Why we need Functional Safety Management?
What is Functional Safety Management?
Standards for functional safety, such as IEC 61508, along with industry-specific standards like the automotive standard ISO 26262, establish criteria for managing functional safety and conducting safety assessments, as well as documenting these processes. Throughout the safety life-cycle, project managers and engineers are required to adhere to these criteria and ensure compliance. Our assistance is provided to companies in establishing a functional safety management system that meets these requirements.
The tasks defined in the lifecycle, along with supportive activities to ensure their proper execution, constitute the “what should be done.”
It involves a series of processes and activities designed to ensure that safety-related systems perform their intended functions under all conditions. The standard defines requirements for the entire lifecycle, including concept, design, implementation, operation, maintenance, and decommissioning of safety-related systems. It also covers risk assessment, safety integrity levels (SIL), and the necessary organizational structures to support these activities.
What is Functional Safety Management?
1. Establishing a Safety Management System (SMS):
Develop a structured framework that includes policies, procedures, and processes for managing safety activities according to IEC 61508. This includes defining roles, responsibilities, resources, and safety objectives.
2. Defining the Safety Lifecycle:
Clearly identify and document each phase of the safety lifecycle (concept, design, development, installation, operation, maintenance, and decommissioning) and the associated safety activities required at each stage.
3. Conducting Hazard and Risk Assessments:
Use methods like Hazard Analysis and Risk Assessment, Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) to identify potential hazards and evaluate risks.
4. Developing a Safety Requirements Specification (SRS):
Based on the risk assessment, specify the safety requirements that the system must meet to reduce risks to an acceptable level.
5. Implementing Safety Design and Architecture:
Design the system according to the SRS, applying safety principles such as redundancy, diversity, and fail-safe mechanisms. Use appropriate safety integrity levels (SILs) as defined by IEC 61508.
6. Verification and Validation (V&V):
Perform verification and validation activities at each stage of the lifecycle to ensure the system meets the specified safety requirements. This includes testing, simulation, inspections, and reviews.
7. Ensuring Competency and Training:
Ensure that all personnel involved in safety-related activities are adequately trained and competent. Maintain records of training and competency assessments.
8. Performing Safety Audits and Assessments:
Conduct regular safety audits and assessments to verify that safety management practices are correctly implemented and maintained. Use independent assessors where necessary.
9. Documenting and Reporting:
Maintain comprehensive documentation throughout the lifecycle, including hazard and risk assessments, SRS, V&V results, change management records, and audit reports. Ensure transparency and traceability of all safety-related activities.
10. Continuous Improvement:
Establish feedback mechanisms to learn from incidents, near-misses, and operational experience to continually improve safety practices and reduce risks over time.
Conclusion
Functional Safety Management according to IEC 61508 is a comprehensive framework that integrates risk management, safety engineering, and systematic procedures throughout the lifecycle of a safety-related system. By adhering to FSM practices, organizations can ensure their systems are designed and operated safely, protecting people, the environment, and assets from potential hazards.