# Common Mistakes & Best Practices in FMEA Creation
FMEA (Failure Mode and Effects Analysis) is a structured method to identify and eliminate potential failure risks in products and processes. But in real-world manufacturing environments, many FMEAs become checkbox documents rather than living tools—due to poor creation practices.
In this guide, we’ll explore the most common FMEA creation mistakes and share best practices to help quality engineers build impactful DFMEA and PFMEA aligned with the AIAG-VDA 7-Step methodology.
🚫 Common Mistakes in FMEA Creation
1. Starting Without Scope or Structure
Jumping directly to failure listing without a defined scope or system/process structure leads to disorganized FMEAs.
2. Listing All Possible Failures
Overloading the sheet with every potential failure (no matter how irrelevant) makes the FMEA bloated and unfocused.
3. Weak Function-Failure-Effect Linkage
Missing or unclear relationships between function → failure mode → effect breaks traceability.
4. Inconsistent S, O, D Ratings
Assigning severity, occurrence, or detection ratings arbitrarily leads to unreliable Action Priority (AP) outcomes.
5. Empty or Vague Controls
Leaving prevention/detection controls blank or using generic terms like “inspection” is a common audit red flag.
6. No Recommended Actions or Follow-Up
Creating FMEA without actionable improvements defeats its core purpose.
7. Treating FMEA as a One-Time Task
Many FMEAs are created only for PPAPs and not updated during engineering or process changes.
✅ Best Practices for FMEA Creation
1. Follow AIAG-VDA 7-Step Method
Use the structure:
Planning → Structure → Function → Failure → Risk → Optimization → Results
2. Start with a Clear Scope
Define system boundaries, assumptions, interfaces, and customer requirements before diving into failure analysis.
3. Use Functional Thinking
Derive failure modes from what the product/process is supposed to do (function), not from what could randomly go wrong.
4. Use Standard Rating Tables
Apply AIAG-VDA S, O, D tables consistently and reference the AP table for action prioritization.
5. List Real & Existing Controls
Document actual current controls—not ideal or planned ones—for accurate risk assessment.
6. Prioritize Using Action Priority
Don’t rely on RPN. Use Action Priority (High, Medium, Low) to decide whether action is required.
7. Connect DFMEA → PFMEA → Control Plan
Ensure logical flow from design risk to process risk to production control strategy.
8. Update FMEAs During Product/Process Changes
Treat FMEA as a living document. Update it during ECNs, customer complaints, or significant process changes.
📌 Bonus Tips
- Use Excel wisely—protect formulas, use dropdowns, highlight AP “H” rows for visibility.
- For complex systems, consider software like APIS IQ, PLATO SCIO, or Knowlence TDC.
- Link critical functions/failures to validations, test plans, or SPC controls.
✅ Related Articles
✅ FAQs
Q: Can I use Excel for FMEA creation?
Yes, for small to mid-sized projects. Use structured templates with filters and AP logic.
Q: What if I don’t have all functions defined yet?
Pause FMEA until function and structure analysis is complete. Guessing leads to weak FMEA quality.
Q: What’s the difference between current controls and recommended actions?
Current controls exist today. Recommended actions are what you’ll do to improve or mitigate risk.
