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§417.5 HACCP計劃的記錄(Records)

   2011-04-19 435
核心提示:  原文后附帶中文翻譯,由食品伙伴網食品論壇網友gaoketian提供,食品伙伴網在此表示感謝! 417.5 Records.  (a) The est

  原文后附帶中文翻譯,由食品伙伴網食品論壇網友gaoketian提供,食品伙伴網在此表示感謝! 

       § 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記錄

  (a)企業必須保留下列證實該企業HACCP計劃的記錄:

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

  (2)書面的HACCP計劃,包括與選擇和制定關鍵控制點和關鍵限值有關的作出決定的文件,及所選擇的監測和審核程序及這些程序的頻率的支持性文件。

  (3)按企業HACCP計劃規定包括記錄的實際時間、溫度或其它可定量的數值在內的:證實監測關鍵控制點和其關鍵限值;加工過程中監測儀器的校正;包括相對于偏離所采取的所有工作在內的糾正措施;審核程序和結果,產品代碼,產品名稱或標記,或屠宰產品每批的記錄。每種記錄都必須包括作記錄的日期。

  (b)發生特殊事件時HACCP計劃所保留的記錄中的每項都必須記錄,還必須記錄的日期和時間,必須由進行登記的企業雇員簽名或草薟。

  (c)產品裝運前企業必須按照本節證明的,檢查與那種產品生產有關的記錄,為保證完整性,可能的話,還應包括符合所有關健限值的決定,包括對產品進行適當處理在內的所采取的糾正措施。在可行的地方,這種檢查必須由不作記錄的人員,最好由按本部417.7受過培訓的某個人或企業的負責官員進行,并簽名和簽署日期。

  (d)計算機保留的記錄

  可采用計算機保留記錄,但要進行適當的控制以保證電子日期和簽名的完整性。

  (e)記錄的保持

  (1) 企業必須按本節(a)(3)段要求保存以下所有記錄:

  屠宰工作至少一年

  冷藏產品至少一年

  冷凍,防腐或貨架穩定的產品至少兩年

  (2) 按本節(a)(3)段要求允許在6個月后現場外保留記錄,如FSIS雇員需要,這種記錄可在24小時內收回現場并給予提供。

  (f)官方復查:

  本部分所要求的所有記錄,所有計劃和程序都必須提供給官方復查和拷貝。



 
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