Fmea 23s4t
This document was ed by and they confirmed that they have the permission to share it. If you are author or own the copyright of this book, please report to us by using this report form. Report 3b7i
Overview 3e4r5l
& View Fmea as PDF for free.
More details w3441
- Words: 1,953
- Pages: 25
Analyze Opportunity Part 1 Failure Modes Effect Analysis
(FMEA)
Learning Objectives To understand the use of Failure Modes Effect Analysis
(FMEA) To learn the steps to developing FMEAs To summarize the different types of FMEAs To learn how to link the FMEA to other Process tools
2
Benefits Allows us to identify areas of our process that most impact
our customers Helps us identify how our process is most likely to fail Points to process failures that are most difficult to detect
3
Application Examples Manufacturing: A manager is responsible for moving a
manufacturing operation to a new facility. He/she wants to be sure the move goes as smoothly as possible and that there are no surprises. Design: A design engineer wants to think of all the possible ways a
product being designed could fail so that robustness can be built into the product. Software: A software engineer wants to think of possible problems
a software product could fail when scaled up to large databases. This is a core issue for the Internet.
4
What Can Go Wrong?
What Is A Failure Mode? A Failure Mode is: The way in which the component, subassembly, product, input,
or process could fail to perform its intended function Failure modes may be the result of upstream operations or may cause downstream operations to fail Things that could go wrong
5
FMEA Why Methodology that facilitates process improvement Identifies and eliminates concerns early in the development of a process or design Improve internal and external customer satisfaction Focuses on prevention FMEA may be a customer requirement (likely contractual) FMEA may be required by an applicable Quality Management System Standard (possibly ISO)
6
FMEA A structured approach to: Identifying the ways in which a product or process can fail Estimating risk associated with specific causes Prioritizing the actions that should be taken to reduce risk Evaluating design validation plan (design FMEA) or current
control plan (process FMEA)
7
When to Conduct an FMEA Early in the process improvement investigation When new systems, products, and processes are being
designed
When existing designs or processes are being changed When carry-over designs are used in new applications After system, product, or process functions are defined,
but before specific hardware is selected or released to manufacturing
8
Examples
History of FMEA First used in the 1960’s in the Aerospace industry during
the Apollo missions In 1974, the Navy developed MIL-STD-1629 regarding the use of FMEA In the late 1970’s, the automotive industry was driven by liability costs to use FMEA Later, the automotive industry saw the advantages of using this tool to reduce risks related to poor quality
9
A Closer Look
The FMEA Form
Identify failure modes and their effects
10
Identify causes of the failure modes and controls
Prioritize
Determine and assess actions
Specialized Uses
Types of FMEAs Design Analyzes product design before release to production,
with a focus on product function Analyzes systems and subsystems in early concept and design stages Process
Used to analyze manufacturing and assembly processes
after they are implemented
11
Team Input Required
FMEA: A Team Tool A team approach is necessary.
Team should be led by the Process Owner who is the
responsible manufacturing engineer or technical person, or other similar individual familiar with FMEA. The following should be considered for team : – Design Engineers – Process Engineers – Materials Suppliers – Customers
12
– Operators – Reliability – Suppliers
Process Steps
FMEA Procedure 1. For each process input (start with high value inputs), determine the ways in which the input can go wrong (failure mode) 2. For each failure mode, determine effects Select a severity level for each effect
3. Identify potential causes of each failure mode Select an occurrence level for each cause
4. List current controls for each cause Select a detection level for each cause
13
Process Steps
FMEA Procedure (Cont.) 5. Calculate the Risk Priority Number (RPN) 6. Develop recommended actions, assign responsible persons, and take actions Give priority to high RPNs MUST look at severities rated a 10
7. Assign the predicted severity, occurrence, and detection levels and compare RPNs
14
Information Flow
FMEA Inputs and Outputs
15
Inputs
Outputs
C&E Matrix Process Map Process History Procedures Knowledge Experience
List of actions to prevent causes or detect failure modes
FMEA
History of actions taken
Severity, Occurrence, and Detection
Analyzing Failure & Effects
Severity Importance of the effect on customer requirements Occurrence Frequency with which a given cause occurs and creates failure modes (obtain from past data if possible) Detection The ability of the current control scheme to detect (then prevent) a given cause (may be difficult to estimate early in process operations).
16
Rating Scales
Asg Rating Weights
There are a wide variety of scoring “anchors”, both
quantitative or qualitative Two types of scales are 1-5 or 1-10 The 1-5 scale makes it easier for the teams to decide on scores The 1-10 scale may allow for better precision in estimates and a wide variation in scores (most common)
17
Rating Scales Severity 1 = Not Severe, 10 = Very Severe
Occurrence 1 = Not Likely, 10 = Very Likely
Detection 1 = Easy to Detect, 10 = Not easy to Detect
18
Asg Rating Weights
Calculating a Composite Score
Risk Priority Number (RPN) RPN is the product of the severity, occurrence, and
detection scores.
Severity
19
X Occurrence X
Detection
=
RPN
Key Points
Summary An FMEA:
Identifies the ways in which a product or process can fail Estimates the risk associated with specific causes Prioritizes the actions that should be taken to reduce risk FMEA is a team tool There are two different types of FMEAs: Design Process
Inputs to the FMEA include several other Process tools such as
C&E Matrix and Process Map. 20
Description of FMEA Worksheet Protection:The spreadsheets are not protected or locked.
System Subsystem Component Design Lead Core Team
Potential
FMEA Number
Failure Mode and Effects Analysis
Prepared By
(Design FMEA)
FMEA Date Revision Date
Key Date
Page
of
8
Current Design Controls
8
1
R P N
Responsibilit Recommend y & Target ed Completion Action(s) Date
Actions Taken
64
Response Plans and Tracking
Write down each failure mode and potential consequence(s) of that Severity - On a scale of 110, rate the Severity of each failure (10= most severe). See Severity Likelihood - Write down the potential cause(s), and on a scale of 1-10, rate the Likelihood of each failure (10= most likely). See
21
D e t
Risk Priority Number - The combined weighting of Severity, Likelihood, and Detectability. RPN = Sev X Occ X Det
Detectability - Examine the current design, then, on a scale of 1-10, rate the Detectability of each failure (10 = least detectable). See Detectability sheet.
New RPN
P r o b
New Det
Potential Effect(s) of Failure
New Occ
Item / Function
Potential Failure Mode(s)
Potential S Cause(s)/ e Mechanism v (s) of Failure
New Sev
Action Results
Detection Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain
PROBABILITY of Failure Likelihood of DETECTION by Design Control Ranking 10 Very High: Failure is almost inevitable
Design control cannot detect potential cause/mechanism and subsequent failure mode Very remote chance the design control will detect potential cause/mechanism and subsequent failure mode Remote chance the design control will detect potential cause/mechanism and subsequent failure mode Very low chance the design control will detect potential cause/mechanism and subsequent failure mode Low chance the design control will detect potential cause/mechanism and subsequent failure mode Moderate chance the design control will detect potential cause/mechanism and subsequent failure mode Moderately High chance the design control will detect potential cause/mechanism and subsequent failure mode High chance the design control will detect potential cause/mechanism and subsequent failure mode Very high chance the design control will detect potential cause/mechanism and subsequent failure mode Design control will detect potential cause/mechanism and subsequent failure mode
Effect Hazardous without warning Hazardous with warning Very High
SEVERITY of Effect
9
1 in 3
9
1 in 8
8
1 in 20
7
1 in 80
6
5
1 in 400
5
4
1 in 2,000
4
1 in 15,000
3
1 in 150,000
2
<1 in 1,500,000
1
8
High: Repeated failures
7 6
3
Moderate: Occasional failures
Low: Relatively few failures
2 1
Ranking 10
High
Very high severity ranking when a potential failure mode affects safe system operation without warning Very high severity ranking when a potential failure mode affects safe system operation with warning System inoperable with destructive failure without compromising safety System inoperable with equipment damage
Moderate
System inoperable with minor damage
6
Low
System inoperable without damage
5
Very Low
System operable with significant degradation of performance
4
Minor
System operable with some degradation of performance
3
Very Minor
System operable with minimal interference
2
None
No effect
1
22
Failure Prob Ranking >1 in 2 10
9 8 7
Remote: Failure is unlikely
FAILURE MODE AND EFFECTS ANALYSIS Responsibility: Prepared by:
Item: Model: Core Team:
FMEA number: 123456 1 of 1 Page : FMEA Date (Orig):
Rev: 1 Action Results
Process Function
23
Potential Failure Mode
Potential S Potential Cause(s)/ Effect(s) of e Mechanism(s) of v Failure Failure
O c c u r
Current Process Controls
D e t e c
R P N
Recommended Action(s)
Responsibility and S O D Target Actions Taken e c e Completion Date v c t
R P N
Drilling - A drill bit enters the work piece axially and cuts a blind hole or a through hole with a diameter equal to that of the tool. A drill bit is a multi-point tool and typically has a pointed end. A twist drill is the most commonly used, but other types of drill bits, such as a center drill, spot drill, or tap drill can be used to start a hole that will be completed by another operation The operator drills a blind hole through the work piece. Chances that he might drill through the table are high (hole being too deep).
• Design a Failure Mode Effect and Analysis (FMEA) for this process. Process function (i.e. Blind hole) and Potential failure (i.e. 24 Hole too deep/Not deep enough)
FAILURE MODE AND EFFECTS ANALYSIS
√
Item: Model: Core Team:
√
Drill Hole Responsibility: Student Name Current Prepared by: Student Name J. Doe (Engineering), J. Smith (Production), Student Name (Quality)
√
Potential Failure Mode
Process Function
√
Drill Blind Hole
Hole too deep Hole not deep
√
Potential Effect(s) of Failure
Break through bottom of plate Incomplete thread
√
S Potential Cause(s)/ e Mechanism(s) of v Failure
7
Improper machine set up
3
Operator training and instructions
3
√
63
5
Improper machine set up
3
Operator training and instructions
3
45
5
None
9
225
√
√
√
Current Process Controls
√
√
123456 1 of 1 2017/01/01
Rev:
1
Action Results
O c c u r
5 Broken Drill
25
FMEA number: Page : FMEA Date (Orig):
D e t e c
R P N
Recommended Action(s)
Responsibility and Target Completion Date Actions Taken
S e v
O c c
D e t
R P N
0
√ √
Install Tool Detectors
J. Doe
√
√ 2008/03/01
√5
√ 5
√1
√0 25
(FMEA)
Learning Objectives To understand the use of Failure Modes Effect Analysis
(FMEA) To learn the steps to developing FMEAs To summarize the different types of FMEAs To learn how to link the FMEA to other Process tools
2
Benefits Allows us to identify areas of our process that most impact
our customers Helps us identify how our process is most likely to fail Points to process failures that are most difficult to detect
3
Application Examples Manufacturing: A manager is responsible for moving a
manufacturing operation to a new facility. He/she wants to be sure the move goes as smoothly as possible and that there are no surprises. Design: A design engineer wants to think of all the possible ways a
product being designed could fail so that robustness can be built into the product. Software: A software engineer wants to think of possible problems
a software product could fail when scaled up to large databases. This is a core issue for the Internet.
4
What Can Go Wrong?
What Is A Failure Mode? A Failure Mode is: The way in which the component, subassembly, product, input,
or process could fail to perform its intended function Failure modes may be the result of upstream operations or may cause downstream operations to fail Things that could go wrong
5
FMEA Why Methodology that facilitates process improvement Identifies and eliminates concerns early in the development of a process or design Improve internal and external customer satisfaction Focuses on prevention FMEA may be a customer requirement (likely contractual) FMEA may be required by an applicable Quality Management System Standard (possibly ISO)
6
FMEA A structured approach to: Identifying the ways in which a product or process can fail Estimating risk associated with specific causes Prioritizing the actions that should be taken to reduce risk Evaluating design validation plan (design FMEA) or current
control plan (process FMEA)
7
When to Conduct an FMEA Early in the process improvement investigation When new systems, products, and processes are being
designed
When existing designs or processes are being changed When carry-over designs are used in new applications After system, product, or process functions are defined,
but before specific hardware is selected or released to manufacturing
8
Examples
History of FMEA First used in the 1960’s in the Aerospace industry during
the Apollo missions In 1974, the Navy developed MIL-STD-1629 regarding the use of FMEA In the late 1970’s, the automotive industry was driven by liability costs to use FMEA Later, the automotive industry saw the advantages of using this tool to reduce risks related to poor quality
9
A Closer Look
The FMEA Form
Identify failure modes and their effects
10
Identify causes of the failure modes and controls
Prioritize
Determine and assess actions
Specialized Uses
Types of FMEAs Design Analyzes product design before release to production,
with a focus on product function Analyzes systems and subsystems in early concept and design stages Process
Used to analyze manufacturing and assembly processes
after they are implemented
11
Team Input Required
FMEA: A Team Tool A team approach is necessary.
Team should be led by the Process Owner who is the
responsible manufacturing engineer or technical person, or other similar individual familiar with FMEA. The following should be considered for team : – Design Engineers – Process Engineers – Materials Suppliers – Customers
12
– Operators – Reliability – Suppliers
Process Steps
FMEA Procedure 1. For each process input (start with high value inputs), determine the ways in which the input can go wrong (failure mode) 2. For each failure mode, determine effects Select a severity level for each effect
3. Identify potential causes of each failure mode Select an occurrence level for each cause
4. List current controls for each cause Select a detection level for each cause
13
Process Steps
FMEA Procedure (Cont.) 5. Calculate the Risk Priority Number (RPN) 6. Develop recommended actions, assign responsible persons, and take actions Give priority to high RPNs MUST look at severities rated a 10
7. Assign the predicted severity, occurrence, and detection levels and compare RPNs
14
Information Flow
FMEA Inputs and Outputs
15
Inputs
Outputs
C&E Matrix Process Map Process History Procedures Knowledge Experience
List of actions to prevent causes or detect failure modes
FMEA
History of actions taken
Severity, Occurrence, and Detection
Analyzing Failure & Effects
Severity Importance of the effect on customer requirements Occurrence Frequency with which a given cause occurs and creates failure modes (obtain from past data if possible) Detection The ability of the current control scheme to detect (then prevent) a given cause (may be difficult to estimate early in process operations).
16
Rating Scales
Asg Rating Weights
There are a wide variety of scoring “anchors”, both
quantitative or qualitative Two types of scales are 1-5 or 1-10 The 1-5 scale makes it easier for the teams to decide on scores The 1-10 scale may allow for better precision in estimates and a wide variation in scores (most common)
17
Rating Scales Severity 1 = Not Severe, 10 = Very Severe
Occurrence 1 = Not Likely, 10 = Very Likely
Detection 1 = Easy to Detect, 10 = Not easy to Detect
18
Asg Rating Weights
Calculating a Composite Score
Risk Priority Number (RPN) RPN is the product of the severity, occurrence, and
detection scores.
Severity
19
X Occurrence X
Detection
=
RPN
Key Points
Summary An FMEA:
Identifies the ways in which a product or process can fail Estimates the risk associated with specific causes Prioritizes the actions that should be taken to reduce risk FMEA is a team tool There are two different types of FMEAs: Design Process
Inputs to the FMEA include several other Process tools such as
C&E Matrix and Process Map. 20
Description of FMEA Worksheet Protection:The spreadsheets are not protected or locked.
System Subsystem Component Design Lead Core Team
Potential
FMEA Number
Failure Mode and Effects Analysis
Prepared By
(Design FMEA)
FMEA Date Revision Date
Key Date
Page
of
8
Current Design Controls
8
1
R P N
Responsibilit Recommend y & Target ed Completion Action(s) Date
Actions Taken
64
Response Plans and Tracking
Write down each failure mode and potential consequence(s) of that Severity - On a scale of 110, rate the Severity of each failure (10= most severe). See Severity Likelihood - Write down the potential cause(s), and on a scale of 1-10, rate the Likelihood of each failure (10= most likely). See
21
D e t
Risk Priority Number - The combined weighting of Severity, Likelihood, and Detectability. RPN = Sev X Occ X Det
Detectability - Examine the current design, then, on a scale of 1-10, rate the Detectability of each failure (10 = least detectable). See Detectability sheet.
New RPN
P r o b
New Det
Potential Effect(s) of Failure
New Occ
Item / Function
Potential Failure Mode(s)
Potential S Cause(s)/ e Mechanism v (s) of Failure
New Sev
Action Results
Detection Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain
PROBABILITY of Failure Likelihood of DETECTION by Design Control Ranking 10 Very High: Failure is almost inevitable
Design control cannot detect potential cause/mechanism and subsequent failure mode Very remote chance the design control will detect potential cause/mechanism and subsequent failure mode Remote chance the design control will detect potential cause/mechanism and subsequent failure mode Very low chance the design control will detect potential cause/mechanism and subsequent failure mode Low chance the design control will detect potential cause/mechanism and subsequent failure mode Moderate chance the design control will detect potential cause/mechanism and subsequent failure mode Moderately High chance the design control will detect potential cause/mechanism and subsequent failure mode High chance the design control will detect potential cause/mechanism and subsequent failure mode Very high chance the design control will detect potential cause/mechanism and subsequent failure mode Design control will detect potential cause/mechanism and subsequent failure mode
Effect Hazardous without warning Hazardous with warning Very High
SEVERITY of Effect
9
1 in 3
9
1 in 8
8
1 in 20
7
1 in 80
6
5
1 in 400
5
4
1 in 2,000
4
1 in 15,000
3
1 in 150,000
2
<1 in 1,500,000
1
8
High: Repeated failures
7 6
3
Moderate: Occasional failures
Low: Relatively few failures
2 1
Ranking 10
High
Very high severity ranking when a potential failure mode affects safe system operation without warning Very high severity ranking when a potential failure mode affects safe system operation with warning System inoperable with destructive failure without compromising safety System inoperable with equipment damage
Moderate
System inoperable with minor damage
6
Low
System inoperable without damage
5
Very Low
System operable with significant degradation of performance
4
Minor
System operable with some degradation of performance
3
Very Minor
System operable with minimal interference
2
None
No effect
1
22
Failure Prob Ranking >1 in 2 10
9 8 7
Remote: Failure is unlikely
FAILURE MODE AND EFFECTS ANALYSIS Responsibility: Prepared by:
Item: Model: Core Team:
FMEA number: 123456 1 of 1 Page : FMEA Date (Orig):
Rev: 1 Action Results
Process Function
23
Potential Failure Mode
Potential S Potential Cause(s)/ Effect(s) of e Mechanism(s) of v Failure Failure
O c c u r
Current Process Controls
D e t e c
R P N
Recommended Action(s)
Responsibility and S O D Target Actions Taken e c e Completion Date v c t
R P N
Drilling - A drill bit enters the work piece axially and cuts a blind hole or a through hole with a diameter equal to that of the tool. A drill bit is a multi-point tool and typically has a pointed end. A twist drill is the most commonly used, but other types of drill bits, such as a center drill, spot drill, or tap drill can be used to start a hole that will be completed by another operation The operator drills a blind hole through the work piece. Chances that he might drill through the table are high (hole being too deep).
• Design a Failure Mode Effect and Analysis (FMEA) for this process. Process function (i.e. Blind hole) and Potential failure (i.e. 24 Hole too deep/Not deep enough)
FAILURE MODE AND EFFECTS ANALYSIS
√
Item: Model: Core Team:
√
Drill Hole Responsibility: Student Name Current Prepared by: Student Name J. Doe (Engineering), J. Smith (Production), Student Name (Quality)
√
Potential Failure Mode
Process Function
√
Drill Blind Hole
Hole too deep Hole not deep
√
Potential Effect(s) of Failure
Break through bottom of plate Incomplete thread
√
S Potential Cause(s)/ e Mechanism(s) of v Failure
7
Improper machine set up
3
Operator training and instructions
3
√
63
5
Improper machine set up
3
Operator training and instructions
3
45
5
None
9
225
√
√
√
Current Process Controls
√
√
123456 1 of 1 2017/01/01
Rev:
1
Action Results
O c c u r
5 Broken Drill
25
FMEA number: Page : FMEA Date (Orig):
D e t e c
R P N
Recommended Action(s)
Responsibility and Target Completion Date Actions Taken
S e v
O c c
D e t
R P N
0
√ √
Install Tool Detectors
J. Doe
√
√ 2008/03/01
√5
√ 5
√1
√0 25
Related Documents 3m3m1z
Fmea 23s4t
June 2020 3
Fmea 23s4t
November 2022 0
Fmea 23s4t
May 2020 12
Fmea 23s4t
October 2020 0
Fmea 23s4t
July 2020 0
Fmea Loket 1f4719
September 2020 0More Documents from "mawande" xfd
D. Summers Chap 11 Quality Function Deployment Slides v2w6r
April 2022 0