§417.5 HACCP计划的记录(Records)

　　原文后附带中文翻译，由食品伙伴网食品论坛网友gaoketian提供，食品伙伴网在此表示感谢！　

       § 417.5   Records.

　　（a） The establishment shall maintain the following records documenting the establishment's HACCP plan:

　　（1） The written hazard analysis prescribed in §417.2（a） of this part, including all supporting documentation;

　　（2） The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP's and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

　　（3） Records documenting the monitoring of CCP's and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment's HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code（s）, product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

　　（b） Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.

　　（c） Prior to shipping product, the establishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure completeness, including the determination that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record（s）, preferably by someone trained in accordance with §417.7 of this part, or the responsible establishment official.

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

　　（e） Record retention. （1） Establishments shall retain all records required by paragraph （a）（3） of this section as follows: for slaughter activities for at least one year; for refrigerated product, for at least one year; for frozen, preserved, or shelf-stable products, for at least two years.

　　（2） Off-site storage of records required by paragraph （a）（3） of this section is permitted after six months, if such records can be retrieved and provided, on-site, within 24 hours of an FSIS employee's request.

　　（f） 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.

　　§417.5记录

　　（a）企业必须保留下列证实该企业HACCP计划的记录：

　　（1）本部分417.2（a） 规定的书面的危害分析，包括所有的支持性文件。

　　（2）书面的HACCP计划，包括与选择和制定关键控制点和关键限值有关的作出决定的文件，及所选择的监测和审核程序及这些程序的频率的支持性文件。

　　（3）按企业HACCP计划规定包括记录的实际时间、温度或其它可定量的数值在内的：证实监测关键控制点和其关键限值；加工过程中监测仪器的校正；包括相对于偏离所采取的所有工作在内的纠正措施；审核程序和结果，产品代码，产品名称或标记，或屠宰产品每批的记录。每种记录都必须包括作记录的日期。

　　（b）发生特殊事件时HACCP计划所保留的记录中的每项都必须记录，还必须记录的日期和时间，必须由进行登记的企业雇员签名或草莶。

　　（c）产品装运前企业必须按照本节证明的，检查与那种产品生产有关的记录，为保证完整性，可能的话，还应包括符合所有关健限值的决定，包括对产品进行适当处理在内的所采取的纠正措施。在可行的地方，这种检查必须由不作记录的人员，最好由按本部417.7受过培训的某个人或企业的负责官员进行，并签名和签署日期。

　　（d）计算机保留的记录

　　可采用计算机保留记录，但要进行适当的控制以保证电子日期和签名的完整性。

　　（e）记录的保持

　　（1） 企业必须按本节（a）（3）段要求保存以下所有记录：

　　屠宰工作至少一年

　　冷藏产品至少一年

　　冷冻，防腐或货架稳定的产品至少两年

　　（2） 按本节（a）（3）段要求允许在6个月后现场外保留记录，如FSIS雇员需要，这种记录可在24小时内收回现场并给予提供。

　　（f）官方复查：

　　本部分所要求的所有记录，所有计划和程序都必须提供给官方复查和拷贝。