§123.9 HACCP记录(Records)

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   　　§ 123.9   Records.

　　（a） General requirements. All records required by this part shall include:

　　（1） The name and location of the processor or importer;

　　（2） The date and time of the activity that the record reflects;

　　（3） The signature or initials of the person performing the operation; and

　　（4） Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.

　　（b） Record retention. （1） All records required by this part shall be retained at the processing facility or importer's place of business in the United States for at least 1 year after the date they were prepared in the case of refrigerated products and for at least 2 years after the date they were prepared in the case of frozen, preserved, or shelf-stable products.

　　（2） Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility or the importer's place of business in the United States for at least 2 years after their applicability to the product being produced at the facility.

　　（3） If the processing facility is closed for a prolonged period between seasonal packs, or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack but shall be immediately returned for official review upon demand.

　　（c） Official review. All records required by this part and all plans and procedures required by this part shall be available for official review and copying at reasonable times.

　　（d） Public disclosure. （1） Subject to the limitations in paragraph （d）（2） of this section, all plans and records required by this part are not available for public disclosure unless they have been previously disclosed to the public as defined in §20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in §20.61 of this chapter.

　　（2） However, these records and plans may be subject to disclosure to the extent that they are otherwise publicly available, or that disclosure could not reasonably be expected to cause a competitive hardship, such as generic-type HACCP plans that reflect standard industry practices.

　　（e） Tags. Tags as defined in §123.3（t） are not subject to the requirements of this section unless they are used to fulfill the requirements of §123.28（c）.

　　（f） Records maintained on computers. The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.

　　§123.9记录

　　（a）一般要求，本部分所要求的所有记录须包括：

　　（1）本部分所要求的所有记录必须保存在加工厂，或进口商在美国的商务处，冷藏品的记录至少要保存一年，冷冻、腌制或货架期稳定的产品至少要保存两年。

　　（2）所记录活动的日期和时间

　　（3）操作执行者的签名或者首写字母，以及

　　（4）必要时，对产品和生产编号的识别。加工和其它信息在观察时要及时记录。

　　（b）记录的保存

　　（1）本部分所要求的所有记录必须保存在加工厂，或进口商在美国的商务处，冷藏品的记录至少要保存一年，冷冻、腌制或货架期稳定的产品至少要保存两年。

　　（2）加工者正在使用的，与设备和工艺的适用性有关的记录，包括科学研究和评估结果，必须在加工厂或进口商在美国的商务处保存两年以上。

　　（3）如果加工厂要在生产季节的间隔期停产一段时间，或者在加工船上存放记录的位置有限，或者是在一个偏远的加工点，记录可以在季节生产结束时转送到其他适当的地点，但在官方需要审查时，必须能立即取回。

　　（c）官方复查：本部分要的所有记录、计划和加工工序在适当时候，必须能提供给官方复查和复制。

　　（d）资料的公开

　　（1）由于本条款（d）段（2）的限制，本部分所要求的计划和记录不许对外公开，除非按照本章§120.81的规定，原先已对外公开，或者它们与业已淘汰的产品和配方有关，或者它们已不再是本章§120.61所定义的贸易机密、商业秘密或金融情报。

　　（2）然而，对于公众可通过其它途径获得，或外传后不会导致竞争上的不利，如反映标准工厂规范的HACCP计划样板，这些记录可以公开。

　　（e）标签。123.3（t）定义的标签除非完全符合§123.28（c）的要求；否则不运用本部分要求。

　　（f）电脑存储的记录。可以使用电脑保存记录，但必须采取相应的控制措施，以保证电子数据和签名的完整性。

　　更多有关美国FDA水产品HACCP法规内容，请点击美国FDA水产品HACCP法规汇总。