Design and Process Fmea Worksheet
Design and Process Fmea Worksheet
Prepared by:
Item Name: FMEA Team:
FMEA Date (Orig): Revision:
Potential Effect on S O D R S O D
Process Step or Current Process Future
Potential Failure Mode Customer Because of E Potential Causes C E P Actions Recommended Resp.& Target Date Actions Taken E C E
Variable or Key Input Controls RPN
Defect V C T N V C T
Detection of cause?
Risk Priority # to
Future Occurance
What are the actions for
Future Detection
How probable is
How frequent is
Future Severity
How Severe is
cause likely to
In what ways can the What is the impact on What are the existing reducing the Occurrence What were the actions
effect to the
rank order
customer?
What causes the Key
concerns
What is the process Process Step, Variable, the Key Output Variables controls that either of the cause, or Who's Responsible for implemented? Include
Occur?
Input to go wrong?
step? Or Variable ? or Key Input go wrong? (customer requirements) prevent the failure mode improving Detection? the recommended completion month/year.
(How could the failure
Or Input ? (chance of not meeting or internal from occurring or detect Should have actions action? What date? (Then recalculate
mode occur?)
requirements) requirements? it should it occur? on high RPN's or resulting RPN.)
Severity of 9 or 10.
Check of Application
Clerk Reviews
Checks Being Printed Checks Have To Be Re- Incorrect Information On Form for Correct
Customer Application 6 4 8 192 information with Clerk Manager Completed 8 2 4 64
Incorrectly Issued Application Form Information by Data Enty
customer
Operator
Information Entered in
Checks Being Printed Checks Have To Be Re-
Data Entry Wrong Field on
Incorrectly Issued
Application Form
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Process FMEA
Prepared by:
Item Name: FMEA Team:
FMEA Date (Orig): Revision #:
Potential Effect on S O D R S O D
Process Step or Variable 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
or Key Input RPN
Defect V C T N V C T
Future Occurance
Risk Priority # to
to the customer?
Future Detection
How probable is
How frequent is
What are the actions for
Future Severity
cause likely to
In what ways can the What are the existing What were the actions
What is the impact on the reducing the Occurrence of
Process Step, Variable, or What causes the Key Input controls that either prevent Who's Responsible for the implemented? Include
Occur?
Key Output Variables the cause, or improving
What is the process step? Key Input go wrong? to go wrong? (How could the failure mode from recommended action? What completion month/year.
(customer requirements) or Detection? Should
(chance of not meeting the failure mode occur?) occurring or detect it should date? (Then recalculate resulting
internal requirements? have actions on high RPN's
requirements) it occur? RPN.)
or Severity of 9 or 10.
8 2 4 64
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All Rights Reserved, Juran Institute, Inc. Process Design and Process FMEA
Design FMEA
Prepared by:
Item Name: FMEA Team:
FMEA Date (Orig): Revision:
S O D R S O D
Item Potential Effect on Customer Future
Potential Failure Mode E Potential Causes C Current Process Controls E P Actions Recommended Resp.& Target Date Actions Taken E C E
Function Because of Defect RPN
V C T N V C T
Future Occurance
Risk Priority # to
to the customer?
Future Detection
How probable is
How frequent is
Future Severity
cause likely to
What are the Existing Controls What are the actions for
In what ways can the What is the impact on the Key What were the actions
List every conceivable failure & Procedures (Fail-Safe, reducing the Occurrence of the Who's Responsible for the
Occur?
What is the component, Component, Subsystem or Output Variables (customer implemented? Include
and/or failure mechanism for Tests, Mathemat.Calcs)that cause, or improving Detection? recommended action? What
function, or feature? System potentially fail to meet requirements) or internal completion month/year. (Then
each failure mode prevent either the cause or the Should have actions on high date?
the Design Intent ? requirements? recalculate resulting RPN.)
failure mode RPN's or EASY FIXES
8 2 4 64
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All Rights Reserved, Juran Institute, Inc. Design Design and Process FMEA
Design and Process FMEA (Rating Factors)
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 insignificant remote
1,000,000 > 1.67 before reaching the next customer
100%
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 degradation of performance supporting documentation
5,000 approx. 1.0 next customer undetected
95
Customer dissatisfaction due to reduced performance Occasional failures Controls may detect or prevent the potential failure from
4 2,000 < 1.0 reaching the next customer
90
Customer is made uncomfortable or their productivity is Relatively moderate failure Moderate likelihood that the potential failure will reach
5 reduced by the continued degradation of the effect rate 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
7 component failure without complete loss of function. supporting documentation 50 or prevented before reaching the next customer 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 violation of governmental regulations Design Verification* testing 10 50
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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All Rights Reserved, Juran Institute, Inc. Rating Factors Design and Process FMEA