Hazard Analysis of Critical Control Points (HACCP) is a risk-based approach to controlling critical control points in food production to prevent food safety issues. Most food facilities are required to develop a scientifically validated HACCP Plan prior to selling food to the public.
Food Safety Plans (FSP) use preventive methods to control food safety hazards. FSMA now requires food facilities not subject to HACCP to possess an FSP. Food facilities subject to this regulation must possess a scientifically validated FSP prior to selling food to the public.
To import food products into the US, importers must complete a Foreign Supplier Verification Program (FSVP). Verification activities must be performed by a FSPCA certified Qualified Individual. FSVP ensures foreign suppliers manufacture, store and distribute food under the same sanitary conditions and standards as domestic suppliers.
For foreign suppliers without an entity in the United States, an FSVP agent is required for lawful entry. Please visit our sister company's website for additional information on our FSVP Agent services here.
FDA Inspectors can thoroughly inspect your facility, collect samples, swab for microbiological contamination, which may lead to recommendations for enforcement and regulatory action. Warning letters are issued by the FDA to individuals or firms as notification of observed violations to federal regulations during these inspections. Failure to comply could lead to seizure, injunction, criminal prosecution, misdemeanor fines or even imprisonment. Warning letters are posted publicly and could tarnish your brand and reputation.
The FDA Food Modernization Act (FSMA) Preventive Controls for Human Food is now final. FSMA for covered facilities establishes requirements for a science-based written food safety plan, hazard analysis, preventive controls, monitoring, corrective actions and corrections, verification activities, supply chain controls, recall management, and record-keeping.
The Produce Safety Rule (PSR) is part of the Food Safety Modernization Act (FSMA) and is the first ever mandatory federal standard for growing, packing, and holding of fresh produce for human consumption. The PSR establishes science-based minimum standards for farmers to ensure food safety.
Food companies, from the smallest farm to the largest manufacturer, are subject to local, state, and federal regulations. Food companies must comply with federal regulations pertaining to US Food Code, FSMA, food safety, FSVP, FDA, USDA, labeling and claims compliance, recall and traceability, and more. Failure to comply can result in a variety of regulatory action enforcement.
A GAP Analysis is typically conducted with a basis of assessing the current state and effectiveness of existing processes within a food company. To qualify for GFSI certification, food companies must perform a GAP Analysis of their food safety management processes. The analysis identifies and examines for gaps or deficiencies in the system prior to applying for certification. This methodology can be applied to achieve any food safety program objective.
The Food Safety Modernization Act (FSMA) puts an emphasis on prevention. A comprehensive supplier approval system is the first preventive control for many food companies. An expert lead supplier audit identifies gaps in the supplier quality, manufacturing, and shipping processes, allowing your company to correct non conformances and mitigate risks. FSMA puts the responsibility on the food company to ensure food safety farm to fork.
Relevant, adequate food safety training is paramount for food facilities. Foodborne illness costs upwards of 23 billion dollars annually to consumers, food industry and the national economy. Mandatory food safety training varies by state and food industry. Every employee within an organization is responsible for food safety and it is crucial employees understand and appreciate the consequences of food safety failures.
Environmental Monitoring Programs (EMP) assess the effectiveness of sanitation and other prerequisite programs within a food facility. An effective EMP uses science based, statistically robust designs to measure relevant, meaningful data. A robust EMP allows for food companies to seek and destroy microbiological hazards before a regulatory inspection or consumer illness event.
Spoilage and food safety issues are significantly driven by failures in the cold supply chain. A single temperature deviation can affect the quality and food safety of the food throughout the entire supply chain to the consumer. Cooling and refrigeration inconsistency is one of the largest factors of food spoilage. eCommerce food companies have special considerations to ensure food safety; cold chain, temperature control, temperature monitoring, appropriate packaging, inventory controls and robust supplier management.
Is your food business looking for a practical, science-based Environmental Monitoring Program?
Large consulting firms and other organizations usually partner with third party laboratories to provide suggestions on program design for Environmental Monitoring Programs (EMP). The recommendations are generally motivated by the potential revenue from increased testing, laboratory reagents, or equipment “required” by a client. The motivation of the consulting firm is to gain financial incentives by means of referrals. The lab is motivated to sell more testing.
These same companies provide a costly program service fee or high hourly rate for program implementation. Included in their costly services are nothing more than generic industry standard program templates. The client’s personalized program is typically deduced from generalized process flow charts and decisions trees of basic product and process information.
What makes us different?
We are scientists that know business. We appreciate your business’ need to provide safe food while maintaining sustainable business practices. We do not partner with labs and our guidance does not necessarily incur heavy investment, which can significantly affect your bottom line, nor is it tied to any outside financial incentives. Our programs are science-based, expertly developed, industry-leading, cost-effective, and most importantly, accepted by Federal regulators.
We provide feasible solutions, tailored to your business operations, and needs. Our only motivation is ensuring food safety and compliance for our valued clients. We believe food safety can be achieved on any budget and we strive to ensure our science-based solutions are practical and cost-effective.
Whether your food business is a new operation or an existing operation that has not previously implemented an Environmental Monitoring Program, we have business practical solutions!
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Recent non conformance during GFSI audit for EMP? Do you have questions about your program? Aren't sure if the FDA will accept it? Call us today to conduct a GAP Analysis of your existing program!
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Recent non conformance during GFSI audit due to no risk assessment? Risk assessment not accepted by the FDA? Opening a new operation and need to conduct a risk assessment?
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