1、Designation:D828619Standard Guide forProcessing Cannabis Product Complaints1This standard is issued under the fixed designation D8286;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 i
2、ndicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide is applicable to organizations engaged in thecultivation,processing,testing,packaging and labeling,storage,distribution,or transportation of cannabis p
3、roductsintended for human and animal consumption,including thosederived from hemp.This guide describes the minimum require-ments for maintaining a product complaint system for finishedcannabis products and ensures that all complaints are received,processed,investigated,documented,and appropriate cor
4、rec-tive and preventive actions are implemented in a timelymanner.1.2 This guide applies to all cannabis-derived productscommercially manufactured and distributed for consumer use.1.3 UnitsThe values stated in SI units are to be regardedas the standard.No other units of measurement are included inth
5、is standard.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
6、 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 TechnicalBarr
7、iers to Trade(TBT)Committee.2.Terminology2.1 For definitions of terms see ASTM Standards:D37-WK60576(in process at ASTM)Standard Terminology Relat-ing to Cannabis.2.2 Definitions of Terms Specific to This Standard:2.2.1 complaint,nany written,electronic or verbal com-munication that alleges deficien
8、cies,non-conformance tospecifications,or adulteration in the product after it is releasedfor distribution.2.2.2 complainant,nperson who reports complaint.2.2.3 corrective action and preventive action(CAPA),nsystematic approach that includes actions needed to correct,avoid occurrence,and eliminate th
9、e cause of potential noncon-forming product and other quality problems.2.2.4 quality,ndegree to which a set of inherent charac-teristics fulfills requirements.2.2.5 quality issue,nany issue that may negatively impactproduct quality.2.2.6 quality management,ncoordinated activities to di-rect and cont
10、rol an organization in regard to quality.2.2.7 root cause,nfactor that caused the concerningcondition.2.2.8 trend,nsequence or pattern of data.3.Significance and Use3.1 A product complaints program is an essential part of theorganizations Quality Management System.The ability todocument,investigate,
11、and correct issues related to productcomplaints provides manufacturers with opportunities for im-provement.Putting in place appropriate corrective and preven-tive actions can lead to increased customer satisfaction,prod-uct safety,and increased market share.3.2 Requirements of regulatory bodies or g
12、overnmentaldepartments supersede the recommendations in this guide.4.Procedure4.1 Product labeling should include contact information forthe manufacturer that allows consumers to promptly and easilyreport complaints.4.2 A manual or electronic system should be established totrack and manage product c
13、omplaints.This system ensures thatcomplaints are appropriately investigated and trended,that thepotential or actual product quality or health risks are identified,and corrective and preventive actions(CAPA)are imple-mented.Recurring similar complaints may not require newinvestigations but may requir
14、e CAPA.4.3 A unique control number should be issued to eachproduct complaint as well as a category(e.g.,medical vs.non-medical),typeofcomplaint(e.g.,particulate,discoloration,off-odor,labeling,defective product,etc.),andprioritization.1This guide is under the jurisdiction of ASTM Committee D37 on Ca
15、nnabis andis the direct responsibility of Subcommittee D37.02 on Quality ManagementSystems.Current edition approved Oct.1,2019.Published October 2019.DOI:10.1520/D8286-19.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international st
16、andard 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 Copyright by ASTM Intl(all rights reserved);Fri Nov 29 03:37:22 EST 2019Downloaded/printed byUniversity of Michigan(University of Michigan)pursuant to License Agreement.No further reproductions authorized.