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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public as defined in §20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in §20.61 of this chapter.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記錄
(a)一般要求,本部分所要求的所有記錄須包括:
(1)本部分所要求的所有記錄必須保存在加工廠,或進(jìn)口商在美國(guó)的商務(wù)處,冷藏品的記錄至少要保存一年,冷凍、腌制或貨架期穩(wěn)定的產(chǎn)品至少要保存兩年。
(2)所記錄活動(dòng)的日期和時(shí)間
(3)操作執(zhí)行者的簽名或者首寫字母,以及
(4)必要時(shí),對(duì)產(chǎn)品和生產(chǎn)編號(hào)的識(shí)別。加工和其它信息在觀察時(shí)要及時(shí)記錄。
(b)記錄的保存
(1)本部分所要求的所有記錄必須保存在加工廠,或進(jìn)口商在美國(guó)的商務(wù)處,冷藏品的記錄至少要保存一年,冷凍、腌制或貨架期穩(wěn)定的產(chǎn)品至少要保存兩年。
(2)加工者正在使用的,與設(shè)備和工藝的適用性有關(guān)的記錄,包括科學(xué)研究和評(píng)估結(jié)果,必須在加工廠或進(jìn)口商在美國(guó)的商務(wù)處保存兩年以上。
(3)如果加工廠要在生產(chǎn)季節(jié)的間隔期停產(chǎn)一段時(shí)間,或者在加工船上存放記錄的位置有限,或者是在一個(gè)偏遠(yuǎn)的加工點(diǎn),記錄可以在季節(jié)生產(chǎn)結(jié)束時(shí)轉(zhuǎn)送到其他適當(dāng)?shù)牡攸c(diǎn),但在官方需要審查時(shí),必須能立即取回。
(c)官方復(fù)查:本部分要的所有記錄、計(jì)劃和加工工序在適當(dāng)時(shí)候,必須能提供給官方復(fù)查和復(fù)制。
(d)資料的公開
(1)由于本條款(d)段(2)的限制,本部分所要求的計(jì)劃和記錄不許對(duì)外公開,除非按照本章§120.81的規(guī)定,原先已對(duì)外公開,或者它們與業(yè)已淘汰的產(chǎn)品和配方有關(guān),或者它們已不再是本章§120.61所定義的貿(mào)易機(jī)密、商業(yè)秘密或金融情報(bào)。
(2)然而,對(duì)于公眾可通過(guò)其它途徑獲得,或外傳后不會(huì)導(dǎo)致競(jìng)爭(zhēng)上的不利,如反映標(biāo)準(zhǔn)工廠規(guī)范的HACCP計(jì)劃樣板,這些記錄可以公開。
(e)標(biāo)簽。123.3(t)定義的標(biāo)簽除非完全符合§123.28(c)的要求;否則不運(yùn)用本部分要求。
(f)電腦存儲(chǔ)的記錄。可以使用電腦保存記錄,但必須采取相應(yīng)的控制措施,以保證電子數(shù)據(jù)和簽名的完整性。
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