DHF Document Creation Service

Generate Design History File (DHF) and Quality Management System (QMS) documents with proper formatting, traceability, and regulatory compliance.

Overview

The document creation service:

1. •Selects appropriate template based on document type
2. •Generates content addressing specific regulatory requirements
3. •Maintains traceability to DCA items, hazards, and requirements
4. •Applies consistent formatting and naming conventions
5. •Updates the document registry

Usage

/create-dhf <doc-type> <project-path>              # Create new document
/create-dhf <doc-type> <project-path> --from-gap GAP-01  # Create to remediate gap
/create-dhf <doc-type> <project-path> --revision   # Create new revision

Document Types

Workflow

Phase 1: Initialization (Programmatic)

1. •Determine template based on document type
2. •Get next document ID from registry (if new)
3. •Create document shell via LibreOffice MCP:
   code

   libreoffice/create_document
   

4. •Populate header metadata:
   • •Document ID
   • •Title
   • •Revision number
   • •ECR reference
   • •Date
   • •Author fields

Phase 2: Content Generation (LLM)

1. •

   Read context:

   • •Gap details from gaps.json (if --from-gap)
   • •Related documents for consistency
   • •DCA requirements being addressed
2. •

   Fetch regulatory text:

   • •Use /ecfr for FDA regulations
   • •Reference Master Standards Database
3. •

   Generate content addressing:

   • •Standard clause requirements
   • •Existing document patterns
   • •Traceability references (DCA-xxx, HZ-xx, SR-xx)

Phase 3: Traceability (Hybrid)

1. •

   [Code] Extract trace IDs from content:

   • •System requirements: SYS-xxx
   • •Software requirements: SRS-xxx
   • •Hazards: HZ-xx
   • •Causes: C-xx
   • •Safety requirements: SR-xx
   • •DCA items: DCA-xxx
2. •

   [Code] Validate against registry:

   • •Verify referenced IDs exist
   • •Flag unknown references
3. •

   [Code] Update traceability matrix:

   • •Extend existing traceability data
   • •Link DCA → Document → Verification

Phase 4: Assembly (Programmatic)

1. •

   Insert content via LibreOffice MCP:

   code

   libreoffice/insert_text_at_position
   libreoffice/format_text
   

2. •

   Apply formatting:

   • •Use format_document Python module from Higi scripts
   • •Consistent heading styles
   • •Proper list formatting
   • •Table formatting
3. •

   Generate filename:

   code

   [DTG] DHFD-XX Title RXX ECRXXX YYYY-MM-DD.odt
   

4. •

   Save to appropriate location:

   • •New documents: <project>/active/drafts/
   • •Released documents: Appropriate V-Model stage folder

Phase 5: Registry Update (Programmatic)

1. •

   Update registry.json:

   • •Add new document entry
   • •Update revision if existing
2. •

   Update gap status (if --from-gap):

   • •Set remediation_doc in gaps.json
   • •Update gap status to in_progress

Document Naming Convention

[Prefix] DHFD-{number}[.variant] {Title} R{revision} ECR{number} {date}.{ext}

Examples:
[DTG] DHFD-89.1 Higi Green AAC User Manual R01 ECR155 2026-02-03.docx
[DTG] DHFD-28 Risk Analysis R7 ECR149 2026-01-28.odt
QA-UEP-007-B Summative Evaluation Protocol R2 ECR149 2026-02-01.docx

Template Sections by Document Type

Risk Analysis (DHFD-28)

1. •Purpose
2. •Scope
3. •Risk Management Process Overview
4. •Hazard Identification
5. •Risk Estimation Methodology
6. •Design FMEA
   • •Hazard List (HZ-xx)
   • •Cause Analysis (C-xx)
   • •Safety Requirements (SR-xx)
7. •Risk Evaluation
8. •Risk Control Implementation
9. •Residual Risk Evaluation
10. •Overall Residual Risk Assessment
11. •Traceability References

Usability Engineering Plan (QA-UEP-007-A)

1. •Purpose
2. •Scope
3. •Use Specification
   • •Intended Use
   • •Intended Users
   • •Use Environment
4. •User Interface Characteristics
5. •Hazard-Related Use Scenarios (HRUS)
6. •Critical Tasks
7. •Evaluation Plan
8. •Traceability to Risk Analysis

Software Requirements Specification (DHFD-26)

1. •Purpose
2. •Scope
3. •Definitions
4. •System Overview
5. •Software Requirements
   • •Functional Requirements
   • •Performance Requirements
   • •Interface Requirements
   • •Safety Requirements (from SWHA)
6. •Traceability to System Requirements
7. •Verification Methods

Integration

From Gap Analysis

Use --from-gap to create documents that directly address identified gaps.

To Traceability

Documents link to DCA items and feed into build_traceability_matrix.py.

To Project Management

New documents may trigger review scheduling via /ecr-manager.

Example

User: /create-dhf usability-protocol Work/Clients/Qualira/Higi/special_510k --from-gap GAP-01

Claude: Creating Summative Evaluation Protocol to address GAP-01 (Missing summative usability evaluation)...

Reading context:
- Gap GAP-01: Missing summative evaluation per IEC 62366-1 Clause 5.9
- DCA items: DCA-045, DCA-046, DCA-047
- Related docs: QA-UEP-007-A (Use Specification)

Generating protocol addressing:
- Critical tasks from HRUS (T1-T12)
- Test setup and environment
- Participant criteria (15 representative users)
- Task scenarios with success criteria
- Data collection forms

Created: [DTG] QA-UEP-007-B Summative Evaluation Protocol R1 ECR149 2026-02-03.odt
Location: special_510k/active/drafts/

Updated:
- registry.json: Added QA-UEP-007-B entry
- gaps.json: GAP-01 status → in_progress, remediation_doc → QA-UEP-007-B

Reference

• •Format module: Work/Clients/Qualira/Higi/scripts/format_document/
• •Protocol template: Work/Clients/Qualira/Higi/scripts/create_protocol_with_content.py
• •Naming convention: Work/Clients/Qualira/Higi/CLAUDE.md