Maintaining Records

Coding Products

It is important for every processor to work out some type of coding system for their products. You must be able to identify the year and day the product was packed as well as the batch number if processing more than one per day. If you have more than one processing facility, that too needs to be identified. It is also necessary to record these codes on your invoices to identify initial distribution. This will enable you to recall all products from a particular code, if there is a problem. All cases and individual containers must be coded. These codes need to be changed often, to enable easy identification of lots during sale and distribution.

Any method of coding that is recognizable by the processor is acceptable. Some use alphabetical letters to identify certain months. Example: A for January, B for February and so on. The Julian date can also be useful. February 2 would be the 33rd day of the year. Accurate record keeping is a must.

Recalls

A recall can be a devastating experience for a food manufacturer resulting in loss of product, reputation and future sales. Many small firms who have been involved in the recent extensive recalls have experienced such heavy financial losses that recovery will be extremely difficult, if not impossible. Millions of dollars have been spent by some companies to retrieve a single product. No one can afford a recall.

Perhaps the best way to avoid one is to understand what they are and why they are necessary. The Food and Drug Administration lists three classes of recalls.

Class I Recalls

Class I recalls represent emergency situations and involve the removal from the market of products in which the consequences may be either immediate or long-range, life threatening, and involve a direct cause-effect relationship such as the presence of Clostridium botulinum toxin in foods. When such circumstances occur, the FDA requites that the recall be made to the consumer level, that the product be placed on the public recall list and that a public warning be issued via the news media. The effectiveness check for Class I recalls must be such as to assure 100 percent removal of all known direct accounts and sub accounts and, if necessary, product in possession of consumers.

Class II Recalls

Class II recalls represent priority situations (as opposed to emergency for Class I recalls) in which the consequence may be either immediate or long-range and with possible or potential life threatening or hazardous to health situation. These might include conditions such as: the presence of pathogenic microorganisms in food exclusive of Clostridium botulinum, improper calibration of thermometers, unnecessary exposure to radiation, etc. For a Class II recall, the FDA requires that the product be removed to the retail or dispensing level; that notice of the recall be placed on the public recall list; and when in the public interest there is a need, that there be a press release announcing the recall. The effectiveness check for such a recall would be made on removal adequacy at levels reflecting the degree of consumer hazard associated with the violation.

Class III Recalls

Class III recalls represent routine situations in which the consequences to life are remote or non-existent. These would involve recalls because of adulteration or misbranding not involving a health hazard. They might also include defects in food relating to esthetic qualities, label violations, etc. Removal in such cases would be made to the wholesale level and mention would be made of the recall on the public recall list. A press release ordinarily would not be issued but the FDA would consider each case in the light of the particular circumstances. Effectiveness checks for a Class III recall would be an exception rather than the rule. FDA may request the firm to submit a statement attesting to the amount of stocks returned and the disposition of them.

Market Withdrawals

In addition to the three classes of recalls, the FDA procedure provides for Market Withdrawals. Market Withdrawals include removals of products from the market involving no violations or only minor violations that would not be subject to legal action under existing compliance policy. No effectiveness check is required for Market Withdrawals and these actions are not placed on the FDA Weekly Recall List.

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