Cannabis Federal Readiness Checklist

☐ Manufacturing SOPs implemented

☐ Batch production records maintained

☐ Product specifications established

☐ Process controls documented

☐ Cleaning procedures documented

☐ Cleaning records maintained

☐ Sanitation schedules established

☐ Verification activities performed

☐ Quality responsibilities assigned

☐ Deviations documented

☐ Non-conforming product procedures established

☐ Product release procedures implemented

☐ Lot tracking system established

☐ Recall procedures tested

☐ Product disposition procedures documented

☐ Retention sample program established

Manufacturing Score:      / 16

☐ Quality policy established

☐ Quality objectives defined

☐ Management responsibilities assigned

☐ Leadership reviews conducted

☐ Core business processes documented

☐ Process performance measured

☐ Continuous improvement activities documented

☐ KPIs tracked regularly

☐ Business risks identified

☐ Risk assessments conducted

☐ Risk mitigation plans established

☐ Risk reviews performed

QMS Score:      / 12

☐ SOP approval process exists

☐ Document revisions tracked

☐ Obsolete documents removed

☐ Employees access current versions

☐ Training records maintained

☐ Maintenance records maintained

☐ Audit records maintained

☐ Corrective action records maintained

Documentation Score:     / 8

☐ New hire training documented

☐ Role-specific training established

☐ Refresher training conducted

☐ Training effectiveness verified

☐ Employee qualifications documented

☐ Competency evaluations performed

☐ Training gaps identified

☐ Corrective training implemented

Training Score:       / 8

☐ New hire training documented

☐ Role-specific training established

☐ Refresher training conducted

☐ Training effectiveness verified

☐ Employee qualifications documented

☐ Competency evaluations performed

☐ Training gaps identified

☐ Corrective training implemented

Training Score:       / 8

☐ Vendor qualification process established

☐ Licenses verified

☐ Insurance certificates reviewed

☐ Vendor performance monitored

☐ Critical suppliers identified

☐ Approved vendor list maintained

☐ Supplier issues documented

☐ Supplier corrective actions tracked

Supplier Qualification Score:      / 8

☐ Maintenance schedules established

☐ Maintenance records maintained

☐ Critical equipment identified

☐ Maintenance responsibilities assigned

☐ Calibration program established

☐ Calibration records maintained

☐ Equipment inspections performed

☐ Equipment failures investigated

Equipment Score:     / 8

☐ Audit schedule established

☐ Audit criteria defined

☐ Qualified auditors assigned

☐ Audit reports completed

☐ Findings tracked

☐ Corrective actions assigned

☐ Effectiveness verified

☐ Leadership reviews audit results

Audit Score:      / 8

Your organization likely has significant gaps that may impact regulatory readiness, operational consistency, lender confidence, insurance outcomes, and future growth opportunities.

Foundational systems exist but require improvement to support federal readiness and operational scalability.

Your organization demonstrates many characteristics of a mature operation but may still have opportunities for improvement.

Your organization has established many of the systems commonly associated with ISO 9001, GACP, GMP, and operational excellence programs.

Want a deeper evaluation?

The Red Wolf Risk Federal Readiness Assessment provides a comprehensive review of your organization’s:

• ISO 9001 Readiness
• GMP Readiness
• GACP Readiness
• CAPA Program
• Training Systems
• Supplier Controls
• Equipment Management
• Operational Governance
• Insurance Readiness
• Lender Due Diligence Readiness

Federal cannabis reform may arrive in many forms, such as Schedule III classification, FDA oversight, pharmaceutical partnerships, institutional investment, interstate commerce, or international opportunities. Regardless of the pathway, operators with mature quality systems and operational controls will be best positioned to lead the market. To ensure your cannabis business readiness, use this cannabis operations checklist to evaluate your organization’s compliance and identify any gaps before regulators, lenders, investors, insurers, or strategic partners do.