We offer microbiological food safety consulting services
to the food and feed industries in a wide range of areas
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.
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.
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.
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.
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.
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.
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 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.
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
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
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.
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.
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. See Consulting>Risk
In addition to consulting we provide food safety microbiology related
expert witness testimony including, review of briefs and depositions related
to food safety, court testimony, and expert opinions related to microbiological food safety..