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Sheet 1: Introduction

Introduction

The Failure Mode and Effects Analysis (FMEA) is a qualitative reliability and risk analysis method for preventive quality assurance. In a systematic team-based approach, the FMEA aims to identify all possible kind of failure modes, their causes and the effects that can occur. The following risk analysis leads to a comprehensive list of prioritized risks. Through the definition of corrective actions and the control of an effective implementation, FMEA increases functionality and reliability of products and processes.

In quality management various types are differentiated. The three main variants are the design FMEA, the process FMEA and the system FMEA. This guide aims to support the application of a design FMEA (DFMEA) in open source product development (OSPD). The design FMEA analyzes and assesses the functionality of a product, its modules and components. It can be applied on the item, subsystem or on component level. Communities that want to foster quality improvements in OSPD are invited to follow this guide.
The example shows the application of a design FMEA to a butane lighter. However, the five steps can be likewise used to assess (assembly) processes or complete systems.

The advantages of using FMEA in OSPD are manifold. The risk analysis is an important feature to build trust and confidence in open source hardware (OSH) across the community and with other stakeholders. Failure prevention decreases effort, saves time and after all costs. By pointing out risks and weak spots of the product, the FMEA identifies important areas of improvement and guides development activities. Transparency, a key value of open source product development, can be improved by giving a clear overview about the system's structure, its functionality and a clear documentation about identified risks. The maturity of products and its modules can be significantly enhanced. Overall, the FMEA improves quality and reliability and paves the way to an overall product success.

Sheet 2: Guide

Spalte1
Five step guide for a comprehensive analysis

Five steps procedure

Example

Step 1
1. Definition

Start with a clear definition of the product, module or component that is assessed. Define the system's objectives and its requirements. Identify all different working conditions that are supposed to be part of the analysis.
Fill out the header of FMEA template (see tab "FMEA Template" part 1).

The example shows the implementation of FMEA for a do it yourself butane lighter. The project was published by Jack Taylor (source: own representation). He built the lighter initially for himself but he decided to share his design and find some fellow contributors who would like to work with him on an improved version. CAD-files for the case and a part list are publicly available. However, the assembly instruction is rather shallow and difficult to understand. The butane lighter is designed to light up candles or cigarattes. The lighter is intended to work inside and outside, no matter if it is rainy, windy or cold (until -10 °C).

Step 2
2. System Analysis

The system analysis comprises three different steps. In the structure analysis the system elements and the system structure are defined. Breakdown the product into subsystems, modules and components, right to the level of characteristics of a single component to derive a structure tree. The number of levels can be arbitrary. In the functional analysis the functions and the required performance standards of each element in the structure tree are listed and described as detailed as possible. The failure analysis derives possible failures for all listed functions. Often failures are just the negation of a function. This is the most important and crucial step and needs careful consideration of all operating conditions. Finally, the connections between failure modes, their failure causes and related failure effects are derived from the structure tree (see figure 1). Fill out part 2 of the template.
Figure 1: System analysis

Figure 2 : Overview and structure analysis of butane lighter

Step 3
3. Risk Assessment

Through the risk assessment crucial risks are identified and prioritized. Therefore, the risk priority number (RPN) is calculated for each risk. Start with a description of preventive and control actions that are already estabilished (see part 3 in template). Use a rating scale of one to ten to score the severity (S) of the failure effect and the occurrence (O) and detection (D) probability of the failure cause. A rating of one means very low risk while a rating of ten implies a very negative assessment (hence, high severity, occurs all the time, no chance of detection). Note that preventive actions, which are already established, reduce the occurrence probability. Control actions lower the rating for the detection of a failure cause. After rating, the RPN is calculated by multiplying S, O and D.
Rating tables to assess S, O and D

Figure 3: System analysis of butane lighter with functions and failures

Step 4
4. Define Optimization Actions

In this step you define measures to reduce the identified risks. First, prioritze the risks by sorting the RPN scores in descending order. Corrective actions should be defined for failures that have a RPN of 125 or higher or if at least one of the scores of S, O or D is greater than 8. However, this is rather a rule of thumb and other risks can still be significant enough to define corrective actions. Preferrably, actions prevent the occurrence of a failure cause. Alternatively, the detection can be improved or the severity of a failure effect mitigated.

Step 5
5. Proof of Efficiency

Document the actions that were undertaken. Assess S, O and D again and calculate the improved RPN. Is the outcome sufficient? Or should further corrective actions be initiated?

Sheet 3: Example FMEA

FMEA Form Sheet

Project:
Design FMEA x
Process-FMEA

butane lighter "sunny light XL"
Name / Community:
Process/ Product Name:
Contributor:
Email Address:
Date modified:
Commit Message:

Jack Taylor
butane lighter "sunny light XL"
Jack Taylor
j.taylor@example.com
12/7/2018
Initial Commit

O*
S*
D*
RPN*

2.
flint assembly
flint does not create spark
no flame
bad quality of flint
flint seller is recommended
4
8
8
256
further documentation and specifications about required flint composition, reassess recommended flint seller
J. Doe
part list includes further specifications about flint material and link to recommended product and the supplier
2
8
8
128

1.
flint assembly
flint brakes
no spark
material is not hard enough
flint seller is recommended
4
8
8
256
further documentation and specifications about required flint composition, reassess recommended flint seller
J. Doe
part list includes further specifications about flint material and link to recommended product and the supplier
2
8
8
128

20
flint assembly
flint wheel stuck
assembly not functioning
material corroded

5
6
8
240
choose wheel with corrosion resistant coating
J. Doe
different suppliers have been tested and the best one is documented
3
6
8
144

5.
flint assembly
not enough friction
no spark
bad wheel material composition

3
8
9
216
further documentation and specifications about wheel composition, specific product is recommended
J. Fonda
further documentation and specifications about wheel composition, specific product is recommended, emphasizing importance of wheel quality to users
2
8
8
128

4.
flint assembly
flint wheel stuck
assembly not functioning
dirt between wheel and casing

7
6
5
210
Include cleaning of parts in assembly instruction
J. Fonda
assembly instruction includes cleaning step
4
6
5
120

13.
lighter
no spark
no flame
flint loose

5
8
5
200
construct case with tube to stabilize flint
J. Fonda
redesign of spring and flint assembly including tube for stabilization
2
8
5
80

16.
lighter
spark too small
no flame
relaxed setting

5
8
5
200
construct case with tube to stabilize flint, reassess spring force (change length and/ or constant)
J. Fonda
redesign of spring and flint assembly including tube for stabilization, specification about required spring
2
8
5
80

15.
lighter
no spark
no flame
flint stuck

5
8
5
200
analyze tolerances in flint assembly
J. Fonda
analysis and specifications of required spring force. Spring type chosen and considered in redesign of spring and flint assembly.
2
8
5
80

19.
flint assembly
flint stuck
no spark
wrong assembly

6
8
4
192
improve assembly instruction
J. Doe
assembly instruction revised, several user testings
4
7
4
112

8.
flint assembly
relaxed setting
no reliable spark
spring force too low

5
6
6
180
analyze required spring force (change length and constant), document specifications
J. Doe
analysis and specifications of required spring force. Spring type chosen and considered in redesign of spring and flint assembly.
2
6
6
72

9.
flint assembly
relaxed setting
no reliable spark
spring too short

5
6
5
150
analyze required spring force (change length and constant), document specifications
J. Doe
analysis and specifications of required spring force. Spring type chosen and considered in redesign of spring and flint assembly.
2
6
5
60

10.
flint assembly
flint stuck
difficult handling
spring force too high

5
5
6
150
analyze required spring force (change length and constant), document specifications
J. Doe
analysis and specifications of required spring force. Spring type chosen and considered in redesign of spring and flint assembly.
2
6
5
60

17.
lighter
no reliable spark
no reliable functioning of lighter
relaxed setting

5
6
5
150
construct case with tube to stabilize flint
F. Fonda
redesign of spring and flint assembly including tube for stabilization
2
6
5
60

18.
lighter
difficult handling of flint assembly
difficult usage of lighter
flint stuck

5
5
5
125

11.
flint assembly
flint stuck
difficult handling
spring too long

5
5
4
100

7.
flint assembly
loose case
lighter not usable
wrong screw thread
screw specifications documented
3
8
3
72

14.
lighter
no spark
no flame
flint broken

3
8
3
72

6.
flint assembly
loose spring
instable spark
wrong screw thread
screw specifications documented
3
6
3
54

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...Sheet introduction the failure mode and effects analysis fmea is a qualitative reliability risk method for preventive quality assurance in systematic teambased approach aims to identify all possible kind of modes their causes that can occur following leads comprehensive list prioritized risks through definition corrective actions control an effective implementation increases functionality products processes management various types are differentiated three main variants design process system this guide support application dfmea open source product development ospd analyzes assesses its modules components it be applied on item subsystem or component level communities want foster improvements invited follow guidethe example shows butane lighter however five steps likewise used assess assembly complete systems advantages using manifold important feature build trust confidence hardware osh across community with other stakeholders prevention decreases effort saves time after costs by pointi...

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Spalte1	Five step guide for a comprehensive analysis	Five steps procedure	Example
Step 1	1. Definition Start with a clear definition of the product, module or component that is assessed. Define the system's objectives and its requirements. Identify all different working conditions that are supposed to be part of the analysis. Fill out the header of FMEA template (see tab "FMEA Template" part 1).		The example shows the implementation of FMEA for a do it yourself butane lighter. The project was published by Jack Taylor (source: own representation). He built the lighter initially for himself but he decided to share his design and find some fellow contributors who would like to work with him on an improved version. CAD-files for the case and a part list are publicly available. However, the assembly instruction is rather shallow and difficult to understand. The butane lighter is designed to light up candles or cigarattes. The lighter is intended to work inside and outside, no matter if it is rainy, windy or cold (until -10 °C).
Step 2	2. System Analysis The system analysis comprises three different steps. In the structure analysis the system elements and the system structure are defined. Breakdown the product into subsystems, modules and components, right to the level of characteristics of a single component to derive a structure tree. The number of levels can be arbitrary. In the functional analysis the functions and the required performance standards of each element in the structure tree are listed and described as detailed as possible. The failure analysis derives possible failures for all listed functions. Often failures are just the negation of a function. This is the most important and crucial step and needs careful consideration of all operating conditions. Finally, the connections between failure modes, their failure causes and related failure effects are derived from the structure tree (see figure 1). Fill out part 2 of the template.	Figure 1: System analysis		Figure 2 : Overview and structure analysis of butane lighter
Step 3	3. Risk Assessment Through the risk assessment crucial risks are identified and prioritized. Therefore, the risk priority number (RPN) is calculated for each risk. Start with a description of preventive and control actions that are already estabilished (see part 3 in template). Use a rating scale of one to ten to score the severity (S) of the failure effect and the occurrence (O) and detection (D) probability of the failure cause. A rating of one means very low risk while a rating of ten implies a very negative assessment (hence, high severity, occurs all the time, no chance of detection). Note that preventive actions, which are already established, reduce the occurrence probability. Control actions lower the rating for the detection of a failure cause. After rating, the RPN is calculated by multiplying S, O and D.	Rating tables to assess S, O and D	Figure 3: System analysis of butane lighter with functions and failures
Step 4	4. Define Optimization Actions In this step you define measures to reduce the identified risks. First, prioritze the risks by sorting the RPN scores in descending order. Corrective actions should be defined for failures that have a RPN of 125 or higher or if at least one of the scores of S, O or D is greater than 8. However, this is rather a rule of thumb and other risks can still be significant enough to define corrective actions. Preferrably, actions prevent the occurrence of a failure cause. Alternatively, the detection can be improved or the severity of a failure effect mitigated.
Step 5	5. Proof of Efficiency Document the actions that were undertaken. Assess S, O and D again and calculate the improved RPN. Is the outcome sufficient? Or should further corrective actions be initiated?

FMEA Form Sheet

	Project:		Design FMEA x							Process-FMEA
	butane lighter "sunny light XL"		Name / Community:		Process/ Product Name:					Contributor:	Email Address:	Date modified:	Commit Message:
			Jack Taylor		butane lighter "sunny light XL"					Jack Taylor	j.taylor@example.com	12/7/2018	Initial Commit




																	O*	S*	D*	RPN*
2.	flint assembly	flint does not create spark	no flame	bad quality of flint	flint seller is recommended	4	8	8	256	further documentation and specifications about required flint composition, reassess recommended flint seller	J. Doe	part list includes further specifications about flint material and link to recommended product and the supplier	2	8	8	128
1.	flint assembly	flint brakes	no spark	material is not hard enough	flint seller is recommended	4	8	8	256	further documentation and specifications about required flint composition, reassess recommended flint seller	J. Doe	part list includes further specifications about flint material and link to recommended product and the supplier	2	8	8	128
20	flint assembly	flint wheel stuck	assembly not functioning	material corroded		5	6	8	240	choose wheel with corrosion resistant coating	J. Doe	different suppliers have been tested and the best one is documented	3	6	8	144
5.	flint assembly	not enough friction	no spark	bad wheel material composition		3	8	9	216	further documentation and specifications about wheel composition, specific product is recommended	J. Fonda	further documentation and specifications about wheel composition, specific product is recommended, emphasizing importance of wheel quality to users	2	8	8	128
4.	flint assembly	flint wheel stuck	assembly not functioning	dirt between wheel and casing		7	6	5	210	Include cleaning of parts in assembly instruction	J. Fonda	assembly instruction includes cleaning step	4	6	5	120
13.	lighter	no spark	no flame	flint loose		5	8	5	200	construct case with tube to stabilize flint	J. Fonda	redesign of spring and flint assembly including tube for stabilization	2	8	5	80
16.	lighter	spark too small	no flame	relaxed setting		5	8	5	200	construct case with tube to stabilize flint, reassess spring force (change length and/ or constant)	J. Fonda	redesign of spring and flint assembly including tube for stabilization, specification about required spring	2	8	5	80
15.	lighter	no spark	no flame	flint stuck		5	8	5	200	analyze tolerances in flint assembly	J. Fonda	analysis and specifications of required spring force. Spring type chosen and considered in redesign of spring and flint assembly.	2	8	5	80
19.	flint assembly	flint stuck	no spark	wrong assembly		6	8	4	192	improve assembly instruction	J. Doe	assembly instruction revised, several user testings	4	7	4	112
8.	flint assembly	relaxed setting	no reliable spark	spring force too low		5	6	6	180	analyze required spring force (change length and constant), document specifications	J. Doe	analysis and specifications of required spring force. Spring type chosen and considered in redesign of spring and flint assembly.	2	6	6	72
9.	flint assembly	relaxed setting	no reliable spark	spring too short		5	6	5	150	analyze required spring force (change length and constant), document specifications	J. Doe	analysis and specifications of required spring force. Spring type chosen and considered in redesign of spring and flint assembly.	2	6	5	60
10.	flint assembly	flint stuck	difficult handling	spring force too high		5	5	6	150	analyze required spring force (change length and constant), document specifications	J. Doe	analysis and specifications of required spring force. Spring type chosen and considered in redesign of spring and flint assembly.	2	6	5	60
17.	lighter	no reliable spark	no reliable functioning of lighter	relaxed setting		5	6	5	150	construct case with tube to stabilize flint	F. Fonda	redesign of spring and flint assembly including tube for stabilization	2	6	5	60
18.	lighter	difficult handling of flint assembly	difficult usage of lighter	flint stuck		5	5	5	125
11.	flint assembly	flint stuck	difficult handling	spring too long		5	5	4	100
7.	flint assembly	loose case	lighter not usable	wrong screw thread	screw specifications documented	3	8	3	72
14.	lighter	no spark	no flame	flint broken		3	8	3	72
6.	flint assembly	loose spring	instable spark	wrong screw thread	screw specifications documented	3	6	3	54

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