BIO-QMS TRACK File Consistency Audit
Date: 2026-02-14 Scope: 16 TRACK files (A-P), MASTER-TRACK-INDEX, 341 tasks, 78 sections Author: Claude (Opus 4.6) via Explore agent
Executive Summary
The BIO-QMS TRACK system demonstrates excellent structural consistency and comprehensive task coverage (341 tasks, zero gaps in numbering, perfect INDEX alignment). However, 3 CRITICAL issues must be resolved before execution begins.
Overall Assessment: Strong foundation, 3 CRITICAL / 8 HIGH / 5 MEDIUM / 4 LOW issues
Task Count Summary
| Track | Name | Sections | Tasks | Numbering |
|---|---|---|---|---|
| A | Presentation & Publishing | 6 | 34 | Sequential 1-6.4 |
| B | Competitive Intelligence & GTM | 4 | 24 | Sequential 1-4.6 |
| C | Technical Foundation | 5 | 30 | Sequential 1-5.6 |
| D | Compliance & Security | 5 | 21 | Sequential 1-5.4 |
| E | Operations & Deployment | 4 | 16 | Sequential 1-4.3 |
| F | Documentation & Training | 5 | 18 | Sequential 1-5.2 |
| G | Revenue & Billing Operations | 5 | 24 | Sequential 1-5.4 |
| H | Customer Operations | 5 | 22 | Sequential 1-5.3 |
| I | Sales & Business Development | 5 | 20 | Sequential 1-5.3 |
| J | Product Management & Analytics | 5 | 22 | Sequential 1-5.3 |
| K | Platform Reliability & Maintenance | 5 | 20 | Sequential 1-5.4 |
| L | Data & Business Intelligence | 5 | 20 | Sequential 1-5.3 |
| M | Security Operations | 5 | 18 | Sequential 1-5.3 |
| N | Legal & Regulatory Operations | 5 | 18 | Sequential 1-5.3 |
| O | Partner Ecosystem | 4 | 16 | Sequential 1-4.4 |
| P | Accessibility & Internationalization | 5 | 18 | Sequential 1-5.2 |
| TOTAL | 78 | 341 | Zero gaps |
CRITICAL Issues (3)
CRITICAL-1: Sprint S7 Severely Overloaded
Finding: Sprint S7 (weeks 13-14) has 60 tasks across 11 tracks = 30 tasks/week. This is 3.5x heavier than S5 and 4x heavier than S9.
Sprint Load Distribution:
| Sprint | Weeks | Tasks | Tasks/Week | Load |
|---|---|---|---|---|
| S1 | 1-2 | 15 | 7.5 | Light |
| S2 | 3-4 | 15 | 7.5 | Light |
| S3 | 5-6 | 27 | 13.5 | Medium |
| S4 | 7-8 | 29 | 14.5 | Medium |
| S5 | 9-10 | 20 | 10 | Medium |
| S6 | 11-12 | 41 | 20.5 | Heavy |
| S7 | 13-14 | 60 | 30 | OVERLOADED |
| S8 | 15-16 | 50 | 25 | Heavy |
| S9 | 17-18 | 11 | 5.5 | Light |
| S10 | 19-20 | 14 | 7 | Light |
Impact: Sprint S7 will fail at any realistic team velocity. Downstream sprints cascade delay.
Recommendation: Redistribute L.1-L.2 (8 tasks) and O.1 (4 tasks) to S8-S9, bringing S7 down to ~48 tasks.
CRITICAL-2: ~40+ Intra-Track Dependencies Not in MASTER-TRACK-INDEX
Finding: The MASTER-TRACK-INDEX lists 25 explicit cross-track dependencies (all verified correct). However, individual TRACK files contain ~40+ intra-track Depends On: clauses that are NOT reflected in the INDEX.
Examples of missing dependencies:
- A.1 -> A.2, A.3 (within Track A)
- G.1 -> G.2 (within Track G)
- L.1 -> L.2 (within Track L)
- P.2 -> P.3 (within Track P)
Impact: Dependency tools cannot see the full graph. Cycle detection is incomplete. Sprint planning cannot optimize properly.
Recommendation: Merge all intra-track dependencies into MASTER-TRACK-INDEX dependency table.
CRITICAL-3: 20+ Referenced Documents Unverified
Finding: TRACK files reference 20+ supporting documents by filename (e.g., 16-prisma-data-model.md, 68-user-experience-journeys.md). None were verified to exist during this audit.
Key References to Verify:
| Reference | Referenced By | Expected Location |
|---|---|---|
| 05-market-analysis.md | B.1.6 | docs/market/ |
| 16-prisma-data-model.md | C.1 | docs/architecture/ |
| 20-capa-deviation-*.md | C.2 | docs/state-machine/ |
| 22-rbac-role-based-access-control.md | C.1.4 | docs/architecture/ |
| 58-gap-analysis-framework.md | D.1 | docs/compliance/ |
| 62-unified-execution-plan.md | B.2.8 | docs/product/ |
| 63-data-architecture.md | L.1 | docs/operations/ |
| 64-security-architecture.md | M overview | docs/operations/ |
| 66-operational-readiness.md | K, P | docs/operations/ |
| 68-user-experience-journeys.md | H.1.1, P.1.4 | docs/operations/ |
Impact: Tasks cannot be executed if referenced documents are missing.
Recommendation: Audit all referenced docs before Sprint S1 starts.
HIGH Issues (8)
HIGH-1: Task Decomposition Needed (Track F)
F.1.5 ("Search & Reporting user guide") is too large. Should decompose into:
- F.1.5.1: Search guide
- F.1.5.2: Standard reports guide
- F.1.5.3: Custom query builder guide
HIGH-2: Task Decomposition Needed (Track L)
L.5.1 ("FDA submission data package") is a 3-5 day task, not 1 task. Should decompose into:
- L.5.1.1: Design CSV export schema per FDA guidelines
- L.5.1.2: Implement audit trail extraction with filters
- L.5.1.3: Implement validation evidence export
HIGH-3: Task Decomposition Needed (Track C)
C.3 (Agent Orchestration) is missing 3 subtasks:
- Agent tool definition and registry
- Agent state management and memory
- Agent output parsing and validation
HIGH-4: Inconsistent Dependency Notation
Mixed formats across tracks: range notation (X.n-Y.n), list notation (X.n, Y.n), and prose ("All tracks"). Track F.5.2 references "All tracks" without specific task IDs.
Recommendation: Standardize to comma-separated list format.
HIGH-5: No Resource Allocation Documented
No FTE/capacity assigned to any track or sprint. Sprint S6 allocates 41 tasks in 2 weeks (20.5 tasks/week), implying 4-5 developers at 4-5 tasks/week each with zero buffer.
Recommendation: Create resource allocation plan showing FTE per agent per sprint.
HIGH-6: Agent Bottleneck Risk
frontend-react-typescript-expert peaks at 38 tasks in S6-S7. If a single agent handles all frontend work, this creates a critical bottleneck.
HIGH-7: Tool/Platform Decisions Needed by S5
Payment gateway, analytics platform, and i18n library selections are not yet documented but tasks in S5+ depend on them.
HIGH-8: Acceptance Criteria Quality
C.3.4 acceptance criteria is procedural, not outcome-focused. Missing quantifiable success metrics (throughput, latency, error budget). D.2.4 lacks auditor-review standard definition.
MEDIUM Issues (5)
- Team capacity assumptions undocumented — Implicit 20+ tasks/week without stated team size
- Section title formatting inconsistency — Minor title mismatches between INDEX and TRACK files
- C.3.4 vague acceptance criteria — Needs quantifiable metrics
- D.2.4 procedural acceptance criteria — Should be outcome-focused ("passes independent auditor review")
- No cross-track agent coordination protocol — Multiple agents may modify same codebase areas
Structural Consistency: PASS
All 16 TRACK files follow identical structure:
- YAML frontmatter with all required fields
- Status Summary table with section breakdown
- Section headers with Sprint/Priority/Depends On
- Task lists with checkbox format (
- [ ] TRACK.SECTION.TASK:) - Detailed acceptance criteria per task
Format compliance: 100% (16/16 files) Numbering gaps: Zero INDEX alignment: Perfect (341 INDEX = 341 file count) Circular dependencies: None detected Cross-track dependency resolution: All 25 dependencies resolve correctly
Critical Path Analysis
Longest dependency chain:
C.1 (backend scaffold, S3) -> C.2-C.5 (features, S4-S5) -> D.2-D.5 (compliance, S4-S6) -> E.1-E.4 (ops, S5-S7)
Spans S3-S7 (5 sprints, 10 weeks minimum).
C.1 is the single biggest bottleneck — it gates 11+ downstream sections across 4 tracks.
Recommendations (Priority Order)
Before Sprint S1:
- Verify all 20+ referenced documents exist and are current
- Rebalance S7 (move 12 tasks to S8-S9)
- Document team capacity assumptions
Before Task Assignment:
- Decompose F.1.5, L.5.1, C.3 into subtasks
- Standardize dependency notation
- Add intra-track dependencies to MASTER-TRACK-INDEX
Before Execution:
- Refine acceptance criteria for C.3.4, D.2.4
- Create resource allocation plan
- Establish cross-TRACK dependency graph tool
Files Analyzed: MASTER-TRACK-INDEX.md + TRACK-A through TRACK-P (17 files total)