What is Functional Safety Management (FSM)
Functional Safety Management (FSM) is the “glue” that holds the Safety Lifecycle together in IEC61511. The Functional Safety Management Plan (FSMP) is a critical document prescribed in IEC 61508 and ISO 26262 Standards, outlining how functional safety will be achieved and maintained throughout the project’s lifecycle, including operation. To be compliant, End Users need to have an FSM plan in place that covers all phases of the Safety Lifecycle: Analysis, Implementation & Operation
Structured Framework of Functional Safety Management (FSM)

- Roles and Responsibilities: Identifies key roles and assigns responsibilities within the development process. It must be delineated and communicated.
- Personnel Competency: All persons involved in any overall, E/E/PE system or software lifecycle activity, including activities for verification, management of functional safety, and functional safety assessment, shall have the appropriate competence (qualifications, technical knowledge, and experience ) relevant to the specific duties that they have to perform.
- Documentation Structure: Adequate information to effectively perform each action during every phase of the safety lifecycle, management of functional safety, verification, and validation of functional safety management system.
- Verification task for each step: Verification tasks are critical to ensure adherence to safety standards and maintain traceability throughout the safety lifecycle.
The FSMP ensures that functional safety activities, roles, resources, and responsibilities are systematically organized to achieve safety goals effectively. Below is an explanation of the methodology used to develop and implement an FSMP
Methodology to Develop and Implement an FSMP

- ExperienceFunctional Safety Standards
- The foundation of an FSMP lies in compliance with relevant standards such as IEC 61508, ISO 26262, or industry-specific Standards. These standards guide safety lifecycle phases, processes, and techniques to manage functional safety.
- Key Steps:
- Identify the applicable standards and regulations.
- Define safety requirements based on these standards.
- Incorporate specific industry guidelines where applicable.
- Defining the Scope
- The FSMP must clearly define its scope to ensure alignment with project objectives and stakeholder requirements.
- Key Steps:
- Identify the system, processes, or components under consideration.
- Specify boundaries, assumptions, and constraints of the functional safety system.
- Document interfaces with other systems.
- Assigning Roles and Responsibilities
- Establishing accountability and clarity of roles is crucial for effective implementation.
- Key Steps:
- Identify stakeholders, including safety managers, engineers, and verification personnel.
- Assign specific responsibilities for activities within the safety lifecycle, such as hazard identification, risk assessment, and validation.
- Ensure competency requirements are defined and met for all personnel.
- Safety Lifecycle Planning
- The FSMP should outline the entire safety lifecycle, including phases from concept through decommissioning.
- Key Steps:
- Define key milestones and deliverables for each phase.
- Integrate functional safety activities with the overall project schedule.
- Establish review gates to monitor progress and compliance.
- Risk Management and Assessment
- Risk management is a core component of functional safety, ensuring hazards are identified, assessed, and mitigated appropriately.
- Key Steps:
- Perform a Hazard and operability study (HAZOP), failure mode and effects analysis (FMEA), or similar techniques to identify hazards.
- Evaluate risks using methods such as risk matrices or layer of protection analysis (LOPA).
- Define Safety integrity level (SIL) requirements based on risk tolerability criteria.
- Development and Verification of Safety Functions
- The FSMP must ensure that safety functions are designed, implemented, and verified by the defined safety requirements.
- Key Steps:
- Translate safety requirements into specific safety functions.
- Implement safety functions using hardware, software, or procedural measures.
- Conduct verification activities such as reviews, tests, and inspections to ensure compliance.
- Validation and Certification
- Validation ensures that the implemented system meets its safety objectives, while certification demonstrates compliance to external stakeholders.
- Key Steps:
- Conduct validation testing under real-world conditions.
- Prepare documentation for certification audits.
- Liaise with certifying bodies for independent assessments.
- Change and Configuration Management
- Managing changes systematically is essential to maintaining functional safety throughout the system’s lifecycle.
- Key Steps:
- Establish a change management process to evaluate impacts on functional safety.
- Maintain a configuration management system to track design versions.
- Document and assess all changes for compliance with safety requirements.
- Periodic Reviews and Audits
- Regular reviews and audits ensure ongoing compliance and effectiveness of the FSMP.
- Key Steps:
- Schedule internal and external audits at defined intervals.
- Review safety performance metrics and incident reports.
- Update the FSMP based on lessons learned and evolving standards.
- Training and Awareness
- Developing competency and promoting awareness among stakeholders is critical to the success of the FSMP.
- Key Steps:
- Provide training on functional safety principles and processes.
- Conduct workshops to align all team members with the FSMP.
- Maintain records of training and certifications.
- Documentation and Communication
- A well-documented FSMP facilitates clear communication among all stakeholders and serves as evidence of compliance.
- Key Steps:
- Maintain comprehensive records of all functional safety activities.
- Use a centralized system for document management.
- Ensure all stakeholders have access to relevant FSMP documentation.
By adhering to this methodology, organizations can systematically manage functional safety risks and achieve compliance with industry standards, ensuring the safe and reliable operation of systems and processes throughout their lifecycle.
Why Choose a Functional Safety Management Plan?
Implementing an FSMP ensures compliance with industry standards, mitigates risks, and enhances the reliability of systems. By adopting a structured approach, organizations achieve safe operations while maintaining traceability and accountability.