HACCP Introduction –

7 Principles

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

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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

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US Space Agency - NASA

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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”

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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?
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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

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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

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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.

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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

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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.

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Module 2

1. Introduction to HACCP

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

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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.

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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.
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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

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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

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Pre-requisite Programmes

Systems that are normally in place before the HACCP

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

• Codex General Principles

of Food Hygiene
• Relevant Codes of Practice
• Relevant Food Safety
Legislation

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Food Safety Pre-requisite Programmes

• Also called “Good Manufacturing Practices”

• Provides a sound foundation of HACCP
• Covers ‘Low Risk’ hazards
• Allows the HACCP plan to be focused &
specific
• Give a formal support network for HACCP
team
• Enables stream-lined HACCP plans

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Food Safety Programmes
What programmes do we have?

CROP to CONSUMER
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AIB and
Internal
Audits

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Other Pre-requisites
Vendor Assurance
• All raw materials

People Programmes
• Hygiene Training
• Site Experts and Trainers

Quality Management
• QA systems
QAS
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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
(IPS)
Plant Food
Safety
Systems
(CRP)
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Document Control
• Many documents in a
HACCP system
• Need to keep updated and
current
• Methods for withdrawal and
destruction of obsolete/out of
date documents
• Vital to ensure correct
records kept

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Record-keeping

• All monitoring forms for

CCPs or SCPs need to be
maintained in retrievable
format for 3 years (see local
requirements)
• Some records need only be
kept for shelf life + 6
months

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Traceability
• Ability to track where materials have
come from, and go to
• ‘One step up and one step down’
• All materials labelled by batch and
lot
• Segregate each batch and lot from
similar materials
• Trail to link raw material batches and
final product codes

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Calibration
• Not all technical equipment
electronically controlled
• Other equipment needs to be
calibrated by trained staff, e.g. :
✓ Laboratory analytical equipment
✓ On-line moisture meters
✓ Metal detectors
✓ Hand-held engineering test apparatus

• Without calibration, information

given may be inaccurate and our
records are worthless!

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Pre-requisite Programmes
Evaluation of Pre-requisites in place
• HACCP will work well if supported by other sound practices
• Need to evaluate these practices and activities
• Deficiencies and gaps in existing systems need to be
identified
• “Gap Analysis” will help to identify these so that a complete
framework exists on which to build the HACCP system

Effectiveness of Pre-requisites
• Completed pre-requisite programmes need to be validated in
the same way as HACCP to confirm their effectiveness
• Procedures for verification will include audit, inspections,
testing and analysis
• Documentation and records are required
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Role of Quality Pre-requisites
• Key quality systems need to be in place to
ensure an effective HACCP system
• HACCP plans should only cover food safety
not quality
• There is an essential relationship between
quality and food safety programmes, but……..

A HACCP plan must stick to its scope:

FOOD SAFETY
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What is HACCP?

Hazard Analysis & Critical Control Point

• Structured, preventative system

• Achieves Food Safety through:

❑ Hazard Identification

❑ Control of Hazards

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Why do we need HACCP?
• To protect the consumers of our products
• Eliminate Food Safety Risk to the business
• Legal Requirement in many countries (EU food
legislation applied from 1 January 2006)
• PepsiCo chosen system for Food Safety and Risk
Assessment:
• Simple
• Effective
• Understandable

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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

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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 !

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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" 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 !

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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!

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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!

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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!

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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!

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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”

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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”
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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

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Codex step 1

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

1. Assemble HACCP Team

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The HACCP team

• Process line representative(s)

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

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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

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Process Flow Charts

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Process Flow Charts

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

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

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Hazard Analysis

What does Codex say about Hazard Analysis ?

“The process of collecting and

evaluating information on
hazards and conditions leading
to their presence to decide
which are significant for food
safety and therefore should be
addressed in the HACCP plan”

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Collecting and evaluating information

• Brainstorming (use the HACCP team)
• Research (R&D and scientific and trade literature,
public health statistics)
• Analysis of available data (AIB reports , internal SOS
audits)
• Consumer complaints data
• Consumer surveys and reports
• Talking to people on the line
• Practical observation
• Shelf life and challenge studies
• Consider users and abusers

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What is a Hazard?

A HAZARD is...

A property which may cause a product

to be unsafe for consumption

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What are the three types of Hazard?

There are 3 main types of Hazard………

• Chemical

• Physical

• Biological
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Identify the Hazards at each step in the process

1. 2.
Peeling Peel

3.

Slicing

4. 5. 6.

Oil Frying Waste oil

7.

Seasoning

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3.

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Hazard Analysis
The process of hazard analysis is the result of:
 collecting information on hazards
 evaluating their significance

Using a Risk Assessment Model to

determine what goes into the HACCP
plan

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Risk assessment

A Risk Assessment Model should be used

so that the risk assessment can be as objective
as possible and to enable the ‘ranking’ of
hazards as to their importance

RISK = Severity x Frequency

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Is the Hazard significant?

1. Ask yourself:
“What will be the severity of the outcome?”

2. Ask yourself:
“How often does it happen, what is the frequency?”

These two together = Significance or RISK

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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
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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

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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.

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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
Specific Control Point • Will need a high level of checking. Magnets

• Also called “Pre-Requisites”

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

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‘Engineering out’ hazards - examples...

• Making alterations to equipment to prevent metal-to-

metal contact
• Modifying equipment to prevent Allergen cross-
contamination
• Re-designing equipment to make it easier to clean

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Preventing or reducing hazards - key questions

• Is this controlled by a pre-requisite GMP

programme?
• Is there equipment or processing which
prevents the hazards being present at later
stages?
• If we cannot prevent the hazard occurring, is
our only option to monitor potential
contamination to ensure that unsafe product
cannot leave our factory?

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What is a CCP?

Critical Control Points – CODEX

definition

“A step where control can be

applied and is essential to
prevent, eliminate or reduce a
food safety hazard to acceptable
levels”

CCP’s should be identified with the aid of a

Decision Tree and/or Risk Assessment Matrix

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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
CONTROL
NO
NO 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
Stop Stop
CCP CCP
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* = Proceed to next hazard or step in the described
process
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What CCPs could we expect at suppliers?

• Are the Metal Check Records completed fully?

• Are the correct Test Pieces used by a trained person?
• Is Corrective action taken if the test fails?
• Is action taken for reject product?

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CCP: Filtration
Critical Control Limit:
Present and intact filters/screens that prevent
Process Step: passage of objects >7mm.
Inline filtration at closest
point prior to filling. PepsiCo Operational Target:
Gatorade “Clear”: 15 µm
Gatorade “Cloudy”: 25-40
µm
Hazard: Juices without added pulp: 2.4 mm
Foreign objects > 7mm* Juices with added pulp: 6.4
mm

Monitoring:
Filters/Screens are inspected (i) present and (ii) intact, at a defined
frequency. Abnormal extraneous material with potential risks found on
Documentation: intact screens are noted for root cause and investigative proposes (i.e.
• Filter/Screen Inspection Log gaskets, plastic, glass, or metal fragments)
• Extraneous Material Log
• Hold and Release Records
• Corrective Action Records Corrective Action:
• Verification Records • 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
process, and replace with functional filter/screen.
• Notify designated quality employee to determine disposition of the
product. Establish statistical sampling plan to evaluate likelihood of
hazard in product and for the disposition of product. Corrective action
*FDA Compliance Policy Guide and disposition records must be documented.
#555.425 (FDA, 2001a).
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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

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Verification:
“verb; to establish truth or correctness by examination or demonstration”
(Oxford English Dictionary)
Which means…..

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 .

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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?)?

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