Why FMEA Still Fails Even After Teams Do It

 Why FMEA Still Fails Even After Teams Do It 

Failure Mode & Effects Analysis (FMEA) is one of the most powerful preventive tools in manufacturing and the automotive industry. Yet, in real situations, defects still escape, customer complaints continue, and OEM audits point out FMEA as “ineffective” or “not updated.”
So why does FMEA fail even though companies are spending hours preparing it?

The truth is simple: Most organizations do FMEA because they must, not because they benefit from it.
It becomes a documentation activity instead of a risk-prevention activity.

Let’s dive into the real reasons why FMEA fails and what you can do to fix it.



1. FMEA Is Treated as a One-Time Document

One of the most common reasons for FMEA failure is that organizations treat it as a “PPAP document” rather than a “living document.”

Teams rush to complete the FMEA only during:

  • New project development
  • Customer requirement
  • PPAP submission
  • Audit preparation

Once submitted, it lies in a folder untouched until the next problem hits.

Why this causes failure:

  • New risks never get added
  • Process changes are not reflected
  • Lessons from customer complaints are not updated
  • Control plan becomes outdated
  • SOPs don’t match the latest risks

FMEA is supposed to evolve with the process. When the shop floor changes but FMEA doesn’t, the tool becomes irrelevant.

2. Teams Perform FMEA Without Real Shop-Floor Inputs

Many FMEAs are created sitting inside a meeting room with:

  • Old documents
  • Assumptions
  • Past experiences

But without actual Gemba (shop-floor) observation, the risks identified are incomplete or theoretical.

Examples of shop-floor insights often missed:

  • Operator shortcuts
  • Workarounds
  • Tool wear patterns
  • Difficult-to-hold parts
  • Poor fixture stability
  • Real cycle time pressure
  • Variation between shifts

An FMEA without shop-floor reality is only a guesswork document — and that’s why it fails.

3. FMEA Ratings Are Manipulated Just to Reduce RPN

Teams often try to “fit” the RPN within a safe zone to impress auditors or customers.

Common manipulations include:

  • Artificially reducing Severity
  • Reducing Occurrence without evidence
  • Increasing Detection rating just to reduce risk score

This makes FMEA look clean on paper but weak in practice.

Real-life example:
Occurrence reduced from 6 to 3 simply because the supervisor said “defects rarely happen,” but no data was checked.

When numbers are adjusted without data, FMEA becomes a false representation of risk.

4. Team Members Are Present, But Not Participating

Many FMEA meetings are done with:

  • One person talking
  • Others silently listening
  • Members signing the attendance sheet
  • No cross-functional discussion

An effective FMEA needs genuine inputs from:

  • Quality
  • Production
  • Maintenance
  • Design
  • Tool room
  • Process engineering
  • Operator / supervisor

When FMEA becomes a “quality engineer’s job,” it fails instantly.

5. FMEA Does Not Include Lessons Learned from Past Failures

Every customer complaint, internal rejection, breakdown, or field failure should update the FMEA.
But in real life, this hardly happens.

Why this happens:

  • No structured process to capture lessons learned
  • No ownership of updating documents
  • Gap between problem-solving team and FMEA team
  • Lack of audit tracking

Because of this, the same failures repeat, making FMEA ineffective.

6. FMEA Is Not Linked to Control Plan, Work Instructions & SOPs

This is one of the biggest reasons for failure.

In theory:

  • FMEA → Identifies risks
  • Control Plan → Specifies controls
  • SOP → Shows how to do the job
  • Checklist → Verifies process stability

But in many companies, these documents do not match each other.

Example:
FMEA says “visual inspection every 1 hour,”
But Control Plan shows “visual inspection every 2 hours,”
And SOP doesn’t mention it at all.

When alignment is missing, operators do not follow what FMEA demands, resulting in defects.

7. No Data-Based Evidence for Occurrence (O) Rating

Occurrence rating should be based on:

  • Process capability (Cp, Cpk)
  • Defect rate (ppm)
  • Rejection trend
  • SPC control chart stability
  • Historical data

But many FMEAs use occurrence ratings based on “feeling.”

When data is not reflected in O-rating, risks are wrongly estimated, leading to failure.

8. Detection (D) Controls Are Overestimated

Most FMEAs fail because teams think their detection controls are highly effective, while reality is different.

Examples:

  • Visual inspection assumed to be very reliable
  • Operator judgment assumed to be consistent
  • Old gauges assumed to be accurate
  • No MSA done, but D-rating kept low

This creates a false sense of security.

Detection is usually the weakest link in manufacturing, and overestimating it leads to major quality escapes.

9. No Priority for High-Risk Items

FMEA identifies high-risk items, but no action plan is created.

Common reasons:

  • No time
  • No resources
  • Production pressure
  • “We are already doing enough” mindset
  • No management involvement

Without closing actions, FMEA becomes a list of problems without solutions.

10. FMEA Training Is Poor or Missing

Many engineers filling FMEAs have never received proper training in:

  • AIAG & VDA Manual
  • Severity-Occurrence-Detection criteria
  • Function vs Failure Mode logic
  • Linkage with Control Plan
  • Interpretation of actions

When people do not understand the tool, they cannot use it correctly.

11. Management Does Not Review or Challenge the FMEA

If management treats FMEA as “just another document,” the team will not give importance either.

Reviews are needed for:

  • High-risk items
  • Customer complaints
  • New processes
  • New equipment
  • Process changes
  • Corrective actions

Without leadership involvement, FMEA stays weak.

How to Make FMEA Truly Effective

Here are the practical fixes:

✔ Make FMEA a living document

Update it during every process change, complaint, and improvement activity.

✔ Conduct FMEA at the Gemba

Real risks are visible only on the shop floor.

✔ Use data for all ratings

Especially for Occurrence and Detection.

✔ Ensure cross-functional participation

FMEA quality depends on team diversity.

✔ Link FMEA with CP, SOP, and work instructions

All documents must reflect the same risks and controls.

✔ Review FMEA quarterly

Adjust priorities based on performance.

✔ Train the team

AIAG & VDA understanding is essential for effective analysis.

#FMEA #AIAG #VDA #QualityEngineering #AutomotiveQuality #ManufacturingExcellence #PPAP #APQP #QualityTools #ZeroDefect #RiskManagement #ProcessImprovement #LeanQuality #Industry40Quality

 

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