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When the Feds Come Knocking. Are You Ready?

Before I was Bradley Barnard, the Chief Business Advisor for B-Hive Cannabis Venture Group or Director of Compliance for Sunday Goods and The Pharm, I was Bradley the Federal CSI (Consumer Safety Inspector) for the USDA Food Safety Inspection Service (FSIS).

When I think of today’s MIE (Medically Infused Edibles), I often wonder about the safety process and facilities in which they are prepared. A normal visit on my patrol to a food processing facility contained many elements that I review and observe. Upon arrival I can get a good feeling as what to expect when I walk inside. If there is hair and beard nets, cigarette butts and trash all over the parking lot, is a good indication that there is are not effective SOP/GMP processes in place. To me, that immediately reflects on the Senior Management Commitment.

If #plantsafety is not mentioned anywhere, chances are there are some costly missed time accidents that could have been avoided. Are the outer doors unlocked or some wide open? If so, my mind switches to the #FoodDefenseSystem and #PestManagementPractices. Those thoughts are happening just on my walk from the car to the entrance. Imagine when I walk in and everybody jumps on their radios and disperses. I know then chances are I am going to be writing a few Non-Compliance Reports or NR’s. These NRs state the regulation violation and has areas for corrective actions and preventive measures are taken in a timely manner. I continue to walk to the company provided FDA/USDA office and prepare my PPE, grab my assigned tasks and head for the Quality Dept.

Once there, I review SOP plan and the previous days SOP monitoring for review. Are all the dates and times correct and signed or initialed? Then I would review the Plant #HACCP Plan or Food Safety Plan and previous days paper-work and the Pre-Shipment Review signed by a Senior Manager stating that all products were produced in accordance to regulation and CCP’s and SOPs were active and effective for that processing period. Were there any ingredients not list on the USDA FSIS List of Safe and Suitable Ingredients? Are there Allergens and a plan to store and use them without cross-contamination? Are the CCP’s (Critical Control Points) monitoring and direct observations documented with any deviations corrected and preventive measures implemented? Is there an effective and robust Microbial Testing plan in place? Other things I want to see is your Sanitary Design Checklist for your equipment.

What level of cleaning can the equipment withstand? How is it being cleaned and sanitized and is it in accordance to the Master Sanitation Plan and SSOP’s (Sanitation Standards Operating Procedures)? This is why I encourage my customers to implement a HACCP Plan or a Food Safety Plan when preparing MIE’s. There is even Juice HACCP for beverages. Utilizing these in you Quality Management System will decrease the liability of harming a consumer while providing relevant documentation that can be used in a court of law to defend your process.

Again, I walk through the facility I am looking for any signs or possibility of adulterated product. Are the Labels on product providing the required elements? Is there something in the box or bag that is not on the label? Misbranding can lead to costly recalls and fines. In the cannabis industry, we are capable of aligning our systems and processes with USDA and FDA regulations. Why not take your company and process to the next level by choosing the standards that go beyond and above State Level requirements?  GMP Certification, ISO 9000 (Technical Standard), ISO 9001 Quality Management Systems, ISO 22000 Food Safety Management are very good ways to add value to your company and pricing. You want to develop a Culture of Safety and Compliance?  Want to be the “Best of the Best”? Standards based on USDA and FDA Best practices are the way to do it.

https://www.fda.gov/media/72067/download

https://www.cfsanappsexternal.fda.gov/scripts/foodSafetyPlanBuilder/

Bradley Barnard

Chief Business Advisor at B-HIVE

LinkedIn Profile

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