Failure Mode & Effect Analysis (FMEA)

Description

The Failure Modes and Effects Analysis (FMEA) form allows users to systematically identify and evaluate potential failures in design, manufacturing, assembly processes, or product and service delivery. It provides a structured workflow to assess failure risks by ranking Severity, Occurrence, and Detectability, allowing users to calculate and compare the initial Risk Priority Number (RPN) with the revised RPN after implementing mitigation measures.

The form enables organizations to document failure analysis, track improvements, and ensure compliance with industry standards. It also supports ongoing risk management by facilitating updates, approvals, and maintaining records for regulatory and operational traceability.

Access the Failure Mode & Effect Analysis

• Step #1: Move your cursor to the "MODULE" tab located in the top-left corner of the screen.

• Step #2: In the drop-down menu that appears, hover over "Quality Assurance Management". This will expand a new menu displaying the following modules:

  • Incidents, CAPA & Non-Conformances

  • Risk Assessment & FMEA

• Step #3: Pass your cursor over "Risk Assessment & FMEA". Another drop-down menu will appear, showing the forms available within this module.

• Step #4: Select the "Failure Mode & Effect Analysis" option from the drop-down menu to access the form.

Guide to Access Failure Mode & Effect Analysis

Notes: Only active users with a license, access rights, and privileges for this form can access the information. If you do not have access to a specific form or its functionalities, contact your company’s system owner or administrator to request the necessary access and privileges.