Not legal advice. Methodology and industry baselines only. Counsel must verify licensing before category change.
PM and Discovery SOP — Facility Conversion
Authority: 01-RFP-RESPONSE.md Section 6
Intake form: 09-FACILITY-QUESTIONNAIRE.md
1. Purpose
Standard operating procedure for Black Rock–led facility baseline cataloging and conversion project management — minimizing catastrophic downtime and compliance failures.
Aligns with engagement gates in 09-WHAT-TO-DO-AND-FIT.md.
2. RACI
| Activity |
Lab (license holder) |
Black Rock |
Together |
| Production execution |
R/A |
I |
— |
| Final QA release |
R/A |
C |
— |
| Facility questionnaire |
R |
C |
A on completeness |
| Walkdown and gap matrix |
C |
R |
A on findings |
| Conversion roadmap |
C |
R |
A at feasibility gate |
| SOP development |
C |
R |
A before pilot |
| Supply schedule |
C |
R |
A at supply alignment gate |
| CapEx POs >$25k |
A |
C |
Compliance checkpoint |
| Regulatory counsel |
R/A |
I |
— |
| Buyer introductions |
C |
R |
Post-pilot |
R = Responsible, A = Accountable, C = Consulted, I = Informed
3. Pre-mobilization (before site entry)
| Step |
Action |
Deliverable |
| 1 |
Execute NDA |
Signed NDA |
| 2 |
Confirm insurance / access |
COI if required |
| 3 |
Send facility questionnaire |
09-FACILITY-QUESTIONNAIRE.md |
| 4 |
Intro regulatory counsel |
Call notes |
| 5 |
Schedule walkdown dates |
Agenda |
| 6 |
Assign PM and lab counterpart |
RACI chart |
Gate: Questionnaire ≥80% complete before walkdown.
4. Discovery week schedule
Day 1–2 — Physical walkdown
| Task |
Detail |
| Photo / video log |
All production areas (NDA scope) |
| Equipment nameplates |
Manufacturer, model, serial, MOC |
| Utility identification |
Electrical, steam, compressed air, chilled water |
| Dust collection |
Nameplate CFM, filter type, last change |
| Safety systems |
Explosion venting, fire suppression, gas detection |
| Quarantine / warehouse |
Sq ft, lockable, FIFO practice |
Output: Equipment register (spreadsheet).
Day 3–4 — Process mapping
| Task |
Detail |
| Current-state flour line |
Single-line diagram if flour exists |
| Current-state extraction |
P&ID or sketch from operator interview |
| Material flows |
Receiving → release paths |
| Batch record review |
Redacted sample from lab |
| METRC / LIMS demo |
Traceability workflow |
Output: Current-state process maps (flour / extraction / hybrid).
Day 5 — Airflow and dust assessment
| Task |
Detail |
| AHU zones |
Dedicated vs shared return |
| Pressure differentials |
Spot check if gauges exist |
| Combustible dust inventory |
NFPA 652 applicability |
| Gap vs kratom mesh target |
Vendor CFM recommendation request |
Output: HVAC / dust preliminary gap list.
Week 2 — Gap workshop
| Task |
Detail |
| Present draft 02-EQUIPMENT-GAP-MATRIX.md |
Walk through reuse / retrofit / net-new |
| Scenario recommendation |
A vs B with scoring framework |
| Cost BOE range |
04-COST-FRAMEWORK.md low/base/high |
| Action items |
Owner and date per item |
Gate: Feasibility sign-off — proceed to supply alignment or stop.
5. Project management cadence
Weekly status (during conversion)
| Agenda item |
Duration |
| Schedule vs critical path |
10 min |
| Open CAPAs / deviations |
10 min |
| CapEx and PO status |
10 min |
| Regulatory / licensing |
5 min |
| Supply alignment (Black Rock) |
10 min |
| Risks and decisions |
15 min |
Gate reviews (mandatory)
| Gate |
Criteria to pass |
| Discovery complete |
Questionnaire + walkdown + gap matrix draft |
| Feasibility approved |
Scenario A or B selected; BOE range accepted |
| Supply alignment |
Inbound schedule matches pilot capacity |
| Controlled launch |
3 pilot COAs pass; QCU release on commercial |
| Sales integration |
Buyer path defined before scale commitments |
6. Risk controls (non-negotiable)
| Rule |
Rationale |
| No production scale until kill-step validation documented |
Micro public-health risk |
| No commingled batch records (cannabis + kratom) |
Regulatory separation |
| Compliance checkpoint before PO >$25k |
CapEx alignment to license path |
| No scale without passed third-party COA |
AKA GMP / buyer requirement |
| Counsel sign-off before category change announcement |
Jurisdiction risk |
| No medical or "FDA approved" claims in SOPs or labels |
03-COMPLIANCE-NOTES.md |
7. Deliverables by phase
| Phase |
Black Rock deliverable |
Lab deliverable |
| Discovery |
Gap matrix, process maps, scenario memo |
Questionnaire, access, records |
| Feasibility |
BOE, timeline, equipment list |
CapEx approval, counsel review |
| Technical conversion |
SOP drafts, chemist coordination |
Pilot execution, training |
| QA framework |
COA panel spec, release checklist |
QCU adoption, lab contracts |
| Production launch |
Supply coordination |
Commercial batches |
| Scale |
Buyer intros |
Volume commitments |
8. Tools and artifacts
9. Escalation
| Trigger |
Escalate to |
| THC cross-contact above limit |
Lab QCU + counsel; halt kratom release |
| Kill-step validation fail (×2) |
Black Rock chemist track + equipment vendor |
| License path blocked |
Pete + counsel; pause CapEx |
| Schedule slip >2 weeks |
Weekly → bi-weekly exec sync (Pete / lab owner) |
| Supply mismatch at pilot |
Black Rock supply alignment gate |
10. Discovery duration
| Mode |
Duration |
| On-site full walkdown |
5 days + Week 2 workshop |
| Virtual + local photos |
2–3 weeks |
| Hybrid |
1 on-site day + remote follow-ups |
Total discovery to feasibility memo: typically 2–4 weeks.