The Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) impacts every aspect of the U.S. food system, from farmers to manufacturers to importers. Under FSMA, every company that produces, handles, or distributes food-grade products/ingredients must determine their compliance requirements to ensure the distribution of only pure and unadulterated food product. In addition, the U.S. Department of Agriculture (USDA) and local health departments have their own requirements when it comes to safe food.
In today’s economic climate, it is difficult for companies to devote the resources required to maintain compliance activities at a sustained and satisfactory level—but it is essential. KTL understands the importance of developing and maintaining key internal controls that ensure the reliability of compliance systems and meet regulatory requirements.
KTL’s Approach
Our team examines the entire workplace; determines regulatory applicability (i.e., FDA, USDA, department of health, state, local); identifies and assesses food safety hazards and risks; and then helps our clients develop and implement appropriate processes and controls for safe and compliant operations. We understand the importance of developing and maintaining key internal controls that ensure the reliability of compliance systems and that adhere to current and pending regulations, industry standards, and other requirements.
KTL offers a comprehensive approach to food safety compliance, including compliance assessment, food safety program development, and training, to address the FSMA regulatory standards, as well as customer, USDA, department of health, and other local requirements. This approach allows companies to:
- Determine food safety and quality assurance (FSQA) program requirements that must be developed, implemented, incorporated into existing programs, and/or verified to meet Section 117 current Good Manufacturing Programs (cGMPs), and then
- Develop a food safety plan and food safety management system (FSMS) to manage all food safety compliance requirements, procedures, documents, and training.
Compliance Services
KTL is an innovator and developer of services that help industry improve performance and ensure ongoing food safety compliance. Our services include:
- Regulatory analysis, including applicability evaluations and requirements inventory development
- Food safety program development (e.g., food defense and intentional adulteration, food labeling, FSVP, sanitation, building commissioning, validation and verification, traceability, etc.)
- Food due diligence assessments to support merger and acquisition activity
- Third-party compliance assessments
- Food safety policy, plan, and procedure development based on regulatory requirements and organizational needs (e.g., food safety plan, HACCP plan, GMPs, etc.)
- Compliance auditing
- Compliance efficiency tool development and implementation for compliance tracking and document/data management
- Food safety training
- Ongoing/outsourced compliance support to meet federal, state, permit, and local food safety requirements and current trends (e.g., food safety culture, combustible dust, dietary supplements, PSM, voluntary recalls, ammonia refrigeration, sustainable food management)