ASTM D8308-20

Standard Practice for Cannabis/Hemp Operation Compliance Audits

SIGNIFICANCE AND USE
4.1 Intended Use—This practice is intended for use by parties who either develop, plan, and conduct internal or external audits, or are interested in the audit process since they are the subject of compliance audits or they mandate such audits to occur.  
4.2 Terms and Concepts—The definition of terms in Section 3 and the perspectives on scale, objectives, and types of audits in Annex A3 provide concepts that help clarify the different roles involved in an audit, the various elements of an audit, and how this standard applies to different situations. This standard is written in terms that accommodate audits for different objectives and sizes.  
4.3 Application—Compliance audits are used to identify gaps between some criteria and the actual operational conditions. Knowledge of compliance gaps are used to assess various risks, guide corrective action and improvement efforts, prevent fines and penalties, or provide stakeholders an objective evaluation of an operation and its potential safety, financial, or other risks. A user of this practice should understand and adapt the audit concepts, process, and responsibilities in this practice to their specific organizational structure and situation.  
4.4 Audit Scale—The scale of an audit can range from an internal audit of a small single operation with fewer than ten employees to an external audit of a large corporation with facilities at multiple international locations. In either case, large or small, the principles in this practice shall be followed to produce objective and credible results.  
4.5 Audit Criteria—As the cannabis industry develops globally and continues to gain acceptance, both new and previously established standards, regulations, policies, and best practices are being developed, adopted, evolving, and applied to this industry. Due to this evolving nature, diligent attention is needed by auditing bodies to maintain up-to-date audit criteria and protocols.
SCOPE
1.1 Purpose—This practice identifies the minimum requirements for the planning, conduct, and reporting of compliance audits of a cannabis/hemp business. It provides information on terms, procedures, and responsibilities.  
1.2 Intent—The intent is to provide specific instruction needed to develop reliable audit programs and procedures that are used to conduct audits that produce credible, consistent, and objective evidence and findings related to compliance with one or more standards, regulations, policies, best practices, or quality specifications.  
1.3 Organization—This practice is organized in the following manner:    
Section  
Scope  
1  
Referenced Documents  
2  
Terminology  
3  
Significance and Use  
4  
Audit Process Overview  
5  
Audit Programs  
6  
Audit Process  
7  
Record Management  
8  
Keywords  
9  
Roles and Responsibilities  
Annex A1  
Auditor Qualifications and Staffing  
Annex A2  
Scale, Objectives, and Perspectives of an Audit  
Annex A3  
1.4 Nothing in this practice shall preclude observance of federal, state, or local regulations which may be more restrictive or have different requirements.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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.

General Information

• Status: Historical
• Publication Date: 14-Jan-2020
• ICS: 65.020.20 - Plant growing
• Technical Committee: D37 - Cannabis
• Drafting Committee: D37.02 - Quality Management Systems

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: D8308 − 20
Standard Practice for
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Cannabis/Hemp Operation Compliance Audits
This standard is issued under the fixed designation D8308; 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. Referenced Documents
2
2.1 ASTM Standards:
1.1 Purpose—This practice identifies the minimum require-
ments for the planning, conduct, and reporting of compliance D8229 Guide for Corrective Action and Preventive Action
audits of a cannabis/hemp business. It provides information on (CAPA) for the Cannabis Industry
terms, procedures, and responsibilities.
3. Terminology
1.2 Intent—The intent is to provide specific instruction
3.1 Definitions of Terms Specific to This Standard:
needed to develop reliable audit programs and procedures that
3.1.1 action plan, n—a plan to correct negative audit find-
are used to conduct audits that produce credible, consistent,
ings and close compliance gaps.
and objective evidence and findings related to compliance with
3.1.2 audit, v—see compliance audit.
one or more standards, regulations, policies, best practices, or
quality specifications. 3.1.3 audit authority, n—the entity that authorizes, or
initiates, the audit process.
1.3 Organization—This practice is organized in the follow-
3.1.3.1 Discussion—The audit authority may be internal to
ing manner:
theauditedentity,suchasadepartmentmanager,aCEO,orthe
Section
board of directors, or external, such as a financial stakeholder,
Scope 1
Referenced Documents 2 a business customer, or a government authority having juris-
Terminology 3
diction.
Significance and Use 4
Audit Process Overview 5 3.1.4 audit criteria, n—the set of requirements that are
Audit Programs 6
applicable to the objective and scope of an audit. Examples
Audit Process 7
include standards, regulations, laws, policies, best practices,
Record Management 8
Keywords 9
quality specifications, and industry best practices.
Roles and Responsibilities Annex A1
3.1.5 audit data, n—data collected during an audit to sup-
Auditor Qualifications and Staffing Annex A2
Scale, Objectives, and Perspectives of an Audit Annex A3
port the audit findings. Examples: Photos, notes, documents,
records, forms, and answers.
1.4 Nothing in this practice shall preclude observance of
federal, state, or local regulations which may be more restric-
3.1.6 audit finding, n—a statement of the audited entity’s
tive or have different requirements.
conformity against the audit criteria at the time of the audit.
3.1.6.1 Discussion—The audit finding is the good/bad,
1.5 This standard does not purport to address all of the
conformity/nonconformity statement that results from an
safety concerns, if any, associated with its use. It is the
evaluation of the audit data collected. It can also be the
responsibility of the user of this standard to establish appro-
collective conformity/nonconformity of each question or crite-
priate safety, health, and environmental practices and deter-
ria. The audit finding(s) is not the audit data that supports the
mine the applicability of regulatory limitations prior to use.
audit finding.
1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3.1.7 audit objective(s), n—broad statement(s) of what the
ization established in the Decision on Principles for the
audit intends to accomplish.
Development of International Standards, Guides and Recom-
3.1.8 audit plan, n—documentation that describes the
mendations issued by the World Trade Organization Technical
objective, scope, specific responsibilities, schedule, logistics,
Barriers to Trade (TBT) Committee.
deliverables, completion requirements and other plan details
for a particular audit.
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This practice is under the jurisdiction of ASTM Committee D37 on Cannabis
2
and is the direct responsibility of Subcommittee D37.02 on Quality Management For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Systems. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved Jan. 15, 2020. Published February 2020. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D8308-20. the ASTM website.
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D8308 − 20
3.1.9 audit program, n—an auditing body’s procedures, 3.1.22 documents, n—written policies, processes,
protocols, methods, and techniques for conducting an audit. procedures, plans, standards, specifications, and
...