FSMA Food Safety Plans
Preventive Controls Food Safety Plans for covered FDA-regulated facilities.
Food Safety Plans under FDA's Preventive Controls framework are not simply HACCP plans with a different title. We provide PCQI-led development and reanalysis around the hazards and Preventive Controls applicable to the facility.
PCQI-led support
Start with the hazard analysis. Build only the controls the analysis supports.
The Food Safety Plan should reflect the facility, products, processes, and reasonably foreseeable hazards. Where Preventive Controls are required, the plan must also define the monitoring, corrective-action or correction, and verification activities needed to manage them.
We can develop a new plan, reanalyze an existing plan, or help correct a plan that has drifted away from the current operation.
Plan elements
A facility-specific Preventive Controls framework.
Hazard Analysis
Evaluate known or reasonably foreseeable biological, chemical, and physical hazards.
Process Controls
Time, temperature, formulation, or other process controls where required by the hazard analysis.
Food Allergen Controls
Controls addressing allergen cross-contact and labeling where applicable.
Sanitation Controls
Sanitation controls where environmental or cross-contact hazards require them.
Supply-Chain Controls
Supplier-related controls and verification activities when a supply-chain-applied control is required.
Monitoring & Verification
Monitoring, corrections/corrective action, validation where applicable, verification, and reanalysis.
Practical documentation
The written plan has to match the operation.
We design the supporting records and responsibilities around the facility's actual workflow so the plan can be implemented consistently and reviewed efficiently.
Need an FDA Food Safety Plan?
Tell us what you manufacture and how the process works. We can help determine the right starting point.