This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method used to evaluate potential failure modes in a design, process or service and their causes and effects. It involves analyzing potential failures, their likelihood and severity, and identifying actions to address potential failures with high risk priority numbers. The document defines key terms in FMEA like severity, occurrence, detection and risk priority number. It also outlines the FMEA process, including steps to identify potential failure modes, effects, causes, current controls and priority actions.

1. Failure Mode & Effect Analysis
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2. Learning Bites
• Understand the concept of FMEA
• Identify the terminologies of FMEA
• Determine steps in measuring and analyzing the potential failure modes
• Define steps in measuring the critical points of failure.
• Deploy the concept in your workplace to reduce the potential failures.

3. What is FMEA
• FMEA stands for Failure Mode & Effect Analysis.
• An Advanced Quality Planning Tool used to evaluate Potential Failure Modes and
their Causes.
• Prioritizes potential failures according to their risk and drives action to eliminate or
reduce their likelihood of occurrence
• Provides a disciplined methodology for documenting this analysis for future use and
continuous process improvement
• By itself, an FMEA is NOT a problem solver. It is used in combination with other
problem solving tools.

4. Role of FMEA in Quality System
Quality
Process Business
Improvement Objectives
QFD
QOS
Problem Problem
Solving Prevention
FTA
RFTA
8-D DOE
Control
APQP
Plan
FMEA
SPC
Tools
Special
Characteristics

5. Design & Process FMEA
Design FMEA Involves study of product
DFMEA is an analytical technique utilized primarily to ensure
potential failure modes and their associated causes are
identified, considered, and addressed in the design phase.
FMEA
Process FMEA Involves study of processes
PFMEA is an analytical technique utilized primarily for
continuous analysis of potential failure modes and their
associated causes during the processes.

6. Important Terms in FMEA
• CAUSE - cause of a failure mode is a deficiency that results in a failure mode. It is
description of how the process could result in a failure.
• SEVERITY - is an assessment of the seriousness of the effect of the potential failure
mode to the customer. Severity applies to the effect only.
• OCCURRENCE - the number of times the cause has resulted in the failure mode
before any additional process control are applied.
• DETECTION - is rating corresponding to the likelihood that current process will detect
the failure mode before it gets to the customer.
• RPN (Risk Priority Number) - is a measure of process risk and should be used to rank
order the risks/concerns.
RPN = SEVERITY x OCCURRENCE x DETECTION

7. FMEA Roadmap
POTENTIAL FAILURE MODE
EFFECT DETERMINE SEVERITY
CAUSE DETERMINE OCCURRENCE
CURRENT CONTROLS DETERMINE DETECTABILITY
ACTIONS LEADING TO
DETERMINE RPN
CONTINUOUS IMPROVEMENT

8. FMEA Priority Actions
Changing design Eliminating
SEVERITY (material, failure
geometry, etc) mode
Preventing or
Changing design reducing
OCCURRENCE occurrences of
or process
one
or more causes
Improving
Adding/improving ability
DETECTION
controls/methods to detect the
failure mode

9. FMEA Process Steps
Step 10: Calculate Resulting RPN
Step 9: Take Actions
Step 8: Develop Action Plan
Step 7: Calculate RPNs
Step 6: Assign Detection Ranking
Step 5: Assign Occurrence Ranking
Step 4: Assign Severity Ranking
Step 3: List Potential Effects of
Failure
Step 2: Brainstorm Potential Failure
Modes
Step 1: Review the Process

10. Potential Causes & their Effects
POTENTIAL CAUSES POTENTIAL EFFECTS
METHODS
MACHINERY
FAILURE
NEXT DOWNSTREAM
MATERIALS MODE OPERATION USER
PEOPLE ULTIMATE
CUSTOMER
ENVIRONMENT

11. Standard PFMEA Detection Ranking
Detection Criteria: Likelihood of Detection by Process Control Rank
Almost
No known Controls available to detect Failure Mode or Cause 10
Impossible
Very Remote Very remote likelihood current Controls with detect Failure Mode or Cause 9
Remote Remote likelihood current Controls with detect Failure Mode or Cause 8
Very Low Very low likelihood current Controls with detect Failure Mode or Cause 7
Low Low likelihood current Controls with detect Failure Mode or Cause 6
Moderate Moderate likelihood current Controls with detect Failure Mode or Cause 5
Moderately
Moderately high likelihood current Controls with detect Failure Mode or Cause 4
High
High High likelihood current Controls with detect Failure Mode or Cause 3
Very High Very high likelihood current Controls with detect Failure Mode or Cause 2
Current Controls almost certain to Failure Mode or Cause. Reliable detection controls are
Almost Certain 1
known with similar processes.

12. FMEA Worksheet

13. Summary
• FMEA is created to satisfy a customer or third party requirement, NOT to improve
the process.
• FMEA is developed too late in the process and does not improved the
product/process development cycle.
• The FMEA is perceived either as too complicated or as taking too much time.

15. Thank you very much!
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