Solid SOP’s (Standard Operating Procedures) can make or break the future of your company. Creating procedures in cannabis manufacturing that run smooth and soundly mean a solid business and ease of growth in the future.
At the company level, SOP’s are a set of step-by-step instructions to help workers carry out routine operations. Not only do SOP’s aim to achieve efficiency and performance. They can also reduce miscommunication and failure to comply with industry regulations. We have also found that your employees thrive when they know exactly what is expected of them. Good SOP’s can help with company culture, morale, and efficiency if implemented correctly.
Unfortunately, many businesses in the cannabis industry are slow to adopt these practices. Unaware of the benefits they can have, or unsure of how to go about creating them. Some cannabis SOP’s of particular significance in this industry are also required for cGMP Certification.
CAPA (Corrective and Preventative Action) Plans, Recall Plans, Batch number systems, Sanitation SOP’s, etc. are also essential in the success of a business. For example, a sanitation SOP breaks down the steps so your employees understand exactly how to sanitize both the facility and equipment. If done correctly, this SOP will help investigators understand how and if sanitization is taking place. Proving there is documentation in place to confirm that sanitization is happening in the facility. By making the regulator’s job easier, you are only helping yourself.
For a more concrete example, let’s look at the sanitation SOP in manufacturing or extraction settings. When I was a regulator and found a concentrate that was contaminated, the extraction facility always blamed it on the grow. Then the grow always blamed it on the extraction facility. Of course, neither had any evidence and didn’t do any kind of documentation or testing to prove these theories. If in place, the cannabis SOP and accompanying protocols helps disprove any cross-contamination issues that may arise. Each SOP highlights that your facility has a record of cleanliness.
SOP’s Ensure Long Term Success
There are several ways to avoid this sort of three ring circus. First of all, if you test everything coming into your facility, you can easily root out the contaminated products before they make it into your machines. Make sure to avoid the problem altogether. Second of all, if you have good SOP’s and documentation in place you can disprove any accusation of cross-contamination almost immediately.
While an investigator might still put the product on hold to take more samples. At least they know that your company is going above and beyond to prevent contamination in your facility. Conversely, in an edible product kitchen, having sanitation SOP’s in place will demonstrate that you are well in accordance with FDA standards. Whether you are including how to mix your sanitizer, or what to do if your Quaternary Ammonium pump runs out, etc. It is good practice to create a guide for staff to reference if they aren’t 100% sure about sanitation procedures.
There are many SOP’s your company can implement. Each can help your facility run smoother, and put investigators minds at ease. While these SOPs are not necessarily that difficult to put together for someone that has done it before. Each can make a world of difference during an investigation or regular inspections. Any company that has great SOPs, is sure to do well in this highly regulated industry.
Kim Stuck is the founder and CEO of Allay Consulting, a compliance strategy and services provider serving the hemp, cannabis, and psychedelic industries nationwide. She brings a regulator’s keen eye and wide-reaching knowledge on evolving compliance and safety mandates to support businesses in tightly regulated industries. Previously, Ms. Stuck held a pioneering role as the nation’s first cannabis and hemp specialist for a major metropolitan public health authority. During her tenure with the City of Denver, home to hundreds of cannabis businesses, she worked as an investigator covering cultivation, manufacturing and retail. Her duties included facility inspections; conducting investigations into improper pesticide use and worker safety; creating regulations; instituting recalls; and public outreach. Ms. Stuck holds numerous accreditations, such as certified quality auditor (CQA) and certified professional of food safety (CP-FS), among others. In addition to serving on several industry advisory boards, she has been a member of ASTM International’s cannabis standards committee since its 2017 inception.