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Fda: Food Safety Plan Builder

FDA: Food Safety Plan Builder

The Food Safety Plan Builder (FSPB) v. 1.0 is a user-friendly tool designed to help owners and operators of a food establishment with the development of a food safety plan that is specific to their facilities. The food safety plan is developed using a systematic approach to identify those hazards that require preventive controls to prevent foodborne illness or injury. A Food Safety Plan must contain those components that are needed to be in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule (21 CFR part 117, or “CGMP & PC for Human Food rule”) requirements in Subpart C – Hazard Analysis and Risk-Based Preventive Controls. A Food Safety Plan is a set of written documents that is based on food safety principles and incorporates hazard analysis and preventive controls, including supply-chain programs and a recall plan; and delineates the procedures to be followed for monitoring, corrective actions and verification. Although the content of the Food Safety Plan Builder v. 1.0 is consistent with the Food and Drug Administration’s (FDA) existing regulations and guidance, use of the Food Safety Plan Builder by owners and operators of food facilities does not imply FDA approval of the resultant food safety plan. The Food Safety Plan Builder v. 1.0 is a desktop tool that resides only on the user’s computer. FDA does not track or monitor its use and does not have access to any content or documents saved using this tool.

FDA has taken all reasonable precautions in creating the Food Safety Plan Builder v. 1.0 and the documentation accompanying it. However, FDA is not responsible for errors, omissions or deficiencies regarding the tool and the accompanying documentation. The Food Safety Plan Builder and the accompanying documentation are available for download “as is” and without warranties of any kind, either expressed or implied, including, but not limited to, warranties of performance, merchantability, and fitness for a particular purpose. FDA is not making a commitment in any way to regularly update the tool and the accompanying documentation.

Responsibility for the interpretation and use of the Food Safety Plan Builder v. 1.0 and of the accompanying documentation lies solely with users. In no event shall FDA be liable for direct, indirect, special, incidental, exemplary or consequential damages (including, but not limited to, procurement of substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the use of this software, even if advised of the possibility of such damage.

Third parties’ use of or acknowledgment of the tool and its accompanying documentation does not in any way represent an FDA endorsement of such third parties.