Barrier-Oriented FWGM-Based Fuzzy-FMEA for Risk Assessment and Safety-Barrier Prioritization in Solvent-Based Electrospinning Processes
Abstract
1. Introduction
2. Materials and Methods
2.1. Study System and Process Scope
2.2. Expert Panel, Evaluation Procedure, and Scoring Principles
2.3. FMEA Scoring Criteria
2.4. Conventional FMEA and Auxiliary Comparison Index
2.5. FWGM-Based Fuzzy-FMEA
3. Results and Discussion
3.1. Stepwise Risk Structure and Conventional FMEA Results
3.2. Risk-Priority Re-Ranking Using FWGM-Based Fuzzy-FMEA
3.3. Engineering Interpretation of High-Risk Failure Modes and Safety-Barrier Prioritization
3.4. Risk Reduction Effect of Safety-Barrier Application Scenarios
3.5. Study Limitations and Future Research Directions
4. Conclusions
Supplementary Materials
Author Contributions
Funding
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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| No. | Process Step | Representative Failure Mode |
|---|---|---|
| 1 | Material Review/Approval | Failure to review the safety data sheet (SDS) or omission of additives, resulting in underestimated hazard |
| 2 | Solution Preparation | Preparation outside the hood or prolonged open preparation |
| 3 | Solvent Transfer | Transfer of flammable solvent without bonding/grounding |
| 4 | Syringe Filling/Installation | Leakage or splashing during syringe/needle connection |
| 5 | Equipment Setup | Poor collector grounding, exposed high-voltage parts, and absence of interlocks |
| 6 | Pre-Start Inspection | Start-up without confirming exhaust, door status, or distance |
| 7 | Voltage Application/Start-Up | Dripping/arc generation due to excessive voltage, excessive flow rate, or improper distance |
| 8 | Normal Operation | Direct adjustment of the needle/collector during energization |
| 9 | Response to Abnormalities | Clog removal without shutdown and discharge confirmation |
| 10 | Shutdown/Discharge | Contact under residual-charge condition after power-off |
| 11 | Product Collection | Collection of a wet fiber mat on an open bench |
| 12 | Post-Treatment | Immediate heat treatment of samples with residual solvent |
| 13 | Waste Disposal/Cleaning | Open waste containers and unattended contaminated materials |
| 14 | Maintenance | Opening the power supply or using damaged cables while power remains connected |
| Score | Severity (S) | Occurrence (O) | Detection (D) |
|---|---|---|---|
| 1 | Mild housekeeping-level problem; no health impact | Rare under normal operating conditions | Almost certainly detectable in advance by a checklist, interlock, indicator light, etc. |
| 2 | Minor exposure or localized contamination; first-aid level | May occur intermittently under abnormal or maintenance conditions | Detectable with high probability through an inspection procedure or operator observation |
| 3 | Reversible health effect, small spill, temporary process interruption | May occasionally occur during routine laboratory activity | Detectable depending on operator skill, but omissions are possible |
| 4 | Serious exposure, localized fire, electrical burn, or equipment damage | May occur frequently under unstable operating conditions | Likely to be detected only after the abnormality has progressed |
| 5 | Major accident, severe electric shock, fire/explosion, or fatal toxic exposure | Repetitive or nearly inevitable in the absence of controls | Very difficult to detect before an imminent accident |
| Integer Score | Triangular Fuzzy Number (TFN) |
|---|---|
| 1 | (1, 1, 2) |
| 2 | (1, 2, 3) |
| 3 | (2, 3, 4) |
| 4 | (3, 4, 5) |
| 5 | (4, 5, 5) |
| Hazard Type | Linguistic Weights (S, O, D) | Normalized Weights (, , ) | Applied Steps |
|---|---|---|---|
| Chemical-dominant | H, H, M | (0.368, 0.368, 0.263) | Material Review/Approval (1), Solution Preparation (2), Syringe Filling/Installation (4), Product Collection (11), Post-Treatment (12) |
| Electrical-dominant | VH, M, H | (0.419, 0.242, 0.339) | Equipment Setup (5), Normal Operation (8), Response to Abnormalities (9), Shutdown/Discharge (10), Maintenance (14) |
| Fire/static-dominant | VH, M, M | (0.464, 0.268, 0.268) | Solvent Transfer (3) |
| Combined-dominant | VH, H, H | (0.383, 0.309, 0.309) | Pre-Start Inspection (6), Voltage Application/Start-Up (7), Waste Disposal/Cleaning (13) |
| No. | Process Step | Failure Mode | Main Cause | Potential Effect | Hazard Type | S/O/D | RPN |
|---|---|---|---|---|---|---|---|
| 1 | Material Review/Approval | Failure to review the safety data sheet (SDS) or omission of additives | Use of customary recipes, supplier change, omission of additive/nanofiller review | Inappropriate PPE and ventilation, underestimated toxicity/flammability, process-wide risk propagation | Chemical-dominant | 5/3/4 | 60 |
| 2 | Solution Preparation | Preparation outside the hood or prolonged open preparation | Open-bench work, prolonged container opening, prioritization of convenience | Solvent-vapor exposure, local vapor accumulation, increased flammability risk | Chemical-dominant | 5/3/3 | 45 |
| 3 | Solvent Transfer | Transfer of flammable solvent without bonding/grounding | Lack of bonding/grounding procedure, inadequate electrostatic control | Electrostatic spark ignition, fire, secondary worker exposure | Fire/static-dominant | 5/2/4 | 40 |
| 4 | Syringe Filling/Installation | Leakage or splashing during syringe/needle connection | Overfilling, incomplete Luer connection, forced injection of high-viscosity solution | Skin/eye exposure, contamination, localized vapor release | Chemical-dominant | 4/3/2 | 24 |
| 5 | Equipment Setup | Poor collector grounding, exposed high-voltage parts, and absence of interlocks | Loose grounding wire, homemade apparatus, insulation deterioration, inadequate shielding | Electric shock, arcing, fire, equipment damage | Electrical-dominant | 5/3/4 | 60 |
| 6 | Pre-Start Inspection | Start-up without confirming exhaust, door status, or distance | Absence of a pre-start checklist, rushed operation, and door status not checked | Ignition risk, electric shock, defective fiber formation | Combined-dominant | 5/3/4 | 60 |
| 7 | Voltage Application/Start-Up | Dripping/arc generation due to excessive voltage, excessive flow rate, or improper distance | Unverified start-up conditions, recipe variation, and error in initial settings | Leakage, fiber defects, arcing, localized fire | Combined-dominant | 5/3/3 | 45 |
| 8 | Normal Operation | Direct adjustment of the needle/collector during energization | Ad hoc intervention for process stabilization, insufficient access restriction | Direct electric shock, secondary injury | Electrical-dominant | 5/2/4 | 40 |
| 9 | Response to Abnormalities | Clog removal without shutdown and discharge confirmation | Insufficient understanding of residual charge, absence of a troubleshooting SOP | Electric shock, arc, solution splashing, facial/hand exposure | Electrical-dominant | 5/3/4 | 60 |
| 10 | Shutdown/Discharge | Contact under residual-charge condition after power-off | Mistaken belief that power-off means safe, absence of a discharge verification procedure | Electric shock, arc, secondary accident during shutdown | Electrical-dominant | 5/2/4 | 40 |
| 11 | Product Collection | Collection of a wet fiber mat on an open bench | Insufficient confirmation of drying, handling outside the hood | Residual-solvent exposure, contamination spread | Chemical-dominant | 4/2/4 | 32 |
| 12 | Post-Treatment | Immediate heat treatment of samples with residual solvent | Insufficient drying time, absence of criteria, failure to review equipment suitability | Vapor release, possible fire in the oven, increased exposure | Chemical-dominant | 4/2/4 | 32 |
| 13 | Waste Disposal/Cleaning | Open waste containers and unattended contaminated materials | Stored near equipment for convenience, lid not fully closed | Vapor accumulation, secondary ignition, persistent exposure | Combined-dominant | 5/2/4 | 40 |
| 14 | Maintenance | Opening the power supply or using damaged cables while power remains connected | Unauthorized repair, absence of regular inspection, and damaged cable left unaddressed | Severe electric shock, arc, fire, reduced equipment reliability | Electrical-dominant | 5/2/4 | 40 |
| Rank Group (Implementation Priority) | No. | Process Step | Hazard Type | S/O/D | Conventional RPN | FRPN (TFN) | FRPN (0–100) |
|---|---|---|---|---|---|---|---|
| 1T(1) | 9 | Response to Abnormalities | Electrical-dominant | 5/3/4 | 60 | (3.068, 4.097, 4.737) | 79.35 |
| 1T(2) | 5 | Equipment Setup | Electrical-dominant | 5/3/4 | 60 | (3.068, 4.097, 4.737) | 79.35 |
| 3(3) | 6 | Pre-Start Inspection | Combined-dominant | 5/3/4 | 60 | (2.955, 3.986, 4.667) | 77.39 |
| 4(4) | 1 | Material Review/Approval | Chemical-dominant | 5/3/4 | 60 | (2.873, 3.906, 4.605) | 75.89 |
| 5T(5) | 14 | Maintenance | Electrical-dominant | 5/2/4 | 40 | (2.595, 3.714, 4.419) | 71.52 |
| 5T(6) | 10 | Shutdown/Discharge | Electrical-dominant | 5/2/4 | 40 | (2.595, 3.714, 4.419) | 71.52 |
| 5T(7) | 8 | Normal Operation | Electrical-dominant | 5/2/4 | 40 | (2.595, 3.714, 4.419) | 71.52 |
| 8(8) | 7 | Voltage Application/Start-Up | Combined-dominant | 5/3/3 | 45 | (2.608, 3.648, 4.357) | 70.76 |
| 9(9) | 3 | Solvent Transfer | Fire/static-dominant | 5/2/4 | 40 | (2.554, 3.685, 4.361) | 70.67 |
| 10(10) | 2 | Solution Preparation | Chemical-dominant | 5/3/3 | 45 | (2.582, 3.621, 4.343) | 70.30 |
| 11(11) | 13 | Waste Disposal/Cleaning | Combined-dominant | 5/2/4 | 40 | (2.385, 3.517, 4.270) | 67.81 |
| 12T(12) | 12 | Post-Treatment | Chemical-dominant | 4/2/4 | 32 | (2.001, 3.099, 4.142) | 61.62 |
| 12T(13) | 11 | Product Collection | Chemical-dominant | 4/2/4 | 32 | (2.001, 3.099, 4.142) | 61.62 |
| 14(14) | 4 | Syringe Filling/Installation | Chemical-dominant | 4/3/2 | 24 | (1.935, 2.998, 4.026) | 59.73 |
| Process Step | Safety Engineering Characteristic | Engineering Root Cause | Prioritized Safety-Barrier Package |
|---|---|---|---|
| Material Review/Approval (1) | Upstream information-based hazard | No SDS review, omitted composition, absence of an approval system | Mandatory SDS review, re-approval of composition changes, pre-review system |
| Equipment Setup (5) | Direct high-voltage access hazard | Poor grounding, exposed high-voltage parts, absence of an enclosure/interlock | Grounded enclosure, interlock, grounding continuity check |
| Pre-Start Inspection (6) | Pre-start combined hazard | Ventilation/door/distance not checked, absence of a pre-start procedure | Pre-start checklist, ventilation confirmation, door-closed confirmation |
| Voltage Application/Start-Up (7) | Coupled operational instability and ignition hazard | Excessive voltage, excessive flow rate, improper distance, erroneous initial conditions | Validated operating window, focused initial observation, drip tray |
| Response to Abnormalities (9) | Abnormal-response intervention hazard | Access before discharge, absence of a troubleshooting SOP | De-energize-discharge-verify procedure, access control |
| Solvent Transfer (3) | Electrostatic ignition hazard | Bonding/grounding not implemented | Bonding/grounding, pre-transfer check |
| Shutdown/Discharge (10) | Residual-charge contact hazard | Misconception that power-off means safe, absence of discharge confirmation | Residual-charge confirmation, shutdown checklist |
| Maintenance (14) | Maintenance without de-energization confirmation hazard | Failure to comply with power isolation, damaged cable left unaddressed | De-energized maintenance principle, periodic inspection, and replacement of damaged cables |
| Process Step | Key Safety Barrier | Pre-Control FRPN | Post-Control FRPN | Reduction Rate (%) | Main Dimension of Change |
|---|---|---|---|---|---|
| Response to Abnormalities (9) | De-energize-discharge-verify, troubleshooting SOP, access control | 79.35 | 44.60 | 43.79 | Mostly improved O and D |
| Equipment Setup (5) | Grounded enclosure, door interlock, grounding continuity check | 79.35 | 44.60 | 43.79 | Mostly improved O and D |
| Pre-Start Inspection (6) | Pre-start checklist, exhaust/door confirmation, validated operating window | 77.39 | 48.06 | 37.90 | Mostly improved O and D |
| Material Review/Approval (1) | SDS review gate, composition re-approval, change review | 75.89 | 46.38 | 38.89 | Mostly improved O and D |
| Solvent Transfer (3) | Bonding/grounding, sealed transfer, transfer checklist | 70.67 | 52.38 | 25.88 | Mostly improved O and D |
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Kim, J.G.; Bai, B.C. Barrier-Oriented FWGM-Based Fuzzy-FMEA for Risk Assessment and Safety-Barrier Prioritization in Solvent-Based Electrospinning Processes. Materials 2026, 19, 2673. https://doi.org/10.3390/ma19122673
Kim JG, Bai BC. Barrier-Oriented FWGM-Based Fuzzy-FMEA for Risk Assessment and Safety-Barrier Prioritization in Solvent-Based Electrospinning Processes. Materials. 2026; 19(12):2673. https://doi.org/10.3390/ma19122673
Chicago/Turabian StyleKim, Jong Gu, and Byong Chol Bai. 2026. "Barrier-Oriented FWGM-Based Fuzzy-FMEA for Risk Assessment and Safety-Barrier Prioritization in Solvent-Based Electrospinning Processes" Materials 19, no. 12: 2673. https://doi.org/10.3390/ma19122673
APA StyleKim, J. G., & Bai, B. C. (2026). Barrier-Oriented FWGM-Based Fuzzy-FMEA for Risk Assessment and Safety-Barrier Prioritization in Solvent-Based Electrospinning Processes. Materials, 19(12), 2673. https://doi.org/10.3390/ma19122673

