Failure Mode & Effects

Analysis (FMEA)

Bottom-up Approach

FMEA Types

Potential

Failure Effects

Current Controls

Potential Failure Mode

Design FMEA

Process FMEA

Service FMEA

When to use

Quality Function Deployment

Product Design or Redesign

Process Design or Redesign

Change in Process

Before developing control plan

Planned improvement goals for existing process

Analyzing failures of existing process, product or service

Periodically throughout the life of process, product or service

4 Terms

Severity (S)

Occurrence (O)

Detection (D)

Risk Priority Number RPN = S*O*D

Failure to Open/close

Brittle

Cracked

Warped

Underfilled

Undersized/OversizedPotential

Failure Causes

Overstressing

Incorrect material specified

Improper wall thickness

Improper Tolerance

Design

Process

End effect

Local effect

Next high level effect

Effect on product

Effect on local &

downstream processes

Others

Erratic Operation

Failure to Operate

Noise

Loss of life

Characteristics

Critical

Characteristics (CC)

Significant

Characteristics (SC)

Regulatory Compliance

Product liability

Industrial Standards

Customer requirements

Internal engineering requirements

Product related

Process related

Control tests related

Controls

Prevention Controls

Process

Design

Common Examples

SPC analysis

Product capability studiesFunctional tests

Gauge repeatability

& reproducibility (R&R) studies

Durability tests

Design review & design guidelines Operator training

Procedure

1. Assemble Cross Functional Team (CFT)

2. FMEA Scope identification

(Concept, System, Design, Process or Service

3. Fill FMEA form

4. Functions wise Scope identification

5. Functions wise failure identification

6. Identification of Consequences of each failure mode

7. Severity Rating

14. Recalculation of RPN

13. Identification of recommended actions and implementation of CA & PA

12. RPN Calculation

11. Determination of Detection rating for each process control

10. Identification of current process controls

9. Determination of Occurrence

8. Determination of root cause for each failure mode

Detection Controls

Process

Design

Design standards

Use of reliable components

Error proofing

process capability

performance analysis

prior to production

DOE

Preventive Maintenance

Engineering Analysis (FEA)

Tolerance Analysis

Process inspections

Workmanship standards

Quality Inspection Plan (QIP)

http://1sustainability.blogspot.in MIND MAP OF FAILURE MODE EFFECTIVE ANALYSIS (FMEA) Rev 00 / March 29, 2012

Compiled by Ravi Kiran Muddha Sources: www.asq.org and Guidelines for Failure Mode and Effects Analysis for Medical Devices by Dyadem Press