What is a “Functional Safety Audit”?
IEC61511-1:2016, 3.2.25 – systematic and independent examination to determine whether the procedures specific to the functional safety requirements comply with the planned arrangements, are implemented effectively and are suitable to achieve the specified objectives.
Note: A functional safety audit may be carried out as part of a FSA.
The purpose of the Functional Safety Audit is to determine if functional safety procedures are being correctly and effectively implemented during the project execution. The audit provides a useful means of assessing how effectively systematic failures are being controlled by using procedures to prevent errors in design, construction or operation.
Note that it does not provide any judgement on whether functional safety has been achieved or maintained during the project. It typically forms part of the Quality Management System (QMS) of the organisation responsible for the respective phase of the safety lifecycle. The records of the audits are reviewed as part of the FSAs.
Audit is also a feedback mechanism for senior management. Its purpose is to monitor how well people understand and apply procedures, and whether those procedures are practicable and effective.