4 Need-to-Know FSMA Compliance Facts

Here are four things you need to know to comply with FSMA regulations:

 1. What documentation for FSMA preventive controls can be shared if requested?

If you’re like most companies that have extensive documentation for quality and food safety systems, it would be a good idea to have a pre-approved list of documentation that can be shared if requested during a regulatory inspection, right? Well, if you don’t have a list of approved documentation then that may delay the process for delivering any requested information within the required 24 hours. So some words of advice, @@have the “short list” of approved records to share with the regulators@@ so record requests are handled effectively.

 2. Which FSMA preventive control will likely be the most challenging for most companies?

Documenting what plant GMP programs or process steps that will need to be monitored similar to a HACCP CCP will be understandable for most companies using the FDA guidance documents. In contrast, recording, evaluating and documenting conclusions on supplier approval to satisfy the Supply Chain Program will likely be more challenging. If a significant food safety hazard is controlled by your supplier then a FSMA Supply Chain Program will need to be documented and available for review if requested during a regulatory inspection. In view of the fact that decisions on approving suppliers are typically a corporate activity, do the individual plants have all the necessary documentation? If your company relies on suppliers to control an identified hazard then make sure the required supply chain program documentation is readily available when requested by a regulator for all your plant locations.

 3. Have you analyzed your multicomponent ingredients?

Hazard analysis for multicomponent raw materials has been a recurring problem for identifying hazards. In order to do a thorough review all components in that raw material should be analyzed to see if there are any “reasonable and foreseeable” hazards such as allergens or pathogens. If hazards are identified then the next step would be who will control this hazard, the supplier or the receiving entity.  If the receiving entity of that ingredient will control the identified hazard with a preventive control then a Supply Chain Program will not be necessary but that processor will have to have a documented preventive control for that hazard. If the supplier is controlling the hazard then a documented Supply Chain Program will be needed by the receiving entity using that raw material.

4. Are our suppliers expected to share the status of their regulatory inspections?

As you might expect, the answer depends on who is controlling the identified hazard. If your supplier of raw materials is controlling the hazard then you, the receiving entity would be required to have a supply chain program. If you look at the regulation Subpart G-Supply Chain Program, Section 117.410(d) (1) (iii) (B) it asks you to review the supplier’s compliance with FDA food safety regulations. It goes on to say that “supplier compliance with those regulations, including an FDA warning letter or import alert relating to food safety, or other FDA actions related to food safety…” is information that should be reviewed as part of the supply chain program. Remember that your supplier's regulatory status is just a portion of the verification activities but yes, your supplier’s regulatory compliance would have to be reviewed and documented some form.

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