实用文档risk assessment pouch line.docx
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实用文档riskassessmentpouchline
ProcessRiskAssessment-PouchLine
FlowchartA
ProcessStep
#
Hazard
ControlProcedure
Q1
Y/N
Q2
Y/N
Q3
Y/N
Q4
Y/N
CCP#
Rationaleforhazardelimination
Goodsarrive
CheckPO
A1
A2
M
NA
C
NA
P
NA
Sanitationinspection
A3
M
pathogenContaminationduetobreakage,waterlogging
Visualinspectingperbagsbywarehousestaff
（P14.01RMsreceiptstorageandrelease）
Y
N
N
1RejectbreakageRMoncebreakage
2Sequentstep-labtestbeforeusecaneliminatethehazardtoanacceptablelevel
C
ChemicalContaminationduetovehicletransportedchemicalortreatedbychemical
1Visualinspecting,flappingandsmellingperbagsbywarehousestaff
2checkvehiclesanitationandodorcondition
3signtransportqualityagreementwithRMsuppliers,whichrequestRMvehiclesanitationcomplyingwithfoodsafetyrequirement
（P14.01RMsreceipt,storageandrelease）
Y
Y
N
Y
N
Controlprocedurecanmakesuretheeliminatethehazards.
P
Foreignmatterscontaminationduetobreakage
Visualinspecting,flappingperbagsbywarehousestaff
（P14.01RMsreceipt,storageandrelease）
Y
N
N
1RejectbreakageRMoncebreakage
Metaldetection
M
NA
C
NA
P
MetalfragmentsfromRMandpackage
1detectionlimits:
Fe1.8mm,SUS2.5mm,SS2.5mm
2allRMaredetectedbeforeusing
3periodicallytestingdetectorsensitivitywhenstartup,onceper2hours,detectioncodechange,maintenanceandendup
4segregatethoseabnormalRM
5re-detectsegregatingRM,ifdetectoralarmed,informQStodispose
Y
Y
Y
N
1.IPQAinspectmetaldetectortwicepershift,forkliftdriverinspectitonetimepertwohours
2.vendorverifyandmaintenancemetaldetectoreveryyear
3.Willcontinuouslydetectmetalfragmentsbymagnetfixedinsubsequentprocess（dumping,vibrantsieve）
Re-pileup
EstablishLot
Affixthesmalllabel
AffixpalletIDlabel
Putuprack
Receivereport
EntryinBPCs
A4
A5
A6
A7
A8
A9
A10
M
NA
C
NA
P
NA
ProcessStep
#
Hazard
ControlProcedure
Q1
Y/N
Q2
Y/N
Q3
Y/N
Q4
Y/N
CCP#
Rationaleforhazardelimination
QS（MI）sample
A11
M
pathogencontaminationduetoincorrectorinsanitationsampling
Strictwithasepsistechnique
Samplinginlaminarflow
（P9.14RMsamplingandreleaseprocedure）
Y
Y
N
Y
N
1Samplingareaasahighhygieneonenvironmenthygienemonitorprocedure,labswabbingtesteveryweek
2LabdoublecheckMIsample
C
NA
P
Metalfragmentsduetobreakageofsamplingknife
1useuneasybreakoffknife
2checkknifeintegritybeforesampling
（P9.14RMsamplingandreleaseprocedure）
Y
Y
Y
N
1knifebreakingoffhavenotbeenoccurredincompanyhistory
2Sequentstepsuchasmagneticandvibratesievecaneliminatemetalfragmentsoncesamplingknifebreakoff
CIQtest
A12
M
NA
C
NA
P
NA
QCinspection
COAreview
A13
M
RefertoRMhazardanalysis
C
P
Release
A14
M
NA
C
NA
P
NA
Storage
（Sanitation&check）
A15
M
Pathogencontaminationduetoineffectivepestcontrolandinsects/mice/rodentsinfestedinwarehouse
1SanitationinspectionweeklyonMay-NovansemimonthlyonDec-Apr
（P8.11Pestcontrol）
2Inspectioneveryday
（P14.06warehousesanitationprocedure）
Y
Y
Y
N
1pesticideandpestcontrolvendormustbevaluatedandcertificated
2currentMSDS（materialsafetydatasheet）forpesticideandfumigantsissetup
3effectofpestcontrolhavebeenvalidatedandachievedMJNrequirement
C
Pesticidecontaminationduetounapprovedpesticideorincorrectpractice
1approvedpestcontrolvendor
2pestkillerhavequalificationcertification
3approvedpesticide
4Pesticideusagecontrolsuchasscope,quantity,productdate,expirationdate,rateofapplicationandstorage
5goodpracticeofsprayingpesticideandfumigating
6internalemployeemonitorallprocessofsprayingpesticideandfumigating
Y
N
N
1pesticideandpestcontrolvendormustbevaluatedandcertificated
2currentMSDS（materialsafetydatasheet）forpesticideandfumigantsissetup
3effectofpestcontrolhavebeenvalidatedandachievedMJNrequirement
P
NA
ProcessStep
#
Hazard
ControlProcedure
Q1
Y/N
Q2
Y/N
Q3
Y/N
Q4
Y/N
CCP#
Rationaleforhazardelimination
Reject
Segregateandlabelreject
WO
Returtovendor
Unqualified
Segregateandlabelonhold
Retest
RUD
A16
A17
A18A19A20
A21
A22
A23
M
NA
C
NA
P
NA
FlowchartB
ProcessStep
#
Hazard
ControlProcedure
Q1
Y/N
Q2
Y/N
Q3
Y/N
Q4
Y/N
CCP#
Rationaleforhazardelimination
Receiveshoporder
OBIanddocument
Takeoutrack
cleaning
B1
B2
B2-1
B2-2
M
NA
C
NA
P
NA
Pickup
Doublecheck
（Checkingredientandquantityvs.shoporder）
Putuprack
Preparedtouse
B2-4
B2-5
B2-6
B2-7
M
NA
C
NA
P
NA
Pickupmaterial
Takeoffpacking
B3
B4
M
NA
C
NA
P
NA
Outerpackdisinfection
Cleaning
（weighingmaterials）
B5
M
pathogencontaminationduetoinsufficientdisinfectionorincorrectdisinfectpractice
175%alcoholdisinfectouterpacking
ofweighingmaterials
2towelsareprohibittousingrepeat
3makesurewatervaporizedcompletelybeforeweighing
（I14.25-02Outerpackdisinfectionworkinstruction）
Y
N
N
1Outerpackdisinfectionprovedtobeavalidpracticeformicrocontamination
2ATPSwabbingtestthriceperweekandRLU150
3sanitationinspectionperiodically
C
NA
P
NA
ProcessStep
#
Hazard
ControlProcedure
Q1
Y/N
Q2
Y/N
Q3
Y/N
Q4
Y/N
CCP#
Rationaleforhazardelimination
Transferfromwindow
B6
M
NA
C
NA
P
NA
weighing
B7
M
Pathogencontaminationduetobadpersonapracticelorinvalidequipment
GMPandweighingstartupchecklist.
Y
N
N
ControlledbyPrerequisiteprogramGMPandPM,currentprogramcaneliminatethehazardtoanacceptablelevel.
C
Babygrowthdiseaseduetoinsufficientoroverfullfeedingforvitamins,mineralsandirononstageoneproductswhenitisusedasauniquenutrientresource.
Lactoseintoleranceduetolactosecontamination
1checkeachmateriallabelcomplywithmaterialnameandnumber.
2periodicalcheckforbalanceaccuracywhilestartup,formulachangeandatleastonceper2hours.
3podicalcheckforbalanceaccuracywhilestartup,formulachangeandatleastonceper2hours.
4pecialoperatorcheckshoporder.
5roductsequence：
fromnon-lactosetolactose
6fnot,replaceweighinginstruments,cleaningtowelandbalance,sanitizeworktable
Y
Y
N
Y
Y
P
Metalfragmentscomefrombreakageofscissors,scoop,alsonailsandsealingironcircleoffiberbarrel
1useuneasybreakoffscissors,scoops
2checkscissors,scoopsintegritybeforeusing
3iffindscissorsorscoopsbrokeoff,informsupervisorsimmediately,segregatesuspiciousRMandtrace
brokeoffmetalfragment
4notbeatfiberbarrelwithhammer,complywithsuppliersmethodtounseal
Y
Y
Y
N
Sequentstepsuchasmagneticandvibratesievecaneliminatemetalfragmentsoncesamplingknifebreakoff
Fillinform&packing
store
B8B10
M
NA
C
NA
P
NA
FlowchartP
ProcessStep
#
Hazard
ControlProcedure
Q1
Y/N
Q2
Y/N
Q3
Y/N
Q4
Y/N
CCP#
Rationaleforhazardelimination
Check
E1
E3
M
NA
C
NA
P
NA
Premix
E2
M
NA
C
Dystrophiadueto:
1missingbagsofVitamin,minerals,iron,ARAorDHA
2moreresidualsofVitamin,minerals,iron,ARAorDHAinPEpackingwhenmixing.
1checkallRMsagainstshopordertoavoidmisusing
2premixcomplywithshoporder
3bagsoftheseRMSshouldkeepspareroomafterweighingtoavoidhidinginbundlearea
4checkifthereisresidualsofVitamin,minerals,iron,ARAorDHAinPEpackingafterdumpingeverybags
（P11.05operationprocedureforbatchingarea）
Y
Y
N
Y
N
Currentprocedurecaneliminatethehazardtoanacceptablelevel.
P
NA
Stripoutpackaging
P1-2
M
pathogencontaminationduetoSucroseouterpackageinsufficientdisinfection
Sucroseouterpackageisdisinfectedbeforeentrydumpingroombyusing70%alcohol.
Y
N
N
Notasignificantrisk
Disinfectioncaneliminatethehazardtoanacceptablelevel
C
NA
P
Metalfragmentsduetobreakageofunsealing
knife
1checkintegrityofknifepereveryshift
2ifknifebreakoff,immediatelyinformsupervisor,stopproducing,findanddiscovermetalfragmentsinworkingarea
3checkmagneticandvibratesieve
（P7.082knifeusageandcontrolprocedure）
Y
Y
Y
N
1theseprocedurecouldeliminatemetalfragmenthazardtoanacceptablelevel
2notfoundmetalfragmentsinmagneticinfactoryhistory
ProcessStep
#
Hazard
ControlProcedure
Q1
Y/N
Q2
Y/N
Q3
Y/N
Q4
Y/N
CCP#
Rationaleforhazardelimination
Dumping
P2-2
M
pathogencontaminationduetoSucroseouterpackageinsufficientdisinfection
Sucroseouterpackageisdisinfectedbeforeentrydumpingroombyusing70%alcohol.
Y
N
N
Controlledbytheprerequisiteprogram.
Notasignificantrisk
Disinfectioncaneliminatethehazardtoanacceptablelevel
C
NA
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