Safety Critical Elements
Safety Critical Elements, Performance Standards & Validation
Part of the Safety Case process involves the validation of Safety Critical Elements.
Oracle Risk Consultants provide the following services in this regard:
- Defining the Safety Critical Elements and associated Performance Standards
- Producing the Scope of Validation for agreement by the Regulatory Authority (a pre-requisite for submitting a Safety Case)
- Producing a "Written Scheme of Validation/Verification" detailing precise validation steps to be performed
- Defining the function testing and maintenance requirements for Safety Critical Elements required to meet the pre-defined Performance Standards for incorporation into the Preventative Maintenance System (PMS)
Oracle can also assist clients in the production of Verification Schemes. These are written schemes detailing how the Performance standards are to be met and the performance of the Safety Critical Elements are to be assured through performance testing, QA checking, inspection, routine maintenance, etc.