The Deviation Evaluation (DevCAL Record) screen includes access to deviation-related information. The page is divided into four parts:
DEVIATION INFO- Information about the deviation itself. This information will be used on the printed deviation evaluation report.
- Product Name: name of product being tested
- Container
- Retort
- Plant Name: name of factory where testing was conducted
- Location: location of factory where testing was conducted
- Date(s): date of deviation
- Codes: codes affected
- Quantity
- Hold #
- Description: explanation of what happened
PROCESS FACTORS- Information relative to the Ball Formula heating factors. This information assists in calculating a sterility value for the product affected by the deviation.
- ProCAL # (if used, optional): click "Open Process Calculation" to view the ProCAL record
- Heating Factors (jh, fh, f2, xbh, m+g)
- The m+g is the factor used in the Ball Formula that represents the difference between the retort temperature and cooling water. Traditionally, for Steam retorts, the m+g = 180°F (100°C) and for Water retorts, the m+g = 130°F (72.2°C). If an existing ProCAL record is being used for this evaluation, the m+g is assigned based on the type of retort used for the Heat Penetration test from which the heating factors were derived.
- Product Type: Choose LACF, Acidified, or Other... This sets the z and Tref for the sterility "F" value
ACTUAL CONDITIONS- Actual processing conditions. These assist in calculating a sterility value for the product affected by the deviation.
- Temperature Type: you can choose Fahrenheit or Celsius
- Actual Temperatures: select either a single IT (initial temperature) and RT (retort temperature) or a range of IT's and RT's (selecting "Range IT/RT" will ask you for a "Low" value and a "High" value for the IT and RT ranges, as well as an "Interval" for both; selecting "Single IT/RT" will only ask you for an "Actual IT" and "Actual RT"). Caution must be taken in assigning the correct IT and RT to the sterility equation.
- Come Up Time: This is Come Up Time Credit. NOTE: only add the ACTUAL Come Up Time (CUT) if you are sure that credit can be given for lethality in the Come Up phase. The Ball Formula allows 42% of the Come Up to be applied to the sterility calculation.
- Cook Time: The actual cook time experienced by the affected product during deviation. Caution must be taken in assigning the correct Cook Time to the sterility equation.
- Target Lethality: enter this for Commercial Sterility and Minimum Health.
- To generate the "Calculated Lethality" and see whether it is over or under the targets, click the "Calculate Lethalities" button, for more on this, check out Calculate Lethalities.
COMMENTS-
- Evaluated By: You may choose to document who conducted this evaluation
- Date: The date of the evaluation
- Product Disposition: Enter your disposition of the product in this text box
Also on the Deviation Evaluation Screen: