FSD002: Management of functional safety¶
Title |
FSD002: Management of functional safety |
Current version |
V3 |
Products |
Safety Simplifier |
Requirements |
61508-1, clause 6.2.1-6.2.18 (Management of functional safety) 61508-1, clause 7.1.4.1-7.1.4.8 (Overall lifecycle safety requirements) 61508-2, clause 7.1.3.1-7.1.3.5 (E/E/PE system safety lifecycle requirements) 61508-3, clause 7.1.2.1-7.1.2.8 (Software safety lifecycle requirements) 61508-3, clause 6.2.1-6.2.3 (Additional requirements for management of safety-related software) |
Purpose |
Specify the management, requirements and activities during E/E/PE system and software safety phases, to achieve functional safety |
Input |
61508-1 |
Output |
Management requirements to be followed in all applicable phases of the project |
Table of contents¶
Management of functional safety¶
Motivations¶
According to 61508, a safety function can only be implemented in a complete system which includes the subsystems sensor, logic and actuator. The Safety Simplifier is a component in a complete system and can therefore only provide the logic part. Thus, for further discussion, an element safety function is considered. Since the Safety Simplifier is only intended to be used as a part of a safety function, only the lifecycle activities 9 and 10 from 61508-1 figure 2 (E/E/PE system safety requirements specification and E/E/PE safety-related systems /Realisation) are applicable to the Safety Simplifier; the requirements in chapters 7.2 to 7.9 are not applicable. |
Functional safety is achieved by:
Functional safety is evaluated by:
For a high level overview of the functional safety development process see Appendix QMSDOC-1761341735-37 Functional safety development overview (available in SSP North Quality Management System). |
The following list is also cross checked with QMSDOC-1761341735-45, and the associated competence matrix. Identification of persons and departments responsible for applicable safety lifecycle phases, according to 61508-1 figure 2 and 61508-2 figure 2:
According to 61508-3, figure 4, Software safety lifecycle:
The people involved in the E/E/PE system or software safety lifecycles have:
General documentation requirements:
RISE is responsible for the functional safety assessment.
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a) Phase 3 not applicable for Safety Simplifier, however, general hazard and risk analyses are performed in activities where relevant. See QMSDOC-1761341735-35, and FSWP - Functional Safety Work Packages. b) c) d) e) The document QMSDOC-1761341735-35 (Modification of safety function, available in SSP North) explains the procedues for modifications of safety functions, including risk/hazard analysis and impact analysis. During development/implementation of a change, the change is documented in a work package (FSWP). See FSWP - Functional Safety Work Packages. Every phase in the project shall be planned in advance and the plan shall describe the sequence of work in the phase and also the outcome of the phase. Every phase shall end with an internal audit or review to identify if follow-up activities are needed. See reviews in Reviews - Functional Safety reviews. Meetings with a third party, RISE, performing the functional safety assessment (FSA) are held on regular basis. External audit or reviews with a third party can lead to follow-up activities. The same procedure as for the review applies. Each follow-up activity must be addressed to a person and a date for implementation and a new review must then be set. If the safety functions are involved in a follow-up activity a new impact analysis must be performed to guarantee that the safety functions are not changed. If a follow-up activity requires that all new updates shall be changed or removed, and it is easier to restart from an old version of a document, this is possible when using a version control system. f) Appendix QMSDOC-1761341735-26 Communication for quality and delivery problems (available in SSP North Quality Management System) describes the communication for quality and delivery problems when product related quality problems are reported to SSP North. |
Under the condition that hazardous incidents are reported by customers, SSP North will act according to an established routine. Appendix QMSDOC-1761341735-27 Handle product issues and change requests (available in SSP North Quality Management System) describes the SSP North AB routines. Appendix QMSDOC-1761341735-26 Communication for quality and delivery problems describes the communication for quality and delivery problems when product related quality problems are reported to SSP North. Under the condition that systematic faults that can jeopardise the functional safety are reported by customers, SSP North will act according to an established routine. Appendix QMSDOC-1761341735-27 Handle product issues and change requests process for product issues and change requests describes the SSP North AB routines. |
Functional safety audits shall be performed like a regular review, but with focus on functional safety. The review shall be documented and followed up if necessary. Safety audits are held in accordance with the sub-phases in phase 10 of the lifecycle in 61508. |
Modifications requiring changes to a finished development phase must be approved by the project leader. Modifications to a released product must be approved by the SSP North R&D manager. The document Appendix QMSDOC-1761341735-35 Modification of safety function (available in SSP North Quality Management System) is used to document this kind of modifications. For each modification request an impact analysis must be made. All steps in the modification procedure must be documented. The FSWP defintion is the tool used to comply with this. |
User manuals shall contain information and warnings for potential hazards. Customers are responsible for reporting hazardous incidents to SSP North AB. |
A version control system is applied for version control of all functional safety documents created and maintained, in order to increase the control and overview in the overall document management. Benefits with a version control system are:
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Not applicable, as the Safety Simplifier is only part of a safety function (see Element safety function (MOTIVATION_002_001)). |
a) Techniques and measures are described in FSD303: Techniques and measures. b) c) See General management (MOTIVATION_002_002). |
Competence maintained as new products with safety-related functions are developed on regular basis. Only experienced personnel are involved in the development of the product. See Appointed responsible persons (MOTIVATION_002_003). |
Competence level is considered high, especially with experience from earlier projects involving FSA for 61508. See also Appointed responsible persons (MOTIVATION_002_003). |
The organisation manufacturing the SSP North AB products is required to follow the quality
standard of ISO9000 and the concerned IPC standards for circuit boards and wiring harness.
Reference the |
Covered in the overall 61508 FSA documentation. See also Appointed responsible persons (MOTIVATION_002_003). The activities specified in this document are applied for the complete development lifecycle. Management activities specific for each phase in the safety lifecycle are described in the concerned FSD documents. |
Verifying the 6.2.2 to 6.2.15 requirements is done by completing the checklist Template 61508 Activities (CHLST_template001). |
Overall safety lifecycle¶
The Management of functional safety in 61508-1, clause 6, is applied during the E/E/PE system safety lifecycle phases. |
See Realisation phases (MOTIVATION_002_024). Only lifecycle activities 9 and 10 from 61508-1 figure 2 are applicable to the Safety Simplifier. For each phase in the overall safety lifecycle that is applied, the requirements are met. Achievement of the requirements is controlled with checklists by the third party that is responsible for the functional safety assessment. |
Each phase has one or more corresponding documents which include the scope, activities, input and output of that phase. |
Table 1 in 61508-2 was followed when describing the purpose, input and output for each functional safety document that relates to a specific lifecycle phase. |
The outputs for each phase meet the objectives and requirements for the overall safety lifecycle phase, unless something else is specified in the concerned document.
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See FSD107: System verification plan, validation test specifications and results. The verification requirements are met with verification plans for each phase, verification according to the plan, specified verification criteria, specified techniques and tools to be used, verification procedure to follow and verification reports for documentation use.
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E/E/PE system safety lifecycle requirements¶
The E/E/PE system safety lifecycle specified in 61508-2, figure 2 is applied, as well as phase 9 in 61508-1 figure 2 (Safety requirements specification). ASIC not used in the design. |
The Management of functional safety in 61508-1, clause 6, is applied during the E/E/PE system safety lifecycle phases. See this document FSD002: Management of functional safety. |
Each phase in the realisation of the E/E/PE system safety lifecycle is divided into elementary activities, with scope, input, and output for each activity specified in the corresponding FSD document. As determined in Element safety function (MOTIVATION_002_001), the following phases are considered:
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Software safety lifecycle requirements¶
Example of phases and documentation in 7.1 is followed with one exception; due to the small size of the project the architecture and system design phases are merged, as suggested in 7.1.2.4 and 7.4.5. These are the resulting phases:
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The same procedure as for the E/E/PE system safety lifecycle applies. |
The example in table 1, 61508-3 is followed. Model number for the products, requirements, purpose, input and output is specified in each functional safety document. |
The V-model used, but without architectural level. Tailored V-model not applied. |
The software safety lifecycle is used. |
See general procedures for QA in QMSDOC-1761341735-26. |
Documentation is made according to 61508-1, clause 5. See FSD001: Documentation structure. |
The modification procedure is described in FSD002: Management of functional safety and in the document QMSDOC-1761341735-35 Modification of safety function (available in SSP North Quality Management System). The modification procedure is followed for all modifications to the software, including changes to requirements, design, code, and documentation. |
FSA¶
The functional safety assessment (FSA) is performed by RISE, an independent third party. |
Revision History¶
Date |
By |
Version |
Description |
|---|---|---|---|
2018-05-31 |
Mats Linger |
V2 |
Change of SP to RISE and Q numbers |
2018-10-11 |
Mats Linger |
V3 |
Corrections of spelling |
2023-09-07 |
Nils Odén |
V4 |
Copied over old document to new structure, no change in requirements. |
2024-11-14 |
Nils Odén |
V5 |
Appendix numbers updated with new QMS document ID’s |
2024-12-02 |
William Forsdal |
V6 |
Changes:
|
2025-01-30 |
William Forsdal |
V6 |
Changes:
|
2025-08-03 |
Jesper Ribbe |
V07 |
Changes:
|