Imagine, if you will, this hypothetical scenario:

A quality assurance director is sitting in the office when one of the staff comes in.
The staffer says, “Boss, we got the results back from lot XYZ, and they are not good.”
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
shipped to another country.”

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

It is rare that the 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, 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. 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
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.

Article by: Richard F. Stier, M.S