ASTM D8229-26

4.1 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 problems from various data sources. The CAPA subsystem analyzes and trends data inputs from quality systems and processes to identify if a quality problem is recurring, systemic in nature, or impacts consumer health and safety (see Fig. 1).

Note 2: Each flow chart element in Fig. 1 is described in the necessary detail in the sections below.

1.1 This guide applies to all entities that cultivate, process, manufacture, test, and distribute cannabis products.

1.2 In this guide, corrective action and preventive action (CAPA) are defined.

1.3 This guide covers:

1.3.1 Identification of a problem,

1.3.2 Evaluation of a problem,

1.3.3 Investigation of a problem,

1.3.4 Initiating a CAPA,

1.3.5 The flow of CAPA,

1.3.6 Closeout of CAPA, and

1.3.7 How CAPA may interact with other processes.

1.4 This guide does not go into detail on the processes that may be related or that may interact with the CAPA process. Those processes are defined in other standards. However, in this guide, how CAPA may interact with other processes is described, for example:

1.4.1 Root cause analysis (RCA),

1.4.2 Change management or change control,

1.4.3 Nonconformity,

1.4.4 Deviation, and

1.4.5 Continuous improvement.

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.