We offer microbiological food safety consulting services to the food and feed industries in a wide range of areas

Preparing for a plant visit

Regulatory Compliance
Microbiological and food safety compliance with USDA and FDA guidelines and regulations.The food industry routinely faces new guidelines and regulations related to microbiological control. We have experience assisting hundreds of food processors with on-site contamination investigations, finding answers to the questions, “How, did the “bugs” get into the food or factory?” “How do I prevent this from happening?” and “How should I start up again after having been shut down?” In addition, we are able to assist with USDA/FDA required HACCP plans, GMPs, challenge studies, hold and release testing programs, etc.

Contamination Sleuthing
Kornacki Microbiology Solutions have years of experience and academic training in resolving contamination situations in hundreds of food production facilities. We have guided numerous food manufacturers through national food product recalls. Our diverse food safety experience provides a solid knowledge base and sound principals for application to your unique situation.

On and Off Site Factory Risk Assessments

On-Site Walk-Throughs
We have experience with in-depth factory walk-throughs in which factory areas are categorized as “high”, “medium” and “indirect” risk for potential finished product contamination. Recommendations for further investigations, testing and research often result from such walk-throughs.

Off-Site Walk-Throughs
A theoretical grid of “high”, “medium” and “low” risk product/production environment combinations can be generated (e.g. for multiple suppliers) by combining knowledge of key product parameters and prior GMP audits. However, it is prudent to have these validated by subsequent plant walk throughs and or investigations to validate assumptions.

Quality Assurance Program
Kornacki Microbiology Solutions provide assistance with development of quality assurance programs. Our expertise comes from working with hundreds of food production facilities. Recommendations related to GMPs, HACCP, and testing programs are often presented.
Product Specifications: Intregral to most quality assurance program is development of appropriate ingredient and finish product specifications based upon established criteria. We assist you in developing appropriate statistically based specifications.

Sampling Plans: We are able to assist you in developing both routine and investigational plans for your factory environment. Kornacki Microbiology Solutions also provide guidance on pre-operational testing to validate sanitation of your finished product contact surfaces.

We are able to assist you with statistically based routine and investigational sampling plans for ingredients and finished products.

HACCP: Many HACCP plans are deficient in proper Hazard Analysis and have misidentified far too many Critical Control Points. Validation of selected Critical Control Points, determination of appropriate Critical Limits and HACCP plan Verication is often incomplete. Kornacki Microbiology Solutions can assist you with all the above.

Liaison Between Parties
Liaison Between Factories and Regulators: “We can act as a liaison between factories and regulators. Science-based approaches to curb over-reaching regulatory activity can save much downtime and economic loss.

Liaison Between Ingredient Suppliers and Processing Facilities
Very often disputes between suppliers and processing facilities regarding microbiological test data or safety issues can cause disrupted operations and economic injury. Science based approaches to specifications and resolutions of test result disputes may result in peace of mind and smoother manufacturing operations.

Liaison Between Laboratories and Processing Facilities
Very often positive pathogen results cause companies great expenses and confusion. If these results are based upon inappropriate tests, incomplete assays, or laboratory cross-contamination, a company can discard very expensive product unnecessarily. We are able to ask the type of probing questions to assess the value of certain test results. See Other Microbiological Services.

Sanitary Design of Equipment and Facilities
Post-process contamination is by far the most frequent means that processed foods become contaminated. These events are often related to factory or equipment design issues. Kornacki Microbiology Solutions has a great deal of experience with investigation of equipment and factory design related contamination events. We can provide useful suggestions for prevention and resolution of these issues.

Good Laboratory Practice (GLP)
The release of your product may depend upon the accuracy and reliabity of microbiological test results. The validity of these test results is dependant upon effective implementation of Good Laboratory Practices. Kornacki Microbiology Solutions can help you review and develop appropriate GLPs for your laboratory. We can also provide guidance related to appropriate laboratory design. Seer Other Microbiological Services>Lab Design.

Good Manufacturing Practice (GMP) and Real Risk Assessment
GMP practices are an essential part of safe food production. It is our view that standard GMP checklists and typical numerical scores do not provide adequate assessment of real risks. We are available to do an expanded GMP based assessment. We provide recommendations regarding corrective actions for most situations. We strongly recommend a risk assessment walk through with or without sampling and testing.