In 2024, I authored a piece that focused on positive release¹ and how this program is designed to ensure that food products meet all quality, food safety, sanitation, microbiological, and legal requirements before they are shipped. Positive release programs generally mandate that products are immediately placed "on hold" as soon as they are produced and remain so until all testing and evaluation has been completed. The objective is customer satisfaction. If the products do not meet established criteria for any of the above parameters, they will remain on hold. For this reason, it is imperative that the processor develop, document, implement, and maintain a protocol for how non-conforming products will be handled. The bottom line is to ensure that non-conforming product remains on hold and is not inadvertently shipped.

The procedure for handling non-conforming products should include the following elements:

1. Placing the product on hold
2. Clearly identifying the suspect product and isolating it physically and on computer inventory availability
3. Determining the disposition of the suspect product, which may include additional testing and analysis
4. De-naturing the product and packaging before disposing of the product
5. Verifying that the products in question were properly disposed of
6. Signing off in the corrective and preventive actions (CAPA) log to ensure closure.

As noted above, a product may be placed on hold for any number of reasons. Quality holds are the most common reason for holding product. Examples might be the sensory properties of the product (flavor, color), a packaging issue, or microbial spoilage by non-pathogenic organisms. The author once observed an off-flavor concern in juice packaged in a gable-top carton, caused by elevated sealing temperature of the sealing unit. The product had a "plastic" taste. 

Legal issues are less common, but they do occur. Failure to meet the required parameters established for products having a Standard of Identity is an example of a legal issue. According to the Standard of Identity for pineapple juice from concentrate, the product must have a minimum brix of 12.0. 

Products that do not meet the critical limits established in a company's HACCP plan are potentially unsafe and of greatest concern to processors. All suspect products must be placed on hold. The incident should be fully documented in the company's CAPA log. This usually requires a root cause determination, along with the required preventive measures to be incorporated into the HACCP risk analysis and HACCP plan. The log may be hard copy or electronic and should look similar to the log shown in Table 1.

Table 1 Corrective and Preventive Action Log (Credit: R. Stier, M.S.)

The elements of the CAPA log are defined below:

1. Date: When the concern was first noted.
2. Concern: A standard term should be used for this section to allow for ease of sorting (i.e., pests or equipment failure).
3. Source: Where was the concern discovered—in the HACCP plan, a quality audit, a routine inspection, a pest control operator report, etc.? Use standard terms for sorting.
4. Description: Provide details of the problem.
5. C/P Action: Describe how the issue will be resolved and who has been assigned the responsibility, i.e., "work order No. 123 to physical plant to repair the screen door" or "reviewed procedure with foodservice employee." 
6. C/P Date: When the corrective or preventive action was decided.
7. Completed By/Date: When the work was performed by the responsible person.
8. Verified By/Date: The manager of foodservice operations or a supervisor must verify that the work was completed properly.

The next step is to clearly identify all non-conforming finished product in the warehouse. It should be flagged with a physical hold tag and physically isolated if possible, as well as flagged with a computer hold tag on inventory. Some processors have a designated area in the warehouse where product that is put on hold is stored. 

If product has already been shipped, then the product must also be held offsite or at a third-party warehouse. In some cases, product may need to be kept in a separate room or fenced off and/or locked up. Some operations even surround held product with police tape. Additionally, since many warehouse operations utilize bar codes on products and monitor inventory through these codes, the company must be sure that the suspect product's bar codes are not in the accessible inventory.

The food safety or quality team must then determine what to do with the product in question. Barring any pathogenic contamination, allergen cross-contamination, or other issues of public health significance, there are several options available to the team. These include, but are not limited to:

• Isolating and holding product for safety or quality evaluation.
• Diverting the affected product or ingredient to another line where deviation would not be considered critical.
• Reworking the product. It is important to note that reworked product must be traceable into all finished products. 
• Reprocessing, where allowed, is an option for the product in question. Keep in mind that contaminated product cannot be rendered wholesome by reprocessing.
• Distributing to food banks or similar agencies.
• Denaturing and destroying the product and packaging.

When products are placed on hold for food safety issues, the best route is the most conservative path. Remember Sunland, the nut butter producer? The company had to destroy millions of jars of nut butter because of potential Salmonella contamination. Hopefully, processors are aware of potential concerns with their products and make the appropriate disposition. 

Reworking is a common means of dealing with non-conforming products and ingredients. It is best to rework "like into like," preferably on the same day or production line, to eliminate traceability issues. Most companies establish procedures for reworking products that include how it should be done and specifies the allowable percentages of rework (usually around 10 percent). 

Reprocessing is rarely done since, in most cases, the process adversely affects the sensory properties of the food, especially color and flavor. Some processors will donate to food banks or other agencies; however, this is not an option if the products are potentially unsafe according to the company's HACCP program.

Once disposition of the non-conforming has been completed, the results must be entered into the CAPA log. Finally, the food quality or food safety and HACCP team must verify that the disposition has been completed as specified by the team. It is also incumbent on the team to ensure that the proper documentation of denaturing and disposal has been conducted as prescribed, and that the related records reflect the root cause of the issue and the preventive measures implemented. Those measures must be later reviewed to ensure they have been effective in preventing recurrence of the issue. 

It is up to the processor to develop, document, and implement a program for non-conforming product. A good auditor will review and assess whether this program is effective, so make sure to get it done. 

Reference

1. Stier, R.F. "The Importance of a Positive Release Program." Food Safety Magazine. April 16, 2024. https://www.food-safety.com/articles/9399-the-importance-of-a-positive-release-program.