***You will need Super User/Admin Permissions to do these actions***
There are some key settings to think about when configuring your Issue/CAPA module.
First please consider adding key meta data fields that are part of your process as custom fields. These will appear in the Issues table and can be most helpful in segmenting your data / reports. See this article on creating custom fields and just make sure that they are set with the correct placement. Configuration: Custom Fields
Navigate to Administration > Member Account page and scroll to the bottom to the section called "Issue Types". Here you can Add/Disable or Edit issue types that you are tracking in the app. These are the issue types that will appear in the drop down when you click to log a new issue.
Root Cause Category & CAPA Category
You can edit the list of options that appear in the Root Cause Category and the CAPA Category fields. Navigate to Administration > Member Account page and scroll to the bottom to the section called "Member Category Configuration". Here you can Add/Disable or Edit issue types that you are tracking in the app.
Issue Workflow Approval
In order to be approved for implementation an issue must be approved by investigators, CAPA assignees AND an enforced workflow approval process currently defined by the Site or Dept you have created. So to edit this workflow approval process, you need to first verify that you have defined the sites/depts that you will be logging issues against in ZenQMS.
If you want to add a site, navigate to the Administration > Site Management page and click the Add New Site button at the top to add a new site-- typically these are internal/captive sites.
Once your site list is correct, navigate to Administration > Configuration > Workflow Templates page (see below).
- In the first dropdown select "Issue/CAPA: Site Workflow Approval" option.
- In the second dropdown select the site you want to create a workflow for.
- Use the controls to add or delete workflow steps. For each step, you can name the step, set a reason code AND (importantly) select a user or group of users as authorized signatories for the step. We strongly recommend making this a group designation to make it easier to manage as people come into or leave the company.
Issues: Restricting who can be assigned as Investigator, Final Reviewer or Effectiveness Check Steps.
The application default is to show ALL non-disabled users when picking who should be an investigator, final reviewer or effectiveness check reviewer. This is easy to do.
Navigate to Administration > Configuration > Workflow Templates page (see below).
- In the first dropdown select "Issue/CAPA: Limit user selection for key roles" option.
- In the second dropdown select the site you want to restrict access for.
- In the three sections below you can select individual users OR groups that are authorized for these roles. If you select even one user/group, then those will be the only options that will appear in the dropdowns when 'normal' users are interacting with the module. We strongly recommend making this a group designation to make it easier to manage as people come into or leave the company.