From the Issues Tab, click on the “Log a New Issue” button above the Issues table.
The first three fields are required to log an issue. Enter the Site Name/ID, the Issue Type from the dropdown list, and the date. There may be custom fields added to answer, these may be required fields. If you are not the reporter of the issue, include the the reporter contact name. If you would like to add a detailed description of the issue, type or copy and paste into the long text box at the bottom of the screen. To attach any files to this issue, click the “Upload Files” hyperlink and attach your document. When you are finished entering details, submit your issue.
Upon logging your issue, you will receive a message that your issue is logged and three predetermined users will be notified about the new issue. These users were determined by the Site you chose when logging the issue.
As a Super User, you can walk through the issue investigation. Using the table, search for the issue logged. Click the “Edit” hyperlink. You will be brought directly to the details information of your issue. The lead investigator has been added and determined based on the Site chosen. You can change and/or add up to two co-investigators by choosing the “Manage Team” button.
The Issue Details and Custom Fields are taken from the original screen where you logged in the information. You can update or change this information as necessary. All changes are track under the comments section at the bottom. This is an audit trail of all changes. You can add a bi-directional link to any item within ZenQMS under the Links section.
On the Assessments tab you can enter in information and get a basic risk assessment score and rating. This is calculated by the frequency x impact. This is an optional tool. You will log any Corrective Actions under the Assessments tab. ZenQMS separates Corrective and Preventive actions solely for tracking and trending purposes. To log a corrective action, click the “Add CAPA” button.
Enter the details of your Corrective Action - enter your headline, choose a category from the dropdown list. If this is a true Corrective Action and it has been completed, you can enter the details in the text box or upload an attachment with the documentation press Save and then “Complete this CAPA”. If this Corrective Action has not been completed, choose the implementation date and assign a user from the dropdown list.
All CAPAs will be permanently tied to the issue. Here we have Issue 1909 and CAPA 1909-1. Once the CAPA is completed it will still be associated with the issue.
If you have a Root Cause Analysis, you can add it under the “Root Cause Analysis” tab. Choose a category from the dropdown list. You can type or copy and paste your report into the text box. If your organization has uploaded a template, click the “Insert Template” link. The template will appear in the text box for you to add your information to the report by typing directly into the text box. If you have a completed Root Cause Analysis outside of the software, you can upload the document under the File Attachments by clicking “Upload More” underneath the text box. There is no limit to the file size or type that you can upload. You can upload additional documents as well that may be associated with the Root Cause Analysis under the File Attachments section.
You can summarize your Issue Action Plan under the Action Plan tab. Start by choosing a projected implementation date. This is required. Add your summary by inserting a template and editing within the text box, typing or copying and pasting directly into the text box, or uploading a document under File Attachments underneath the text box.
If you have a Preventive Actions, click the “Add CAPA” button. This process is the exact same as adding a Corrective Action. You can add as many Preventive Actions as needed. They will be permanently associated with the Issue.
Once you have entered all of your details and you are ready to launch your investigation, go to the “Workflow” tab. Your Lead Investigator(s) will be automatically added to sign for approval. If you added any corrective or preventive actions with assigned users, they will also be automatically added to the workflow. You will need to choose an authorized user from the dropdown list under Site Workflow Approval. There may be additional users to assign to additional Site Workflow Approval steps. Lastly, choose a user to provide a final review. If you need a user to complete an Effectiveness Check, add the appropriate step, select the user, and a due date. The lead investigators and any users assigned to CAPAs will all be notified when you launch the workflow. Once they have signed off, the user assigned to complete the Site Workflow Approval will be notified. Once the Site Workflow Approval and all CAPAs have been completed the user assigned to the final review will be notified. If Effectiveness Check is included, the user(s) assigned will need to sign and approve by the deadline chosen.
The following are the states that an Issue may be in depending on the stage within it’s lifecycle.
- Draft: New issues are set to Draft.
- Awaiting approval: Investigator has launched workflow approval for implementation.
- Implementation: Will remain in this state until all CAPAs are completed. When this happens, or if no CAPAs, go to FINAL REVIEW.
- Final Review: This state is automatically set when all CAPAs are completed. During this phase the Final Review step(s) are launched.
- Closed: This state is automatically set when all Final Review steps completed.
- Awaiting Effectiveness Check: Automatically set if any EC steps are active or incomplete.
- Effective: when all EC steps completed.
Failed: if an EC step is rejected.