General Information
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To create an FMEA (Failure Modes and Effects Analysis), a Risk Assessment and an Investigation must be registered beforehand. Fields marked with an asterisk (*) are required for record creation and proper system functionality.
This section captures the essential details of the FMEA, including:
FMEA Name: Specifies the title of the Failure Mode and Effect Analysis, providing a clear reference for identification and tracking.
FMEA Number: A unique identifier assigned to each FMEA. The combination of the Number and Revision must be unique.
Revision: Represents the version of the FMEA. Each revision documents modifications or updates while maintaining the original FMEA Number for traceability.
Category: Defines the classification or type of failure mode being analyzed, helping to group related assessments.
Status: Indicates the current stage of the FMEA (e.g., Open, Under Review, Approved, Closed, Canceled, or Duplicated).
Description: Provides a summary of the FMEA, including the nature of the risk, triggering events, impacted areas, potential consequences, root causes, and exposure. This field ensures a clear understanding of the analysis scope.
This section also includes storage-related details and record management functionalities:
Created By: Automatically set to the user who approved the investigation request.
Created Date: Captures the timestamp of when the investigation is generated and remains uneditable.
Owner and Department: Initially inherited from the investigation request but can be updated.
Some fields, such as Created By and Created Date, are system-generated to ensure traceability, recording both the initiating user and the exact timestamp of creation.
In this section, you can select the Investigation and Risk Assessment related to the Failure Mode & Effect Analysis (FMEA). When an investigation or risk assessment is selected, the system will display the associated information in read-only mode to ensure data integrity.
These linked records provide essential context for identifying potential failure modes and assessing risks effectively. Additionally, clicking on the Failure Mode & Effect Analysis panel will expand the form fields, allowing you to input mitigation strategies, recalculate the Risk Priority Number (RPN), and finalize the FMEA record.
A highlighted blue border will indicate the currently selected section, helping users quickly identify which section they are actively viewing.
To understand the icons in the top-right corner, click . Some icons will appear after all required fields are filled.
By default, the FMEA is assigned to the user who initiated it, referred to as the Owner. Ownership can be reassigned if needed. If the value you want to add doesn’t appear in the list, click the to navigate to the related form.
