So, you have already identified your critical control points (CCPs), set critical limits and established monitoring procedures. Remember that the purpose of the monitoring procedure is to ensure that critical limits are met. So, what if a critical limit is not met? Then you will need to have corrective actions in place to handle deviations. Corrective action plans enable you to immediately correct affected products and prevent the hazard from reaching the consumer.

There are essentially four things you need to know as a food safety professional in a food production setting where you are required to take corrective actions. Firstly, you need to keep affected products separate. Secondly, you must identify the cause of the deviation and adjust the process accordingly. Thirdly, you must decide what to do with the product that you are holding. Fourthly, you must keep a proper record of all corrective action activities. I expand more on each of these essential points below.

Separate and Hold the Affected Products

You will recognize the need to take a corrective action when monitoring activity indicates that critical limits are not met. For example, processing or internal temperature is too low, or metal detector lacks the appropriate sensitivity. The number of products that will need correction depends on the frequency of monitoring. So, if you are checking your metal detector every four hours, then all the products made in that period will have to be separated and held until they can be passed through a functioning metal detector.

Depending on how your system is set up, you may have to stop the line to do this separation. However, if your system is automated, deviated products may be automatically diverted to a holding tank for later evaluation. Regardless of how it is done, this step is essential in preventing potentially contaminated food from getting mixed in with food that will enter distribution.

Identify Cause of Deviation and Adjust Process

Process corrections involve making changes to operating conditions such as temperature, pH, brine concentration, can seam integrity, etc. For example, if heating temperature is too low, this could be due to drop in steam flow resulting from a poorly adjusted steam value or drop in boiler pressure. If cooling temperature is too high, this could be due to defects in the heat transfer system or drop in water flow rate arising from issues with your pumping system. A pH deviation above the minimum limit could be due to inadequate acidification during the formulation step or improper calibration of the pH meter. Lack of proper can seam could be due to defective cans or need for adjustment of can seamer. My point in all these examples is to say that making the appropriate process alteration will have a lot to do with the cause of the problem. Figure out the cause and you will know the right action to take.

Decide What to Do with Product

Deviated products must be held in such a way to prevent or minimize further deterioration. Therefore, place them in a refrigerator or freezer if necessary, to keep them safe. Your decision on what to do with the product on hold will be based on standard operating procedures that you have established to handle the type of deviation. However, you can’t possibly anticipate every single deviation. Therefore, you will have to be prepared to take appropriate actions as needed and then use them as a basis to update your corrective action plan.

Deviated products are held for evaluation because their safety is in question. Therefore, appropriate evaluation must be done to verify safety. This could be a simply re-running of the product though a fully functioning metal detector. Other times, product sampling and testing for biological, chemical or physical hazards is required. Evaluation must be done by a qualified person. This person could be in-house or an outside expert or processing authority. Be aware that for effective evaluation, statistically valid sampling methods, and scientifically validated product testing methods must be used.

After product evaluation, if “no hazard” exists the product can be released “as is” or downgraded and released. However, if a potential hazard exists you must determine if the product should be re-evaluated, re-worked, re-purposed, or refused. Re-evaluation involve re-running the product through a calibrated and functioning instrument e.g. metal detector, designed to detect the hazard. Reworking the product may involve recooking, repackaging, reconditioning into new batches, or converting to a different product. An example of the latter is diverting raw ground beef containing E. coli 0157:H7 to a fully-cooked product line. However, if the product cannot be redeemed through any rework strategy, then it must be dumped following appropriate dumping procedures. 

Establish and Keep Proper Records

A record of all corrective actions taken should be made and maintained, regardless if the product was found to be safe after examination. All production records associated with the deviated product should be available for review. Products held should be clearly and firmly tagged identifying the date, product name, product code, hold number, quantity of product held, and name and signature of responsible individual. You should also keep on file product testing results and processing authority/expert recommendations, as well as a statement outlining the cause of the deviation and how it was corrected.

Courtney Simons
Courtney Simons is a food science professor. He holds a BS degree in food science and a Ph.D. in cereal science from North Dakota State University.
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