HCG helps companies comply with commercial and regulatory requirements. This includes providing FDA Food Safety Preventive Controls Training. Our lead instructors explain this part of FSMA and offer practical advice on what to do next. Email us at firstname.lastname@example.org for information on upcoming trainings.
HCG is available to assist food establishments to develop and implement food safety programs or review the adequacy of existing food safety systems for compliance with regulatory authorities or global food safety standards. Food safety programs include HACCP Plans, SSOP systems, GMPs Pathogen Control Programs and Food Defense Programs.
The Global Food Safety Initiative (GFSI) is a business driven effort toward the improvement and measurement of food suppliers’ abilities to deliver safe food to consumers and customers.
While many companies produce and deliver safe food, only those who have passed an accredited GFSI third party audit can provide the their buyers the expected objective evidence of this ability. Preparing for and gaining certification through a GFSI-accepted audit strengthens food safety systems and customer trust. That strength leads to increased marketing abilities and future profitability.
While there are several types of audits recognized by GFSI, the most common in the United States are the Safe Quality Food (SQF), British Retail Consortium (BRC) and Food Safety System Certification (FSSC 22000) audits.
With most retail customers demanding certification, it is important your company obtain and maintain GFSI status to remain competitive in a global market.
The HACCP Consulting Group has experience assisting companies achieve certification to these audits. We use a practical approach and encourage development of simple, effective management systems. We work with you to examine your strengths and weaknesses. We assist where you need us most, building upon your programs and experience. We can provide draft documents when needed but do not recommend ‘canned’ programs. It is best to develop your company within your culture to achieve a system you can manage and sustain.
At HCG, we are often asked, “How long will this take and what does it cost?” The fastest we have helped a company achieve certification was 3 months, but it can take over a year depending on the complexity of the company and the resources available. We match our pace to meet your needs. There is no set price or standardized implementation plan. We invoice for our time and services ensuring we add value with each encounter. We don’t just build a system to pass an audit. We strengthen your systems to ensure food safety, regulatory compliance and your ability to prove you do things right. Some of the tools we offer include:
HACCP and GFSI training for all levels of the organization
Internal Auditor training and assistance
Pre-audit practice assessments
While HCG can provide assistance in several GFSI accepted schemes, please take a moment to read more about the Safe Quality Food (SQF) system on our website. Because of the high demand in this area, HCG is an SQF Licensed Training Center offering consulting and training services for beginning and advanced SQF systems.
A written Food Defense Plan may describe the many steps your company has taken to reduce the risk of an intentional attack on our nation’s food, and your product.
The question being recently asked by agencies and auditors is –
Do you have a “Functional” Food Defense Plan?
While each piece of the program has a function, the plan itself should have a purpose and achieve results. A functional Food Defense Plan is not just a list of security measures already in place and monitored. Your plan should include a method to systematically prioritize and reduce risk, and then demonstrate progress. This can be achieved through
- A schedule of preventive actions such as inspections or exercises
- An annual examination of strengths and weaknesses
- Documented proactive steps taken to decrease risks and show results
- Documented actions taken to increase the ability to respond to an incident
A variety of Food Defense guidelines can help you identify potential actions. The suggestions include steps to reduce the risk of an attack as well as steps which can improve upon the ability to react, minimize the effects, and recover. All of these steps are valuable but few companies can afford to (or need to) take all the actions suggested. It is important to use a method to justify which actions your company elects to implement and which are postponed or deemed not applicable. A functional plan will achieve this.
The HACCP Consulting Group can help you develop a written program and evaluate your existing systems through a combination of examining checklists and using risk assessment tools that will lead to a proactive, reasonable, functional plan appropriate for your business.
ELIGIBILITY TO EXPORT FOOD PRODUCTS TO THE UNITED STATES
(English and Spanish)
Need help exporting food to the United States?
Understanding and maintaining compliance with USDA, FSIS and FDA regulations will significantly expand the export markets for food products. HCG can help.
The HACCP Consulting Group (HCG) routinely assists government inspection agencies and industry establishments achieve and maintain eligibility to export food products to the United States. We provide training and consulting services leading to compliance with U.S. import and export requirements of the FDA and the USDA.
Countries which are eligible, or want to become eligible to export meat, poultry, egg products, and siluriformes (catfish) to the U.S. must comply with stringent USDA, FSIS regulatory requirements. HCG has assisted numerous countries comply with the FSIS equivalency requirements and they have subsequently come eligible to export to the U.S.
To export and import other foods, establishments in foreign countries must meet many regulations associated with the FDA, Food Safety Modernization Act (FSMA).
HCG professionals have experience assessing exporting countries’ food production inspection systems to determine and address gaps with the USDA, FSIS and FDA requirements. We help in the following areas:
- Inspection laws and regulations.
- Organizational structure.
- Government staffing and training of inspection personnel.
- Ability to take regulatory actions.
- Inspection oversight to verify compliance with USDA, FSIS and FDA regulations.
- National residue control program for animal drugs and pesticides.
- Sanitation Standard Operating Procedures (SSOP).
- Hazard Analysis Critical Control Point (HACCP).
- Humane slaughter reviews of country certified plants to ensure compliance with FSIS regulations.
- Preparation of the FSIS, Self Reporting Tool (SRT) to obtain equivalency to export.
- Preparation for a FSIS audit of an exporting country’s meat and poultry food safety system
- Conducting GAP analyses of country’s food safety system to identify needed areas of improvement.
- Provide detailed guidance on how to adopt and implement internationally accepted food safety standards.
- Assist with development of inspection and enforcement programs.
- Assist with the development of government oversight procedures of SSOP and HACCP plans.
- Provide assistance in developing a national residue control program.
- Provide assistance with developing and comprehensive microbiological testing program.
HCG professionals are accredited by the International HACCP Alliance as Lead Instructors to provide both Basic and Advanced HACCP Training and are also recognized by the Food Safety Preventive Controls Alliance as Lead Instructors for FDA Preventive Control Qualified Individual (PCQI) training. We can provide training to government inspection officials and industry personnel on:
- U.S. model for inspection and enforcement.
- Accredited Basic and Advanced HACCP Training (English and Spanish) and Auditing.
- Good Manufacturing Practices (GMPs).
- Sanitation Standard Operating Procedures (SSOPs) training.
- Food regulatory inspection training for verification of plant’s compliance with FSIS, Pathogen Reduction/HACCP and FDA regulations.
- The equivalence process used by FSIS to export.
- FDA’s Preventive Control Qualified Individual (PCQI) training.
- FDA’s Foreign Supplier Verification Program (FSVP) training.
- Customized services and training to meet the specific needs of the client.
NOTE: Training, in most cases, can be conducted on-site or virtually via Zoom
HCG is capable of delivering several services to aid companies in their pathogen reduction efforts. In addition to working with companies to resolve their FSIS or FDA enforcement corrective actions, we can provide the following assistance:
- Conduct comprehensive assessments of facilities to find harborages
- Suggest appropriate actions to eliminate the harborage
- Prepare long term programs to maintain the control of the pathogen in the environment
- Revise Listeria monitoring programs; and, train all employees on the control of this pathogen
- Work with the engineering functions of a plant to provide advice on facility and equipment design to improve sanitation and flow of materials and personnel.
- Partner with microbiology laboratories to resolve Listeria environmental problems.
- Provide assistance in the work with laboratories and provide aid in validation for the plant programs.
- Assess plant interventions for effectiveness, suggest improvements of the existing interventions, and improve plant programs, tailored to a company’s needs.
- Improve plant validations, review documentation of prerequisite programs, and suggest improvements in internal testing programs.
- Review plant programs for opportunities in the prevention of cross contamination and the separation of raw and cooked processes, incorporating improvements in facilities, equipment design and personnel practices and hygiene
E. coli O157:H7/ STECs
- Assess plant interventions for effectiveness, suggest improvements of the interventions, and improvement of plant programs.
- Work to improve plant validations, review documentation of the prerequisite programs, and suggest improvements in the internal testing programs.
HCG has experts that have extensive experience in a wide variety of other pathogens and processes and would be pleased to provide further information and detailed agendas on how we can help you improve your food safety and regulatory positions.
Labeling errors are a common cause for product recalls due to misbranding. HCG will work with your business to help ensure your labels are accurate and in compliance with regulations. We offer assistance on:
- Individual label development or reviews for FSIS or FDA regulated products
- Individual label development or reviews for products to be shipped to Mexico, Canada, or other countries
- Comprehensive labeling system reviews
- Implementation or review of label management systems to ensure ongoing control within your process
- Development of Child Nutrition programs including Child Nutrition labeling for the National School Lunch Program
A label or labeling system review from HCG can help minimize the vulnerability of your labels and labeling to regulatory action to help ensure:
- Greater confidence in label accuracy
- Lower risk for recalls, regulatory reviews, or potential lawsuits for “misleading” the consumer
- Lower cost associated with a streamlined, efficient label review and control plan
A label and labeling system review is also a cost effective way to increase confidence and strengthen your labeling control system. Our reviews include:
- Examining samples of the types of labels and labeling you use for your products and reviewing the content against the regulatory requirements for the type of product you are labeling
- Evaluating all inputs to generating your labels and labeling
- Assessing your internal system of handling labels and labeling
- Verifying or assisting with improving training for those involved in labels and labeling within your company
- Providing recommendations from the findings in the audit
Contact us for details.
USDA, Food Safety and Inspection Service (FSIS) Regulatory Services
HCG Professionals have a long (20 year) distinguished history of providing sound regulatory assistance to FSIS inspected food establishments across a wide variety of products. Whether it is food safety training, preparing for a Food Safety Assessment (FSA), addressing deficiencies noted as a result of an FSA or Noncompliance Reports (NRs) or validating your process, HCG can help plants navigate through the complex regulatory requirements and maintain, or regain compliance with applicable FSIS regulations.
Utilizing International HACCP Alliance Accredited training materials, HCG has offered in-house and public HACCP training (i.e., basic and advanced) for over 20 years for the meat and poultry industry, both domestically and internationally. The training not only teaches the scientific principles of HACCP but also its practical applications in meat and poultry establishments based on regulatory requirements.
Food Safety Assessments (FSA) Preparedness Services
FSIS has made a commitment to conduct FSAs in each establishment that processes meat or poultry products. These assessments are designed to evaluate the adequacy of the firm’s entire food safety system. These assessments are considered routine, based on the fact that a plant operates under a Grant of Inspection.
In addition to the normal FSA’s, FSIS also conducts FSA’s “for cause”. These “for cause” FSAs may be conducted due to a positive laboratory result for Listeria monocytogenes or E. coli O157:H7, STEC or a company’s product being implicated in a food illness outbreak, either as a product processor or as a supplier to another company. Other factors that may result in a FSA are multiple Non-compliance Records (NRs), especially if they are linked to a common root cause, or if a processor is involved in a product recall.
If FSIS determines that a plant’s operation is not under control, the District Manager may issue a Notice of Intended Enforcement (NOIE), or if the findings are considered severe, a Notice of Suspension (NOS). Regardless, plant management will be required to present a detailed corrective action proposal to the District Office within a limited period of time. The corrective action proposal must address the concerns that are described in the Notice. If plant management does not respond adequately, FSIS may move to withdraw inspection from the plant or the plant’s Grant of Inspection.
HCG professionals can assist plant management prepare for an FSIS, FSA by reviewing plant process control programs including HACCP, SSOP and GMP/Prerequisite programs, supporting documentation, process validation documentation, assessing plant pathogen control programs, reviewing plant sanitation procedures and reviewing plant records.
Regulatory Non-Compliance Responses (NRs, NOIEs, NOS)
From time to time, many food manufacturing facilities experience situations of noncompliance. How they respond to those noncompliance situations can mean the difference between an issue being resolved in a timely manner or an escalation of enforcement activities that, in the worst cases, lead to an interruption of plant operations.
HCG routinely assists plants minimize the impact of a noncompliance event by helping management adequately respond to government notices of noncompliance including Noncompliance Records NRs, Notices of Intended Enforcement NOIEs or Notices of Suspension (NOS).
The FSIS, HACCP regulations require establishments to validate the adequacy of its food safety system to control hazards reasonably likely to occur. To expand on these requirements FSIS published Compliance Guideline – HACCP Systems Validation.
HCG Professionals can assist establishments to develop the necessary validation supporting documentation and/or assess plants’ validation data for compliance with the FSIS requirements and guidelines.
HCG Recall and Crisis Management Assistance
There can come a time when even the best run plant can find itself in a recall or crisis situation. An ingredient supplier might change formulations or an employee may mistakenly release product under testing. If not handled correctly, these situations can bring all plant operations under a regulatory microscope and cause uncontrollable operational or in the worst cases, legal costs.
Having a HCG professional at your side can help contain a crisis and put a plant back in operation. HCG can help investigate the cause of the crisis, suggest actions to prevent the risk of further occurrences, act as a liaison between plant management and regulatory personnel, and assist with responding to government enforcement actions in order to return plant operations to a state of compliance.