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FSMA Regulation Factors the FDA Will Use to Assess Your Facility

As many of you know, the FDA has finally completed the regulations associated with FSMA. What that means for 2015 is that auditors will begin to enforce a greater number of laws. This is no reason to panic. Recently we sent our team of intelligence gathering ninja monkeys to unearth the top 5 factors that could impact your business. In other words, we got the inside scoop.

To start off, FSMA documentation states that the FDA is required to designate each facility as high-risk or non-high-risk. What that means for you? Well it's simple;

High-Risk = increased audits

We all know that the more time an auditor spends on your company, the books or the accounting can lead to compounding infractions and just more money and resources used to fight the infractions vs. making a better business.

The regulation requires all produce facilities have an inspection for FMSA regulations within 5 years of the implementation. For those facilities that are considered “high risk” they will be required to have follow-up inspections every 3 years. For the Non-high-risk facilities, they will be required an FDA inspection once in the seven years, with follow-up inspections at a minimum, of once every five years thereafter.

We have identified some key factors that could make you or break your business in 2015:

  • Food Safety Culture

If your facility has been victim of recall, then as company you would have to focus heavily on improving food safety culture at your facilities (factor #5 below). Even though the improvement in culture will not erase your recall history, it will show the FDA auditors the chances of a recall happening again are very low.

  • Non-Compliance History

If the FDA audit determines that your company has been naughty with respect to compliance in the past, then your chances of being categorized as high-risk are significantly greater. They will look at your recent history as a predictor of future behavior.

  • Financial Stability

It may be a prudent to hire a financial advisor. Why? If your business has a questionable financial situation, then this is the perfect time to kill two birds with one stone; Comply with FSMA and get your business on track. The ability to provide appropriate evidence to the auditors can save you a lot of grief in the long run.

  • Quality Assurance & Control

How robust are your facility’s procedures and programs? Do you provide verification with third-party audits reports? How effective are your company’s risk-based and hazard-analysis programs?

This is one of the most crucial topics in our list because FSMA is looking for a pre-planned handbook that can utilize to address issues as soon as they arise. So, if you conduct food and system audits on a regular basis, stick to it as consistency is key. Most food auditors create a booklet for you company to clearly state what to do when an issue arises.

  • Food-Safety Culture

The last factor and maybe most important is: Your company needs to have prudent corrective actions and preventive measures for perishable goods. These behaviors necessarily need to create a culture within your organization that reinforces the process and procedures that assist in keeping your products and brand safe.

In conclusion the rules are not written to slow you down or be difficult. They are designed to produce a safer more sustainable product for years to come. If you are curious about other factors FSMA audit criteria will be based on, please click HERE to access the third party link below;

Drawn from Food Online

Additional resources: 10 Factors the FDA Will Use to Assess Your Facility, Laurel Maloy

produce traceability, produce

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