A form has been created to facilitate the CAPA (Corrective Action / Preventive Action) development process to ensure that all required elements of a CAPA are discussed and documented to make it effective.

There are four main sections to the CAPA form:

1. Identification and description of the deviation being investigated.
2. Documentation of the immediate actions taken to correct the issue and supporting details.
3. Identification of the results of the root cause analysis that led to the deviation and resulting preventive action(s) to be taken to ensure the issue does not recur.
4. PI signature at two distinct time points:
   1. First signature at the conclusion of the CAPA creation
   2. Second signature when all preventive actions are completed

For more information on the CAPA form, keep on reading.

This form is not yet posted on the CCTO website. We are rolling it out on an as needed basis so we can work individually with groups the first time a CAPA is created using this process. Several groups have already successfully created a CAPA using this form and are in the process of working on their preventive actions.

If you have any questions regarding this topic, or if you need to create a CAPA, please contact us at dsmc-quality@stanford.edu.