ASTM_D_8308_-_21.pdf

Designation:D830821Standard Practice forCannabis/Hemp Operation Compliance Audits1This standard is issued under the fixed designation D8308;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 PurposeThis practice identifies the minimum require-ments for the planning,conduct,and reporting of complianceaudits of a cannabis/hemp business.It provides information onterms,procedures,and responsibilities.1.2 IntentThe intent is to provide specific instructionneeded to develop reliable audit programs and procedures thatare used to conduct audits that produce credible,consistent,and objective evidence and findings related to compliance withone or more standards,regulations,policies,best practices,orquality specifications.This practice can be used internally forpre-audit assessments to identify and correct operational gaps.1.3 OrganizationThis practice is organized in the follow-ing manner:SectionScope1Referenced Documents2Terminology3Significance and Use4Audit Process Overview5Audit Programs6Audit Process7Record Management8Keywords9Roles and ResponsibilitiesAnnex A1Auditor Qualifications and StaffingAnnex A2Scale,Objectives,and Perspectives of an AuditAnnex A3Process DiagramsAnnex A41.4 Nothing in this practice shall preclude observance offederal,state,or local regulations which may be more restric-tive or have different requirements.1.5 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.1.6 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.Referenced Documents2.1 ASTM Standards:2D8229 Guide for Corrective Action and Preventive Action(CAPA)for the Cannabis Industry3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 action plan,na plan to correct negative audit find-ings and close gaps.3.1.2 audit,vsee compliance audit.3.1.3 audit authority,nthe entity that authorizes,orinitiates,the audit process.3.1.3.1 DiscussionThe audit authority may be internal tothe audited entity,such as senior management not involvedwith the day-to-day operations of the operation/area(s)beingaudited;or external,such as a financial stakeholder,a businesscustomer,or a government authority having jurisdiction.3.1.4 audit criteria,nthe set of requirements that areapplicable to the objective and scope of an audit.Examplesinclude standards,regulations,laws,policies,best practices,quality specifications,and industry best practices.3.1.5 audit data,ndata collected during an audit to sup-port the audit findings.Examples:Photos,notes,documents,records,forms,and answers.3.1.6 audit finding,na statement of the audited entitysconformity against the audit criteria at the time of the audit.3.1.6.1 DiscussionThe audit finding is the good/bad,conformity/nonconformity statement that results from anevaluation of the audit data collected.It can also be thecollective conformity/nonconformity of each question or crite-ria.The audit finding(s)is not the audit data that supports theaudit finding.3.1.7 audit objective(s),nbroad statement(s)of what theaudit intends to accomplish.1This practice is under the jurisdiction of ASTM Committee D37 on Cannabisand is the direct responsibility of Subcommittee D37.02 on Quality ManagementSystems.Current edition approved Feb.15,2021.Published March 2021.Originallyapproved in 2020.Last previous edition approved in 2020 as D8308 20.DOI:10.1520/D8308-21.2For 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 Document Summary page onthe ASTM website.Copyright 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.13.1.8 audit plan,ndocumentation that describes theobjective,scope,specific responsibilities,schedule,logistics,deliverables,completion requirements and other plan detailsfor a particular audit.3.1.9 audit program,nan auditing bodys procedures,protocols,methods,and techniques