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Managing Pathogen Testing Data And Compliance

The current Pathogen Testing Protocol being instituted by the FSIS for RTE product processing plants will be setting minefields for processors to nimbly maneuver without finding themselves blown apart by a recall, a plant closure and the resulting costs that mushroom around these incidents.  There are many processors who have been reluctant to test for Listeria monocytogenes because of the ramifications of having a positive sample.  One means to avert the problem is to test for Listeria at the genus and not to specie level.  This has been, and will probably will continue to be a common practice, especially for environmental samples.  This new FSIS directive eliminates the reluctance to test by regulation.

The requirement for documentation of sample sites, sample collection, sample results and after-action results for the sample sites is a key to developing and maintaining a comprehensive science-based pathogen sampling program that will meet FSIS requirements as well as assist in providing a foodsafe product for the customer.  Although this can be done by performing the steps and documenting on paper or even creating “islands of information” with computer aided testing and monitoring equipment, the major problem of non-compliance because of missing data or “pencil data” can arise and cause the most unwanted problems.  The legend of a problem arising and the incessant search of records to find the one page with the one cell that wasn’t completed probably is more true than most people realize because virtually everyone can attest to it.  Of course, the reason that you are searching for that one piece of data for the problem that arose is because it was missing in the first place.

The Sentry9000 system is designed to manage the data collection from control points on the processing floor.  It provides the security for insuring that missed data does not occur and if it does, the personnel to correct the problem are alerted.  You don’t have to wait for a customer or regulatory agency to alert you.

There are two modules for Sentry9000 that  provide the regimentation and documentation needed to successfully manage this sensitive program.  They are Sentry LIMS, the Laboratory Information Management System module, and Sentry ARMS, the Allergenic Response Management System.

Sentry LIMS keeps track of testing demand for  ingredients, in-process, finished product and environmental samples.  It controls Hold and Release for ingredients and products through test designation and test results.  It can provide action steps for sanitation and production personnel when  environmental sample results dictate.  The Sentry LIMS system can be adapted to fit small to large plants and can interact with third-party laboratories to have data entered directly into the Sentry LIMS as it is input at their site.  The system is designed to be the watchdog for sample collection, the reviewer for sample results and the enforcer for action steps resulting from sample testing.

Sentry ARMS was designed to document the sanitation steps for plants that produce products with and without allergens.  The system is based on cleaning protocol and redundant, step-up verification.  It is used to prevent processing lines from operating without full compliance to the plant’s allergen control standard operating procedures.  

The Sentry ARMS module can be easily adapted to interact with the Sentry LIMS program to provide instruction and documentation with verification for Corrective Action steps, Pre-Op Inspections and after action steps for laboratory analyses to comply with FSIS directives for positive pathogen tests and for indicator positive tests.  The interaction provides the compliance trail for verification and the digital media provides the documentation required.  Sentry ARMS is a multi-functional module that can be used not only for allergen control and pathogen control, but provides documentation and verification for basic Sanitation SOP’s, Kosher  Certification and ISO programs.

The Sentry9000 Information Management System is a multi-faceted system capable of providing automatic data management and implementation of tasks when results are outside of established limits.  

October 5, 2003

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