Issues

QBench offers an Issues module to help Users track and resolve Issues, keep track of Root Causes and Corrective and Preventative Action (CAPA), associate Equipment with Issues, and more.

Issues Webinar

The video below feature expert insights, real-world examples, and best practices from our recent webinar series:

Configuring Issues

In order to use Issues, you must have a QMS subscription and the QMS - Issues module must be enabled by an administrator in General Settings. For organization that wish to associate Issues with Equipment, the QMS - Equipment module must also be enabled.

Issues include certain fields -- such as "Title", "Description", and "Status" -- by default. Administrators can change what fields are visible and configure additional Issue fields from Fields and Data Types.

Other Issues configurations can be set from the Issues landing page. QBench administrators or Users with edit-level Issues permissions can:

1. Click on QMS in the site navigation, hover over Issues, then click All
   
   
2. On the Issues landing page, click the blue cog
   
3. Load the Issues Configurations page and see tabs for Categories and Actions
   

Categories

Categories are an optional way to organize your Issues and automatically enable CAPA or disable CAPA workflows (for a more detailed explanation of CAPA and non-CAPA workflows, see CAPA). To create a Category:

1. Click the "New Category" button
2. Set a Category name and, if desired, change the "Default CAPA Required" field (Default CAPA Required is set to No by default)
   
3. Click the "Submit" button to save your new Category

Actions

QBench administrators and Users with edit-level Issues permissions can also create Actions. Users must specify an Action in the "Action Taken" field to close an Issue in QBench. To create an Action:

1. Click the "Actions" tab
2. Click the "New Action" button
3. Enter an "Action Name"
   
4. Click the "Submit" button to save your new Action

Creating an Issue

To create a new Issue:

1. Click on QMS in the site navigation, hover over Issues, then click New Issue
   
2. Fill out the New Issue page. At minimum, all Issues need a Status to be created. Users can also set a Priority, Category, assign an Issue to a specific User, or fill out any other core or additional fields during Issue creation
   
3. After filling out any relevant fields, click the "Create" button to save your Issue. Users will see a button for "New Correspondence" tabs for "Root Cause", "CAPA", "History" and -- if enabled -- "Equipment"
   

Correspondence

To support a collaborative approach to Issue resolution, Users can document Correspondence about Issues. To record new Correspondence about an Issue:

1. Click the "New Correspondence" button
2. Type your message
3. Attach any files, if applicable
4. Click the "Post" button

All Users with at least edit-level Issue permissions can post Correspondence while an Issue is in the REPORTED or OPEN Statuses.

Root Cause

To complete an Issue (regardless of CAPA settings), Users will need to indicate whether a Root Cause analysis is required. To do this:

1. Click the "Root Cause" tab
2. Click the "Root Cause Required" dropdown and select Yes or No as appropriate, then click the "Save" button
   
   • • If you select No, all other Root Cause fields will be hidden
       
3. If you select Yes, a "Date of Root Cause" field will appear, along with a Rich Text field and an Attachment button
   
   If a Root Cause is required, both "Date of Root Cause" and the Rich Text field must be filled out to close the Issue. Adding Attachments to the Root Cause is optional
4. Fill out all required Root Cause fields, then click the "Save" button

CAPA

No CAPA Requirements

All Issues must also indicate whether CAPA is required or not. Organizations not subject to CAPA QMS requirements can bypass QBench's CAPA workflow one of two ways:

• With a Category
  • • Create a Category with "Default CAPA Requirement" set to No
      
    • Assign this Category to your Issues to automatically set the "CAPA Required" field to No
      
• Manually set the "CAPA Required" field to No per Issue by selecting No from the "CAPA Required" dropdown and clicking the "Save" button
  

CAPA Required

CAPA documentation can be required for Issues one of two ways:

• With a Category
  • • Create a Category with "Default CAPA Requirement" set to Yes
      
    • Assign this Category to your Issues to automatically set the "CAPA Required" field to Yes (this will also automatically require a Root Cause)
      
• Manually set the "CAPA Required" field to Yes per Issue by selecting Yes from the "CAPA Required" dropdown and clicking the "Save" button
  

When CAPA is required, all CAPA fields must be completed in order to close the Issue. To complete the CAPA tab after requiring CAPA:

1. Set a "Date of CAPA Completion"
2. Document the Issue's CAPA details in the Rich Text field, and add any Attachments as necessary
3. Click the "Save" button in the CAPA Details section
4. Indicate whether to change the Status of the Issue to PENDING VERIFICATION (for example, when the User who must document Evidence of Effectiveness Details is different from the User who primarily documented the Issue. These Users can also set up email Filters to notify them of new Issues)
   • • If you click "Yes", the CAPA Details section will save, and the Status of the Issue will change to PENDING VERIFICATION
       
       
     • If you click "No", the CAPA Details section will save, and the Status of the Issue will be unchanged
5. In the Evidence of Effectiveness Details section, set a "CAPA Effectiveness Check Date" and a "CAPA Effectiveness Verified Date"
6. Document the Issue's evidence of effectiveness details in the Rich Text field, and add any Attachments as necessary
7. Click the "Save" button in the Evidence of Effectiveness Details section
   

Equipment

Organizations that track Equipment in QBench can associate Equipment with their Issues, and even automatically change the Status of Equipment to Out of Service - See Issue and notify other Users of the problem. To associate Equipment with an Issue:

1. Go to the "Equipment" tab
2. Click the "Add Equipment" button
3. Select any Equipment to associate with the Issue from the "Equipment" dropdown
4. Click the "Submit" button
5. Indicate whether to change the Status of the Equipment to "OUT OF SERVICE - SEE ISSUE"
   • If you click "Yes", the Status of any selected Equipment will be associated with the Issue, set to OUT OF SERVICE - SEE ISSUE, and all QBench Users (or Users in the Equipments' Division(s), if Divisions are configured) will receive a notification that the Equipment is out of service
     
   • If you click "No", any selected Equipment will be associated with the Issue

Closing an Issue

After Root Cause and CAPA have been filled out (to the extent applicable) and any other supporting information (such as Correspondence or associated Equipment) has been added, Users can close Issues in QBench. To close an Issue:

1. Navigate to the "Log" tab
2. Click the "Status" dropdown, then click "CLOSED"
3. "Date Closed" and "Action Taken" fields will appear. Select the date the Issue was closed and what Action was taken
4. Click the "Save" button

History

Changes to Issues are logged under the Issue "History" tab. When changes are made to an Issue, a new History entry is created that records what User modified the Issue at what time, and what Status the Issue was saved in.

More detailed information about what specified fields were modified, including information about changes to associated Equipment and Comments (Correspondence), can be found by clicking on individual History entries.

Landing Page Options

Users can also Export existing Issues and create Filters from the Issues landing page. To return to the landing page from an Issue, click "All" under the Issue name or go to QMS > Issues > All through the site navigation.

Exporting

To Export Issues:

1. If Exporting specific Issues, check the checkboxes next to the Issues you intend to Export
2. Click the blue download button
3. Click "Export Selected" or "Export All" as appropriate to download an .xlsx file

Filtering

Users can also Filter Issues on the landing page. To Filter:

1. Click the blue funnel button
2. Specify your Filter criteria (such as a Status or "Date Opened" or "Due Within" range)
3. Click the "Submit" button

To set up an email alert for changes to a Filter:

1. Create and load a Filter
2. Click the funnel button again, then click "Save New"
3. Enter a name for the Filter, then click the "Save" button
4. Click the funnel button (which now lists the name of the Filter), then click "Email options"
5. Check the "Enable filter emailing" option, set your emailing options as required
   • • • If "Notify me when items are added to this filter" is checked, you will receive an email whenever an Issue meets the criteria of your Filter
         • Selecting the "Include only added items" radio button will only include Issues that newly meet the Filter criteria in your notification
         • Selecting the "Include all items in filter" radio button will include all Issues that meet the Filter criteria in your notification
       • If "Notify me when items are added to this filter" is left unchecked, you will only receive an email notification of Issues that meet your Filter criteria at the specified Frequency
6. Click the "Save" button