Beruflich Dokumente
Kultur Dokumente
Business
Regulatory
Product liability
2
Goal
Risk Evaluation
Risk Control
Post-Production Information
8
Management
Risk Analysis
Assessment
Risk Analysis
Risk Evaluation
Risk Communication
Risk Control
Risk Reduction
Risk Acceptance
unacceptable
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
Example
12
http://www.ece.cmu.edu/~koopman/des_s99/safety_critical/
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
Handling of
Machinery and
Tools
OTHER PROBLEMS
MACHINES
13
Product
Quality Not
Matching
Quality
Standards
Lack of
Maintenance
Frequent
Energy
Breakdowns
Affecting
Product
Operations
Changeover
No Standard
Procedures
Outlined
Poor Building
Procedures
METHODS
14
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
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
15
Cont
Combines Possible Failure:
Severity (rate 1-10)
Occurrence (rate 1-10)
Detect-ability (rate 1-10)
FMEA Process
17
http://www.qualitytrainingportal.com/resources/fmea/fmea_process.htm
Example: FMEA
18
HAZOP Model
19
HAZOP
Methodology Report format
Deviation
E.g.
Flow/No
20
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
21
Occurrence (O)
Use historical data
Similar processes products
Detection (D)
Method validation studies
Historical data
22
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.
23
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
24
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
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
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
27
28
Errors 1
Almost all errors are caused by human error.
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.
31
32
33
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
35
36
37
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
39
Identifyrisks&opportunities
relatedtotheQMSintended
outcomesandthespecified
objectives
Determinethevalueoftherisk
usingtheriskassessment
matrixestablishedbyCHqualitydepartment.
Proposeactionstoreduce
risksandestimatecostofthese
actions.Defineresponsibilities
andtimeframe
Branchmanagement
reviewcommittee
Consolidatedepartmental
riskanalysisandsubmitto
branchmanagementreview
committee
Evaluatethe
effectivenessofthe
actionstakentohandle
risksandgivefeedback
40
41
42
43
44
45
46
RISK ASSESSMENT
No1
Location: Airside
Function/Activity: Non
Destructive Testing
NO
HAZARD
RISK
DESRIPTIO
N
(What is the RISK
& How it
can happen)
RISK
ANALYSES
Reviewed&Approvedby:/Date:..
EFFECT
CONTROL MEASURES
Risk
Level
RISK
ANALYSES
(No Controls)
(No
Controls)
Date: 9/6/2016
4
1
Risk
Level
L
4
FURTHE
R
ACTIONS
TO
REDUCE
RISK
RESPONSIBIL
ITY
-Awareness on OPERATIONS
the layout of
the
maneuvering
area
/ ACES
-HSE induction
for all the staff
47
OPERATIONS/
ACES
RISK ASSESSMENT
No1
Location: Airside
Function/Activity: Non
Destructive Testing
NO
HAZARD
RISK
DESRIPTI
ON
(What is the RISK
& How it
can
happen)
Reviewed&Approvedby:/Date:..
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
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
49
49
50
What Can Go
Wrong?
51
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
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.
55
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.
56
56
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.
60
Controls
prevent
or detect
the Failure Mode prior to engineering
orDesign
Cause
should
it occur
.
release
61
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).
62
A Closer Look
63
63
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
65
Team Input
Required
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
71
FMEA Process
72
http://www.qualitytrainingportal.com/resources/fmea/fmea_process.htm
Create
an Effective
FMEA Team
=QFD
=Brain Storming
= 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
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
76
RPN Considerations
10
RPN Considerations
(continued)
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
Low
Remote
80
FMEA Scoring
Detection
Moderate
VeryLow
Rating
Low
Likelihoodthatcontrolwilldetectfailure
10
9
8
7
High
VeryHigh
81
4
3
2
1
Calculating a
Composite
Score
Severity
82
82
X Occurrence X
Detection
RPN
83
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 !
85
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
87
89
90
91
92
93
94
95
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
99
100
Occurrence(O)
101
Prevention measures
102
103
104
105
106
107
Calculating a
Composite
Score
Thank you
108
108