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RISK ASSESSMENT / ANALYSIS,

Process - Failure Mode & Effect Analysis


(P-FMEA)
Rafat Ahmad
August

What Risks Must Be Managed?


Risk to safety of
patients, users, handlers

Business

Regulatory

Product liability
2

Robert C. Menson, PhD

Goal

Implement an effective Quality


Management System to prevent
product recalls.
Why is this important?

Risk vs. Unreliability


Risk is not the same as Unreliability
Reliability: Probability that a device will function
without failure over a specified period of time or
amount of usage
Reliability is one of the (but not the only) factors
that contributes to system risk
Reliability analysis is often used interchangeably
with risk, but they are two different concepts
Engineers often present reliability statistics rather
than risk values due to difficulty of measuring and
comparing consequence severity
6

Importance of Risk Analysis


Reputation
Customer Satisfaction/Safety
Warranty Costs
Repeat Business
Cost Analysis
Customer Requirements
Competitive Advantage

Risk Evaluation
Risk Control

Post-Production Information
8

Management

Risk Analysis

Assessment

Elements of the Risk Management Process

Typical QRM process


Initiate
Quality Risk Management Process
Risk Assessment
Risk Identification

Risk Analysis

Risk Evaluation
Risk Communication

Risk Control
Risk Reduction

Risk Acceptance

Output / Result of the


Quality Risk Management Process
Risk Review
Review Events

Risk Management tools

unacceptable

What might go wrong


or has gone wrong?
What is likelihood or
probability?
What are the
consequences
(severity)?
What is the level of
risk? Any mitigating
factors?

Risk Assessment Tools

Risk Matrix
PHA= Preliminary Hazard Analysis
FTA=Fault Tree Analysis
Fish Bone Diagram
FME(C)A=Failure Mode Effects (Criticality)
Analysis
Risk Assessment Decision Tree
HAZOP=Hazard Operability Analysis
HACCP=Hazard Analysis and Critical Control Point

10

Fault Trees Analysis


Goal of fault tree analysis
to determine the probability of an event based on
the outcomes of each event in the chronological
sequence of events leading up to it

By analyzing all possible outcomes using


event tree analysis, you can determine the
percentage of outcomes which lead to the
desired result
fault trees analysis can be built with software
to produce reliability estimates
11

Example

12
http://www.ece.cmu.edu/~koopman/des_s99/safety_critical/

Fish Bone Diagram


CAUSES OF POOR PRODUCT
QUALITY

RAW MATERIAL
Low Quality
of Raw
Materials
High Raw
Material
Wastage due to
Improper
Storage
Delays in Material
Delivery

No Process
Improvement
Initiative By
Management
Lack
of
Technological
Advancement
Non-Ideal
Working
Conditions

WORKERS

Lack of Training
and Experience
Poor
Health/Over
Worked
Improper
Behavior at
Work

Wear and Low


Maintenance
Inefficient
Usage of
Operational
Capacity
Improper

Handling of
Machinery and
Tools
OTHER PROBLEMS
MACHINES

13

Product
Quality Not
Matching
Quality
Standards

Fish Bone Diagram


MATERIAL
Material and
Parts
Unavailable
Low Stock of
Custom
Materials in
Warehouse

CAUSES OF DELAY IN CUSTOM


ORDERS
PEOPLE

Long Lead Time for


Required Parts

Lack of
Maintenance
Frequent
Energy
Breakdowns
Affecting
Product
Operations
Changeover

No Standard
Procedures
Outlined
Poor Building
Procedures
METHODS
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High
Employee
Turnover Rate
Insufficient
Number of
Skilled Workers
Lack of
Training and
Motivation

Takes Longer
for Custom
Products
MACHINERY

Custom
Orders of
Customers
Being
Delayed by a
Week on
Average

Failure Mode Effect Analysis (FMEA)


Other wise known as:
Design Failure Mode Effect Analysis (DFMEA)
Process Failure Mode Effect Analysis (PFMEA)

Purpose
Define and guide a logical design process
Identify, quantify, and reduce design risk
Provide a traceable document for design and
development
Justify design activities
Provide a means for continuous product improvement
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Cont
Combines Possible Failure:
Severity (rate 1-10)
Occurrence (rate 1-10)
Detect-ability (rate 1-10)

Product of the parameters is called the RPN, this


value describes the overall risk of each failure
mechanism
High RPN numbers = high risks
Focus on these failure mechanisms first in risk
mitigation process
16

FMEA Process

17
http://www.qualitytrainingportal.com/resources/fmea/fmea_process.htm

Example: FMEA

18

HAZOP Model

HAZOP: HAZard and OPerability study;


Aim: identifying potential hazards and operability problems caused by
deviations from the design intent of both new and existing process plants

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HAZOP
Methodology Report format
Deviation

E.g.
Flow/No

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Cause

Potential cause
of the deviation

Consequence Safeguards

Consequences of
the cause and the
deviation itself

Any existing
devices that
prevent the
cause or make
its consequeces
less painful

Action

Actions to
remove the
cause or
mitigate the
conse-quences

HACCP

Hazard Analysis and Critical Control Point


Risk Management System
Biological Hazards
Chemical Hazards
Physical Hazards
Requires
Prerequisite Quality System Program
Traditionally GMPs

21

Create SOD Tables


Severity (S)
Link to end product functional failure
Medical Department involvement

Occurrence (O)
Use historical data
Similar processes products

Detection (D)
Method validation studies
Historical data

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Evaluation Rules
Concept of ECP:
A process that is in control ( i.e. does not
produce significant defects) but is very difficult
to verify by testing.
The corollary is a process with a "high" level of
defects that can be detected before shipment
to the end user.
If (S) >5 and (D) or (P) >5 then an ECP is
assigned.

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Risk Assessment Decision Tree


Begin

Sev>5
Yes
Prob>5

No
No

Det<5

Yes

Yes
Reduce
Probability or
Increase
Detection

No

Det<5

No

Yes
Assign ECP to
Reduced
Parameter

Assign ECP to
Detection
(Either at that
point or
downstream)

Assign ECP to
Process

END

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Risk Assessment Decision Tree


Begin

Sev>5
Yes
Prob>5

No
No

Det<5

Yes

Yes
Reduce
Probability or
Increase
Detection

No

Det<5

No

Yes
Assign ECP to
Reduced
Parameter

Assign ECP to
Detection
(Either at that
point or
downstream)

Assign ECP to
Process

END

25

Risk Assessment Decision Tree


Begin

Sev>5
Yes
Prob>5

No
No

Det<5

Yes

Yes
Reduce
Probability or
Increase
Detection

No

Det<5

No

Yes
Assign ECP to
Reduced
Parameter

Assign ECP to
Detection
(Either at that
point or
downstream)

Assign ECP to
Process

END

26

Risk Assessment Decision Tree


Begin

Sev>5
Yes
Prob>5

No
No

Det<5

Yes

Yes
Reduce
Probability or
Increase
Detection

No

Det<5

No

Yes
Assign ECP to
Reduced
Parameter

Assign ECP to
Detection
(Either at that
point or
downstream)

Assign ECP to
Process

END

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Clues about Causes


Can any equipment failures contribute to this effect?
Material faults?
Human errors?
Methods and Procedures?
Software performance?
Maintenance errors or the absence of maintenance?
Inaccuracies or malfunction of measurement device(s)?
Environments such as chemicals, dust, vibration, shock and/or temperature?

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Errors 1
Almost all errors are caused by human error.

Forgetfulness - Sometimes we forget things when we are not


concentrating. Example: A person forgets to set his/her alarm clock at night.
Safeguard: Establish a routine which includes checking before going to bed.
Errors due to misunderstanding - Sometimes we make mistakes when
we jump to the wrong conclusion before were familiar with the situation.
Example: A person used to a stick shift pushes the brake petal in an
automatic thinking it is the clutch. Safeguards: Training, checking in
advance, standardizing work procedures.
Errors in identification - Sometimes we misjudge a situation because we
view it too quickly or are too far away to se it clearly. For example, a $1 bill
is mistaken for a $10 bill. Safeguards: Training, attentiveness, vigilance.
29

Errors 2
Errors made by amateurs - Sometimes we make mistakes through lack of
experience. Example: A new worker does not know the operation or is just
barely familiar with it. Safeguards: Training, skill building, work
standardization.
Willful errors - Sometimes errors occur when we decide that we can
ignore the rules under certain circumstances. Example: Crossing a street
against a red light because we see no cars. Safeguards: Basic education,
experience.
Inadvertent errors - Sometimes we are absent minded and make
mistakes without knowing how they happened. Example: Someone lost in
thought tries to cross the street without even noticing whether the light is red
or not. Safeguards: Attentiveness, discipline, work standardization.
Errors due to slowness - Sometimes we make mistakes when our actions
are slowed down by delays in judgment. Example: A person learning to drive
is slow to step on the brake. Safeguards: Skill building, work standardization.
30

Errors 3
Errors due to lack of standards - Some errors occur when there are not
suitable instructions or work standards. Example: A measurement may be
left to an individuals discretion. Safeguards: Work standardization, work
instructions.
Surprise errors - Errors sometimes occur when equipment runs
differently than expected. Example: A Machine malfunction without
warning. Safeguards: Total Productive Maintenance, work
standardization.
Mistakes happen for many reasons, but almost all can be prevented if we
take time to identify when and why they happen and then take steps to prevent
them by using Poka-Yoke methods with consideration to other available
safeguards.

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Decision Criteria / Model


One person makes the decision
One person consults the group, then makes
the final decision
Team or group makes decision based upon
majority rule or consensus

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Risk Assessment Procedure at ACES

33

Risk Assessment Procedure at ACES


Document Title: Risk Management Procedure
Document No. : ACES QP CH09
Process Owner : CH-Quality Department
1. HISTORY OF REVISIONS

Page
Issue No/ Rev. No
Rev. Date

2. PURPOSE
3. SCOPE OF APPLICATION
4. ABBREVIATIONS AND DEFINITIONS
5. OWNERSHIP AND RESPONSIBILITIES
6. PROCESS DESCRIPTION
7. RELATED DOCUMENTS

34

Page 1
of 13
01 / 00
01/08/201
6

Risk Assessment Procedure at ACES


The intended outcomes of ACES-QMS are:
1) to support the continuity and consistency of
service/product delivery by adopting a
transparent and knowledge based management
system.
2) To enhance the efficiency and effectiveness of
those processes which support the business units
and operations;
3) To assure conformity with customer requirements
and applicable regulations.

35

Risk Assessment Procedure at ACES


Scope of Application:
All branches and departments within ACES group
shall implement this procedure. ACES-CH shall
lay down the criteria for risk ranking. This
procedure addresses both internal and external
risks identified by the operational units.

36

Risk Assessment Procedure at ACES


Process description:
Main activities within this core process include:
Establishing the criteria for quantifying risks
Identifying and addressing risks related to QMS and to achieving
objectives
Quantifying the combined risk value and determining actions to
reduce effects.
Estimating the cost of reducing identified risks and defining
responsibilities and time
Establishing a risk register (log) at departments level
Input to management review
Evaluating the effectiveness of actions and updating the risks status
Documentation of all activities and records related to this process.

37

Risk Assessment Procedure at ACES


Ownership and responsibilities:
CH- Quality Department is the owner of the risk management quality
procedure.
The operational departments' managers are responsible for
identifying; and quantifying the risks associated with the department
operations. Risks register -taking actions necessary to reduce risks.
The branch quality manager is responsible for consolidating the
departmental risks registers -submit to the branch management
review for evaluating the effectiveness of the actions.
The branch manager is responsible for ensuring that risks are
addressed in the branch action plan and actions are taken to reduce
the effect of these risks.
The branch marketing officer is responsible for conducting market
research and business intelligence to provide the concerned
personnel with information needed to identify and assess risks. .

38

Branchmanager

Operationaldepartment
managers

Branchqualitymanager

Start

Communicate
annualobjectives
andinitiatethe
actionplan
preparation

Requeststhe
marketingofficerto
conductmarket
researchandbusiness
intelligence

Ensurethatactionsto
addressrisksare
includedintheaction
plan.
Followthestrategic
planning&budgeting
procedureACES-QPCH02

End

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Identifyrisks&opportunities
relatedtotheQMSintended
outcomesandthespecified
objectives
Determinethevalueoftherisk
usingtheriskassessment
matrixestablishedbyCHqualitydepartment.

Proposeactionstoreduce
risksandestimatecostofthese
actions.Defineresponsibilities
andtimeframe

Branchmanagement
reviewcommittee

Consolidatedepartmental
riskanalysisandsubmitto
branchmanagementreview
committee

Evaluatethe
effectivenessofthe
actionstakentohandle
risksandgivefeedback

Risk Assessment Procedure at ACES

40

Risk Assessment Procedure at ACES

41

Risk Assessment Procedure at ACES

42

Risk Assessment Procedure at ACES

43

Risk Assessment Procedure at ACES


Non Destructive Testing of
Salalah Airport Runway, Taxiway
& Aprons

44

45

Risk Assessment Procedure at ACES

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9. WORK RISK ASSESMENT


Activity: Pavements Investigation, Geotechnical evaluation Doc Ref:

RISK ASSESSMENT
No1

Location: Airside
Function/Activity: Non
Destructive Testing

NO

HAZARD

RISK
DESRIPTIO
N
(What is the RISK
& How it
can happen)

Compiled by: ACES

RISK
ANALYSES

Reviewed&Approvedby:/Date:..

EFFECT

CONTROL MEASURES

Risk
Level

Runway A- Accident on Closure of


incursion the Runway
airport or
/
runway
excursio B- Near-miss
n
C-Blockage of
the Runway use
during Takeoff
or landing traffic

RISK
ANALYSES
(No Controls)

(No
Controls)

Date: 9/6/2016

SAFETY MANAGEMENT SYSTEM

4
1

Risk
Level

L
4

FURTHE
R
ACTIONS
TO
REDUCE
RISK

RESPONSIBIL
ITY

-Awareness on OPERATIONS

-Wont enter runway


unless per OAMC Airfield
Duty Manager

the layout of
the
maneuvering
area

-Always escorted with


OAMC Airfield security
personnel

/ ACES

-HSE induction
for all the staff

-Use runway at Notams or


at traffic gap times
defined by the Airfield
Duty Manager in
coordination with ATC
-Daily schedule of the
work will be provided the
day before, latest at 5:00
pm

47

Dispersa Staff may get


Minor
l of staff personal
Injury
on
injury, or being
working hit by other
site
vehicles

Always escorted with


OAMC Airfield security
personnel

OPERATIONS/
ACES

9. WORK RISK ASSESMENT


Activity: Pavements Investigation, Geotechnical evaluation Doc Ref:

RISK ASSESSMENT
No1

Location: Airside
Function/Activity: Non
Destructive Testing

NO

HAZARD

RISK
DESRIPTI
ON
(What is the RISK
& How it
can
happen)

Compiled by: ACES

Reviewed&Approvedby:/Date:..

SAFETY MANAGEMENT SYSTEM

RISK
ANALYSES

CONTROL MEASURES

Risk
Level

RISK
ANALYSES
(No
Controls)

(No
Controls)

EFFECT

Date: 9/6/2016

Risk
Level

FURTHER ACTIONS
TO REDUCE RISK

RESPONSIBIL
ITY

Loss of
communi
cation
between
Staff
supervis
or and
Airfield
Duty
Manager

a- Accident on
the Runway
b- Near-miss
c- Blockage of
the Runway
use during
Takeoff or
landing traffic

Closure
of
airport
or
runway

a) Always escorted
with OAMC Airfield
security personnel
b) Security vehicle is
too close to working
team during work

a) Means of
communication shall be
checked before the
start of work (in
working order and
battery full)

OPERATIONS/
ACES

b) Backup solution as
exchanging other
mobile numbers on site
c) In case of lack of
means of
communication on site,
leaving immediately
the maneuvering area
according to an
approved way from
Airfield Duty Manager
agreed according to the
location of test.

48

DispersalStaff may get Minor


of staff personal
Injury
on
injury, or
working being hit by

Always escorted
with OAMC Airfield
security personnel

OPERATION
S/ ACES

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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RISK ASSESSMENT / ANALYSIS,


Process - Failure Mode & Effect Analysis
(P-FMEA)

50

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

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51

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
52
52
ISO)

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)

53

53

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

54

54

FMEA History
This type of thinking has been around
for hundreds of years. It was first
formalized in the aerospace industry
during the Apollo program in the 1960s.
Initial automotive adoption in the 1970s.
Potential serious & frequent safety issues.

Required by QS-9000 & Advanced Product Quality Planning Process


in 1994.
For all automotive suppliers.

Now adopted by many other industries.


Potential serious & frequent safety issues or loyalty issues.
55

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What is FMEA ?
Definition: FMEA is an Engineering Reliability Tool
That:
Helps define, identify, prioritize, and eliminate known and/or
potential failures of the system, design, or manufacturing
process before they reach the customer. The goal is to
eliminate the Failure Modes and reduce their risks.
Provides structure for a Cross Functional Critique of a
design or a Process
Facilitates inter-departmental dialog.
Is a mental discipline great engineering teams go
through, when critiquing what might go wrong with the
product or process.
Is a living document which ultimately helps prevent, and not react
to problems.

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What is FMEA ?
What it can do for you!
1.) Identifies Design or process related Failure Modes
before they happen.
2.) Determines the Effect & Severity of these failure modes.
3.) Identifies the Causes and probability of Occurrence of
the Failure Modes.
4.) Identifies the Controls and their Effectiveness.
5.) Quantifies and prioritizes the Risks associated
with the Failure Modes.
6.) Develops & documents Action Plans that will
occur to reduce risk.
57

57

Types of FMEAs ?
System/Concept S/CFMEA- (Driven by System
functions) A system is a organized set of parts or
subsystems to accomplish one or more functions. System
FMEAs are typically very early, before specific hardware has
been determined.
Design DFMEA- (Driven by part or component
functions) A Design / Part is a unit of physical hardware
that is considered a single replaceable part with respect
to repair. Design FMEAs are typically done later in the
development process when specific hardware has been
determined.
Process PFMEA- (Driven by process functions &
part characteristics) A Process is a sequence of tasks
that is organized to produce a product or provide a
service. A Process FMEA can involve fabrication,
assembly, transactions or services.
58

58

Types of FMEAs ?
System/Concept S/CFMEA- (Driven by System
functions) A system is a organized set of parts or
subsystems to accomplish one or more functions. System
FMEAs are typically very early, before specific hardware has
been determined.
Design DFMEA- (Driven by part or component
functions) A Design / Part is a unit of physical hardware
that is considered a single replaceable part with respect
to repair. Design FMEAs are typically done later in the
development process when specific hardware has been
determined.
Process PFMEA- (Driven by process functions &
part characteristics) A Process is a sequence of tasks
that is organized to produce a product or provide a
service. A Process FMEA can involve fabrication,
assembly, transactions or services.
59

59

FMEA Terminology
1.) Failure Modes: (Specific loss of a function) is a
concise
description of how a part , system, or manufacturing
process may potentially fail to perform its functions.
2.) Failure ModeEffect: A description of the consequence or
Ramification of a system or part failure. A typical failure mode may
have several effects depending on which customer you consider.
3.) Severity Rating: (Seriousness of the Effect) Severity is the
numerical rating of the impact on customers.
When multiple effects exist for a given failure mode, enter the worst
case severity on the worksheet to calculate risk.

4.) Failure ModeCauses: A description of the design or process


deficiency (global cause or root level cause) that results
in the failure mode .
You must look at the causes not the symptoms of the failure. Most failure
Modes have more than one Cause.
60

60

FMEA Terminology (continued)


5.) Occurrence Rating: Is an estimate number of
frequencies or cumulative number of failures (based on
experience) that will occur (in our design concept) for a
given cause over the intended life of the design.
6.) Failure ModeControls: The mechanisms,
methods, tests,
procedures, or controls that we have in place to PREVENT
the Cause of the Failure Mode or DETECT the Failure Mode

Controls
prevent
or detect
the Failure Mode prior to engineering
orDesign
Cause
should
it occur
.
release

7.) Detection Rating: A numerical rating of the probability that a giv


set of controls WILL DISCOVER a specific Cause of Failure Mode to
prevent bad parts leaving the facility or getting to the ultimate custom
Assuming that the cause of the failure did occur, assess the capabilities of the
controls to find the design flaw..
61

61

FMEA Terminology (continued)


8.) Risk Priority Number (RPN): Is the product of
Severity, Occurrence, & Detection. Risk= RPN= S

xOx

Often
D the RPNs are sorted from high to low for consideration in the action planning
step (Caution, RPNs can be misleading- you must look for patterns).

9.) Action Planning: A thoroughly thought out and well


developed FMEA With High Risk Patterns that is not
followed with corrective actions has little or no value, other
than having a chart for an audit
Action plans should be taken very seriously.
If ignored, you have probably wasted much of your valuable time.
Based on the FMEA analysis, strategies to reduce risk are focused
on:
Reducing the Severity Rating.
Reducing the Occurrence Rating.
Reducing the detection Rating.
62

62

A Closer Look

The FMEA Form

Identify failure modes


and their effects

63

63

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

64

64

Risk Priority Number

65

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.

66

66

The Team
What is a team?
Two or more individuals who coordinate activities
to accomplish a common task or goal.

Maintaining Focus
A separate team for each product or project.

Brainstorm
Brainstorming (the Team) is necessary as the
intent is to discover many possible possibilities.
67

Successful Teams
Are management directed and
focused
Build their own identity
Are accountable and use
measurements
Have corporate champions
Fit into the organization
Are cross-functional

Some teams just Do Not Work


68

Basic Team Rules


Determine if there should be a meeting
Decide who should attend
Provide advance notices
Maintain meeting minutes or records
Establish ground rules
Provide and Follow an agenda
Evaluate meetings
Allow NO interruptions
69

Team Meeting Responsibility


Clarify
Participate
Listen
Summarize
Stay on track
Manage time
Test for consensus
Evaluate meeting process
70

Decision Criteria / Model

One person makes the decision


One person consults the group, then makes the final
decision
Team or group makes decision based upon majority
rule or consensus

71

FMEA Process

72
http://www.qualitytrainingportal.com/resources/fmea/fmea_process.htm

Getting Started on FMEA


Understand your
Customer
Needs
Develop & Evaluate
Product/Process
Concepts

Create
an Effective
FMEA Team

=QFD

=Brain Storming

=4 to 6 Consensus Based Multi


Level Experts

= What we
Define the FMEA are and are
Scope
not working
Determine1
Product or
Process
Functions
73

Determine
3
Effects of
The Failure
Mode

Develop and
Drive
7
Action Plan

Severity Rating

Determine4
2
Determine
Causes of
Failure Modes The Failure
of Function
Mode
Occurrence Rating

Determine5
Controls
Detection Rating

66

Calculate &
Assess Risk

Information
Flow

FMEA Inputs and Outputs

Inputs
Process Map
Process History
Procedures
Knowledge
Experience

74

74

Outputs

FMEA

List of actions to
prevent causes or
detect failure
modes
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
75
to estimate early in process operations).
75

Assigning
Rating
Weights

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)

76

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RPN Considerations

Rating scale example:


Severity = 10 indicates that the effect is
very serious and is worse than Severity =
1.
Occurrence = 10 indicates that the
likelihood of occurrence is very high and is
worse than
Occurrence = 1.
Detection = 10 indicates that the failure is
not likely to be detected before it reaches
the end user and is worse than Detection
= 1.
1
77

10

RPN Considerations

(continued)

RPN ratings are relative to a particular


analysis.
An RPN in one analysis is comparable to
other RPNs in the same analysis
but an RPN may NOT be comparable to
RPNs in another analysis.

78

10

Severity

FMEA Scoring

None

Low

Moderate

High

Extreme

SeverityofEffect

79

Rating

Mayendangermachineoroperator.Hazardouswithoutwarning

10

Mayendangermachineoroperator.Hazardouswithwarning

Majordisruptiontoproductionline.Lossofprimaryfunction,100%scrap.Possiblejiglockand
MajorlossofTaktTime
Reducedprimaryfunctionperformance.ProductrequiresrepairorMajorVariance.
NoticeablelossofTaktTime
Mediumdisruptionofproduction.Possiblescrap.Noticeablelossoftakttime.
Lossofsecondaryfunctionperformance.RequiresrepairorMinorVariance
Minordisruptiontoproduction.Productmustberepaired.
Reducedsecondaryfunctionperformance.
Minordefect,productrepairedor"UseAsIs"disposition.
Fit&Finishitem.Minordefect,maybereprocessedonline.
MinorNonconformance,maybereprocessedonline.
Noeffect

8
7
6
5
4
3
2
1

1in2

<.33

10

1in3

>.33

High

LikelihoodofOccurrence

Failure Capability
Rate
(Cpk) Rating

1in8
Process is not in statistical control.
Similar processes have experienced problems.
1in20

>.51

>.67

Moderate

VeryHigh

FMEA
Scoring
Occurrence

1in80

>.83

>1.00

1in2000

>1.17

1in15k

>1.33

>1.50

>1.67

Failure is almost inevitable

Process is in statistical control but with isolated failures.


Previous processes have experienced occasional
1in400
failures or out-of-control conditions.

Low

Process is in statistical control.

Remote

Process is in statistical control. Only isolated 1in150k


failures associated with almost identical processes.

80

Failure is unlikely. No known failures associated1in1.5M


with almost identical processes.

FMEA Scoring
Detection

No known control(s) available to detect failure mode.

Controls have a remote chance of detecting the failure.

Moderate

VeryLow

Rating

Low

Likelihoodthatcontrolwilldetectfailure

10
9
8
7

Controls may detect the existence of a failure

High

VeryHigh

Controls have a good chance of detecting the existence


of a failure

81

The process automatically detects failure.


Controls will almost certainly detect the existence of
a failure.

4
3
2
1

Risk Priority Number (RPN)

Calculating a
Composite
Score

RPN is the product of the severity, occurrence,


and detection scores.

Severity

82

82

X Occurrence X

Detection

RPN

Risk Priority Number(RPN)


Severity x Occurrence x Detection
RPN is used to prioritize concerns/actions
The greater the value of the RPN the
greater the concern
RPN ranges from 1-1000
The team must make efforts to reduce
higher RPNs through corrective action
General guideline is over 100 =
recommended action

83

The FMEA Worksheet


Product
or
Process

Failure
Mode

Determine
Product or
Process
Functions

S
O
Failure
E Causes C Controls
Effects
V
C

Determine
Effects of
The Failure
Mode
Severity
Determine
Rating
Failure
Modes
of Function

Determine
Causes of
The Failure
Mode
Occurrence
Rating

D R
Actions
E P
/ Plans
T N

Resp. &
Target
Complete
Date

p
S
E
V

p
O
C
C

p
D
E
T

7
Develop
and
Drive
Action Plan

Determine
Controls
Detection
Rating
Calculate
&
Assess
Risk

If an FMEA was created during the Design Phase of the Program, USE IT!
Create an Action Plan for YOUR ROOT CAUSE
and Re-Evaluate the RPN Accordingly
84

p
R
P
N

FMEA Scoring
RPN or Risk Priority Number

The Calculation !

Severity x Occurrence x Detection=


RPN

85

Failure Modes & Effect Analysis


(FMEA) Part or Process Improvement
FMEA is a technique utilized to define, identify, and eliminate
known or potential failures or errors from a product or a process.
Identify each candidate Part or Process, list likely failure
mode, causes, and current controls
Prioritize risk by using a ranking scale for severity,
occurrence, and detection
Mitigate risk Can controls be added to reduce risk?
Recalculate RPN.
Characteristics with high Risk Priority Numbers should be
selected for Improvement and Action Plans Created
Recalculate RPN After Completion of Action Plans to Validate
Improvements
Resp. &
p p p

Product
or
Process

Failure
Mode

Failure
Effects

S
O
E Causes C Controls
V
C

86

Wrong
Drill Bit
Used

Ball Gage
Visual Insp

120

Hole
Oversize Unable to
Drilling
Hole Install BP 5
Fastener

D R
Actions
E P
/ Plans
T N

Kit Drill
Bits

p
Target
S O D R
Complete E C E P
Date
V C T N

010103

51 1 5

Reasons FMEAs fail


1.
2.
3.
4.
5.

87

One person is assigned to complete the FMEA.


Not customizing the rating scales with company
specific data, so they are meaningful to your
company
The design or process expert is not included in
the FMEA or is allowed to dominate the FMEA
team
Members of the FMEA team are not trained in
the use of FMEA, and become frustrated with
the process
FMEA team becomes bogged down with minute
details of design or process, losing sight of the
overall objective

Reasons FMEAs fail


6. Rushing through identifying the failure
modes to move onto the next step of the
FMEA
7. Listing the same potential effect for every
failure i.e. customer dissatisfied.
8. Stopping the FMEA process when the
RPNs are calculated and not continuing
with the recommended actions.
9. Not reevaluating the high RPNs after the
corrective actions have been completed.
88

89

It is the name of the component which is analyzed

90

Identifies the name and ID of the systems or


subsystems

91

Contains names of the responsible individuals that


have the authority to perform task

92

Identifies the team responsible for this design

93

Used for document tracking purposes

94

Contains the original date and revised date

95

Contains the name and Id of item being analyzed as


well as one specific function of the item

96

Contains methods
1. May fail to meet design criteria
2. May cause potential failure in high level systems
and low level system

97

Severity(S)

98

Used to specify any additional controls

99

Reasons for failure

100

Occurrence(O)

101

Prevention measures

102

Risk priority number(RPN)=S*O*D

103

Corrective actions examined by the team

104

Target completion dates

105

After an action has been taken, the actual action


and the effective date should be entered in this
colums

106

S, O, D values should be re-estimated and RPN


should be recalculated

107

Calculating a
Composite
Score

Thank you

108

108