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Cip-Fkcci 2

Root cause analysis is a process used to identify the underlying cause of problems. It is important to determine the root cause rather than just the surface cause, as this prevents recurrence. There are different types and levels of root cause analysis depending on whether the focus is on safety, production processes, or organizational systems. The goal is to identify causal factors beyond the initial reaction, and determine if deficiencies in planning, processes, or management systems contributed to the problem. Finding the true root cause allows organizations to implement lasting solutions.
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0% found this document useful (0 votes)
176 views148 pages

Cip-Fkcci 2

Root cause analysis is a process used to identify the underlying cause of problems. It is important to determine the root cause rather than just the surface cause, as this prevents recurrence. There are different types and levels of root cause analysis depending on whether the focus is on safety, production processes, or organizational systems. The goal is to identify causal factors beyond the initial reaction, and determine if deficiencies in planning, processes, or management systems contributed to the problem. Finding the true root cause allows organizations to implement lasting solutions.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Learning to See MUDA

Calibrating the Eyes

Learning to See MUDA


Calibrating the Eyes

Learning to See MUDA


Calibrating the Eyes

WORLD CLASS
Organization

Building World Class Organizations in 9 Simple Steps..


Total Human Management (THM)

ADD VALUE
at each step
Using
LEAN TOOLS

9
p
e
St

One piece / Small Batch Flow, JIT, Pull Manufacturing

ep
t
S

Kanban,

Process Standardization

ep
t
S

Muda Of
Unused
Human Talent
Muda of Over Production

8
Muda of Inventory

7
Muda of Over Processing

6
p
e
St

TPM, TQM, Lean Office

Muda of Defects / Rework

TFM,TPM,TQM, Lean Office

5S + Muda, Mura, Muri Elimination

ep
St

5
Muda of Waiting

p4
e
t
S

Muda of Motion

3
p
e
St

TFM
Hands-on
Training

Step 1

p
Ste

Muda of Transportation

2
Lack of awareness of Lean Management tools

Identify
Reduce
Eliminate
MUDAs

Wastes or MUDA

Lean Production

The latest incarnation of JIT


Based on Toyota Production System.
Waste elimination
Widely used in automotive manufacturing &
other repetitive mfg.

Its the elimination of waste


Everywhere while adding customer
value

Its a mindset & commitment to


achieve a totally waste-free
operation thats focused on
your customers success
achieved by simplifying and
continuously improving all
processes

Definition
Lean Manufacturing A way to eliminate waste and
improve efficiency in a manufacturing environment
Lean focuses on flow, the value stream and eliminating
muda, the Japanese word for waste
Lean manufacturing is the production of goods using
less of everything compared to traditional mass
production: less waste, human effort, manufacturing
space, investment in tools, inventory, and
engineering time to develop a new product

From the operations perspective

Lean production cuts costs &


inventories rapidly to free cash, which
is critical
It also supports growth by improving
productivity & quality, reducing lead times,
and freeing huge amounts of resources.

From the operations perspective


For example, lean production frees office
and plant space and increases capacity
so companies can
1. Add product lines
2. In-source component production
3. Increase output of existing products without
acquiring new facilities.

Lean Video

Continual Improvement Flow Diagram

Develop
Develop
Measurements
Measurements
forSuccess
Success
for

Define
Define
Problem
Problem
MeasureCurrent
Current
Measure
Performance
Performance

Develop60
60Day
Day
Develop
ActionPlan
Plan
Action
Standardize
Standardize
Operating
Operating
Procedures
Procedures

IdentifyWaste
Wastein
in
Identify
CurrentProcess
Process
Current
ConductGap
Gap&&
Conduct
RootCause
Cause
Root
Analysis
Analysis

Define Should-Be
Should-Be
Define
Process
Process

ImproveCurrent
Current
Improve
Process
Process

Problem Categories
and Problem Solving Approaches

Types of Problems
Simple, cause known; Just do it
issues
Complex, cause unknown; need to dig
deeper issues
Sometimes the financial impact of a
problem dictates how it will be classified

Just Do It Issues
Typically isolated, sporadic
incidents
Are easily fixed; apparent cause
tends to be known
Often recognized during process
planning and reflected in PFMEA

Just Do It Issues

Addressed through troubleshooting,


(diagnosis and remedy) and
reaction plans on control plans,
(control of nonconformity)
Can be fixed by process owner;
addressed at process level
Occurrence should be monitored
ongoing for cost and impact

Dig Deeper Issues


-Sometimes referred to as Chronic
-Long-term and/or complex issues
-Cause is not readily apparent,
unknown
-Require in-depth investigation to
identify root cause
-Addressed through root cause
analysis, disciplined problem
solving and improvement
process

Dig Deeper Issues


-Source of problem typically unknown
-Cross-functional participation needed to solve
-Effective resolution requires both process and
system solution consideration
-Require management intervention via
resource commitment
-When available data re: problem is limited,
may be handled as Just do it based on
impact and/or risk

Steps in Disciplined
Problem Solving
1. Establish Team
2. Operational Problem Definition
3. Containment & Interim Actions, (if
needed)
4. Root Cause Analysis, (process &
system)
5. Plan & Implement Solutions
6. Results of Solutions
7. Verification, (including independent)
8. Closure & Congratulate the Team

Problem Type Considerations


Just Do It
Reflects product or process
controls established when
planning the process
Management decision to
live with such conditions
based on acceptable level of
risk
Should be routinely
evaluated for cost and
impact
Can only be eliminated by
applying disciplined problem
solving to understand true
root cause in order to
improve process

Dig Deeper
Unanticipated conditions
which occur
May also be anticipated
issues for which actual
level of risk is now
determined to be
unacceptable
Require concentrated
investigation to
understand source of
problem and process
factors leading to problem
condition to allow
appropriate solutions

A Note about Fire-fighting!

Fire-fighting is
essentially unprescribed actions taken
on a process without
understanding the
relation of causal factors
and process output
Fire-fighting is
dangerous as these
actions tend not to be
specifically focused to a
particular cause

A Note about Fire-fighting!

The resulting impact


of fire-fighting is
typically not known
ahead of time
Therefore, chaos is
introduced into the
process
A very high-risk
approach to problem
solving!

Problem Type Considerations


Problem
Type

Process of
Origin

Method

Considerations

Just do it

Known

Troubleshooting;
rework

Seen before; can


live with impact
when problem
recurs

Dig Deeper

Unknown

Root cause
analysis

Data-driven
investigation to
determine actual
factors causing
problem condition

Unknown

Fire-fighting

Taking action
possibly on wrong
process; not using
data to confirm
root cause

Prioritize Problems
Most organizations
should only be actively
working on 3-5
disciplined problem
solving efforts, (Dig
Deeper issues), at a
time to balance the use
of resources and get the
most effective solutions;
(no one person should
be working on more
than 2 Dig Deeper
teams at any given time)

Determining the
Root Cause of a
Problem

When should root cause analysis


be performed?
When PROBLEMS occur !!

How does it differ from what we


do now?
USUAL APPROACH
Problem
Identified

Problem
reoccurs
elsewhere!

Firefighting!
Immediate Containment
Action Implemented
Find
someone to
blame!

PREFERRED APPROACH
Problem
Identified

Immediate
Containment
Action
Implemented

Defined
Root Cause
Analysis
Process

Solutions
validated
with data

Solutions are
applied across
company and
never return!

Why Determine Root Cause?


Prevent problems from recurring
Reduce possible injury to personnel
Reduce rework and scrap
Increase competitiveness
Promote happy customers and stockholders
Ultimately, reduce cost and save money

Look Beyond the Obvious

Invariably, the root cause of a


problem is not the initial reaction
or response.
It is not just restating the Finding

Often the Stated Root Cause


is the Quick, but Incorrect Answer
For example, a normal response is:
Equipment Failure
Human Error
Initial response is usually the symptom, not
the root cause of the problem. This is why
Root Cause Analysis is a very useful and
productive tool.

Most Times Root Cause Turns Out


to be Much More
Such as:
Process or program failure
System or organization failure
Poorly written work instructions
Lack of training

Definitions
Cause (causal factor): a condition or event that results
in an effect
Direct Cause: cause that directly resulted in the
occurrence
Contributing Cause: a cause that contributed to the
occurrence, but by itself would not have caused the
occurrence
Root Cause: cause that, if corrected, would prevent
recurrence of this and similar occurrences

Why do we need it
Benefits of RCA
- Real cause of the problem can be found
- Problem recurrence will be minimized

What is Root Cause Analysis?

Root Cause Analysis is an in-depth


process or technique for identifying the
most basic factor(s) underlying a
variation in performance (problem).
Focus is on systems and processes
Focus is not on individuals

Types of RCA

Safety-based RCA
- Investigating Accident and occupational safety and health.
- Root causes:- unidentified risks, or inadequate safety engineering,
missing safety barriers.
Production-based RCA
- Quality control for industrial manufacturing.
- Root causes:- non-conformance like, malfunctioning steps in
production line.

Types of RCA
Process-based RCA
- Extension of Production-based RCA.
- Includes business processes also.
- Root causes:- Individual process failures
System-based RCA
- Hybrid of the previous types
- New concepts includes:- change management, systems
thinking, and risk management.
- Root causes:- organizational culture and strategic management

4 Levels of Root Cause


Defect/Detection Cause = Product level

Direct Process Cause = at Process of Origin


Actual Root Cause = previous process factors
contributing to Process Root Cause, (planning)
System Root Cause = management system
policy/practice contributing to Actual Root Cause

Root Cause Analysis Levels


Level

Root Cause

Consideration

Tools

Other
(Wide)

Product

Defect/Detection
cause

Condition of
controls to
detect problem

Control
Barrier
Analysis

What other
products have
similar
controls?

Process

Direct process
cause, (trigger at
process of origin

Factors at
process of
origin triggering
problem, (5Ms)

Fishbone,
(cause &
effect)

What
processes
have similar
trigger cause?

Plan

Actual root cause,


(led to trigger
cause)

Linkage to
planning
processes that
trigger cause

5 Why with
Hypothesis
testing

What other
processes
affected?

System

weakness in
mgt. policies or
practices

Linkage of mgt.
system to
actual cause

System
Cause
Analysis

(Deep)

Other affected
mgt. policies

When Should Root Cause Analysis be Performed?


Significant or consequential events
Repetitive human errors are occurring during a specific
process
Repetitive equipment failures associated with a specific
process
Performance is generally below desired standard

How to Determine the Real Root


Cause?
Assign the task to a person (team if necessary)
knowledgeable of the systems and processes involved
Define the problem
Collect and analyze facts and data
Develop theories and possible causes - there may be
multiple causes that are interrelated
Systematically reduce the possible theories and possible
causes using the facts

How to Determine the Real Root


Cause? (continued)
Develop possible solutions
Define and implement an action plan (e.g., improve
communication, revise processes or procedures or work
instructions, perform additional training, etc.)
Monitor and assess results of the action plan for
appropriateness and effectiveness
Repeat analysis if problem persists- if it persists, did we get
to the root cause?

Useful Tools For Determining


Root Cause are:

The 5 Whys
Pareto Analysis (Vital Few,
Trivial Many)
Brainstorming
Flow Charts / Process Mapping
Cause and Effect Diagram

Common Errors of Root Cause


Looking for a single cause- often 2 or 3 which contribute
and may be interacting
Ending analysis at a symptomatic cause
Assigning as the cause of the problem the why event that
preceded the real cause

Successful application of the


analysis and determination of the
Root Cause should result in
elimination of the problem

Five Whys Preparation


Five whys is a Root Cause Analysis Tool. Not a problem solving technique. The outcome
of a 5 Whys analysis is one or several root causes that ultimately identify the reason
why a problem was originated. There are other similar tools as the ones mentioned
below that can be used simultaneously with the 5 Whys to enhance the thought process
and analysis.
Problem

Root Cause

Root Cause analysis Tools:


Ishikawa Charts (Fish Bone)
Design of Experiments
5 Whys
Cause & Effect Diagram.
Statistical Data Analysis (Cpk,
Paretto Charts, Anova,etc)

Corrective
Actions

Example #1

Identify Problem
Part polarity reversed on circuit
board

Immediate Action

Additional inspection added after


this assembly process step to
check for reversed part defects
Last 10 lots of printed circuit boards
were re-inspected to check for
similar errors

Root Cause
Part reversed

Why?

Root Cause
Part reversed

Worker not sure of correct part orientation

Why?

Root Cause
Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Why?

Root Cause
Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Engineering ordered it that way from vendor

Why?

Root Cause
Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Engineering ordered it that way from vendor

Process didnt account for possible


manufacturing issues

Corrective Action

Permanent Changed part to one that can


only be placed in correct direction (Mistake
proofed). Found other products with similar
problem and made same changes.
Preventive - Required that any new parts
selected must have orientation marks on
them.

Root Cause Analysis


Example #2

Example #2
Identify Problem
A manager walks past the assembly line and
notices a puddle of water on the floor.
Knowing that the water is a safety hazard,
she asks the supervisor to have someone
get a mop and clean up the puddle. The
manager is proud of herself for fixing a
potential safety problem.

Example #2

But What is the Root Cause?


The supervisor looks for a root cause by asking 'why?

Immediate Action

Knowing that the water is a safety


hazard, the manager asks the
supervisor to have someone get a
mop and clean up the puddle.

Root Cause
Puddle of water on the floor

Why?

Root Cause
Puddle of water on the floor

Leak in overhead pipe

Why?

Root Cause
Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Why?

Root Cause
Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Water pressure valve is faulty

Why?

Root Cause
Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Water pressure valve is faulty

Valve not in preventative maintenance program

Corrective Action
Permanent Water pressure valves placed
in preventative maintenance program.
Preventive - Developed checklist form to
ensure new equipment is reviewed for
possible inclusion in preventative
maintenance program.

Example #3

Root Cause Analysis


Example #3

Example #3

Identify Problem
Customers are unhappy because they are being shipped
products that don't meet their specifications.

66

Immediate Action

Inspect all finished and inprocess product to ensure it


meets customer
specifications.

67

Root Cause
Product doesnt meet specifications

Why?

Root Cause
Product doesnt meet specifications

Manufacturing specification is different from


what customer and sales person agreed to

Why?

Root Cause
Product doesnt meet specifications

Manufacturing specification is different from


what customer and sales person agreed to
Sales person tries to expedite work by calling
head of manufacturing directly

Why?

Root Cause
Product doesnt meet specifications

Manufacturing specification is different from


what customer and sales person agreed to
Sales person tries to expedite work by calling
head of manufacturing directly
Manufacturing schedule is not available for
sales person to provide realistic delivery date

Why?

Root Cause
Product doesnt meet specifications

Manufacturing specification is different from


what customer and sales person agreed to
Sales person tries to expedite work by calling
head of manufacturing directly
Manufacturing schedule is not available for
sales person to provide realistic delivery date
Confidence in manufacturing schedule is not
high enough to release/link with order system

Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Why?

Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system
Parts sometimes not available thereby
creating schedule changes

Why?

Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system
Parts sometimes not available thereby
creating schedule changes
Expediting and priority changes consume
parts not planned for

Why?

Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system
Parts sometimes not available thereby
creating schedule changes
Expediting and priority changes consume
parts not planned for
Manufacturing schedule does not reflect
realistic assembly and test time

Why?

Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system
Parts sometimes not available thereby
creating schedule changes
Expediting and priority changes consume
parts not planned for
Manufacturing schedule does not reflect
realistic assembly and test time

No ongoing review of manufacturing standards

Corrective Action
Permanent Manufacturing standards reviewed and
updated.
Preventive - Regular ongoing review of actuals vs
standards is implemented.

Root Cause Analysis


Example #4

Example #4

Identify Problem
Department didnt complete their project on time

Immediate Action
Additional resources applied to help get the project team
back on schedule
No new projects started until Root Cause Analysis
completed

Root Cause
Didnt complete project on time

Why?

Cause and Effect


Procedures

Personnel
Lack of worker
knowledge

Poor project plan

Poor project
mgmt skills

Lack of resources

Didnt complete
project on time

Inadequate
computer
programs

Materials

Poor
documentation

Inadequate
computer system

Equipment

Cause and Effect


Procedures

Personnel
Lack of worker
knowledge

Poor project plan

Poor project
mgmt skills

Lack of resources

Didnt complete
project on time

Inadequate
computer
programs

Materials

Poor
documentation

Inadequate
computer system

Equipment

Root Cause
Didnt complete project on time

Resources unavailable when needed

Why?

Root Cause
Didnt complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Why?

Root Cause
Didnt complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Lack of specifics given to


Human Resources Dept

Why?

Root Cause
Didnt complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Lack of specifics given to


Human Resources Dept

No formal process for submitting job opening

Corrective Action
Permanent Hired another worker to meet needs of next
project team
Preventive - Developed checklist form with HR for
submitting job openings in the future

Cause and Effect


Diagram
(C&E,

Ishikawa, Fault or Fishbone


Diagram)

Cause & Effect


Diagram
The Cause and effect diagram is also called:
Fishbone Diagram-because of the way it looks
Ishakawa Diagram for the inventor, Dr. Kaoru Ishakawa.
Main Category

Problem/
Desired
Improvement
Cause

Root Cause

What is a Cause and Effect


Diagram?
A visual tool to identify, explore and graphically display,
in increasing detail, all of the suspected possible
causes related to a problem or condition to discover
its root causes.
Not a quantitative tool
Main Category

Cause
Root Cause

Problem/
Desired
Improvement

Why Use Cause & Effect Diagrams?


Focuses team on the content of the problem
Creates a snapshot of the collective knowledge of team
Creates consensus of the causes of a problem
Builds support for resulting solutions
Focuses the team on causes not symptoms
To discover the most probable causes for further analysis
To visualize possible relationships between causes for any problem
current or future
To pinpoint conditions causing customer complaints, process errors or
non-conforming products
To provide focus for discussion

Product/Manufacturin
g
Man
Machine

Materials

Methods
Five Key
Sources of
Variation

+ Environment
Measurement

Use cause and effect diagram to single out


variation sources within the 5Ms + E

7 Ms
Man
Machines
Methods
Mother Nature
Management
Materials
Measurement System

Transactional/Service
People
Policies

Place

Procedures
Five Key
Sources of
Variation

+ Environment
Measurement

Use cause and effect diagram to single out variation


sources within the 4Ps + M&E

Fishbone - Cause and Effect


Diagram
Causes

Effect

Main Category

Problem

bu
S

se
u
a

Cause

Root
Cause

Shows various influences on a process to identify


most likely root causes of problem

Constructing a C&E Diagram


Materials

Methods

Problem/

Maintenance
Machinery

Manpower

Brainstorm to determine root causes and


add those as small branches off major bones

Fishbone Diagram
Example

Same Example More


Detail

Po
or
tra
in
Ca
in
g
n
th
ea
re
ng
in
e

W
ro
ng

No manual

Radio too loud

Wrong fuel mix

Poor driving habits

Manpower

oi
l

oi
lc
ha
ng
e

Poor Gas
Mileage
Bad
oil

No $

Wrong gas

No

Po
or
t

re
ne
ss

aw
a
No

No

on
ey

Poor maintenance

Poor design

Under-inflated tires

Use wrong gears

W
ro
ng

Always late

Poor hearing

ra
in
in
g

Im
pa
tie
nc
e

Drive too fast

Ha
rd

Machinery

Methods

pr
es
su
re
to
in
fla
te

External Example: Why is your car getting


poor gas mileage?

Materials

Manjunath VS

104

Physical C&E
Construction
C&E Fishbone diagrams can be constructed two ways:
Paper and pen
Usually more effective when working in a team
May take multiple sheets of flip chart paper
Many teams find it helpful to do the flip chart method first because
it lends itself to group dynamics. Everyone can see and
participate easier.

Minitab software
Very helpful when sharing diagram with an audience outside of
your team

105

What is Jidoka?
Jidoka is providing machines and operators the ability to detect
when an abnormal condition has occurred and immediately
stop work.
Enables operations to build-in quality at each process and to
separate men and machines for more efficient work.
Jidoka is one of the two pillars of the Toyota Production System
along with just-in-time.
Jidoka is sometimes called autonomation, meaning automation
with human intelligence.

Why Jidoka?

Increase quality
Lower costs
Improve customer service
Reduce lead time

Prevention Techniques
Poka Yoke
Visual control of quality
Prevents defects from happening
Example: A floppy disk can only be inserted into the drive in one
orientation

Andons
Commonly lights to signal production line status
Red: line stopped
Yellow: call for help
Green: all normal

Andon signals require immediate attention

Jidoka Steps

1. The four steps in Jidoka are:


2. Detect the abnormality.
3. Stop.
4. Fix or correct the immediate condition.
5. Investigate the root cause and install a
countermeasure.

SHIGEO SHINGO
POKA-YOKE

Those who are not dissatisfied will never make any


progress. - Shingo

(1909 1990)

Zero Quality Control (ZQC)


An approach to quality management
that relies heavily on the use of Poka
Yoke devices
Successive checks
Self-checks
Each method relies on 100%
inspection whereas traditional SPC
rely on random checks

Poka Yoke

Japanese for mistake-proofing


Poka - inadvertent mistake
Yoke prevent

Developed in the 1960s

Either prevents a mistake from


being made or makes the
mistake obvious at a glance

POKA-YOKE
Fool proofing
Poka-Yoke is an approach for mistakeproofing process using automatic devices or
methods to avoid simple human error
All errors like omitted processing, processing
errors, setup errors, missing parts, wrong
parts, adjustment errors etc are eliminated
using poka-yoke

POKE-YOKE
Shingo believes that quality should be controlled at
the source of the problem not after the problem
has manifested itself
He recommends that inspection should be
incorporated within the process where the
problem has been identified and where it should
be eliminated
It is handling errors as they occur

VSM

115

ERRORS
Forgetfulness due to lack of attention
Misunderstanding because of the lack of familiarity with
a process or procedures
Poor identification associated with lack of attention
Lack of experience
Absentmindedness
Delays in adjustment when process is automated and
equipment malfunctioning

PokaYoke Device
Categories

Prevention device - make


errors impossible
Detection device - Make
errors visible to the operator

PRINCIPLES OF POKA-YOKE

Prediction, or recognizing that a


defect is about to occur and
providing a warning
Detection, or recognizing that defect
has occurred and stopping the
process

EXAMPLES
Machines have limit switches connected to
warning lights that tell an operator when
parts are improperly positioned
Counting devices
Warning messages on a computer

LEVELS OF MISTAKE PROOFING


Designing for potential errors out of the
product or process
Identifying potential defects and stopping a
process before the defect is produced
Finding defects that enter or leave process

Characteristics of Good Poka Yoke


Devices

They are simple and cheap


They are part of the process
They are placed close to
where the mistakes occur

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
What Can Go
Things that could go wrong
Wrong?

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

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

FMEA Inputs and Outputs

Inputs
Brainstorming
C&E Matrix
Process Map
Process History
Procedures
Knowledge
Experience

FMEA

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

Severity, Occurrence, and Detection


Severity
Importance of the effect on customer requirements
Often cant do anything about this

Occurrence
Frequency with which a given cause occurs and
creates failure modes

Detection
The ability of the current control scheme to detect
or prevent a given cause

Risk Priority Number (RPN)

RPN is the product of the severity, occurrence, and


detection scores.

Severity X Occurrence X Detection

RPN

FMEA Worksheet
Process or
Product Name

Prepared by:

Person
Responsible

Date (Orig) ___________ Revised __________

Process
Step

Key
Process
Input

Potential
Failure
Mode

Potential
Failure
Effect

S
e
v

Potential
Causes

O Current
c Controls
c

Sev - Severity of the failure (what impact will it have on our process?)
Occ How likely is the event to occur (probability of occurrence)
Det How likely can the event be detected in time to do something about it
RPN Risk Priority Number (multiply Sev, Occ, and Det)

Page _____ of ______

D R Actions
e P Recommended
t N

S
e
v

O D R
c e P
c t N

How To Complete the


FMEA
General Suggestions
Use large white board or flip chart with a FMEA form drawn
on it during the generation phase
Focus the team on the specific area of study (product or
process).
Have process map available
Have all subassemblies and component part of a product.

Process for FMEA


Process to Change Oil in a Car

3000 miles
driven

Fill with
new oil

Drive car
on lift

Take Car
off lift

Drain Oil

Process
Complete

Replace
Filter

How to Complete the FMEA


Step 1. Complete header information
Step 2. Identify steps in the process
Step 3. Brainstorm potential ways the area
of study
could theoretically fail
(failure modes)

FMEA Worksheet
Process or
Product Name

Change Oil in Car

Prepared by: Leon

Person
Responsible

Leon Mechanic

Date (Orig) __27 Sep 2007___ Revised __________

Process
Step

Key
Process
Input

Potential
Failure
Mode

Potential
Failure
Effect

Fill
with
new
oil

New
Oil
Mech
anic

Wrong
type of
oil

Engine
wear

No oil
added

Engine
Failure

S
e
v

Potential
Causes

O Current
c Controls
c

Sev - Severity of the failure (what impact will it have on our process?)
Occ How likely is the event to occur (probability of occurrence)
Det How likely can the event be detected in time to do something about it
RPN Risk Priority Number (multiply Sev, Occ, and Det)

Page _1____ of __1____

D R Actions
e P Recommended
t N

133

S
e
v

O D R
c e P
c t N

How to Complete a FMEA


Step 4
For each failure mode, determine impact
or effect on
the product or operation using criteria table (next slide)
Rate this impact in the column labeled SEV (severity)

134

Severity (SEV) Rating


SEV

Severity

Product/Process Criteria

None

No effect

Very Minor

Defect would be noticed by most discriminating customers. A portion of the product may have to
be reworked on line but out of station

Minor

Defect would be noticed by average customers. A portion of the product (<100%) may have to be
reworked on line but out of station

Very Low

Defect would be noticed by most customers. 100% of the product may have to be sorted and a
portion (<100%) reworked

Low

Comfort/convenience item(s) would be operable at a reduced level of performance. 100% of the


product may have to be reworked

Moderate

Comfort/convenience item(s) would be inoperable. A portion (<100%) of the product may have to
be scrapped

High

Product would be operable with reduced primary function. Product may have to be sorted and a
portion (<100%) scrapped.

Very High

Product would experience complete loss of primary function. 100% of the product may have to be
scrapped

Hazardous
Warning

Failure would endanger machine or operator with a warning

10

Hazardous
w/out
Warning

Failure would endanger machine or operator without a warning

135

FMEA Worksheet
Process or
Product Name

Change Oil in Car

Prepared by: Leon

Person
Responsible

Leon Mechanic

Date (Orig) __27 Sep 2007___ Revised __________

Process
Step

Key
Process
Input

Potential
Failure
Mode

Potential
Failure
Effect

S
e
v

Fill
with
new
oil

New
Oil
Mech
anic

Wrong
type of
oil

Engine
wear

No oil
added

Engine
Failure

1
0

Potential
Causes

O Current
c Controls
c

Sev - Severity of the failure (what impact will it have on our process?)
Occ How likely is the event to occur (probability of occurrence)
Det How likely can the event be detected in time to do something about it
RPN Risk Priority Number (multiply Sev, Occ, and Det)

Page _____ of ______

D R Actions
e P Recommended
t N

136

S
e
v

O D R
c e P
c t N

How to Complete a FMEA


Step 5
For each potential failure mode identify one or more
potential causes (Could use Affinity Diagram again to
brainstorm ideas)
Rate the probability of each potential cause occurring
based on criteria table (next slide)
Place the rating in the column labeled OCC (occurrence).

137

FMEA Occurrence (OCC Rating)


OCC

Occurrence

Criteria

Remote

1 in 1,500,000 Very unlikely to occur

Low

1 in 150,000

Low

1 in 15,000 Unlikely to occur

Moderate

1 in 2,000

Moderate

1 in 400 Moderate chance to occur

Moderate

1 in 80

High

1 in 20 High probability that the event will occur

High

1 in 8

Very High

1 in 3 Almost certain to occur

10

Very High

> 1 in 2

FMEA Worksheet
Process or
Product Name

Change Oil in Car

Prepared by: Leon

Person
Responsible

Leon Mechanic

Date (Orig) __27 Sep 2007___ Revised __________

Process
Step

Key
Process
Input

Potential
Failure
Mode

Potential
Failure
Effect

S
e
v

Potential
Causes

O Current
c Controls
c

Fill
with
new
oil

New
Oil
Mech
anic

Wrong
type of
oil

Engine
wear

2 Mislabeled

No oil
added

Engine
Failure

1 Hurrying
0

Sev - Severity of the failure (what impact will it have on our process?)
Occ How likely is the event to occur (probability of occurrence)
Det How likely can the event be detected in time to do something about it
RPN Risk Priority Number (multiply Sev, Occ, and Det)

Page _____ of ______

D R Actions
e P Recommended
t N

S
e
v

O D R
c e P
c t N

How to Complete the


FMEA
Step 6
Identify current controls or detection
Rate ability of each current control to prevent or detect the
failure mode once it occurs using criteria table (next
slide)
Place rating in Det column

FMEA Detection (DET)


Rating
DET Detection

Criteria

Almost
Certain

Current Controls are almost certain to detect/prevent the failure mode

Very High

Very high likelihood that current controls will detect/prevent the failure
mode

High

High Likelihood that current controls will detect/prevent the failure mode

Mod. High

Moderately High likelihood that current controls will detect/prevent the


failure mode

Moderate

High Likelihood that current controls will detect/prevent the failure mode

Low

Low likelihood that current controls will detect/prevent failure mode

Very Low

Very Low likelihood that current controls will detect /prevent the failure
mode

Remote

Remote likelihood that current controls will detect/prevent the failure


mode

Very
Remote

Very remote likelihood that current controls will detect/prevent the failure
mode

141

FMEA Worksheet
Process or
Product Name

Change Oil in Car

Prepared by: Leon

Person
Responsible

Leon Mechanic

Date (Orig) __27 Sep 2007___ Revised __________

Page _____ of ______

Process
Step

Key
Process
Input

Potential
Failure
Mode

Potential
Failure
Effect

S
e
v

Potential
Causes

O Current
c Controls
c

D RPN
e
t

Fill with
new oil

New Oil
from
supplie
r

Wrong
type of
oil

Engine
wear

Misread oil
chart for
vehicle

None

No oil
added

Engine
Failure

1
0

Hurrying

Engine light

Sev - Severity of the failure (what impact will it have on our process?)
Occ How likely is the event to occur (probability of occurrence)
Det How likely can the event be detected in time to do something about it
RPN Risk Priority Number (multiply Sev, Occ, and Det)

Actions
Recommended

142

S
e
v

O D R
c e P
c t N

How to Complete the FMEA


Step 7
Multiply SEV, OCC and DET ratings and place the value in the RPN (risk
priority number) column. The largest RPN numbers should get the greatest
focus. For those RPN numbers which warrant corrective action, recommended
actions and the person responsible for implementation should be listed.

SEV * OCC * DET = RPN

( 2 * 3 * 9 = 54 )

Process
Step

Key
Process
Input

Potential
Failure
Mode

Potential
Failure
Effect

S
e
v

Potential
Causes

O
c
c

Current
Controls

D
e
t

RPN

Fill with
new oil

New Oil
from
supplier

Wrong
type of
oil

Engine
wear

Misread
oil chart
for
vehicle

None

54

No oil
added

Engine
Failure

1
0

Hurrying

Engine light

90

Actions
Recommended

143

S
e
v

O
c
c

D
e
t

R
P
N

FMEA Rankings
Rating
High 10

Low

Severity

Occurrence

Detection

Hazardous without
warning

Very high and almost Cannot detect or


inevitable
detection with very
low probability

Loss of primary
function

High repeated
failures

Remote or low
chance of detection

Loss of secondary
function

Moderate failures

Low detection
probability

Minor defect

Occasional failures

Moderate detection
probability

No effect

Failure Unlikely

Almost certain
detection

144

Action Results
Step 8
After corrective action has been taken, place
summary of the results in the Actions
Recommended block
Assign new value for:
Severity
Occurrence
Detection

Calculate new RPN number

145

FMEA Worksheet
Process or
Product Name

Change Oil in Car

Prepared by: Leon

Person
Responsible

Leon Mechanic

Date (Orig) __27 Sep 2007___ Revised __________

Page _____ of ______

Process
Step

Key
Process
Input

Potential
Failure
Mode

Potential
Failure
Effect

S
e
v

Potential
Causes

O Current
c Controls
c

D RPN
e
t

Fill with
new oil

New Oil
from
supplie
r

Wrong
type of
oil

Engine
wear

Misread oil
chart for
vehicle

None

9 54

No oil
added

Engine
Failure

1
0

Hurrying

Engine light

3 90

Sev - Severity of the failure (what impact will it have on our process?)
Occ How likely is the event to occur (probability of occurrence)
Det How likely can the event be detected in time to do something about it
RPN Risk Priority Number (multiply Sev, Occ, and Det)

Actions
Recommended

S
e
v

O D R
c e P
c t N

Oil level
checked by
partner

1
0

146

3
0

Pareto Analysis
Vital Few
Supplier Material Rejections May 06 to May 07
180

Count

160
140
120
100
80
60

Trivial Many

40
20
0

60 % Defect
of
Materia
l
Rejectio
ns

Count
Percent
Cum %

16213934 20 19 19 15 15 14 14 11 9 7 7 3 3 3 3 2 2 1 5
32 27 7 4 4 4 3 3 3 3 2 2 1 1 1 1 1 1 0 0 0 1
32 5966 70 74 78 80 83 86 89 91 93 94 96 96 97 97 98 98 99 99100

Approved for Public Release

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