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1、本模塊作為審核指南,完成模塊中內(nèi)審的考核以確定被審公司是否符合可樂(lè)要求YesDivNo1T-22334561) Questio nn aire:1. Is there a HACCP study in place? 有沒(méi)有進(jìn)行 HACC學(xué)習(xí)2. Does the organization meet HACCP program requirements?組織符合 HACCP要求嗎3. Is the HACCP team assembled?組建了 HACCP、組嗎4. Are all type of products described properly with inten ded use?各

2、種產(chǎn)品的預(yù)期用途作了適當(dāng)描述嗎5. Are there flow diagrams available?有流程圖嗎6. Does the operation have a Hazard Analysis?有危害 分析嗎7. Are all CCPs identified properly? 所有的 CCPs得到識(shí)別嗎8. Are monitoring procedures established for each CCP?對(duì) CCP點(diǎn)有監(jiān)控程序嗎9. Are corrective actions addressed properly for each CCP?有 CCP點(diǎn)的纟片正措施嗎10.

3、Are verification and validation procedures established?建立了驗(yàn)證與確認(rèn)程序嗎11. Are documentation and record keeping requirements established?所有文件與記錄要求得到保存嗎2) Refere nee Stan dards List:Beverage Operati ons Manual* BO-RQ-770Hazard An alysis and Critical Co ntrol Poi nts (HACCP)ProgramTCCQS updates are capture

4、d till December 15, 20053) Specificati ons and Requireme nts Summary:Gen eralSpecificatio ns / Requireme nts1Is there a HACCP study in place?是否有HACC研討B(tài)O-RQ-770 Study is done by follow ing the seve n-pri nciple, twelve-step model described in Codex Alime ntarius and releva nt local authority.進(jìn)行法典里面七大

5、原理、十二步驟的學(xué)習(xí)包括相關(guān)的 地方法規(guī)* All prerequisite requireme nts are met prior to applicatio n e.g. san itatio n, pers onnel hygie ne, GMP, trai ning etc.(Refer to docume nt BO-RQ-770 for prerequisite requireme nts)所有的前提條件都得到滿(mǎn)足,例如:個(gè)人衛(wèi)生、衛(wèi)生 消毒、GM嗣培訓(xùn)等(詳見(jiàn)BO-RQ-7702Does the orga ni zati on meet HACCP program require

6、me nts?組織結(jié)構(gòu)是否符合HACCP? 求?BO-RQ-770 Full commitme nt and invo Iveme nt of man ageme nt and the workforce承諾與全員參與 Reviewed at least annu ally至少要有年度審核 Updates take place each time a cha nge is made to the process, product, or equipme nt當(dāng)工藝、產(chǎn)品或是設(shè)備發(fā)生改變時(shí)的更新 HACCP must be defi ned separately by product type,

7、 process, li ne and locati on. HACC須界定產(chǎn)品類(lèi)型、工藝和生產(chǎn)線(xiàn)還有場(chǎng)所 All pers onnel invo Ived must be trained in HACCP prin ciples.相關(guān)人員須要有HACC原理培訓(xùn)3Is the HACCP team assembled?是否建立了 HACC小組?Typical HACCP team in cludes represe ntatives from engin eeri ng, product ion, san itatio n, quality, and microbiology 一般的HACCP

8、、組隊(duì)員應(yīng)包含 工程、生產(chǎn)、殺菌、品質(zhì)、微 生物等各部門(mén)人員BO-RQ-770 A local HACCP coordi nator or a team leader is appo in ted. 一個(gè)本廠的HACC協(xié)調(diào)員或小組領(lǐng)導(dǎo)是不可缺的 HACCP team con sists of in dividuals with the kno wledge of process and product and expertise to develop an effective program.由各經(jīng)驗(yàn)豐富人員專(zhuān)家組成的 HACCP、組制定一個(gè)有 效的程序 Scope is defi ned b

9、y HACCP teamHACC小組范圍界定4Are all type of products described properly with inten ded use?對(duì)各類(lèi)的意圖使用進(jìn)行了描述 嗎BO-RQ-770 HACCP team develops a full description of the product in cludi ng: HACC小組制定一個(gè)詳細(xì)的產(chǎn)品描述- Product n ame-產(chǎn)品名稱(chēng)- Releva nt food safety info (physical, chemical structure, compositi on,-相關(guān)的食品安全信息(物

10、理的、化學(xué)結(jié)構(gòu)、組 份)- substa nces food con tact materials)-食品接觸材料- Process / preservati on method-工藝與保存方法- Packagi ng- 包裝- Distributio n and storage (durati on andshelf-life, storage con diti ons, distribution and transportation means)-分銷(xiāo)與貯存(產(chǎn)品保質(zhì)期、存貯條件、運(yùn)輸與 分銷(xiāo)方法)- Normal and expected use of the product and a

11、ny vuln erable groups of populati on-產(chǎn)品的正常和預(yù)期用途,不適用人群5Are there flow diagrams available?有流程圖BO-RQ-770 Flow diagrams coveri ng each step in the process within the scope are available.有流程圖在工藝范圍內(nèi)涵蓋每一個(gè)步驟 Diagrams in clude outsourced processes,subc on tracted work, rework, recycli ng and waste removal.流程

12、圖包括代加工、返工、重做、回收和要扔掉廢棄 物 Flow diagrams are con firmed to be correct by compari ng them to actual operati ons.確認(rèn)流程圖是根據(jù)實(shí)際操作情況作了修訂6Does the operati on have a Hazard An alysis?操作是否有危害分析A sig nifica nt food safety hazard in one operatio n may not be sig nifica nt in an other operati on produci ng the same

13、 or similar product.在一個(gè)操作中的食物安全危害 的嚴(yán)重性在另一個(gè)生產(chǎn)同樣或 類(lèi)似產(chǎn)品的操作中可能不是重 大危害A Supportive Safety Measure may be a process , procedure or comp onent of a functioning prerequisite program such as GMP.食品安全的支持程序包括建立 有效的程序或組成部分,如BO-RQ-770* All potential biological, chemical and/or physical hazards are listed and cat

14、egorized.有潛在的生物的、化學(xué)的、物理的危害要列出來(lái)并分 類(lèi) A hazard an alysis is con ducted to ide ntify which hazards are of a n ature that their preve nti on, elim in ati on or reducti on to acceptable level is esse ntial.通過(guò)危害分析確認(rèn)哪一種危害是可以預(yù)防或消除或減 少到可接受水平 Each hazard is evaluated aga in st:通過(guò)下列因素評(píng)估每個(gè)危害- Severity or serious

15、 ness-嚴(yán)重性- Likeli ness to occur-發(fā)生的可能性- Scie ntific data about the n ature of the hazard-關(guān)于危害點(diǎn)的科學(xué)數(shù)據(jù)分析- Con sumer compla ints data-消費(fèi)者投訴資料- Effective ness of existi ng con trol measures-現(xiàn)行控制點(diǎn)的有效性* Records of deliberati ons and rati onal developedGMP.duri ng the an alysis is main tai ned.保存危害點(diǎn)分析過(guò)程中合理的

16、數(shù)據(jù)分析記錄 Con trol measures are decided and categorized a“Critical Control Measures” or SupportiveControl Measures ”確定控制措施并分為“關(guān)鍵控制點(diǎn)”或“次要控制 占”八、 Where a potential hazard is specifically addressed in a HACCP pla n, it is categorized as“significant food safety hazard” and a“Critical Control Measure” is es

17、tablished foreach CCP.如果一個(gè)潛在危害在HACC綱要里被特別說(shuō)明,就可 歸為“重大食品安全危害”并建立一個(gè)“關(guān)鍵控制 點(diǎn)”來(lái)解決每個(gè)CCP An alysis is con ducted for each product type and producti on line and repeated prior to anycha nge in in gredie nts, packag ing materials, product use, formulati on and product ion line layout.危害點(diǎn)分析應(yīng)針對(duì)每一種類(lèi)型的產(chǎn)品、每條生 產(chǎn)線(xiàn),并

18、且在配方、包裝、材料、產(chǎn)品的使用、規(guī) 格及生產(chǎn)線(xiàn)布局變化時(shí)重新進(jìn)行7Are all CCPs identified properly?所有CCP點(diǎn)都得到確認(rèn)嗎? At a process step where con trol is n ecessary for a sig nifica nt hazard, yet no con trol measure exists, the product or process must be modified at that step, or at any earlier or later stage, to in clude a con trol m

19、easure.在某一可能產(chǎn)生重大危害的處 理環(huán)節(jié),應(yīng)有控制點(diǎn)存在,則 在此環(huán)節(jié)的生產(chǎn)或流程必須修 改,或在此環(huán)節(jié)之前(之后) 存在控制點(diǎn)的環(huán)節(jié)必須修改 More tha n one con trol measure may con trol a sig nifica nt hazard; a sin gle Critical con trol measure may con trol more tha n one.BO-RQ-770 Each sig ni fica nt hazard is addressed in determi ning CCPs.每個(gè)嚴(yán)重危害都被確認(rèn)為CCP占 Iden

20、tification for each CCP is accurate and complete.每一個(gè)CCP占的識(shí)別是準(zhǔn)確、完整的 Each CCP is每個(gè)CCP是- Justifiable-合理的-Validated-有效的- Measurable-可度量的-Carefully developed-仔細(xì)判斷的to en sure its effective ness.以確保其有效性 Records for each CCP determ in atio n are available.對(duì)每一個(gè)CCP占的確定所作的各種記錄應(yīng)保存完好 CCPs are mon itored and the

21、procedure /method is一種或以上的控制措施可以只 針對(duì)一個(gè)重大危害,一個(gè)關(guān)鍵 控制點(diǎn)措施可以針對(duì)多于一個(gè) 的危害點(diǎn)In some cases more tha n one Critical limit may be elaborated at a CCP.某些情況下,一個(gè)以上的關(guān)鍵 限值可用于一個(gè)CCP點(diǎn)docume nted in HACCP pla n. CCP點(diǎn)的受控流程/方法應(yīng)在HACC計(jì)劃書(shū)中規(guī)定 HACCP team specified, validated and docume nted the justification and measurement cri

22、teria for critical limits at each CCP. HACC小組應(yīng)對(duì)每一個(gè)CCP關(guān)鍵限值作出定義,確認(rèn) 的理由及測(cè)量標(biāo)準(zhǔn)有效性的確認(rèn),并形成文件化 Critical limits are scientifically based and measurable.關(guān)鍵限值要建立在科學(xué)的基礎(chǔ)上并可度量8Are mon itori ng procedures established for each CCP? 每個(gè)CCP點(diǎn)是否都建立監(jiān)控程 序?Whe n feasible, con ti nu ous mon itori ng is always preferred.若條件許

23、可,持續(xù)性監(jiān)控最理 想BO-RQ-770 All activities associated with con trol of CCP and the acti ons to take whe n any deviati on occurs are addressed in HACCP pla n.所有關(guān)于控制CCP點(diǎn)和發(fā)生偏差時(shí)采取扌日施的要在 HACCP岡要里說(shuō)明 Each CCP is effectively mon itored.每個(gè)CCP點(diǎn)要得到有效監(jiān)控 Mon itori ng procedure for a CCP in cludes對(duì)于CCP點(diǎn)的監(jiān)控措施包括- Schedule

24、d physical, chemical or microbiological measureme nt or observation of a CCP relative to its critical limit to in dicate con trol of the process-對(duì)于CCP點(diǎn)的關(guān)鍵限值控制過(guò)程應(yīng)為定期的理 化、微生物指標(biāo)的檢測(cè)或觀察- Detectio n of loss of con trol at the CCP and definition of how to be monitored-防止CCP點(diǎn)偏離限值的監(jiān)控方法- Evaluati on of the mo

25、n itori ng data by a resp on sible pers on with thek no wledge and authority to carry out corrective acti ons-由具備執(zhí)行糾正措施能力及授權(quán)負(fù)責(zé)人對(duì)監(jiān)控 數(shù)據(jù)進(jìn)行評(píng)估- Sufficie nt freque ncy of mon itori ng , if not continu ous-若非持續(xù)監(jiān)控,則應(yīng)制定保證監(jiān)控效果的足夠 頻率 All records and docume nt associated with CCP mon itori ng are dated and sig

26、ned by the pers on resp on sible for mon itori ng and by a man ageme nt represe ntative trained in HACCP for evaluati on (typically HACCP coordi nator)*所有與CCF點(diǎn)監(jiān)控相關(guān)的記錄與文件應(yīng)有日期記錄, 并由負(fù)責(zé)監(jiān)控的人員及受過(guò) HACC評(píng)估培訓(xùn)(最好是HACC協(xié)調(diào)員)的管理代表簽字確認(rèn)Personnel monitoring the CCP fully understand their purpose and importa nee and t

27、rained in the mon itori ng tech nique that he/she is resp on sible.監(jiān)控CCP點(diǎn)的人員要完全理解他們工作的目的和重要 性,并在所負(fù)責(zé)的監(jiān)控技術(shù)方面受過(guò)培訓(xùn)9Are corrective acti ons addressed properly for each CCP?每個(gè)CCP點(diǎn)都有采取適當(dāng)?shù)母?正措施嗎?BO-RQ-770 Specific corrective actions are developed and docume nted for each CCP.對(duì)每一個(gè)CCP都指定糾偏行動(dòng),并文件化 At a mi nimu

28、m, these activities are specified in HACCP pla n as: HACC計(jì)劃書(shū)中至少應(yīng)明確下列項(xiàng)目- what to do whe n a deviati on occurs-當(dāng)發(fā)生偏離時(shí)該做什麼- who is resp on sible for impleme nti ng corrective actions-誰(shuí)負(fù)責(zé)執(zhí)行糾偏措施- the developme nt and maintenance of a record of actions take n and results.-采取的糾編行動(dòng)及結(jié)果的記錄的建立及保持10Are verifica

29、tion and validati on procedures established?是否建立驗(yàn)證和確認(rèn)程序?BO-RQ-770* Verificati on freque ncy for HACCP pla n is max.12 mon ths, and also takes place whe n cha nges occur that could affect hazard an alysis or HACCP pla n.驗(yàn)證HACC計(jì)劃的頻率至少每年一次,此外當(dāng)發(fā)生了 能影響到危害分析或HACC計(jì)劃的變化后也應(yīng)進(jìn)行驗(yàn) 證 Verification procedure includ

30、es:驗(yàn)證內(nèi)容包括- Review of hazard an alysis docume ntati on-審核危害分析書(shū)- Review of audit results, which review occurs withi n seve n days from the day the records are made-審核結(jié)果的復(fù)查,復(fù)查應(yīng)在審核記錄7日內(nèi)進(jìn)行- Review of process mon itori ng data for con firmati on that CCPs are kept un der con trol-確保CCP處于控制之下的各工序監(jiān)控?cái)?shù)據(jù)的復(fù) 查(確定關(guān)鍵控制點(diǎn)處于控制中)- Calibratio n of process mon itori ng in strume nts-過(guò)程監(jiān)控及測(cè)量設(shè)備的校準(zhǔn)- Communi cati on of verificati on results to the HACCP team.-與HACCP、組交流驗(yàn)證結(jié)果* Validatio n of HACCP program in cludes acti ons to confirm the eleme nt

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