1、Designation:D822221aStandard Guide forEstablishing a Quality Management System(QMS)forConsumer Use of Cannabis/Hemp Products1This standard is issued under the fixed designation D8222;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,th
2、e 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 focuses on the core elements of an effectivequality management system(QMS)necessary to optimizeconsume
3、r and product safety,product quality,and conformancewith requirements from industry,governmental agencies,andother authorities having jurisdiction.This guide incorporatesbasic quality principles,guidelines,and industry best practicesnecessary to establish a QMS adaptable to all organizations.1.2 Law
4、s and regulations from authorities having jurisdic-tion supersede recommendations within this guide.1.3 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
5、environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.4 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 St
6、andards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D8220 Guide for Conducting Recall/Removal Proceduresfor Products in the Cannabis IndustryD8229 Guide for Corrective Action and Preventive Acti
7、on(CAPA)for the Cannabis IndustryD8244 Guide forAnalytical Laboratory Operations Support-ing the Cannabis/Hemp IndustryD8250 Practice for Applying a Hazard Analysis CriticalControl Points(HACCP)System for Cannabis Consum-able ProductsD8282 Practice for Laboratory Test Method Validation andMethod Dev
8、elopmentD8286 Guide for Processing Cannabis Product Complaints2.2 ASQ Document:3Failure Mode and Effects Analysis(FMEA)Brief Summary3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 controlled document,na document with an alpha-numeric assignment that is integrated into a QMS and
9、 subjectto revision and revision tracking.3.1.2 equipment,nnon-expendable,tangible moveableproperty needed for the performance of a task or useful ineffecting an obligation.3.1.3 instrumentation,nequipment capable of performingmeasurements used to generate analytical data(for example,GC-MS,IR,NMR,ba
10、lances,etc.).3.1.4 qualified individual,nan individual who meets ap-plicable skill,experience,education,or other requirements ofan employment position that they hold or seek,and who canperform the essential functions of the job with or withoutreasonable accommodation.3.1.5 planned deviation,npre-app
11、roved deviations fromthe current operational document or system,covering a speci-fied period or number of batches.3.1.5.1 DiscussionPlanned deviations must be approvedbefore execution.Planned deviations should be handledthrough approved change control procedures.3.1.6 recall,na product recall is the
12、 process of retrievingdefective or potentially unsafe goods from consumers andproviding those consumers with compensation.3.1.7 removal,na product is removed from the supplychain,but not for health and safety reasons.3.1.8 unplanned deviation,na state of nonconformancefrom the designed systems or pr
13、ocedures at any stage ofmanufacturing,packaging,testing,holding,or storage of theproduct.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 July 15,2021.Published August
14、2021.Originallyapproved in 2021.Last previous edition approved in 2021 as D8222 21.DOI:10.1520/D8222-21A.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Do
15、cument Summary page onthe ASTM website.3Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203,http:/www.asq.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in
16、 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?3.2 Abbreviated Terms:3.2.1 BMR,nbatch manufacturing record3.2.2 CAPA,ncorrective actions/preventive actions3.2.3 CPP,ncritical process parameters3.2.4 CQA,ncritical quality attributes3.2.5 FMEA,nFailure Mode and Effects Analysi