§114.100 酸化食品的记录(Records)

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　　   § 114.100   Records.

　　（a） Records shall be maintained of examinations of raw materials, packaging materials, and finished products, and of suppliers' guarantees or certifications that verify compliance with Food and Drug Administration regulations and guidance documents or action levels.

　　（b） Processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, shall be maintained and shall contain sufficient additional information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production.

　　（c） All departures from scheduled processes having a possible bearing on public health or the safety of the food shall be noted and the affected portion of the product identified; these departures shall be recorded and made the subject of a separate file （or log identifying the appropriate data） delineating them, the action taken to rectify them, and the disposition of the portion of the product involved.

　　（d） Records shall be maintained identifying initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use.

　　（e） Copies of all records provided for in paragraphs （b）, （c）, and （d） of this section shall be retained at the processing plant or other reasonably accessible location for a period of 3 years from the date of manufacture.

　　[44 FR 16235, Mar. 16, 1979, as amended at 65 FR 56479, Sept. 19, 2000]

　　§114.100记录

　　（a）必须保存下列记录：原材料、包装材料和成品的检测记录；供应商的担保或者证书，以证实符合食品与药物管理局的规章和指标或者使用范围。

　　（b）表示遵守工艺规程的加工（杀菌）和生产的记录，测量pH的记录和其它确保产品安全的关键因素的记录都必须保存好。另外还须包括足够的其它资料，如产品代号、日期、容器规格和产品，以备对每批产品或部分产品进行公共卫生危害性检验时用。

　　（c）对于违背工艺规程，可能带有健康或卫生问题的食品必须加以说明，受影响的部分食品必须加以区分。与工艺规程的偏差必须记录下来，并单独存档（或者记录适当的数据），所采取的纠正方法以及有关产品的处理都必须记录在案。

　　（d）必须保存产品成品初始分销记录。这样，在必要时就可以把可能受污染的，或因其它原因不适宜使用的食品按批号区分出来。

　　（e）本节（b），（c）和（d）中规定的记录文本必须在加工厂或其它合适的、便于到达的地方保存起来，保存期从制造日起3年。

　　更多关于美国FDA酸化食品HACCP法规，请详见美国FDA酸化食品HACCP法规第113和114部分汇总