How Will Monitoring Be Done?

• Control Strategy Example 1 - Time/temperature control

For receiving of refrigerated (not frozen) cooked, ready-to-eat or raw, ready-to-eat products to be stored, or processed without further cooking:

How: Use a time/temperature integrator for product internal temperature monitoring during transit;

OR

Use a maximum indicating thermometer for ambient air temperature monitoring during transit;

OR

Use a digital time/temperature data logger for product internal temperature or ambient air temperature monitoring during transit;

OR

Use a recorder thermometer for ambient air temperature monitoring during transit;

OR

Use a dial or digital thermometer for internal product temperature monitoring at receipt;

OR

Make visual observations of the adequacy of ice or other cooling media in a sufficient number of containers to represent all of the product.

For raw material, in-process, or finished product refrigerated storage or for refrigerated processing:

How: Use a digital time/temperature data logger;

OR

Use a recorder thermometer;

OR

Use a high temperature alarm with 24-hour monitoring.

For raw material, in-process, or finished product storage under ice or chemical cooling media:

How: Make visual observations of the adequacy of ice or chemical cooling media in a sufficient number of containers to represent all of the product.

For cooling after cooking:

How: Use a dial or digital thermometer and visual check on time of cooling;

OR

Use a digital time/temperature data logger;

OR

Use appropriate instruments (e.g. dial thermometer, digital time/temperature data logger) and/or visual observations as necessary to measure the critical aspects of the process that affect the rate of cooling, as established by a cooling rate study.

Example:
A crayfish processor has identified cooling after the cook step as a critical control point for pathogen growth and toxin formation. The processor established a cooling critical limit of no more than two hours from 140° F (60° C) to 70°F (21.1°C) and no more than four more hours from 70° F (21.1° C) to 40° F (4.4° C). The processor uses marked batches of cooked product to monitor the cooling process. The time that the marked batch is removed from the cooker is monitored visually and the internal temperature of the product in that batch two hours after cooking and four more hours after cooking is monitored with a dial thermometer.

Example:
Another crayfish processor has similarly identified cooling as a critical control point and has established the same critical limit. The processor uses a digital time/temperature data logger to monitor the cooling rate of the cooked product.

Example:
Another crayfish processor has similarly identified cooling as a critical control point. This processor has performed a cooling rate study that determined that a cooling rate of no more than two hours from 140°F (60° C) to 70° F (21.1° C) and no more than four more hours from 70° F (21.1° C) to 40° F (4.4° C) can be achieved as long as certain conditions are met in the cooling process. The study determined that the following critical limits must be met: a cooler temperature of no more than 60°F (15.6° C) during the first two hours of cooling and no more than 40° F (4.4° C) during the remainder of cooling; and, no more than 1000 lbs of crayfish in the cooler. The processor monitors the cooler temperature with a recorder thermometer and monitors the weight of product at receiving with a scale.

For unrefrigerated processing and packaging:

How: Use a dial or digital thermometer for product or ambient air temperature;

AND/OR

Make visual observations of length of exposure to unrefrigerated conditions.

Example:
A crab meat processor has identified a series of processing steps (e.g. backing, picking, and packing) as critical control points for pathogen growth. The processor established a critical limit of no more than two cumulative hours of exposure to unrefrigerated temperature during these processing steps. The processor uses marked product containers to monitor the progress of the product through the three processing steps. The time that the marked container is removed from and returned to refrigeration is monitored visually.

Example:
Another crabmeat processor with identical CCPs, has established a more complex set of critical limits -no more than two cumulative hours with product internal temperatures above 70°F (21.1°C), and no more than six cumulative hours with product internal temperatures above 50° F (10° C). This processor also uses marked containers to monitor the progress of the product through the process. However, in addition to monitoring time, the processor also monitors product internal temperature for the marked containers. This monitoring technique provides the processor more flexibility in processing but requires more monitoring effort.

Example:
Another crabmeat processor that fully cools the product before handling has identified the same CCPs. The processor has determined through study that, under ordinary circumstances, in 3 1/2 hours of exposure to ambient (room) temperature the product will remain below 70°F (21.1°C). The processor has set a critical limit of 3 1/2 hours out of refrigeration. The processor monitors visually the time that picking begins after each batch of crabs is brought into the processing room and the time that the last of the containers of crabmeat from this batch has been placed on ice.

Example:
A lobster meat processor has identified the meat removal process as a critical control point for pathogen growth. The operation is performed under near refrigeration conditions (50°F [10°C]). The processor has determined that exposure time sufficient to jeopardize the safety of the product at these temperatures is not reasonably likely to occur. The processor only monitors ambient air temperature with a digital data logger.

How Often Will Monitoring Be Done (Frequency)?

• Control Strategy Example 1 - Time/temperature control

For receiving of refrigerated (not frozen) cooked, ready-to-eat or raw, ready-to-eat products to be stored, or processed without further cooking:

Frequency: Each shipment.

For raw material, in-process, or finished product refrigerated storage or for refrigerated processing:

Frequency: Continuous monitoring by the instrument itself, with visual check of the instrument at least once per day.

For raw material, in-process, or finished product storage under ice or chemical cooling media:

Frequency: At least twice per day;

OR

For finished product storage, at least immediately prior to shipment.

For cooling after cooking:

Frequency: At least every two hours;

OR

For critical aspects of the cooling process, as often as necessary to ensure control of the process.

For unrefrigerated processing and packaging:

Frequency: At least every two hours;

OR

Each batch.

Who Will Perform the Monitoring??

• Control Strategy Example 1 - Time/temperature control

Who: With recorder thermometers, time/temperature integrators, high temperature alarms, maximum indicating thermometers, and digital data loggers, monitoring is performed by the equipment itself. However, anytime that such instrumentation is used, a visual check should be made at least once per day in order to ensure that the critical limits have consistently been met. These checks, as well as dial thermometer checks, time of expo sure checks, and adequacy of ice or other cooling media checks may be performed by the receiving employee, the equipment operator, a production supervisor, a member of the quality control staff, or any other person who has an understanding of the process and the monitoring procedure.

Enter the "What," "How," "Frequency," and "Who" monitoring information in Columns 4, 5, 6, and 7, respectively, of the HACCP Plan Form.

STEP #16: Establish corrective action procedures.

For each processing step where "pathogen growth and toxin formation as a result of time/temperature abuse" is identified as a significant hazard on the HACCP Plan Form, describe the procedures that you will use when your monitoring indicates that the CL has not been met.

These procedures should: 1) ensure that unsafe product does not reach the consumer; and, 2) correct the problem that caused the CL deviation. Remember that deviations from operating limits do not need to result in formal corrective actions.

Following is guidance on establishing corrective action procedures for the control strategy example discussed in Step #12.

• Control Strategy Example 1 - Time/temperature control

For receiving of refrigerated (not frozen) cooked, ready-to-eat or raw, ready-to-eat products to be stored, or processed without further cooking:

Corrective Action: Reject shipment, if the CL is not met;

OR

Hold the product until it can be evaluated based on its total time/temperature exposure;

AND

Discontinue use of supplier or carrier until evidence is obtained that transportation practices have changed.

Note: If an incoming lot that fails to meet a receiving critical limit is mistakenly accepted, and the error is later detected, the following actions should be taken: 1) the lot and any products processed from that lot should be destroyed, diverted to a nonfood use or to a use in which the critical limit is not applicable, or placed on hold until a food safety evaluation can be completed; and 2) any products processed from that lot that have already been distributed should be recalled and subjected to the actions described above.

For other critical control points:

Corrective Action: Take one or several of the following actions as necessary to regain control over the operation after a CL deviation:

• Add ice to the affected product;

  OR

• Make repairs or adjustments to the malfunctioning cooler;

  OR

• Move some or all of the product in the malfunctioning cooler to another cooler;

  OR

• Return the affected in-process product to the cooler;

  OR

• Freeze the affected product;

  OR

• Modify the process as needed to reduce the time/temperature exposure;

AND

Take one of the following actions to product involved in the critical limit deviation:

• Destroy the product;

  OR

• Hold the product until it can be evaluated based on its total time/temperature exposure;

  OR

• Cook or recook the product. In this case, special attention must be paid to the fact that any Staphylococcus aureus or Bacillus cereus toxin that may be present may not be inactivated by heat;

  OR

• Divert the product to a use in which the critical limit is not applicable (e.g. divert crabmeat to a stuffed flounder operation). In this case, special attention must be paid to the fact that any Staphylococcus aureus or Bacillus cereus toxin that may be present may not be inactivated by heat;

  OR

• Divert the product to a non-food use.

Enter the corrective action procedures in Column 8 of the HACCP Plan Form.

STEP #17: Establish a recordkeeping system.

For each processing step where "pathogen growth and toxin formation as a result of time/temperature abuse" is identified as a significant hazard on the HACCP Plan Form, list the records that will be used to document the accomplishment of the monitoring procedures discussed in Step #15. The records should clearly demonstrate that the monitoring procedures have been followed, and should contain the actual values and observations obtained during monitoring.

Following is guidance on establishing a recordkeeping system for the control strategy example discussed in Step #12.

• Control Strategy Example 1 - Time/temperature control

For receiving of refrigerated (not frozen) cooked, ready-to-eat or raw, ready-to-eat products to be stored or processed without further cooking:

Records: Receiving record showing the results of the time/temperature integrator checks;

OR

Printout from digital time/temperature data logger;

OR

Recorder thermometer chart;

OR

Receiving record showing the results of the maximum indicating thermometer checks;

OR

The results of internal product temperature monitoring at receipt;

AND

The date and time of departure and arrival of the vehicle;

OR

Receiving record showing the results of the ice or other cooling media checks.

For raw material, in-process, or finished product refrigerated storage or refrigerated processing:

Records: Printout from digital time/temperature data logger;

OR

Recorder thermometer chart;

OR

Storage record showing the results of the high temperature alarm checks.

For raw material, in-process, or finished product storage under ice or chemical cooling media:

Records: Storage record showing the results of the ice or other cooling media checks.

For cooling after cooking:

Records: Processing record showing the results of the time/temperature checks;

OR

Printout from digital time/temperature data logger;

OR

Appropriate records (e.g. processing record showing the results of the time and temperature checks and/or volume of product in cooler, printout from digital time/temperature data logger) as necessary to document the monitoring of the critical aspects of the process that affect the rate of cooling, as established by a cooling rate study.

For unrefrigerated processing and packaging:

Records: Processing records showing the results of time and/or temperature checks;

OR

Printout from digital time/temperature data logger.

Enter the names of the HACCP records in Column 9 of the HACCP Plan Form.

STEP #18: Establish verification procedures.

For each processing step where "pathogen growth and toxin formation as a result of time/temperature abuse" is identified as a significant hazard on the HACCP Plan Form, establish verification procedures that will ensure that the HACCP plan is: 1) adequate to address the hazard; and, 2) consistently being followed.

Following is guidance on establishing verification procedures for the control strategy example discussed in Step #12.

• Control Strategy Example 1 - Time/temperature control

AND

When digital time/temperature data loggers, recorder thermometers, or high temperature alarms are used for in-plant monitoring, check for accuracy against a known accurate thermometer (NIST-traceable) at least once per day;

AND

When digital time/temperature data logger or recorder thermometers are used for monitoring of transport conditions at receiving, check for accuracy against a known accurate thermometer (NIST-traceable). Verification should be conducted on new suppliers' vehicles and at least quarterly for each supplier thereafter. Additional verifications may be warranted based on observations at receipt (e.g. refrigeration units appear to be in poor repair, or readings appear to be erroneous);

AND

When visual checks of ice or cooling media are used to monitor the adequacy of coolant, periodically measure internal temperatures of fish to ensure that the ice or cooling media is sufficient to maintain product temperatures at 40°F (4.4°C) or less;

AND

When dial or digital thermometers or maximum indicating thermometers are used for monitoring, check for accuracy against a known accurate thermometer (NIST-traceable) when first used and at least once per year thereafter. (Note: optimal calibration frequency is dependent upon the type, condition, and past performance of the monitoring instrument.)

Enter the verification procedures in Column 10 of the HACCP Plan Form.

See also:

FDA Seafood List

Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book)

Seafood Information and Resources