Comply with FDA and USDA time regulations.

Grey Clock

The Food Processing industry is subject to quality assurance practices requiring an accurate time source in the areas of production, filling, seaming, cooling, and heating.

FDA Food and Drug Administration

CFR – Code of Federal Regulations, Title 21, Section 11.10 (e); Electronic Records

  • (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

CFR – Code of Federal Regulations, Title 21, Volume 2, Section 113.60 Containers

  • (a) Closures. Regular observations shall be maintained during production runs for gross closure defects. Any such defects shall be recorded and corrective action taken and recorded. At intervals of sufficient frequency to ensure proper closure, the operator, closure supervisor, or other qualified container closure inspection person shall visually examine either the top seam of a can randomly selected from each seaming head or the closure of any other type of container being used and shall record the observations made. For double-seam cans, each can should be examined for cutover or sharpness, skidding or deadheading, false seam droop at the crossover or lap, and condition of inside of countersink wall for evidence of broken chuck. Such measurements and recordings should be made at intervals not to exceed 30 minutes.
  • (b) Teardown examinations for double-seam cans shall be performed by a qualified individual and the results therefrom shall be recorded at intervals of sufficient frequency on enough containers from each seaming station to ensure maintenance of seam integrity. Such examinations and recordings should be made at intervals not to exceed 4 hours. The results of the teardown examinations shall be recorded and the corrective action taken, if any, shall be noted.
  • (c) Coding. The packing period code shall be changed with sufficient frequency to enable ready identification of lots during their sale and distribution. Codes may be changed on the basis of one of the following: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers that constitute the batch do not extend over a period of more than one personnel shift.

5) Assessing Holding Time and Temperatures and Date Marking Hot and cold holding temperatures, as well as cooling time and temperatures, of potentially hazardous foods (TCS foods) should be thoroughly checked with a thermocouple, thermistor, or other appropriate temperature measuring device during each inspection. This includes the temperature of potentially hazardous food (TCS food) during transport, e.g., hot holding carts being used to transport food to patient rooms in a hospital, satellite kitchens, or off-site catering events. As a rule, every effort should be made to assess every hot and cold holding unit in the food establishment during a risk-based inspection Use of an infrared thermometer for verifying holding temperatures is not consistent with Food Code requirements since verifying only the surface temperature of the food may not alert inspectors to problems that exist under the food’s surface. Such problems could stem from improper cooling, in the case of cold-held foods, or improper reheating, in the case of hot-held foods. In addition, inspectors should not stir a food before taking its temperature since it is important to know the temperature of the food before it is agitated.

The geometric center of a product is usually the point of measurement of product temperature particularly when measuring the critical limit for cold holding. The hot holding critical limit may need additional measurements taken at points farthest from the heat source, e.g., near the product surface for food held on a steam table. Temperatures monitored between packages of food, such as cartons of milk or packages of meat, may indicate the need for further examination. However, the temperature of a potentially hazardous food (TCS food) itself, rather than the temperature between packages, is necessary for regulatory citations. In large holding units and on steam tables, it is necessary to take the temperatures of foods in various locations to ensure that the equipment is working properly. If deviations are noted in the product temperatures, it is important to take extra steps to find out whether the problem is the result of equipment failure or whether a breakdown in a process such as cooling or reheating is the reason for the problem. Corrective actions for foods found in violation should be required based on the jurisdiction’s regulatory food code. If foods are to be discarded, forms such as those used for stop sale or embargo may need to be completed and signed by the person in charge in accordance with the jurisdiction’s regulatory food code. In order to properly evaluate the degree of time and temperature abuse and the proper disposition of the affected food, several issues must be considered. Answers to these questions, in combination with observations made during the inspection, should provide inspectors with enough information to make the appropriate recommendation for on-site correction:

Are there any written procedures in place for using time alone as a public health control and, if so, are they being followed properly? What are the ingredients of the food and how was it made? Is it likely that the food contains Clostridium perfringens, Clostridium botulinum, or Bacillus cereus as hazards? Has there been an opportunity for post-cook contamination with raw animal foods or contaminated equipment? If there has been an opportunity for post-cook contamination, can the hazards of concern be eliminated by reheating? Are the food employees practicing good personal hygiene including frequent and effective handwashing? Was the food reheated or cooked to the proper temperature before being allowed out of temperature control? What is the current temperature of the food when taken with a probe thermometer?

How long has the food been out of temperature control (ask both the manager and food employees)? Are the answers of the food employees and the manager consistent with one another?

Is it likely that food has cooled to its current temperature after being out of temperature control for the alleged time? Will the food be saved as leftovers?

How long before the food will be served?

Given what is known about the food, the food’s temperature, the handling of the food, and the alleged time out of temperature, is it reasonably likely that the food already contains hazards that cannot be destroyed by reheating? Even if food can be reconditioned by reheating, steps should be taken by the person in charge to ensure compliance in the future. Examples include repairing malfunctioning or inoperative equipment or implementing a risk control plan (RCP) to modify preparation procedures or to institute a procedure for monitoring holding temperatures of food.

If using time only or time-temperature combinations in lieu of temperature for controlling the growth and toxin-formation of pathogenic bacteria, strict controls must be in place and followed. . Inspectors should verify that the written procedures are on-site and followed in accordance with the Food Code. Date marking is the mechanism by which active managerial control of time-temperature combinations can prevent the growth of Listeria monocytogenes in potentially hazardous (TCS), ready-to-eat foods during cold storage. With exceptions, all ready-to-eat, potentially hazardous foods (TCS foods) prepared on-site and held for more than 24 hours should be date marked to indicate the day or date by which the foods need to be served or discarded. Inspectors should ask questions to ascertain whether the system in place to control for L. monocytogenes meets the intent of the Food Code. Food that should be date marked and is not should be discarded.

(6) Assessing Reheating for Hot Holding In order to assess a food establishment’s control of reheating for hot holding, the time of day that the inspection occurs is a key factor. Every effort should be made to schedule an inspection during pre-opening preparation. If inspections are conducted during pre-opening preparation or other preparation periods, inspectors should ask questions regarding the history of hot-held foods. Foods in compliance for minimum hot holding temperatures may have in fact been improperly reheated before being placed into hot holding units or steam tables.

If items are found “reheating” on the steam table, further inquiry is needed to assess whether the equipment in question is capable of reheating the food to the proper temperature within the maximum time limit. Corrective action for foods found out of compliance for reheating for hot holding would depend on how long the food had been out of temperature and other factors. In most cases, however, the food may be rapidly reheated and hot held.

(7) Assessing Cooling Improper cooling remains a major contributor to bacterial foodborne illness. Cooling temperatures and times need to be closely evaluated during every inspection. In order to assess whether a food establishment has control over cooling, the time of day that the inspection occurs is critical. Early morning inspections allow an opportunity to verify that leftovers from the night before were cooled properly or cooled using a proper cooling method. Alternatively, afternoon inspections may allow an inspector to verify cooling of products that may have been prepared that morning. Because many food establishments prepare bulk products only on certain days of the essential that inspectors become as familiar as possible with each operation and schedule their inspections accordingly.

Due to the time parameters involved in cooling, inspectors should always inquire at the beginning of the inspection whether there are any products currently being cooled. This allows inspectors an opportunity to take initial temperatures of the products and still have time to re-check temperatures later in the inspection in order to verify that critical limits are being met.

Problems with cooling can often be discovered through inquiry alone. Even when no cooling is taking place, inspectors should ask the food employees and managers questions about the cooling procedures in place.

When examining cold holding units, bulk containers and buckets, tightly packed pans, shrouded rolling racks, or closed rolling cabinets should warrant further temperature and time investigation. Bulk containers and buckets should be opened since they are commonly reused for food storage and cooling.

The geometric center of a product is often chosen as the point of measurement of product temperature particularly when measuring the critical limits for cooling. For foods that are being cooled, temperature profiles throughout the product may show proper temperatures at outer edges and hot spots at the core of the product. Inspectors can verify cooling by first taking a temperature measurement in the geometric center of the product, then at various points around the perimeter of the product. Warmer temperatures in the center of the product, in combination with cooler temperatures around the perimeter, indicate that a product is cooling. Additional questions should be asked to ascertain the cooling time parameters of the food in question. Information gained from food employees and management, in combination with temperature measurements taken, should form the basis for assessing compliance of cooling during an inspection. The following guidance may be used for determining the appropriate corrective action for improper cooling. Cooked hot food may be reheated to 165 ºF for 15 seconds and the cooling process started again using a different cooling method if the food is:

Above 70 °F and two hours or less into the cooling process; and Above 41 °F and six hours or less into the cooling process.

Cooked hot food should be discarded immediately if the food is: Above 70 °F and more than two hours into the cooling process; or Above 41 °F and more than six hours into the cooling process.

A different, more accelerated, cooling method may be used for prepared ready-to-eat foods if the food is above 41 °F and less than four hours into the cooling process; however, such foods should be discarded if the food is above 41 °F and more than four hours into the cooling process.

USDA United States Department of Agriculture

USDA Food Safety and Inspection Service 9 CFR Part 320

Records To Be Kept by Official Establishments and Retail stores That Grind Raw Beef Products

The Food Safety and Inspection Service (FSIS) amended its recordkeeping regulations to require that all official establishments and retail stores that grind raw beef products for sale in commerce maintain records including the date and time each lot of raw ground beef product is produced; and the date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized.