Functional safety activities are most effective by integration into a well-established and proven quality management system. Functional safety requirements should increase the rigour of the design engineering of a product, software element or system and be traceable to the appropriate standard e.g. IEC 61508 and IEC 61511.
How To Show Functional Safety Compliance
The following are typical documents required to demonstrate functional safety compliance:
– Functional safety plan;
– Process Hazard Analysis (PHA);
– Determination of Safety Integrity Level (SIL);
– Safety Requirement Specification;
– Verification and validation plans;
– Functional Design Specification (FDS);
– Software Design Specification (SDS);
– SIL Verification;
– Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT);
– Proof test procedures;
– Functional safety assessment;
– Operations and maintenance manual;
– Safety manual;
– Defect, non-conformance and demand reporting.
What inputs are required by FSES in order to conduct the Study?
Depending on the exact requirements of the study, the documentation will change. Upon award of contract FSES will provide the client with a list of the required inputs in order to conduct the study.Will there be a Workshop?
If there is insufficient documentation available, a workshop may be required. The requirements for a workshop will also be dependent on the scope of work required by the client. This will be discussed with the client prior to award of contract.
What is the expected output of the Study?
On award of the study FSES will review the documentation available and identify any shortfalls against the appropriate standards (i.e. IEC 61508 and IEC 61511). If required, a workshop will be facilitated, whereby the required information will be extracted from the relevant personnel in order to demonstrate compliance.
FSES will prepare a report describing the scope of work, a detailed methodology, along with all the requirements of the appropriate standards outlined and the relevant evidences documented to show compliance.
If part of the scope of work, FSES will also produce the required relevant procedures, processes, template documents and deliver training as required in order to show functional safety compliance.
FSES consultants have considerable experience in all of the above activities and can provide assistance in demonstrating functional safety compliance. This can be carried out for a single project or assistance can be given to create procedures, processes, template documents and deliver any required training to allow a company to demonstrate functional safety as a core competence.
For more information, or to discuss your needs for reviewing the design engineering, please contact us using the form below or email [email protected] .