
Sensor failure (e.g., wheel speed sensor malfunction) [OR gate].
Controller failure (e.g., ESC control unit malfunction) [AND gate].
Root Causes: Power supply issues, sensor hardware failure, software
error, communication loss, etc.
Comparison Between FMEA and FTA
Aspect FMEA FTA
Bottom-up (component-level Top-down (system-level failure or
Approach
failure analysis) hazard analysis)
Individual failure modes and their Root causes of a specific
Focus
effects undesirable event
Analysis Primarily qualitative with some Primarily qualitative, but can be
Type quantitative elements used for probabilistic risk
Aspect FMEA FTA
assessment
List of potential failure modes with Fault tree diagram showing logical
Output
risk prioritization relationships between failures
Identifying and mitigating failures
Understanding and addressing
Use Case at the component or subsystem
system-level failures and hazards
level
Integrating FMEA and FTA in Functional Safety
Both FMEA and FTA play critical roles in the overall safety analysis process
defined by ISO 26262. These methods can be used in conjunction to ensure
comprehensive risk identification and mitigation throughout the lifecycle:
FMEA is generally used earlier in the development process to identify
potential failure modes at the component level.
FTA is often used later in the process, especially when specific hazards or
system failures are identified that require a deeper understanding of the
root causes.
By using both methods, teams can ensure that risks are identified both at the
component level and at the system level, leading to more robust safety
strategies.
Conclusion
Safety planning and supporting processes, such as FMEA and FTA, are essential
for managing functional safety in automotive systems. A well-structured safety
plan ensures that all safety activities are aligned with ISO 26262, while
supporting processes like FMEA and FTA provide critical insights into potential
failure modes and system-level hazards. By integrating these tools into the
functional safety lifecycle, organizations can ensure a systematic approach to
identifying, assessing, and mitigating risks, thereby ensuring compliance with
ISO 26262 and safeguarding the safety of vehicles and their occupants.
4. Role-Based Certification and Assessment Process
Introduction to Role-Based Certification and Assessment Process
ISO 26262 emphasizes the importance of ensuring that professionals involved in
the functional safety lifecycle are adequately trained and certified to perform
their roles effectively. The role-based certification and assessment process helps
to ensure that individuals and organizations meet the necessary competence and
safety standards, particularly in the automotive sector where safety is critical.
The certification process is structured to assess the knowledge, skills, and
experience of individuals working at various levels of responsibility—ranging
from engineers to experts—ensuring compliance with ISO 26262 and improving
the safety integrity of electrical/electronic (E/E) systems in vehicles.
Overview of ISO 26262 Certification Levels
ISO 26262 recognizes various roles within the automotive supply chain, from
OEMs (Original Equipment Manufacturers) to Tier 1 and Tier 2 suppliers, and
assigns specific responsibilities to individuals at each level. Certification
programs are tailored to these roles, helping professionals gain the knowledge
and skills required for their specific responsibilities in the safety lifecycle.
ISO 26262 Certification Levels:
Automotive Functional Safety Engineer (AFSE):
Designed for engineers responsible for implementing functional
safety requirements in the design, development, and testing of E/E
systems.
Focuses on the practical application of ISO 26262, ensuring
compliance with the standard at the engineering level.
Automotive Functional Safety Professional (AFSP):
Aimed at professionals with broader responsibilities, such as project
or safety managers, who oversee the functional safety lifecycle,
from concept to production.
Emphasizes safety management, planning, and the integration of
safety across systems and teams.
Automotive Functional Safety Expert (AFSE):
For individuals in leadership positions who are responsible for the
overall functional safety strategy, decision-making, and compliance
across multiple projects or product lines.
Involves a deep understanding of ISO 26262 and the ability to guide
teams in implementing functional safety measures.
Role-Specific Responsibilities and Certification Requirements
ISO 26262 assigns specific functional safety responsibilities to various roles
within the automotive ecosystem. Certification ensures that individuals are
competent in executing these responsibilities based on their role within the
organization.
OEM (Original Equipment Manufacturer):
Responsibilities:
Define safety requirements for the entire vehicle.
Ensure that the vehicle-level safety goals are met through the
integration of components and subsystems.
Coordinate safety activities across the supply chain and monitor
compliance with ISO 26262.
Certification Focus:
OEM professionals require certification that ensures they are
capable of managing and overseeing the overall functional safety
strategy across the entire vehicle, with particular attention to
integrating safety activities from Tier 1 and Tier 2 suppliers.
Tier 1 Supplier:
Responsibilities:
Design, develop, and supply complete subsystems (e.g., braking
systems, steering controls) that comply with the safety
requirements specified by OEMs.
Ensure that subsystems meet the safety goals through detailed
design, testing, and validation.
Certification Focus:
Tier 1 professionals must be certified to ensure that they can
develop safety-compliant subsystems and components. They are
responsible for implementing safety measures and validating that
these meet the technical safety concepts provided by the OEM.
Tier 2 Supplier:
Responsibilities:
Supply individual components (e.g., sensors, actuators) that
conform to the safety requirements passed down by Tier 1 suppliers
or OEMs.
Ensure that the safety integrity of their components is maintained
and documented.
Certification Focus:
Tier 2 professionals are typically certified to ensure they can
develop and deliver components that meet stringent safety
requirements, particularly in the context of component-level fault
analysis and safety testing.
Role of Functional Safety Manager:
Responsibilities:
Oversee the planning, implementation, and tracking of all safety-
related activities within a project.
Ensure that all functional safety tasks (e.g., hazard analysis, risk
assessment, validation) are executed according to ISO 26262
requirements.
Certification Focus:
Certification focuses on ensuring that the safety manager has the
competence to manage the safety lifecycle, oversee the preparation
of the safety plan, and ensure that all stakeholders are aligned with
the safety goals.
Certification Process Overview
The ISO 26262 certification process follows a structured path to ensure that
professionals and organizations meet the necessary safety standards. This
involves a combination of theoretical knowledge, practical experience, and
examination to validate that candidates understand and can apply the principles
of ISO 26262.
Steps in the Certification Process:
Training:
Individuals undergo formal training covering ISO 26262’s principles,
processes, and methodologies. Training is usually role-specific and
focuses on the responsibilities outlined by the standard.
Examination:
Candidates must pass an examination that tests their
understanding of ISO 26262 and their ability to apply its
requirements in their specific role.
The exam typically covers key areas such as safety management,
hazard analysis, risk assessment, safety lifecycle management, and
the implementation of safety measures.
Experience Requirements:
For higher certification levels, such as the Automotive Functional
Safety Expert, practical experience in the application of ISO 26262
is required. Candidates may need to demonstrate experience
working on safety-critical projects or systems.
Certification:
Upon passing the exam and meeting the experience requirements,
individuals receive their ISO 26262 certification for their specific
role.
Certifications are typically valid for a certain period, after which
professionals must renew their credentials to ensure they are up-to-
date with any revisions or updates to the standard.
Re-Certification:
ISO 26262 is continuously updated, and professionals must maintain their
certification by participating in ongoing training and demonstrating
continued competence in functional safety.
Functional Safety Assessment Process
The functional safety assessment process evaluates whether the safety goals
and requirements outlined in ISO 26262 have been properly implemented
throughout the product’s lifecycle. It ensures compliance with safety standards
and helps organizations avoid potential risks associated with safety-critical
systems.
Types of Assessments:
Internal Assessments:
Conducted by the organization’s own safety management teams to
monitor and ensure that functional safety activities are being
carried out according to the safety plan.
Focus on evaluating the effectiveness of safety measures and
processes during development, production, and operation.
External Assessments (TÜV or Other Accredited Bodies):
Independent assessments performed by third-party organizations
(e.g., TÜV) to ensure that safety activities conform to ISO 26262
requirements.
These assessments are often a requirement for obtaining
certification and can involve audits of processes, documentation,
and safety work products.
Assessment Phases:
Safety Plan Review:
The assessor reviews the safety plan to ensure it aligns with ISO
26262 requirements and contains all necessary activities, roles, and
responsibilities.
Safety Case Review:
The safety case is a comprehensive document that justifies the
system’s safety by demonstrating how all identified risks have been
mitigated. Assessors will verify that the safety case covers all
potential hazards and includes sufficient evidence of testing and
validation.
On-Site Audits:
Assessors may conduct on-site audits to review work processes, test
results, and overall adherence to the safety plan. These audits
ensure that safety activities have been integrated into the product’s
development and production lifecycle.
Final Assessment Report:
After completing the assessment, the assessors provide a report
detailing their findings, which includes whether the system meets
the safety goals and any recommendations for improvements. The
report is critical for achieving certification.
Benefits of Role-Based Certification and Assessment
The role-based certification and assessment process under ISO 26262 provides
several key benefits to individuals, organizations, and the automotive industry as
a whole:
Ensures Competency: Certification guarantees that individuals possess
the necessary knowledge and skills to perform their safety-related
responsibilities effectively.
Improves Safety Compliance: By having certified professionals in key
roles, organizations can ensure better compliance with ISO 26262,
reducing the likelihood of safety-related incidents and recalls.
Increases Trust: Certified professionals and independently assessed
safety processes enhance trust with customers, regulators, and partners.
Mitigates Risk: The structured assessment and certification process
helps identify potential safety risks early in the development lifecycle,
ensuring that appropriate measures are taken to mitigate them.
Facilitates Innovation: By ensuring that safety processes are robust,
organizations can focus on innovation while maintaining high safety
standards.
Conclusion
Role-based certification and assessment are essential components of ensuring
that the functional safety requirements defined by ISO 26262 are met across the
automotive development lifecycle. Certification programs, tailored to specific
roles like engineers, professionals, and experts, help ensure that the right skills
and knowledge are applied at every stage. Meanwhile, the assessment process
provides a critical check on the effectiveness of these safety measures,
promoting safe and reliable systems for modern vehicles.
1. What is functional safety in the context of ISO 26262?
o Functional safety refers to the part of a system that ensures
safety is maintained even in the event of system failures. It ensures
that automotive electronic systems (e.g., braking, steering)
continue to operate safely or transition to a safe state when a
failure occurs. Functional safety addresses hazards caused by
malfunctions in electrical and electronic systems.
Example: In an Anti-lock Braking System (ABS), functional safety ensures that if
a sensor fails, the vehicle doesn’t lose all braking control but can still decelerate
safely.
2. Explain the concept of the safety lifecycle as defined by ISO
26262.
o The safety lifecycle is a structured process that covers the entire
lifespan of a safety-related system, from concept to
decommissioning. It ensures that safety is built into the system at
every phase, including development, production, and operation. The
lifecycle includes planning, design, implementation, testing,
validation, and continuous monitoring.
Example: For an airbag system, the safety lifecycle includes defining safety
requirements, implementing crash detection software, validating the system
through crash simulations, and ensuring it remains safe after production.
3. What is the role of safety management in ISO 26262?
o Safety management ensures that the processes, activities, and
work products meet the requirements of ISO 26262. It involves
planning, tracking, and assessing safety activities, coordinating
functional safety across all involved teams, and ensuring that safety
is considered throughout the lifecycle of the project.
Example: The safety manager oversees all aspects of safety-related activities
for a new braking system, ensuring compliance with ISO 26262, assigning tasks,
and reviewing safety work products.
4. What are the main phases of the ISO 26262 safety lifecycle?
o The main phases include:
Concept phase: Define safety goals based on hazard
analysis.
Product development: Design hardware and software to
meet safety goals.
System integration: Ensure the components work together
safely.
Production and operation: Maintain functional safety
during production and in use.
Decommissioning: Ensure safety during system retirement.
Example: For a cruise control system, the phases ensure that safety is
considered from initial design through production and decommissioning.
5. What is the importance of a safety plan in functional safety
management?
o A safety plan outlines all functional safety activities, roles,
responsibilities, and resources required to ensure compliance with
ISO 26262. It ensures that safety activities are planned and tracked
throughout the development lifecycle.
Example: A safety plan for an electric power steering system would include
tasks like risk analysis, design verification, and validation.
6. How are safety activities integrated into project-independent,
development, and post-production phases?
o Project-independent activities involve establishing safety policies
and ensuring that a functional safety culture exists across the
organization. Development-phase activities include hazard and
risk analysis, safety concept design, and safety validation. Post-
production activities focus on maintaining safety in production,
monitoring field performance, and managing modifications.
Example: Post-production safety activities for an electronic braking system
include monitoring field performance data to identify and address safety issues.
7. What are the key supporting processes in ISO 26262 functional
safety management?
o Key supporting processes include configuration management,
change management, verification and validation,
documentation, FMEA (Failure Modes and Effects Analysis),
and FTA (Fault Tree Analysis). These ensure that safety-related
work products are consistent, verified, and traceable.
Example: Configuration management ensures that different versions of the
brake control software are correctly tracked and traceable.
8. Explain the difference between FMEA (Failure Modes and Effects
Analysis) and FTA (Fault Tree Analysis).
o FMEA is a bottom-up approach that identifies potential failure
modes at the component level and analyzes their effects on the
system. FTA is a top-down approach that starts with a specific
undesired event (e.g., system failure) and works backward to find
the causes.
Example: In FMEA, you would analyze the failure modes of a pressure sensor,
while in FTA, you would analyze how a brake failure could occur.
9. What is the purpose of the safety culture in ISO 26262?
o A strong safety culture ensures that safety is prioritized
throughout the organization. It involves raising awareness,
promoting safety responsibilities, and ensuring that safety is
embedded in all processes and decisions.
Example: An organization with a strong safety culture encourages engineers to
report potential risks in the design of an airbag system.
[Link] are the different roles and responsibilities for OEM, Tier 1,
and Tier 2 suppliers under ISO 26262?
o OEMs are responsible for system-level safety and integration. Tier
1 suppliers design and develop entire subsystems (e.g., braking
systems), ensuring compliance with the OEM's safety goals. Tier 2
suppliers provide individual components (e.g., sensors) and must
meet the safety requirements defined by Tier 1 suppliers.
Example: For an adaptive cruise control system, the OEM ensures the system
integrates with other vehicle systems, Tier 1 designs the radar system, and Tier
2 provides the radar sensors.
[Link] is the difference between Automotive Functional Safety
Engineer (AFSE), Automotive Functional Safety Professional
(AFSP), and Automotive Functional Safety Expert (AFSE)?
o AFSE focuses on implementing safety processes at the engineering
level, AFSP manages safety activities, ensuring compliance, and
AFSE Expert leads functional safety at an organizational level, with
strategic responsibility across projects.
Example: An AFSE might focus on ensuring a specific braking algorithm is
compliant, while an AFSP ensures overall project safety processes are followed.
[Link] is the purpose of role-based certification in ISO 26262?
o Role-based certification ensures that individuals have the
necessary skills and knowledge to fulfill their functional safety roles,
aligning with ISO 26262's competence requirements.
Example: An engineer developing an airbag deployment system would need
certification to demonstrate their understanding of safety design and
compliance.
[Link] does ISO 26262 ensure compliance through the use of work
products and documentation?
o ISO 26262 mandates the creation of specific work products (e.g.,
safety plans, hazard analyses, verification reports) at each phase of
the safety lifecycle. These ensure traceability, compliance, and
auditability.
Example: A hazard analysis report for an automatic emergency braking system
would document identified hazards, risks, and safety measures.
[Link] the steps involved in the functional safety audit and
assessment process.
o Audits review processes and activities to ensure they comply with
ISO 26262, while assessments evaluate whether safety goals have
been met. Both involve reviewing documentation, testing results,
and work products to ensure compliance.
Example: An audit of the electric steering system would involve reviewing the
design, development, and testing documentation.
[Link] is the ASIL (Automotive Safety Integrity Level) and why is it
important in ISO 26262?
o ASIL classifies risks based on Severity (S), Exposure (E), and
Controllability (C). ASIL defines the level of rigor required for
safety measures, with ASIL D requiring the highest safety
standards.
Example: An airbag system might be assigned ASIL D due to the high severity of
failure during a crash.
[Link] is ASIL determined during the hazard and risk analysis
process?
o ASIL is determined by assessing the severity of the hazard, the
frequency of exposure, and the controllability by the driver or
system. Each criterion is rated, and the combination determines the
ASIL level.
Example: A hazard where brake failure could lead to a crash in highway traffic
might be rated S3 (high severity), E4 (frequent exposure), and C3 (difficult to
control), resulting in ASIL D.
What is the purpose of ISO 26262 in the automotive industry?
a) To optimize vehicle performance
b) To ensure functional safety of electronic systems
c) To reduce production costs
d) To manage supply chain risks
Answer: b) To ensure functional safety of electronic systems
Explanation: ISO 26262 focuses on safety, not vehicle performance,
costs, or supply chain management.
Which volume of ISO 26262 covers the overall management of
functional safety?
a) Volume 1
b) Volume 3
c) Volume 5
d) Volume 9
Answer: a) Volume 1
Explanation: Volume 1 deals with the management of functional safety,
while other volumes address technical aspects like hardware and software.
Which process ensures that safety is considered throughout the
development and operational phases?
a) Risk management
b) Change management
c) Safety lifecycle management
d) Supplier management
Answer: c) Safety lifecycle management
Explanation: The safety lifecycle ensures functional safety is considered
at every stage, unlike risk, change, or supplier management, which have
narrower scopes.
Which of the following tasks is essential in project-independent safety
management?
a) Performing safety validation
b) Establishing a safety culture
c) Implementing hardware design
d) Conducting FMEA
Answer: b) Establishing a safety culture
Explanation: Project-independent safety management focuses on setting
up frameworks like safety culture, not specific tasks like validation or
FMEA, which are project-specific.
What is the role of the safety plan in functional safety management?
a) Assigns hardware requirements
b) Identifies safety goals and test procedures
c) Outlines all functional safety activities and roles
d) Defines vehicle system architecture
Answer: c) Outlines all functional safety activities and roles
Explanation: The safety plan organizes all activities and responsibilities,
unlike safety goals (from HARA) or hardware-specific requirements.
What is the relationship between ASIL and risk?
a) ASIL decreases with higher severity of hazards
b) ASIL increases as the risk increases
c) ASIL decreases as controllability decreases
d) ASIL is unaffected by exposure
Answer: b) ASIL increases as the risk increases
Explanation: ASIL is a measure of risk, combining severity, exposure, and
controllability. Higher risk requires a higher ASIL.
What is the role of the functional safety audit in ISO 26262?
a) To identify hardware fault tolerance
b) To review the implementation of safety processes
c) To verify component reliability
d) To analyze software errors
Answer: b) To review the implementation of safety processes
Explanation: Functional safety audits review processes, not specific
hardware or software errors.
Which of the following is NOT part of functional safety management?
a) Safety planning
b) Supply chain cost analysis
c) Process audits
d) Change management
Answer: b) Supply chain cost analysis
Explanation: Functional safety management does not involve cost
analysis but focuses on safety processes and change management.
What does FTA primarily analyze in ISO 26262?
a) The cost of component failure
b) The sequence of failures leading to system faults
c) The effectiveness of validation tests
d) The communication between software and hardware
Answer: b) The sequence of failures leading to system faults
Explanation: FTA traces system faults back to their root causes, while the
other options are not relevant to fault tree analysis.
Why is ASIL D the most stringent level in ISO 26262?
a) It applies to low-exposure events
b) It corresponds to the highest severity and low controllability
c) It only applies to hardware malfunctions
d) It is related to software performance requirements
Answer: b) It corresponds to the highest severity and low
controllability
Explanation: ASIL D is required for the most critical systems where
failures could lead to high-severity accidents and are hard to control.
What is the primary purpose of the ISO 26262 standard?
a) Increase vehicle performance
b) Ensure functional safety of automotive systems
c) Reduce production costs
d) Streamline software development
Answer: b) Ensure functional safety of automotive systems
Explanation: ISO 26262 focuses on ensuring the functional safety of
automotive electronics, not on improving vehicle performance or reducing
costs.
Which phase in the ISO 26262 lifecycle is primarily responsible for
defining safety goals?
a) Product development phase
b) Concept phase
c) Production phase
d) Hardware testing phase
Answer: b) Concept phase
Explanation: The concept phase identifies potential hazards and defines
safety goals based on hazard and risk analysis.
What is the focus of the functional safety lifecycle in ISO 26262?
a) Verifying cost-effective solutions
b) Ensuring safety across the entire vehicle lifecycle
c) Managing supply chain risks
d) Implementing advanced driver-assistance systems (ADAS)
Answer: b) Ensuring safety across the entire vehicle lifecycle
Explanation: The functional safety lifecycle ensures that safety is built
into every stage, from concept to decommissioning, not just cost or
specific technologies like ADAS.
Which of the following activities occurs during the development phase
of the safety lifecycle?
a) Supplier selection
b) Safety planning
c) Hazard and risk analysis (HARA)
d) System decommissioning
Answer: c) Hazard and risk analysis (HARA)
Explanation: HARA is performed in the development phase to identify
hazards and assign Automotive Safety Integrity Levels (ASIL).
What does ISO 26262 require to ensure that safety activities are
properly planned and executed?
a) Safety audit
b) Safety plan
c) Fault injection testing
d) Product validation
Answer: b) Safety plan
Explanation: A safety plan is required to outline all safety-related
activities, their timing, and responsibilities to ensure that functional safety
objectives are met.
Which of the following is NOT a focus of ISO 26262?
a) Functional safety
b) Risk assessment
c) Product performance
d) Hazard identification
Answer: c) Product performance
Explanation: ISO 26262 focuses on safety, not performance metrics like
speed, fuel efficiency, or driving dynamics.
Who is responsible for overseeing functional safety in an automotive
project?
a) Product manager
b) Supplier manager
c) Functional Safety Manager
d) Hardware engineer
Answer: c) Functional Safety Manager
Explanation: The Functional Safety Manager ensures that all safety-
related activities are executed according to the safety plan and ISO 26262
requirements.
Which supporting process focuses on tracking and controlling project
versions?
a) Configuration management
b) Fault Tree Analysis (FTA)
c) HARA
d) Failure Mode and Effects Analysis (FMEA)
Answer: a) Configuration management
Explanation: Configuration management ensures that all versions of the
project are controlled and tracked, especially in safety-critical systems.
What is the main purpose of ASIL levels in ISO 26262?
a) To define hardware specifications
b) To categorize suppliers by capability
c) To determine the required rigor of safety measures
d) To calculate product development costs
Answer: c) To determine the required rigor of safety measures
Explanation: ASIL levels (A-D) determine the rigor of the safety measures
based on the risk and severity of the hazards.
Which of the following tools is used to trace safety issues from top-
level system failures to root causes?
a) Fault Tree Analysis (FTA)
b) Hazard Analysis
c) Regression testing
d) FMEA
Answer: a) Fault Tree Analysis (FTA)
Explanation: FTA is a top-down approach used to trace system-level
failures to their root causes, unlike FMEA, which is a bottom-up analysis.