The final rule requires record review prior to shipping. Failure to perform a records review could lead to product being designated adulterated. The purpose of this requirement is to provide the establishment a final check to be certain that no products are released without meeting the critical limits of the HACCP plan under which they were produced. Commonly referred to as the "Pre-shipment review requirement," it is possibly the most misunderstood, hard to understand requirement of the HACCP regulations.

In an effort to clarify the pre-shipment review we have done some homework with FSIS. Our current understanding of the regulatory requirement is that before any products are moved outside the control of the producing establishment, the records associated with the documented results of critical control point monitoring and verification activities must be reviewed and documented. Pre-shipment reviews can be completed even though there may be some verification activities called for in the HACCP plan which may not have been completed at the time the pre-shipment review is considered to be necessary. For example, a microbiological sample may be required as part of a verification activity. If the analysis of this verification sample is not available at the time of the pre-shipment review, the pre-shipment review may be made anyway. If the subsequent receipt of the analysis indicates a critical limit deviation, it may be necessary to regain control of the product; even so, this would not be considered a failure of the pre-shipment review requirement.

No specific directions are given regarding the form or manner in which this review is to be made and recorded, where it is to be made, or when it is to be made, except that it is to be " . . conducted, dated, and signed . . " by the person who made the review and must be made "Prior to shipping product. . . ".

FSIS has clarified "shipping" to mean that the pre-shipment review must be carried out while the producing establishment still has control of the product. This means that the pre-shipment review could be done at the producing establishment before any movement of the product; at an intermediate storage location where control of the product is maintained by the producing establishment; or possibly even on vehicles which are transporting product to ultimate purchasers if the establishment still maintains control of the product and appropriate documentation is available to carry out the required review of records as required in the final rule.

The pre-shipment review requirement states that "Where practicable. . " it should be carried out by someone ". . who did not produce the records(s). . and "Preferably. . " by a person trained in HACCP, or by "the responsible establishment official .. ". This provides latitude, particularly for small and very small establishments, in identifying who will make the pre-shipment reviews, even having different personnel doing these under differing circumstances. For example, persons doing monitoring or verification activities could also be made responsible for doing pre-shipment reviews. If products are to be shipped directly from the establishment, an on-site person may do the required review. If some products go to an intermediate storage location, but remain under the control of producing establishment, a different person may do the review when shipments are to be made from this location -- again the records necessary to carry out the review must be available to the reviewer. These persons are not required to be HACCP trained even though the preference is that they should be. At a minimum, our recommendation is that they be trained to fully understand the significance of doing the pre-shipment review, how to do it, and how to document what they have done, including any actions requiring disposition of the product by other than shipping it to a purchaser for consumption.

As earlier stated the specifics of formatting pre-shipment reviews are not mandated. It is only required that they be done, documented, and appropriate actions taken as necessary. Again, this permits establishments to accommodate their own unique operations. Whatever procedure(s) is adopted by the establishment, be sure to write it up and have it on record for review in the event you are called upon to produce it.

If anyone has additional suggestions, please let us know by calling (510) 527-4580 or e-mail [email protected]. We will respect your anonymity, but your ideas may help others who are searching for the easiest and best way to comply with this often confusing requirement of the regulations.

1- Sufficient space is reserved on CCP Monitoring and Verification forms to accommodate Pre-Shipment Review results. The responsible person reviews the monitoring/verification documentation at the CCP location(s) and initials and dates the action when completeness is ensured. If determined not complete, the action necessary is documented on the form and the appropriate action is initiated according to company policies. Copies of the completed monitoring/verification/pre-shipment review forms are identified to batches, lots, or other production coding system and kept with appropriate pallets of product or on record in some other manner in order that pending shipments can be easily cleared. (See also no. 3, below)

2- Copies of completed Monitoring and Verification forms identified with finished batches, lots, or other production coding system accompany these finished products to storage or shipping areas where they are reviewed by a designated responsible pre-shipment reviewer. The results of the pre-shipment review may be recorded in space reserved on these forms for that purpose, or on separate forms (appropriately titled) which are also identified to the finished products.

3- Copies of completed Monitoring and Verification forms, identified with finished batches, lots, or other production coding system, are kept on file and each shipment, before loading, is individually checked against the pertinent filed Monitoring and Verification forms. When the first pre-shipment review is made of these products, an appropriate entry is made so that subsequent checks of individual shipments from the same production will require only noting that the earlier pre-shipment reviewed was done. When these pre-shipment reviews ensure completeness, loading and shipping takes place. When necessary, appropriate action is initiated according to company policies to effect proper disposition of the product.

4- Forms for recording that pre-shipment reviews have been completed on multiple individual shipments from the same finished products should be considered to avoid potential difficulties in confirming compliance with this requirement. Appropriate notations on individual invoices; separate forms filed with shipping documents; or copies of individual invoices or shipping documents, filed with pre-shipment review documents are some suggestions.