This page is meant to help log initial review of the Issue, including notation of past experience with similar issues, FMEA type impact rating, and logging of any immediate Corrective Actions that were undertaken. None of these items are mandatory fields.
- Verify the source of the reported issue.
- Log whether this issue has happened in the past and catalog past actions taken in the text box.
- Optional: Enter a Frequency and Potential Impact value to calculate an FMEA type impact score and rating.
- Optional: Click the button and follow the instructions to log any immediate 'Corrective' actions taken (note you will add Preventive actions in the Action Plan). Clicking the button will open the CAPA Management window. Repeat the process as many times as needed. All items will be listed here with current status.
- Comments: Any user with access to this Issue can add comments. Click the button to add a comment. Comments are designated by default, but you can set any comment to 'All Reviewer' to share it with any external client/partner that you have shared the Issue with.