haccp年會中英文演講38

HACCPintheFocusofGFSIApprovedStandardsMarjanSmitInternationalSupplierAuditing

HeadOfficeHACCPintheFocusofGFSIAppContentofthePresentationIntroductionofthesubjectHACCPinGFSIendorsedstandardsJudgingaHACCPstudyforanauditFrequentlyidentifiedNon-ConformitiesonHACCPduringanaudit.Summary.2ContentofthePresentationIntIntroductiontothesubject(1)EventhoughtheCodexisclearinitsdemandsaboutHACCP:everyindividualinterpretsthecriteriainadifferentway.EspeciallytheHazardAnalysisandDefiningtheCCP’sisdonedifferent.Someofourauditeeshaveusedacompleteteamofexpertsandproduced10HACCPbooks.Anotherauditeeappointedthequalitymanagertomakethestudyandhedelivers1HACCPbook.3Introductiontothesubject(1Introductiontothesubject(2)SomeauditeeshavenoHACCPbookatallbutcontrolalltherelevantCCP’s.Somecompanieshaveidentified74CCP’s,butthereal3CCP’sarecontrolledintherightway.Somecompanieshaveidentified3CCP’s,butselectedthewrongCCP’sandtherealCCPisnotcontrolled.4Introductiontothesubject(2Introductiontothesubject(3)Wehaveseen63differenttypesofdecisiontreesindifferentcountries.Wehaveidentifiedatleast27softwaresystemsforHACCP.PeoplewhodevelopHACCPintheirownfactorydothiswiththeirstateofknowledge:therearemorethan100interpretations.SupplierstothefoodindustryuseHACCPtosell:“YouNeedTheseLampsforHACCP………”5Introductiontothesubject(3HACCPinGFSIendorsedstandards(1)3KeyElementsofaGFSIConformingFoodSafetyStandards:FoodSafetyManagementSystemsGoodAgricultural/Manufacturing/DistributionPractices(GAP/GMP/GDP)HazardAnalysis&CriticalControlPoint(HACCP)6HACCPinGFSIendorsedstandarHACCPinGFSIendorsedstandards(2)“ThesubmittedstandardrequiresaHazardAnalysisandCriticalControlPoint(hereafter,HACCP)system,orequivalent,todemonstratefoodsafetymanagement.ThedescribedHACCPsystemshall…”--Page25,theGlobalFoodSafetyInitiativeGuidanceDocument,4thEdition7HACCPinGFSIendorsedstandarTherefore…TheHACCPanalyzingmethodcanbeappliedinmanydifferentways.Itistheresponsibilityofthefoodproducer(auditee)tomaketherightchoices.ItistheresponsibilityoftheauditortoseeifthesechoicescomplywiththeHACCPdemandsintheselectedstandard.8Therefore…TheHACCPanalyzingJudgingaHACCPStudyatanaudit(1)Fortheauditor,thedemandsintheauditedstandardisalwaysleadingtheway.Theauditorisnotallowedtosay:youhavetomakethispointinyourprocessaCCP.ThescopeoftheHACCPstudyhastocoverthescopeoftheaudit.9JudgingaHACCPStudyatanauJudgingaHACCPStudyatanaudit(2)HACCPwillalwaysbeoneofthefirstthingsauditorswilllookfor.InGFSIrecognizedstandardsHACCPisseenasanintegratedpartofprocesscontrol.However,thereisoneproblemfortheauditorwhoauditsagainstBRCorIFS:he/sheislimitedinhertime!!10JudgingaHACCPStudyatanauInordertocheckaHACCPstudyafollowingtoolisoftenused:Select1CCPandlettheauditeeexplaintheHACCPstudy-howtheycametothisCCP.Select1otherCCPandcheckhowthisiscontrolled,monitoredandregistered.Inthiswaytheauditorcan,veryeffectively,samplethestudyandformajudgment.JudgingaHACCPStudyatanaudit

(3)11InordertocheckaHACCPstudJudgingaHACCPstudyatanAudit(4)Elementsinthedocumentationthatarechecked:Doesthescopecoverallproductsandprocesses?ArethelastprocesschangesandnewproductscoveredintheHACCPstudy?TrainingrecordsontheHACCPteammembersIstheHazardanalysescomplete(productandprocess,microbiological,chemical,physicalallergens,etc)?12JudgingaHACCPstudyatanAuJudgingaHACCPstudyatanAudit(5)DidthecompanyusedliteraturetomakessurethattheselectedHazardarerelevant?Arethecriticallimitsbasedonstudiesonlegislationapplicablefortheactivity?AretheCCP’srelevantfortheindustry?HowdidthecompanyverifytheirHACCPstudy?13JudgingaHACCPstudyatanAuJudgingaHACCPstudyatanAudit(6)ArecorrectiveactionsonCCPthatwentoutofthecriticallimitstakenontimeandanalyzedtopreventreoccurrence?Duringthefactorytour,staffwillbeinterviewedtochecktheirknowhowandcontrolofCCPischeckedduringoperations.14JudgingaHACCPstudyatanAuNC’sonHACCPthatoftenappear

(1)Scopedoesnotcoverthecompleteproductrange:someprocessesarenotpartofthestudy.(outsourcing)Studyisperformedbyoneperson:notamultidisciplinaryteam.Studydoesnotincludetherealsituationbutisbasedontheory.Managementisnotcommitted.15NC’sonHACCPthatoftenappeaNC’sonHACCPthatoftenappear

(2)Hazardanalysesisnotcheckedwithliteratureonrelevanthazards(micro,physical,chemical)andthereforethewholeHACCPstudyisdifficulttojudge.TheHACCPstudydidnotspecifythespecificmicro’slikeforexamplelisteriaetc.Thereforethecontrolmeasuresaredifficulttojudge.RawmaterialsarenotpartoftheHACCPstudy.16NC’sonHACCPthatoftenappeaNConHACCPthatoftenappear(3)Hygiene(GMP)risksarenottakenintoaccount.GMPrisksareidentifiedasCCP’sWrongdecisiontree:tomanyCCP’s.Criticallimitsarevague,frequencytolowOperatorsarenotwelltrainedoncontrollingtheCCPVerificationisnotperformedbythecompany.17NConHACCPthatoftenappearSummaryTheauditorhastojudgeinashorttimetheHACCPstudyofanauditee.Heneedstobeconvincedofthefollowingthing:doestheauditeeknowwhatheisdoingandisthesafetyoftheproductnotatsteak!!Otherwise:NonConformitieswillbegivenintherankingfromCriticaltoMajorandMinor.18SummaryTheauditorhastojudgSummaryThedemandsforHACCPintheGFSIrecognizedstandardsarehigh!!Apracticalapproachwiththefocusonimplementationisimportant!!Goodluckwiththeimplementation!!MarjanSmit19SummaryThedemandsforHACCPiHACCP：GFSI認可標準的聚焦點MarjanSmit國際供應(yīng)商審核協(xié)會總部HACCP：GFSI認可標準的聚焦點MarjanSmit內(nèi)容提要總體介紹GFSI認可標準中的HACCP在審核過程中評價

HACCP的分析結(jié)果審核過程中常見的HACCP不符合項小結(jié)21內(nèi)容提要總體介紹21總體介紹(1)盡管食品法典（

Codex）在HACCP方面的要求很清楚，但是不同的人對標準的理解和解釋不盡相同。特別是進行危害分析和確定關(guān)鍵點的做法各異。有的受審核方召集大量專家并撰寫10多本HACCP手冊。有的受審核方指派質(zhì)量經(jīng)理做相關(guān)研究并由他來撰寫1本HACCP手冊22總體介紹(1)盡管食品法典（Codex）在HACCP方面總體介紹(2)有的受審核方根本就沒有HACCP手冊，但對所有有關(guān)的關(guān)鍵點實施了控制。有的企業(yè)確定了74個關(guān)鍵控制點，但只對其中3個關(guān)鍵點實施了正確的控制。有的企業(yè)確定了3個關(guān)鍵控制點，但所選擇的關(guān)鍵控制點是錯誤的，而真正的關(guān)鍵控制點并沒有得到控制。23總體介紹(2)有的受審核方根本就沒有HACCP手冊，但對所總體介紹(3)我們在不同的國家看到了63種不同的方式。我們發(fā)現(xiàn)至少有27個不同HACCP軟件系統(tǒng)。在工廠里負責建立和發(fā)展HACCP體系的人員是根據(jù)各自對該體系的理解程度開展工作的，現(xiàn)有100多種不同版本的理解。

食品工業(yè)的供應(yīng)商使用HACCP是為了銷售其產(chǎn)品：“應(yīng)該借HACCP的光………”24總體介紹(3)我們在不同的國家看到了63種不同的方式。24GFSI標準中的HACCP(1)GFSI食品安全標準的3個要素:食品安全管理體系良好農(nóng)業(yè)/制造/銷售規(guī)范(GAP/GMP/GDP)危害分析&關(guān)鍵控制點(HACCP)25GFSI標準中的HACCP(1)GFSI食品安全標準的3個GFSI標準中的HACCP(2)“所提交的標準要求有危害分析和關(guān)鍵控制點（HACCP）或與其相當?shù)捏w系，來展示對食品安全的管理。上述HACCP體系應(yīng)…..”--GFSI指導(dǎo)性文件，第4版，第25頁26GFSI標準中的HACCP(2)“所提交的標準要求有危害分析因此…HACCP的分析方法包含以下幾個方面：食品生產(chǎn)者（受審核方）有責任作出正確的選擇。審核員有責任驗證上述選擇是否符合相關(guān)標準在HACCP方面的要求27因此…HACCP的分析方法包含以下幾個方面：27在審核過程中評價

HACCP的分析結(jié)果(1)對于審核員來講，審核所依據(jù)的標準的要求應(yīng)起主導(dǎo)作用。審核員不允許說：你必須將這一點包括到你的關(guān)鍵點控制過程中。HACCP的專業(yè)范圍應(yīng)覆蓋審核的專業(yè)范圍。28在審核過程中評價HACCP的分析結(jié)果(1)對于審核員來講，在審核過程中評價

HACCP的分析結(jié)果(2)HACCP總是審核員要首先關(guān)注的方面之一--在GFSI標準中HACCP被看作是過程控制不可分割的一部分。但是，依據(jù)BRC或IFS進行審核的審核員遇到的一個問題，就是他可能會受到時間上的限制29在審核過程中評價HACCP的分析結(jié)果(2)HACCP總是在評價

HACCP的分析結(jié)果時經(jīng)常會運用下列手段：抽取一個關(guān)鍵控制點，讓受審核方介紹其HACCP分析方法—即他們是怎么確定該關(guān)鍵點的。另外抽取一個關(guān)鍵控制點并檢查該關(guān)鍵點是如何被控制、監(jiān)督和登記的。這樣審核員便可以非常有效的抽樣并形成結(jié)論。在審核過程中評價

HACCP的分析結(jié)果(3)30在評價HACCP的分析結(jié)果時經(jīng)常會運用下列手段：在審核過程在審核過程中評價

HACCP的分析結(jié)果(4)需檢查的文件要素：專業(yè)范圍是否包括所有產(chǎn)品和過程？過程的改變和新產(chǎn)品是否被HACCP分析所覆蓋？HACCP小組成員培訓(xùn)記錄危害分析是否完全（產(chǎn)品和過程分析,微生物分析，化學(xué)分析，物理反應(yīng)分析等？）31在審核過程中評價HACCP的分析結(jié)果(4)需檢查的文件要素在審核過程中評價

HACCP的分析結(jié)果(5)企業(yè)是否進行了相關(guān)研究來確定所選擇的危害的關(guān)聯(lián)性？對關(guān)鍵性限度的設(shè)定是否是在對與該活動相關(guān)的法律法規(guī)進行研究的基礎(chǔ)上進行的？關(guān)鍵控制點是否與該行業(yè)有關(guān)?企業(yè)是如何驗證其HACCP分析結(jié)果的？32在審核過程中評價HACCP的分析結(jié)果(5)企業(yè)