HACCP Introduction –

7 Principles

HACCP Introduction - 7 Principles VERSION 2, June 2008 Page 1

 HACCP Introduction
The History of HACCP
• The most common template (tool) for a
food safety plan follows principles laid out
under a program called HACCP
• Back in 1959, the US space agency NASA
faced a simple but mundane problem when
planning its first manned space flights:
How and what was it going to feed
astronauts ?
• The American food company Pillsbury
(now part of General Mills) was called into
help.
HACCP stands for Hazard Analysis & Critical Control Points

HACCP Introduction VERSION 1 : November 2010 2

 HACCP Introduction
US Space Agency - NASA

HACCP Introduction VERSION 1 : November 2010 3

 HACCP Introduction
US Space Agency - NASA
• How did they know that the Food
is Safe?
• Is End Product Testing Sufficient?
• How Many Samples to Test?
NASA concluded…..
“With standard QC..No way we could be sure that there
would not be a problem”
“Our present QC system is testing Raw Material and
Finished Product”
“Sampling and testing of each batch of food is impractical”

HACCP Introduction VERSION 1 : November 2010 4

 HACCP Introduction

Example

If 1 of 1000 batches was defective (0.1%)…..

If test 60 batches…..
If we say “Yes” for release…….>94% chance for release
Then still would miss defective batches!

How many finished batches do you test?

!
Raw Material Processing Finished Product Storage & Transport
QC? QC ? QC QC?
HACCP Introduction ? 1:
VERSION November 2010 5
 HACCP Introduction
HACCP Introduction
• HACCP was developed by Pillsbury Company (USA) in 1959
• The HACCP concept was pioneered in the 1960s by the Pillsbury Company,
the US Army and NASA as a collaborative development for the production of
safe foods for the United States space program.
• 1973 Pillsbury published comprehensive document on Hazard Analysis
• 1974 - FDA used HACCP principles in development of low-acid regulations.
• 1980’s – major food companies began to utilize HACCP Principles
• 1993 the Codex Alimentarius Commission adopted Guidelines for the
application of the Hazard Analysis Critical Control Point (HACCP) system –
to include 7 Principles. Further updates were provided in 1997.
• The HACCP system for food safety is now adopted as national guidelines or
required regulations in many countries.

This PepsiCo International HACCP Training is based on

1997 Codex and NACMCSF HACCP 1997 Guidelines

HACCP Introduction VERSION 1 : November 2010 6

CAC ( FAO + WHO) National Advisory Committee on Microbiological Criteria for Foods
 HACCP Introduction
HACCP

Systematic Approach for:

Identification and assessment of Hazards associated with
Manufacturing, Distribution, and use of Food Products as
well as the definition of Preventative Measures for their
Control

HACCP focuses solely on Significant Hazards that are

Reasonably Likely to result in unacceptable health
risk to consumers

HACCP Introduction VERSION 1 : November 2010 7

 HACCP Introduction
HACCP is a Tool

• Hazard Analysis Critical Control Points (HACCP) is a tool and

is not designed to be a stand alone program.

• To be effective, other tools must include: adherence to good

manufacturing practices, sanitation standard operating
procedures, and a personal hygiene program.

HACCP Introduction VERSION 1 : November 2010 8

 HACCP Introduction
Why is Food Safety so Important ?

• More countries will incorporate Food Safety principles

into their food legislations

• Food Safety Plans will be made mandatory for more

categories of products

• In the long run, food business operations not based

on Food Safety will not be acceptable by the industry,
consumers, government and other stakeholders

HACCP Introduction VERSION 1 : November 2010 9

 HACCP Introduction
Roles & Responsibilities

• Management commitment
• A clear understanding of the principles of
Food Safety system
• Provide for sufficient resources for
training
• Allocate resources for implementation
• Take ownership of the Food Safety
system
• The need to share experiences with other
sectors to ensure that adequate provision
is made for food safety.

HACCP Introduction VERSION 1 : November 2010 10

 HACCP Introduction
Module 2

1. Introduction to HACCP

2. Pre-requisite Programmes
3. Developing a HACCP System
4. What are the Hazards
5. Assessing the Risk
IPS
6. Critical Control Points (CCPs)
7. Validation, Verification and Review
8. Implementation, Communications and Maintenance

HACCP Introduction VERSION 1 : November 2010 11

 HACCP Introduction
Prerequisite Programs

Steps or procedures that control the

operational conditions within the food
establishment, allowing for environmental
conditions that are favorable for safe and
wholesome food manufacturing

Prerequisite programs are the foundation

for establishment of HACCP and guidelines
for production of safe products.

HACCP Introduction VERSION 1 : November 2010 12

 HACCP Introduction

How Do These Programs Fit Together ?

The Umbrella shows the

programs and how they
link together -now we will
look at some of these
programs in more detail

A common diagram of a quality /

food safety system: the Umbrella.
HACCP Introduction VERSION 1 : November 2010 13
 HACCP Introduction
Prerequisite Programs

Prerequisite Programs address operational

conditions providing a foundation of a HACCP
System
Manufacturing Facility Design
Receiving and Storage
Equipment Performance and Maintenance
Sanitation and Pest Control
Recall and Traceability
Personnel Training

HACCP Introduction VERSION 1 : November 2010 14

 HACCP Introduction
Prerequisite Programs
There are five (5) basic requirements :-
1. Documented – all aspects written down
(what, how, where, when, who)
2. Effectively implemented - monitored and
supervised
3. Assessed for effectiveness
4. Corrective action must be taken when
problems are identified
5. Records kept of monitoring & corrective action

HACCP Introduction VERSION 1 : November 2010 15

 HACCP Introduction
Pre-requisite Programmes

Systems that are normally in place before the HACCP

plan is developed to ensure the business is operating
according to:

•• Codex
CodexGeneral
GeneralPrinciples
Principles
of
of Food
FoodHygiene
Hygiene
•• Relevant
RelevantCodes
Codesof
of Practice
Practice
•• Relevant
RelevantFood
FoodSafety
Safety
Legislation
Legislation

HACCP Introduction VERSION 1 : November 2010 16

 HACCP Introduction
Food Safety Pre-requisite Programmes

•• Also
Alsocalled
called “Good
“GoodManufacturing
ManufacturingPractices”
Practices”
•• Provides
Providesaa sound
sound foundation
foundation of
ofHACCP
HACCP
•• Covers
Covers‘Low
‘Low Risk’
Risk’ hazards
hazards
•• Allows
Allowsthe
theHACCP
HACCPplanplanto
tobe
befocused
focused&&
specific
specific
•• Give
Giveaaformal
formal support
support network
networkfor
for HACCP
HACCP
team
team
•• Enables
Enablesstream-lined
stream-lined HACCP
HACCPplans
plans

HACCP Introduction VERSION 1 : November 2010 17

 HACCP Introduction
Food Safety Programmes
What programmes do we have?

CROP
CROPto
toCONSUMER
CONSUMER
HACCP Introduction VERSION 1 : November 2010 18
 HACCP Introduction

es
sit
rt
pe
Ex
P
CC
HA

AIB and
Internal
Audits
Ps
GM

HACCP Introduction VERSION 1 : November 2010 19

 HACCP Introduction
Other Pre-requisites
Vendor
VendorAssurance
Assurance
•• All
Allraw
rawmaterials
materials

People
PeopleProgrammes
Programmes
•• Hygiene
HygieneTraining
Training
•• Site
SiteExperts
Expertsand
andTrainers
Trainers

Quality
QualityManagement
Management
•• QA
QAsystems
systems QAS
HACCP Introduction VERSION 1 : November 2010 20
 HACCP Introduction
HACCP and Quality Management
Quality Management Document control
ensures the level of
QUALITY is consistently Record keeping
met
Traceability
HACCP & CRP
Plant
ensures the Calibration
manufacture of Quality
SAFE products Systems
Plant Food (IPS)
Safety
Systems
(CRP)
HACCP Introduction VERSION 1 : November 2010 21
 HACCP Introduction
Document Control
•• Many
Many documents
documents in in aa
HACCP
HACCP system
system
•• Need
Need to to keep
keep updated
updated and
and
current
current
•• Methods
Methods for for withdrawal
withdrawal and
and
destruction
destruction of of obsolete/out
obsolete/out of
of
date
date documents
documents
•• Vital
Vital to
to ensure
ensure correct
correct
records
records kept
kept
HACCP Introduction VERSION 1 : November 2010 22
 HACCP Introduction

Record-keeping

•• All
All monitoring
monitoring formsforms for for
CCPs
CCPs oror SCPs
SCPs needneed to to be
be
maintained
maintained in in retrievable
retrievable
format
format for
for 33 years
years (see
(see local
local
requirements)
requirements)
•• Some
Some records
records needneed only
only be
be
kept
kept for
for shelf
shelf life
life ++ 66
months
months

HACCP Introduction VERSION 1 : November 2010 23

 HACCP Introduction
Traceability
•• Ability
Abilityto
totrack
trackwhere
wherematerials
materialshave
have
come
comefrom,
from,and
and go
go to
to
•• ‘One
‘Onestep
stepupupand
andone
onestep
stepdown’
down’
•• All
Allmaterials
materialslabelled
labelled by
bybatch
batch and
and
lot
lot
•• Segregate
Segregateeach eachbatch
batchand
andlot
lot from
from
similar
similarmaterials
materials
•• Trail
Trail to
tolink
linkraw
raw material
materialbatches
batchesandand
final
finalproduct
productcodes
codes

HACCP Introduction VERSION 1 : November 2010 24

 HACCP Introduction
Calibration
•• Not
Notall
alltechnical
technical equipment
equipment
electronically
electronicallycontrolled
controlled
•• Other
Otherequipment
equipment needs
needsto
tobebe
calibrated
calibratedbybytrained
trainedstaff,
staff, e.g.
e.g.::
 Laboratory
Laboratoryanalytical
analyticalequipment
equipment
 On-line
On-linemoisture
moisturemeters
meters
 Metal
Metaldetectors
detectors
 Hand-held
Hand-heldengineering
engineeringtest
testapparatus
apparatus
•• Without
Without calibration,
calibration,information
information
given
givenmay
maybebeinaccurate
inaccurateand
andour
our
records
recordsare
areworthless!
worthless!

HACCP Introduction VERSION 1 : November 2010 25

 HACCP Introduction
Pre-requisite Programmes
Evaluation of Pre-requisites in place
••HACCP
HACCPwillwillwork
workwell
wellififsupported
supportedby byother
othersound
soundpractices
practices
••Need
Needtotoevaluate
evaluatethese
thesepractices
practicesand
andactivities
activities
••Deficiencies
Deficienciesand
andgaps
gapsin inexisting
existingsystems
systemsneedneedto
tobe
be
identified
identified
••“Gap
“GapAnalysis”
Analysis”will
willhelp
helpto toidentify
identifythese
thesesosothat
thataacomplete
complete
framework
frameworkexists
existson
onwhich
whichto tobuild
buildthe
theHACCP
HACCPsystem
system

Effectiveness of Pre-requisites
••Completed
Completedpre-requisite
pre-requisiteprogrammes
programmesneed needtotobebe validated
validatedin
in
the
thesame
sameway
wayas asHACCP
HACCPto toconfirm
confirmtheir
their effectiveness
effectiveness
••Procedures
Proceduresfor
forverification
verificationwill
willinclude
includeaudit,
audit,inspections,
inspections,
testing
testingand
andanalysis
analysis
••Documentation
Documentationandandrecords
recordsare
arerequired
required
HACCP Introduction VERSION 1 : November 2010 26
 HACCP Introduction
Role of Quality Pre-requisites
•• Key
Key quality
quality systems
systems need
need to to be
be in
in place
place to
to
ensure
ensure anan effective
effective HACCP
HACCP system
system
•• HACCP
HACCP plans
plans should
should only
only cover
cover food
food safety
safety
not
not quality
quality
•• There
There is
is an
an essential
essential relationship
relationship between
between
quality
quality and
and food
food safety
safety programmes,
programmes, but……..
but……..

A HACCP plan must stick to its scope:

FOOD SAFETY
HACCP Introduction VERSION 1 : November 2010 27
 HACCP Introduction

What is HACCP?

Hazard Analysis & Critical Control Point

•• Structured,
Structured, preventative
preventative system
system
•• Achieves
Achieves Food
Food Safety
Safety through:
through:
 Hazard
 Hazard Identification
Identification
 Control
 Control of
of Hazards
Hazards
HACCP Introduction VERSION 1 : November 2010 28
 HACCP Introduction
Why do we need HACCP?
•• To
Toprotect
protect the
theconsumers
consumers ofofour
our products
products
•• Eliminate
EliminateFood
FoodSafety
SafetyRisk
Risktoto the
thebusiness
business
•• Legal
LegalRequirement
Requirement ininmany
manycountries
countries (EU
(EUfood
food
legislation
legislationapplied
appliedfrom
from11January
January2006)
2006)
•• PepsiCo
PepsiCochosen
chosen system
system for
forFood
FoodSafety
Safetyand
andRisk
Risk
Assessment:
Assessment:
•• Simple
Simple
•• Effective
Effective
•• Understandable
Understandable

HACCP Introduction VERSION 1 : November 2010 29

 HACCP Introduction
Seven Principles of HACCP

Principle 1 Hazard Analysis

Principle 2 Identified CCP’s
Principle 3 Establish Critical Limits
Principle 4 Monitor CCP’s
Principle 5 Establish Corrective Action
Principle 6 Verification
Principle 7 Record Keeping

HACCP Introduction VERSION 1 : November 2010 30

 HACCP Introduction
Principle 1 - Hazard Analysis
• Identify the potential hazard(s) associated with
food production at all stages, from primary
production, processing, manufacture and
distribution until the point of consumption.
• A flow diagram of the complete process is
important in conducting the hazard analysis. The
significant hazards associated with each
specific step of the manufacturing process are
listed.

If you don’t know what the

hazards are, then find out !

HACCP Introduction VERSION 1 : November 2010 31

 HACCP Introduction
Principle 2 - Identified CCP’s

• Determine the points, procedures or

operational steps that can be controlled to
eliminate the hazard(s) or minimize its (their)
likelihood of occurrence.

• A "step"
step means any stage in food production
and/or manufacture including the receipt
and/or production of raw materials, transport,
formulation, processing, storage, etc.

Failure at a CCP has a direct

impact on food safety !

HACCP Introduction VERSION 1 : November 2010 32

 HACCP Introduction
Principle 3 - Establish Critical Limits
• Establish critical limit(s) which must be met
to ensure the CCP is under control.
• Critical limits are the operational boundaries
of the CCPs which control the food safety
hazard(s).
• All CCP's must have preventive measures
which are measurable!
• The criteria for the critical limits are
determined ahead of time in consultation with
competent authorities.
Unless you can MEASURE,
you can’t control!

HACCP Introduction VERSION 1 : November 2010 33

 HACCP Introduction
Principle - 4 Monitor CCP’s
• Establish a system to monitor control of the
CCP by scheduled testing or observations.

• It allows processors to assess trends before

a loss of control occurs. Adjustments can be
made while continuing the process.

• The monitoring interval must be adequate to

ensure reliable control of the process.

Monitoring is effective data

collection to enable decision making!

HACCP Introduction VERSION 1 : November 2010 34

 HACCP Introduction
Principle - 5 Establish Corrective Action
• Establish the corrective action to be taken
when monitoring indicates that a particular
CCP is not under control.
• HACCP is intended to prevent product or
process deviations. However, should loss of
control occur, there must be definite steps in
place for disposition of the product and for
correction of the process.
• These must be pre-planned and written
Failure requires: stopping the process,
hold the products, correcting the problem
and recording the action!

HACCP Introduction VERSION 1 : November 2010 35

 HACCP Introduction
Principle - 6 Verification

• Establish procedures for verification to

confirm that the HACCP system is working
effectively

• The system should be subject to periodic

revalidation using independent audits or
other verification procedures.

Proving the system is effective

and product is safe!

HACCP Introduction VERSION 1 : November 2010 36

 HACCP Introduction
Principle - 7 Record Keeping

• The HACCP system requires the preparation

and maintenance of a written HACCP plan
together with other documentation.

• Usually, the simplest record keeping system

possible to ensure effectiveness is the most
desirable.

Not documented -
it did
“Not documented, notnot
it did happen!
happen”

HACCP Introduction VERSION 1 : November 2010 37

 HACCP Introduction
7 Principles Summary
• Prevention rather than Inspection
• Systematic Approach
• Identifies Hazards in the Process
• Identifies Critical Points for Control and Monitoring
• Focus is on Safety and not Quality

Raw Processing Transportation Shelf life/

Processing Heat Treatment Filling and Storage Consumption
Material

“Farm Fork”
HACCP Introduction VERSION 1 : November 2010 38
 HACCP Introduction
12 Codex steps & 7 principles
7 12. Establish documentation & record keeping

6 11. Establish verification procedures

5 10. Establish corrective actions
4 9. Establish monitoring system for CCP’s
3 8. Establish critical limits for CCP’s

2 7. Determine Critical Control Points (CCP’s)

1 6. List hazards, conduct hazard analysis, consider control measures

5. On-site confirmation of flow diagram

4. Construct flow diagram

3. Identify intended use

2. Describe product

1. Assemble HACCP Team

HACCP Introduction VERSION 1 : November 2010 39
 HACCP Introduction

Codex step 1

• Multi-disciplined
• Individual Expertise
• HACCP-Trained
• Familiar with Process

1. Assemble HACCP Team

HACCP Introduction VERSION 1 : November 2010 40
 HACCP Introduction
The HACCP team

•• Process
Processline
linerepresentative(s)
representative(s)
•• Packaging
Packagingrepresentative
representative
•• Support
Supportservices
services(Engineers)
(Engineers)
•• Production
Productionmanagement
management representative
representative(e.g.
(e.g. FLM)
FLM)
• HACCP Who needs
Project to be part of the HACCP team?
Leader
• HACCP Project Leader
•• Subject
SubjectSpecialist
Specialist (Microbiologist,
(Microbiologist, Regulatory
Regulatory affairs)
affairs)

HACCP Introduction VERSION 1 : November 2010 41

 HACCP Introduction

Codex steps 2 to 4
Describe Product Intended Use Process Flow

• Specification
• Ingredients (incl. Allergens)
• Processing requirements
• Labelling requirements

4. Construct flow diagram

3. Identify intended use

2. Describe product

1. Assemble HACCP Team

HACCP Introduction VERSION 1 : November 2010 42
 HACCP Introduction
Process Flow Charts

HACCP Introduction VERSION 1 : November 2010 43

 HACCP Introduction
Process Flow Charts

1. 2.
Peeling Peel
Flow Charts
• Simple
3.

Slicing
• All inputs
• All outputs
4. 5. 6.
• All process steps
Oil Frying Waste oil • Numbered steps
• Describe process
7. • Not equipment
Seasoning

HACCP Introduction VERSION 1 : November 2010 44

 HACCP Introduction

Hazard Analysis

What does Codex say about Hazard Analysis ?

“The
“The process
process of of collecting
collecting andand
evaluating
evaluating information
information on on
hazards
hazards andand conditions
conditions leading
leading
to
to their
their presence
presence to to decide
decide
which
which are
are significant
significant forfor food
food
safety
safety and
and therefore
therefore should
should be be
addressed
addressed in in the
the HACCP
HACCP plan”
plan”

HACCP Introduction VERSION 1 : November 2010 45

 HACCP Introduction

Collecting and evaluating information

••Brainstorming
Brainstorming (use
(usethe
theHACCP
HACCPteam)
team)
••Research
Research(R&D
(R&Dand
andscientific
scientificand
andtrade
tradeliterature,
literature,
public
publichealth
healthstatistics)
statistics)
••Analysis
Analysisof
ofavailable
availabledata
data(AIB
(AIBreports
reports,,internal
internalSOS
SOS
audits)
audits)
••Consumer
Consumercomplaints
complaintsdata
data
••Consumer
Consumersurveys
surveysand
andreports
reports
••Talking
Talkingto
topeople
peopleon
onthe
theline
line
••Practical
Practicalobservation
observation
••Shelf
Shelflife
lifeand
andchallenge
challengestudies
studies
••Consider
Considerusers
usersand
andabusers
abusers

HACCP Introduction VERSION 1 : November 2010 46

 HACCP Introduction
What is a Hazard?

A HAZARD is...

A property which may cause a product

to be unsafe for consumption

HACCP Introduction VERSION 1 : November 2010 47

 HACCP Introduction
What are the three types of Hazard?

There are 3 main types of Hazard………

• Chemical

• Physical

• Biological
HACCP Introduction VERSION 1 : November 2010 48
 HACCP Introduction
Identify the Hazards at each step in the process

1. 2.
Peeling Peel

3.

Slicing

4. 5. 6.
Oil Frying Waste oil

7.

Seasoning

HACCP Introduction VERSION 1 : November 2010 49

 HACCP Introduction

3.

HACCP Introduction VERSION 1 : November 2010 50

 HACCP Introduction
Hazard Analysis
The
Theprocess
processofof hazard
hazard analysis
analysis isisthe
theresult
result of:
of:
collectinginformation
collecting information on
onhazards
hazards
 evaluating
 evaluating their
their significance
significance

Using
Using aa Risk
Risk Assessment
Assessment Model
Model to
to
determine
determine what
what goes
goes into
into the
the HACCP
HACCP
plan
plan
HACCP Introduction VERSION 1 : November 2010 51
 HACCP Introduction

Risk assessment

AA Risk
Risk Assessment
Assessment Model
Model should
should be
be used
used
so
so that
that the
the risk
risk assessment
assessment can
can be
be as
as objective
objective
as
as possible
possible and
and to
to enable
enable the
the ‘ranking’
‘ranking’ of
of
hazards
hazards as
as to
to their
their importance
importance

RISK
RISK == Severity
Severity xx Frequency
Frequency
HACCP Introduction VERSION 1 : November 2010 52
 HACCP Introduction
Is the Hazard significant?

1.
1.Ask
Ask yourself:
yourself:
“What
“Whatwill
will be
bethe
the severity
severityof
of the
theoutcome?”
outcome?”

2.
2.Ask
Ask yourself:
yourself:
“How
“How often
oftendoes
doesitithappen,
happen, what
whatis
isthe
the frequency?”
frequency?”

These
These two
two together
together == Significance
Significance or
or RISK
RISK

HACCP Introduction VERSION 1 : November 2010 53

 HACCP Introduction

Risk Assessment Model - Severity

Severity RISK = Severity x Frequency
Severity
if Multipl
controls Severity of affect if Hazard Occurs ier
fail
Mild disappointment to the consumer. May lead to a complaint, no business
Little
Damage interruption. Minor consequences.
1

Very minor medical treatment, (for example a broken tooth). Consumer

Damage
disappointed and likely to lead to a complaint to the Company.
2

Illness at home. Medical treatment not necessary. A disappointed consumer

Serious
Damage very likely to lead to a complaint to a regulatory authority.
3

Very Illness at home with medical treatment necessary. A very disappointed

Serious
consumer. A significant risk of proscecution.
4
Damage
Disaster Hospitalization required. Significant risk of proscecution. Media coverage.
Serious
Intervention by ‘Crisis management team’. Damage to ‘branded ‘ image.
5
Illness
Death. Top level ‘crisis management’ Certain risk of proscecution.
Catast-
rophic Destruction of ‘brand’
6
HACCP Introduction VERSION 1 : November 2010 54
 HACCP Introduction
Risk Assessment Model - Frequency

RISK = Severity x Frequency

Frequency
Probability of
hazard Multipl
occurring if
Frequency That Hazard Could Occur
ier
process fails
Almost
Impossible
Less than once a year, no history of it occurring 1

Un-Likely Very occasional, has been known to occur 2

Small Risk Isolated event that result after manual operations 3

Likely Product or operational factors that can be expected to be present 4

Certain Product or operational factors that the process is expected to control 5

HACCP Introduction VERSION 1 : November 2010 55

 HACCP Introduction

Guideline Actions from the Risk Assessment

Probably controlled by a Good Manufacturing Practice (GMP).

1 –5 Check nature of problem against existing pre-requisite
programmes

A consumer issue. With some risk to consumer safety.

6–9 Certainly needs control by a GMP, could be a
Specific Control Point (SCP)

Use Codex decision tree for hazards. Implications for corrective

10 – 16 action procedures. Report/resolve and record at next HACCP review.
Definitely either a GMP or an SCP, may be a CCP

Likely to be a Critical control point (CCP). Use Codex decision tree

16 + for hazards. Failure may result in food poisoning incidents or
Product Recall. Initiates special HACCP review.

HACCP Introduction VERSION 1 : November 2010 56

 HACCP Introduction
GMPs, SCPs and CCPs

• A step in the food production process where

CCP a control measure can be applied
• Must control the hazard to a safe level, or
Critical Control Point eliminate it completely.

• May occur at several points in the

SCP
process
• Do not give complete control of a Hazard Magnets
Specific Control Point
• Will need a high level of checking.

GMP • Also called “Pre-Requisites”

• Provide a sound foundation for HACCP
METAL
METAL
Good Manufacturing • Control ‘Low Risk’ hazards Contact
Practice

HACCP Introduction VERSION 1 : November 2010 57

 HACCP Introduction
‘Engineering out’ hazards - examples...

•• Making
Makingalterations
alterations to
toequipment
equipmenttotoprevent
preventmetal-to-
metal-to-
metal
metalcontact
contact
•• Modifying
Modifyingequipment
equipmentto toprevent
preventAllergen
Allergencross-
cross-
contamination
contamination
•• Re-designing
Re-designingequipment
equipmentto tomake
makeitit easier
easier to
toclean
clean

HACCP Introduction VERSION 1 : November 2010 58

 HACCP Introduction
Preventing or reducing hazards - key questions

•• Is
Isthis
thiscontrolled
controlledbyby aapre-requisite
pre-requisiteGMP
GMP
programme?
programme?
•• Is
Isthere
thereequipment
equipment or or processing
processingwhich
which
prevents
preventsthe thehazards
hazards being
beingpresent
present atat later
later
stages?
stages?
•• IfIfwe
wecannot
cannotprevent
prevent the
thehazard
hazardoccurring,
occurring,isis
our
our only
onlyoption
optionto
tomonitor
monitor potential
potential
contamination
contaminationto toensure
ensurethat
thatunsafe
unsafe product
product
cannot
cannotleave
leaveour
our factory?
factory?

HACCP Introduction VERSION 1 : November 2010 59

 HACCP Introduction
What is a CCP?

Critical Control Points – CODEX

definition

“A step
“A stepwhere
where control
control can
canbe
be
appliedand
applied andisisessential
essentialtoto
prevent, eliminate
prevent, eliminate ororreduce
reduce aa
foodsafety
food safetyhazard
hazard to
to acceptable
acceptable
levels”
levels”

CCP’sshould
CCP’s shouldbe
beidentified
identifiedwith
withthe
theaid
aidof
ofaa
DecisionTree
Decision Treeand/or
and/orRisk
RiskAssessment
AssessmentMatrix
Matrix

HACCP Introduction VERSION 1 : November 2010 60

 HACCP Introduction

CCP Decision Tree

Questions to be answered for each potential hazard at each process step. Do not proceed where
the hazard is managed by a pre-requisite or GMP programme:

Q1. Are the control

measures in place for the Modify process or product
hazard?
YES
YES NO Is the control at this step
NO Not a
necessary for food safety? CCP Stop
Q2. Is the process step *
specifically designed to
eliminate or reduce the hazard YES
to an acceptable level? CRITICAL
CONTRO
NO
NO L POINT
Q3. Could contamination with YES Q4. Will a subsequent process
the hazard occur at
step eliminate or reduce the
unacceptable level(s) or increase
hazard to an acceptable level?
to unacceptable level(s)?
NO Not a YES Not a
CCP Stop Stop
CCP
* *
HACCP Introduction
* = Proceed to next hazard or step in the described
VERSION 1 : November 2010 61

process
 HACCP Introduction
What CCPs could we expect at suppliers?

••Are
Arethe
theMetal
MetalCheck
CheckRecords
Recordscompleted
completedfully?
fully?
••Are
Arethe
thecorrect
correctTest
TestPieces
Piecesused
usedby
byaatrained
trainedperson?
person?
••Is
IsCorrective
Correctiveaction
actiontaken
takenififthe
thetest
testfails?
fails?
••Is
Isaction
actiontaken
takenfor
forreject
rejectproduct?
product?

Portfolio Risk Table

HACCP Introduction VERSION 1 : November 2010 62

 HACCP Introduction
CCP: Filtration
Critical
CriticalControl
ControlLimit:
Limit:
Present
Presentand
andintact
intactfilters/screens
filters/screensthat
thatprevent
prevent
Process Step: passage of objects >7mm.
passage of objects >7mm.
Inline filtration at closest
point prior to filling. PepsiCo
PepsiCoOperational
OperationalTarget:
Target:
Gatorade
Gatorade“Clear”: 15
“Clear”: 15µm
µm
Gatorade
Gatorade“Cloudy”: 25-40
“Cloudy”: 25-40
µm
µm
Juices
Hazard: Juiceswithout
withoutadded
addedpulp:
pulp: 2.4
2.4mm
mm
Juices
Juiceswith
withadded
addedpulp: 6.4
Foreign objects > 7mm* mm
pulp: 6.4
mm

Documentation:
Documentation:
• Filter/Screen Inspection Log
• Filter/Screen Inspection Log
• Extraneous Material Log
• Extraneous Material Log
• Hold and Release Records
• Hold and Release Records
• Corrective Action Records
• Corrective Action Records
• Verification Records
• Verification Records
*FDA Compliance Policy Guide
#555.425 (FDA, 2001a).
HACCP Introduction
Monitoring:
Monitoring:
Filters/Screens are inspected (i) present and (ii) intact, at a defined
Filters/Screens are inspected (i) present and (ii) intact, at a defined
frequency. Abnormal extraneous material with potential risks found on
frequency. Abnormal extraneous material with potential risks found on
intact screens are noted for root cause and investigative proposes (i.e.
intact screens are noted for root cause and investigative proposes (i.e.
gaskets, plastic, glass, or metal fragments)
gaskets, plastic, glass, or metal fragments)
Corrective
CorrectiveAction: Action:
• If filter/screen is not (i) present or (ii) intact during verification, put the
• If filter/screen is not (i) present or (ii) intact during verification, put the
product produced since the last acceptable check on hold, stop the
product produced since the last acceptable check on hold, stop the
process, and replace with functional filter/screen.
process, and replace with functional filter/screen.
• Notify designated quality employee to determine disposition of the
• Notify designated quality employee to determine disposition of the
product. Establish statistical sampling plan to evaluate likelihood of
product. Establish statistical sampling plan to evaluate likelihood of
hazard in product and for the disposition of product. Corrective action
hazard in product and for the disposition of product. Corrective action
and disposition records must be documented.
and disposition records must be documented.
VERSION 1 : November 2010 63
 HACCP Introduction
Validation:
“verb; to validate, ratify; valid, sound, defensible of reasonable objection”
Which means…..
(Oxford English Dictionary)
Obtaining evidence that the elements of the
HACCP plan are effective

• The HACCP team will check that the HACCP study is valid and that if
correctly followed will deliver safe food.
• The aims of this audit are:
 To ensure the scope of the HACCP is correct and still valid.
 To ensure the HACCP study has been completed correctly
according to the seven Codex principles.
 To ensure that any changes to the process, product or equipment
have been reflected in the HACCP study

HACCP Introduction VERSION 1 : November 2010 64

 HACCP Introduction
Verification:
“verb; to establish truth or correctness by examination or demonstration”

Which
(Oxford Englishmeans…..
Dictionary)

Monitoring and Evaluating compliance

with the HACCP plan
• This is focussed on how well the CCPs are being controlled.
• The aims of this audit are:
 To check that monitoring records are complete for each CCP.
 To check that the person completing the CCP checks and records
has been trained.
 To check that any equipment used for monitoring CCPs has been
calibrated.
 To check that appropriate corrective action has been taken where
any of the CCP checks have failed.

HACCP Introduction VERSION 1 : November 2010 65

 HACCP Introduction

Ten point Checklist for HACCP

HACCP Control Plan

 1. Was a multi-disciplined team used for the

HACCP study?
 2. Are Product descriptions and intended
use details available for all products?
 3. Is the Process Flow Diagram up to date
and signed off as correct?
 4. Are all hazards listed including:
Biological, Physical and Chemical (including
Allergens)?
 5. Have Hazards been risk assessed?
 6. Have CCPs been identified using a
decision tree or expert panel?
 7. Are all CCPs controlled to within the
Critical limits and monitored frequently?
 8. Have corrective actions been taken for
any CCP failures?
 9. Are verification/validation procedures
completed frequently (at last annually)?
 10. Is the HACCP plan up to date (reviewed
annually?)?

HACCP Introduction VERSION 1 : November 2010 66