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!
§ 123.8 Verification.
?。╝) Overall verification. Every processor shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include, at a minimum:
?。?) Reassessment of the HACCP plan. A reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way or at least annually. Such changes may include changes in the following: Raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product. The reassessment shall be performed by an inpidual or inpiduals who have been trained in accordance with §123.10. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of §123.6(c).
?。?) Ongoing verification activities. Ongoing verification activities including:
?。╥) A review of any consumer complaints that have been received by the processor to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;
?。╥i) The calibration of process-monitoring instruments; and,
?。╥ii) At the option of the processor, the performing of periodic end-product or in-process testing.
(3) Records review. A review, including signing and dating, by an inpidual who has been trained in accordance with §123.10, of the records that document:
?。╥) The monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within 1 week of the day that the records are made;
?。╥i) The taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with §123.7. This review shall occur within 1 week of the day that the records are made; and
(iii) The calibrating of any process control instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the processor's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the processor's written procedures. These reviews shall occur within a reasonable time after the records are made.
?。╞) Corrective actions. Processors shall immediately follow the procedures in §123.7 whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.
?。╟) Reassessment of the hazard analysis. Whenever a processor does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur, the processor shall reassess the adequacy of that hazard analysis whenever there are any changes that could reasonably affect whether a food safety hazard now exists. Such changes may include, but are not limited to changes in: Raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product. The reassessment shall be performed by an inpidual or inpiduals who have been trained in accordance with §123.10.
?。╠) Recordkeeping. The calibration of process-monitoring instruments, and the performing of any periodic end-product and in-process testing, in accordance with paragraphs (a)(2)(ii) through (iii) of this section shall be documented in records that are subject to the recordkeeping requirements of §123.9.
§123.8驗(yàn)證
?。╝)總體驗(yàn)證。每個(gè)加工者都必須驗(yàn)證其HACCP計(jì)劃能有效控制有理由而且有可能發(fā)生的食品安全危害,且計(jì)劃得到有效執(zhí)行。驗(yàn)證至少包括以下內(nèi)容:
?。?)對(duì)HACCP計(jì)劃的復(fù)審。當(dāng)發(fā)生任何可能影響危害分析的變化,或在任何方面改變HACCP計(jì)劃,或者至少每個(gè)年度,都要對(duì)HACCP計(jì)劃的適用性進(jìn)行復(fù)審。這些變化可以是:原料或原料來(lái)源,產(chǎn)品配方,加工方法或體系,成品銷(xiāo)售體系或預(yù)期用途和用戶(hù)。復(fù)審必須由經(jīng)過(guò)按照§123.10培訓(xùn)的人員進(jìn)行。當(dāng)復(fù)審表明計(jì)劃已不再完全符合§123.6(c)的要求時(shí),必須立即修改HACCP計(jì)劃。
?。?)實(shí)施驗(yàn)證措施。包括:
?。╥)復(fù)查加工者收到的各種消費(fèi)者投訴,以確定它們是否與關(guān)鍵控制點(diǎn)的執(zhí)行有關(guān),或發(fā)現(xiàn)存在有尚未識(shí)別的關(guān)鍵控制點(diǎn);
?。╥i)工序監(jiān)測(cè)儀器的校正;
?。á#└鶕?jù)加工者的選擇,定期進(jìn)行成品和半成品的檢驗(yàn)。
(3)復(fù)查記錄。復(fù)查包括簽字和日期,由經(jīng)過(guò)按§123.10培訓(xùn)的人員進(jìn)行,內(nèi)容包括:
?。╥)關(guān)鍵控制點(diǎn)的監(jiān)測(cè)。復(fù)查至少是為了確保記錄的完整,并且證實(shí)記錄所記的數(shù)據(jù)是在關(guān)鍵限值內(nèi),復(fù)查必須在作記錄后一周內(nèi)進(jìn)行。
?。áⅲ┎扇〖m正措施。復(fù)查至少是為了確保記錄完善,并且證實(shí)按照§123.7采取了糾正措施。復(fù)查必須在作記錄后一周內(nèi)進(jìn)行。
?。á#┬UP(guān)鍵控制點(diǎn)上所用的工序監(jiān)控裝置,并進(jìn)行各種定期的成品和半成品檢驗(yàn),這是加工記錄。這些復(fù)查要在作記錄后合理的時(shí)間內(nèi)進(jìn)行。
(b)糾偏行動(dòng)。當(dāng)驗(yàn)證程序(包括對(duì)消費(fèi)者投訴的復(fù)查)顯示需要采取糾正措施時(shí),加工必須立即執(zhí)行§123.7的程序。
(c)危害分析的重新評(píng)估。由于危害分析表明無(wú)發(fā)生食品安全的可能和理由。而制定HACC計(jì)劃的加工者,當(dāng)出現(xiàn)任何可能會(huì)對(duì)食品安全危害的存在產(chǎn)生影響的變化時(shí),重新審查危害分析的適應(yīng)性。這些變化包括,但不限于:原料及其來(lái)源、產(chǎn)品配方、加工方法或體系,成品銷(xiāo)售體系或預(yù)期用途、成品的消費(fèi)者等變化。重新審查必須由經(jīng)過(guò)按照§123.10進(jìn)行培訓(xùn)的人員實(shí)施。
?。╠)記錄保存。按照本部分(a)段((2)(ii)至(iii),對(duì)工序監(jiān)按裝置的校正;成品和斗成品的定期檢驗(yàn)都要做好記錄,并符合123.9的記錄保存要求。
更多有關(guān)美國(guó)FDA水產(chǎn)品HACCP法規(guī)內(nèi)容,請(qǐng)點(diǎn)擊美國(guó)FDA水產(chǎn)品HACCP法規(guī)匯總。
更多國(guó)外法規(guī)翻譯,請(qǐng)聯(lián)系食品翻譯中心
編輯:foodfagui