FOCUS Standards – Manufacturing

To download the complete FOCUS Standards click here.

Overview

FOCUS Standards form the foundation for a rigorous, comprehensive quality and safety system that provides cannabis business owners, consumers, regulators and the public with a single, concise, accepted standard that protects public health and consumer safety, and safeguards the environment.

FOCUS Standards are developed according to internationally accepted voluntary consensus processes to ensure robust, impartial standards. Volunteer members of FOCUS Standards development committees include professionals from the cannabis industry, regulatory agencies, quality assurance, occupational safety, medical services, law enforcement, education, science and research, consumers, patients and the public.

Scope

This FOCUS Standard provides direction for cannabis extraction operations and cannabis-infused products producers to meet safety and quality requirements.

This document uses the word operation to indicate a cannabis company, business, facility, laboratory or individual location that is applying the FOCUS Standard.

The terms must and shall are used interchangeably to indicate requirements; the terms should, could, may and can are used to indicate flexibility or to provide examples.

The standards identify job titles for specific responsibilities to add clarity. The organization’s job descriptions, work assignments and training will define each worker’s actual title and responsibilities. Depending on an operation’s size and structure, one worker may cover several roles (or job titles) to meet a requirement.

1. Management Summary
A. Management Capability
B. Product Quality
C. Health and Safety
D. Security
E. Procedures and Training
F. Regulatory Compliance
G. Organization Structure

2. Business Practices
A. Goal Setting
B. Business Assessments
C. Licenses and Permits
D. Business Insurance
E. Accounting Standards
F. Operational Controls
G. Document Controls
H. Advertising Methods
I. Records Management
J. Records Inventory List

2.1 Fair Labor Practices
A. Fair Labor Standards
B. Workplace Discrimination
C. Work Contracts
D. Worker Policies
E. Workers Compensation Insurance
F. Worker Data

2.2 Social Sustainability
A. Community Relations
B. ADA Compliance
C. Business Certifications
D. Cannabis Industry Support

2.3 Crisis Management
A. Crisis Management Plan
B. Crisis Plan Training and Testing

3. Training
A. Worker Training Program
B. Food Safety Training
C. Quality Control Training
D. Training Manager
E. Comprehensive Training Materials
F. Regulatory and Law Enforcement Interaction
G. Product Quality Expertise

4. Worker Practices
A. Worker Cleanliness
B. Hand Sanitation
C. Wounds and Infections
D. Protective Clothing
E. Prohibited Items
F. Eating and Drinking
G. Smoking and Tobacco Products
H. Control of Drug Use
I. Violence and Weapons
J. GMP Signage

5. Health and Safety
A. Health and Safety Program
B. Health and Safety Risk Assessment
C. Health and Safety Procedures and Training
D. Health and Safety Manager
E. Personal Protective Equipment
F. Safety Signage
G. Accident or Emergency Procedures
H. First Aid
I. Eyewash Stations

6. Security
A. Security Program
B. CPTED Approach
C. Security Risk Assessment
D. Security Qualifications
E. Security Training
F. Security of Records
G. Security Incident Reporting
H. Background Checks

6.1 Physical Security
A. Physical Barriers
B. Grounds and External Areas
C. Door Locks
D. Facility Access Controls
E. Restricted Area Access Controls
F. Visitor Access Controls
G. Product Controls
H. Theft/Product Loss Plan
I. Cash Management

6.2 Alarm Systems
A. Facility Alarm System
B. Alarm Monitoring
C. Motion Detection
D. Panic Buttons
E. Alarm System Maintenance

6.3 Video Surveillance
A. Video Monitoring
B. Video Recording Security
C. Video Quality and Coverage
D. Continuous Video Monitoring
E. Video Retention
F. Video System Maintenance

6.4 Transport Security
A. Transportation Security Procedures
B. Transport Manager
C. Transport Agents
D. Transport Agent Credentials
E. Delivery Route Process
F. Shipment Invoice
G. Transport Packaging
H. Transport Vehicle Controls

7. Product Quality
A. Quality Management System
B. Hazard Control Plan – HACCP
C. Production Hazard Analysis
D. Critical Control Points
E. CCP Assignments
F. CCP Forms Readiness
G. Production Flow Charts
H. Product Manufacturing Processes
I. Product Classification and Control
J. Product Specifications
K. Control of Contaminants
L. Control of Allergens
M. Pre-Operation Inspections
N. Production Records
O. Yield Analysis and Reconciliation
P. Nonconformance to Process
Q. Product Rejection Process
R. Quarantined Products and Materials
S. Corrective Action Reports
T. CCP Records Verification
U. Revising the Hazard Control Plan
V. Assessing the Hazard Control Plan
W. CCP Records Management

8. Production Operations
A. Environmental Controls
B. Cleanability of Facility
C. Cross Contamination Prevention
D. Cannabis Inventory
E. Hazardous Materials

9. Production Equipment
A. Equipment Management
B. Equipment Design
C. Equipment Calibration
D. Independent Thermometers
E. Product Containers
F. Cooling Coils
G. Utensils, Wares, and Tools

10. Water Use and Quality
A. Water Use Plan
B. Water Use Risk Assessment
C. Water Quality Analysis

11. Extraction Operations
A. Quality and Safety Controls
B. Equipment Installation and Training
C. Production Training
D. Emergency Procedures
E. Food-Grade Chemicals

11.1 Water-Based Extraction
A. Water Quality
11.2 CO2-Based Extraction
A. CO2 Monitoring
B. Use of Dry Ice
11.3 Ethanol or Alcohol-Based Extraction
A. Food-Grade Ethanol
B.
11.4 Solvent-Based Extraction
A. Solvent Safety
B. Solvent Recovery
C. Food-Grade Solvents
D. Waste Solvent Disposal

12. Product Testing
A. Product Testing Plan
B. Sampling Procedures
C. Test Lab Standards
D. Allowable Thresholds
E. Microbiological Testing
F. Solvent and Chemical Residue
G. Metals
H. Pesticide Residue
I. Potency and Cannabinoid Profile
J. Contamination and Filth
K. Stability Testing
L. Test Results Analysis
M. Batch Monitoring
N. Test Records

13. Packaging and Labeling
A. Packaging and Labeling Specifications
B. Labeling Protocol
C. Warning Labels
D. Cannabis Infused Product Labels
E. Exit Packaging
F. Child Resistant Packaging
G. Tamper Evident Packaging

14. Traceability and Recall
A. Traceability System
B. Product Recall Program
C. Recall Mock Test
D. Complaints Procedure

15. Product Storage
A. Product Storage
B. Storage Area Access Control
C. Quarantined Material Segregation
D. Storage Area Construction
E. Cleaning
F. Pest Control

16. Receiving and Transport
A. Product Transfers
B. Supplier Qualifications
C. Incoming Goods Inspection
D. Raw Materials Inspection
E. Vehicle Inspections
F. Sealed Trailers and Trucks
G. Contract Carriers

17. Facility Maintenance
A. Facility Maintenance Plan
B. Plumbing Contamination
C. Ventilation and Exhaust Fans
D. Foot Disinfectant Dips
E. Conservation Plan
F. Grounds Maintenance

18. Pest Control
A. Pest Management Plan
B. Pest Contamination Inspections
C. Pest Control Devices
D. Domestic Animals

19. Sanitation and Cleaning
A. Sanitation Procedures and Training
B. Master Sanitation Schedule
C. Cleaning Equipment and Supplies
D. Cleaning Equipment Identification
E. General Cleanliness
F. Sanitation Logs
G. Flood Drain Cleaning
H. Swab Testing
I. Product Protection During Cleaning

20. Sanitary Facilities
A. Toilet and Handwashing Facilities
B. Secondary Hand Sanitation Stations
C. Ware-Washing Sink
D. Drinking Water
E. Changing Area

21. Waste Management
A. Waste Management Plan
B. Hazardous Materials Disposal
C. Sustainable Packaging
D. Cannabis Waste Disposal
E. Waste Container Control