Turn FSMA Mandate Into a Competitive Advantage
Implementation of Food Safety Modernization Act (FSMA) rules will become mandatory for small food businesses in September 2017. A good portion of small food manufacturing companies lack sophisticated quality systems to help them assure compliance or electronic databases to track required activities and document compliance. Now is the time to get serious about devising compliance systems. By doing this task right, you will not only be able to comply with the mandate, but also create a competitive advantage in capturing new market shares.
If you are a small food manufacturer and would like to expand your market to include large distribution channels, you should embrace the FSMA mandate as an opportunity to raise your compliance to the level desired by large retail chains. Most often, the big chains want you to successfully pass a food safety audit performed by their own auditors or a third party auditor. For sure, FDA audit readiness prepares you for commercial audits, as well. The basic compliance requirements are very similar between FSMA and Global Food Safety Initiative (GFSI). So, if your facility is compliant with FSMA, you have facilitated the path towards a successful GFSI audit, being British Retail Consortium (BRC), Safe Quality Food (SQF) code, or others.
Meeting an FSMA audit requirement will increase the customer’s trust of your business practices and gives you a competitive advantage in business-to-business (B2B) commerce. It also proves transparency in your food safety practices, which in turn builds a stronger consumer confidence in your products and promotes your brand.
FSMA has a risk-based approach. Warren Buffet said it well, “risk comes from not knowing what you’re doing.” The first step towards compliance is to make sure you know everything you need to know and minimize the risk of a violation. The best start is to evaluate your existing quality system. You don’t need to dismantle it; just perform a gap analysis and identify the holes in the system — keep those parts that match the new requirements and amend it to include whatever is lacking. If you have an HACCP plan or a GSFI certificate program, the chances are that you already have a portion of the FSMA requirements in place.
FSMA approaches food safety and quality from a preventive perspective which is normally more divisive and cost-effective than a reactive approach. Let’s review rudimentary components of the FSMA risk-based preventive control measures:
- Assign a Preventive Controls Qualified Individual (PCQI) to create and maintain a food safety plan. This individual needs to be sufficiently trained on FSMA preventive controls, have enough experience in this field, or a combination of the two.
- Establish a process for hazard analysis. Determine what hazards are likely to happen in your specific processing steps and which ones could cause serious adverse health consequences or death to humans or animals. Define relevant preventive controls for those hazards.
- Create a risk-based food safety plan to include the following major components:
- Prerequisite Programs such as GMPs according to 21 cfr part 117 mandated by FSMA for environmental monitoring, personnel hygiene, plant sanitation, pest control, food contact surface sanitation, appropriate facility design, storage and shipment, etc.
- Allergen Control
- Biological, Chemical, and Physical Hazard Control
- Economically-Motivated Food Safety Hazards and Controls
- Supply Chain Preventive Controls
- Verification and Validation Procedures: Depending on the severity of the potential hazard, verification and validation activities could be decided. For example, if you purchase cheese as an ingredient, your verification activity might be to perform an on-site audit of the supplier to make sure they have an adequate safety plan. If the ingredient is salt, your verification plan may include review of the supplier’s quality documents and compliance history. Validation can be justified by reference to a scientific study to support the control used or by doing an in-house study to determine if the preventive controls are adequate.
- Record-Keeping Procedures: Records are required to demonstrate that corrective actions, verification, calibration, validation, record review, analytical testing, training of the qualified individuals, etc. are documented. Records must contain actual values and be created concurrently with the activity. Original records or true copies must be retained at least two years. You should be able to retrieve and provide records within 24 hours of request by FDA. Electronic records are acceptable if they are compliant with Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11).
- Recall Plan: A written recall plan is required to identify the recall steps and the responsible persons to take those steps. It should explain how and when to notify the FDA, the distribution channels involved, the public, and how to return or dispose of the affected food. When food presents a reasonable probability that its use will cause serious adverse health consequences or death to humans or animals (Class I Recall), manufacturers are required to report to the FDA within 24 hours of learning about the hazard. It’s a good idea to run mock recalls once a year.
- Review of the safety plan annually or upon any significant change in the safety plan.
You need a robust, quality system to support effective implementation of your food safety plan. Such a quality system includes the following components:
- CAPA System: FSMA requires conducting an investigation when a non-compliant event happens. Each deviation should be dealt with through a corrective action or preventive action (CAPA). The effectiveness of the CAPA should be verified consequent to the implementation.
- Food Safety Complaints: The complaints that come from the customers or the final consumers should be investigated, documented, and followed by appropriate actions, if necessary.
- Comprehensive GMP Training Program: The employees who should be trained on sections of 21 CFR Part 117 pertaining to their function and the training records should be maintained. The important thing is to plant the culture of compliance and achieve employee buy-in to ensure FSMA compliance is maintained in an on-going basis.
- Validation and Verification: Validation of the systems and processes guarantees that they function consistently and effectively for their purpose. Verification of the activities confirms that the right activities have taken place.
- Documentation, Document Retention and Control: A reliable system should be implemented to retain documents. The best idea is to employ an electronic document control system that is compliant to 21 CFR Part 11. Such system facilitates document creation, revision and retirement. It also makes it easier to maintain a substantial volume of documents by saving space and gaining easy access to documents when necessary, e.g., at the time of an FDA audit or a class I recall.
- Foreign Supplier Verification Plan: If you use any imported ingredients, you need to establish and follow written procedures for supplier verification activities to ensure you import from approved foreign suppliers. Type and frequency of the verification activities depends on the assessment of the risk of the food and the capabilities and the compliance history of the foreign supplier. These activities may include on-site auditing, sampling and testing of food products, or a review of the supplier food safety records. Your own auditor can perform these audits or you can use a certified third party auditor.
Knowing what to do is just the beginning. Time is running out! Start to train your staff or get help from consultants to implement the FSMA risk-based preventive controls. Remember, as Benjamin Franklin once said, “an ounce of prevention is worth a pound of cure.”
About the Author
Nikoo Arasteh is a quality and compliance consultant to food industry as well as biotech and pharmaceutical industries. She has more than 20 years of experience in quality management, project management, validation and R & D.