1.1 本指南适用于种植、加工、制造、测试和分销大麻产品的所有实体。 1.2 本指南定义了纠正措施和预防措施（CAPA）以及有效的CAPA过程和CAPA子系统的重要性。 1.3 本指南定义了关于建立识别、分析、测量和纠正质量问题的适当流程和程序的说明。 1.4 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 3.1 在问题成为系统性问题或对消费者健康和安全构成风险之前，识别和应对机会的能力对于保持合规性和实现消费者期望至关重要。CAPA过程是一种系统方法，用于记录、识别和纠正来自各种数据源的现有和潜在质量问题。 CAPA子系统分析质量系统和流程的数据输入并对其进行趋势分析，以确定质量问题是否是重复出现的、系统性的或影响消费者健康和安全的（参见 图1 ). 图1 CAPA过程与CAPA子系统

1.1 This guide applies to all entities that cultivate, process, manufacture, test, and distribute cannabis products. 1.2 This guide defines corrective action and preventive action (CAPA) and the significance of an effective CAPA process and CAPA subsystem. 1.3 This guide defines instruction on the establishment of adequate processes and procedures for the identification, analysis, measurement, and correction of quality issues. 1.4 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. 1.5 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. ====== Significance And Use ====== 3.1 The ability to identify and respond to opportunities before issues become systemic or are a risk to consumer health and safety is vital to maintaining compliance and achieving consumer expectations. The CAPA process is a systematic approach for documenting, identifying, and correcting existing and potential quality issues from various data sources. The CAPA subsystem analyzes and trends data inputs from quality systems and processes to identify if a quality issue is recurring, systemic in nature, or impacts consumer health and safety (see Fig. 1 ). FIG. 1 CAPA Process versus CAPA Subsystem