Not legal advice. Methodology and industry baselines only. Counsel must verify licensing before category change.
Scenario A — Hard Changeover (Facility Shutdown and Re-tool)
Authority: 01-RFP-RESPONSE.md Section 5
Cost reference: 04-COST-FRAMEWORK.md
1. Overview
Hard changeover stops cannabis production entirely, decontaminates the facility, retrofits equipment for kratom powder, validates processes, and restarts exclusively on botanical SKUs.
Default recommendation when cannabis revenue can pause and reuse of milling/packaging assets is strong.
2. Critical path
flowchart TD shutdown[ProductionShutdown] --> decon[DecontaminationAndResidueClearance] decon --> retrofit[EquipmentRetrofitAndKillStepInstall] retrofit --> iq[IQ_OQ_PQ] iq --> sop[SOPAndQMSDeployment] sop --> pilot[ThreeValidationPilotLots] pilot --> release[FirstCommercialRelease]
3. Phase detail
Phase 0 — Pre-shutdown (Week −2 to 0)
| Activity | Owner |
|---|---|
| Complete facility questionnaire | Lab + Black Rock |
| Regulatory counsel briefing on category change | Lab counsel |
| Final cannabis production run + inventory disposition | Lab |
| METRC close-out per state rules | Lab compliance |
| Contractor POs for kill step / dust upgrades | Lab / Black Rock PM |
| NDA and insurance confirmation | Both |
Phase 1 — Shutdown and decontamination (Week 1–2)
| Activity | Detail |
|---|---|
| Production stop | No new cannabis batches after cutoff date |
| Equipment strip-down | Remove cannabis-specific tooling (CR packaging, etc.) |
| Chemical / residue clearance | Swab THC on contact surfaces; document limits |
| Deep sanitation | Full facility clean per decon SOP |
| Waste manifest | Regulated cannabis waste disposed per state rules |
| Dust system purge | Replace filters; inspect duct for resin buildup |
| Room sign-off | QA release on "cleared for botanical" status |
Exit gate: Written decon clearance signed by QCU.
Phase 2 — Retrofit and install (Week 3–10)
| Activity | Detail |
|---|---|
| Kill-step install | Steam tunnel, batch oven, or contracted irradiation workflow |
| Dust / HVAC upgrade | CFM, HEPA, explosion venting per mill vendor spec |
| Mill mesh / seal upgrade | Target 40–80 mesh; dust-tight connections |
| Packaging reconfig | Labeler, batch coder, QR system |
| LIMS / batch record | Migrate off METRC to supplement batch system |
| Quarantine area | Lockable hold with negative pressure if shared building |
Exit gate: Equipment IQ complete — nameplate, installation, utilities verified.
Phase 3 — IQ / OQ / PQ (Week 8–12, overlaps Phase 2 tail)
| Activity | Detail |
|---|---|
| Airflow mapping | Document ACH and pressure differentials |
| Mill OQ | Particle size vs speed feed curve |
| Kill-step OQ | Temp/time profile; biological indicator or micro challenge |
| Metal detector OQ | Test pieces at reject threshold |
| Cleaning validation | Swab program for changeover (if any shared tools) |
Exit gate: PQ protocol approved; ready for pilot lots.
Phase 4 — SOP and training (Week 6–12, parallel)
| SOP package | Priority |
|---|---|
| Receiving and quarantine | P1 |
| Kill-step operation | P1 |
| Milling and blending | P1 |
| Packaging and labeling | P1 |
| COA review and release | P1 |
| Sanitation and pest control | P1 |
| Deviation / CAPA / recall | P2 |
Training log signed before pilot runs.
Phase 5 — Validation pilot lots (Week 11–14)
| Lot | Purpose |
|---|---|
| Pilot 1 | Full process; third-party COA; identify gaps |
| Pilot 2 | CAPA closure; confirm kill-step efficacy |
| Pilot 3 | Repeatability; AKA GMP audit readiness dry run |
Exit gate: Three consecutive lots pass full COA panel.
Phase 6 — First commercial release (Week 14+)
- QCU release on commercial batch size
- Supply chain aligned (Black Rock intake schedule)
- Downstream buyer notification (if offtake exists)
4. Downtime metrics
| Case | Shutdown to first production run | Notes |
|---|---|---|
| Aggressive | 8 weeks | Flour line + kill step in stock; minimal HVAC work |
| Base | 10–14 weeks | Standard retrofit + 3 pilot lots |
| Conservative | 16–20 weeks | Major HVAC; extraction room repurposing; permit delays |
Formula:
Total_downtime = decon_weeks + retrofit_weeks + validation_weeks
Base case: 2 + 6 + 4 = 12 weeks (midpoint of 10–14 range).
5. Risk register
| Risk | Mitigation |
|---|---|
| THC cross-contact on release | Swab program with defined limits before pilot |
| Kill-step fails micro challenge | Alternate method scoped in discovery; vendor support |
| Permit / license delay | Counsel engaged Week −2; no scale until path clear |
| Supply gap during restart | Black Rock supply alignment gate before Phase 5 |
| Cost overrun on HVAC | CFM audit in Week 1 walkdown |
6. When to choose Scenario A
| Condition | Fit |
|---|---|
| Cannabis wind-down approved | ✓ Strong |
| Reusable mill + pack line | ✓ Strong |
| Single AHU — cannot segregate | ✓ Strong (B not viable) |
| AKA GMP target within 6 months | ✓ Strong |
| Must preserve cannabis revenue | ✗ Choose B or delay |
7. ROI summary vs Scenario B
| Metric | Scenario A advantage |
|---|---|
| Total CapEx | Lower — no segregation premium |
| Time to AKA GMP | Faster — single QMS |
| Compliance risk | Lower — no dual-framework audit |
| Revenue during transition | None — primary tradeoff |
See strategic comparison in 06-SCENARIO-B-PHASED-OPS.md.