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The Importance of Functional Safety Assessment and its Application
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8.2 Perform
FSAs are subject to the ‘judgement’ made by the assessor during the time of the assessment. This
judgement is typically arrived at based on the evidence provided by the project team. The project
team is requested to provide the necessary evidence for every activity that has been followed to
deliver the lifecycle phase outcome.
This typically includes review of the functional safety management system utilised for execution of the
respective activities such as the assessments, processes, design, engineering, verification and
validation applied and the eventual requirements for operation and maintenance of the respective
phase deliverables.
An FSA will focus on the work done since the previous functional safety assessment and the extent of
remediation to date. This is required to ensure implementation of any corrective actions identified as
part of the earlier assessments performed and the commitment of the team in establishing functional
safety.
The assessment will need to review the activities & associated assumptions identified during the
specific lifecycle phase(s), its implementation and the outputs obtained during each phase of the
safety lifecycle.
Assessments shall also be made on all the relevant claims of compliance as made by the suppliers
and other parties responsible for achieving functional safety. This may also cover the review of the
assessment records made by the supplier organisations for their deliverables. This is to ensure
functional safety is not compromised by the supporting supply chain.
Assessment shall be made for personnel competency, who are involved in each phase of the
lifecycle. Evidence of competency assessment, its process, the implementation of how competencies
are assessed, basis of competency assessment and the relevant actions from any competency gap
closures will need to be reviewed for all parties involved in any safety lifecycle phase.
Review of evidence of the document control, management of change, configuration management,
design & engineering, verification & validation processes applied shall be part of the FS assessment
process.
Where design, development and production tools are used, its output and their impact on functional
safety shall be subject to FS assessment. The assessment review will need to identify if there is no
compromise on functional safety while utilising such tools for design, development and testing of the
SIS.
All modifications are subject to FSAs. The standard mandates that assessment shall review the
impact of the proposed modification(s), without which, the modifications shall not be implemented.
FSAs shall include review of the functional safety audit report(s) and the evidence of the respective
corrective action reports raised by the audit.
Periodic FSAs during the Operation and Maintenance phase of the lifecycle, shall review whether the
O&M activities are performed against the designed requirements and assumptions. When
decommissioning of the SIS occurs either in part or full, the FSAs shall review for any impact on
functional safety performance demanded on the remainder of the operating plant SIS or other
dependent SIS.
Documented evidence for all the activities under review shall be identified and recorded when
performing an FSA.