ASTM_D_8229_-_19.pdf

Designation:D822919Standard Guide forCorrective Action and Preventive Action(CAPA)for theCannabis Industry1This standard is issued under the fixed designation D8229;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide applies to all entities that cultivate,process,manufacture,test,and distribute cannabis products.1.2 This guide defines corrective action and preventiveaction(CAPA)and the significance of an effective CAPAprocess and CAPA subsystem.1.3 This guide defines instruction on the establishment ofadequate processes and procedures for the identification,analysis,measurement,and correction of quality issues.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Terminology2.1 Definitions:2.1.1 aberrant results,naberrant results2.1.2 active failure,nerrors made by frontline workerssuch as manufacturing technicians,machine operators,drivers,and so forth.2.1.3 adverse trend,ntrend of deficiencies(issues)thatmay negatively impact quality if not corrected.2.1.4 change management system,nformal process usedto ensure that changes to a product or system are introduced ina controlled and coordinated manner.2.1.5 closed-loop system,nsystem that an operation,process,or mechanism is regulated by feedback.2.1.6 consumer,nperson or organization that receives aproduct or service anywhere within a products life cycle.2.1.7 consumer product,nany tangible product for salethat is used for personal,family,household,or non-businesspurposes.2.1.8 correction,nimmediate action to eliminate a de-tected nonconformity.2.1.8.1 DiscussionCorrections are typically one-timefixes.Corrections are also known as remedial or containmentactions.2.1.9 corrective action,naction to eliminate the causes ofa detected nonconformity or other undesirable situation.2.1.9.1 DiscussionCorrective action is taken to preventrecurrence of the issue.2.1.10 corrective action and preventive action,CAPA,nsystematic approach that includes actions needed to correct,avoid occurrence,and eliminate the cause of potential noncon-forming product and other quality problems.2.1.11 corrective action and preventive action(CAPA)plan,nencompasses the identification of corrective or preventiveactions or both,the verification and validation of corrective orpreventive actions or both,and the evaluation of the planseffectiveness.2.1.12 dataanalysis,nanalyzingprocesses,workoperations,concessions,quality audit reports,quality records,service records,complaints,returned product,and othersources of quality data to identify existing and potential causesof nonconforming product or other quality problems.2.1.12.1 DiscussionAppropriate statistical methodologyshould be used when necessary to detect recurring qualityproblems.2.1.13 data sources,nprocesses within a quality manage-ment system(QMS)that provide quality information that couldbe used to identify nonconformities or potential nonconformi-ties.2.1.14 deviation,ndeparturefromanapprovedinstruction,procedure,specification,or standard.2.1.15 harm,nphysical injury or damage to the health ofpeople or damage to property or the environment.2.1.16 hazard,npotential source of harm.1This guide is under the jurisdiction of ASTM Committee D37 on Cannabis andis the direct responsibility of Subcommittee D37.02 on Quality ManagementSystems.Current edition approved June 1,2019.Published July 2019.DOI:10.1520/D8229-19Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 2.1.17 human error,ndeparture from acceptable or desir-able practices on the part of an individual resulting in anunacceptable or undesirable result.2.1.18 human factor,ndiscipline concerned with design-ing machines,operations,and work environments to matchhuman capabilities,limitations,and needs.2.1.19 in-conformance data,ndata that meet the estab-lished acceptance criteria.2.1.20 initial impact assessment