The Food Safety Modernization Act (FSMA) was enacted in January 2011. It affects all aspects of the food industry, from manufacturing to importation. The scientists at ToxStrategies participated in the rule making and have extensive knowledge of the final rules. Our comprehensive experience and consistent involvement provide the ability to assist companies in meeting the requirements for FSMA compliance and advise the ongoing evolution of their food safety and defense programs.
FSMA requires each facility to have a Preventive Control Qualified Individual (PCQI) to oversee its food safety plan and a Food Defense Qualified Individual (FDQI) to oversee its food defense plan. ToxStrategies offers training for PCQIs and FDQIs utilizing the FDA-recognized standardized curriculum and curriculum from the Food Protection and Defense Institute. Participants who complete the training offered by ToxStrategies will be recognized as Qualified Individuals and will receive documentation to satisfy the regulatory requirement.
Our consultants have extensive experience in areas that include the following:
Corporate Training Programs
- PCQI & FDQI training
- Employee training programs
- General food safety training
- Current good manufacturing practice (cGMP) training
- Sanitation/employee hygiene
Good Manufacturing Practices
- Documentation
- Hygiene and sanitation programs
Supplier Verification
- Establishment of a program to evaluate suppliers based on risk
- Creation of database to capture supplier history and deviations
General Support
- Facilitate discussion with multidisciplinary teams
- Simplify information for usability
- Assist in identifying areas of risk and vulnerability
- Build institutional memory for easy recall of key documents
Food Safety Plan
- Development, auditing, and review of written food safety plan
- Credentialed review of hazard analysis and control-point determinations
Hazard Analysis
- Risk assessment of ingredients and processing
- Identification of hazards with technical and scientific documentation
Preventive Controls
- Establishment of tolerance levels
- Scientific validation for established controls
- Initial validation programs
Verification and Surveillance
- Review of customer complaints with trend identification
- Review and assessment of monitoring, corrective actions, and verification data
Food Defense Plan
- Development, auditing, and review of written food safety plan
- Credentialed review of vulnerability assessments and mitigation strategies
Vulnerability Assessment
- Assessment of procedures, steps, and processes
- Identification of actionable process steps with technical and scientific documentation
Mitigation Strategies
- Establishment of risk-based measures to reduce vulnerability
- Tailoring of strategies to specific facility practices
Crisis Management
- Technical support for adverse event or program deviations
- Product recalls
- Reportable food registry
For more information about ToxStrategies’ consulting services, please contact us.