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Section 3 Three Slides On Page - Design 2022
Section 3 Three Slides On Page - Design 2022
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Design & Development
8.3 Design and development of
products and services (ISO 9001:2015)
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
Design Inputs
Considerations
functional and performance requirements
(Customer needs)
statutory and regulatory requirements;
information derived from previous similar
design and development activities;
standards or codes of practice that the
organization has committed to implement;
potential consequences of failure due to
the nature of the products and services
(Robust design techniques: FMEA, QFD,
DFX, DFSS)
Topic Covered
Robust Design
FMEA
QFD
DFX
DFSS
6
Robust Design
The idea behind robust design is to improve the
quality of a product by minimizing the effects of
variation without eliminating the causes.
Robust design has minimum sensitivity to variations in
uncontrollable factors.
Noise
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Noise Factors
Outer Noise
Consumer’s usage conditions, Temperature change,
Shock, Vibration, Humidity, Light
Inner Noise
Deterioration, Rusting
Between Product Noise
Piece to piece variation where they are supposed to
be the same
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Ways to Reduce the Effect of Noise
Reduce Noise
Make choices that reduce the variation
in the noise.
Interactions
Make choices that reduce the slope of
the transfer function
Nonlinear Effects
For non-linear transfer functions use a
flatter portion of the curve
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Larger-is-better (yield)
S/N = −10 *log(mean square of resiprocal response)
= −10 *log(Σ(1/Y2)/n)
15
Topic Covered
Robust Design
FMEA
QFD
DFX
DFSS
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FMEA
Failure Mode and Effect Analysis:
The FMEA is a design tool used to
systematically analyze potential failures
and identify the their effects.
Identify
Prioritize
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FMEA Concept
FMEA
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FMEA
Concept
FMEA
Design Process
FMEA FMEA
- System
Production Assembly
- Subsystem
FMEA FMEA
- Component
FMEA
- System - System
- Subsystem - Subsystem
- Component - Component
FMEA FMEA
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FMEA
Failure Mode and Effect Analysis:
It is proactive tool (Before the problem
happens / not the after effect analysis)
It is a living document
20
FMEA
Process / Failure Mode Failure Severity Cause(s) of Occurrence Current Detection R Recommende
Requirement Effect (1-10) failure mode (1-10) Controls (1-10) P d actions
(KPIVs) N
Perfume (1-10) • Unclear (1-10) • Review and 4 96
Making • Inconsistent specificatio 3 approve
quality 8 n specification
• Receiving • Wrong by design
ingredients
• Substandard 6 • Third party 4 192
material certification
supplied by • In house test
supplier lab
• Mixing
21
FMEA
Risk Priority Number (RPN)
Severity (1-10) x Occurrence (1-10) x
Detection (1-10)
Severity
Severity 1 – No effect/ client might not
even notice it
Severity 10 – Serious safety hazard
without warning
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FMEA
Occurrence
Occurrence 1 – Rare event, no data of such
type of failure in past
Occurrence 10 – Failure almost inevitable
Detection
Detection 1 – Current system almost
certainly detect the problem (automation)
Detection 10 – Current system can not
detect the problem
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FMEA
Identify key process steps
Identify failure mode
Identify failure effects/severity
Identify causes/occurrence
Identify controls /detection
Calculate Risk Priority Number (RPN)
Prioritize by RPN – Higher RPN first
Determine action plan
Recalculate RPN
24
FMEA
Update FMEA when there is plan to
change / actual change of :
Design
Application
Material
Process
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Design for X
Activities to
Design for Manufacturing/Manufacturability (DFM)
Design for Assembly
Design for Maintainability
Design for Cost
Design for Logistics
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Design for Manufacturing/Assembly
Activities to
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Design for Reliability
Summary
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Design for X
80% of costs are fixed at the time of design
Conflicting Xs with each other – Integrated product
development teams
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Design for X
Some common actions
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DFSS Methodologies
DMADV
DMADOV
IDOV
36
DFSS Methodologies
DMADV
DMADOV
IDOV
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DMADV
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DMADOV
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IDOV
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Design Review
Reviews are conducted as the design
work progresses. Some industries use
30%, 60% and 90% design completion
stages for design reviews.
Multi discipline review for complex
products or projects.
42
Design Review
Areas of review (typical examples):
Design meets product objective
Assumptions validation
Competitor analysis
Alternative approaches
Demonstration of model (3D) or product
Risks and uncertainties
Budget, schedule, safety, quality concerns
Layout and maintainability
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Voice of the customer (VOC)
Voice of the customer (VOC) is a term used to describe the
in-depth process of capturing a customer's expectations,
preferences and aversions. (stated and unstated)
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Cost
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Technical Drawing and Specifications
Views – First angle and Third angle
projections
Title Block
Lines
Dimensioning
Tolerances
GD&T (Geometric Dimensioning and
Tolerancing)
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First and Third Angle Projection
Four quadrants
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First and Third Angle Projection
Third Angle Projection
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Title Block
Typical Title Block information:
Organization’s name/logo
Drawing title
Drawing number
Sheet number
Revision number
Approvals – Prepared, Checked, Approved
Units of measurement
Scale
First Angle/Third Angle projection
Other details as applicable: Tolerances,
Finish, Weight, Heat treatment etc.
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Title Block
Additional information:
Bill of materials
Notes
Zones – e.g. A5, B3
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Lines
Construction line – light solid
Hidden details
Centerline
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Lines
Dimension line
Break line
Cutting Plane
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Dimensioning
Chain Dimensioning
Where the accumulation of tolerances
does not affect the functional
requirements.
Parallel Dimensioning
A number of single dimension lines are
drawn parallel to one another
Running Dimensioning
Similar to parallel dimensioning
Dimensions are superimposed in one line.
Origin point should be marked.
62
Tolerances
Tolerance provide the lowest and the
highest value a dimension can have.
Two common ways to show tolerance
Plus /minus tolerance
Upper and lower value
Tolerances allow for interchangeability
of parts.
63
Tolerances
Least Material Condition (LMC)
The limit defined by a tolerance or combination
of tolerances that exists on or inside the
material of a feature(s).
Maximum Material Condition (MMC)
The limit defined by a tolerance or combination
of tolerances that exists on or outside the
material of a feature(s).
64
Tolerances
Clearance Fit
When there is extra space between two
mating parts.
Interference Fit
When two mating parts interfere when
assembled.
Transition Fit
It can be clearance or interference fit
depending upon the actual dimension.
65
GD&T Symbols
Geometric Dimensioning and
Tolerancing
Structured language of symbols, rules and
definitions that allows the geometrical
features of mechanical parts to be defined
according to functional limits of
imperfection.
Provides universal language for supplier,
checker, and the buyer.
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Simple Example of a Sheet
1000 mm +/- 5 mm
500 mm +/- 5 mm
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Simple Example of a Glass Sheet
1000 mm +/- 5 mm
500 mm +/- 5 mm
Flatness:
Two Sets of Parallel Planes
where the entire referenced
surface must lie.
0.2
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Datum
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Datum Reference Frame
Three perpendicular datum planes.
z
y
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GD&T Symbols
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MMC and LMC
Maximum Material Condition (MMC)
refers to a feature-of-size that contains
the greatest amount of material, yet
remains within its tolerance zone. Some
examples of MMC include:
– Smallest hole diameter
– Largest pin diameter
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Review Design Review
reviews are conducted to evaluate
the ability of the results of design
Design and development to meet
requirements
Control
Validation Verification
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Verification
ISO 9001:2015 Requirement: (8.3.4c)
verification activities are conducted to
ensure that the design and development
outputs meet the input requirements;
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Validation
ISO 9001:2015 Requirement: (8.3.4d)
validation activities are conducted to
ensure that the resulting products and
services meet the requirements for the
specified application or intended use;
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Review, Verification & Validation
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Predictive and Preventive Maintenance
Preventive Predictive
Regular maintenance to lessen Determined by the condition of
the chance of failure equipment
Example: Car service, oil change Example: regular vibration
monitoring, oil analysis, thermal
imaging to discover trends.
Triggered by time, meter or Triggered by condition
event
Cost effective but needs initial
investment
85
Reliability
The probability that an item will perform
a required function without failure under
stated conditions for a stated period of
time.
86
Reliability
Why do products fail?
Design might not be capable to perform the
intended function (wrong assumption,
design defect)
Manufacturing Defects
Lack of controls such as inspection
Components overstressed
Variation in components
Wear out, Poor maintenance
87
Reliability
Measuring or quantifying Reliability
MTTF
MTTF – Mean Time to Failure
MTBF MTBF – Mean Time Between Failures
MTTR MTTR – Mean Time to Repair
Availability
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MTTF
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90
Reliability
MTBF
MTTF MTTR
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Mean Time Between Failures (MTBF)
MTBF follows exponential distribution
during constant failure rate period.
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MTBF
MTTF MTTR
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Availability
A = MTBF / (MTBF+MTTR)
A = (Uptime) / (Uptime + downtime)
MTBF
MTTF MTTR
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Reliability Models
IIIE-3 Identify, define, and distinguish
between the basic elements of reliability
models such as exponential, Weibull,
and bathtub curve.
Bathtub curve
Exponential
Weibull
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1200
1000
800
Reliability 600
Test
400
200
0
0 1 2 3 4 5 6 7 8 9
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Year Units Working Hazard Rate
0 1000
1 950 0.05
2 910 0.04
3 880 0.03
4 860 0.02
5 840 0.02
6 820 0.02
7 800 0.02
8 750 0.06
Reliability 9 690 0.08 The hazard function is the
instantaneous rate of failure at a given
Test time.
Hazard Function
1200 0.09
0.08
1000
0.07
800 0.06
0.05
600
0.04
400 0.03
0.02
200
0.01
0 0.00
0 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9
100
Hazard Functions
The hazard function is the instantaneous
rate of failure at a given time.
Hazard Function
Three functions and associated 0.09
0.08
distribution 0.07
0.06
101
Bathtub Curve
Pattern of failure over time for non-
repairable items (Hazard rate vs time)
Three types of hazards:
Decreasing hazard rates are observed in items
which become less likely to fail as their
survival time. (Burn-in)
A constant hazard rate is characteristic of
failures which are caused by the application of
loads in excess of the design strength, at a
constant average rate.
Wearout failure modes follow an increasing
hazard rate
102
Bathtub Curve
Pattern of failure over time for
repairable items (Failure Rate vs time)
Three types of hazards:
Repairable systems can show a decreasing
failure rate when reliability is improved by
progressive repair, as defective parts which
fail relatively early are replaced by good
parts.
A constant hazard rate is characteristic of
failures which are caused by the application of
loads in excess of the design strength, at a
constant average rate.
Wearout failure modes follow an increasing
hazard rate
103
Hazard Functions
Three functions and associated Hazard Function
distribution
0.09
0.08
than 1
0.04
0.03
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1000
800
600
400
200
0
0 1 2 3 4 5 6 7 8 9
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Back to Basics - Probability
Simple example of probability - Venn
Diagram
Joint Probability:
Union: Probability that events A or B occur:
P(A ∪ B)
Intersection: Probability that events A and B
occur: P(A ∩ B)
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Probability
Mutually Exclusive Events: When two
events cannot occur at the same time
107
Probability
Rule of Addition
The probability that Event A or Event B occurs
=
Probability that Event A occurs
+
Probability that Event B occurs
-
Probability that both Events A and B occur
108
Probability
Rule of Multiplication:
The probability that Events A and B both occur
=
Probability that Event A occurs
x
Probability that Event B occurs, given that A has
occurred
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Reliability
Reliability is defined as the probability
that a device will perform its intended
function during a specified period of
time under stated conditions.
110
Reliability
The reliability of a missile is 0.80. If two
missiles is fired, what is the probability
of at least one hit? (Assume both
missiles are independence)
Approach 1:
P(A ∪ B) = P(A) + P(B) - P(A ∩ B)
P(A ∩ B) = P(A) P(B|A)
Approach 2: Tree diagram
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Reliability
The reliability of a missile is 0.80. If two
missiles is fired, what is the probability
of at least one hit? (Assume both
missiles are independence)
Approach 1:
P(A ∪ B) = P(A) + P(B) - P(A ∩ B)
P(A ∩ B) = P(A) P(B|A)
Approach 2: Tree diagram
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System Reliability
Series R1=0.90 R2=0.80
System works if all components work
R series = R1 x R2 x R3 …. Rn
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System Reliability
Parallel
System works if any one components
works R1=0.90
R parallel = 1 – (1 - R1 ) x (1 - R2) x (1 - R3)….
(1 – Rn) R2=0.80
114
System Reliability
Calculate the reliability of the below
system: R5=0.90
R2=0.90 R6=0.90
R1=0.80 R4=0.50
R3=0.90 R7=0.20
R2,3 = 1 – (1 – 0.90 ) x (1 – 0.90)
115
System Reliability
Calculate the reliability of the below system if 3 out of 4
should be working for the system to work?
R1=0.90 Probability of zero failures
P(0) = 0.90 x 0.90 x 0.90 x 0.90 = 0.65
R2=0.90 P(1) = 0.10 x 0.90 x 0.90 x 0.90 x 4 = 0.29
R3=0.90
Reliability = 0.65 + 0.29 = 0.94
R4=0.90
Probability for parallel components
R5,6,7,8 = 1 – (1 – 0.90 ) x (1 – 0.90) x (1 – 0.90) x (1 – 0.90) = 0.9999
116
Weibull Distribution
It’s a continuous variable distribution.
(Just like Normal distribution is)
Probability Density Function
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Hazard Functions
The hazard function is the instantaneous
rate of failure at a given time.
Three functions and associated
distribution
Decreasing hazard function: Weibull
distribution with a shape parameter (k) less
than 1
Constant hazard function: Exponential
distribution/ Weibull distribution with k = 1
Increasing hazard function: Weibull
distribution, with k > 1
118
Weibull Distribution
k (kappa) is the shape parameter,
k = 1 for constant hazard. At k = 1 Weibull
distribution reduces to Exponential
Distribution
⁄
P(t)= e
λ (lamba) is the scale parameter.
Failure Rate (λ) = 1 / MTBF
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Weibull Distribution
Question: My car has a constant failure rate of 10-4 per hr. What is
the probability of driving 1000 hr without failure.
= 𝑒 10 = 𝑒 10
⁄ −4 −4
P(t)= e = 𝑒 =𝑒 . = 0.904
121
Weibull Distribution
Question: At 1000 hr. my car has the reliability of 0.904. Assuming
the reliability to follow the exponential distribution, what is the
MTBF?
⁄
P(t)= e
⁄
0.904 = e
ln(0.904) = -1000/MTBF
-0.100 = -1000/MTBF
MTBF = 1000/0.1 = 10,000
122
Weibull Distribution
Question: The MTTF for a computer mouse is 500 hrs. What
percent of mouse will survive 1500 hrs of service? Assume
constant rate of failure (or exponential distribution)
123
Assessment Tools
Reliability / Safety / Hazard Assessment Tools:
Failure Mode and Effects Analysis (FMEA)
Failure Mode Effects and Criticality Analysis
(FMECA)
Fault Tree Analysis (FTA)
124
FMEA
Failure Mode and Effect Analysis:
The FMEA is a design tool used to
systematically analyze potential failures
and identify their effects.
Identify
Prioritize
125
FMEA Concept
FMEA
126
FMEA
Concept
FMEA
Design Process
FMEA FMEA
- System
Production Assembly
- Subsystem
FMEA FMEA
- Component
FMEA
- System - System
- Subsystem - Subsystem
- Component - Component
FMEA FMEA
127
FMEA
Failure Mode and Effect Analysis:
It is proactive tool (Before the problem
happens / not the after effect analysis)
It is a living document
128
FMEA
Process / Failure Mode Failure Severity Cause(s) of Occurrence Current Detection R Recommende
Requirement Effect (1-10) failure mode (1-10) Controls (1-10) P d actions
(KPIVs) N
Perfume (1-10) • Unclear (1-10) • Review and 4 96
Making • Inconsistent specificatio 3 approve
quality 8 n specification
• Receiving • Wrong by design
ingredients
• Substandard 6 • Third party 4 192
material certification
supplied by • In house test
supplier lab
• Mixing
129
FMEA
Risk Priority Number (RPN)
Severity (1-10) x Occurrence (1-10) x
Detection (1-10)
Severity
Severity 1 – No effect/ client might not
even notice it
Severity 10 – Serious safety hazard
without warning
130
FMEA
Occurrence
Occurrence 1 – Rare event, no data of such
type of failure in past
Occurrence 10 – Failure almost inevitable
Detection
Detection 1 – Current system almost
certainly detect the problem (automation)
Detection 10 – Current system can not
detect the problem
131
FMEA
Identify key process steps
Identify failure mode
Identify failure effects/severity
Identify causes/occurrence
Identify controls /detection
Calculate Risk Priority Number (RPN)
Prioritize by RPN – Higher RPN first
Determine action plan
Recalculate RPN
132
FMEA
Update FMEA when there is plan to
change / actual change of :
Design
Application
Material
Process
133
FMECA
FMEA and FMECA are basically similar.
FMECA extends FMEA by including a
criticality analysis.
134
135
Fault Tree Analysis
AND gate
Output occurs if all inputs occur.
If any of the inputs fail, the system fail. OR gate AND gate
represents series connection.
R1=0.90 R2=0.80
R series = R1 x R2 x R3 …. Rn
136
R2=0.80
137
138
Fault Tree Analysis
Find the reliability of this system,
assuming the reliability of each input as
0.9
0.9999948
OR gate AND gate
0.81
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dFMEA, pFMEA, uFMEA
dFMEA = Design FMEA
pFMEA = Process FMEA
uFMEA = Use FMEA
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dFMEA, pFMEA, uFMEA
Use FMEA is used to assure that the use-related risks are
considered and mitigated to an acceptable level.
Some examples of use “Failure Modes”
Window blinds with string pose a risk of child strangulation.
Drawer Chests Tip-Over and Entrapment Hazards
Medicines - Failure to Meet Child Resistant Packaging Requirement
145
Hazard Analysis
Risk vs Hazard
"Hazard" is the harm that something can cause.
The harm may be physical injury, damage to health, property and/or the environment.
Hazard is an intrinsic or "built-in" characteristic.
146
HACCP
Hazard Analysis and Critical Control Points, or HACCP
HACCP is a systematic preventive approach to food safety from biological,
chemical, and physical hazards in production processes that can cause the
finished product to be unsafe and designs measures to reduce these risks to
a safe level. (Wikipedia)
The focus of HACCP is the prevention of hazards.
147
HACCP
Hazard Analysis and Critical Control Points, or HACCP
The first step (principle) of HACCP is to conduct a Hazard Analysis.
Plan to determine the food safety hazards and identify the preventive measures
the plan can apply to control these hazards.
A food safety hazard is any biological, chemical, or physical property that may
cause a food to be unsafe for human consumption
148
HACCP
Hazard Analysis and Critical Control Points, or HACCP
Hazard: A biological, chemical, or physical agent that is reasonably likely to
cause illness or injury in the absence of its control.
Hazard Analysis: The process of collecting and evaluating the information
on hazards associated with the food under consideration to decide which are
significant and must be addressed in the HACCP plan.
149
HACCP
Hazard Analysis and Critical Control Points, or HACCP
When performing hazard analysis (for food processing facility) consider
these factors:
Ingredients (microbiological, physical or chemical hazards)
Processing (cooking, pasteurizing)
Facility and equipment being used
Sanitization
Storage and Packaging
etc.
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