We have all heard the English-language proverb, “An apple a day keeps the doctor away”. Although straight forward, my compliance brain takes me to asking further questions – which apples are the most nutritious, how were the apples grown, where were the apples grown, on an on. Basically, without asking too many questions, the proverb is expressing that eating healthy now will lower your risk of health issues and a future doctor’s visit. What you do now will contribute to your future (preventive) vs. addressing the issue now (reactionary). This simple saying is applicable to many aspects of life: healthcare, car maintenance, relationships, and even more so applicable to compliance.

In this installment of Allay’s compliance newsletter, we showcase the difference between proactive and reactive approaches to compliance!

Preventive Approach to Compliance

Predicting a future failure and creating systems to avoid failure from occurring is a preventive approach. In the “an apple a day keeps the doctor away” proverb, the apple is the form of prevention. Apples are nutritious, full of fiber and antioxidants. Eating healthy foods are beneficial to one’s health; even though food is one aspect of preventive health, food is still a foundation of overall health. As with health, compliance is multifaceted yet focusing on prevention is primary when protecting the company. There are many aspects of the cGMP & GACP quality management programs that focus on preventive compliance:

• Approved Supplier Program. Suppliers of all ingredients, equipment, and product touching surfaces are to be approved prior to purchasing and being brought into the facility. This is a first line of defense when allowing products into the facility.
• Preventive Maintenance Program. A schedule is determined to outline the frequency of maintenance for each piece of equipment used at the facility. Rather than waiting for equipment to break down, the preventive maintenance helps reduce disruptions in operation.
• Food Defense Program. The Food Defense Program describes the steps taken to protect food, products, and the production process from intentional contamination or adulteration such as from acts of terrorism, disgruntled employees, consumers, competitors, or from economically motivated acts.
• Foreign Supplier Verification Program. The Foreign Supplier Verification Program was established through the Food Safety Modernization Act (FSMA) which requires importers to ensure that each imported food & supplement ingredient (human & animal) into the United States meets appropriate US food safety standards to ensure that the supplier’s food is not adulterated and is not misbranded.

Reactive Approach to Compliance

A reactive approach focuses on fixing the issue once it already has occurred. Although not ideal, reactive approach to compliance is still needed. The preventive programs are layers of protection for companies, but all companies need to plan for the unexpected interruptions in operation. Here are a handful of quality management programs that address reactive approach to compliance:

• Recall Plan. The Recall Plan clearly states what to do when a product is needing to be recalled off the shelves, how to notify impacted customers, what to do at the manufacturing/distributing warehouse, etc. Other cGMP programs cover the prevention of product recalls.
• Customer Complaints. Various preventive programs help reduce customer complaints; however, all companies should expect complaints. Addressing complaints (founded and unfounded!) are a must. This reactionary approach helps determine how your quality management program can be better.
• Emergency Action Plans (EAP). The EAP is to assist and organize employer and employee actions during a workplace emergency in efforts to save human lives, structural damage, and product damage.

Both Approaches are Needed

Although a preventive approach to compliance will certainly save a company time and money, a reactionary approach is needed when unforeseen circumstances occur. Companies can create as many preventive programs as possible, yet sometimes quality or safety issues arise and need to be addressed ASAP. Companies are encouraged to create both preventive and reactive programs. However, some programs include both elements (this is a win win!). Here are a few examples of programs that contain both preventive and reactive elements.

• Training. Training of staff is a must and is one of the most important aspects of any quality and safety program. Training clearly defines expectations for staff from the start of employment, frequently throughout the year, when processes change, when a safety or quality issue is identified, and when staff does not follow procedures.
• Hazardous Communication Plan. The HazCom Plan must have preventive methods that reduces the risk of incidents related to hazardous materials and education of staff. On the flip side, the Hazardous Communication Plan also includes reactionary step-by-step procedure on what to do in case of a hazardous chemical spill or other related safety issues with hazardous material.
• Pest Control Program. The Pest Control Program addresses both how to prevent pests from entering the facility and what to do when pests make their way inside the facility.
• Corrective Action Preventive Action (CAPA) Plan. The CAPA has components of both reactive and preventive components. The name of the program is literally what the plan is covering – first correct, then prevent. When implementing a CAPA plan, operators are first tasked to correct the issue. Once corrected, the operation must identify the root cause that caused the upset in process, then put a control measure in place to prevent it from occurring in the future. The act of a identifying the root cause is still reactionary, but when identifying the true cause, a prevention can be put in place.

Federal & State Preventive & Reactive Compliance Programs

The government, both at the federal and state level, requires companies to create preventive & reactive programs to ensure product and workplace safety. For example, the FDA has certain requirements that help ensure prevention measures are taken at manufacturing facilities: Food Defense Plan, Foreign Supplier Verification Program, Product Safety Plan, etc. OSHA requires companies to have Emergency Action Plans (primarily reactionary) and Hazardous Communication Plans (contains both preventive & reactive).

Many states are requiring aspects of preventive/reactive compliance in their cannabis regulations, while other states are beginning to offer incentives to gaining cGMP/GACP certification which include preventive and reactive programs. Just a handful of states are requiring these certifications for their cannabis licensees. States requiring certification include Michigan (GACP immature plant sales & cGMP/HACCP for infused beverages), New York (hemp manufacturer selling dietary supplements cGMP), Florida (cGMP), and Maryland (cGMP, 111, 210).

In Need of Compliance and Certification Support?

Creating preventive and reactive compliance programs is a necessary for any operation, especially in the marijuana, hemp and mushroom space. We hope sharing these different compliance approaches provides useful insight and an opportunity to learn from our experience. If your company’s values and goals include compliance, we are here to help! Allay Consulting compliance services work one-on-one with your company to create a realistic Quality Management System that is unique to your company’s values and goals.

Contact Allay Consulting to learn more about implementing a cGMP system, written documentation, facility compliance, certification readiness, and employee education!