Designation:D8229−19StandardGuideforCorrectiveActionandPreventiveAction(CAPA)fortheCannabisIndustry1ThisstandardisissuedunderthefixeddesignationD8229;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideappliestoallentitiesthatcultivate,process,manufacture,test,anddistributecannabisproducts.1.2Thisguidedefinescorrectiveactionandpreventiveaction(CAPA)andthesignificanceofaneffectiveCAPAprocessandCAPAsubsystem.1.3Thisguidedefinesinstructionontheestablishmentofadequateprocessesandproceduresfortheidentification,analysis,measurement,andcorrectionofqualityissues.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpracticesanddeter-minetheapplicabilityofregulatorylimitationspriortouse.1.5Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecom-mendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.2.Terminology2.1Definitions:2.1.1aberrantresults,n—aberrantresults2.1.2activefailure,n—errorsmadebyfrontlineworkerssuchasmanufacturingtechnicians,machineoperators,drivers,andsoforth.2.1.3adversetrend,n—trendofdeficiencies(issues)thatmaynegativelyimpactqualityifnotcorrected.2.1.4changemanagementsystem,n—formalprocessusedtoensurethatchangestoaproductorsystemareintroducedinacontrolledandcoordinatedmanner.2.1.5closed-loopsystem,n—systemthatanoperation,process,ormechanismisregulatedbyfeedback.2.1.6consumer,n—personororganizationthatreceivesaproductorserviceanywherewithinaproduct’slifecycle.2.1.7consumerproduct,n—anytangibleproductforsalethatisusedforpersonal...
