Do you know where your procedure gaps are?
What are Standard Operating Procedures?
As a plant, cannabis practically grows itself as long as basic parameters for nutrients, light, and temperature are met. Compliantly cultivating cannabis on a large scale is hard work nonetheless. Commercial cannabis cultivators need their crops to perform reliably and reproducibly with consistent quality. Growers need to follow standardized practices to achieve this.
Operations that are constantly modify their processed will struggle with consistency and an inability to determine root cause when things go wrong. Standard operating procedures (SOPs) are documents that detail how to perform tasks, when to perform tasks, what materials to use, and what related data needs to be recorded. Using SOPs is a great way to control a process and ensure that changes to a process are well founded.
In this first part of The Ultimate Guide to SOPs for Cannabis Industry, we will talk about what SOPs are, why SOPs for cannabis matter, and review some tips for writing SOPs for cannabis and implementing them in your cannabis business. Part Two of this guide will elaborate on the different types of SOPs and quality programs that are vital to success and compliance in the cannabis industry.
Commercial cannabis cultivators need their crops to perform reliably and reproducibly with consistent quality. Growers need to follow standardized practices to achieve this.
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.
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.
How to Write a Standard Operating Procedure for the Cannabis Industry
An SOP should explain why processes are performed, who is responsible, materials and equipment, definitions, and the procedures/steps necessary to accomplish each process. Emergency procedures and health and safety issues should also be noted in SOPs, especially for pesticide and nutrient use. Regulatory consultants, lawyers, and business consultants can help guide and inform processes.
- Make instructions of the procedure clear, concise, and actionable
- Use well thought-out procedures that will withstand time
- Validate procedures and verify processes as they are performed
Why do SOPs for Cannabis Matter?
Cannabis standard operating procedures encompass more than the grow. They are also used to control the use of nutrients for cannabis, integrated pest management, and much more. A system of SOPs that encompass production, storage, sanitation, 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.
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. Validating SOPs 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. 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 can make the difference between profit and loss, and compliance or court case.
Tips for Implementing and Writing Cannabis SOPs
1. Keep SOPs At Work Areas
Keeping SOPs at the work area where the process takes place isn’t just a good idea, it is actually a requirement of GMP. To learn more about GMP for cannabis check out GPP vs. GMP for Cannabis Quality Assurance.
Workers should be able to access the information easily as they are working. If workers have to go look for an SOP, they are more likely to carry on and make a guess or a mistake instead of tracking down the SOP. It is also a good idea for managers to periodically audit work with the SOP in hand to ensure processes are being carried out correctly, and to identify areas that may need clarification or further training.
2. Be Concise
An SOP should be very concise and focused on what is to be done, not why it is to be done. More explanation and detail can be provided in training materials, but the SOP itself should focus on the steps of a process. If a particular step needs to be explained in more detail, a document called a work instruction can be made to accompany the SOP. Where an SOP gives a broader explanation of how a process is done, work instructions are more specific and often include pictures and diagrams.
3. Control Variables of the Procedure
Conducting risk assessments and developing a HACCP (hazard analysis and critical control points) plan will help identify variables in processes. SOPs help to ensure that a procedure is repeatable and yields reliable outcomes. In order to achieve this it is vital that SOPs capture variables and risks and prescribe methods to work that will reduce or eliminate variables and risks. Consistency is especially important in cannabis cultivation because the quality and quantity of floral yield and cannabinoid content are directly influenced by how the plants are cared for.
4. Make Verification Part of the Process
Process SOPs should include steps where data is recorded and verifications are made. This is the most basic quality assurance activity that all cannabis cultivators should perform. An example would be an employee preparing nutrient solution records the amount of each component they used, and a manager verifies the recipe prior to use. Both the employee and manager sign and date the record and the company retains the record in case a future problem requires them to look back.
SOPs should also be specific and include information such as how much of each nutrient to add, which measuring cups are used to prepare nutrients, and at which temperature and conditions to store the nutrients.
5. Assign Responsibility
Before an SOP lists the steps of a procedure, it first identifies who is responsible for the different aspects of the procedure. To return to the nutrient example, an SOP for nutrient preparation would explain that the horticultural staff prepares and applies the solution and documents preparation and use; the manager verifies the record; and quality assurance staff reviews the records and stores them. Clear job descriptions and clearly assigned tasks will help ensure that all employees know what their role is and what they are responsible for. This also makes it much easier to manage performance metrics and sets a clear chain of command.
6. Work with Compliance Experts
Compliance consultants and lawyers should be consulted when it comes to your standard operating procedures and quality management system. Many growers and horticultural consultants have "SOPs" that they will provide, but these often focus on how to perform a process without consideration of how to legally perform the process. Even if your horticultural consultant has a Ph.D., it is not a Ph.D. in law or regulatory compliance. Any SOP a consultant provides should be reviewed, verified, and customized to the specific business.
7. Perform Process Validations
A process validation tests SOPs to ensure they are effective at controlling variables. Process validations consist of performing a procedure repeatedly and gathering data and metrics on the process. If the data shows a statistically significant rate of success, the procedure can be considered valid. Any change to the procedure will require it to be re-validated, so it is important to decide on a process that will not need to be changed in the future.
8. Manage Change
At the end of an SOP there is always a section called "Change Control." This section tracks any changes made to the document and who made the changes when. A change control procedure should exist to govern how changes to SOPs are managed. To avoid confusion and mistakes, old SOPs must be taken out of circulation, employees must be notified and trained on the changes, and multiple members of management should be involved in approving the changes.
Even if your horticultural consultant has a Ph.D., it is not a Ph.D. in law or regulatory compliance. Any SOP a consultant provides should be reviewed, verified, and customized to the specific business.
How to Write Cannabis SOPs
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.
Document Title: SOP Template
Authored By: GrowerIQ
Document Number: QAD003
Approved By: QA
Document Revision: 0
Effective Date: JAN 01 2019
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:
This procedure elaborates the correct technique used to propagate (clone) a new plant and to facilitate new root development in clones.
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:
3.1 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
Change Reason and Description
Updated materials section
Clarified section 6.1.3
Cannabis SOPs Available from GrowerIQ
GrowerIQ can provide you with all of the standard operating procedures needed for cannabis cultivation, cannabis production, and for cannabis quality assurance. These SOPs are written to reflect industry standards in cannabis and regulatory compliance. Cannabis cultivation SOPs are guided by master grower methods and polished with regulatory expertise. GrowerIQ can also customize SOPs to make sure they fit any cultivation method. New to growing? GrowerIQ can help get the ball rolling and guide clients through the licensing and application process.
QMS001.0 Quality Manual (custom only)
QMS002.0 Documentation Control System
QMS003.0 Good Documentation Practices
QMS004.0 Data Integrity Policy
QMS005.0 Corrective Action and Preventive Action
QMS006.0 Hazard Analysis and Critical Control Points System Establishment
QMS007.0 Risk Assessment
QMS008.0 Complaint Handling
QMS009.0 Recalls and Returns
QMS010.0 Planned and Unplanned Deviations
QMS011.0 Document Review and Approval
QMS012.0 Controlled Document and Record Retention
QMS013.0 Electronic Documentation
QMS014.0 Training Program
QMS015.0 Post Market Surveillance
QMS016.0 Vendor Qualification
QMS017.0 Receipt of Master Production Documents
QMS018.0 Self Inspection
QMS019.0 Annual Product Quality Review
QMS020.0 Batch Release for Distribution
QMS021.0 Storage and Handling of Retained Samples
QMS022.0 Sample Preparation and Testing
OPS001.0 Shipping, Receiving, and Material Handling
OPS002.0 Inventory Control
OPS003.0 Destruction of Product
OPS004.0 Handling of Damaged Product
OPS005.0 Sanitation and Maintenance
OPS006.0 Employee Health and Hygiene
OPS007.0 Reporting of Security Incidents and Suspicious Activity
OPS008.0 Client Registration
OPS009.0 Integrated Pest Management
OPS010.0 Material Storage
PRO001.0 Outdoor Cannabis Cultivation (Alternate SOP)
PRO001.0 Mother Plants
PRO002.0 Clonal Propagation
PRO004.0 Vegetative Growth
PRO005.0 Floral Growth
PRO006.0 Harvest and Post-Harvest Processing
Keep reading with Part Two of The Ultimate Guide to SOPs for the Cannabis Industry to learn more about what these SOPs contain!
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