J. Functional Safety Assessment

IEC 61511 requires that a functional safety assessment (FSA) be performed prior to the introduction of process materials in to the equipment under control (EUC). This requirement is similar to the pre-startup safety review (PSSR) called for by OSHA and other regulatory bodies around the world.

IEC 61511 requires that at least one senior, competent, independent (from the project team) person, take part in the FSA. This independent individual must have the authority to prevent the process unit startup, if necessary.

The Functional Safety Assessment is documented in a "SIS validation plan" and is usually performed by the user/operator in conjunction with the engineering contractor and/or the SIS vendor. The FSA should at minimum verify the following:

• The SIS has been constructed, installed and tested in accordance with the SRS.
• All procedures for safety, operation, maintenance and management of change (MOC) are complete and in place.
• Any pending PHA and/or SRS issues are resolved and implemented.
• Operations and maintenance personnel are trained and competence is documented.
• Application software is validated in accordance with validation plan.
• All safety instrumented functions perform according to the SRS.
• Bypasses, overrides and reset functions perform in accordance with SRS.
• SIS is not affected by adverse interactions of the BPCS or any shared instrumentation.
• Loss of utilities do not impede proper SIS action.
• Verification of EMC immunity.
• BRPB or other manual independent e-stop operate correctly.
• Critical Safety alarms function as per the SRS.
• HMI graphics function correctly.
• SIS safety validation (SAT) completed prior to startup.
• PSSR completed. All bypasses returned to normal, isolation valves set to startup position, test materials removed and all forces removed.