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Risk Assessment Tools for

Identifying Hazards and


Evaluating Risks
Associated with
IVD Assays
Robert C. Menson, PhD
AACC Annual Meeting
Philadelphia, PA
22 July 2003

What Risks Must Be


Managed?
Risk to safety of
patients, users, handlers

Business

Regulatory

Product liability
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AACC 2003 Edutrak

Risk Evaluation
Risk Control

Management

Risk Analysis

Assessm
ent

Elements of the Risk


Management Process

Post-Production Information
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Risk Assessment Tools


Risk Matrix
FTA=Fault Tree Analysis
PHA= Preliminary Hazard Analysis
FME(C)A=Failure Mode Effects
(Criticality) Analysis
HAZOP=Hazard Operability Analysis
HACCP=Hazard Analysis and Critical
Control Point
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Applications of Risk
Analysis
Design
Production
Premarket Notifications
Complaints
MDR
Change Control
Failure Analysis
Etc.
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Risk Management
Life Cycle

Concept & Feasibility

Development

Scale-Up & Transfer

Production

System Level Assessment


Design Assessment
Process Assessment
Customer Feedback
Assessment

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Risk Management
& Design Control

Concept
& Feasibility

Design
Control

Requirements

Risk
Assessment

Preliminary
Hazard
Analysis

Menson & Associates, Inc

Planning

Plan

Development

Specifications

Risk
Management
Plan

Scale-Up & Transfer


Test
Methods &
Results

Detailed Analysis
(FMEA, FTA, HACCP, HAZOP)

AACC 2003 Edutrak

Production

Productions
Methods

Change
Records

Risk
Management
Report

Risk
Reviews

Key Concepts of Risk


The frequency of the potential harm;
z

How often the loss may occur;

The consequences of that loss;


z

How large the loss might be;

The perception of the loss;


z

How seriously the stakeholders view the


risk that might affect them.

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Risk Management Terms


Intended Use/Purpose
Harm
Hazard
Risk
Residual Risk
Tolerable Risk

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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

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Harm
Physical injury or damage to health of
people, or damage to property or the
environment.

ISO/IEC Guide 51:1999, definition 3.3


Guidelines for inclusion of safety aspects in
standards.
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Hazard
Potential source of Harm

ISO/IEC Guide 51:1999, definition 3.5


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Risk
Combination of the probability of
occurrence of harm and the severity of
harm.

ISO/IEC Guide 51:1999, definition 3.2


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Residual Risk
Risk remaining after protective
measures have been taken.

ISO/IEC Guide 51:1999, definition 3.9


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Tolerable Risk
Risk which is accepted in a given context
based on the current values of society.

ISO/IEC Guide 51:1999, definition 3.7

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Hazard Identification
Laws
Codes
Standards

Hazard
Identifcation

Events
MDRs
Accidents
Etc

List
of
Hazards

Brainstorming
PHA
FTA
FMEA

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Risk Matrix
Frequency

Severity
Negligible

Minor

Major

Severe

Frequent

Probable

Occasional

Remote

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Increasing Probability of Occurrence

ALARP Curve
Intolerable Region

ALARP
Broadly
Acceptable
Region

Maximum
Tolerable
Risk

Increasing Severity of Harm


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FMEA vs FTA
FMEA
Assumes
component or part
failure
Identifies
functional failure
as a result of part
failure

Menson & Associates, Inc

FTA
Assumes failure of
the functionality of
a product
Identifies
part/module failure
as cause of
functional failure

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FMEA vs. FTA


FMEA
Done for entire design

FTA
Too difficult to do for entire
design

Systematic way to
predict new problems

Systematic way to predict


causes for usually know
problems

A bottoms-up analysis

A top down analysis

People expect the same


results from FTA which
is not true

People do not expect the


same results from and FMEA

Menson & Associates, Inc

Often a fault tree is used for a


problem or an accident.

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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
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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

e.g. raw material outside specification


failure of safety switch
failure of test method

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FTA Basic Symbols


Basic Flow

FAULT

OR

AND

Fault in a box indicates that it is a


result of subsequent faults
Connects a preceding fault with a
subsequent fault that could cause a
failure
Connects two or more faults that
must occur simultaneously to cause
the preceding fault

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FTA During Design


P O O R F IT
IN H A N D

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

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FTA Lab Failure


Other

Patient Death

Outliers

Calibration
Error

OR

Lab Error

OR

Systematic

OR

Interference

Other

Random

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FTA During Reliability


OR

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

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2. X 10 -8

CMPT C DRIFTS

3. x 10-9

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4. x 10-9

REFERENCE
DRIFTS
1. x 10 -9

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What is FMEA?
FMEA
z Failure Mode and Effects Analysis

FMECA
z Failure Mode Effects and Criticality

Analysis

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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
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FMEA
Bottom up approach
Evaluates specific failures
Detailed analysis tool
z

Use in conjunction with PHA and FTA

Complements FTA
z

May lead to different failure results

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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
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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

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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
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Definitions
Risk Priority Number
(RPN)
z

= (S) x (O) x (D) or (V)


z
z Severity (S)
z
z Likelihood of occurrence (O)
z
z Likelihood of detection (D)
z
z Likelihood of verification (V)

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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

FMEA Num ber


Page
of
P re p a re d B y
F M E A D a te (O rig .)

(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

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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

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Sources of Process
Defects?
Omitted processing
Processing errors
Errors setting up
work pieces
Missing parts
Wrong parts

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Adjustment error
Processing wrong
work piece
Mis-operation
Equipment not set
up properly
Tools and fixtures
improperly prepared

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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

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HAZOP
Haz ard and Op erability Study
Bottom up analysis
z Deviations from design intentions
z Systematic brainstorming based on guide
words
z

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HAZOP
Guide Words
No/Not
z More
z Less
z As well as
z Other than
z

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Hazop Model
Design Statement
Activity

Material

Transfer

Powder

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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

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Larger tank
Inaccurate
gage
Liquid
Wrong powder

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HAZOP Plan
Guide Deviation Causes Risk

Action

NO

Interlock

Powder
flow

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Valve
Low
closed
Line
Med
blocked
Pump
Med
broken

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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

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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

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HACCP Decision Tree


P re v e n tiv e
M e a s u re s
E x is t

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

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S to p
Not a CCP

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HACCP Worksheet
Firm Name:

Product Description:

Firm Address:

Method of Storage and Distribution


Intended Use and Consumer

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
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HACCP Plan
Firm Name:

Product Description:

Firm Address

Method of Storage and Distribution:


Intended use and Consumer:

(1)
Critical
Control
Point

(2)
Significan
t Hazards

(3)
Critical
Limits for
each
Action

Monitoring

(4)
What

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(8)
Corrective
Actions

(5)
How

(6)
Frequency

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(9)
Record
s

(10)
Verification

(7)
Who

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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
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IVD Hazards, Patient Harm


and Risk Controls
Donald M. Powers, PhD
AACC Annual Meeting
Philadelphia, PA
22 July 2003

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