Eight complete FMEA worksheets — manufacturing, automotive, healthcare, software, food processing, aerospace, plus non-technical administrative and cold chain logistics — with Severity, Occurrence, and Detection scores, RPN calculations, and recommended actions. Use these as references when building your own FMEA or explaining the method to your team.
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Each example uses the standard AIAG-VDA scoring format: RPN = Severity (S) × Occurrence (O) × Detection (D), each rated 1–10. Items highlighted in red have RPN ≥ 100 or Severity ≥ 9 and require immediate corrective action. For a full explanation of the rating scales and the 7-step process, see the complete FMEA guide.
1 Manufacturing — Injection Molding (PFMEA)
ManufacturingScope: Process FMEA for a polypropylene bracket injection molding cell. The team analyzed four process steps: material preparation, mold filling, cooling, and ejection. Five failure modes were identified across these steps.
| Process Step | Failure Mode | Effect | S | Cause | O | Controls | D | RPN |
|---|---|---|---|---|---|---|---|---|
| Material prep | Wet pellets (moisture > 0.02%) | Splay defects; weakened part; scrap | 7 | Dryer malfunction; wrong drying time | 3 | Moisture meter check before run | 5 | 105 |
| Mold filling | Short shot (incomplete fill) | Defective part — scrap; production delay | 7 | Insufficient injection pressure | 4 | Visual inspection 1/shift | 4 | 112 |
| Mold filling | Flash at parting line | Dimensional non-conformance; assembly failure | 5 | Excessive clamp pressure; worn tooling | 3 | CMM check 2/shift | 3 | 45 |
| Cooling | Warpage (> 0.5 mm flatness) | Assembly failure; customer complaint | 6 | Uneven cooling; blocked water line | 5 | CMM flatness check 1/hour | 3 | 90 |
| Ejection | Part sticking to mold | Part damage; production stoppage | 6 | Insufficient draft angle; worn ejector pins | 3 | Operator visual each cycle | 4 | 72 |
2 Automotive — Brake System Assembly (PFMEA)
AutomotiveScope: Process FMEA for a disc brake caliper assembly line at a Tier 1 automotive supplier. Required as part of IATF 16949 APQP documentation. Note how items with S = 9 require action even when RPN appears low.
| Process Step | Failure Mode | Effect | S | Cause | O | Controls | D | RPN |
|---|---|---|---|---|---|---|---|---|
| Banjo bolt assembly | Brake fluid leak at fitting | Reduced braking; potential accident | 9 | Under-torqued fitting; operator skips torque wrench | 2 | Torque wrench click audit, 100% check | 2 | 36 |
| Piston installation | Piston installed reversed | Brake drag; uneven wear; vehicle pull | 7 | No poka-yoke; operator error | 3 | Visual check by line supervisor | 4 | 84 |
| Dust boot seating | Dust boot not fully seated | Corrosion ingress; premature wear; field return | 6 | Manual press operation; insufficient force | 4 | Go/no-go gauge check, 1 per hour | 3 | 72 |
| Brake pad installation | Wrong friction material grade installed | Inadequate braking performance; noise; safety concern | 9 | Look-alike part numbers; kitting error | 2 | Barcode scan at point of use | 2 | 36 |
| Leak test | Leak test pressure set too low (pass bad parts) | Defective calipers escape to vehicle assembly | 8 | Gauge drift; calibration lapse | 2 | Calibration log, annual schedule | 4 | 64 |
3 Healthcare — Surgical Site Infection Prevention (PFMEA)
HealthcareScope: Process FMEA for the surgical site preparation and sterile field maintenance process in an orthopedic operating room. Developed as part of a Joint Commission quality improvement initiative. Healthcare FMEA often uses the same RPN structure but adds a criticality review for any S ≥ 8.
| Process Step | Failure Mode | Effect | S | Cause | O | Controls | D | RPN |
|---|---|---|---|---|---|---|---|---|
| Skin antisepsis | Inadequate prep coverage (area too small) | Surgical site infection (SSI); extended hospital stay | 8 | No standard boundary marked; surgeon variation | 4 | Verbal confirmation by scrub tech | 5 | 160 |
| Skin antisepsis | Antiseptic solution applied before drying | Chemical burn; reduced antiseptic efficacy; SSI risk | 7 | Time pressure; no timer used | 4 | Policy checklist in OR | 4 | 112 |
| Sterile draping | Sterile drape contaminated during placement | Break in sterile field; SSI risk; procedure may be halted | 8 | Drape contacts non-sterile surface; inadequate team spacing | 3 | Circulator monitors sterile field | 3 | 72 |
| Instrument handling | Non-sterile instrument passed onto sterile field | Sterile field breach; potential infection | 9 | Distraction; look-alike sterile/non-sterile packaging | 2 | Two-nurse sterile confirmation | 2 | 36 |
| Wound closure | Retained surgical sponge | Re-operation; patient harm; malpractice claim | 10 | Manual count error; distraction; emergent cases | 2 | Manual count before/after; X-ray on count discrepancy | 3 | 60 |
4 Software — User Authentication Service (SFMEA)
SoftwareScope: System FMEA for a B2B SaaS authentication service handling OAuth 2.0 login, session management, and password reset flows. Conducted as part of a pre-launch security and reliability review. Software FMEA follows the same RPN logic; Severity 9–10 items typically involve data breaches or compliance violations.
| Function / Service | Failure Mode | Effect | S | Cause | O | Controls | D | RPN |
|---|---|---|---|---|---|---|---|---|
| OAuth login | Authorization code reuse (replay attack) | Unauthorized account access; data breach | 9 | Code not invalidated after first use | 2 | Code TTL set to 60s; no reuse check | 5 | 90 |
| Session management | Session token not invalidated on logout | Session hijacking; unauthorized access after logout | 8 | Stateless JWT; no server-side revocation list | 4 | Token expiry set to 24h; no revocation | 6 | 192 |
| Password reset | Password reset link valid for > 24 hours | Account takeover if email is compromised | 8 | No TTL enforcement on reset tokens | 3 | Manual security review quarterly | 6 | 144 |
| Login endpoint | No rate limiting — brute force possible | Password enumeration; account compromise | 8 | Rate limiter not applied to /auth/login | 3 | WAF in front of service | 4 | 96 |
| Error handling | Stack trace returned in 500 response | Internal paths and library versions exposed; recon aid for attacker | 6 | Debug mode enabled; no error sanitization | 4 | None — not currently checked | 8 | 192 |
5 Food Processing — Pasteurization Line (PFMEA)
Food ProcessingScope: Process FMEA for an HTST (High-Temperature Short-Time) pasteurization line at a dairy plant. HACCP (Hazard Analysis Critical Control Points) is the food industry’s equivalent of FMEA; here the same RPN structure is applied to the pasteurization critical control point. FDA 21 CFR Part 110 compliance is in scope.
| Process Step | Failure Mode | Effect | S | Cause | O | Controls | D | RPN |
|---|---|---|---|---|---|---|---|---|
| Pasteurization / Heat treatment | Product temperature below 72°C (161.6°F) | Surviving pathogens (Listeria, Salmonella); consumer illness; recall | 10 | Heat exchanger fouling; flow rate too high | 2 | Continuous temp recorder; flow diversion valve (FDV) | 1 | 20 |
| Flow diversion valve | FDV fails to divert (stuck open) | Under-processed product reaches filler; pathogen risk | 10 | Valve actuator failure; pneumatic fault | 2 | FDV position sensor; daily function test | 2 | 40 |
| CIP (clean-in-place) | CIP cycle terminated early | Residual biofilm; microbial contamination of next batch | 9 | Operator manual override; timer fault | 2 | CIP log review; ATP swab test after cycle | 3 | 54 |
| Holding tube | Holding time < 15 seconds | Insufficient pasteurization; pathogen survival | 10 | Flow rate exceeds design maximum | 2 | Flow meter interlock; FDV triggers if flow too high | 1 | 20 |
| Filler/packaging | Post-pasteurization recontamination | Pathogen in final product; short shelf life; recall | 9 | Filler not sanitized; aseptic barrier breach | 2 | Pre-run sanitation check; environmental swabbing | 4 | 72 |
6 Aerospace — Landing Gear Actuator (DFMEA)
AerospaceScope: Design FMEA for a hydraulic actuator in a commercial aircraft main landing gear system. Performed per SAE ARP4761 guidelines. In aerospace, Severity = 10 items are treated as “catastrophic” and must achieve a target probability of < 10−9 per flight hour through redundancy and design changes, regardless of current RPN.
| Function / Component | Failure Mode | Effect | S | Cause | O | Controls | D | RPN |
|---|---|---|---|---|---|---|---|---|
| Actuator / Extend gear on command | Actuator fails to extend (gear up on landing) | Gear-up landing; hull loss; fatalities | 10 | Hydraulic seal failure; blocked port | 1 | Redundant hydraulic circuit; manual extension backup; pre-flight check | 1 | 10 |
| Actuator / Retract gear after takeoff | Actuator extends uncommanded in flight | Increased drag; structural overload above Vlo | 9 | Control valve stiction; electronic fault | 1 | Dual-channel control valve; BITE monitoring | 2 | 18 |
| Actuator body / Contain hydraulic pressure | External hydraulic leak (actuator body crack) | Hydraulic fluid fire risk; loss of primary hydraulics | 9 | Material fatigue; stress concentration at port boss | 2 | FEA stress analysis; NDT inspection on prototypes | 3 | 54 |
| Position sensor / Report gear state | False “gear down and locked” indication | Crew believes gear down; no precautionary action before landing | 10 | Sensor wiring short; connector corrosion | 2 | Dual independent sensors; disagree logic in FCC | 2 | 40 |
| Locking mechanism / Lock gear down | Over-centre lock does not engage | Gear collapses on landing; hull damage; injuries | 10 | Wear on lock link; debris in mechanism | 1 | Mechanical design safety factor; functional test every 500 cycles | 2 | 20 |
7 Administrative — Invoice Approval Process (Non-Technical PFMEA)
AdministrativeScope: Process FMEA for a finance team's invoice-approval workflow. FMEA is not just for manufacturing — any process with measurable failure modes benefits from systematic risk scoring. Severity here translates to financial / compliance impact rather than safety harm.
| Function / Process Step | Failure Mode | Effect | S | Cause | O | Controls | D | RPN |
|---|---|---|---|---|---|---|---|---|
| Invoice receipt / Match to PO | Invoice received without matching PO | Manual triage; payment delay; vendor dispute | 5 | Vendor sends invoice before PO is created in ERP | 7 | AP clerk visual review | 5 | 175 |
| Approval routing / Send to manager | Routed to wrong approver | Approval delay 2–5 days; possible duplicate approval | 4 | Outdated approver mapping; manager on PTO not redirected | 6 | Workflow auto-routing rules | 4 | 96 |
| Approval / Manager reviews and approves | Invoice approved without reading | Fraudulent / duplicate / over-budget invoice paid | 8 | Approver fatigue (50+ invoices/day); no spot-check | 5 | None — trust-based | 9 | 360 |
| Payment / ERP triggers ACH transfer | Payment to wrong bank account | Funds lost; vendor unpaid; reconciliation effort | 9 | Vendor master data not updated; phishing email "new bank" | 3 | Two-person verification on bank changes > $10k | 3 | 81 |
| Reconciliation / Match payment to ledger | Payment posted to wrong GL account | Audit finding; misstatement; late close | 5 | Manual GL coding error | 5 | Month-end reconciliation review | 3 | 75 |
8 Logistics — Cold Chain Shipping Line (PFMEA)
LogisticsScope: Process FMEA for an international cold chain shipping line moving temperature-sensitive pharmaceuticals between manufacturer and distributor. Severity reflects product loss + regulatory non-compliance under GDP (Good Distribution Practice). A single excursion can result in batch rejection (six- to seven-figure cost).
| Function / Process Step | Failure Mode | Effect | S | Cause | O | Controls | D | RPN |
|---|---|---|---|---|---|---|---|---|
| Pre-conditioning / Cool refrigerated container to 2–8°C | Container loaded above setpoint | Temperature excursion within first 4 h; product degradation | 8 | Pre-cool cycle skipped to meet departure window | 4 | Pre-departure temperature log review by dispatcher | 4 | 128 |
| Loading / Place product in refrigerated container | Product placed against container wall (heat conduction) | Hot spots; localized excursion; partial batch loss | 7 | Loader untrained on stacking SOP; rushed loading | 5 | Quarterly loader training; pallet placement diagram | 6 | 210 |
| Transit / Maintain 2–8°C continuously | Refrigeration unit fails mid-transit | Full container loss; recall risk; regulatory report | 10 | Compressor failure; coolant leak; power loss at port | 2 | Real-time GPS+temp monitoring; redundant battery; SLA with carrier | 2 | 40 |
| Customs hold / Container parked at port | Container unplugged from shore power during inspection | Temperature drift; excursion logged; partial loss | 8 | Customs officer unfamiliar with cold chain; no holding plug | 6 | Pre-arrival paperwork to customs; insulated container 24h ride-through | 7 | 336 |
| Receiving / Verify temperature log on arrival | Excursion noted but product accepted | Out-of-spec product enters distribution; patient safety risk | 10 | Receiving clerk pressured to accept; missing OOS procedure | 3 | Automated rejection in WMS if log shows excursion > 30 min | 3 | 90 |
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Explore Free RCA Tools →Quick Reference: RPN Risk Levels
These thresholds are guidelines — set your own based on industry and risk tolerance. Always act on S ≥ 9 regardless of RPN.
- RPN < 50 — Low risk. Monitor; no immediate action required.
- RPN 50–99 — Moderate. Plan corrective action; review at next scheduled meeting.
- RPN 100–199 — High. Assign action, owner, and due date. Follow up within 30 days.
- RPN ≥ 200 — Critical. Immediate action required before next production run or release.
- S ≥ 9 (any RPN) — Always review and assign action, regardless of Occurrence and Detection scores.
Related Resources
- FMEA: The Complete Guide — RPN formula, rating scales, 7-step process, DFMEA vs PFMEA
- Free FMEA Template — Excel & Google Sheets — blank worksheet with all 12 columns ready to fill in
- RCA Tools Compared: 5 Whys, Fishbone, FTA, FMEA & Pareto
- Pareto Analysis: The Complete Guide — use Pareto to prioritize which failure modes to act on first
- Free 5 Whys Tool — investigate failures that your FMEA did not prevent