This article includes images and features of the new Events UI. This will be available in existing customer sandbox accounts October 24, 2022 and be released to production accounts on November 23, 2022. New customer production accounts will have the new Events UI starting October 24, 2022.

This article details components of the Events workflow and functionality. Jump ahead to:

Events Severity and Probability (Risk)

When creating an event, you’ll indicate the Severity and Probability of the event. During event creation, this is an initial judgment and it may change over time which is why these properties can be updated as the event is investigated.

The "Risk" parameter is calculated using the Severity and Probability values as inputs.

However, some organizations use a 5-point risk assessment scale, which can cause some confusion when it comes to applying their assessment to Qualio's built-in risk calculation. Below is a suggestion of how some organizations manage these differences.

Example 5-point Risk Calculation Table

Note: The customer is to define the quantitative/qualitative threshold for each level of severity and probability, as this varies by product and scale of distribution.

Calculate the Risk Priority Number (RPN) using the labels on the 5-point scale above and the formula below.

Severity x Probability = RPN

Then, convert the RPN into Risk Level by defining a threshold for Low, Medium, and High. And finally, when entering severity and probability on the event, confirm the auto-calculated risk aligns with the 5-point scale Risk using the table below. Adjust fields as needed.

Create Products and Root Causes

Events can be categorized by Product and/or Root Causes. This facilitates dynamic event reporting, allowing users to search for events by product and root cause along with other filters like status and owner.

Once created, Products and Root Causes can be specified during initial event creation or later by editing the event.

How To Create New Products

  1. Navigate to the Events tab, and select the Products sub-tab.

  2. Click the Add product button.

  3. Provide a Product Name and additional details of the product in the Description field, to help users understand what the product is.

  4. Then click the Add product button.

How To Create New Root Causes

  1. Navigate to the Events tab, and select the Root Causes sub-tab.

  2. Click the Add root cause button.

  3. Provide a Product Name and additional details of the product in the Description field, to help users understand what the product is.

  4. Then click the Add product button.

Export Events

Generate a report of multiple events

  1. From the Quality Events tab, select either the Events or Tasks sub-tab.

  2. Then use the filters to identify events or tasks needed in the report.

  3. Click the expansion menu to the right of the filters.

  4. Select either an Export list as XLSX or PDF.

  5. The file will be prepared and prompt users to click to download.

  6. Exported report will be downloaded to your computer.

Export a Single Event

  1. From the Quality Events tab, select the Events sub-tab.

  2. Select an event by clicking anywhere in the line item. (Hint: Use filters to narrow results and identify the event.)

  3. Click the Export Event button.

  4. A zip file will be prepared and prompt users to click to download.

  5. Exported zip file will be downloaded to your computer. The zip file will contain:

    1. Event PDF with details and properties including probability, risk, owner, creator, creation and resolution dates.

    2. Documented steps for each phase (Analysis, Tasks, and Validation) of the event as well as Status and Status Updated date/time stamp.¹

    3. Validation PDF - a separate document for validation results is provided to…

    4. Attachments - Any attachment included in any step of the event. (Included PDFs will indicate a link to attachments. When clicked, users will be taken to the step/attachment in Qualio. However, the attachments are included in the zip file.)

Note 1 - Draft events will have a watermark.

Event Step IDs

Each step in an event is assigned an ID for identification and search functionality. Step IDs are derived from their related event type prefix. Example: a CAPA event would generate step IDs with a prefix of CAPA.

Next, an auto-incrementing letter will be added to the end of the event prefix, starting with A. Example: the first step of a CAPA event would be CAPAA, the second step would be CAPAB, etc. If enough steps are added to an individual event, double letters will be appended starting at AA. Example: CAPAAA, CAPAAB, CAPAAC, CAPAAD, etc.

Lastly, an auto-incrementing number is appended following a dash. However, this number is assigned in the order of creation of all event steps in your instance of Qualio. Example: NCR-1 and NCR-2 have been created by two different users in the system. The user who created NCR-2 is the first to click “Create” on step 1 of his/her NCR, therefore, the step ID is NCRA-1. The user who created NCR-1 clicks “Create” on step 1 the following day and that step ID is NCRA-2.

Step IDs can be found while initially creating the step, or will be displayed on the Dashboard and in the Workspace when actions are needed on the step.

Step Creation


Event Workspace

Event and Task Date Fields

Events and tasks include several date/time fields that can be viewed within the application and/or exported formats. But depending on the export format (PDF and XLSX) and what is being exported (single event or event/task report) not all are displayed. Below is a comprehensive list of what fields are displayed with definitions.

1. The event date field Completed At is the same as the event date field Resolved At.

2. The task date field Completed At is the same as the task date field Closed At.

3. The Last Modified date field is the same as the Updated At field.

Compare Versions of an Event

Similar to Qualio Documents, managing an event content step through multiple updates and versions, it can be helpful to understand when major and minor versions are auto-incremented, and compare one version against another version.

When viewing the event step, you can select which version to display and which version to compare it against using the two respective buttons. New content will be highlighted in green and removed content will be shown in red.

An event step’s version number is automatically incremented (starting at 1) and controlled by triggers within the document lifecycle to update either the major or minor version.

  • Major Version

    • Whole number before the decimal point. Example: 4.0 represents the fourth major version of an event step.

    • Increments are triggered when an event is approved.

  • Minor Version

    • Decimal number to the right of the decimal point. Example: 0.2 represents the second minor version of an event step.

    • Increments if the event step is put back into draft status after being sent for review or approval.

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