FOCUS Standards – Laboratory

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 laboratory operations 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

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. Staff Training Program
B. Quality and Technical Training
C. Proficiency Reviews
D. Hygiene Training
E. Ongoing Training Program
F. Comprehensive Training Materials
G. Regulatory and Law Enforcement Interaction

4. Staff Practices
A. Staff 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. GLP/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. Cash Management

6.2 Alarm Systems
A. Facility Alarm System
B. Alarm Monitoring
C. Motion Detection
D. 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. Quality Control
A. Lab Management System
B. Quality Management Responsibility
C. Lab Risk Assessment
D. Staff Qualifications
E. Quality Status and Updates
F. Environmental Controls
G. Computer Functionality
H. Quality Control Checklist
I. Out-of-Specification Products
J. Corrective Action Process
K. Cross Contamination Prevention
L. Water Quality Analysis

8. Laboratory Methods
A. Laboratory Methods
B. Process Procedures
C. Pre-Test Inspections
D. Data Protocols
E. Chemical Assay Procedure
F. Quality Control Samples
G. Lab Method Comparison
H. Sample Handling Procedures
I. Sample Control and Destruction
J. Storage Controls

9. Test Methods
A. Test Methods
B. Test Method Validation
C. Active Tests
D. Test Method Tracking
E. Polymerase Chain Reaction Testing

10. Data and Records Management
A. Records Management
B. Records Inventory List
C. Standard Reporting Format
D. Error and Complaints Process
E. Report Control and Retention

11. Laboratory Equipment
A. Equipment Management
B. Equipment Design
C. Equipment Verification
D. Equipment Calibration
E. Critical Equipment Installation

12. Receiving and Transport
A. Supplier Qualifications
B. Incoming Sample Inspection
C. Incoming Goods Inspection
D. Vehicle Inspections
E. Contract Carriers

13. Facility Management
A. Facility Maintenance Plan
B. Ventilation and Exhaust Fans
C. Pest Control
D. Conservation Plan
E. Grounds Maintenance
F. Hazardous Materials
G. Domestic Animals

14. 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

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

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