Product Recall Procedure | PM1030

Product Recall Procedure

The Product Recall Procedure outlines the methods for responding to a notice of nonconforming and potentially unsafe products in order to prevent, eliminate, or reduce the likelihood of harm to the consumer.

The Product Recall Procedure applies to all of your company’s recalled products and all processing associated with those products. (16 pages, 2739 words)

Product Recall Responsibilities:

The Quality Assurance Manager is responsible for initiating and overseeing product recalls and ensuring their adequate implementation, as well as their effectiveness.

The Quality Assurance Manager is responsible for determining the scope of the recall and for segregation and testing of recalled product to determine proper disposition.

The Public Relations Manager is responsible for communicating information on company product recalls to regulatory authorities and the customer/consumer.

All Production Personnel are responsible for identifying nonconformities which could result in product recalls and for cooperating with the Product Manager in the recall effort.

The Accounting Manager is responsible for documenting reimbursable costs connected with product recalls and reimbursing such costs, where applicable.

Top Management is responsible for formally authorizing product recalls.

Product Recall Definitions:

Hold – (n.) Time period used for investigation after a product has been identified as nonconforming and/or potentially unsafe; (v.) halt shipment/distribution of product found or believed to be not in conformance.

Nonconforming product – Product that is not (i.e., does not perform) in accordance with customer, standards-based, customary, or statutory/regulatory requirements.

Recall – (v.) Remove a product from the market primarily because using it may cause health problems or possible death. (n.) Request to return to the maker a batch or an entire production run of a product, usually due to discovery of safety issues. A recall is an effort to limit liability for corporate negligence and/or to improve (or avoid damage to) public relations. A recall may be based on an internal or external finding (e.g., consumer complaint). A recall is sometimes known as a “withdrawal.”

Segregate – Spatially isolated recalled product from other products (until such time as the recalled product may be safely disposed).

Top Management – A group of company officials comprised of the company’s chief executive officer and chief financial officer, at a minimum.

Product Recall Procedure Activities

• Product Recall Initiation
• Product Recall Communications
• Handling Recalled Product
• Review of Product Recall Process

Product Recall Procedure Forms

• Product Recall Request (Internal) Form
• Food Product Recall Checklist Form
• Non-Food Product Recall Checklist Form
• Product Return Form