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On this page
  • Incident Description
  • Root Cause Hypothesis
  • Incident Impact and Response
  • Investigation Decision

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  1. Help Center
  2. CIQA eQMS User Guide
  3. Modules
  4. Quality Assurance Management
  5. Incidents, CAPA & NC Management
  6. Incident Registration

Incident Information

PreviousIncidents OverviewNextClosure

Last updated 3 months ago

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This section allows users to input key details required for registering an incident. Fields marked with an asterisk (*) are mandatory for the record's creation and proper functioning. The form includes the following fields:

  • Number: A unique identifier assigned to each incident. The combination of Number and Revision must be unique.

  • Revision: Indicates the version of the incident record. Each revision reflects modifications or updates made to the incident while retaining its original Number for tracking purposes.

  • Status: Indicates the current status of the incident (Open, Under Review, Closed or Duplicated).

    • The status can be modified depending on the decision:

      • If the decision is Pending, the status cannot be changed.

      • If the decision is Yes, the status can be updated to either Open or Under Review.

      • If the decision is No, the status can be updated to any option.

    • Changing the status to Under Review locks all other fields except the status field. Once set to Closed, the record can no longer be edited.

  • Registration Date: Select the actual date of registration; future dates are not allowed.

  • Notified By: Automatically populated with the user initiating the record creation. Ownership can be reassigned if required.

  • Type: Specifies whether the incident is New, Repeated, or Other.

  • Classification: Allows categorization of the incident based on pre-defined classifications or the creation of a new one.

  • Severity: Assigns a severity level to the incident based on its impact.

  • Who Observed the Incident?: Allows selection of users directly involved or observing the incident.

  • Notify To: Allows selection of users who should be informed about the incident.

  • Duplicated From: Displays reference information if the incident is duplicated from another record.

Notes:

  • The incident status will automatically change to Under Review if the associated investigation request is updated to Under Review, and its status cannot be modified unless the investigation request is reverted to Open.

  • The incident status will update to Closed when the investigation is marked as Closed or Canceled. If an investigation is not required and the investigation request is Approved or Canceled, the incident status will also update to Closed and remain uneditable.

You can add a new classification directly from the dropdown menu by selecting the "Add [Your Classification]" option. Once added, the new classification will be available for selection in future incident records.

Incident Description

This section allows users to detail the incident, providing key information about what occurred, how and where it happened, and the timeline. It focuses on capturing all relevant details necessary for accurate documentation and analysis.

Root Cause Hypothesis

This section is designed to capture the initial hypothesis regarding the root cause of the incident. Users can document the most probable or potential sources of the issue and assess the likelihood of occurrence to support further investigation and resolution.

Incident Impact and Response

This section is designed to capture the immediate effects and responses related to the incident. Users can document critical details such as initial impacts, injuries or illnesses, property damage, and immediate actions taken to address the situation and prevent further consequences.

Investigation Decision

This section allows users to determine whether an investigation is required for the incident and document the reasoning behind the decision. Users can provide supporting evidence, observations, or context in the justification field to explain their choice. Selecting Yes will make the incident eligible to be included in an investigation request.

If the value you want to add doesn’t appear in the list, click the to navigate to the related form. To understand the icons in the top-right corner, click .

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Investigation Required
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Classification Added for Future Selection.