QUALITY MANAGEMENT

SYSTEMS

HACCP

Prof. EJOH Richard

1
 PLAN
 History
 What and why and how of HACCP
 Benefits of HACCP
 Prerequisite
 Seven HACCP principles
 Types of hazards
 14 steps

2
 History
HACCP was developed in the 1960’s by:
 Pillsbury Corporation
 US Army Laboratories at Natick
 N.A.S.A (National Aeronautics and Space Administration)
Food production processes needed to
eliminate pathogens and toxins

They required food with a quality level as

close to 100 % assurance
3
 History
Originally – Microbiological safety

Then later extended to Physical and

chemical hazards

4
 History
The need for an effective food safety
assurance method

 Food borne diseases remain one of the most

widespread public health problems in the
contemporary world, and an important cause of
reduced economic productivity, despite progress
in food science and technologies.

 The increasing incidence of many food borne

diseases, e.g. salmonellosis and
campylobacteriosis, in many regions of the world.

 Increased knowledge and awareness of the 5

The need for an effective food safety
assurance method
 The possibility of detecting minute amounts of
contaminants in food, due to advances in science.
 Emerging foodborne pathogens, e.g. Listeria
monocytogenes, verocytotoxîn producing E. coli, Campylobacter spp, food bome
.
trematodes, etc
 An increase in the number of vulnerable people.
 Increased awareness of the economic
consequences of food borne diseases.
 Industrialization and increased mass production,
leading to:
i) increased risks of food contamination; and
ii) considerably larger numbers of people
affected.
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The need for an effective food safety
assurance method
 Urbanization, leading to a more complex food
chain, and thus greater possibilities for food
contamination.
 New food technologies and processing methods,
causing concern either about the safety of the
products themselves or the eventual
consequences due to inappropriate handling
during preparation in households or food
service/catering establishments.
 Changing lifestyles, depicted by an increasing
number of people eating outside the home food
service or catering establishments, at street food
stalls, or in fast-food restaurants.
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The need for an effective food safety
assurance method
 Increased worldwide tourism and international
trade in foodstuffs, leading to a greater exposure
to food borne hazards from other areas.
 Increased contamination of the environment.
 Increased consumer awareness of food safety.
 Lack of or decreasing resources for food safety.

8
Hazard Analysis Critical Control
Point (HACCP)

Is a system of food control which helps to identify food safety and

helps to decide which are critical to consumer safety

9
What is HACCP?

• Powerful food safety management system

• Structured, preventive hazard analysis system

• Product safety through the identification and management of

hazards

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Hazard Analysis

• Identification of Hazards at each step in the process

• Identification of preventative measures

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Why adopt HACCP?
• Total Commitment of company - quality
• Company policy on continuous quality improvement
• Customer pressure
• Guarantees regarding product liability
• Cost reduction and efficient management by a
preventive approach
• reduce the incidence of food borne disease
• ensure a safe food supply for the population
• promote (facilitate) trade in food products
• promote tourism
• Government pressure

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 Stake holders in the
implementation of HACCP?
• industries involved in al stages of the food chain
• policy makers and planners who have the mandate to
facilitate the adoption of HACCP systems
• government authorities, including legislators, regulatory
food control officials and health education bodies
• academia, training and research institutes
• nongovernmental organizations
• Consumers

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Benefits of HACCP
• Systematic approach
• Preventative system
• Increases confidence
• Effective use of resources
• Cost effective control system
• Helps demonstrate due diligence
• Strengthens quality management systems
• Product quality dividend
• Facilitates regulatory / customer inspection

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Objective and contents
•Objective
• To introduce the HACCP system and its definitions and
terminology

•Contents
• The seven HACCP principles
• Explanation of logical steps in applying HACCP
• Training and partnership

Slide 15
Introducing the Codex guidelines
• HACCP has gained widespread international
acceptance as an important tool for improving food
safety management
• Codex guidelines on the application of HACCP
adopted in 1993 – revisions adopted in 1995, 1997
and 2003

Slide 16
HACCP guidelines
• Outline the internationally agreed seven principles
underlying HACCP
• Establish HACCP terminology and definitions
• Identify logical sequence of tasks that may be
followed in applying HACCP principles

Slide 17
Prerequisites to HACCP
• Food businesses must have programmes consistent
with the Codex General Principles of Food Hygiene in
place before considering application of HACCP
• Prerequisite programmes must
• Include training
• Be fully operational
• Be verified

Slide 18
Why prerequisite programmes?
• The purpose of HACCP is to allow businesses to focus
control at critical points
• Without well functioning prerequisite programmes
we risk either
• Identifying so many critical points that we cannot focus our
efforts and resources
• Not taking sufficient account of hazards that should have
been controlled by our GHPs....but are not

Slide 19
Specificity of HACCP
• Application of HACCP principles is the responsibility of
each individual business for each of its operations
• Generic HACCP models or codes of hygiene practice
can provide guidance - but for any specific application
critical control points need to be rigorously
determined

Slide 20
Specificity of HACCP
• HACCP plans are likely to vary among enterprises
making the same product because of differences in
• Ingredient source
• Formulation
• Processing equipment and methods
• Storage conditions
• Experience, knowledge and attitudes of personnel

Slide 21
Flexibility of HACCP
• HACCP systems must be appropriate to the business
under consideration
• Nature and size of operation
• Human and financial resources
• Infrastructure etc.
• All seven principles must be applied in any HACCP-
based system

Slide 22
Appropriate measures
Problems must be defined and solutions found
according to the context

Slide 23
Constraints facing small businesses
• Often do not have the resources or expertise on-site
to develop and implement an effective HACCP plan
• Availability of expert advice from other sources is
important
• Advice must be specific to products and processes
under consideration

Slide 24
HACCP training
• Training in HACCP principles and their application is
required by
• Personnel in industry
• Government
• Academia
• Joint training among different stakeholder groups
could facilitate dialogue and collaboration

Slide 25
Industry HACCP plans
• Working instructions and procedures should be
developed for operating personnel
• Specific training for personnel can be developed to
support the HACCP plan according to their defined
tasks

Slide 26
The seven HACCP principles (1)
1. Conduct a Hazard Analysis
1. A. Prepare a flow diagram
2. B. Identify & list hazards
3. C. Specify the control measures

2. Identify the CCP’s in the process using a

decision tree

3. Establish target level(s) and tolerances for each

CCP

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The seven HACCP principles (2)
4. Establish a monitoring system for each CCP
5. Establish corrective actions when CCP’s are
moving out of control

6. Establish documentation and records

7. Verify control is working and review scheme

regularly

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Food Safety Management

HACCP IS THE KEY

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Definitions (1)

Critical Control Point

• A process or action which if controlled will eliminate
or reduce a hazard to an acceptable level

Hazard
• A biological, chemical or Physical property with the
potential to cause harm

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Definitions (2)

Risk
• An estimate of the probability of a hazard occurring

Of concern
• A judgement of the seriousness of a failure to
control a critical point

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Definitions (3)

High concern
• A judgement that without control there is a life
threatening risk

Medium concern
• A judgement that there is a threat to the consumer
and the threat must be controlled

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Definitions (4)

Low concern
• A judgement that there is little threat to the consumer
but it may be advantageous to control it

Preventative measures
• Physical, chemical or other factors which can be used
to prevent or eliminate an identified hazard of reduce
it to acceptable levels

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 HACCP the 14 steps (1)
1. Define terms of reference
2. Select the HACCP team
3. Describe the product
4. Identify intended use
5. Construct a flow diagram
6. On-site verification of a flow diagram
7. List all hazards
8. Apply HACCP decision tree

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 HACCP the 14 steps (2)

9. Establish target levels and tolerances for CCP

10. Establish monitoring system for each CCP
11. Establish a corrective action plan
12. Establish a record keeping/documentation
13. Verification
14. Review the HACCP plan

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 WHY 14 instead of 12 steps

1. Define the Terms of Reference and the

Scope of the Plan as the very first step.
Do not be very ambitious

14) Review the HACCP Plan

-frequently…
Is the plan still appropriate to the process?

36
Barriers to successful HACCP
implementation
• Lack of understanding
• Resistance to change
• Lack of time
• Lack of resource
• Inadequate training

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 1. Define terms of reference
•What will be covered by the HACCP plan?
• A specific product?
• A specific production process?

Minimal requirements
• Until departure of factory?
• Until consumption?

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 2. Select the HACCP team
•Commitment of management.
• Awareness about contradiction between quality and production.
•Commitment of the whole company.
• ‘education’ of all employees at every level.
•Selecting the HACCP team.
• Knowledge about HACCP-system project manager
• quality assurance manager (knowledge on microbiological and
chemical hazards)
• production manager (knowledge on production, hygienic design
etc.)
• external advise (if needed)

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3. Describe the product
• A complete description of the product as defined in
co-operation with the intended client.
- Product - specific quality
description specifications
- process - labelling specifications
description - Storage conditions
- Physical product - Minimal shelf life
specification - Packaging
- chemical product - distribution
specification
- preparation before use
- Microbiological
- Intended consumer
specifications
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4. Identify intended use

• Part of extensive product specification

• Indicate specific groups of consumers:
• elderly
• infants
• pregnancy
• Might affect the ‘level of concern’ of some hazards

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5. Construct a flow diagram

• To provide a clear, simple description of the process

from receipt to distribution.
• A plan of the plant
• Storage
• All products (and ingredients)
• All inputs
• Equipment
• Waste products

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5. Construct a flow diagram (1)
SYMBOLS ACCORDING TO 1S0 9004-4

START or END

PROCESS

PROCESS - STEP

TEMPORARY / INTERMEDIATE STORAGE

INPUT OR OUTPUT 0F A PRODUCT

DOCUMENT
Registration form or Checklist
Working-instruction, Procedure or
System

CONTROL

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5. Construct a flow diagram
(2) SYMBOLS ACCORDING TO 1S0 9004-4
DOCUMENTS

No
DECISION

Yes

FLOW 0F MATERIAL &

INFORMATION OR
TRANSPORTATION

CONNECTOR

PROCESS PROCESS-STEP
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5. Construct a flow diagram (3)
START
Example of
Summary Process :
diagram Recieving
materials

Warehouse
Cold &
Storage
Frozen
storage

Processing

Packaging

Storage

END 45
 5. Construct a flow diagram (4)
Example of Detail Flow START

diagram 1 Red
indicate
s CCP
Working
Process-Step Check Instruction
Control or proced.
list

Rework
3

Process-
Packaging
Step
material

Rework (3)
3/4 By-product (4)
or waste

End-
product

46
END
6. On-site verification of a flow
diagram
• Detect differences between theory and practise
• All shifts
• Special attention to storage and delays

47
 7. List all hazards
For each processing step:
• Identify the potential species-related hazards
• Identify the potential process-related hazards
• Identify contamination points
• determine probability
• asses severity (risk)
• preventative measures

48
8. Apply HACCP decision tree: identify
CCP’s Hazard Analysis Critical Control Points
Factory: Sensient Dehydrated Flavors BV Product: Freeze dried green peas
Page 1 of 3 Process: Receiving, Transporting, Freeze drying, and Packaging
N Proc Hazard C Cause R Preventive measures Corrective Wh By Document/
r ess at A measures e who System
step * n m

1 Rece -Foreign P Contamination 2 Compliance to Laboratory 10 Lab RM

iving matter C prior to arrival 2 specification verification 10 head specificatio
-Chemical M Contamination 2 Regulated by law and Review supplier 10 Facil n
residue prior to arrival random checking every quality ity Procedure
Contaminatio Contamination year Laboratory mana of receiving
n of prior to arrival Compliance to verification ger
microorganis specification
m
2 Stora No hazard - - - - - - - -
ge
-
20C
3 Cool Contaminatio M Contamination 2 Good hygienic practice Implement GHP 10 Fore WI no.
-8C n of by employees man Checklist
microorganis Oper no.
m ator

4 Empt Foreign P Parts of RM 2 Apply GMP Prepare GMP 2 QA GMP

y matter packaging Carry out GMP Facil manual
material training (handling ity
of raw material mana
included) ger
Implement GMP
measures
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Risk assessment

High High Risk High Risk

Risk High Risk Medium High Metal
Detector
Low Severity Severity Severity
3 4 4
Medium Risk Medium Risk Medium
Low Severity Medium Risk
2 Severity High
3 Severity
4
Low Risk Low Risk Low Risk
Low Severity Medium High
Low 1 Severity Severity Sorting
Risk
2 3

Low Hazard High

Hazard
Severity
Severity 50
8. Apply HACCP decision tree: identify
CCP’s
Raw Material
CCP Decision Q1. IS THERE A NAMED HAZARD
Tree ASSOCIATED WITH THIS RAW MATERIAL?

Yes No Proceed to next raw

material

Q2. WILL PROCESSING, INCLUDIN CORRECT

CONSUMER USE, GUARANTEE REMOVAL OF
HAZARD OR REDUCTION TO A SAFE LEVEL?

Raw material
quality likely No
to be a CCP Yes
for this
hazard
Q3. IS THE STEP SPECIFICALLY DESIGN TO
ELIMINATE OR REDUCE THE LIKELY
OCURRENCE OF THE HAZARD TO AN
ACCEPTABLE LEVEL?
Raw
material Yes No Proceed to next raw
quality material
likely to be
a CCP for
this hazard
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Source: Raw Material Critical Control Point Decision Tree (Dillon et
8. Apply HACCP decision tree: identify
CCP’s Q1 IS THERE A HAZARD AT THIS PROCESS STEP?
General -WHAT IS IT?
CCP Decision No
Tree Yes
Not a CCP
Stop*

Q2 DO PREVENTIVE MEASURE (S) EXIST FOR THE IDENTIFIED

HAZARD?
Modify step, process or product
Yes No

Is control necessary at this step for safety? Yes

No
Not a CCP Stop*

Q3 IS THE STEP SPECIFICALLY DESIGNED TO ELIMINATE, REDUCE OR PREVENT THE

LIKELY OCCURRENCE OF THE HAZARD TO AN ACCEPTABLE LEVEL?

No
Yes
Q4 COULD CONTAMINATION OCCUR AT OR INCREASE TO UNACCEPTABLE LEVEL
(S)?

Yes
No
Not a CCP Stop*
Q5 WILL A SUBSEQUENT STEP OR ACTION ELIMINATE OR REDUCE THE HAZARD
CRITICAL
TO AN ACCEPTABLE LEVEL?
CONTROL
No POINT

Yes Not a CCP Stop*

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*Stop and proceed with the next hazard at current step or the next step in the described process
8. Apply HACCP decision tree: identify
CCP’s
IDENTIFICATION OF CCPs APPLYING THE DECISION TREE
Table 2: Identification of CCP’s

Company: Sensient Dehydrated Flavors BV Department(s): Quality Assurance

Product: Freeze dried green peas

N Process-step Hazard(s) Q Q Q Q Q CCP Description

r 1 2 3 4 5

1 Receiving Foreign matter Y Y N N - No RM Specification

Chemical Y N - - - No Regulated by law
residue Y Y N N - No RM Specification
Contamination
of
microbiological
pathogens

2 Storage at –20°C No hazard N - - - - No

3 Cool at -8°C Contamination Y Y N N - No Less time for m/o growth

of
microorganism

4 Empty Foreign matter Y Y N N - No GMP (Personal and Building

hygiene)

5 Storage (Hopper) Foreign matter Y Y N N - No GMP(Building hygiene)

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9. Establish target levels and
tolerances for CCP
• For each CCP:
• Target level
• Tolerance

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10. Establish monitoring system for
each CCP
• Monitoring should provide this information in time for
corrective action to be taken to regain control of the process
before there is a need to segregate or reject the product.
• Relatively easy and quickly
• temperature
• time
• moisture level
• metal detection
• pH
• aw
• visual inspection
• Microbiological analyses not appropriate for monitoring

55
11. Establish a corrective action
plan
• Action plan when Control is lost
• Who to be informed, reporting
• What to do with the product
• How did it occur and prevention in future
• Responsibility for decision making

56
 Monitoring system
LEVELS AND CRITICAL LIMITS FOR CCPs, MONITORING SYSTEM, CORRECTIVE ACTION
PLAN, AND VERIFICATION PROCEDURES
Step Why? Preventive Set value Procedur Frequency Corrective Registration Respon
C measures Tolerances e or action sibility
CP Critical Limit Instructio
n

1 Sorting Inadequate Prerequisit Insects, metal Working Constantly Stop Non Operator
protection against e program particles, glass instructio production conformanc QA manager
hazardous (Equipme pieces shall be n Check the e report Foreman
extraneous nt, absent Registrati sorting
material could Personnel) Other foreign on form machine
result in wood or matters e.g. Re-sort the
glass stones, wood, product
contamination of plastic, paper,
the peas insect
fragment 1 per
100 kg
maximum

2 Metal Improper removal Prerequisit 0.7 mm Working Every 4 Put on Non Operator
detector of metal from e program Ferrous instructio hours hold conformanc QA manager
magnet could (Equipme 1.2 mm non- n Pass the e report Foreman
result in metal nt, Ferrous Registrati product
contamination of Personnel) on form the last 4
the finished hours
product through
the
detector
Clean the
magnet

57
12. Establish a record keeping/documentation system

• For every procedure, process, control system keep a

record
• Use uniform formats
• for ‘in control’ and ‘out control’
• Also for suppliers

58
13. Verification
• Verification of the HACCP system:
• Methods to verify random sampling and analysing
(microbiological or chemical analyses)
• Intensified analysis of intermediate or final products
• analyse actual food safety during storage, distribution, end-
use
• Inspection of operation (internal audit)
• validation of critical limits
• consult experts, specialists
• review critical limits and corrective actions

59
14. Review and update the HACCP
plan
• Review or up-date the HACCP plan when:
• changes in raw material
• changes in product
• changes in processing
• changes in factory layout
• changes in cleaning and disinfection programme
• changes in packaging, storage or distribution
• changes at consumer site
• changes in hazard/risk knowledge

60
Case study
Case study 1
Explanation of the process steps of Milk reception
• 1)Churn reception
The churns are off loaded from the truck, put on the conveyor belt. The caps are removed and put
aside for cleaning. Samples of milk are taken from the churns. The product is tested on various
parameters like temperature, dirt, antibiotics, cell count, etc.
• 2) Tipping
The churns are turned and emptied. The churns are kept upside down so that the rest of the milk
drips back through a pipe in the weighing bowl.
• 3) Weighing.
The milk reception is divided into 2 sections, each section is equipped with a bowl to weigh the
incoming milk. Each weighing bowl represents the volume provided by I farmer. The weight will be
registered. A sieve might be integrated in this part; in this case, a separate process-step has to he
included
• 4) Filtering
Particles of dirt and pieces of foreign matter are captured through this filter.
Basically, it is a protective measure to prevent damage of equipments in the further processing.
• 5) Pumping
The milk has to be stored temporarily in a Tank. For this reason the milk has to be pumped through a
filter and a cooler into the tank.
• 6) Cooling
The milk will be cooled in a Plate Cooler to a temperature of 40C. It is necessary to maintain this
temperature to prevent the growth of spoilage- and pathogenic bacteria
• 7) Cold storage 61
Case study
• 8) Floating tank
To continue processing, the milk is passed through a Floating tank which is also the return tank of the
unpasteurised milk
• 9) Pumping
The milk will be pumped through the pasteuriser which consists of the clarificator, the regenerative
elements of the pasteuriser and the homogeniser.
• The pump consist of the control loop for pressure control, a pressure transmitter, a controller and a
pneumaticly controlled regulating valve.
• 10) Pre Heating
The milk is preheated up to 63 o C (in this example) with the objective to achieve the optimum
temperature for Clarification and Standardisation of the milk.
• I I) The Separator is used to separate the cream and carry out clarification simultaneously.
Extraneous matter has to be removed from the milk. If not, it may appear as sediment in the liquid milk
and as dirt in other products, especially after storage.
• Filtering is the simplest way to remove the impurities, but it also has the disadvantage that all the milk has
to pass through the dirt that accumulates on the filter and part of the extraneous matter will dissolve in
the milk that passes through the filter. Moreover, micro organisms will be washed out of dirt. Bacteria
present in clumps or in dirt particles will be dispersed throughout the milk. The milk and cream are
separated in the same equipment.
• 12) Pre Heating
Further preheating is necessary to carry out the homogenisation. The product is preheated to 68 0C which
is the required temperature for homogenisation.

62
Case study
• 14) Homogenisation
The objective of homogenisation is to reduce the size of the larger fat globules in
milk, normally varying from 0.1 to 15 micrometres to less than 2 micrometers. This
effectively prevents separation. Homogenisation takes place UPSTREAM in the
processing this means before pasteurisation.
• 15) Pasteurisation
This step is necessary to kill all vegetative pathogenic bacteria. Pasteurisation takes
place at 72.5 0C for 15 seconds
• 16) Cooling
The milk is cooled down in various stages in the regenerative of the pasteuriser.
Finally, the milk is cooled down with ice water in the same pasteuriser equipment.
The temperature to be achieved is 4 0C. This temperature is necessary to prevent
the growth of spoilage bacteria.
• 17) Cold storage
The milk is temporary stored in a tank at 4 0C awaiting further processing (Filling in
sachets). The cold storage is necessary to prevent the growth of Spoilage organism
and the development of Bacillus (Cereus) spores
• 18) Pumping
For further processing the milk is pumped to the filling machine.
• 19) Coding
The plastic is fed into the filling machine. Prior to the actual filling, the laminate is
foreseen with an expiry date which is contact printed on the plastic. 63
Case study
• 20) Sterilisation of plastic
The plastic is sterilised with an UV lamp. The machine will not start filling if the lamp is not working.
• 21) Filling
The milk is tilled in the Low density polyethylene plastic. The milk is filled in a I liter package.21)
Sealing
• 22) Sealing
The plastic is sealed longitudinal and on the top and bottom. At this stage samples are taken from
the very first sachets and checked on pH, dilution and other parameters to ensure the safety and
quality of the milk.
• 23) Secondary Packaging
The plastic are packed in returnable plastic containers.
These returnable plastic containers have to be cleaned & sanitised in advance.
• 24) Stacking
The plastic containers are stacked on a pallet.
• 25) Cold storage
The pallets are stored in the cold storage at a temperature of 4 OC awaiting dispatch.
• 26) Dispatch
The pallets are foreseen with a label with product information and loaded into the trucks
• 27) Distribution
The pasteurised milk is distributed within 1 to 2 hours to the various outlets in the city with
refrigerated trucks of 6 oC
64
65
QSE :The DANGER……………..?

66
 The Crocodile principles

• Identify
the
danger

67
The Crocodile principles

• Judge the risk

68
The Crocodile principles

• Screen
From danger

69
The Crocodile principles

• Eliminate
The
Danger

70
The Crocodile principles

• Search for an alternative

71
The Crocodile principles

• Personal
protection resources

72
The Crocodile principles

• And otherwise………..Run>>>>>

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