Recalling Product from a Distributor
We are in the process of creating a Recall/traceability program. Who's responsible to recall product when we send product to a distributor? In a mock recall process, do we just prove how many units went to the distributor? and will it be their responsibility to recall the product themselves in a real recall?
Thank you in advance.
You have to know how many units of product you shipped to the distributor, they are responsible for recalling wherever they sold those units. You only need to go one level down and one level up.
You asked for references:
FDA: "Direct consignments" who you sold the food to.
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTIONSubpart C--Hazard Analysis and Risk-Based Preventive Controls
Sec. 117.139 Recall plan.For food with a hazard requiring a preventive control:
(a) You must establish a written recall plan for the food.
(b) The written recall plan must include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions as appropriate to the facility:
(1) Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;
(2) Notify the public about any hazard presented by the food when appropriate to protect public health;
(3) Conduct effectiveness checks to verify that the recall is carried out; and
(4) Appropriately dispose of recalled food--e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.
SQF (GFSI Standard)
2.6.2 Product Trace (Mandatory)
2.6.2.1 The responsibility and methods used to trace product shall be documented and implemented to ensure:
i. Finished product is traceable to the customer (one up) and provides traceability through the process to the manufacturing supplier and date of receipt of raw materials, food contact packaging and materials and other inputs (one back)
; ii. Traceability is maintained where product is reworked; and
iii. The effectiveness of the product trace system shall be reviewed at least annually as part of the product recall and withdrawal review (refer to 2.6.3.3) 2.6.2.2
If you've ever conducted a recall before, FDA basically requires your tracing ability to be able to identify all of the affected product, otherwise you have to expand the recall until you would realistically capture the affected products. Then the "effectiveness checks" include monitoring disposal to ensure that the recall was as effective as you had the power to make it.
FDA's guidance for what happens during a recall: https://www.fda.gov/...e/ucm129259.htm
Also Title 21 part 1 subpart J indicates that your records need to identify the "previous sources of food" and "subsequent recipients of food".
In addition to the regulatory requirements and need for effective traceability, remember that if it is your brand, you need to make sure the distributor not only has effective processes in place for recalling but also you have agreements in place about who is going to communicate not just with regulators but also to other customers and consumers. Poor recall strategy leads to poor communications which can quickly have a negative impact on a brand. Including these key elements in your program can help protect your brand.