ASTM D8229-19

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: D8229 − 19
Standard Guide for
Corrective Action and Preventive Action (CAPA) for the
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Cannabis Industry
This standard is issued under the fixed designation D8229; 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 2.1.6 consumer, n—person or organization that receives a
product or service anywhere within a product’s life cycle.
1.1 This guide applies to all entities that cultivate, process,
2.1.7 consumer product, n—any tangible product for sale
manufacture, test, and distribute cannabis products.
that is used for personal, family, household, or non-business
1.2 This guide defines corrective action and preventive
purposes.
action (CAPA) and the significance of an effective CAPA
2.1.8 correction, n—immediate action to eliminate a de-
process and CAPA subsystem.
tected nonconformity.
1.3 This guide defines instruction on the establishment of
2.1.8.1 Discussion—Corrections are typically one-time
adequate processes and procedures for the identification,
fixes. Corrections are also known as remedial or containment
analysis, measurement, and correction of quality issues.
actions.
1.4 This standard does not purport to address all of the
2.1.9 corrective action, n—action to eliminate the causes of
safety concerns, if any, associated with its use. It is the
a detected nonconformity or other undesirable situation.
responsibility of the user of this standard to establish appro-
2.1.9.1 Discussion—Corrective action is taken to prevent
priate safety, health, and environmental practices and deter-
recurrence of the issue.
mine the applicability of regulatory limitations prior to use.
2.1.10 corrective action and preventive action, CAPA,
1.5 This international standard was developed in accor-
n—systematicapproachthatincludesactionsneededtocorrect,
dance with internationally recognized principles on standard-
avoid occurrence, and eliminate the cause of potential noncon-
ization established in the Decision on Principles for the
forming product and other quality problems.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
2.1.11 corrective action and preventive action (CAPA) plan,
Barriers to Trade (TBT) Committee.
n—encompasses the identification of corrective or preventive
actions or both, the verification and validation of corrective or
2. Terminology
preventive actions or both, and the evaluation of the plan’s
effectiveness.
2.1 Definitions:
2.1.1 aberrant results, n—aberrant results
2.1.12 data analysis, n—analyzing processes, work
operations, concessions, quality audit reports, quality records,
2.1.2 active failure, n—errors made by frontline workers
service records, complaints, returned product, and other
such as manufacturing technicians, machine operators, drivers,
sources of quality data to identify existing and potential causes
and so forth.
of nonconforming product or other quality problems.
2.1.3 adverse trend, n—trend of deficiencies (issues) that
2.1.12.1 Discussion—Appropriate statistical methodology
may negatively impact quality if not corrected.
should be used when necessary to detect recurring quality
2.1.4 change management system, n—formal process used
problems.
to ensure that changes to a product or system are introduced in
2.1.13 data sources, n—processes within a quality manage-
a controlled and coordinated manner.
mentsystem(QMS)thatprovidequalityinformationthatcould
2.1.5 closed-loop system, n—system that an operation,
be used to identify nonconformities or potential nonconformi-
process, or mechanism is regulated by feedback.
ties.
2.1.14 deviation, n—departure from an approved
instruction, procedure, specification, or standard.
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This guide is under the jurisdiction ofASTM Committee D37 on Cannabis and
is the direct responsibility of Subcommittee D37.02 on Quality Management
2.1.15 harm, n—physical injury or damage to the health of
Systems.
people or damage to property or the environment.
Current edition approved June 1, 2019. Published July 2019. DOI: 10.1520/
D8229-19 2.1.16 hazard, n—potential source of harm.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D8229 − 19
2.1.17 human error, n—departure from acceptable or desir- 2.1.35 root cause, n—gap in a process input or supporting
able practices on the part of an individual resul
...