This Product Quality Plan is a template delivered to you instantly in MS Word format with California-compliant placeholder text. Our supplied placeholder answers have been proven successful in previous California cannabis application submissions. This Department of Cannabis Control (DCC) document is required for Manufacturing license applicants.
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The State of California defines a cannabis product quality plan (§ 40253) as such:
The product quality plan shall address the hazards associated with the premises or the manufacturing process that, if not properly mitigated, may cause the product to be adulterated or misbranded, or may cause the product to fail laboratory testing or quality assurance review.
(b) To create the product quality plan, licensees shall conduct a comprehensive assessment of the overall manufacturing process, identifying each step from component intake through transfer of product from the premises, to determine the potential risks associated with each step, the preventive measures to mitigate the potential risks identified, the methods to evaluate and monitor the effectiveness of the preventive measures, and action to take if a preventive measure was unsuccessful.
(c) The product quality plan shall evaluate the following potential risks to cannabis product quality:
(1) Biological hazards, including microbiological hazards;
(2) Chemical hazards, including radiological hazards, pesticide contamination, solvent or other residue, natural toxins, decomposition, or allergens;
(3) Physical hazards, such as stone, glass, metal fragments, hair, or insects;
(4) Process failures that may lead to product contamination, allergen cross-contact, packaging errors, labeling errors, or other errors affecting cannabis product quality.
(d) The product quality plan shall identify the preventive measure that will be implemented to mitigate each potential risk identified pursuant to subsection (c). Examples of preventive measures include, but are not limited to:
(1) Cleaning and sanitizing of equipment and utensils to mitigate against risk of microbiological hazards;
(2) Conducting in-house testing of raw cannabis to mitigate against the risk of pesticide contamination;
(3) Establishing an allergen control program to ensure that allergen cross-contact does not occur between product types;
(4) Implementing procedures to ensure homogeneity of cannabinoids into a cannabis product to mitigate against the risk of a non-homogeneous product.
(e) The product quality plan shall identify methods to evaluate and monitor the effectiveness of the preventive measures in mitigating the potential risks identified in subsection (c). Methods for evaluation and monitoring of preventive measures include, but are not limited to, the following:
(1) Review of test results conducted to determine contamination such as pesticide residue;
(2) Maintaining and reviewing cleaning, sanitizing, or maintenance logs to verify such actions have been taken;
(3) Conducting environmental testing to determine if equipment or utensils are contaminated with pathogens;
(4) Monitoring the temperature of raw materials that need to be held below 41 degrees Fahrenheit to prevent microbial contamination.
(f) The product quality plan shall identify actions to be taken if the evaluation and monitoring of the preventive measure indicates that the risk was not properly mitigated. The corrective action shall be specific to the type of product under evaluation and the specific risk to be mitigated. Examples of corrective actions that may be taken include, but are not limited to:
(1) Destruction of product components or finished product;
(2) Further processing of cannabis extract to remove impurities;
(3) Reworking the unfinished product to further homogenize the cannabinoids.
(g) The licensee shall maintain the product quality plans and documentation of preventive measures, monitoring results, and corrective actions and make the records available to the Department upon the Department’s request, including during the Department’s onsite inspection of the premises. Nothing in this chapter requires the disclosure of product quality plans other than to the Department and its inspectors and agents. The licensee may consider the product quality plan subject to trade secret protection.
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A Product Quality Plan in California, is the equivalent of an HACCP Plan in other states. HACCP stands for Hazard Analysis and Critical Control Points, which is an analysis and strategy around the steps of the manufacturing process that make the product vulnerable to contamination. It might be during transfer into another container, during the addition of ingredients, during a heating or cooling process, etc.
The types of contamination that can happen are physical (like dust or debris), chemical (like pesticide residues), microbial (like bacterial growth), process (like a measuring or labeling error) or can relate to unintended allergen exposure. These are, essentially, all of the ways that a product can become dangerous to the consumer, and it’s the job of the State to set up rules to ensure that a dangerous consumer experience is avoided.
Other industries have been required to deal with product quality and contamination prevention for decades through state and federal quality assurance regulations. Any company that sells food products, herbal or dietary supplements, for example, must also have these types of plans in place.