When a food facility deviates from the critical control points (CCPs) in its HACCP program, it can be attributed to a couple of reasons. Either the CCP itself failed or the staff failed to follow the HACCP plan.
When a CCP fails, it is typically identified by the person monitoring during the CCP check. For example, the metal detector may have failed to identify one of the check pieces, the internal temperature may be too cold for a cooking CCP, or the internal temperature may be too hot for a cooling CCP.
Since the processing step must be working to ensure the hazard being controlled is eliminated or reduced to an acceptable level, the corrective action outlined on the master plan must be followed. Corrective actions typically include what to do with the product in process, how to fix the problem, and what to document.
What should be done with product that is still coming down the line?
One option is to stop the line. In some processes, this will destroy everything upstream. Another option is to divert the product to another line that has a functioning CCP. You can also choose to keep making the product, but place it on hold until the issue is resolved appropriately. The most drastic measure would be to destroy everything coming down the line until the CCP is repaired.
How is the problem fixed?
The solution will depend on the issue at hand. The corrective action might involve raising the oven temperature, slowing down the line, calling maintenance, or whatever other action the HACCP team has identified as the appropriate correction for a failed CCP. These will be included in the HACCP master plan.
If product is placed on hold, the held product either must be run through the same functioning CCP, be graded out of the human/pet food flow, or be destroyed. For example, if the metal detector failed, the held product can be passed through the same metal detector after it has been repaired, or it can be passed through a similar, working metal detector. If the product is graded out of the human/pet food flow, there are a few things to keep in mind. Some companies make food-grade as well as nonfood-grade materials. If there is no evidence that there is anything wrong with the product—based on the CCP—the product could be directed to animal feed. However, regulations are changing for animal feed, and this option may not be viable with new laws.
What should be documented?
Any time a deviation occurs, detailed information must be recorded and kept on file. At a minimum, this documentation should include:
when the issue was identified.
description of the issue.
immediate actions taken to the line and the product.
what was done to solve the problem.
what happened to the affected product. If the product was redirected, include the steps taken before the product was released.
who did what tasks.
when (date and time) these tasks were conducted.
What human failures contribute to CCP failure?
When the staff fails to follow the HACCP plan, it also can result in CCP deviation. There are a number of human failures that can contribute to CCP failure. Employees could forget to monitor and not check the CCP, or they could perform the check, but not on time. For example, maybe they were supposed to check every 60 minutes, but did the check after 80 minutes. Or, they performed the check on time, but did it incorrectly. For example, the oven temperature was checked, not the product temperature, or the metal detection test piece was put on top of the product instead of inside the product. Other human failures include using incorrect test piece sizes for metal detection and completing the documentation before the monitoring activity is completed (falsification of documentation).
Human errors are typically identified by the verifier (the person watching the person doing the check or reviewing the documentation), though monitors can also find that they made an error.
When CCP deviations are a result of employee failure, the product may not need to be placed on hold, but that depends on the CCP. Product does not typically need to be placed on hold for incorrect monitoring frequency. Monitoring frequencies are based on financial impacts (e.g., how much product you are willing to put on hold if a CCP does not work). If a check was not done at the set time and the CCP is working fine (metal detector, screen integrity, etc.), then the CCP did not fail, the monitor failed to follow the plan. For example, if the magnet pull test is supposed to be done weekly, but the monitor skips a week, and the checks conducted in the prior and following weeks reveal that the magnet is working appropriately, there is no reason to place the product on hold. Magnets do not lose their magnetism and then gain it back. This also would apply to sifters and screens. If the screen does not have a rip or tear in it, no hold is needed; this is because these devices would not tear and then magically repair themselves.
How are such errors and deviations corrected?
Some deviations and resulting corrective actions will need to be assessed by the quality manager. For example, if the thermometer used to check the internal temperature of the product was not calibrated/checked on the right frequency and is found to be accurate when it is checked, the product does not need to be placed on hold.
However, if the thermometer is inaccurate when checked, this is an incredibly difficult situation and both the quality and plant manager should be involved with this decision. If the critical limit involves a minimum temperature and the thermometer reads lower than actual, the product is acceptable. But, if the critical limit involves a minimum temperature and the thermometer is reading higher than actual, the product must be put on hold and either reprocessed or destroyed.
If the critical limit involves a maximum temperature and the thermometer is reading higher than actual, no hold is needed. If the critical limit involves a maximum temperature and the thermometer is reading lower than actual, the product must be destroyed.
Some human errors will result in a corrective action that involves destroying the product. When the internal temperature of the product is to be taken per batch and you cannot recook the product due to the creation of quality defects, the product should be destroyed if a temperature check is not taken for a batch.
How much do you know about...
Following is a short quiz to gauge how much you know about deviation reports. For the scenario described below, how many deviation reports should be completed?
Situation. The metal detector check was not done for an entire shift. The first check of the detector at the start of the first shift reveals that the detector does not work. Product from the previous shift is placed on hold to be run through a properly functioning metal detector. The plant manager runs 10% of the product through a functioning metal detector and none was rejected, so all of the held product is shipped.
So, how many deviation reports should be completed?
Answer. Three:
The metal detector check was not done for an entire shift. The employee failed to follow the plan.
The first check of the detector at the start of the first shift showed that the detector did not work. The CCP failed.
The plant manager ran 10% of the product through a functioning metal detector, no rejections, so all of the held product was shipped. The manager failed to follow the corrective action plan.
When a CCP fails, it is typically identified by the person monitoring during the CCP check. For example, the metal detector may have failed to identify one of the check pieces, the internal temperature may be too cold for a cooking CCP, or the internal temperature may be too hot for a cooling CCP.
Since the processing step must be working to ensure the hazard being controlled is eliminated or reduced to an acceptable level, the corrective action outlined on the master plan must be followed. Corrective actions typically include what to do with the product in process, how to fix the problem, and what to document.
What should be done with product that is still coming down the line?
One option is to stop the line. In some processes, this will destroy everything upstream. Another option is to divert the product to another line that has a functioning CCP. You can also choose to keep making the product, but place it on hold until the issue is resolved appropriately. The most drastic measure would be to destroy everything coming down the line until the CCP is repaired.
How is the problem fixed?
The solution will depend on the issue at hand. The corrective action might involve raising the oven temperature, slowing down the line, calling maintenance, or whatever other action the HACCP team has identified as the appropriate correction for a failed CCP. These will be included in the HACCP master plan.
If product is placed on hold, the held product either must be run through the same functioning CCP, be graded out of the human/pet food flow, or be destroyed. For example, if the metal detector failed, the held product can be passed through the same metal detector after it has been repaired, or it can be passed through a similar, working metal detector. If the product is graded out of the human/pet food flow, there are a few things to keep in mind. Some companies make food-grade as well as nonfood-grade materials. If there is no evidence that there is anything wrong with the product—based on the CCP—the product could be directed to animal feed. However, regulations are changing for animal feed, and this option may not be viable with new laws.
What should be documented?
Any time a deviation occurs, detailed information must be recorded and kept on file. At a minimum, this documentation should include:
when the issue was identified.
description of the issue.
immediate actions taken to the line and the product.
what was done to solve the problem.
what happened to the affected product. If the product was redirected, include the steps taken before the product was released.
who did what tasks.
when (date and time) these tasks were conducted.
What human failures contribute to CCP failure?
When the staff fails to follow the HACCP plan, it also can result in CCP deviation. There are a number of human failures that can contribute to CCP failure. Employees could forget to monitor and not check the CCP, or they could perform the check, but not on time. For example, maybe they were supposed to check every 60 minutes, but did the check after 80 minutes. Or, they performed the check on time, but did it incorrectly. For example, the oven temperature was checked, not the product temperature, or the metal detection test piece was put on top of the product instead of inside the product. Other human failures include using incorrect test piece sizes for metal detection and completing the documentation before the monitoring activity is completed (falsification of documentation).
Human errors are typically identified by the verifier (the person watching the person doing the check or reviewing the documentation), though monitors can also find that they made an error.
When CCP deviations are a result of employee failure, the product may not need to be placed on hold, but that depends on the CCP. Product does not typically need to be placed on hold for incorrect monitoring frequency. Monitoring frequencies are based on financial impacts (e.g., how much product you are willing to put on hold if a CCP does not work). If a check was not done at the set time and the CCP is working fine (metal detector, screen integrity, etc.), then the CCP did not fail, the monitor failed to follow the plan. For example, if the magnet pull test is supposed to be done weekly, but the monitor skips a week, and the checks conducted in the prior and following weeks reveal that the magnet is working appropriately, there is no reason to place the product on hold. Magnets do not lose their magnetism and then gain it back. This also would apply to sifters and screens. If the screen does not have a rip or tear in it, no hold is needed; this is because these devices would not tear and then magically repair themselves.
How are such errors and deviations corrected?
Some deviations and resulting corrective actions will need to be assessed by the quality manager. For example, if the thermometer used to check the internal temperature of the product was not calibrated/checked on the right frequency and is found to be accurate when it is checked, the product does not need to be placed on hold.
However, if the thermometer is inaccurate when checked, this is an incredibly difficult situation and both the quality and plant manager should be involved with this decision. If the critical limit involves a minimum temperature and the thermometer reads lower than actual, the product is acceptable. But, if the critical limit involves a minimum temperature and the thermometer is reading higher than actual, the product must be put on hold and either reprocessed or destroyed.
If the critical limit involves a maximum temperature and the thermometer is reading higher than actual, no hold is needed. If the critical limit involves a maximum temperature and the thermometer is reading lower than actual, the product must be destroyed.
Some human errors will result in a corrective action that involves destroying the product. When the internal temperature of the product is to be taken per batch and you cannot recook the product due to the creation of quality defects, the product should be destroyed if a temperature check is not taken for a batch.
How much do you know about...
Following is a short quiz to gauge how much you know about deviation reports. For the scenario described below, how many deviation reports should be completed?
Situation. The metal detector check was not done for an entire shift. The first check of the detector at the start of the first shift reveals that the detector does not work. Product from the previous shift is placed on hold to be run through a properly functioning metal detector. The plant manager runs 10% of the product through a functioning metal detector and none was rejected, so all of the held product is shipped.
So, how many deviation reports should be completed?
Answer. Three:
The metal detector check was not done for an entire shift. The employee failed to follow the plan.
The first check of the detector at the start of the first shift showed that the detector did not work. The CCP failed.
The plant manager ran 10% of the product through a functioning metal detector, no rejections, so all of the held product was shipped. The manager failed to follow the corrective action plan.
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