Why are SOPs important for a successful manufacturing business?
In cannabis industries worldwide, governments mandate producers to have Standard Operating Procedures (SOPs). But beyond regulatory requirements, SOPs also help you standardize processes, maintain quality, produce consistent results, identify efficiencies, and improve training. These benefits are just the tip of the iceberg of why SOPs are important for your cannabis business.
Producers need to have their SOPs in place before licensing to demonstrate their understanding of the regulatory requirements and responsibilities to the government. Cannabis producers usually purchase SOP sets, which include SOPs for quality, security, compliance, sanitation and operations (we will touch on examples of SOPs later).
Purchasing SOPs is easy. You can get them from various consultants for around 10-20k. What’s challenging is knowing what to do with them, tailoring them to your processes, and writing them in a way that doesn’t cause more work. Even in you purchase a set, you will need to create your own cultivation SOPs and processing SOPs because they will depend on your specific internal processes.
Understanding why SOPs are important and knowing how to write them can help you create SOPs that work well in your operations. Your SOPs will become easier to follow, reduce the number of mistakes employees make and ultimately enable you to scale.
Why are SOPs important?
What are SOPs? SOPs are written documents that contain step-by-step instructions on how to complete specific tasks or processes. The main objective of SOPs in a facility is to instruct workers on how to complete a specific task in a standardized way that maintains consistency and quality results, even if different people are completing it.
SOPs in highly regulated industries, such as an SOP in the cannabis industry, the instructions will include specific regulatory requirements. This means the advantages of Standard Operating Procedures (SOPs) are not only to help maintain product quality, but SOPs are important in helping companies comply with the regulations.
What is an SOP in the cannabis industry?
SOPs exist in many different departments of a cannabis operation, and it’s common to see SOPs for quality, security, compliance, sanitation, maintenance and operations.
SOPs used in different cannabis facilities will differ, mainly on the operations side of things. For example, while one company might manufacture edible cannabis, another may focus on producing dried cannabis, so the SOPs they follow will be very different. The SOPs that will generally stay the same from one cannabis company to another are quality, security, sanitation and compliance - these SOPs are unlikely to be updated much. So, why are operational SOPs so important?
What is a Cultivation SOP?
Cultivation SOPs are a type of operational SOP that revolve around your cultivation processes. Cultivation procedures can include the actual process of growing and any ancillary activities. Ancillary activities might consist of tasks such as instructions on how to mix nutrients, how to apply fertilizers, or how to prune plants. Here are some examples of Cultivation SOPs you might see in a cannabis facility:
- Cloning of cannabis plants or sowing cannabis plant seeds
- Transferring plants
- Trimming and pruning
- Addition of nutrients
- Application of fertilizers
- Application of pest control product
What is a Processing SOP?
Processing SOPs are also operational SOPs. However, they include any process that occurs to the cannabis after harvest. Processing SOPs will vary depending on the cannabis products you manufacture, including drying, curing, extraction, edible cannabis manufacturing, pre-roll manufacturing, etc. You need a cannabis processing licence in Canada and other jurisdictions to complete these tasks. The furthest that cannabis cultivators can process cannabis is drying or flash freezing. Here are some examples of Processing SOPs you might see in a cannabis facility:
- Drying, curing and burping cannabis
- Flash freezing
- Milling
- Extraction processing
- Edible manufacturing
- Pre-roll manufacturing
- Encapsulation (e.g. tablets or capsules)
Now that you know why operational SOPs are important let's talk about how SOPs can impact your business.
Scaling with SOPs and Records
The quality of your SOPs can set you up for success or hold you back from scaling - this is why operational SOPs are important.
You may ask, are operations different in the cannabis industry? Well, compared to traditional manufacturing environments such as pharmaceuticals and automotive, they really are. This is another reason why SOPs are so important for producers.
Minimize SOP deviations
A unique challenge that cannabis producers face is writing SOPs that allow for flexibility. For example, if you’re a cannabis cultivator that grows multiple cultivars, you know that the needs of the different cultivars vary quite a bit. The amount of light, the nutrient mixture, the temperature, and the number of days to harvest can differ between cultivars and even between different batches of the same cultivar.
It may already be evident that constantly changing procedures might make maintaining and updating cultivation SOPs challenging. This is very true, and that’s why the way you write the SOP can significantly impact the efficiency of your operations, for better or worse.
SOPs are a significant component of a Quality Management System (QMS), which aims to streamline and standardize business processes to meet customer requirements and continually improve satisfaction. As part of this system, SOPs have to be followed exactly. If an employee doesn’t follow a procedure as listed in the SOP (i.e. deviates from an SOP), a deviation must be completed that documents the mistake. Once a deviation is opened, an investigation may be completed to determine the root cause of why this mistake occurred. The investigation can lead to a Corrective Action or a Preventative Action (CAPA), which aims to correct the mistake or prevent it from happening again. You can see how much work a mistake can create.
Here’s an example of a Cultivation SOP that causes deviations and how to make it more flexible. Say your SOP dictates that the temperature in the flowering room must be between 20-25 degrees celsius. Your master grower brings the temperature down to 18 degrees to bring out the colour, trichome density and smell of the cannabis. Because 18 degrees is outside the prescribed range, they complete a deviation, and Quality Assurance (QA) investigates to find out that this temperature drop did not impact the product quality. They can amend the SOP to prevent deviations and additional QA work in the future by extending the temperature range of 18-25 degrees, allowing more flexibility for the master grower.
That’s why flexible cannabis SOPs are important. This avoids constantly updating SOPs and prevents all that extra work (deviations, investigations and CAPAs).
Digital Record-keeping
SOPs also have associated forms and records that must be completed by the employee when executing a particular task or process. For example, if an employee is following a Cultivation SOP for pest scouting, they will need to use a pest scouting form. The form might have fields to complete, such as the date and time, the name of the person filling out the form, the room and batches where they did the pest scouting, and notes on any pests, diseases or disorders found on the cannabis plants. The completed forms related to a lot or batch are added to a batch production record.
Many facilities complete all their records on paper. The challenge with this system is that paper records can be damaged (imagine them getting wet in a grow room), lost, incomplete or has poor legibility. This can lead to a significant amount of additional work and inefficiency in a cannabis facility and can make audits and inspections extremely stressful. As a result, many cannabis producers leverage cannabis software such as Elevated Signals to help them digitize their recordkeeping and create batch records in seconds.
Inefficient recordkeeping can slow down cannabis producers and get in the way of them scaling their businesses. Teams that leverage cannabis software have better visibility into their operations, save QA resources and have better forecasting capabilities, positioning them for growth. If this sounds all too familiar, speak to our team about how we can help.
You should now understand why SOPs are so important for cannabis businesses. Now, let's jump into how to write a killer SOP.
How to write and update cannabis SOPs
Most cannabis producers purchase a standard SOP set (because who are we kidding…we’re not writing hundreds of SOPs from scratch). If you’re unsure where to get them, we know some people who can help.
What cannabis producers need to know is how to customize and update their SOPs based on their procedures and understand the approval and implementation process. We explained in the sections above why flexible SOPs are important in the cannabis industry.
Step 1: Writing and updating SOPs
For best results, SOPs need to be updated or customized by a subject matter expert. If you want a cultivation SOP detailing how to prune plants, the master grower or someone who works in the cultivation department should write it. These individuals are the ones who know the process best. If someone in a different department writes the SOP, it creates more back and forth between the teams, slowing down the process.
When writing the SOP, you need to be specific as possible and not leave anything up to interpretation. Theoretically, someone should be able to follow the SOP without having anyone ever physically show them how to complete the task. Assume they know nothing and have never done this task before. For example, think about making a peanut butter and jelly sandwich. Which sort of assumptions could you make if you were writing instructions for how to make one? You might forget instructions like “get the SMOOTH peanut butter from the cupboard in the kitchen,” or you might assume they know to use a butter knife and not a steak knife. You might miss a critical step in your SOP if you make assumptions. This is why specific SOPs are important.
Another way to make the instructions specific and easier to follow is by adding pictures along with the instructions (ever put together IKEA furniture?).
Step 2: Reviewing SOPs
Once you’ve written or updated your SOP, you’ll need a reviewer. Technically, the SOP only needs an author, a reviewer and an approver. But ideally, it should have two reviews; the first reviewer should also be a subject matter expert manager (cultivation or operations manager, for example), someone familiar with the process and can verify that the instructions are correct. The second reviewer should be someone from the quality department to ensure that the process is still compliant and meets good production practices (GPP) or other standards such as GMP.
Step 3: Approving SOPs
Finally, you’re ready for approval. The head of QA does this. In Canada, for example, this would be the Quality Assurance Person (QAP). The QAP must approve all SOPs before implementation in the facility.
Step 4: Training and Implementing SOPs
What does SOP implementation mean? It means that you can use it in production. But before that happens, the employees following this SOP must be trained on it and demonstrate competency. Only trained staff can complete this task! Training can be conducted one-on-one or in a group training for efficiency. Teams should have a learning management system to help them keep track of what SOPs and policies they're trained on (you guessed it, there is an SOP for that).
Now you know why SOP writing is important, you’re ready to tackle your own SOPs. Good luck out there!
What are some Cannabis SOP Examples?
In the list below, you’ll find examples of cannabis SOPs that producers would likely have at their facilities. These are the SOPs that regulators could ask for during licensing (apart from some specific production SOPs), and that’s why they are important SOPs.
Cannabis SOP Examples
Production
- Distribution, transfer and receipt of cannabis materials
- Cloning of cannabis plants or sowing cannabis plant seeds
- Trimming and pruning
- Addition of nutrients
- Application of fertilizers
- Application of pest control products
- Harvesting
- Drying, curing and burping cannabis
- Flash freezing
- Milling
- Extraction processing
- Edible manufacturing
- Pre-roll manufacturing
- Encapsulation (e.g. tablets or capsules)
- Cannabis sampling and testing
- Bulk cannabis packaging and labelling
- Samples labelling
- Immediate container packaging and labelling
- Discrete units
- Storage of cannabis
- Storage of cannabis waste
- Storage of ingredients used in products
- Storage and handling of samples and retains
- Cannabis destruction
Quality
- Risk assessment
- Deviations
- Investigations
- Corrective Actions and Preventative Actions
- Change Controls
- Self-inspection
- Recall
- Complaint Handling
- Returns
- Adverse events
- Batch Release
- Quarantine
- Vendor qualification
- Good Documentation Practices
- Training program
- Employee Health and Hygiene
- Personal Protective Equipment (PPE)
Sanitation
- Cleaning and sanitation of GPP areas
- Cleaning and sanitation of non-GPP areas
- Sanitation of equipment
Facility and Equipment
- Environmental Monitoring
- Preventative maintenance of equipment
- IQ/OQ/PQ Qualification and validation of equipment
- Calibration of scales
- Integrated pest management
Security
- Visitors and Contractors
- Visual Monitoring
- Access Control
- Site Perimeter
- Alarm response
- Theft and loss of cannabis
- Security Incident report
We hope you found this blog useful and learned why cannabis SOPs are important for cannabis businesses. You might also be interested in our blog about three operational mistakes that are putting your cannabis facility at serious risk, which also discusses the importance of SOPs.