1. Enter the details of the non-conformance or issue which is giving rise to the corrective action - This section populates automatically with the question o/requirement from which the corrective action was raised in a self-assessment audit or site audit.

2. Complete the comments you have for the site on the non-conformance noted - This section will populate with the comments given to the non-conforming requirement if the corrective action was raised from a site audit or site self-assessment.

3.Determine the risk level that the non-conformance is likely to poise by selecting a risk value for each criterion (Note: this risk model can be replaced with a different model).

4. Attach or link to any document or website.

5. Provide a detailed report for your justification of the risk values selected.

6. Determine who is responsible for investigating the non-conformance.

7. Determine who is responsible for the review stage of the investigation.

8.Establish a date of completion for the investigation.

This section gives the site an opportunity to respond to the corrective action. The contact chosen as "Responsible (Action)" in the previous stage will receive an email notification notifying them that they must complete this stage. The site in question is required to complete the following steps:

1. Investigation/Root Cause Analysis: A short overview of the investigation conducted concerning the corrective action.

2. Corrective Action: Details of the actions that have been taken by the site to correct the situation.

3. Prevention Action: Any preventative actions that will prevent the problem from re-occurring in the future.

4. Completion Date: Date completed.

5. Add File: An option for the site to add a file if applicable.

The contact chosen as "Responsible (Review)" in the "Corrective Actions Details" stage will receive an email notification notifying them that they must complete this stage (if alerts are in place).

1. Report: Here you are required to review the site's response and then create a review report for the site to view.

2. Choose a decision from the dropdown for the site corrective action:

• 1. Additional Information Required: If you require additional information from this site. This option can be chosen multiple times until all necessary information has been submitted by a site - refer to section below for more details.
• 2. Closed - Approved: If you wish to close this site corrective action and approve the Corrective Action.
• 3. Closed - Not Approved: If you would like to close this site corrective action but do not wish to approve the corrective action.
• 4. Closed - Dropped: If you wish to close this corrective action and take no action.
• 5. Closed - Not Concluded: If you can’t come to a conclusion on the site corrective action and want to close it.

1. If "Additional Information Required" was selected in the Review Stage, the site will be prompted to respond again in the "Additional Information Stage".

You will once again be required to review your site's response and decide if this Site Corrective Action is approved or not and then close out the record.