Developing an Efficient 1- (248) 280 - 4800

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Process FMEA
1 Planning For FMEA 2 FMEA Development

Gather:
• Design Input Special Enter all Process Note:
Planning Steps and a •If on paper leave plenty of
Characteristics
• Surrogate Process Flow description into space for further analysis
• Team : far left Column
 Process Owner
 Design Representative
 PVT-Problem Data Person Note the low risk items
 Supplier and give reason why no
 Process Contraries analysis was necessary
Types of Failures:
Review Update/ •Process Flow Diagram •Characteristics from Matrix
Process Flow Enter all Failure (if applicable)
Modes one after •Full Failure
another •Partial
• Characteristics linked to •Intermittent
Link Design
Customer Satisfaction •Unintended
Characteristics •What Operations affect these
to Process Steps
Characteristics
•List up to 5 in the same box
Enter Effects of
(grouped) per each failure mode
Medium: Failure and Select
•Place severity # beside each effect
-New Technology Severity
in parenthesis ex: (4)
-Past Concerns •Place largest severity of the group
Determine Which -Design Characteristics Affected
Steps require into severity column
High:
analysis -Safety to Operator •Refer to Severity Chart for Scale
High / Med / Low -Safety in Use B
-Regulatory Requirement
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 Developing an Efficient Process FMEA Detection/Prevention
D - Visual Inspection
B Consider P - Mistake Proofing
4 Process P - Proximity Switch
Controls P - Lock outs
P - Line Interlock
Severity is 9 or 10? Failure Mode be D - D & R chart
Add to Action Column
eliminated? List Process Controls:
3 IF IF -Responsible Person
•Multiple Controls are likely
Yes Yes -Date of Completion
•Determine Detection value for each item
No Take Action to Reduce
No Severity / Occurrence record it in parenthesis ex: (5)
•Move the smallest item into Detect. column
Review Severity,
start at highest and SEV is 9/10 Determine Action
& OCC > 1, Yes to Reduce Occur.
go to lowest SEV is 5 - 8
DET > 1 ? IF
& OCC > 4 ? or Improve
Fault Tree Analysis
Controls
Yes No

Determine: F. M IF Calculate RPN •Ensure all

What are the causes
Risk Priority Number YC/YS have
for the Failure Mode? No SEV x OCC x DET actions
Pareto RPN •All actions
Root Causes
For 9/10 SEV must have
names / dates
Top 20% of Failure Modes
Enter the Causes •All team
by RPN
Into FMEA Form members
Types of Causes:
•Method R must sign-in
•Man Determine:
P •Header info
•Material •Environment How probable is each N must be
•Machine •Noises cause as it contributes to
Failure Modes complete
Refer to Occurrence Note: Typically there are numerous the failure mode?
Chart for Scale Causes, be sure to allow for space if •Enter into Occur. Column Warning!
Completing FMEA on paper.
Do not select arbitrary RPN to be below
Based on 80/20 Rule
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