ABSTRACT
No matter how complete the quality systems and process controls are within a company, it is inevitable that an ingredient, packaging material, or intermediate or finished good will be considered out of specification. This might be for any possible reason, varying from food safety issues such as physical, microbiological, chemical, or allergenic contamination to just a quality issue such as granulation, color, or appearance. 21CFR110.80(b)9 states that “food, raw materials, and other ingredients that are adulterated within the meaning of the act shall be disposed of in a manner that protects against the contamination of other food.” Additionally, section 110.80(a)5 says that “material scheduled for rework shall be identified as such.” The way a company meets these legal requirements and handles these substandard products correctly is outlined in its hold/defective material program. The three basic parts to an effective hold/defective are the hold process, the release process, and the destruction process-each of which is supported by adequate record keeping.
