Functional safety

Developing a functional safety management (FSM) system

1-Day Training Course

Course description:

This course provides training in setting up a system of procedures to manage the functional safety related activities within an organisation (FSM).

The course covers the generic aspects from IEC 61508 that apply to all organisations, such as defining the right policies, roles and responsibilities, supplier assessments, modification, functional safety assessment, etc. A key topic is competence and how to define the requirements, allocate staff and assess competence in order to maintain records.

The course also covers identifying procedures to cover the specific technical activities that the organisation deals with. The example shown overleaf is for the realisation phase from IEC 61508-2 covering the procedures from requirements definition through the development activities, verification and validation.

The relationship between the ISO 9001 Quality Management System and Functional Safety Management is explained and how these can be combined for an efficient set of management procedures.

Target audience:

The course is intended for those who are already familiar with functional safety principles but who are concerned with developing company-wide procedures for functional safety activities and/or for staff who need to understand the implications of FSM on their roles and responsibilities.

Learning outcomes:

Participants gain a thorough understanding of the scope of Functional Safety Management from IEC 61508 and related standards and will be equipped to develop the detailed procedures for their organisation.

Supporting material:

Manuals based on the lecture slides are provided together with example procedures, templates, process diagrams and documentation maps. Example documents can be provided in electronic format for maximum benefit.

Training Course Outline

1. Introduction to Functional Safety Management
• Overall scope, aims and objectives of FSM
• How does FSM relate to the QMS (ISO 9001)
• Differences in FSM between the functional safety standards
2. Policies, procedures and an overall framework
• Structure and content of an overall FSM procedure (provided by Silmetric for guidance)
• FSM requirements from IEC 61508, IEC 61511, IEC 62061 and ISO 13849 (as relevant), spotlighting the differences from each standard
3. Identifying the relevant lifecycle activities
• Workshop discussion to define the client’s activities
• Review of the existing ISO 9001 QMS procedures
• Sector/application specific FSM requirements to be included
4. Lifecycle documentation (realisation phase)
• Key realisation documents required (such as design specifications, detailed design documentation, reliability analysis, application software, verification and test, safety manual)
5. Verification and validation procedures
• Walkthrough of the verification checklists (provided by Silmetric as guidance/templates) for key realisation lifecycle stages (e.g., design requirements, architecture, detailed design, validation, safety manual)
6. Managing competence
• Defining competence requirements, records, allocating tasks and ongoing competence assessment
• Guidance for various roles based on a walkthrough of the Silmetric guidance sheets (provided)
7. Functional Safety Audit
• Guidance on audit checks at defined stages in the lifecycle
• Audit records and input to management review
8. Functional Safety Assessment
• Independence and competence of the assessment team
• Assessment procedures, tools and methods
• Making a claim of conformity (self-declaration or certification)

* the topics shown above cover the realisation lifecycle but other lifecycle phases can be covered instead