A process deviation is an error or change, in a critical condition of the scheduled process, which may reduce the sterilizing value the product receives, or which raises a question regarding the public health safety and/or commercial sterility of the product. FDA defines a Process Deviation as "...Whenever any process is less than the scheduled process..."
When a Process Deviation occurs, FDA states that the processor may either (a) fully reprocess that portion of the production involved or, alternatively, (b) set aside that portion of the production involved for further evaluation as to any potential public health significance. Such evaluation shall be made by a competent processing authority and shall be in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health.
"Evaluating a Deviation" refers to the evaluation made by the Process Authority to determine if the product is safe. CALSoft enables Process Authorities the ability to evaluate processing deviations using the Ball Formula method, heating factors properly derived from heat penetration data from the product in question, and the actual Retort Temperature (RT) and Initial Temperature (IT). The Ball Formula will calculate an estimated Fo value for the cook parameters provided. The Process Authority must ultimately make the decision whether to release or hold/destroy the affected product.
To evaluate a deviation, click on the "Deviation Evaluation" button on the CALSoft homepage. The middle panel will display the "recently used" Deviation Evaluation Files (DevCAL Records) that were opened in CALSoft.
This page will allow the user to create a New Deviation Evaluation or Open an Existing Deviation Evaluation.
Click the "New" button to begin a new Deviation Evaluation. CALSoft will then create a new DevCAL record in the database. You can then proceed to evaluating devations.