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

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.