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Analyze Opportunity Part 1
Analyze Opportunity Part 1
Learning Objectives
Learning Objectives
Benefits
Benefits
Application Examples
Application Examples
What Is A Failure Mode
What Is A Failure Mode
FMEA
FMEA
FMEA
FMEA
When to Conduct an FMEA
When to Conduct an FMEA
History of FMEA
History of FMEA
The FMEA Form
The FMEA Form
Types of FMEAs
Types of FMEAs
FMEA: A Team Tool
FMEA: A Team Tool
FMEA Procedure
FMEA Procedure
FMEA Procedure (Cont
FMEA Procedure (Cont
FMEA Inputs and Outputs
FMEA Inputs and Outputs
Severity, Occurrence, and Detection
Severity, Occurrence, and Detection
Rating Scales
Rating Scales
Rating Scales
Rating Scales
Risk Priority Number (RPN)
Risk Priority Number (RPN)
Summary
Summary

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Analyze Opportunity Part 1

Analyze Opportunity Part 1.ppt
1 Analyze Opportunity Part 1

Analyze Opportunity Part 1

Failure Modes Effect Analysis (FMEA)

2 Learning Objectives

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

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3 Benefits

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

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4 Application Examples

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.

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5 What Is A Failure Mode

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

What Can Go Wrong?

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6 FMEA

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)

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7 FMEA

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)

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8 When to Conduct an FMEA

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

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9 History of FMEA

History of FMEA

First used in the 1960s in the Aerospace industry during the Apollo missions In 1974, the Navy developed MIL-STD-1629 regarding the use of FMEA In the late 1970s, 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

Examples

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10 The FMEA Form

The FMEA Form

A Closer Look

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11 Types of FMEAs

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

Specialized Uses

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12 FMEA: A Team Tool

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 members: Design Engineers Operators Process Engineers Reliability Materials Suppliers Suppliers Customers

Team Input Required

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13 FMEA Procedure

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

Process Steps

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14 FMEA Procedure (Cont

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

Process Steps

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15 FMEA Inputs and Outputs

FMEA Inputs and Outputs

Inputs

Outputs

C&E Matrix Process Map Process History Procedures Knowledge Experience

List of actions to prevent causes or detect failure modes History of actions taken

FMEA

Information Flow

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16 Severity, Occurrence, and Detection

Severity, Occurrence, and Detection

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).

Analyzing Failure & Effects

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17 Rating Scales

Rating Scales

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)

Assigning Rating Weights

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18 Rating Scales

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

Assigning Rating Weights

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19 Risk Priority Number (RPN)

Risk Priority Number (RPN)

RPN is the product of the severity, occurrence, and detection scores.

Severity

X

Occurrence

X

Detection

=

RPN

Calculating a Composite Score

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20 Summary

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.

Key Points

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Analyze Opportunity Part 1
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