The state of CA requires that all infused edibles operations develop and implement product quality procedures for their operations. This plan then needs to be submitted as part of the licensing application process, also known as form BCC-LIC-017, Non-Laboratory Quality Control Procedures. The questions in this form seem to be simple, but they are just the tip of the iceberg. To answer these questions in a compliant way, QA managers or a manager of the operation must first build a well thought through quality control system.
When working with infused edibles customers on creating food safety and quality control systems, I always refer to FDA FSMA (Food Safety Modernization Act) guidance. That is because from a food safety and quality assurance standpoint infused edibles are not at all different from the conventional food we buy at the supermarkets. Hence the same principles apply: evaluating hazards, understanding critical control points, controlling contamination, implementing GMP practices, controlling allergens and foreign materials etc. The most important thing to understand is that by carefully analyzing your infused edibles operation and implementing quality system you are not just satisfying state requirements, but, more importantly, you are setting your company up for success. Strong process controls anda fully implemented GMP program mean higher quality products with consistent efficacy which in turn help you to develop higher consumer loyalty.
So how do you start? Below find my recommended steps to get underway on developing your product quality system:
- Download FDA’s FSMA HACCP and HARPC plan template- there is a handy tool called Food Safety Plan Builder and get started!
- Assemble a food safety/quality assurance team- this is a very important step. Strong QA programs can only be implemented when there is a full management commitment to this process. A hallmark of a well-run food manufacturing operation (infused edibles or conventional food) is a CEO or a COO who is involved, active and open to feedback when it comes to ensuring food safety. As an auditor, I always know that my audit will be productive if a CEO or a founder are present at the opening meeting. Make sure that your quality assurance team includes people from all functions: operations, management, shipping/receiving and maintenance and R&D.
- PCQI (Preventive Controls Qualified Individual) Training- while having a PCQI on staff this isn’t a state requirement, it is cost-effective way to get your QA manager up to speed on how to develop, implement and monitor process controls and GMP programs in your operation. PCQI courses are offered in person in virtually every county in CA (approx. $450-$750 for a 2.5-3 day classroom style course)- a great investment considering that you will now have an in-house resource for safety and quality.
- Evaluate and describe your products- what product category they belong to? What risk category? This is where a qualified experienced consultant can provide your team with a head start on how to build your system in a way that suits your product profile. Remember, there is no “one size fits all” HACCP or a HARPC plan. For example, if an infused edibles operation X produces gummies, hard candy and filled chocolates this doesn’t mean that one HARPC plan can be applicable for all types of products. In this particular case, there must be three different plans- one for gummies, one for hard candy and one for chocolates. This is because the processes and the ingredients are very different; therefore hazards are different as well.
- Develop a process flowchart- this is a map of your operations. Typically flowcharts outline ingredient journey through your facility and how they are combined as part of processing them into a product. You do not need to include QA programs, such as compliance testing for your products or ingredients. Those will be covered under your preventive controls.
- Hazard analysis for ingredients: the objective of this step is to understand what types of biological, chemical, physical and radiological hazards might be present in the ingredients you use. A QA manager who attended a PCQI course can do this independently. Hazard analysis must be done for each ingredient as well as the processing aid (if present) used in your edibles. I use a handy FDA guidance called Hazard Analysis and Risk Based Preventive Controls for Human Food- Draft for the Industry, appendix 1, potential hazards for foods and processes.
- Process Hazard analysis- this is done for your processing steps and must follow your flowchart. Depending on the complexity of your operations, you may need a help of a qualified consultant at this point to help your QA manager to apply principles that they learned in the PCQI class.
- Determine whether hazards in your facility will be controlled via critical control points (CCP), preventive controls (PC) or a combination of the two. For most confectionary manufacturers, there is at least 1 CCP (metal detection) and several PC’s such as sanitation, supplier assurance, allergen control etc.
- Start outlining what are the PC and CCP’s in
your operations and writing policies that detail how the hazards are to be
controlled. Below are some examples of what this means.
- Example 1: you have identified that Salmonella spp (i.e. species) (a biological hazard) may be present in dark chocolate that is used in your infused filled dark chocolate truffles. The programs that need to be implemented in your operation then would include Supplier Assurance program (which will require certificate of analysis for Salmonella spp. to be present for every lot that enters your operation) and Shipping/Receiving procedures which will guide the staff to check for the appropriate documentation at receiving.
- Example 2- you manufacture some products that are allergen free on the same equipment where products with allergens are manufactured. Allergens are considered to be chemical hazards. Therefore, preventive controls in place are: Allergen control program, Sanitation program, Supplier Assurance Program and GMP. All of those programs together will be able to provide basic controls for ensuring that undeclared allergens in your product present risk to the allergen sensitive consumer.
- GOOD NEWS- your risk analysis is now complete. Now you are ready to start working on your programs and processes! That is because you have done your homework and understand WHAT you need to control in your operations. It’s time to work on HOW you are going to control it.
Developing product quality plan requires quite a bit of work but is very much worth it. It’s easy to see the benefits of a well thought out and implemented product quality system:
- Demonstrating compliance with CA state requirements.
- Consistent quality and efficacy of the products you manufacture.
- Avoidance of significant costs (and potentially penalties) associated with quality holds on product, non-compliance and product recalls.
- Compliant facilities and operations that are inspection ready.
- Higher customer satisfaction and strong brand loyalty.
- Higher staff satisfaction.
So get started and reach out to me if you need help developing a Quality Assurance Program for your operations.
Food Safety and Quality Consultant
SQF Certified auditor
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 California code of regulations, title 16, div. 42, bureau of cannabis control, § 5506
 Not applicable for all ingredients, only for certain ones like spices, tea or some others.
 D. A Powell, C.J. Jacob, B.J Chapman, Enhancing food safety culture to reduce rates of foodborne illness, Food Control, Volume 22, Issue 6, June 2011, pp 817-822.