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    May 2014 - Risk Assessment - Make It Easier Than It Appears

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    ManivannanMudhaliar
    This document discusses risk assessment as addressed in API Spec Q1 9th Edition Clause 5.3. It notes that risk assessment only applies to impacts on delivery of product and product quality. It also discusses how other clauses in Q1 are related to risk assessment, even if not explicitly mentioned in Clause 5.3. It encourages using ISO 31000 as a reference for understanding how to apply a risk assessment approach and outlines basic principles for a risk management system. Finally, it provides examples of how risks could be identified through other Q1 processes like control of nonconforming product or preventive maintenance.

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    May 2014 - Risk Assessment - Make It Easier Than It Appears

    Uploaded by

    ManivannanMudhaliar
    42 views4 pages
    This document discusses risk assessment as addressed in API Spec Q1 9th Edition Clause 5.3. It notes that risk assessment only applies to impacts on delivery of product and product quality. It also discusses how other clauses in Q1 are related to risk assessment, even if not explicitly mentioned in Clause 5.3. It encourages using ISO 31000 as a reference for understanding how to apply a risk assessment approach and outlines basic principles for a risk management system. Finally, it provides examples of how risks could be identified through other Q1 processes like control of nonconforming product or preventive maintenance.

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    risk assessment - ISO 9001

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    Risk Assessment

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    This document discusses risk assessment as addressed in API Spec Q1 9th Edition Clause 5.3. It notes that risk assessment only applies to impacts on delivery of product and product quality. It also discusses how other clauses in Q1 are related to risk assessment, even if not explicitly mentioned in Clause 5.3. It encourages using ISO 31000 as a reference for understanding how to apply a risk assessment approach and outlines basic principles for a risk management system. Finally, it provides examples of how risks could be identified through other Q1 processes like control of nonconforming product or preventive maintenance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    42 views4 pages

    May 2014 - Risk Assessment - Make It Easier Than It Appears

    Uploaded by

    ManivannanMudhaliar
    This document discusses risk assessment as addressed in API Spec Q1 9th Edition Clause 5.3. It notes that risk assessment only applies to impacts on delivery of product and product quality. It also discusses how other clauses in Q1 are related to risk assessment, even if not explicitly mentioned in Clause 5.3. It encourages using ISO 31000 as a reference for understanding how to apply a risk assessment approach and outlines basic principles for a risk management system. Finally, it provides examples of how risks could be identified through other Q1 processes like control of nonconforming product or preventive maintenance.

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    16/04/2016

    May2014RiskAssessmentMakeitEasierthanitAppears

    May2014RiskAssessmentMakeitEasierthanit
    Appears

    RiskAssessment
    MakeitEasierthanitAppears
    APISpec.Q19thEditionaddressesthesubjectofriskinClause5.3,RiskAssessmentand
    Management.Itisimportanttounderstandthatriskassessmentasaddressedinthissectiononly
    appliestoimpactupon:
    Deliveryofproduct
    Productquality
    TheorganizationisresponsibleforimplementingtheserequirementsinordertoconformtoaQ1
    qualitymanagementsystem.WhileQ1outlinesthehighlevelrequirementsforthissubject,itdoes
    notprovidedetailsabouthowtoimplementit.
    Inordertobetterunderstandyourjourneytoimplementation,itisimportanttounderstandthe
    circularnatureofQ1.Forexample,thefollowingQ1clausesaredirectlyorindirectlyrelatedtothe
    subjectofriskassessment,whetherornottheyhavebeenspecifiedinClause5.3:
    3.1.19

    DefinitionofRisk

    4.5

    ControlofRecords

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    5.2(d)

    Planning

    5.4.2(g)

    DesignandDevelopmentInputs

    5.5

    ContingencyPlanning

    5.7.8(note)

    PreventiveMaintenance

    5.10.1

    DeliveryofNonconformingProduct

    5.11

    ManagementofChange

    6.5.2(f)

    [ManagementReview]InputRequirements

    Bibliography

    ISO31000,RiskmanagementPrinciplesand
    guidelines

    AsreferencedintheBibliography,itisimportanttohaveacopyofISO31000,Riskmanagement
    Principlesandguidelines(1).WhileISO31000identifiesgenericrequirementsforthe
    implementationofariskmanagementsystemthatcouldapplytomostriskbasedsituations,its
    contentsarerelevantforunderstandinghowtoapplyariskassessmentculturethatisrelatedto
    Clause5.3sintent(i.e.,deliveryofproductandproductquality).
    Shownbelow,Figure1outlinesthebasicprinciplesforariskmanagementsystem.Thisstructure
    providesasimplisticandunderstandableformatforcontentthatshouldbeincludedinaprocedure
    inordertomeettherequirementsofClause5.3.
    Figure1
    ExcerptfromISO31000(1)
    Concurrently,itisimportanttounderstandthereferencestoriskfromothersectionsinQ1.Shown
    belowareexcerptsfromtwootherQ1clausesrelatedtoriskassessment.

    5.5ContingencyPlanning
    5.5.1General
    Theorganizationshallmaintainadocumentedprocedureforcontingencyplanningneededto
    addressriskassociatedwithimpactondeliveryandqualityofproduct.
    Contingencyplanningshallbebasedonassessedrisks(see5.3),andoutputshallbe
    documentedandcommunicatedtotherelevantpersonnelandupdatedasrequired.
    5.5.2PlanningOutput
    Thecontingencyplanshallinclude,ataminimum:
    a)actionsrequiredinresponsetosignificantriskscenariostomitigateeffectsofdisruptive
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    incidents

    5.11ManagementofChange
    5.11.3MOCNotification
    Theorganizationshallnotifyrelevantpersonnel,includingthecustomerwhenrequiredby
    contract,ofthechangeandresidualornewriskduetochangesthathaveeitherbeeninitiatedby
    theorganizationorrequestedbythecustomer.
    WhileClauses5.5and5.11bothcontainrequirementsrelatedtorisk,theirrequirementsarenot
    explicitlyandholisticallymentionedinClause5.3.
    ThenotecontainedinClause5.3asquotedbelowisimportantinunderstandinghowto
    implementariskassessmentandmanagementprocedure:
    NOTERiskassessmentcanincludeconsiderationofseverity,detectionmethods,and
    probabilityofoccurrence.
    Dependingonyourorganizationsvernacular,thewordsseverityandprobabilitycouldbe
    synonymouswiththewordsconsequence(2.18)(1)andlikelihood(2.19)(1)respectively.ISO
    31000specifiesthedefinitionsforconsequenceandlikelihood,aswellasnumerousother
    definitionsassociatedwithriskmanagement.Thesewordshelpidentifytheboundariesofarisk
    event,thedegreetowhichriskcouldbedisruptivetoyourorganization.
    Inpartoftheriskassessmentprocess,typically,organizationscreateariskmatrixthatillustrates
    consequenceononeaxisandlikelihoodontheotheraxis,whichgeneratesarisknumberthatis
    associatedwiththedegreeofsignificanceofariskevent.
    ThenoteinClause5.3alsoaddressesdetectionmethods.Whiletheyappeartobeself
    explanatory,detectionmethodsmaybefoundinothersectionsofQ1andcouldbeusedtoidentify
    howorwhereriskwasinitiallyidentified,forexample:
    ControlofNonconformingProduct(e.g.,aproductnonconformancedocumentingamaterial
    problem)
    InspectionandTesting(e.g.,visualcharacteristicsthatconsiderablydeviatefromacceptance
    criteria)
    CorrectiveAction(e.g.,adocumentedsuppliernonconformityonacrackedfastener)
    PreventiveAction(e.g.,aprocesschangethatrequiresnewanddifferentprocessequipment)
    DesignInput(e.g.,adesignchangeduetoafieldfailure)
    Planning(e.g.,acustomerorderrequiringtheuseofmaterialsnotusedbefore)
    PreventiveMaintenance(e.g.,repetitiveequipmentfailuresforequipmentusedinacritical
    process)
    OnceyougainanunderstandingofhowtheinterrelatednessofothersectionsinQ1provideinput
    totheriskassessmentandmanagementprocess,thedocumentationandimplementationofthe
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    processshouldnotbesodaunting.Inshort,alwaysconsider:
    HowQ1clausesinterrelatewithotherQ1clauses
    HowtheintegrationofabibliographicreferencecanfacilitateconformitytoQ1
    1.InternationalOrganizationforStandardizationISO31000,RiskmanagementPrinciplesand
    guidelines
    OurServices

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