Failure Mode and Effect Analysis

Severity Rating
Severity: The effect of the Failure Mode on the Product

Rankin Effect Effect on the Product

g

10 Failure to Meet Safety Affects safe Product operation and/or involves noncompliance with government
and/or Regulatory regulation without warning.
Requirements

9 Affects safe Product operation and/or involves noncompliance with government

regulation with warning.

8 Loss or Degradation Loss of primary function

of Primary Function (Product inoperable, does not affect safe Product operation)

7 Degradation of primary function

(Product operable, but at a reduced level of performance)

6 Loss or Degradation Degradation of secondary function

of Secondary (Product operable, but comfort / convenience functions inoperable)
Function

5 Degradation of secondary function

(Product operable, but comfort / convenience functions at reduced level of
performance)

4 Annoyance Apperance or Audible Noice, Product operable item does not conform and noticed by
most customers (>75 %).

3 Apperance or Audible Noice, Product operable item does not conform and noticed by
many customers (>50 %).

2 Apperance or Audible Noice, Product operable item does not conform and noticed by
discriminating customers (<25 %).

1 No effect No visible effect

 Failure Mode and Effect Analysis
Occurrence Ranking
Occurence: the likelihood that a cause will occur potentially resulting in the Failure Mode
within the predicted lifetime of the Product

Rankin Likelihood of Failure Help guide, when No data available! If data available then
g Occurence of cause (Number of failures pr.
(is proportionel with the level of Item/Product)
experience/knowledge of design)

10 Very High New technology/new design with no history ≥ 100 per Thousand
≥ 1 in 10

9 High Failure is inevitable with new design, new application, 50 per Thousand
or change in duty cycle/operating conditions and/or no 1 in 20
prior experience

8 Failure is likely with new design, new application, or 20 per Thousand

change in duty cycle/operating conditions and/or very 1 in 50
limited experience

7 Failure is uncertain with new design, new application, 10 per Thousand

or change in duty cycle/operating conditions and/or 1 in 100
limited experience

6 Moderate Frequent failures associated with similar designs 2 per Thousand

or in design simulations or testing (CAE, CAD, FEA 1 in 500
etc.)
and/or some experience can be utilized

5 Occasional failures associated with similar designs or 0,5 per Thousand

in design simulations and testing (CAE, CAD, FEA 1 in 2000
etc.) and/or some experience can be utilized

4 Isolated failures associated with similar designs or in 0,1 per Thousand

design simulations and testing (CAE, CAD, FEA etc.) 1 in 10.000
and/or technology/material guidelines/calculations
exists

3 Low Only isolated failures associated with almost identical 0,01 per Thousand
design or in design simulation and testing. Experience
level is very high (e.g. proven design standards, best 1 in 100.000
practice or common materials, ect.)

2 No observed failures associated with almost identical ≤0,001 per Thousand

design or in design simulation and testing. Experience 1 in 1.000.000
level is very high (e.g. proven design standards, best
practice or common materials, ect.)

1 Very Low Failure is eliminated through prevention control. No expected failures

 Failure Mode and Effect Analysis
Detectablility
Detectability: the ability of the Design Control to detect potential cause and/or
sub-sequent failure mode in the Development Phase

Rankin Certainty of detection Likelihood of detection by Design Control before engineering release
g

10 No Detection No current design control; cannot detect or is not analyzed

Opportunity

9 Not Likely to Detect at Design analysis/detection controls have a weak detection capability; virtual analysis
any Stage (e.g. CAE, FEA) is not correlated to expected actual operating conditions.

8 Post design Freeze Product validation after design freeze and prior to launch with pass/fail testing,
and Prior to Launch Output: A pass/fail statement - Acceptance criteria must be pre-defined
(Gate 4)

7 Product validation after design freeze and prior to launch with test to failure testing,
Output: How did the tested system/component fail and when

6 Product validation after design freeze and prior to launch with degradation testing,
Output: How did the tested system/component fail and when. A degradation curve is
avalible

5 Prior to Design Freeze Product validation prior to design freeze using pass/fail testing,
(Gate 3) Output: A pass/fail statement - Acceptance criteria must be pre-defined

4 Product validation prior to design freeze using test to failure testing,

Output: How did the tested system/component fail and when

3 Product validation prior to design freeze using degradation testing,

Output: How did the tested system/component fail and when. A degradation curve is
avalible

2 Virtual Analysis - Design analysis/detection controls have strong detection capability. Virtual analysis
Correlated (e.g. CAE, FEA, ect.) is highly correlated with actual and/or expected operating
conditions prior to design freeze.

1 Detection Not Failure cause or failure mode cannot occur because it is fully prevented through
Applicable; Failure design solutions
Prevention
 Help guide
No ID Write in the no. From the interface matrix. When there are several requirements / failures please give unique no. ID. As shown
below.
E.g.
101.01
101.02
101.03
Interface/ Component/ Interface:
Function Write in the interface/component from the interface matrix

Example for a Ball Pen:

Barrel/Tip
Requirements Requirements:
• What are the requirements to the intented function or item?
• What requirements do we get from the source documents?

Examples for Ball Pen:

Barrel provides sufficient clearnce for tip to actuate without binding
Potential Failure Mode Potential Failure Mode:
The failure mode is the lack of requirement fulfillment.
The manner in which a system, subsystem, component fails to meet its intended purpose or function. Look at the requirement,
should be concise.

Example for ball pen:

The tip is unable to actuate
Potential effect(s) of failure Potential Effect(s) of Failure:
The effects of the Failure Mode on the function.
• Consider what the severity is, for the product?
A failure mode can have multiple effects

Make a description that is consice so it is easier to refer to later.

Example of effect for Ball pen:

The user is unable to use pen
Severity (S) Severity (S):
• The Severity is scored according to the impact that the failure mode has on the product.
• The Severity is the rank associated with the most serious effect, which is scored according to the evaluation criteria’s.
• You find the Severity rating scale in the sheet "Severity".
Potential cause Potential causes:
Potential cause of design-error.
Identify causes of each Failure Mode by asking
• What could cause the item to fail in this manner, or under which circumstances?
• How could the item fail to meet its engineering specifications or intended function?
• What information in the P-diagram might have been overlooked?
• What can experience provide for potential causes?
Take the cause back to the design.

Consider:
Wrong material choice
Faulty specification of dimensions/tolerances
Wrong surface system
Calculation error
Too close or too far to adjacent part

Finding the right cause is important; do not use the DFMEA session as a root cause analysis session. If the cause is not known
now then take the time it in a smaller forum later to investigate. Methods such as 5 Why´s can be used.
Assumption: The product will be delivered according to specification. However, the design may cause manufacturing deficiencies
or misbuilds: where the misbuilds are a result of variation due to the design specification. In case of manufacturing deficiencies
or misbuilds caused by design: it must be handled in the DFMEA.

Example for Ball pen:

Barrel designed too small/tip designed too large
Current Control Prevention Current Controls Prevention:
Activities that are currently implemented to prevent the Cause of Failure or Failure Mode from happening.

Redundancy systems
Design guidelines
Design manuals
Best practice in industry
Independent double calculations
Field experience and Lessons Learned
Simulation tools (CAD, FEA.....)

(Example of Prevention activities: calculations, Industry standards used)

 Note: Calculations can be used both as prevention and a detection method.
Prevention: as an analysis of concept to establish design.
Detection: as a validation of your design.

Example for Ball pen:

Tolerance stack up calculation, 3D review of solution
Occurrence (O) Occurrence (O):
Indication of how sure we are that the design will fulfill the design intend.
We need to justify The Occurrence ranking from what we have put into Current control Prevention.
• What calculations have we made and how certain are we on the calculations
• How much experience do we have with similar requirements/materials/design/standards etc.
• Rate the likelihood that the component will fail according to the lifetime of the Product.
• You find the Occurrence rating scale in the sheet "Occurrence"
Current Controls Detection Current Controls Detection:
Activities that are currently implemented to detect the cause of failure before design release.

• Put in all Control actions that has been conducted.

E.g:
Accerated lifetime test (ALT)
Functional tests
Test to failure
Degradation tests
Material tests
Validation of simulations/calculations
Reviews

If you have not planned an activity, then it needs to be stated in the reccomended action, as the activity might require change in:
time, budget or ressouces.

Note: Calculations can be used both as prevention and a detection method.

Prevention: as an analysis of concept to establish design.
Detection: as a validation of your design.
Detection (D) Detection (D):
The ability of the design control to detect potential cause / failure mechanism in the development phase.
We need to justify The Detection ranking from what we have put into Current Control Detection.
• You find the Detection rating scale in the sheet "Detection"
RPN RPN:
The Risk Priority Number (RPN) is the product of Severity (S), Occurrence (O) and Detection (D) ranking.
RPN = (S) x (O) x (D)
An estimate of the current project risk, related to the characteristics of failure

If the RPN is 210 or more, mitigation actions must be taken.

Risks with a RPN value higher than 125 needs to be considered.