Project:** [Your Railway System Name]
SIL Target:** 4
Assessment Date:** [Target Date]
Notified Body:** [Name]
Document Submission Checklist
Phase 1: Project Planning & Safety Strategy (Before Design)
| Document | File | Status | Notes |
| Safety Plan | 01_SAFETY_PLAN.dox | ☐ Draft ☐ Review ☐ Approved | Overall safety lifecycle approach |
| V&V Plan | 02_VERIFICATION_VALIDATION_PLAN.md | ☐ Draft ☐ Review ☐ Approved | Testing and verification strategy |
| Configuration Management Plan | 03_CONFIGURATION_MANAGEMENT_PLAN.dox | ☐ Draft ☐ Review ☐ Approved | Change control and CM procedures |
| Tool Qualification Report | 04_TOOL_QUALIFICATION.md | ☐ Draft ☐ Review ☐ Approved | If using specialized MISRA tools |
Phase 2: Requirements & Analysis (Requirements Phase)
| Document | File | Status | Notes |
| System Requirements Specification (SRS) | 05_SRS_TEMPLATE.md | ☐ Draft ☐ Review ☐ Approved | All functional & safety requirements |
| Hazard Analysis & Risk Assessment (HARA) | 06_HARA_TEMPLATE.dox | ☐ Draft ☐ Review ☐ Approved | Failure modes and risk assessment |
| Safety Requirements Specification (SafeRS) | 07_SAFE_REQUIREMENTS_TEMPLATE.md | ☐ Draft ☐ Review ☐ Approved | Derived safety requirements |
| RteFramework Integration Plan | 08_RTE_INTEGRATION_PLAN.md | ☐ Draft ☐ Review ☐ Approved | How RteFramework is used |
Phase 3: Design (Design Phase)
| Document | File | Status | Notes |
| Architecture Design Document (ADD) | 09_ARCHITECTURE_DESIGN.md | ☐ Draft ☐ Review ☐ Approved | System and software architecture |
| Detailed Design Document (DDD) | 10_DETAILED_DESIGN.md | ☐ Draft ☐ Review ☐ Approved | Module-level design specifications |
| OSAdapter Design Document | 11_BACKEND_DESIGN.md | ☐ Draft ☐ Review ☐ Approved | OS/RTOS-specific OSAdapter design |
| Traceability Matrix | 12_TRACEABILITY_MATRIX.md | ☐ Draft ☐ Review ☐ Approved | Req → Design → Code → Test |
| Design Review Report | 13_DESIGN_REVIEW_REPORT.md | ☐ Draft ☐ Review ☐ Approved | Findings from design review |
Phase 4: Implementation & Verification (Implementation Phase)
| Document | File | Status | Notes |
| Code Review Checklist | 14_CODE_REVIEW_CHECKLIST.md | ☐ In Progress ☐ Complete | MISRA + EN 50128 review findings |
| Code Review Report | 15_CODE_REVIEW_REPORT.dox | ☐ Draft ☐ Review ☐ Approved | Formal code review results |
| Static Analysis Report | 16_STATIC_ANALYSIS_REPORT.md | ☐ Draft ☐ Review ☐ Approved | MISRA tool output (cppcheck or certified tool) |
| Coding Standards Compliance | 17_CODING_STANDARDS.md | ☐ Draft ☐ Review ☐ Approved | Deviation from MISRA rules (if any) |
| Test Plan | 18_TEST_PLAN.md | ☐ Draft ☐ Review ☐ Approved | Unit, integration, system test strategy |
| Unit Test Report | 19_UNIT_TEST_REPORT.md | ☐ In Progress ☐ Complete | Module-level test results |
| Integration Test Report | 20_INTEGRATION_TEST_REPORT.md | ☐ In Progress ☐ Complete | System integration test results |
| Coverage Analysis | 21_COVERAGE_ANALYSIS.md | ☐ Draft ☐ Review ☐ Approved | Code coverage metrics & analysis |
Phase 5: Certification & Safety Case (Assessment Phase)
| Document | File | Status | Notes |
| Safety Case | 22_SAFETY_CASE.dox | ☐ Draft ☐ Review ☐ Approved | Main argument for system safety |
| Functional Safety Assessment | 23_FUNCTIONAL_SAFETY_ASSESSMENT.md | ☐ Draft ☐ Review ☐ Approved | SIL verification evidence |
| RteFramework Verification Report | 24_RTE_VERIFICATION.md | ☐ Draft ☐ Review ☐ Approved | How RteFramework was verified |
| Deviation Management Report | 25_DEVIATION_MANAGEMENT.md | ☐ Draft ☐ Review ☐ Approved | All MISRA/EN 50128 deviations |
| Assessment Readiness Checklist | 26_ASSESSMENT_READINESS.md | ☐ Draft ☐ Review ☐ Approved | Pre-assessment verification |
Phase 6: Notified Body Assessment (Assessment Phase)
| Document | File | Status | Notes |
| Notified Body Assessment Report | 27_ASSESSMENT_REPORT.md | ☐ Submitted ☐ In Review ☐ Complete | Official assessment findings |
| Assessment Finding Closure Report | 28_FINDING_CLOSURE.md | ☐ In Progress ☐ Complete | Resolution of assessment findings |
| Certification Certificate | 29_CERTIFICATE.md | ☐ Pending ☐ Received | SIL 4 certification (from Notified Body) |
Quick Reference: Which Templates to Use
Minimal Set (MVP for SIL 4)
Required absolute minimum:
1. Safety Plan (01)
2. SRS (05)
3. HARA (06)
4. Architecture Design (09)
5. Code Review Report (15)
6. Static Analysis Report (16)
7. Unit Test Report (19)
8. Traceability Matrix (12)
9. Safety Case (22)
10. RteFramework Verification (24)
Standard Set (Recommended)
Add to minimal set:
- V&V Plan (02)
- SafeRS (07)
- RteFramework Integration (08)
- Detailed Design (10)
- OSAdapter Design (11)
- Test Plan (18)
- Integration Test Report (20)
- Coverage Analysis (21)
- Deviation Management (25)
Complete Set (Belt & Suspenders)
All documents (01-29)
Needed for large/critical systems or complex RTOS OSAdapters
Document Dependencies
Safety Plan (01)
├─→ V&V Plan (02)
└─→ SRS (05)
├─→ HARA (06)
│ └─→ SafeRS (07)
└─→ Architecture Design (09)
├─→ Detailed Design (10)
├─→ OSAdapter Design (11)
└─→ Traceability Matrix (12)
├─→ Code Review Report (15)
├─→ Static Analysis Report (16)
├─→ Test Plan (18)
├─→ Unit Test Report (19)
├─→ Integration Test Report (20)
└─→ Coverage Analysis (21)
└─→ Safety Case (22)
└─→ Notified Body Assessment (27)
Timeline Estimate
| Phase | Duration | Output Documents |
| Planning | 2-4 weeks | 01, 02, 03 |
| Requirements | 4-8 weeks | 05, 06, 07, 08 |
| Design | 4-8 weeks | 09, 10, 11, 12, 13 |
| Implementation | 8-16 weeks | 14, 15, 16, 17, 18, 19, 20, 21 |
| Assessment Prep | 2-4 weeks | 22, 23, 24, 25, 26 |
| Notified Body Assessment | 3-6 months | 27, 28, 29 |
| TOTAL | 6-12 months | |
Review & Approval Workflow
Each document should follow this workflow:
1. DRAFT
Author writes initial version
Self-review for completeness
2. TECHNICAL REVIEW
Peer review by technical team
Review for technical accuracy
Comments and revisions
3. SAFETY REVIEW
Functional Safety Manager reviews
Checks compliance with Safety Plan
Verifies traceability
4. MANAGEMENT REVIEW
Project Manager sign-off
Ensures resources are allocated
5. APPROVED
Document placed under change control
Baseline established
No changes without Change Request
6. RELEASED TO NOTIFIED BODY
Submitted as part of assessment package
Document Control Template
Each document should include:
---
Document ID: [Project]-[Number]-[YY.MM]
Title: [Document Name]
Revision: [A/B/C/...]
Date: [Date]
Status: [DRAFT / REVIEW / APPROVED / RELEASED]
Author: [Name]
Reviewed By: [Name]
Approved By: [Name, Safety Manager]
Change History:
| Rev | Date | Author | Change |
|-----|------|--------|--------|
| A | 2026-08-01 | [Name] | Initial draft |
| B | 2026-08-15 | [Name] | Incorporated review comments |
---
[Content]
Submission Package to Notified Body
When ready for assessment, package should include:
[PROJECT_NAME]_SIL4_Assessment_Package/
├── 01_SAFETY_PLAN.dox
├── 02_VERIFICATION_VALIDATION_PLAN.md
├── 03_CONFIGURATION_MANAGEMENT_PLAN.dox
├── 04_TOOL_QUALIFICATION.md
├── 05_SRS.md
├── 06_HARA.md
├── 07_SAFE_REQUIREMENTS.md
├── 08_RTE_INTEGRATION_PLAN.md
├── 09_ARCHITECTURE_DESIGN.md
├── 10_DETAILED_DESIGN.md
├── 11_BACKEND_DESIGN.md
├── 12_TRACEABILITY_MATRIX.md
├── 13_DESIGN_REVIEW_REPORT.md
├── 14_CODE_REVIEW_CHECKLIST.md
├── 15_CODE_REVIEW_REPORT.dox
├── 16_STATIC_ANALYSIS_REPORT.md
├── 17_CODING_STANDARDS.md
├── 18_TEST_PLAN.md
├── 19_UNIT_TEST_REPORT.md
├── 20_INTEGRATION_TEST_REPORT.md
├── 21_COVERAGE_ANALYSIS.md
├── 22_SAFETY_CASE.dox
├── 23_FUNCTIONAL_SAFETY_ASSESSMENT.md
├── 24_RTE_VERIFICATION.md
├── 25_DEVIATION_MANAGEMENT.md
├── 26_ASSESSMENT_READINESS.md
├── SOURCE_CODE/
│ ├── src/
│ ├── include/
│ ├── tests/
│ └── CMakeLists.txt
├── BUILD_ARTIFACTS/
│ ├── cppcheck-report.xml
│ ├── test-results.xml
│ └── coverage-report.html
└── README.md (Overview of package)
Success Criteria for Each Phase
Planning Phase ✓
- Safety Plan approved by Functional Safety Manager
- V&V approach defined and realistic
Requirements Phase ✓
- SRS complete and reviewed
- HARA identifies all critical failure modes
- Safety requirements derived and traced
- RteFramework integration approach documented
Design Phase ✓
- Architecture reviewed and approved
- Design traceability established
- Design review findings resolved
Implementation Phase ✓
- Code review 100% complete (all files reviewed)
- Static analysis passed (MISRA compliance verified)
- Test coverage >90% (SIL 4 target)
Assessment Phase ✓
- Safety Case complete and compelling
- All deviations documented and justified
- Notified Body assessment scheduled
- Assessment findings resolved
Next Steps
- Select appropriate templates from 01-29 based on your project scope
- Customize each template with your project-specific content
- Assign document owners for each template
- Schedule document reviews according to workflow
- Establish document baselines once approved
- Plan submission to Notified Body
See individual template files for detailed guidance on each document.
1.18.0