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Professionnel Documents
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Business
Regulatory
Product liability
Menson & Associates, Inc
Risk Evaluation
Risk Control
Management
Risk Analysis
Assessm
ent
Post-Production Information
Menson & Associates, Inc
Applications of Risk
Analysis
Design
Production
Premarket Notifications
Complaints
MDR
Change Control
Failure Analysis
Etc.
Menson & Associates, Inc
Risk Management
Life Cycle
Development
Production
Risk Management
& Design Control
Concept
& Feasibility
Design
Control
Requirements
Risk
Assessment
Preliminary
Hazard
Analysis
Planning
Plan
Development
Specifications
Risk
Management
Plan
Detailed Analysis
(FMEA, FTA, HACCP, HAZOP)
Production
Productions
Methods
Change
Records
Risk
Management
Report
Risk
Reviews
Intended Use/Purpose
Use of a Product, Process or Service
in accordance with the specifications,
instructions and information provided
by the manufacturer
ANSI/AAMI/ISO 14971:2000, definition 2.5
10
Harm
Physical injury or damage to health of
people, or damage to property or the
environment.
11
Hazard
Potential source of Harm
12
Risk
Combination of the probability of
occurrence of harm and the severity of
harm.
13
Residual Risk
Risk remaining after protective
measures have been taken.
14
Tolerable Risk
Risk which is accepted in a given context
based on the current values of society.
15
Hazard Identification
Laws
Codes
Standards
Hazard
Identifcation
Events
MDRs
Accidents
Etc
List
of
Hazards
Brainstorming
PHA
FTA
FMEA
16
Risk Matrix
Frequency
Severity
Negligible
Minor
Major
Severe
Frequent
Probable
Occasional
Remote
17
ALARP Curve
Intolerable Region
ALARP
Broadly
Acceptable
Region
Maximum
Tolerable
Risk
18
FMEA vs FTA
FMEA
Assumes
component or part
failure
Identifies
functional failure
as a result of part
failure
FTA
Assumes failure of
the functionality of
a product
Identifies
part/module failure
as cause of
functional failure
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FTA
Too difficult to do for entire
design
Systematic way to
predict new problems
A bottoms-up analysis
20
FTA
Assumes fault and analyzes possible
causes
Connection tool for PHA* to subsystems
or modules
Top down
Deductive
Evaluate system (or subsystem) failures
Considered more structured than FMEA
Graphical presentation--visual picture
*Preliminary Hazard Analysis
Menson & Associates, Inc
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Failures
Primary--Due to internal causes that
include poor design or use of inappropriate
materials
Secondary--Due to failures in the operation
that include equipment failure
Control--Due to failures in the systems that
are in place to protect the quality and
safety
z
z
z
22
FAULT
OR
AND
23
A S P E C T R A T IO
T O O H IG H
OR
M A JO R
D IA M E T E R
TO O LARG E
Competing
Design Criteria
A S P E C T R A T IO
TO SM ALL
DOES NOT
R E S T R IC T
S P IL L A G E
OR
BASE
FLATNESS
B A S E S IZ E
TO O SM ALL
R IM T O F IL L
IN S U F F C IE N T
24
Patient Death
Outliers
Calibration
Error
OR
Lab Error
OR
Systematic
OR
Interference
Other
Random
25
HAZARD
4. x 10-9
DRIFT>
LIMIT
AND
SYSTEM
FAILURE
CMPT A FAILS
5. x 10
OR
1. x 10-16
CMPT B FAILS
-9
2. X 10 -8
CMPT C DRIFTS
3. x 10-9
4. x 10-9
REFERENCE
DRIFTS
1. x 10 -9
26
What is FMEA?
FMEA
z Failure Mode and Effects Analysis
FMECA
z Failure Mode Effects and Criticality
Analysis
27
What is FMEA?
Powerful prioritization tool
Inductive
High effective tool for identifying critical
quality attributes
High structured
Methodical
Breaks large complex designs into
manageable steps
Menson & Associates, Inc
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FMEA
Bottom up approach
Evaluates specific failures
Detailed analysis tool
z
Complements FTA
z
29
Advantages of FMEA
Less analyst dependent than FTA
Allows direct criticality assessment of
components
Valuable troubleshooting aid
Identifies areas of weak design
Identifies areas of high risk
Prevention planning
Identifies change requirements
Menson & Associates, Inc
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Disadvantages of FMEA
Does not consider operator error
Tedious
May not apply to all systems--especially
software
May require extensive testing to gain
information
May miss some failure modes
z
z
Time pressures
Information missing
31
Definitions
Criticality -- Weighting of hazard severity with the
probability of failure
Severity -- Seriousness of effect through its
impact of the system function
Occurrence -- Likelihood a specific failure will be
caused by a specific cause under current
controls
Verification -- Ability of the current evaluation
technique to detect potential failure during design
Detection -- Ability of the current manufacturing
controls to detect potential failure before
shipping
Menson & Associates, Inc
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Definitions
Risk Priority Number
(RPN)
z
33
FMEA Example
P O T E N T IA L F A IL U R E M O D E A N D E F F E C T S A N A L Y S IS
Im u n n o a s s a y D e v ic e
S u b s y s te m
C o m p o n e n t _ S u p p o r t_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ R e s p o n s ib ility
X
P ro c e s s
(r e v .)
C o re T e a m :
_______________________________________________________________________________________________
D e v ic e /
P o te n tia l
P o te n tia l
F u n c tio n
F a ilu r e
Mode
E ffe c t(s )
o f F a ilu r e
P o te n tia l
C a u s e (s )
o f F a ilu r e
C u rre n t
C o n tr o ls
R
P
N
R e c o m m e n d e d R e s p o n s ib ilit
A c tio n R e s u lts
y
A c tio n (s )
a n d T a rg e t
A c tio n s
R
C o m p le te D a te T a k e n S O D P
N
S u p p o rt
S y s te m
-
H o ld s A n tib o d y
S e p a r a te s
A n a ly te
F a ils to
S e p a r a te
a n a ly te
N o An sw er
E rro n e o u s
R e s u lt
F a ls e H i
F a ls e L o
7
9
W ro n g
M a te r ia l
60
3
3
5
5
105
135
D e v e lo p s C o lo r
34
Process FMEA
Identifies potential product-related process
failure modes
Assesses the potential customer effects of the
failures
Identifies the potential internal and external
manufacturing or assembly process causes
Identifies process variables on which to focus
controls for
z
z
z
z
reducing occurrence or
increasing detection of the failure conditions
35
Sources of Process
Defects?
Omitted processing
Processing errors
Errors setting up
work pieces
Missing parts
Wrong parts
Adjustment error
Processing wrong
work piece
Mis-operation
Equipment not set
up properly
Tools and fixtures
improperly prepared
36
FMEA Summary
Powerful tool for summarizing:
Important modes of failure
z Factors causing these failures
z Effects of these failures
z Risk prioritization
z Identifying plan to control and monitor
z Cataloging risk reduction activities
z
37
HAZOP
Haz ard and Op erability Study
Bottom up analysis
z Deviations from design intentions
z Systematic brainstorming based on guide
words
z
38
HAZOP
Guide Words
No/Not
z More
z Less
z As well as
z Other than
z
39
Hazop Model
Design Statement
Activity
Material
Transfer
Powder
Destination
Hopper
40
HAZOP
No
More
Transfer
Powder
Hopper
Valve closed
Line blocked
Pump broken
Pump fast
Tank empty
Valve closed
Hopper full
Other
than
Larger tank
Inaccurate
gage
Liquid
Wrong powder
41
HAZOP Plan
Guide Deviation Causes Risk
Action
NO
Interlock
Powder
flow
Valve
Low
closed
Line
Med
blocked
Pump
Med
broken
Who
Operator
training
PM
42
HACCP
Risk Management System
Biological Hazards
z Chemical Hazards
z Physical Hazards
z
Requires
Prerequisite Quality System Program
z Traditionally GMPs
z
43
HACCP Steps
1. Conduct hazard analysis and identify
2.
3.
4.
5.
6.
7.
preventive measures
Identify Critical Control Points.
Establish critical limits
Monitor each critical control point
Establish corrective action to be taken when
deviation occurs
Establish verification procedures
Establish record-keeping system
44
M o d ify S te p
S te p E lim in a te
or R educe
Yes
No
Yes
Is c o n tr o l
N e c e s s a ry fo r
S a fe ty
No
Excess
C o n ta m in a tio n
P o s s ib le
No
Yes
Yes
No
Subsequent
S te p s e lim in a te
or R educe
Yes
No
C r itic a l
C o n tro l
P o in t
S to p
Not a CCP
45
HACCP Worksheet
Firm Name:
Product Description:
Firm Address:
Material/
processin
g step
Identify potential
hazards
introduced,
controlled or
enhanced at this
step(1)
Are any
potential
safety
hazards
significant?
(Y/N)
Justify
your
decisions
for column
3.
What preventative
measures can be
applied to prevent
the significant
hazards?
Is this
step a
critical
control
point?
(Y/N)
Biological
Chemical
Physical
Menson & Associates, Inc
46
HACCP Plan
Firm Name:
Product Description:
Firm Address
(1)
Critical
Control
Point
(2)
Significan
t Hazards
(3)
Critical
Limits for
each
Action
Monitoring
(4)
What
(8)
Corrective
Actions
(5)
How
(6)
Frequency
(9)
Record
s
(10)
Verification
(7)
Who
47
Contact Information
Robert C. Menson, Phd
Menson & Associates, Inc
Quality Systems and Compliance
For FDA Regulated Industries
PO Box 480
Newport, RI 02840
Phone: 1.401.847.6320
Email: r.menson@alumni.duke.edu
Menson & Associates, Inc
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