ASTM D8286-19

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8286 − 19
Standard Guide for
1
Processing Cannabis Product Complaints
This standard is issued under the fixed designation D8286; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2.2 complainant, n—person who reports complaint.
2.2.3 corrective action and preventive action (CAPA),
1.1 This guide is applicable to organizations engaged in the
n—systematic approach that includes actions needed to correct,
cultivation, processing, testing, packaging and labeling,
avoid occurrence, and eliminate the cause of potential noncon-
storage, distribution, or transportation of cannabis products
forming product and other quality problems.
intended for human and animal consumption, including those
derived from hemp.This guide describes the minimum require-
2.2.4 quality, n—degree to which a set of inherent charac-
ments for maintaining a product complaint system for finished
teristics fulfills requirements.
cannabis products and ensures that all complaints are received,
2.2.5 quality issue, n—any issue that may negatively impact
processed, investigated, documented, and appropriate correc-
product quality.
tive and preventive actions are implemented in a timely
2.2.6 quality management, n—coordinated activities to di-
manner.
rect and control an organization in regard to quality.
1.2 This guide applies to all cannabis-derived products
2.2.7 root cause, n—factor that caused the concerning
commercially manufactured and distributed for consumer use.
condition.
1.3 Units—The values stated in SI units are to be regarded
2.2.8 trend, n—sequence or pattern of data.
as the standard. No other units of measurement are included in
this standard.
3. Significance and Use
1.4 This standard does not purport to address all of the
3.1 Aproduct complaints program is an essential part of the
safety concerns, if any, associated with its use. It is the
organization’s Quality Management System. The ability to
responsibility of the user of this standard to establish appro-
document, investigate, and correct issues related to product
priate safety, health, and environmental practices and deter-
complaints provides manufacturers with opportunities for im-
mine the applicability of regulatory limitations prior to use.
provement. Putting in place appropriate corrective and preven-
1.5 This international standard was developed in accor-
tive actions can lead to increased customer satisfaction, prod-
dance with internationally recognized principles on standard-
uct safety, and increased market share.
ization established in the Decision on Principles for the
3.2 Requirements of regulatory bodies or governmental
Development of International Standards, Guides and Recom-
departments supersede the recommendations in this guide.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee. 4. Procedure
4.1 Product labeling should include contact information for
2. Terminology
the manufacturer that allows consumers to promptly and easily
2.1 For definitions of terms see ASTM Standards: D37-
report complaints.
WK60576 (in process at ASTM) Standard Terminology Relat-
4.2 A manual or electronic system should be established to
ing to Cannabis.
track and manage product complaints.This system ensures that
2.2 Definitions of Terms Specific to This Standard:
complaints are appropriately investigated and trended, that the
2.2.1 complaint, n—any written, electronic or verbal com-
potential or actual product quality or health risks are identified,
munication that alleges deficiencies, non-conformance to
and corrective and preventive actions (CAPA) are imple-
specifications, or adulteration in the product after it is released
mented. Recurring similar complaints may not require new
for distribution.
investigations but may require CAPA.
4.3 A unique control number should be issued to each
1
This guide is under the jurisdiction ofASTM Committee D37 on Cannabis and
product complaint as well as a category (e.g., medical vs.
is the direct responsibility of Subcommittee D37.02 on Quality Management
non-medical), type of complaint (e.g., particulate,
Systems.
discoloration, off-odor, labeling, defective product, etc.), and
Current edition approved Oct. 1, 2019. Published October 2019. DOI: 10.1520/
D8286-19. prioritization.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Pa
...