FMEA (FAILURE MODE AND EFFECTS ANALYSIS) CHECKLIST Created by ChecklistGuro (https://checklistguro.com) --- PROCESS DEFINITION & SCOPE --- [ ] 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) (Design, Setup, Operation, Inspection, Maintenance) [ ] Departments/Teams Involved (Engineering, Manufacturing, Quality, Maintenance, Supply Chain) --- PROCESS FLOW DIAGRAM & STEP IDENTIFICATION --- [ ] 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) (Accurate and Complete, Requires Minor Adjustments, Requires Significant Revision) --- POTENTIAL FAILURE MODES --- [ ] 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 --- [ ] 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 --- [ ] Material Supplier Quality Issues [ ] Equipment Maintenance Deficiencies (Lack of Preventative Maintenance, Incorrect Lubrication, Calibration Errors, Worn Components) [ ] Process Parameter Drift (e.g., Temperature) [ ] Operator Training Gaps [ ] Design Error (if applicable) (No Error, Material Specification Error, Dimensional Error, Process Instruction Error) [ ] Environmental Factors (e.g., Humidity, Vibration) [ ] Cycle Time Variation [ ] Tooling Wear/Damage (No Wear/Damage, Minor Wear, Significant Wear, Damage) --- SEVERITY RATING (S) --- [ ] Define Severity Scale [ ] Severity Rating (S) - Product Impact (1 - No Effect, 2 - Minor Defect (Cosmetic), 3 - Moderate Defect (Functional, Repairable), 4 - Major Defect (Non-Functional, Significant Repair Required), 5 - Catastrophic Failure (Unsafe, Total Loss)) [ ] Justification for Selected Severity Rating [ ] Severity Rating (S) - Customer Impact (1 - No Impact, 2 - Minor Inconvenience, 3 - Moderate Dissatisfaction, 4 - Significant Dissatisfaction/Complaint, 5 - Safety Risk/Legal Action) [ ] Numerical Severity Value (for Calculation) [ ] Documentation of Assessment --- OCCURRENCE RATING (O) --- [ ] Define Occurrence Rating Scale (1: Remote, 2: Occasional, 3: Low, 4: Moderate, 5: High, 6: Very High) [ ] Occurrence Rating [ ] Justification for Occurrence Rating [ ] Contributing Factors to Occurrence (Operator Error, Equipment Malfunction, Material Variation, Process Parameter Drift, Environmental Conditions, Maintenance Issues, Design Flaw) [ ] Data/Source Used for Rating [ ] Historical Occurrence Data (if available) [ ] Rating Confidence Level (High, Moderate, Low) --- DETECTION RATING (D) --- [ ] Existing Control/Inspection Method? (Yes, Formal Inspection, Yes, Informal Observation, Yes, Automated System, No, None Currently Exists) [ ] Detection Rating (D) - Scale 1-10 (10=Perfect Detection) [ ] Justification for Detection Rating (D) [ ] Type of Control/Inspection (Visual Inspection, Measurement, Testing, Statistical Process Control (SPC), Other) [ ] Describe the Current Detection Method in Detail [ ] Effectiveness of Current Detection Method? (Highly Effective, Moderately Effective, Minimally Effective, Not Effective) [ ] Potential Improvements to Current Detection Method --- RISK PRIORITY NUMBER (RPN) CALCULATION --- [ ] Severity Rating (S) [ ] Occurrence Rating (O) [ ] Detection Rating (D) [ ] RPN (S x O x D) [ ] RPN Justification/Notes [ ] Is RPN > Threshold? (Yes, No) [ ] Threshold Value (If Applicable) --- RECOMMENDED ACTIONS --- [ ] Detailed Description of Recommended Action [ ] Estimated Cost of Action (USD) [ ] Action Priority (High, Medium, Low) (High, Medium, Low) [ ] Target Implementation Date [ ] Responsible Department (Engineering, Manufacturing, Quality, Maintenance, Procurement) [ ] Responsible Person/Team [ ] Supporting Documentation (e.g., Drawings, Specifications) [ ] Action Type (Select all that apply) (Process Change, Equipment Modification, Training, Design Change, Supplier Change) [ ] Justification for Selected Action --- ACTION IMPLEMENTATION & VERIFICATION --- [ ] Planned Completion Date for Action [ ] Estimated Cost of Action Implementation (USD) [ ] Detailed Description of Action Implementation [ ] Person Responsible for Action Implementation (John Doe, Jane Smith, David Lee) [ ] 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) (Pass, Fail) [ ] Comments/Notes on Verification Results --- RE-EVALUATION & RPN UPDATE --- [ ] 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? (Yes, No, Partially) [ ] Explanation/Justification for any rating changes. [ ] Supporting Documentation (e.g., test results, inspection reports) [ ] Next Review Date --- DOCUMENTATION & REVIEW --- [ ] FMEA Document Revision History [ ] Date of Last FMEA Review [ ] FMEA Document Version Number [ ] Review Status (Not Reviewed, Review Complete, Revision Required) [ ] Summary of Review Findings/Comments [ ] Supporting Documentation (e.g., revised process maps) [ ] Reviewer Signature [ ] Reviewer Name (Printed) --- END OF TEMPLATE --- Transform this text into a digital, automated, and trackable mobile app! Visit: https://checklistguro.com/templates/manufacturing/fmea-failure-mode-and-effects-analysis-checklist (Click "Install Template" to launch your digital inspection tool immediately)