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§417.5 HACCP計(jì)劃的記錄(Records)

   2011-04-19 中國(guó)食品網(wǎng)中食網(wǎng)10110

  原文后附帶中文翻譯,由食品伙伴網(wǎng)食品論壇網(wǎng)友gaoketian提供,食品伙伴網(wǎng)在此表示感謝! 

       § 417.5   Records.

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

 ?。?) 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.

 ?。?) 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.

 ?。╞) 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.

 ?。╟) 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 inpidual who did not produce the record(s), preferably by someone trained in accordance with §417.7 of this part, or the responsible establishment official.

 ?。╠) 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.

 ?。╡) 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.

 ?。?) 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.

 ?。╢) 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(yè)必須保留下列證實(shí)該企業(yè)HACCP計(jì)劃的記錄:

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

 ?。?)書面的HACCP計(jì)劃,包括與選擇和制定關(guān)鍵控制點(diǎn)和關(guān)鍵限值有關(guān)的作出決定的文件,及所選擇的監(jiān)測(cè)和審核程序及這些程序的頻率的支持性文件。

 ?。?)按企業(yè)HACCP計(jì)劃規(guī)定包括記錄的實(shí)際時(shí)間、溫度或其它可定量的數(shù)值在內(nèi)的:證實(shí)監(jiān)測(cè)關(guān)鍵控制點(diǎn)和其關(guān)鍵限值;加工過(guò)程中監(jiān)測(cè)儀器的校正;包括相對(duì)于偏離所采取的所有工作在內(nèi)的糾正措施;審核程序和結(jié)果,產(chǎn)品代碼,產(chǎn)品名稱或標(biāo)記,或屠宰產(chǎn)品每批的記錄。每種記錄都必須包括作記錄的日期。

 ?。╞)發(fā)生特殊事件時(shí)HACCP計(jì)劃所保留的記錄中的每項(xiàng)都必須記錄,還必須記錄的日期和時(shí)間,必須由進(jìn)行登記的企業(yè)雇員簽名或草薟。

  (c)產(chǎn)品裝運(yùn)前企業(yè)必須按照本節(jié)證明的,檢查與那種產(chǎn)品生產(chǎn)有關(guān)的記錄,為保證完整性,可能的話,還應(yīng)包括符合所有關(guān)健限值的決定,包括對(duì)產(chǎn)品進(jìn)行適當(dāng)處理在內(nèi)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(guò)培訓(xùn)的某個(gè)人或企業(yè)的負(fù)責(zé)官員進(jìn)行,并簽名和簽署日期。

 ?。╠)計(jì)算機(jī)保留的記錄

  可采用計(jì)算機(jī)保留記錄,但要進(jìn)行適當(dāng)?shù)目刂埔员WC電子日期和簽名的完整性。

 ?。╡)記錄的保持

 ?。?) 企業(yè)必須按本節(jié)(a)(3)段要求保存以下所有記錄:

  屠宰工作至少一年

  冷藏產(chǎn)品至少一年

  冷凍,防腐或貨架穩(wěn)定的產(chǎn)品至少兩年

 ?。?) 按本節(jié)(a)(3)段要求允許在6個(gè)月后現(xiàn)場(chǎng)外保留記錄,如FSIS雇員需要,這種記錄可在24小時(shí)內(nèi)收回現(xiàn)場(chǎng)并給予提供。

 ?。╢)官方復(fù)查:

  本部分所要求的所有記錄,所有計(jì)劃和程序都必須提供給官方復(fù)查和拷貝。

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