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5.1. Functional Safety Management System (FSMS) and Competence Requirements
A Functional Safety Management System (FSMS) consists of proven and validated procedures, methodologies,
templates and report outlines, covering those essential elements of hazard and risk assessment; SIL
determination; SIS design and SIL capable hardware, SIS installation, SIS commissioning and validation and
SIS operations and maintenance. A FSMS is used in the design of a COTS product and during the Application
Design. It’s typically an extension of the existing Quality Assurance/Quality Management process and has a
lifespan from conception to decommissioning of the SIS and beyond to become part of the organization best
engineering practices and work processes.
Figure 4: Root Cause of Control System Failures
As indicated, the safety standards call for competence of personnel. This requirement shouldn’t be interpreted
as a need for safety experts in every aspect of the design, commissioning or operation and maintenance of a
SIS, but instead as the need for an evaluation of the appropriate expertise and experience required to perform a
particular job function in any phase of the safety lifecycle. In practical terms, those involved with activities
related to a safety system should have demonstrated “competence” either by formal training, certification or
accreditation or on-the-job relevant experience.