Implementing a HACCP Plan for a Cannabis Facility
By Tyler Williams

With legal cannabis gaining ground in new states, quality control is an issue every facility should be focused on. So what is a HACCP Plan? HACCP (Hazard Analysis Critical Control Point) is a management system in which safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement, and handling, to manufacturing, distribution, and consumption of the finished product. 

HACCP takes a systematic approach to the identification, evaluation, and control of hazards based on the following seven principles:

1. Conduct a hazard analysis
2. Determine the critical control points (CCPs)
3. Establish critical limits
4. Establish monitoring procedures
5. Establish corrective actions
6. Establish verification procedures
7. Establish recordkeeping and documentation procedures

Why Should a Cannabis Organization Implement HACCP?

HACCP is a proven risk management system that has been used since the 1950s in multiple industries including food & beverage, dietary supplements, and pharmaceuticals. It only makes sense that HACCP makes its way into the cannabis industry’s best practices. By utilizing HACCP, cannabis organizations can minimize risk, reduce recalls, and improve product quality and consistency. Additional benefits include increased consumer confidence, protecting your brand’s reputation, and reducing costs through reduction of product losses and rework.

What is the first step in developing a HACCP plan? Before anything else, management buy-in is vital. For the successful implementation of any HACCP plan, management must be strongly committed to the HACCP concept. An organization’s commitment to HACCP by top management provides company employees with a sense of the critical importance of producing safe products.

Implementing HACCP for a Cannabis Facility
In the development of a HACCP plan, five preliminary tasks need to be accomplished before the application of the seven HACCP principles to a specific product and process can begin. The five preliminary tasks are:

1. Assemble the HACCP Team
2. Describe the product and its distribution
3. Describe the intended use and target market of the product
4. Develop a process flow diagram
5. Verify the process flow diagram

How to Implement HACCP

1. Assemble the HACCP Team (Preliminary Task 1) The first step in developing a HACCP plan is to assemble a HACCP team. The HACCP team should be multi-disciplinary and consist of individuals who have significant knowledge of the product and the process. Examples of potential members of a HACCP team include people from Quality Assurance, Sanitation, Maintenance, Production, Engineering, and Senior Management. 

2. Describe the Product and its Distribution (Preliminary Task 2) Once the HACCP team is established, their first task is to describe the product and its distribution. This consists of a general description of the product, ingredients, processing methods, and how the product will be stored and distributed (see figure 1).

Product Name(s)	Strawberry Lemonade Gummies
Product Description	Cannabis-infused strawberry lemonade gummies with 25 mg base THC.
Ingredients	Agar Agar, Pectin, Sugar, Water, Corn Syrup, Citric Acid, Cannabis Distillate, Strawberry Oil, Pink Lemonade Oil, Fiesta Pink, Vivid Red, Sour Sugar Coating (Granulated Sugar, Citric Acid, Malic Acid)
Allergens	N/A
Packaging	Primary: Child Resistant Mylar Bag Secondary: Corrugated Box
Labeling Instructions	Must follow state labeling requirements: [Insert Link to State Requirements]
Shelf Life	6-Months
Storage and Distribution	May be stored at ambient temperature or may be refrigerated. Recommended temperature range between 34-75º F.
Intended Use	To be consumed by medical cannabis patients and/or adult (21+) recreational cannabis consumers.
Target Market	Adults 21+ and medical cannabis patients

Figure 1: Example Product Description for Strawberry Lemonade Gummies

3. Describe the Intended Use and Target Market of the Product (Preliminary Task 3) The next task for the HACCP team is to describe the normal expected use of the product and its intended users. Here the HACCP team should identify if the product is meant for the general public or a specific segment of the population (i.e., medical patients or recreational consumers).

4. Develop a Process Flow Diagram (Preliminary Task 4) The purpose of the flow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the flow diagram must cover all the steps in the process which are directly under the control of the organization (see figure 2).

Figure 2: Example Process Flow Diagram for Gummy Manufacturing

5. Verify the Process Flow Diagram (Preliminary Task 5) Once the process flow diagram is created, the HACCP team should perform an onsite review of the operation to verify the accuracy and completeness of the process flow diagram. If there are discrepancies, then modifications shall be made.

Examining and Implementing the Principles of HACCP

Hazard Analysis (Principle 1)

After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identifies appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards that are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled (see figure 3). Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan.

It’s important to consider the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer in the hazard analysis. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is defined as a biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard, as used throughout this article, is limited to safety.

Figure 3: Example of Process Step 1A Hazard Analysis

Control Points (Principle 2)

A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining Critical Control Points (CCPs). 

Using the process flow from figure 2, we can see there have been two CCPs identified. One for cooking and one for holding products waiting for third-party testing. The reason that these two steps are considered CCPs is that they are essential to prevent hazards. CCP1 is considered a kill step because we are cooking the product to the appropriate internal temperature to eliminate the hazard of foodborne pathogens. CCP2 is essential because we cannot release the product to consumers before testing to ensure that no pathogens or chemical residues exist in the finished product. The reason the holding of the product is considered the CCP and not the actual testing is that the test is completed by a third-party lab which is outside of the control of the organization. Additionally, the control we have at the facility is ensuring that product that has not passed third-party testing requirements does not get comingled with finished products that have passed third-party testing.

Critical Limits (Principle 3)

A critical limit is a maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of a hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits, which are established for reasons other than product safety (see figure 4). 

Figure 4: Example of Critical Limit Worksheet

HACCP Plan Monitoring (Principle 4)

Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes. First, monitoring is essential to product safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is a loss of control and a deviation occurs at a CCP, i.e., exceeding, or not meeting a critical limit. Third, it provides written documentation for use in verification. As we can see from the Critical Limit Worksheet example from figure 4, we have identified what is being monitored, how it is being monitored, the frequency at which it is being monitored, and who is responsible for that monitoring activity.

HACCP Plan Corrective Actions (Principle 5)

The HACCP system for product safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail, and deviations from established processes may occur. An important purpose of corrective actions is to prevent products that may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant products, and (c) record the corrective actions that have been taken. 

Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. 

Individuals who have a thorough understanding of the process, product, and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining the disposition of a non-compliant product. In figure 4, we see that the corrective action is to destroy the product if it does not meet the critical limits. This is not always the case. In some states, regulators allow for products to be remediated if it fails to meet critical limits.

HACCP Plan Verification Procedures (Principle 6)

Verification is defined as those activities—other than monitoring—that determine the validity of the HACCP plan and that the system is operating according to the plan. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. Verification may be broken down into three categories:

1. Validation – test that the Critical Limits prevent, eliminate, or reduce the hazard to an acceptable level.
2. Verification – assure that all required information is written down and documented.
3. Reassessment – consider potential new hazards, and examine changes in raw materials, personnel, packaging, or any other changes that could affect the hazard analysis.

HACCP Plan Recordkeeping and Documentation (Principle 7)

Maintaining proper records is an essential part of the HACCP plan. Records serve as written documentation of the company’s compliance with its plan and help identify trends that could result in a deviation if not corrected. As the saying goes, “If it’s not documented, it didn’t happen”.  

Finally, it’s clear that establishing and implementing HACCP in a facility can be a daunting task. Need help taking the first step in developing a HACCP plan? Get in touch with the CSQ team today!