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2014 06 23 FMEA Slides

The document discusses Failure Mode and Effects Analysis (FMEA) as a tool to evaluate risks in processes. It describes the key steps in conducting an FMEA, including identifying potential failure modes and their causes and effects, then prioritizing them by calculating a Risk Priority Number based on severity, occurrence, and detection ratings. The document provides an example of using an FMEA to analyze the process of making coffee, identifying some potential failure modes and starting to analyze their risks. It also briefly describes a simple risk assessment tool using a risk matrix to evaluate probability and impact of risks.

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Madhan Raj
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© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
114 views

2014 06 23 FMEA Slides

The document discusses Failure Mode and Effects Analysis (FMEA) as a tool to evaluate risks in processes. It describes the key steps in conducting an FMEA, including identifying potential failure modes and their causes and effects, then prioritizing them by calculating a Risk Priority Number based on severity, occurrence, and detection ratings. The document provides an example of using an FMEA to analyze the process of making coffee, identifying some potential failure modes and starting to analyze their risks. It also briefly describes a simple risk assessment tool using a risk matrix to evaluate probability and impact of risks.

Uploaded by

Madhan Raj
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 19

The FMEA Tool

Agenda
Abbreviations
FMEA

What is an FMEA and why to use it


Steps involved in an FMEA
How to use an FMEA

Simple Risk Assessment Tool


Steps for Simple Risk A
Risk Assessment Grid

FMEA Exercise
Discussion
2

Abbreviations

FMEA Failure mode and effects analysis


SEV Severity
OCC Occurrence
DET Detection
RPN Risk Priority Number (SEV*OCC*DET)

Purpose of an FMEA
To evaluate the risks associated with the steps in a process, any
process
An FMEA functions by using a structured methodology to;
Facilitate process improvement
Identify the ways in which a process can fail and rank the severity of
the failure
Estimating the risk associated with each step
To evaluate the effectiveness of current controls

Prioritize all of the above

Steps in the FMEA


1. For each Process Step, list ways that it can vary or go wrong (Failure Modes)
2. Identify Effects associated with each Failure Mode
3. List all Causes for each Failure Mode (These could be outputs from a previous
process step or additional inputs to this step).
4. List the Current Controls for each Cause
5. Create Severity, Occurrence, and Detection rating scales
6. Assign Severity, Occurrence and Detection ratings to each Cause
7. Calculate the risk priority number for each potential Failure mode scenario
8. Determine recommended actions, with responsible parties assigned and
estimated date of completion, to reduce High RPNs - Estimate effect of
Actions on RPN (SEV, OCC, DET).
9. Take appropriate actions and re-calculate all RPNs

FMEA Components

What is
the
process
step being
analyzed?

What is the impact on the


Key Output Variables
(Customer Requirements) or
internal requirements?

What is
the Effect
on the
Outputs?

In what way could


the process step
fail to meet
requirements?
6

S
E
V

O
C
C

Potential Causes

What are the causes of this


Failure Mode? Typical failure
cause result from process
inputs.

Current Controls

What are the existing controls


and procedures (inspection and
test) that prevent the cause or the
Failure Mode? Should include
an SOP number.

What can go
wrong with
the Input? /
Why does
this happen?

How
Bad?

How
Often?

D
E
T

R
P
N

How well can you


detect cause or FM?

In what way could the


process step/function
potentially fail to meet
process requirements or
intent?

Potential Failure Effects

How often does cause


or FM occur?

What is the
process step/
function under
investigation?

Potential Failure Mode

How Severe is the


effect to the
customer?

Process
Step/Function

How can
this be
found?

How well can


we detect?

Risk Priority Number (RPN)


The output of an FMEA is the Risk Priority Number
The RPN is a calculated number based on information you provide
regarding
the potential failure modes,
the effects, and
the current ability of the process to detect the failures before reaching the
customer

The severity of the effects * rating on how often it occurs * ability to


detect

RPN = Severity X Occurrence X Detection


Effects

Causes

Controls

The Risk Priority Numbers are then sorted and actions are recommended for the top issues
7

Example: Making Coffee: Inputs and


Outputs

Inputs

Filter
Measured coffee
Type of coffee
Quality of coffee
Quantity of water
Quality of water
Temperature
Time
Altitude

Making Coffee

Outputs
Hot
Fresh
Good Tasting
Right Price

Making Coffee Process Map


Cleaned
Equipment
Clean
Equipment
water
soap
scrub time
temp

Inserted
Filter

Coffee
Added

Insert
Filter

Add Coffee
to Filter

Position filter

quantity
grade
type
caffeine

Add
Water
quantity
purity
temperature

Perked
Coffee
Perk
Coffee
heat
time
altitude

Warm Coffee
Urn
heat
time
temp

Water
Added

Good Tasting
Hot Coffee

Coffee Starting the FMEA

Clean
equipment

In what way could the


process step/function
potentially fail to meet
process requirements or
intent?

Equipment not clean

Potential Failure Effects


What is the impact on the
Key Output Variables
(Customer Requirements) or
internal requirements?

Bad tasting coffee

S
E
V

Potential Causes
What are the causes of this
Failure Mode? Typical failure
cause result from process
inputs.

O
C
C
How often does cause or
FM occur?

What is the
process step/
function under
investigation?

Potential Failure Mode

How Severe is the effect


to the customer?

Process
Step/Function

Current Controls
What are the existing controls
and procedures (inspection and
test) that prevent the cause or the
Failure Mode? Should include
an SOP number.

Not enough water


Residual soap
Insufficient scrub time
Insufficient rinse

Insert filter

Filter not centered

Grounds in coffee

Filter not installed on


center
Filter slipped from center
Filter wrong size

Add grounds to
coffee

Too much grounds

Too strong coffee


Grounds in coffee

Add grounds to
coffee

10

Too little grounds

Too weak coffee

Not measured properly


poured in too much
Not measured properly
poured in too much
Not measured properly
poured in too little

Sort by RPN and recommend actions for top RPNs first

Mitigate the Risk


Determine recommended actions, with responsible parties assigned and
estimated date of completion, to reduce High RPNs - Estimate effect of
Actions on RPN (SEV, OCC, DET).
Take appropriate actions and re-calculate all RPNs

R
P
N

Actions
Recommended
What are the
actions for reducing
the occurrence of
the cause, or
improving
detection?

11

Resp.

Actions Ta ke n

Who is
Note the actions
Responsible for the
taken. Include
recommended
dates of completion.
action?

S
E
V

O
C
C

D
E
T

R
P
N

FMEA Summary
The FMEA is used to record information about failures
and their causes
Input to the FMEA can begin from information gained
from the Process Map or SOP
Take just do it actions as they are uncovered
Including factors which contribute to severe failures in
the Data Collection plan may provide information to be
used in Improvement and Control Phases.

12

Simple Risk Assessment Tool


Used to assess a project, event or
simple process

13

Steps

14

High

Yellow Light:
Proceed with
Caution

Red Light:
Red Light:
Address before
Do Not Proceed
Proceeding

Medium

Yellow Light:
Proceed with
Caution

Yellow Light:
Red Light:
Proceed with
Reassess Project
Caution

Low

Probability of Occurrence

Risk Grid Assessment

Green Light:
Proceed

Yellow Light:
Proceed with
Caution

Red Light:
Address before
Proceeding

Medium
Impact on Project

High

Low

15

Example

16

Risk
Description

Probability
of
Occurrence

Impact
on
Project

Category
Rating

Action

New Status

Resource for
New Process

High

Documentation
offiste

High

Billing done
offsite

High

Resource vs.
Payoff

Low

IT Constraints

High

CAP Contracts

Low

Red Light:
Finance to resolve resource
Plan for Staffing
High
Do Not
issue
Established
Proceed
Red Light:
Billing Manager needs to be
Adressed in Staffing
High
Do Not
involved. Need to involve
Plan
Proceed
new insurance manager
Red Light:
Billing Manager needs to be
New Insurance
High
Do Not
involved. Need to involve manager hired and in
Proceed
new insurance manager
loop
Yellow Light:
Medium Proceed with Build measure into process
Caution
Red Light:
Go to manual process
Involve programers. Use RFS
High
Do Not
if necessary - 2nd
process
Proceed
phase automated
Green Light: Need communication from
Low
Proceed
Managed Care

Exercise
Work in teams
Use the SIPOC provided for the process
Start to create a FMEA on making a Peanut
Butter and Jelly Sandwich

17

Process
Supplier

Input

Grocery

Process

Output

Customer

Plate

sandwich

Kid

Shelf

Peanut Butter

wrapper

Refridgerator

Jelly

dirty knife

Counter

Bread

Drawer

Baggie

PROCESS

Knife
Chef

PROCESS STEPS

Put Bread on
Plate

18

Add Peanut
Butter

Add Jelly

Cut Sandwich

Wrap Sandwich

Discussion

19

How did it go?


Where did you have trouble?
Can you think of other applications?
Questions?
ASQ Information - http://asq.org/learn-aboutquality/process-analysistools/overview/fmea.html

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