Skip to content

Quality Documentation Set

Last updated: 2026-02-11 21:34:43 UTC

This folder is the primary quality-documentation workspace for traceable development.

Document Chain (Primary)

The core trace chain is:

RA -> SRS -> SDD -> SVVP/STP -> STR -> RTM

  • RA: Risk Analysis
  • SRS: Software Requirements Specification
  • SDD: Software Design Description
  • SVVP: Software Verification and Validation Plan
  • STP: Software Test Protocol (test cases/procedures)
  • STR: Software Test Report (executed evidence)
  • RTM: Requirements Traceability Matrix

Files in This Folder

  • RiskAnalysis.md: quality-grade risk register with hazard IDs and controls.
  • Bugs/: defect management docs and bug log.
  • Bugs/BugTracker.md: prioritized defect log with reproducible behavior and acceptance criteria.
  • SoftwareRequirementsSpecification.md: testable software requirements with stable IDs.
  • SoftwareDesignDescription.md: architecture/design mapped to requirement IDs.
  • SoftwareVerificationAndValidationPlan.md: V&V strategy, protocols, evidence expectations.
  • TraceabilityMatrix.md: RA/SRS/SDD/test bidirectional traceability.
  • Evidence/: STR-style evidence artifacts (logs, screenshots, summaries) stored under STR-* paths.
  • CybersecurityPlan.md: secure-by-design controls and evidence for connected-device software.
  • DevelopmentSOP.md: default development process and quality gates.
  • RegulatoryReferences.md: FDA primary-source references used for this doc set.

Relationship to Existing Docs

Existing project docs remain active working references:

  • Docs/Requirements/Requirements.md
  • Docs/Requirements/RiskAnalysis.md
  • Docs/Architecture/Architecture.md
  • Docs/Analysis/Marjorie_AlgorithmIO_GapAnalysis.md

Quality docs in this folder are intended to become the structured, auditable source for:

  • requirement IDs
  • risk controls
  • design linkage
  • verification evidence linkage

Practical Usage

For any safety-impacting change:

  1. Update RiskAnalysis.md (or confirm no risk delta).
  2. Add/update requirement IDs in SoftwareRequirementsSpecification.md.
  3. Update design notes in SoftwareDesignDescription.md.
  4. Add/update tests in SoftwareVerificationAndValidationPlan.md.
  5. Update TraceabilityMatrix.md.
  6. Execute tests and attach evidence references.

Tag Navigation

Quality tag IDs are linkable across docs for direct navigation:

  • RA-* anchors live in RiskAnalysis.md.
  • SRS-* anchors live in SoftwareRequirementsSpecification.md.
  • SDD-* anchors live in SoftwareDesignDescription.md.
  • TV-* anchors live in SoftwareVerificationAndValidationPlan.md.
  • TraceabilityMatrix.md cross-links these IDs for bidirectional traversal.