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Failure Mode and Effects Analysis (FMEA)

Dashboard Overview​

The FMEA module facilitates the systematic identification and mitigation of potential failure modes.

FMEA Dashboard

Dashboard Columns​

  • Process Step / Function: The operation or function being analyzed.
  • Failure Mode: The specific way the process or product could fail.
  • Failure Effect: The consequence of that failure on the end user.
  • Current Controls: Existing measures to prevent or detect the failure.
  • Grouping: Organize analysis by process step or system function for focused review.
  • Listing Page: View a complete table of all failure modes, sort by RPN to prioritize high-risk items, and track mitigation status.
  • AI Generation Reference: utilize AI to propose potential failure modes and causes based on component type and historical failure data.

Processing an Analysis​

Detailed entry forms allow for precise scoring and documentation of each failure mode.

FMEA Entry Form

Key Data Points​

  • Item/Component & Function: Define what is being analyzed and its intended purpose.
  • Failure Mode & Cause:
    • Mode: The failure itself (e.g., "Seal not formed").
    • Cause: The root reason (e.g., "Temperature too low").
  • Scoring Fields:
    • Severity (S): Impact of the failure.
    • Occurrence (O): Likelihood of the cause occurring.
    • Detection (D): Likelihood of detecting the failure before it reaches the user.
  • RPN (Risk Priority Number): Calculated as $S \times O \times D$.

RPN​

  • Risk Priority Number = Severity × Occurrence × Detection.
  • Use RPN thresholds to prioritize actions and reviews.

FMEA Structure​

  • Failure Mode: what can go wrong.
  • Effects: outcomes to patient/product.
  • Causes: root causes and contributing factors.
  • Controls: current controls and recommended mitigations.