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FMEA Number:
Process Name:
Process Responsibility:
Prepared By:
Affected Product(s):
Process or
Prepared by: Page ____ of ____
Product Name:
S O D R S O D R
Key Process Actions
Process Step Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls E P Resp. Actions Taken E C E P
Input Recommended
V C T N V C T N
cause or FM occur?
What are the existing controls and
cusotmer?
process step Process Input? Input go wrong? Output Variables (Customer go wrong? procedures (inspection and test) for reducing the Responsible actions taken with the
Requirements) or internal that prevent eith the cause or the occurrance of the for the recalculated RPN? Be
requirements? Failure Mode? Should include an Cause, or improving recommended sure to include
SOP number. detection? Should action? completion month/year
have actions only on
high RPN's or easy
fixes.
0 0
0 0
0 0
0 0
0 0
0 0
0 0
0 0
0 0
0 0
0 0
0 0
Page 2
FMEA – Scale for Severity
Opportunity for improvement.
1 Minor
Corrective action not required
2 Low <1.0%
3 Moderate <10%
4 Frequent >10%
5 High >15%
FMEA Scale for Detectability
1 Very High >99%
2 High 96% - 99%
3 Moderate 80% to 95%
4 Low 70% to 79%
5 Very Low Less than 70%
Risk Rating Scale 1-10
LIKELIHOOD OF
RATING DEGREE OF SEVERITY OCCURRENCE ABILITY TO DETECT
1 Customer will not notice the Likelihood of occurrence is Sure that the potential failure
adverse effect or it is remote will be found or prevented
insignificant before reaching the next
customer
2 Customer will probably Low failure rate with supporting Almost certain that the
experience slight annoyance documentation potential failure will be found or
prevented before reaching the
next customer
3 Customer will experience Low failure rate without Low likelihood that the
annoyance due to the slight supporting documentation potential failure will reach
degradation of performance the next customer
undetected
4 Customer dissatisfaction due to Occasional failures Controls may detect or prevent
reduced performance the potential failure from
reaching the next customer
5 Customer is made Relatively moderate failure rate Moderate likelihood that the
uncomfortable or their with supporting documentation potential failure will reach the
productivity is reduced by the next customer
continued degradation of the
effect
6 Warranty repair or significant Moderate failure rate without Controls are unlikely to detect
manufacturing or assembly supporting documentation or prevent the potential failure
complaint from reaching the next
customer
7 High degree of customer Relatively high failure rate with Poor likelihood that the
dissatisfaction due to supporting documentation potential failure will be detected
component failure without or prevented before reaching
complete loss of function. the next customer
Productivity impacted by high
scrap or rework levels.
8 Very high degree of High failure rate without Very poor likelihood that the
dissatisfaction due to the loss supporting documentation potential failure will be detected
of function without a negative or prevented before reaching
impact on safety or the next customer
governmental regulations
9 Customer endangered due to Failure is almost certain Current controls probably
the adverse effect on safe based on warranty data or will not even detect the
system performance with significant DV testing potential failure
warning before failure or
violation of governmental
regulations
10 Customer endangered due to Assured of failure based on Absolute certainty that the
the adverse effect on safe warranty data or significant DV current controls will not detect
system performance without testing the potential failure
warning before failure or
violation of governmental
regulations
Page 6
Control Plan
Project Description:
Date (Rev):
Reaction
Who Where When
Plan
Key Process Output Variable
Capability Status Sheet
Upper Lower
Customer Requirement Measurement %R&R or P/T
Spec Target Spec Cp
(Output Variable) Technique Ratio
Limit Limit
ble
Sample
Cpk Date Actions
Size