Process FMEA

FMEA Instructions
1) Identify and name the process, product or service. Identify who has responsibility, and identify the team.
2) List the item functions in column A.
3) Identify possible failure modes in column B.
4) Describe potential effect(s) of failure modes in column C.
5) Use the provided table (in the Rating Factors Tab) to identify severity in column D.
6) Identify potential causes of failure in column E. Describe these in terms of something that can be corrected or can be controlled.
7) Rate the liklihood of the identified failure casue occurring in column F. Use the provided table in the Rating Factors Tab.
8) Describe the current process controls to prevent the failure mode in column G.
9) Use the provided table (in the Ratings Factors Tab) to determine the liklihood that that failure cause will be detected.
10) The Risk Priority Number will be calculated automatically.
11) Use the RPN to identify further actions in columns J, K, and L. Once action is taken, recalculate RPN.

Prepared by:
Item Name: FMEA Team:
FMEA Date (Orig): Revision #:

Potential Effect on S O D R S O D
Process Step or Variable or Future
Potential Failure Mode Customer Because of E Potential Causes C Current Process Controls E P Actions Recommended Resp.& Target Date Actions Taken E C E
Key Input RPN
Defect V C T N V C T

cause likely to Occur?

How Severe is effect

rank order concerns

Detection of cause?

Future Occurance
What are the actions for

Risk Priority # to
to the customer?

Future Detection
How probable is
How frequent is

Future Severity
What are the existing What were the actions
In what ways can the Process What is the impact on the reducing the Occurrence of
What causes the Key Input controls that either prevent Who's Responsible for the implemented? Include
Step, Variable, or Key Input Key Output Variables the cause, or improving
What is the process step? to go wrong? (How could the failure mode from recommended action? What completion month/year.
go wrong? (chance of not (customer requirements) or Detection? Should
the failure mode occur?) occurring or detect it should date? (Then recalculate resulting
meeting requirements) internal requirements? have actions on high RPN's
it occur? RPN.)
or Severity of 9 or 10.

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 Process FMEA

FMEA Instructions
1) Identify and name the process, product or service. Identify who has responsibility, and identify the team.
2) List the item functions in column A.
3) Identify possible failure modes in column B.
4) Describe potential effect(s) of failure modes in column C.
5) Use the provided table (in the Rating Factors Tab) to identify severity in column D.
6) Identify potential causes of failure in column E. Describe these in terms of something that can be corrected or can be controlled.
7) Rate the liklihood of the identified failure casue occurring in column F. Use the provided table in the Rating Factors Tab.
8) Describe the current process controls to prevent the failure mode in column G.
9) Use the provided table (in the Ratings Factors Tab) to determine the liklihood that that failure cause will be detected.
10) The Risk Priority Number will be calculated automatically.
11) Use the RPN to identify further actions in columns J, K, and L. Once action is taken, recalculate RPN.

Prepared by:
Item Name: FMEA Team:
FMEA Date (Orig): Revision #:

Potential Effect on S O D R S O D
Process Step or Variable or Future
Potential Failure Mode Customer Because of E Potential Causes C Current Process Controls E P Actions Recommended Resp.& Target Date Actions Taken E C E
Key Input RPN
Defect V C T N V C T

cause likely to Occur?

How Severe is effect

rank order concerns

Detection of cause?

Future Occurance
What are the actions for

Risk Priority # to
to the customer?

Future Detection
How probable is
How frequent is

Future Severity
What are the existing What were the actions
In what ways can the Process What is the impact on the reducing the Occurrence of
What causes the Key Input controls that either prevent Who's Responsible for the implemented? Include
Step, Variable, or Key Input Key Output Variables the cause, or improving
What is the process step? to go wrong? (How could the failure mode from recommended action? What completion month/year.
go wrong? (chance of not (customer requirements) or Detection? Should
the failure mode occur?) occurring or detect it should date? (Then recalculate resulting
meeting requirements) internal requirements? have actions on high RPN's
it occur? RPN.)
or Severity of 9 or 10.

Check of Application Form

Checks Being Printed Checks Have To Be Re- Incorrect Information On Clerk Reviews information
Customer Application 6 4 for Correct Information by 8 192 Clerk Manager Completed 8 2 4 64
Incorrectly Issued Application Form with customer
Data Enty Operator

Checks Being Printed Checks Have To Be Re-

Data Entry Data Entry Error
Incorrectly Issued

Information Entered in
Checks Being Printed Checks Have To Be Re-
Data Entry Wrong Field on Application
Incorrectly Issued
Form

All Rights Reserved, Juran Institute, Inc. Process Design and Process FMEA
 Design FMEA

FMEA Instructions
1) Identify and name the process, product or service. Identify who has responsibility, and identify the team.
2) List the item functions in column A.
3) Identify possible failure modes in column B.
4) Describe potential effect(s) of failure modes in column C.
5) Use the provided table (in the Rating Factors Tab) to identify severity in column D.
6) Identify potential causes of failure in column E. Describe these in terms of something that can be corrected or can be controlled.
7) Rate the liklihood of the identified failure casue occurring in column F. Use the provided table in the Rating Factors Tab.
8) Describe the current process controls to prevent the failure mode in column G.
9) Use the provided table (in the Ratings Factors Tab) to determine the liklihood that that failure cause will be detected.
10) The Risk Priority Number will be calculated automatically.
11) Use the RPN to identify further actions in columns J, K, and L. Once action is taken, recalculate RPN.

Prepared by:
Item Name: FMEA Team:
FMEA Date (Orig): Revision #:

Potential Effect on S O D R S O D
Future
Item Function Potential Failure Mode Customer Because of E Potential Causes C Current Process Controls E P Actions Recommended Resp.& Target Date Actions Taken E C E
RPN
Defect V C T N V C T
F
u

cause likely to Occur?

How Severe is effect

rank order concerns

Detection of cause?

Future Occurance
What are the Existing What are the actions for

Risk Priority # to
to the customer?

Future Detection
t

How probable is
How frequent is

In what ways can the
What is the component, Component, Subsystem or
function, or feature? System potentially fail to
meet the Design Intent ?
Future Severity
What were the actions
What is the impact on the Controls & Procedures (Fail- reducing the Occurrence of u
List every conceivable failure Who's Responsible for the implemented? Include
Key Output Variables Safe, Tests, the cause, or improving r
and/or failure mechanism recommended action? What completion month/year.
(customer requirements) or Mathemat.Calcs)that prevent Detection? Should have e
for each failure mode date? (Then recalculate resulting
internal requirements? either the cause or the actions on high RPN's or
RPN.) R
failure mode EASY FIXES
P
N

All Rights Reserved, Juran Institute, Inc. Process Design and Process FMEA
 Design and Process FMEA Rating Factors

RATING DEGREE OF SEVERITY PROBABILITY OF OCCURRENCE ABILITY TO DETECT

FREQUENCY Detection
Cpk
( 1 in … ) Certainty
Customer will not notice the adverse effect or it is Likelihood of occurrence is Sure that the potential failure will be found or prevented
1 1,000,000 > 1.67 100%
insignificant remote before reaching the next customer
Customer will probably experience slight annoyance Low failure rate with Almost certain that the potential failure will be found or
2 supporting documentation 20,000 1.33 prevented before reaching the next customer 99%

Customer will experience annoyance due to the slight Low failure rate without Low likelihood that the potential failure will reach the
3 5,000 approx. 1.0 95
degradation of performance supporting documentation next customer undetected
Customer dissatisfaction due to reduced performance Occasional failures Controls may detect or prevent the potential failure
4 2,000 < 1.0 90
from reaching the next customer
Customer is made uncomfortable or their productivity is Relatively moderate failure rate Moderate likelihood that the potential failure will reach
5 reduced by the continued degradation of the effect with supporting 500 the next customer 85
documentation
Warranty repair or significant manufacturing or Moderate failure rate without Controls are unlikely to detect or prevent the potential
6 assembly complaint supporting documentation 100 failure from reaching the next customer 80

High degree of customer dissatisfaction due to Relatively high failure rate with Poor likelihood that the potential failure will be detected
component failure without complete loss of function. supporting documentation or prevented before reaching the next customer
7 50 70
Productivity impacted by high scrap or rework levels.

Very high degree of dissatisfaction due to the loss of High failure rate without Very poor likelihood that the potential failure will be
8 function without a negative impact on safety or supporting documentation 20 detected or prevented before reaching the next 60
governmental regulations customer
Customer endangered due to the adverse effect on safe Failure is almost certain based Current controls probably will not even detect the
system performance with warning before failure or on warranty data or significant potential failure
9 10 50
violation of governmental regulations Design Verification* testing

Customer endangered due to the adverse effect on safe Assured of failure based on Absolute certainty that the current controls will not
10 system performance without warning before failure or warranty data or significant 2 detect the potential failure < 50
violation of governmental regulations Design Verification* testing

*Design Verification Testing (DVT): Test conducted when designing new products/services to verify that the optimal process design performs at the level specified by customer requirements (CTQs).
DVT is a methodical approach used to identify and resolve problems before finalizing the process for new products/services.

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