Add-Ins
I have been very happy with the LabSoft LIMS USDA NR module as it tracks Noncompliance reports and lays down a proper paper trail. You can manage a number of plants or an individual plant from a regulatory standpoint such as trends, inspectors, departments etc. Appeals and plant responses are always on file along with the history and plant profile. Auto generated e-mails can be sent to department supervisors for investigation, documentation and follow-up. It just makes good business sense to document your corrective/preventative actions. Once implemented it is an organizational tool that saves time as well as indicates where there are opportunities for plant improvement/HACCP training and employee development. I would not hesitate to recommend this system to anyone involved with accurate documentation of Inspection activity and noncompliance reports.

Lamar Hendricks
Director, Regulatory Compliance
Sara Lee Foods

USDA NR (Noncompliance Record)


LabSoft LIMS USDA NR is an intuitive tool for managing USDA FSIS Noncompliance Record (NR) Form 5400-4. This Add-In Module allows you to focus on root-cause(s) and determine the reasons, circumstances, and responsible parties of noncompliance events. It provides a flexible method to store, access, manage and report all facets of an NR.

  • FSIS Directive 5400.5 - Supports FSIS Directive 5400.5 (part of Pathogen Reduction-Hazard Analysis and Critical Control Point (HACCP) Systems final rule July 1996).

  • NR Incidents - Track and analyze the individual incidents contained within an NR.  This allows you to focus on the root-cause(s) and determine the reasons, circumstances, and responsible parties.

  • Encapsulation - Store and view all the related documents including: image of the original 5400-4, Responses and Appeals, USDA replies and any supporting attachments.  Supports any format including Word®, Excel®, Acrobat® PDF, etc.

  • Correspondence Standardization - Use configurable templates to standardize your Responses and Appeals.  Easily setup template fields that will auto populate from your database.

  • Auto E-mail - Automatically E-mail responsible "stake-holders" when an NR reaches certain stages such as:
    1. New NR received
    2. Response/Appeal waiting for internal review
    3. Internal Reviewer has completed review
    4. USDA has responded

  • User Configurable - Add your own fields and codes.

  • On-Line Review - Allow on-line review of the original NR along with all Responses and Appeals before they are sent to the USDA.

  • Security - Role-based and Facility based security.

  • Reporting - View samples of user configured reports.

Figure 1 is an example of a Noncompliance Record stored in the LabSoft LIMS database. More than one incident may be linked to a Noncompliance Record.


Figure 2 is an example of the incident tracking available to each Noncompliance Record stored in the LabSoft LIMS database.
LIMS NR Software

Figure 3 illustrates samples of user configured reports.
LIMS NR report LIMS NR Report - Fiscal Period LIMS NR Report - Incidents LIMS NR Reports - Reasons LIMS NR Reports - Summary


• A stand-alone version of LabSoft LIMS' USDA NR Add-In is available. To learn more visit LabSoftNR.com.

 
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