FMEA (Failure Mode and Effects Analysis) Checklist
Boost your manufacturing process! Download our free FMEA (Failure Mode and Effects Analysis) Checklist. Identify, analyze, and mitigate potential failures, reduce defects, and improve quality - all with this easy-to-use manufacturing checklist. Prevent costly downtime and enhance efficiency today!
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Process Definition & Scope
Ensures the process being analyzed is clearly defined and the scope is appropriate for the analysis. This includes understanding inputs, outputs, and key process steps.
Process Name
Brief Process Description
Process Boundaries (Start & End Points)
Process ID / Part Number (if applicable)
List of Key Inputs to the Process
List of Key Outputs from the Process
Stage of Process (e.g., Design, Setup, Operation, Inspection)
Departments/Teams Involved
Process Flow Diagram & Step Identification
Confirms a clear and accurate process flow diagram exists and each process step is distinctly identified and numbered for consistent referencing.
Process Flow Diagram (PDF, PNG, JPEG)
Brief Description of the Process
Total Number of Process Steps Identified
Step 1: Process Step Description
Step 1: Process Step Number
Step 2: Process Step Description
Step 2: Process Step Number
Notes on Step Definition and Boundaries
Process Flow Diagram Accuracy Assessment (Initial Review)
Potential Failure Modes
Focuses on identifying all possible ways a process step could fail, considering different conditions and error sources.
Failure Mode 1: Describe the specific way the process step could fail.
Failure Mode 2: Describe the specific way the process step could fail.
Failure Mode 3: Describe the specific way the process step could fail.
Failure Mode 4: Describe the specific way the process step could fail.
Failure Mode 5: Describe the specific way the process step could fail.
Failure Mode 10: Describe the specific way the process step could fail.
Potential Effects of Failure
Evaluates the impact of each failure mode – what consequences arise for the product, process, or customer.
Immediate Impact on Product Quality
Impact on Subsequent Processes
Impact on Customer Satisfaction
Impact on Safety (Operator or Environment)
Impact on Regulatory Compliance
Potential for Product Recall or Warranty Claims
Impact on Production Schedule or Throughput
Potential Causes of Failure
Identifies the root causes that could lead to each failure mode. This includes materials, equipment, methods, environment, and manpower.
Material Supplier Quality Issues
Equipment Maintenance Deficiencies
Process Parameter Drift (e.g., Temperature)
Operator Training Gaps
Design Error (if applicable)
Environmental Factors (e.g., Humidity, Vibration)
Cycle Time Variation
Tooling Wear/Damage
Severity Rating (S)
Assesses the seriousness of the effect of failure. Uses a pre-defined scale to quantify the impact.
Define Severity Scale
Severity Rating (S) - Product Impact
Justification for Selected Severity Rating
Severity Rating (S) - Customer Impact
Numerical Severity Value (for Calculation)
Documentation of Assessment
Occurrence Rating (O)
Estimates the likelihood of the failure mode occurring. Uses a pre-defined scale based on historical data or experience.
Define Occurrence Rating Scale
Occurrence Rating
Justification for Occurrence Rating
Contributing Factors to Occurrence
Data/Source Used for Rating
Historical Occurrence Data (if available)
Rating Confidence Level
Detection Rating (D)
Evaluates the ability to detect the failure mode *before* it impacts the customer. Assesses existing controls and inspection methods.
Existing Control/Inspection Method?
Detection Rating (D) - Scale 1-10 (10=Perfect Detection)
Justification for Detection Rating (D)
Type of Control/Inspection
Describe the Current Detection Method in Detail
Effectiveness of Current Detection Method?
Potential Improvements to Current Detection Method
Risk Priority Number (RPN) Calculation
Calculates the RPN (Severity x Occurrence x Detection) for each failure mode. This prioritizes areas for improvement.
Severity Rating (S)
Occurrence Rating (O)
Detection Rating (D)
RPN (S x O x D)
RPN Justification/Notes
Is RPN > Threshold?
Threshold Value (If Applicable)
Recommended Actions
Defines specific actions to eliminate or mitigate the failure modes with high RPN values. Includes assigned responsibility and deadlines.
Detailed Description of Recommended Action
Estimated Cost of Action (USD)
Action Priority (High, Medium, Low)
Target Implementation Date
Responsible Department
Responsible Person/Team
Supporting Documentation (e.g., Drawings, Specifications)
Action Type (Select all that apply)
Justification for Selected Action
Action Implementation & Verification
Confirms that recommended actions have been implemented and their effectiveness in reducing risk has been verified.
Planned Completion Date for Action
Estimated Cost of Action Implementation (USD)
Detailed Description of Action Implementation
Person Responsible for Action Implementation
Supporting Documentation (e.g., SOP changes, training records)
Date of Verification/Validation
Description of Verification Method (how was the action verified)
Verification Result (Pass/Fail)
Comments/Notes on Verification Results
Re-Evaluation & RPN Update
Updates the RPN after implementing corrective actions to demonstrate risk reduction and ongoing process improvement.
Date of Re-evaluation
Summary of Changes Made (Brief Description)
New Severity Rating (S) for each failure mode
New Occurrence Rating (O) for each failure mode
New Detection Rating (D) for each failure mode
New RPN Calculated (S x O x D)
Did the action effectively reduce the risk?
Explanation/Justification for any rating changes.
Supporting Documentation (e.g., test results, inspection reports)
Next Review Date
Documentation & Review
Ensures the FMEA document is complete, accurate, and readily available for review and updates. Includes revision history.
FMEA Document Revision History
Date of Last FMEA Review
FMEA Document Version Number
Review Status
Summary of Review Findings/Comments
Supporting Documentation (e.g., revised process maps)
Reviewer Signature
Reviewer Name (Printed)
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