The Food Safety Modernization Act (FSMA) is a multi-component set of regulations. Most large companies have had internal resources and a past history with Hazard Analysis and Critical Control Point (HACCP) programs to make the leap to FSMA without too much difficulty. However, small- to mid-sized companies are finding themselves challenged with modernizing their Food Safety Systems. Several factors are causing distress, including limited resources of people, time, and finances; transitioning the operations of each production line from current Good Manufacturing Practices (cGMPs) to FSMA preventive controls; the additional recordkeeping and paperwork burdens; and of course, the looming upcoming deadline of compliance by Fall of 2017.
At this point, small- to mid-sized companies need to take a deep breath and move forward at a good pace by developing a plan to implement their FSMA program on a step-by-step basis. Some companies may even seek the assistance of outside consultants. The following suggestions for small- to mid-sized food companies can help plan and manage the task at hand.
- Establish if you must comply. If you are a Registered Food Facility with the FDA selling food in the U.S., you most likely must follow FSMA rules.
- Get support and a resource commitment from management. Find a Food Safety Champion in the organization to get the ball rolling. Reinforce the importance of a food safety culture within the company.
- Make an implementation plan considering the existing Food Safety System. If you only have cGMPs in place, look toward HACCP principles and HACCP plans to help you transition into FSMA. If you have a HACCP plan, your job will be easier since you can build on HACCP to develop a Food Safety Plan.
- Identify an internal or external preventive controls qualified individual (PCQI) who will oversee the development of the Food Safety Plan. This may include a staff person taking a course to become a PCQI from an organization, like the Food Safety Preventive Controls Alliance.
- Begin development of the Food Safety Plan with the PCQI. This includes analysis for biological, chemical, and physical hazards and assigning preventive controls (e.g. process controls, food allergen controls, sanitation controls, and supplier controls) to those hazards likely to cause illness or injury.
- Develop and establish ways to monitor these controls and establish corrective action procedures to follow if the controls fall outside of limits.
- Scientifically validate process controls and verify that the Food Safety Plan is working (verify the monitoring activities) and that the plan is designed properly by auditing the controls (verify that the plan effectively controls the hazards).
- Establish and update recordkeeping procedures to ensure accurate records and documents for use by the organization and/or by inspectors.
- Provide training on the Food Safety System for management and for line workers who have responsibility to manage the preventive controls.
Take a Step Back
The implementation of FSMA rules for food companies is a perfect opportunity to step back and look at the current equipment, the products being produced, and operations to see if hazards can be eliminated so that fewer controls need be applied. For example, consider changes to a filling machine that is used for multiple products, some products with allergens and some without allergens. If the current design allows pockets of product to accumulate, potentially causing a cross-contact hazard of allergen containing product, the hazard may be eliminated by upgrading to a filler that incorporates sanitary design features that can prevent cross-contact situations. As another example, many raw ingredients can contain physical hazards like stones or small metal fragments. Placing foreign object removal measures upstream as part of cGMPs may eliminate the necessity of a preventive control downstream to remove an incorporated object or discard a product that contain foreign objects. The idea here is to simplify the Food Safety Plan by considering design modifications that could assist in managing and mitigating any potential hazards before they become a significant hazard that must be controlled as part of the plan.
For small- to mid-sized companies, the conversion to modern Food Safety Systems may be a formidable task and the clock is ticking. The effort, however, can bring advantages and benefits that go beyond the duty to comply with FSMA. These include a reduction in consumer complaints, higher quality products, less possibilities of a recall, a better position to litigate if a problem should occur, proof of compliance to the FDA, and a business advantage if a customer requires an updated Food Safety Plan.
Dr. Barach, principal for Barach Enterprises LLC, is a lecturer, training professional, consultant, and educator in food safety systems, food sanitation, HACCP, and FSMA. Reach him at Jeff.firstname.lastname@example.org.
For Further Reading
For more information, Dr. Barach recently authored a plain-language guidebook that assists small- to mid-sized food companies with the task of complying with FSMA human food rules. “FSMA and Food Safety Systems: A Guide to Understanding and Implementing the Rules” is available here.