“So what does FSMA mean for me, and how should I prepare?”
I have devoted more than ten years to the food and beverage industry, and for the past year, the most frequent questions I get are around the Food Safety Modernization Act (FSMA). In a recent industry-wide benchmark conducted by Kalypso, the majority of respondents were worried about what FSMA was and how it would be enforced, but were optimistic about the positive impact of proactive compliance. The outstanding question for many of them is, “How do we make sure we are ready for FSMA?” Here’s some background and a basic framework for getting started.
A Bit of Background
It has been over four years since President Obama signed FSMA, a collection of seven different food safety topics ranging from Preventative Controls for Human food to Third Party Accreditation guidelines, into law. FSMA’s aim is to ensure the U.S. food supply is kept safe by shifting the focus from responding to contaminations through recalls to preventing them. This major change from defense to offense will have dramatic consequences for food and beverage manufacturers throughout the industry—requiring additional due-diligence, documentation and preparation. The FDA has signaled that they believe most large manufacturers will be compliant at the time of enforcement, but worry that the majority of medium to small manufacturers will not.
Some key facts to consider:
- FSMA will empower the FDA to proactively confirm food safety of manufacturers instead of waiting for an event
- FSMA’s seven topics are wide-reaching, causing some large organizations to face regulations defined under multiple topic areas within FSMA
- Enforcement of requirements will be based on organization size and time of final ruling (September 2016 is the first wave)
- Each topic has a different metric for determining organization size
- Although not all topics are final, enough guidance on the remaining five has been provided to start preparing now
Start by understanding where the organization stands. There may be as little as 11 months left to become compliant. In order to understand and prioritize preparations, apply the following analysis to your current operations:
- Interpretation: What does FSMA mean to the company? Does it fall under multiple areas? When does compliance start?
- Understanding: Does the company know about FSMA? Is everyone from the C-suite to the line manager aware of its importance?
- Organization: Are the right roles and responsibilities in place to handle FSMA? Who will coordinate efforts?
- Processes: Do existing processes, policies and procedures capture the right information?
- Tools & Systems: Is there an existing infrastructure and set of in-house tools to capture information at the right time, in the right format?
Completing this framework will be time consuming, but will provide tremendous value by identifying potential gaps and enabling strategic prioritization. Careful consideration will need to be given on how to make already complex internal processes FSMA compliant, and what type of tools might be needed.
FSMA is finally a reality, organizations should take steps now to prepare themselves for a new compliance reality.
On-Demand Webcast - Watch this on demand webinar during which George Young, chairman of Kalypso and a 20-year veteran in the consumer packaged goods and food and beverage industries, and Colin Speakman, senior manager and an expert in quality and regulatory systems, discuss how your organization can prepare for the new regulatory requirements. Watch Now!