QUALITYASSURANCEMANUAL(QAM)FOR

GAMMARADIATIONPROCESSINGFACILITY(GRAPF)

A.
(i)

(ii)

QUALITYASSURANCEPROGRAM(QAP)

An adequate quality assurance (QA) program, including appropriate quality control

measures,shallbeestablishedforthedesignandmanufacture,construction,operationand
industrial safety of irradiators. Compliance with the ISO 9000 or IS 14000 series is
desirable. Records of all QA procedures shall be maintained for the entire life of the
irradiator.
FollowthequalityassurancerequirementspecifiedinAppendixBofAERBsafetystandard
titled'LandBasedStationaryGammaIrradiators'[AERB/RFIRRAD/SS6(Rev.1);2007].

B.

1.

QUALITYASSURANCEINDESIGNOFGRAPF
QualityAssuranceProgramme
The responsible organization shall develop and implement a QA programme, which
describes the overall arrangements for the management, performance and assessment of
the GRAPF. This programme should also provide the means to ensure that all work is
suitablyplanned,correctlyperformedandproperlyassessed.Proceduresshouldbedefined
bytheresponsibleorganizationforcontrolofdesignactivitiestoensurethatthedesignof
theGRAPFfulfilsthespecifiedrequirements.

1.1

Grading
Agradedapproachbasedontherelativeimportancetoradiologicalsafetyofeachitem,
serviceorprocessshallbeused.

1.1.1 Thedesignactivities,whichcouldbegraded,include:

(a)
Thelevelanddetailofanalysisofdesign
(b)
Theneedforandlevelofdesignreviewandapproval
Thedegreeofverificationofdesign
(c)
(d)
Thecontrolsappliedtodesignchange
(e)
Thedetailofdesignrecordsandtheirretentiontimes
(f)
Theneedforalternativecalculationstobecarriedout
(g)
Theneedtoqualifyortestthedesignoutput
(h)
Theneedforqualificationtestsfordesign

1.2 Organisation

Theresponsibleorganisationshallidentifytheprincipaldesignerwhohasresponsibilityfor
specifyingthedesignrequirementsandforapprovingthedesignoutputonitsbehalf.

1.3 Interfaces

Interfacearrangementsshallbeagreedbetweenorganisationsinvolvedindesignactivities.
Interfacethatshouldbeaddressedareforexample:

(a) Interfacesbetweentechnicaldisciplineswithinthedesignorganisation
(b) Principaldesignerwith:

(i)
(ii)
(iii)
(iv)
(v)
(vi)

Sitingorganisation
Constructionorganisation
Commissioningorganisation
Operatingorgansiation
Decommissioningorgansiation
Regulatorybody

1.4

Planning
Plansusedindesignshouldincludethefollowingwhereappropriate:

(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)

1.5

Scopeofwork,includingworkcarriedoutbyotherorganisations
Designmethods
Softwarerequirements(softwaretobedevelopedorsoftwarecodestobevalidated
foruse)
Testrequirements,includingqualificationtests,prototype,seismic,etc.
Designreview,verificationandvalidationrequirements
Resourcerequirements
Specialtrainingrequirements
Scheduleofactivities
Pointsatwhichchecksofthedesignprocesswilltakeplaceandthefrequencyof
suchchecks
Inputsfromsafety,reliability,maintainability,humanfactors,standardizationand
otherdisciplines.

NonconformanceControlandCorrectiveActions

Asystemforthecontrolofnonconformancesandtheircorrectiveactionsshouldbe
established.

1.6 DocumentControlandRecords

Procedures for the preparation, review, approval, issue, modification and control of
documentsshallbeestablished.

C.
QUALITYASSURANCEDURINGCONSTRUCTIONOFCIVILENGINEERINGSTRUCTURES
OFGRAPF

1.
QualityAssuranceProgramme

The responsible organisation shall develop and implement a QA programme, which

describes the overall arrangements for the management, performance and assessment of
civil engineering structures for gamma irradiators during construction. This programme
shouldprovidethemeanstoensurethatallworkissuitablyplanned,correctlyperformed
andproperlyassessedinordertoimplementdesignintentintheconstruction.

1.1

Grading

Work procedures should be defined for control of construction activities at site and it
should be reviewed and approved before use. A graded approach based on the relative
importance to safety of each item, service or process shall be used. The construction
activities,whichcouldbegraded,include:

(a)
(b)
(c)
(d)
(e)

1.2

Qualificationofspecialconstructionprocessesandthepersonneltocarrythemout
Detailandneedforinspectionplans
Leveloftraceability
Levelofinprocesscontrolsandneedforholdpoints
Recordsandarchivedsamples

Organisation
Theresponsibleorganisationshouldformallyappointapersononitsstafftoberesponsible
for construction activities. The appointed person should have the necessary resources
withintheconstructionorganisationtodischargethefollowingresponsibilities:

(i)

1.3

Ensuring that construction and installation work is carried out in accordance with
design specifications, drawings, procedures and instructions, including the
implementationofspecifiedQArequirements.
(ii)
Ensuring that construction and installation work undertaken, including work by
suppliers, is coordinated, conducted and completed in accordance with planned
programmesofwork.
(iii) Controllingaccesstotheconstructionsite.

Interfaces
Interfacearrangementsshouldbeagreedbetweentheconstructionorganisation,suppliers
andotherorganisationalunitsperformingthework.Theyshouldbedefinedinwritingand
shouldbeincludedinprocurementdocuments.Interfacesthatshouldbeaddressedare:

(a)
(b)
(c)
(d)
(e)
(f)

1.4

1.5

Constructionorganizationwithsupplier
Constructionorganizationwithoperatingorganisation
Supplierswithsubsuppliers
Constructionorganisationwiththeprincipaldesigner
Constructionorganisationwithsitingorganization
Interfacesbetweenconstructionorganisationandtheregulatorybody

Planning

Allconstructionactivitiesshouldbeplanned.Theplanshoulddefine:

(a)
Theactivitiestobeperformedinmanageableunits
(b)
Theplannedsequentialorderanddurationoftheseactivities
(c)
Theresourceallocationforeachactivity
NonconformanceControlandCorrectiveActions

The nonconformances that are required to be reported to the construction organisation

shouldbeidentified.Suitablecorrectiveactionshouldalsoberecorded.

1.6

DocumentControlandRecords
Procedures for the preparation, review, approval, issue, modification and control of
documentsshouldbeestablished.Therecordsystemshouldbeestablishedwhichincludes
the arrangements and responsibilities for the categorisation, receipt, indexing, storage,
retrieval and disposal of construction records. Records should include all those, which
recordtheasbuiltconditionofstructures,systemsandcomponents.

1.7 The civil engineering construction should be carried out following the relevant Indian
standardcodes/specifications.Qualityofcivilconstructionshouldsatisfytherequirements
of appropriate Indian standard codes/specifications and that of product specifications.
TypicallistoftopicstobecoveredinQAprogrammeforthecivilengineeringconstructionis
givenasbelow:

(a)
Formwork,shutteringandpreconstructionactivities
(b)
Concreting&curing
(c)
Postconcreteinspection
(d)
Repair
(e)
Fabricationanderectionofembeddedparts(EP)
(f)
Fabrication&erectionofstructuralsteel
(g)
Brickwork
(h)
Groundingnetwork
(i)
Paintingforsteelstructure
(j)
Finishing&repaircontrol
(k)
Paintingofmainplantstructures/concretesfaces
(l)
Listofprocedures
(m)
Miscellaneous items such as organisation chart of QA civil, flow chart showing
productionofgooduniformconcrete,schematicdiagramonprocedureofconcrete
mixdesignetc.
(n)
Densityoftheconcreteinconstructionofwallsandroofofirradiationcellshallbe
maintained at least 2.5 g/cc and it shall be ensured that no voids or air gaps are
presentduringconcretefilling.

D. INDUSTRIALSAFETYDURINGCONSTRUCTIONOFCIVILENGINEERINGSTRUCTURES

A policy reflecting industrial safety regulations should be established for all personnel,
including suppliers and visitors. These should be in line with the prevailing factory rules.
Thepolicyshouldincludearrangementsfortheeffectiveplanning,organisation,monitoring
andreviewofthepreventiveandprotectivemeasures.

Management should provide all necessary support to the Contractor to ensure health and
safetyoftheconstructionpersonnel.

(i)
Jobhazardanalysisshouldbepreparedbeforethestartofconstruction.
(ii)
Industrialsafetyattheconstructionsiteshouldbeenforcedbyasafetyofficer.
(iii) Allconstructionequipmentshouldbetestedpriortoitsuse.
(iv)
Constructionpersonnelshouldbegivenorientationprogramonindustrialsafety.

(v)
(vi)

E.

Accidentstatisticsshouldbemaintainedattheconstructionsite.
Appropriatearrangementsforfiresafetyandfirstaidshouldbeavailable.

QUALITYCONTROLRESPONSIBILITYOFMANUFACTURER/DESIGNER

(i)
(ii)
(iii)
(iv)
(v)
(vi)

EquipmentandInstrumentquality&certification
Manufacturing material quality, tolerance of parts, fabrication specifications,
inspectionmanufacturing&testsadopted,qualityassuranceprocedures.
Qualityofcomponentsused
Certificationofwiring,electricalandmechanicalsafety
Documentationofqualityassuranceandcontrolprocedures
Specifications of wire rope, source rack, hydraulic piping and pumps, sensors and
theirqualityassurance.