The boss says, "Okay, let's put it on hold." 

"That will be tough to do," the staffer says. "It's been shipped." 

"What do you mean?" the QA director asks. "You know this shouldn't happen." 

"Well, marketing had an order to fill and demanded it go out," the staffer explains. "It's now in Los Angeles." 

This is a nightmare scenario for a company. The only thing good about the situation (if there is anything good) is that the product has not yet gotten to the customer. This is also why many companies develop, document, implement, and maintain a positive release program. Positive release is a simple concept; nothing is released for shipment until all of the food safety, quality, and sanitation checks have been completed, and then submitted and reviewed by the quality group. 

The introduction to a positive release program might read as follows: The company is committed to providing its clients and customers with products that meet established food quality and food safety specifications, plus any legal requirements or grade standards established by the regulatory agencies. For this reason, the company has established a "positive release program." This program will ensure that all necessary testing and analysis has not only been completed, but has also been reviewed by management to verify that the work has been carried out properly. 

How a company sets up a positive release program depends on the individual company and the products it produces, but it must include safety, quality, microbiology, and any legal elements.

It is the rare food processor that does not have an established HACCP plan for all of its products. A designated member of the quality staff will review all HACCP records for each production run prior to release to ensure that the Critical Control Points (CCPs) were monitored as planned, met established critical limits, and that records were filled out properly. The review of HACCP records will also include any corrective actions that were undertaken. Management will sign and date the HACCP records verifying that they were reviewed. The person doing the review shall be a Preventive Controls Qualified Individual (PCQI) or be working under the direct supervision of a PCQI. 

All records pertaining to food quality shall also be examined. All records that are maintained to ensure the quality of the plant's products will also be subject to review and sign-off. These include (but are not limited to) records related to cleaning and sanitizing, startups, in-house testing, sensory analysis, and lot identification. 

Many products are subjected to microbiological testing for quality, safety, or by request of the customer, who may ask that each lot purchased be accompanied by a certificate of analysis (COA) that includes the microbiological results. Depending on the buyer, testing may be done by the processor or by a third-party laboratory. When testing results are completed, they will be compared to specifications. No product will be released unless records meet established specifications. The quality group will review the microbiological records verifying that the products meet specifications and sign or initial the results, as was done for the quality and safety data.

Depending on the product and the state, verification of legal requirements may be part of the positive release program. As an example, some products must be graded by the U.S. Department of Agriculture's Agricultural Marketing Service (USDA's AMS). These products must be reviewed and graded by AMS prior to being released as inventory for sale. Another example is the release of low-acid or acidified foods. In California, the records must be reviewed and approved by the state through the University of California Laboratory for Research in Food Preservation.

Some processors also include a review of cleaning and sanitizing records in the positive release program. To ensure that all of the required records are available for review, many companies include a checklist that highlights all required records for each lot. This checklist may also serve as a summary that the records were not only received for review, but also met all necessary requirements. 

One element that some companies have included in their positive release program is a protocol for releasing product before all of the necessary records have been submitted and reviewed. Most quality people dislike this element, but marketing can be very insistent that they have the capability to fill orders, if necessary. There are certain times of the year when food processors may be literally packing to order; they produce and quickly ship. If a food processor finds itself in this situation, then it should make an effort to review some records prior to shipment. 

The product history should also be considered when it comes to early release. If the product has a history of few problems, then people may be more comfortable with early release. The author was in one facility, years ago, that had established an early release program at the insistence of marketing. Quality, distribution, and the production manager did not agree with this decision, so they included language in the procedure that any product subject to early release would require sign-off by these three department heads. I was informed confidentially that each time an early release was requested, one of the three would mysteriously disappear so that only two persons would be available to sign.

The positive release program should be included in the internal audit program at least once per year. The auditors will be instructed to review several days of records to ensure that the process has been followed as designed. The review must also include any early releases to ensure that no issues were encountered with these lots.

In summary, positive release programs are designed to ensure that any food product that is produced meets all quality, safety, sanitation, microbiological, and legal requirements before it is shipped. The ultimate goal is customer satisfaction.