pre inspection check list

7/28/2019 Pre Inspection Check List

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Questionnaire

Listotherstandardstheoperatormaycomplywith: Remark:

Yes No Remark

4 ManagementSystem

4.1 Generalrequirements

a IsthereadocumentedMSinplace?

b DoestheMSincluderegulatory,safetyandcustomerrequirements?

c

Doesthe

MS

cover

all

the

operators

activities?

d Arethereotheractivitiesthatconflictwiththefeedsafetyrequirements?

4.2 Managementprinciples

a Canemployeescommitmenttofeedsafetyandqualitybedemonstrated?

b AreHACCPprinciplesapplied?

c Isaneffectivechangecontrolsystemimplemented?

d IsthereasysteminplacetoinformManagementincaseofthreatstoproduct

qualityandfeedsafety?

e

Isthere

asystem

in

place

to

ensure

management

is

kept

up

dated

on

all

relevantlegislation,feedandfoodsafetyissuesandotherrelevantguidelines?

4.3 Generaldocumentationrequirements

a Doesawrittenqualityandsafetypolicyexist?

b IsthereaQualityManualinplace?

c Aredocumentedproceduresandrecordsavailable?

d IsthescopeoftheMSdefined?

e ArequalityproceduresestablishedaspartoftheMS?

f Do quality procedures cover the prerequisite program in support of the

HACCPprogram?

g AreHACCPproceduressufficienttoensurefeedsafety?

h Arespecificationsandtestingproceduresforincomingmaterialsandfinished

productsdocumented?

i Aremasterformulaeandoperatinginstructionsforeachproductorgroupof

productsinplace?

j AreProcessingrecordsforeachbatchofproductavailable?

k

AreStandard

Operating

Procedures

(SOPs)

for

all

activities

under

the

scope

of

theMSdocumented?

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l Aredocumentsunambiguousandincludetitle,natureandpurpose?

m Aredocumentsapproved,signedanddatedbyappropriateauthorised

responsibleperson(s)?

n Aredocumentskeptuptodate?

5

Managementresponsibility

5.1 Managementcommitment

a CanManagementcommitmenttofeedsafetyandqualitybedemonstrated?

5.2 QualityandSafetyPolicy

a Doesthequalityandsafetypolicyspecifytheoperatorsobjectivesincluding

regulatoryandcustomerrequirements?

b Isthepolicyadequatelycommunicated?

c Does the operator have the basic resources necessary to fulfil the stated

objectives?

d AretheManagementandHACCPsystemsdocumented,reviewed,updated

andcommunicatedtokeystaff?

5.3 Responsibility,authorityandcommunication

a IsasuitablyqualifiedHACCPteamleaderappointed?

b IsthescopeoftheHACCPsystemclearlydefined?

c Dojobdescriptionsexistforeachindividualorgroupofindividuals?

d Isthereasysteminplacetoidentifyandcorrectproblemswithinthe

managementand

HACCP

systems?

e Isasuitablyqualifiedpersonappointedtoensurecompliancewithregulatory

requirements?

f Isanorganisationalchartavailable?

5.4 Managementrepresentative

a Isamanagementrepresentativewithresponsibilityforqualityandsafety

appointed?

b Doesthemanagementrepresentativereporttotopmanagement?

c

Doresponsibilities

include

promotion

of

awareness

of

customer

requirements?

5.5 Managementreview

a Isadocumentedprocedureinplaceformanagementtoreviewthesuitability

andeffectivenessoftheMSandHACCP?

b Arerecordsofthisreviewavailable?

c Isthereviewconductedperiodicallyandpredefinedintervals?

d Areconclusionsdrawnandactionstakendocumentedaspartofthereview?

e Allactionscommunicatedtokeypersonnelwithintheorganisation?



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6 Resourcemanagement

6.1 Provisionofresources

a Anorganisationalchartexistsandisupdated?

b Appropriatepersonshavebeenassignedresponsibilitiestocomplywith

externalrequirements?

c Thedesignisappropriate?

6.2 Humanresources

a Thestaffissufficientandskilledtocomplywithexpectedtasksand

requirements?

b Jobdescriptionsareavailableandupdated?

c Necessarycompetenceareavailableindisciplinesconcerning:

- Feedsafety

- HACCP

- Hygiene

- Quality

- Healthandsafety

- Environment

d Levelofcompetenceisdocumentedandmaintained?

e Isthereasufficientlevelonpersonnelhygienefacilitiesandpersonelhygiene?

6.3 Infrastructure

a The facility is designed to facilitate a good environment as described in

6.3.2.1?

b Thefacilityisdesignedtomakeiteasytocleanifnecessary?

c Thefacilityissuitabletominimizefeedsafetyrisks?

d Necessaryutilitiesareavailablee.g.

- Potablewaterorotherwaterquality

- Steam

- Pressuredair

- Heatingsystem

- Extractionunits

- Other

relevant

utility

system

6.4 Maintenanceandcontrolofmonitoringandmeasuringdevices

a Aformalcalibrationsystemisinplace?

b Thisincludesitemstobecalibrated?

c Appropriatecalibrationintervalsaredefined

d Calibrationresultsaredocumented?

e Aformalpreventivemaintenancesystemexists?

f Appropriatemaintenanceintervalsaredefined?

g

Maintenancework

is

documented?



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h Maintenanceworkdoesnotinterferewithproductsafety?

6.5 Cleaning

a Aformalcleaningprogramexistscovering:

- Dailyhousekeeping

- Periodic

deep

cleaning

- Cleaningaftermaintenance

b Theprogramdefinesresponsibility?

c Postevaluationiscovered?

d Cleaningrecordsarecurrentlyfilledin?

e Proceduresoncleaningofequipmentexistandtheysupporthygieneandfeed

safety?

f Employeesaretrainedincleaningproceduresandthetrainingisdocumented?

6.6

Pest

control

a Aformal(documented)preventivepestcontrolsystemisinplace?

b Theresponsibility:Inhouseorcontracted?

c Ensurethatrelevantpreventivemeasuresaretaken,re.:

- Rodents,outsideandinside

- Insects,flyingandcrawling

- Birds

- Otherrelevantpests

d Ensure amap or schematics of preventivemeasures showing the locations

exist

and

are

updated?

e Pestactivitiesaredocumented?

f Applied pesticides/chemicals are suitable for the purpose (Product Data

Sheet)?

g Ensurelegalityofthepesticide/chemicals?

h Theplantismaintainedreasonablyclearofinfestation?

6.7 Wastecontrol

a Waste materials are properly identified to avoid mixup with production

materials?

b Waste is handled properly to avoid risks forworkers or environment, both

internallyandexternally?

7 Productrealisation

7.1 Productrequirements

a Asystemtoidentifyexternalrequirementisimplemented?

b Theexternalrequirementarecommunicatedandcompliedwith?

c Requirementsandcompliancearedocumented?

d

Requirementsspecified

by

customers

are

controlled

and

implemented?



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e Proceduresareinplacetocomplywithidentifiedrequirements?

f Relevantproductinformationisinplace?

g Theinformationiscommunicatedtothecustomer?

h Informationprovidedbycustomersarereceivedandimplemented?

7.2 HACCPprogram

a AHACCPprogramisdevelopedandmaintained?

b Amultidisciplinaryteamisannounced?

c Acompetentteamleaderisappointed?

d AdequatetrainingoftheHACCPteammembersissupplied?

e Anadequateprerequisitequalityprogramexists?

f AHACCPanalysisisperformedanddocumented?

- The

Critical

Control

Points

(CCPs)

are

identified

- Criticallimitsarespecified

- Monitoringisprovided

- Adeviationprocedureisestablishedandimplemented

- Verificationproceduresareestablishedandimplemented

- Allproceduresandrecordsarearchived

g Possiblebiological,physicalandchemicalhazardsareconsidered

7.3 Designanddevelopment

a Developmentplans are issuedprior to relevantphasesof thedevelopment

process?

b Thedevelopmentplanconsidersrisksrelatedtosafety?

c HACCPisconsidered?

d Aformalchangecontrolprocedureexists?

e Changesareapprovedbeforeimplementation?

f Changesarecontrolledanddocumented?

g Changesimplementedarereviewed,verifiedandarchived?

h Safety,qualityandregulatoryrequirementsarecoveredbythechangecontrol

procedure?

7.4 Handlingofincomingmaterials

a Newsuppliersarecoveredbyanapprovalprocess?

b Approved suppliers are documented, reviewed, reevaluated and the

documentationisuptodate?

c Thereviewisdoneperiodicallyatapredeterminedinterval?

d Purchasedincomingmaterialhasanagreedspecification?

e Specificationscomplywithfeedsafetytopicsandlegislativerequirements?

f

Awritten

procedure

on

handling

of

incoming

materials

exists?



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g Incomingmaterialsareregistereduniquelyandinclude?

- Suppliersnameandlot/batchnumber

- Operatorslot/batchnumber

- Nameofmaterial

- Quantityanddateofreceipt

- Possiblyexpiredateh Incoming bulk materials are stored according to adequate separation

procedures?

i Materialsareinspectedbefore,duringandafterunloading?

j Theinspectionincludescontamination,pestinfestationanddocumentationof

findings?

k Nonconformitiesarerecorded?

l Recordsofinspectionresultsaredocumentedandarchived?

m

Incomingmaterials

are

released

before

use?

n Documentationismaintainedincaseaproductisreturnedtothesupplier?

7.5 Productionoffinishedgoods

a Productionareasareaccessibletoauthorizedpersonnelonly?

b Productionisrunaccordingtoformalproductionplanning?

c Theproductionplanisdistributedtorelevantpersons?

d Productionrecordsarekepttoprovecompliancewithmasterformula?

e Crosscontaminationispreventedorcontrolled?

f Eachproducthasaspecification,uniquenameand/orcode?

g Eachproducthasapredifinedlabel?

h Finishedproductsareclearlymarkedandidentified?

i Eachproducthasapredefinedpackaginginstruction?

j Thepackagingprocessiscontrolledtoavoidcontaminationandmixup?

k Deliveriesareinspectedpriortodispatch?

l Theinspectionisdocumented?

m

Nonconforming

products

are

segregated

and

stored

in

amanner

to

prevent

failures?

n Storage facilities are operated in a manner to prevent failures during

handling?

o Storagefacilitiesaresuitabletopurpose,e.g.cleanliness,ventilation,dryand

temperaturecontrolled?

p Adefinedstockrotationsystemisinplace,e.g.FIFO?

q Outdatedstockiscontrolledandsegregated

r Loose bulkmaterials are controlled and segregated from other loose bulk

material?



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s Awrittenverificationprocedureisinplace?

t Verificationdatademonstratesthatallproductionprocessesachieveplanned

results?

u Verificationdatademonstratesthatcarryoveriscontrolled?

v

Atraceability

system

is

in

place,

including

tracing

back

from

the

final

product

throughqualitycontroldataandbatchrecordstotherawmaterialsusedand

thesuppliers?

w Deliveriescanbetracedtocustomers, includingcustomername,date,batch

andamount?

x Astabilityprogramisdefinedandongoing?

y Product environment is controlled during storage to preserve conformance

withqualityandsafetyrequirements?

7.6 Transport

a Agreementswithsubcontractorsaredocumented

b Selection of transporters takes into consideration their ability to fulfill the

operatorsrequirementsascertifiedbythiscode?

c Transportersarecontrolled,evaluatedandmeetexpectedqualityandsafety

requirements?

d Requirements in this code are applied by the operator also to transports

arrangedbythebuyer?

e Proceduresareinplacetoensureproductintegrityduringtransport?

f

Packagingprovides

adequate

protection

for

the

raw

material

or

finished

goods?

g Procedures are in place to control all relevant risks found in the operators

HACCP?

h If cleaning is required the cleaning certificates shall include all relevant

information needed to evaluate if the supplied container is suitable for

loading?

i Procedures are in place to safeguard against unwanted or forbidden

contaminants?

8

Systemreview


a Doesaformalreviewsystemexist?

b Doesthesystemincludecollectionofdata?

c Doesthesystemincludeanalysisofthedata?

d Doesthesystemincludeaconclusion?

e Doesthesystemincludeactionsforimprovementoriginatingfromthe

conclusion?

f

Aretime

scales

for

improvements

defined

and

maintained?



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8.2 Internalaudits

a Isascheduledauditprograminplace?

b Areinternalauditscarriedout?

c Arethescopeofauditsdefined?

d Arefeedsafetyissuesincludedinthescope?

e Arethefrequencyofauditsdefined?

f Areauditorssuitablytrained?

g Areauditsandnonconformitiesreportedanddocumented?

h Arereportsdistributedtokeystaff?

i Areformalfollowupsreported?

j Arecorrectednonconformitiesverified?

9

Controlof

non

conforming

products


a Doesaformalsystemexistonhowtohandlenonconformingproducts?

b Productidentification?

c Documentationofnonconformities?

d Evaluationofrootcauses?

e Documentationofcorrectiveactions

andverificationsteps?

f

Doestheprocedurecover

Segregation,handling

and

assessment

ofnonconformingproductincluding:

RejectedMaterials?

AcceptedMaterialswithrestrictions?

Justificationofpotentialalternative

usewithinfeedsafetyrequirements?

g Isstaffawareoftheseprocedures?

h Isclearmarkingofnonconformingproductinplaceoranothermeansof

control?

i Arerecordsofnonconformitiesmaintained?

9.2 Complainthandlingsystem

a Doesaformalcustomercomplainthandlingsystemexist?

b Isresponsibilityforcontrollingcomplaintsdefined?

c Doesthesystemincludesufficientcustomerandproductinformation?

d Cause?

e Seriousness?

f

Arethecomplaintsevaluated

accordingto:

Customer?



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g Otherrelevanttopics?

h Arecomplainttopicsusedtopreventreoccurrence?

i Aretherelatedcorrectiveactionscarriedthrough?

j Isfeedbackgiventothecustomer?

9.3 Recall

a Doesaformalrecallprocedureexist?

b Isresponsibilityassignedtoanappropriateperson?

c Istherecallprocessadequatelydescribed?

d Doestherecallprocedureincludehandling,reassessmentand/ordisposalof

recalledproduct?

e Areeffectivecorrectiveandpreventativeactionsimplemented?

f Arerecallsrecorded?

g Istherecallproceduretestedregularly?

h Arethetestrecallsdocumented?

i Aretheoutcomesofthetestrecallsevaluated?

9.4 Crisismanagement

Doesacrisismanagementprocedureexist?

Isresponsibilityfornotifyingcustomersandregulatoryauthoritiesdefined?

Isresponsibilityforconductingaproductrecalldefined?

10

Statisticaltechniques

a Arestatisticaltechniquesapplied?

b Hastheuseofstatisticaltechniquesbeenevaluatedanddefined?

c Isanoverviewofeachstatisticaltechniqueavailable?

d Arethesuitabilityoftechniquesdocumented?

e Doestheoperatorpossessthenecessarystatisticalcompetencies?


pre inspection check list

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