The person-in-charge shall ensure that: Low-acid foods are processed and labeled in accordance with 21 CFR 113; Acidified foods are processed and labeled in accordance with 21 CFR 114; When canning is taking place, a scheduled process is used that takes into account the critical factors and limits that are likely to influence the food’s safety, stability, or shelf life, such as: Food characteristics; Spoilage organisms; Time and temperature of thermal process; Cooling parameters; Acidification; Storage conditions; Design and performance of the processing equipment; and Batch size and configuration; Before a food processing plant processes food in a closed vessel, such as a retort or steam cabinet, a process authority performs a thermal process validation study that includes: Heat penetration tests; Heat distribution tests; Cooling parameters; and Any other measurements, observations, or calculations needed to ensure that the process is effective and reliable; The scheduled thermal process and validation study are re-established each time there is a change in the processing system; and All thermal processes and validation studies being used are available for inspection by the Department.