Design FMEA - Failure Mode and Effect Analysis

Scope of the analysis

Product Module Sub Module /A
Pen XX XX
Scope of FMEA FMEA Level FMEA Tea
✘Product Facilitator
Module
Sub module To see the rest of the team: Go to
Assemblies Coregroup
Sub-assemblies

Source documents and links FMEA Type

✘Requirements Concept FMEA
✘Design Specification System FMEA
✘Test /simulation reports ✘Design FMEA

Failure reports from the field

Previously made FMEAs
Higher / Lower level DFMEA
✘Calculations

Warranty cases
Other (specify)
ysis

Sub Module /Assembly

XX
FMEA Team
Facilitator

To see the rest of the team: Go to the "MoM-Team" sheet

Coregroup
 Parameter Diagram

A P-Diagram is a structured method to identify intended inputs and outputs (Functions) for the subject under investigation
The P-Diagram:
- Describes noise factors, control factors, ideal function and error states
- Assists in the identification of: potential Causes for Failure, Failure Modes, potential Effects of Failure and Current Controls
Noice factors
Hot/cold environment
Hard thrusts

Inputs Design

Force from user of XX Pen

Control factors

Test of actuation 10.000 times

New unknown material
tion

trols
Legend
Input
Inputs required for the component to deliver response / function

Design
Outputs The design/product in scope

Ability to provide ink to paper Output

Responses are ideal, intended functional output

Failure Modes
Breaks when it is dropped
Does not provide sufficient grip
Noice factors
Noise Factors are unintended interfaces/conditions and interactions
control that may lead to failure of the function.
Control factors
Control Factors (Prevention and Detection) are the means to make
the items function more robust (unlikely to break or fail)
Failure Modes
Failure mode is a deviation of intended Function (= Potential Failure M
d

er response / function

onditions and interactions outside

are the means to make

o break or fail)

nction (= Potential Failure Mode).

 Pictures of product in scope

No. 300
Tip
No. 200
Barrel
No. 100
Clip
 Boundary Diagram

A boundary diagram is a graphical illustration of the relationship between external sub-systems, assemblies, sub-assemblies and components beyond the
Boundary Diagram determines the external scope of the FMEA.

XXX XXX XXX

XXX Pen Grip for user

XXX XXX Actuation for use

blies and components beyond the object.

XXX

Grip for user

Actuation for user

 Design FMEA - Failure Mo
CHARACTERISTICS OF FAILURE

No ID Interface/ Component/ Function Requirements Potential Failure Mode

100.01 Clip

101.01 Clip/Barrel

101.02 Clip/Barrel
Provides grip for user for
product lifetime (10
200.01 Barrel years)

Must be able to
withstand temperature
range of -25 to +55
200.02 Barrel Degrees

Barrel provides sufficient

clearnce for tip to
201.01 Barrel/Tip actuate without binding

201.02 Barrel/Tip
Design FMEA - Failure Mode and Effect Analysis
CURRENT RATING

Potential effect(s) of failure S Potential cause Current Control Prevention O

T RATING ACTIONS

Current Controls Detection D RPN Recomended actions Agreed Actions Action Owner
ACTIONS PLANNED RATING INPUTS TO..

Action Due date Action Status Comments S O D RPN Risk Type

INPUTS TO..

Classification