Not too many words in the English language cause heads to turn and skin to crawl like the word recall. Product recalls are situations that all companies try their best to avoid, but if a recall is necessary, how does a company effectively develop and implement a plan without undue delay and confusion?
The actions to consider when conducting a product recall can be grouped into seven areas. Each of these areas should be executed carefully and thoroughly in order to effectively manage the recall activity. This article discusses the following seven recall areas: conducting a health-hazard assessment, planning a course of action, contacting the US Food and Drug Administration, getting the word out, the importance of keeping accurate records, staying focused, and when is the recall actually ended?
What is a recall and when is it necessary?To effectively manage a product recall, it is important to first understand what constitutes a recall and when it is necessary. Simply put, a recall is necessary when a product is found to be defective in some way, and removing it from the market is the only way to ensure consumer safety. Recalls can be either voluntary (i.e., undertaken by the manufacturer or distributor at any time) or can be initiated at the request of FDA (usually reserved for urgent and serious situations).
A recall usually results from one or a combination of the following situations:
1. Company discovery: A company discovers, through its own routine testing program, that a product lot does not meet one or more of the specifications that are established for that product.
2. Customer complaint: Often a problem is discovered from customer complaints.
3. FDA observation: Recalls can also be necessitated as a result of an observation made by FDA during an inspection. Significant compliance deficiencies noted by FDA can result in a company having to recall some or all of its drug lots.
Conducting a health-hazard assessment