FSMA, signed into law by President Obama in 2011, made sweeping reforms within the food industry. For some, these reforms were necessary to enact sooner than others based on differing compliance dates. Large food companies came first, to be followed by smaller businesses. So how can mid-sized food companies look to those that have already been through the wringer with FSMA? Luckily, the big companies are talking, and we have been listening.
1. Efforts should be focused on a few key areas.
When it comes to consolidating efforts, large food companies have tried it all and have finally identified where to aim necessary and effective action within their premises.
Many claim that the training aspect is the most vital for successful compliance. By training personnel throughout every level of the company, true understanding of the requirements can be attained and employed. Rather than simply carrying out required tasks, training adds comprehension of the purpose of each task. The FDA has clarified that “the most important goal that the FDA expects of any training program is the outcome” (qtd here). And it is up to each company to determine the training that is needed for a favorable outcome. For some, it has been effective to send workers to a variety of trainings in order to ensure that the overall message of what is required is correctly interpreted by the individuals involved in food processing.
(RELATED: Shine a light on your supply chain with a FREE FOOD SUPPLIER ASSESSMENT.)
Without proper evidence, anything that a company does is void. This in mind, it is clear why large food companies would emphasize the importance of record-keeping. One source simplified what is expected for record-keeping with the statement, “document everything and keep your records.” Of course, the implications of this simplification are huge, yet there is a solid truth behind it that mid-sized companies should note.
Since companies are ultimately looking to please the powers that be (the FDA, in this case), knowing what they value will be a guiding factor. When the FDA inspects, they will be focused on 4 main areas:
- Pathogen control
- Allergen control
- Sanitation and cleaning
- Environmental monitoring.
Referencing these details should be the focal point of all implementations.
2. Food safety must be a culture.
Food safety doesn’t take form solely in documentation, and ingraining it within the culture of companies is a major way that large companies have achieved compliance. Brian Perry of Bay Valley Foods LLC confirmed that “[food safety culture] is probably the most important piece of how FSMA readiness is demonstrated” (qtd here). When every person in your company network is consistently working towards food safety, there is little doubt that compliance can be fully attainable.
3. Mock inspections are the way to ace real FDA inspections.
Prominent stand-out examples of companies that are performing well under FSMA all seem to have something in common: the institution of mock inspections. These inspections guarantee that the state of a company is accurately perceived and highlight both the faults and strengths within the company. Practice makes perfect, and practice for the FDA means inspection. Some carry out mock inspections of their own operations while others opt to engage an outside entity to do so on their behalf.
4. Transparency on every level leads to real solutions.
Top-down transparency within a company and with FDA interaction is what keeps many large companies on the right track. All records should be made available across supply chains, led by an example modeled by management. Fostering a relationship with nearby FDA offices is an integral part of this process. Dan Herzog (Gonella) discusses the benefits of doing so in an interview saying, “We’ve contacted our FDA offices, we’ve learned their names, we know they’re coming” (qtd here). He goes on to discuss the benefits of doing so, including eliminating the element of surprise that often adds stress to inspections.
As mid-sized food companies continue to embark on the journey of hazard analysis and control implementation, it will always be helpful to look at the forerunners of FSMA. Large companies will often come across the inevitable roadblocks with compliance first, so awareness of their failures and successes will serve as a roadmap for those following behind them.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at firstname.lastname@example.org.
About the Author
Michael de la Torre is the CEO of FDAzilla.