AADvance Safety Manual - Tuv-fs.com

Functional Safety ManagementChapter 3This chapter explains the principles that should be applied to managing the safetyrelated system.In This ChapterThe Safety Management System ...................................................................... 3-4The Safety Life-cycle........................................................................................... 3-4Functional Safety Assessment .......................................................................... 3-4Safety Integrity Design ....................................................................................... 3-4The Safety Management SystemA prerequisite for the achievement of functional safety is the creation and use ofprocedures and other measures as part of a safety lifecycle, collectively known as aSafety Management System. The Safety Management System defines the genericmanagement and technical activities necessary to achieve and maintain functional safetyin the product design and development. In many cases, the Safety Management andQuality systems will be integrated within a single set of procedures. The integratorshould have an accredited quality management system.The Safety Management System shall include: A statement of the policy and strategy for achieving and maintaining functionalsafety. A safety planning procedure, which shall result in the definition of the safetylifecycle stages to be applied, the measures and techniques to be applied at eachstage, and the responsibilities for completing these activities. Definitions of the records to be produced and the methods of managing theserecords, including change control. The change control procedures shall includerecords of modification requests, the impact analysis of proposed modifications andthe approval of modifications. The baseline for change control shall be definedclearly. Configuration items shall be uniquely identified and include version information.Examples of configuration items are system and safety requirements, system designdocumentation and drawings, application software source code, test plans, testprocedures and test results. Methods of ensuring that persons are competent to undertake their activities andfulfill their responsibilities.The Safety Life-cycleThe safety life-cycle is defined by the IEC 61508 standard. It is designed to structure asystem's development into defined stages and activities as follows: Scope definitionDocument number 553630 Issue 7: February 2010 3-1