Compliance with FDA Food Safety Modernization Act (FSMA)

According to this act, food production facilities have to assign a “qualified Individual” to be responsible for food safety program. This individual is required to conduct a multifactor hazard analysis, and based on the analysis results, design a written plan for preventive hazard control, implement the plan and be responsible for the related record keeping. They should also implement a comprehensive "foreign supplier verification plan" to ensure safety and quality of imported materials. For details, refer to the FSMA slide deck under the "Presentations" tab.

We assist the Food industry to implement or refine their quality systems in compliance with FSMA to include all of the following requirements:  

1. Hazard Analysis
   We help you in hazard analysis using Risk Assessment (Failure Mode and Effect Analysis) methodology. At the end of this process, you will have a list of potential hazards and a strategy to deal with each risk.
    
2. Preventive Controls
   We set up all preventive controls in the following categories, as required by FSAM:
    
   1. Employee training 
   2. Sanitation procedures 
   3. Environmental monitoring program
   4. Implementation of GMPs
   5. Food allergen controls 
   6. Recall contingency plan 
   7. Supplier verification program
       
3. Monitoring procedures / SOPs
   We prepare all needed procedures including SOPs, SSOPs, logs, batch production records, etc.
    
4. Corrective Actions & Effectiveness verification
   We write procedures for managing deviations, train you to handle discrepancies, and set up systems to make sure your corrective actions are effective.
    
5. Record Keeping / documentation system
   We train you on the requirements of record keeping, write needed Standard Operation Procedures (SOP) for a good documentation and record keeping system.