Full PSCI SAQAudit Report Template.docx

Full PSCI SAQAudit Report Template.docx

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FullPSCISAQAuditReportTemplate

PharmaceuticalSupplyChainInitiative（PSCI）

Self-AssessmentQuestionnaireandAuditReport

forPharmaceuticalIndustrySuppliers

API,DosageFormulation,ChemicalsandIntermediateChemicalManufacturers

GUIDANCEFORCOMPLETION

Sectionsmarkedinorangeneedtobefilledinbythesupplierbeforetheaudit.Sectionsmarkedingreywillbefilledbytheauditteamduring/aftertheonsiteaudit.Pleasedonotchangethereportformatanddonotchangetheanswersgivenbytheotherparty.Supplierandauditorsareaskedtocompleteallquestionsthatapply.Ifaquestiondoesnotapply,pleasemarkitNA（NotApplicable）.Wewouldexpectthefollowingtypesofsupplierstocompleteallthequestions:

API,DosageFormulation,ChemicalsandIntermediateChemicalManufacturers.

AUDITORANDAUDITREPORTINFORMATION

ReportNumber:

ReportOwner:

Note:

thisisthecompanypayingfor/sponsoringtheaudit.IfaPSCIMember,thenameshouldberemovedbeforethereportisuploadedtothePSCIauditsharingplatform

DateofAudit:

DD/MM/YYYY

initial

followup

other,pleasespecify

DateandTypeofPreviousAudit（ifapplicable）:

DD/MM/YYYY

initial

followup

other,pleasespecify

AuditFirmName:

LeadAuditorName:

Title:

Namesoffurtherauditors:

Title:

PhoneNumber:

EmailAddress:

FACILITYDETAILS

CompanyName:

SiteName（ifdifferent）:

ParentCompanyName（ifapplicable）:

SiteStreetAddress:

SiteCity:

SiteState/Province/County:

SitePostal/ZipCode:

SiteCountry:

SITECONTACTINFORMATION

SiteRepresentativeName（host）:

Title:

PhoneNumber:

EmailAddress:

ManagementRepresentativeName:

Title:

HSE（Health,Safety,EnvironmentalProtection）RepresentativeName:

Title:

HR（HumanResources）RepresentativeName:

Title:

EXECUTIVESUMMARY

Overallfindings

Pleasecheckapplicablebox（es）andindicatethenumberoffindings

Critical

NumberofCriticals

Other

NumberofOthers

None

A

ManagementSystems

B

Ethics

C

Labor

D

EnvironmentalProtection

E

Health&SafetyComplianceandRiskManagement

Itisnotpossibleinanaudit,withalimitedtimeframe,toidentifyeveryarearequiringattention.Itistheresponsibilityoftheauditedpartytoestablish,implementandmaintaineffectivesystemsandproceduresthatcomplywiththeregulatoryrequirements.Duetothesizeofthesiteonlythemostimportantbuildings,facilities,andHSEtopicscouldbeinspectedordiscussedduringtheaudit.

CriticalFindings:

Areveryhighriskfindingsthatrequireimmediateactiontoprotecthumanlife,thehealthofemployeesortheenvironment;Mayresultinlossoflicensetooperateorseriousdamagetoreputation;Requireimmediatecorrectiveactionbythesupplier;Needtobecommunicatedtotheauditsponsorpriortoauditreportfinalization.

OtherFindings:

Areallothermajororminorauditfindings,whichneedtobecorrectedbythesupplierinanappropriateperiodoftime.

Attitudeofworkers（towardsmanagement,workplace,andtheinterviewprocess）:

Note:

donotdocumentinformationthatcouldputtheworkeratrisk

Attitudeofmanagement（toauditandauditprocess）:

Summaryofmainfindings:

FacilityBackgroundInformation

Pleaseindicatewhichofthefollowingbestdescribesthisfacility（checkallthatapply）:

API（activepharmaceuticalingredient）manufacture

Biologicalmanufacture

Chemicalmanufacture

ContractResearchLaboratories

FinishedFormulations

Logistics/Warehouse

PrimaryPackaging

Other（pleasedescribe）

Comments:

Isthefacilitylocatedinaregionthathasexperiencedanyofthefollowingnaturaldisastersintheprevious50years:

Flood

Earthquake

Damagingwindstorm

Wildfires

VolcanicActivity

TsunamiImpact

Hurricane/Typhoon

Tornado

Describethetypeofworkcurrentlybeing,orproposedtobeperformedatthisfacility（includeproducttypessuchasantibiotics,solvents）:

PleasedescribethefacilityHSE（HealthSafety&Environment）resources（numberofstaffortimespentonHSE）:

Pleaseprovideacopyofthecompany’sorganizationchartindicatingareasofexpertiseinHSEandwhethertheyarefulltime.PleaseprovidequalificationsofthefulltimeHSEpeople.

Whatistheprimarylanguagespokenbythemajorityoftheemployeesatthislocation?

Primarylanguage:

Otherlanguages（spokenbyatleast10%oftheworkforce）:

Iscompanysponsoredhousingprovidedtoanycontractorfulltimeemployeesworkingatthislocation?

YesNo

Ifyes,whatistheapproximatenumberofworkerslivingincompany-providedhousing:

NumberofEmployees/WorkersbyCategory（Providedatafortheentiresite.Also,pleasenotethattheremaybeworkers/employeeswhofitintomultiplecategoriesandshouldbeaccountedforundereachapplicablecategory（i.e.,thereisoverlapbetweencategories）

Male

Female

Totalemployeepopulationonsite（includingtemporary,part-timeandcontractworkers）

Fulltimeemployees/workersdirectlyemployedbythecompany

Part-timeemployees/workersdirectlyemployedbythecompany

Indirect,contractordispatchemployees/workers

Employees/workersundertheageof18

MigrantorForeignWorkers

Studentworkers（includestudents,apprenticesandinterns）

TotalSiteArea（m2）:

ManufacturingArea（m2）:

Doesyourcompanyownthefacility?

YesNo

Ifno,whoownsthefacility?

Ifthefacilityisnotownedbytheparentcompany,arethefollowingwithinyouroperationalcontrol?

Wastewatertreatmentplant?

YesNo

Utilities?

YesNo

Security?

YesNo

Managementoftheroadways?

YesNo

Indicateifthesiteisinarural,industrial,residentialormixedcommercialsetting

Rural

Industrial

Residential

Mixedcommercialsetting

Pleaseattachalocalareamapwithwatersourcesifavailable.

Whenwasthissiteinitiallyconstructed?

Pleaseindicatetheyearsofindustrialuseofthesite.

MANAGEMENTSYSTEMSSelf-AssessmentQuestionnaire-Questionsmarkedwithanasterisk（*）areforinformationonlyandshouldnotbeconsideredforpotentialfindingsbytheauditor.

AuditorVerification

Pleaseprovideobservations,details,commentsandanysupportingdocuments

CommitmentandAccountability

1*

Doesthefacilityhaveanyethics,labor,environment,healthandsafetymanagementsystemaccreditations,certifications,orawards?

OHSAS18001YesNo

ISO14001YesNo

ISO50001YesNo

SA8000YesNo

InvestorsinpeopleYesNo

Other（e.g.Awards,OSHAVPP,EMAS）pleaselist:

YesNo

Comments

2

Doesmanagementengageemployeesinopentwo-waycommunication?

（e.g.TownHallmeetings,employeesurveys,managementfactoryrounds,management-employeesQ&Asessions）

YesNo

Pleaseexplain:

YesNo

Comments

LegalandCustomerRequirements

3*

ArethereanyissuesrelatedtoEthics,Labor,Environment,Health,andSafety（HSE）RegulatoryCompliance?

Isthereanyongoinglitigationorregulatorynoticeswithrespecttoregulatorycompliance?

YesNo

Arethereanyhistoricalmajorregulatoryactions?

YesNo

Anycontinuous/prolongedsituationswhereregulatorycompliancerequirementsareexceeded（withinthepast12months）?

YesNo

Pleaseexplain:

YesNo

Comments

4

DoesthefacilityassessongoingcompliancewithHealth,Safety,andEnvironment,BusinessEthicsissues,andLaborregulations?

YesNo

Pleaseexplain:

YesNo

Comments

5

DoesthefacilityensurethatsuppliersandserviceprovidersoperategoodpracticeswithregardtothePSCIPrinciples（i.e.,labor,ethics,environment,health&safety,andmanagementsystems）

YesNo

Ifyes,how?

Byon-siteassessment/audit:

YesNo

Bydesk-topassessment（e.g.questionnaires）:

YesNo

Pleaseexplain:

YesNo

Comments

RiskManagement

6

Doesthefacilityuseriskassessmentandriskmitigationmethodologiestoassessandmanagebusiness,reputation,andlegalrisks?

Businessrisks:

YesNo

Reputationrisks:

YesNo

Legalrisks:

YesNo

Pleaseexplain:

YesNo

Comments

7

DoesthefacilityhaveaprocesstomanagechangecontrolforHSE（e.g.rawmaterials,processes,personneletc.）?

YesNo

Pleaseexplain:

YesNo

Comments

8

Hasthefacilitydevelopedandimplementedasite-basedBusinessContinuityManagementplanthatincludesthefollowingelements:

Identificationofthemajorfacilitydependenciesthatcancreatebusinessinterruptionatthesite?

YesNo

Ariskassessmentoftheidentifieddependenciesanddevelopedaprioritizedremediationofthoserisks?

YesNo

Prioritizedkeysupplyinitiativesanddeterminedtherecoverytimeobjectiveforkeyproductionareas?

YesNo

Pleaseexplain:

YesNo

Comments

9

Doesthefacilityhavesecuritysystemsforcontrollingphysicalaccesstothefacilities?

YesNo

Pleaseexplain:

YesNo

Comments

Documentation

10

Doesthefacilitymaintaindocumentationforkeyissues?

YesNo

Doesthisinclude:

Auditfindings

InjuryandIllnessLogs

WorkerBenefitsandPayInformation

InspectionsbyRegulatoryAgencies

WorkerComplaints

PerformanceAssessments

DocumentationofTraining

YesNo

Comments

TrainingandCompetency

11

Areworkersmadeawareofpoliciesandprocedures,andaretheytrainedaccordingly?

YesNo

Pleaseexplainhowpoliciesandproceduresarecommunicatedandimplemented:

Pleasedescribetrainingsineachofthefollowingareas:

Ethics:

Labor:

Environment,health&safety:

Emergencypreparedness/response:

YesNo

Comments

ContinualImprovement

12

Doesthefacilityperformself-assessmentsand/orinternalauditstoimprovetheeffectivenessofitsl