The Ultimate Guide to SOPs for the Cannabis Industry: Part I

Standard operating procedures are controlled documents that provide a comprehensive list of tasks, procedures, and policies. SOPs guide employees in executing and performing their assigned tasks. SOPs help ensure compliance with both internal and external policies and regulations.

SOPs are found in many types of businesses such as laboratories, food and drug manufacturing, mechanical manufacturing, and biotechnology. Even businesses that are not required to have SOPs to meet laws and regulations can benefit from these step-by-step instructions about how daily tasks are supposed to be performed and monitored. Speaking of which, if you haven't already, check out our resource on Cannabis Manufacturing Equipment Financing and Cannabis Insurance if you're not already informed on the topics.

Cannabis industry statistics show us that the cannabis industry is very tightly regulated and businesses such as cannabis cultivators and cannabis extractors are required to have SOPs. Companies that are leading the cannabis industry have very effective SOPs that are managed by a Quality Assurance (QA) department. Having good documentation and well written procedures is a competitive advantage because it enables employees to perform tasks effectively, and provides clear policies and organization that help the business run efficiently. We have curated a list of resources that we suggest all readers to check out after reading this article: 7 Things You Need to Know About the Cannabis Industry, What Is a Bill of Sale, What is a Unit of Sale, Learn about what a Cannabis Greenhouse is, Cannabis Greenhouse Design Services, Greenhouse Management System, and Reducing Operational Costs Cannabis.

Cannabis standard operating procedures encompass more than the grow. They are also used to control the use of nutrients for cannabis, cannabis extraction, integrated pest management, and much more. A system of SOPs that encompass production, storage, sanitation and extraction method, business operations, and quality assurance are collectively called a Quality Management System (QMS). A parent document called the quality manual presents a summary of which regulations are to be met by the QMS and how they meet those standards, something that a Quality Assurance Person can help with. It is crucial to add SOP creation to your cannabis business plan if you want your grow to thrive. Another commonality we are finding to become more prevalent is commercial grow rooms in the cannabis business.

SOPs are a preventative measure in many ways. For example, the last thing you want is for your grow to be effected by cannabis spider mites. Optimized SOPs reduce the chances of this happening to nearly 0%. 

Industry leading cannabis consulting firms say that SOPs can make the difference between profit and loss, and compliance or court case. The process of writing SOPs begins with analyzing operations and recording the practices that are being used. After analyzing operations, key variables must be identified. These variables are aspects of a process which the SOP seeks to control. Before an SOP is put into use it has to be tested to validate that it provides verifiable control for variables. A major step in SOP creation is validating SOPs, as it helps to avoid massive failures and unforeseen circumstances.

In addition to providing structure for cannabis businesses , SOPs are also required by licensing and regulatory bodies. In order to start a cannabis cultivation facility in Canada, owners must complete an application process that includes submission of their standard operating procedures to have their share in Canadian cannabis supply. In addition to Canadian law, some cultivators may also want their SOPs to meet the requirements of Good Manufacturing Practices (GMP). GMP is a system of regulatory guidances that seeks to ensure the quality and safety of consumable products. Different versions of GMP may be applied depending on the scope of a business, its final cannabis product, and the location of the business.

SOPs for any business follow a standard format. While some slight variations in format exist, these basic elements will be found in almost any standard operating procedure.

The first element of an SOP is the header. This portion should include the document title, a unique document number, and a revision number. The SOP should also include an effective date and who has authored and approved the document.

The next section of the SOP will state the purpose and scope of the procedure. The purpose and scope of an SOP should be concise and state why the SOP exists and what it is applied to. Here is an example of the purpose and scope sections from the GrowerIQ Clonal Propagation SOP:

1.0  Purpose

This procedure elaborates the correct technique used to propagate (clone) a new plant and to facilitate new root development in clones. 

2.0  Scope

This procedure applies to the 5-14 day process of clonal propagation in the cultivation facility. 

As discussed in the SOP tips section, it is important for SOPs to assign responsibility to specific employees. The Responsibility section is where this information is elaborated. Here is an example of how the Responsibility section of a SOP should look from the GrowerIQ Clonal Propagation SOP:

3.0  Responsibility

3.1  Senior Person In Charge (SPIC):  The SPIC is responsible for determining authorized suppliers of genetic material.

3.2  Responsible Person In Charge (RPIC):  The RPIC is responsible for authorizing the authorizing the cloning of a mother plant. The RPIC oversees plant care and verifies documentation and records.

3.3  Quality Assurance (QA):  QA is responsible for verifying the identity and quantity of the genetic material is maintained through its lifecycle and for verifying the identity and quantity is maintained for the lifecycle of cloned plant material.

3.4  Horticultural Staff: It is the responsibility of the horticultural staff to adhere to this procedure. Horticultural staff is responsible for performing seed germination, mother plant cloning, and care of all plants at all stages of their lifecycle. Horticultural staff must ensure the identity and quantity of plants in all life stages is maintained and verified by QA.

Before getting to the actual procedure, a SOP should have sections for Definitions, Materials and Equipment, and should make note of and safety precautions that need to be taken. For cannabis cultivation SOPs, these sections are generally very simple. When it comes to SOPs for cannabis nutrients and pesticide SOPs for cannabis warnings about chemical hazards and instructions for safe handling and storage should be elaborated.

The middle section of the SOP is where the actual procedure goes. The procedure portion of the SOP should list the steps of a process from start to finish and contain steps for documenting the process and steps where someone not performing the task verifies that the person performing the task is doing so correctly. If a business has a Quality Assurance officer, they will likely play this role in the procedure.

After the procedure, the SOP should list the criteria or metrics that must be met for the procedure to be valid. This may include measurements, verification steps, recording data, and ensuring proper environmental conditions are in place. The Criteria section may also reference regulatory guidances and laws that govern the process. After the Criteria section, there is a section for Associated Documents. Any other SOPs, forms, logs, and work instructions that are referenced in the SOP should be listed in that section. This helps identify other documents that may need to be updated when an SOP is edited and makes it easy to find the logs and forms that go along with the process.

The last section of an SOP is the Change Control. Any changes made to an SOP are described in this section and the author and approver are logged for each change. When an SOP is revised it should always be given a new revision number. This number should also be updated on the header of the document so it is easy to tell old copies from new copies.

9.0  Change Control