Process FMEA

Quick Reference Guide

> By Øystein Larsen / Nov 08
 Process FMEA
Quick Reference Guide

> This is a Quick Reference Guide to help Eltek Valere

revision leader and members to do a correct and efficient
FMEA.

> The content prinsipals are gathered from ”PFMEA

methode card” and ”PFMEA ref card” made by Quality
Assosiates International inc. However, a lot of the content
has been modified to fit our organisation and how we by
past experience has sucsessfully been running PFMEA’s.

1- (248) 280 - 4800

www.quality-one.com

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 Developing an Efficient Process FMEA
Planning For PFMEA
1 2 FMEA Development
Team :
 Process Owner
 All sub process responsible Note:
 Process QA responsible Enter all Process
Planning •If on paper leave plenty of
 Design Representatives Steps and a
description into far space for further analysis
(Technical, Process, QA)
Supplier (optional) left Column

Gather: Types of Failures:

•Process Flow Diagram Note the low risk items and •Characteristics from Matrix
• Procedures / Requirements give reason why no analysis (if applicable)
•All work instructions was necessary •Full Failure
•Statistics (Production SPC •Partial
results, WATS results, ETS field •Intermittent
Determine Process data, EPI customer complaints •Unintended
Flow (real process, • Characteristics linked to Enter all Failure
not theoretical) Modes one after
product quality and
another
Customer Satisfaction •List up to 5 in the same box
•What Operations affect these (grouped) per each failure mode
Identify critical characteristics •Place severity # beside each effect
process steps Enter Effects of
in parenthesis ex: (4)
Failure and Select •Place largest severity of the group
Medium: Severity
-New Technology into severity column
-Past Concerns
-Design Characteristics and quality Affecting
High:
Determine which -Safety to Operator •Refer to Severity Chart for Scale
process steps require
analysis
-Safety in Use B
-Regulatory Requirement
High/ Med/ Low risk Low:
-Non directly quality and/or safety drivers

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 Developing an Efficient Process FMEA
Detection/Prevention
D - Visual Inspection
Consider P - Mistake Proofing
B Process P - Proximity Switch
4 Controls P - Lock outs
P - Line Interlock
3 Severity is 9 or 10?
Failure Mode be Add to Action Column D - D & R chart
eliminated? -Responsible Person List Process Controls:
IF IF -Date of Completion •Multiple Controls are likely
Yes Yes Take Action to Reduce •Determine Detection value for each item
Severity / Occurrence record it in parenthesis ex: (5)
No •Move the smallest item into Detect. column
Review Severity,
start at highest and No SEV is 9/10
go to lowest & OCC > 1, Determine Action to
Yes
Fault Tree Analysis SEV is 5 - 8 DET > 1 ? IF Reduce Occur. or
& OCC > 4 ? Improve Controls
F. M No
Determine: •Ensure all
What are the causes Calculate RPN
Critical and
for the Failure Mode? Yes Risk Priority Number
SEV x OCC x DET Significant
Root Causes IF Failures have
No Pareto RPN
For 9/10 SEV actions
•All actions
Enter the Causes Types of Causes: must have
Top 20% of Failure
Into FMEA Form •Man •Method Determine: Modes names / dates
•Material •Environment How probable is each by RPN •All team
•Machine •Noises cause as it contributes to members
the failure mode? R must sign-in
Note: Typically there are numerous
Refer to Occurrence • Enter into Occur. Column P •Header info
Causes, be sure to allow for space if
Chart for Scale N must be
Completing FMEA on paper.
Failure Modes complete

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 • Name of
Control Prevention Control Detection
Brainstorm causes team
Brainstorm causes • man •Reduce Occurrence Planned Evaluation member to
• Verb-noun Anti function • man • material Method to/from carry issue.
• measurable for functional • material • method • Control Plan • Name of
• method • machine • Tools
is desirable approach • environment • Mistake Proofing champion
• objective • machine
• full • environment Determine Root • Date action
• subjective • partial Determine Root cause if CC desired
• intermittent cause if CC completion
• excess function
Top 20% of Failure
Modes by RPN
See Severity See Occurrence
Chart on
Criteria's on opposite side
Separate page
R
P
N
See Critical and
*Note: Zero (0) rankings Significant Characteristics
for Severity, Occurrence Action guidelines next page
or Detection are not allowed
Failure Modes

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 PFMEA - Prioritizing

Actions are Required:

Critical & Significant
(by Priority) Characteristics Action Guidelines

1.) Confirmed CC is a Critical 10 Top 20% of Failure

Characteristic to be 1.) Confirmed Critical Characteristic
9 Modes by RPN
addressed on Control
Plan) 8
S 2.) Confirmed Significant
7
e Characteristic; Action R
2.) An SC is a confirmed v 6 Required P
Significant Characteristic to e 5 N
be addressed on Control r
Plan) i
4 ANNOYANCE
t 3
ZONE
3.) RPN-Top
y 2 20% by pareto Failure Modes
3.) For the top 20% Failure 1
Modes / Causes (Pareto by 1 2 3 4 5 6 7 8 9 10
RPN) Occurrence

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 PFMEA – Criterias for Detection
Detection Criteria A B C Detection Methode Rank
Almost Absolute certainty of Non -Detection X Cannot detect or is not checked. 10
Impossible

Very Remote Controls will probably not X Control is achieved with indirect or random checks only. 9
detect.

Remote Controls have poor chance X Control is achieved with visual inspection only. 8
of detection.

Very Low Controls have poor chance of detection. X Control is achieved with double visual inspection only. 7
Low Controls may detect. X X Control is achieved with charting methods, such as SPC 6
(Statistical Process Control).

Moderate Controls may detect. X Control is based on variable gauging after parts have left 5
the station, or Go/NoGo gauging performed on 100% of
the parts after parts have left the station.

Moderately Controls have a good chance to detect X X Error Detection in subsequent operations, OR gauging 4
High performed on set-up and first-piece check (for set-up
Causes only).

High Controls have a good chance to detect. X X Error Detection in-station, OR error Detection in 3
subsequent operations by multiple layers of acceptance;
supply, select, install, verify. Cannot accept discrepant
part.

Very High Controls almost certain to detect. X X Error Detection in-station (automatic gauging with 2
automatic stop feature). Cannot pass discrepant part.

Certain Controls certain to detect. X Discrepant parts cannot be made because item has been 1
error proofed by process/product design.

Inspection Types: A = Error Proofed

B = Gauging
C = Manual Inspection

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 PFMEA – Criterias for Severity
Severity Severity of Effect Rank
Hazardous May endanger machine operator or assembly operator. Failure affects safe 10
(no warning) product operation or noncompliance with government regulation. Failure will
occur without warning.
Hazardous May endanger machine operator or assembly operator. Failure affects safe 9
(with warning) product operation or noncompliance with government regulation. Failure will
occur with warning.
Very High Major disruption to production line. 100% of product may have to be scrapped. 8
The product is inoperable with loss of primary Function.
High Minor disruption to production line. Product may have to be sorted and a 7
portion scrapped. The product is operable, but at a reduced level of
performance.
Moderate Minor disruption to production line. A portion of the product may have to be 6
scrapped (no sorting). Product is operable, but some comfort / convenience
item(s) are inoperable.
Low Minor disruption to production line. 100% of the product may have to be 5
reworked. Product is operable, but some comfort / convenience items operate
at a reduced level of performance.
Very Low Minor disruption to production line. Product may have to be sorted and a 4
portion reworked. Fit & finish or squeak & rattle item does not conform. Most
Customers notice the defect.
Minor Minor disruption to production line. A portion of the product may have to be 3
reworked on-line but out-of-station. Fit & finish or squeak & rattle item does
not conform. Average customers notice the defect.
Very Minor Minor disruption to production line. A portion of the product may have to be 2
reworked on-line but in-station. Fit & finish or squeak & rattle item does not
conform. Discriminating customers notice the defect.
None The Failure Mode has no Effect. 1

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 PFMEA – Criterias for Occurence
Probability of Failure Likely failure rate Ppk Rank

 100 per thousand pieces 10

<0.55
Very High: Persistent failures
50 per thousand pieces 9
>0.55

20 per thousand pieces 8

>0.78
High: Frequent failures
10 per thousand pieces 7
>0.86

5 per thousand pieces 6

>0.94

Moderate: Occasional failures 2 per thousand pieces >1.00 5

1 per thousand pieces 4

>1.10

0.5 per thousand pieces 3

>1.20
Low: Relatively few failures
0.1 per thousand pieces 2
>1.30

 0.01 per thousand pieces 1

Remote: Failure is unlikely >1.67

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