Workshop on hygiene requirements for
milk and dairy production
AGR 56024
organised in co-operation with
The Palestine Standards Institution
Venue:
Ramallah, Palestine
May, 19th-20th, 2014
Processing milk products
Application of HACCP principles
Dr. Conrad Maas, Germany
Traditional food production
 Shelf life (“keepability”) and organoleptic
quality oriented
 Production methods based on experience
 Safety taken for granted, later reliance on
end - product testing
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Traditional regulatory measures
“Food Control”
• Based on :
 observation and “testing” of samples
 detection of spoilage (“unhealthy”) and fraud
• The system was:
 retroactive, and
 provided little health protection, particularly
regarding pathogenic organisms
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Traditional food control
•
"Snap-shot"
inspection for
compliance with
GHP/GMP
• +
• End - product
testing
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Traditional food inspection

“Flash” observation of hygiene

Checking compliance with regulations

Regulations on GMP used often vague terms
such as: “as appropriate”
“when necessary”


•
Little distinction between trivial and important
matters concerning safety
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End - product testing
 not
reliable
 costly
 waste of food
 cost of analysis
 time
consuming
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Tools for Food Safety
Food Safety Monitoring
System
Quality Monitoring Sysem
Long Term Quality
Management Strategy
e.g. ISO 9000, 22000
e.g. TQM
General
Specific
Specifications
Specifications
All Quality Elements
Food Safety
Management Plan
GMP/GHP
(product/process
=Basic Condition
specific)
Quality System
= HACCP-Plan
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Critical Control Point
versus
Quality Control Point
• CCP
• QCP
• Food quality
• Decision tree not
applicable
• Critical limit not
appropriate
• Likely to be every step
or activity
– Significant food
hazard
– Decision tree may be
useful
– Critical limit must be
set
– Preferably only a Ramallah
few may 2014
European legislation
• Preambulum Reg. EC/852/2004
(Food Hygiene)
•
•
“The application of hazard analysis and critical control
point (HACCP) principles to primary production is not yet
generally feasible.”
•
“The HACCP system is an instrument to help food business
operators attain a higher standard of food safety.”
•
“The HACCP requirements should take account of the principles
contained in the Codex Alimentarius. They should provide
sufficient flexibility to be applicable in all situations, including in
small businesses.”
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HACCP systeme versa
Hygiene management
HACCP
systeme
Hygiene
management
means preventive
food safety
management
is a precondition
for the
implementation of
HACCP
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HACCP CONCEPT
Hazard analysis, risk assessment,
determination of CCP´s, control
measures
cleaning
and
disinfection
pest control
temperature
measurement
personal
hygiene
No cross
contamination
Proper layout and make up of building
technical preconditions
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conditions for a successful managing
of the HACCP-concept
• not very complicated
• not involved into the quality system
• HACCP must be easily to manage
• simple handling
• effective control of relevant hazards
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• The company-specific HACCP plan must clearly
specify the products covered by this study (scope,
boundaries). They may use the legal name, its
own product codes or other pertinent description.
• The HACCP team must identify a complete list of
all the characteristics, ingredients and production
techniques for this type of product(s). This
information should allow the HACCP team to
define the final specifications.
– product identification
– composition
– physico-chemical composition (e.g. water
activity (aw), acidity)
– the main processing effect on microbial growth
(e.g. type of heat treatment)
– the packaging (MAP, material)
– the date of minimum shelf life, the conditions
for storage
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• Target group:
– Average consumers
– Young, Old, Pregnant and
Immunodeficient
– Only people suffering from cows' milk
allergy or lactose intolerance, should
not consume these products
• Storage:
– Condition: ambient versus chilled
– Shelf life: 7 days, 30 days, 4 months,
6-9 months
• Usage
– Kitchen (bakery): cheese, cream
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Example: UHT-LDP & UHT Cream
Raw Milk
Reception
Storage Raw Milk
Standardization
Intermediate storage
Cream
Mixing ingredients
Intermediate storage
UHT-treatment +
homogenisation
Intermediate aseptic storage
Aseptic filling
Paletisation
Storage
Transport
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Distribution
risk assessment
3. detection of occurence of damages
probability of occurence is to be estimated:
a) conditions within the relevant environment
b) crossing of organisms in the environment
c) kind and quantity of the organisms
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‘Risk’ terminology
‘Risk’ terminology
Negligible
So rare that it does not merit to be
considered
Very low
Very rare but cannot be excluded
Low
Rare but does occur
Medium
Occurs regularly
High
Occurs very often
Very high
Events occur almost certainly
Examples from (OIE, 2004; EFSA, 2006):
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Documentation
as few as possible, as much as needed
HACCP-plan
 responsabilities
 description of the product
 intended use of the product
 hazards to control
 flow diagram of CCP´s
 critical limits
 corrective actions
 sampling plan
 documentation of results
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Quality control
• A system for maintaining standards
• in production or in a product,
• especially by inspecting samples
• of the product
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Number of reported cases
Incidence of infectious enteritis
and typhoid fever in Germany
250,000
Infectious enteritis
200,000
150,000
100,000
Typhoid and paratyphoid fevers
50,000
0
1946 1951 1956 1961 1966 1971 1976 1981 1986 1991
Years
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2014
Increased incidence of
foodborne diseases in UK
50
45
40
35
30
25
20
15
10
5
0
*
Laboratory reports of gastrointestinal infections in
England and Wales
Campylobacters
Salmonellae
Rotavirus
Shigellae
Giardia
Cryptosporidia
80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95
* x 1000
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Emergence of foodborne
diseases
E.coli O157/H7 in UK
ngland & Wales Northern Ireland
1
Laboratory Isolation of
E.coli O157:H7
6
9
500
50
76
No. of Isolations
89
450
49
0
119
1
250
1
400
362
2
473
1
390
2
350
411
3
m FBD surveillance DB
300
Scotland
England & Wales
250
Northern Ireland
200
150
100
50
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Increased awareness of
the economic consequences of
foodborne diseases

medical care costs

loss of productivity

loss of food

reduced food trade

decrease in tourism
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Increase in the number
of vulnerable people

elderly

immunocompromised individuals

pregnant women

infants and young children

undernourished individuals
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Urbanization
• A longer and more
complex food
chain;
Agricultural production
Processing & manufacturing
Transport & distribution
• thus greater
• opportunities for
• food contamination
Food service &
catering
establishments
Household food
preparation
Transport & serving
Consumption
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Street food
vending
operations
Changing lifestyles

increase in food service and
mass catering establishments
(including street food vendors)

travel

role of women

migrationRamallah may 2014

Changing lifestyles

increase in food service and
mass catering establishments
(including street food vendors)

travel

role of women

migrationRamallah may 2014

Objectives of application of the
HACCP system
Prevention of foodborne illness
Reduction of costs
of food analyses
More efficient
quality assurance
system
Protection of reputation
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Reduction of
losses due to
product recall
Control in “space age”

Preventative

Having control over something

Ensuring safety and quality of
products by “building - in” and
“engineering out”

Minimizing risks
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HACCP concept

Identifying potential food safety
problems

Determining how and where these
can be controlled or prevented

Describing what to do and training
the personnel

Implementation
and
recording
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Traditional food safety
assurance system
• GMP/GHP
• for safe food
production
• +
• End- product testing
• for obtaining assurance
of
• safety
•
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Microbiological process control
• Having control over
• conditions
• which may lead to
• unacceptable
• or growth, survival, spread
• contamination
• with / of undesirable microorganism
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Example of processing for safety
Pasteurization
•






Safety assured by adequate
heating time & temperature
Reliance on monitoring
to detect deviations
Timely adjustments and
corrective actions
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Background for HACCP
This is Risk!
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37
Background for HACCP
This is Risk Management!
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38
Setting up of a HACCP system
Food business operators (FBO’s)
equipment for maintaining a HACCP system
experiences in registration and approval of
establishments
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H A C C P
HACCP should help to identify, analyse and
control severe health risks
preventing security system for the
production of safe food
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7 principles of HACCP
principle 1
Hazard Analysis
principle 2
Critical Control Points (CCP)
principle 3
Critical Limits
principle 4
Monitoring
principle 5
Corrective Actions
principle 6
Verification
principle 7
Documentation
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prerequisites for the implementation of HACCP
hygiene plan
 GHP must already be followed
 hygiene measures and testing should be
documented after plan
HACCP-Team
 microbiological, epidemiological knowledge
 chemical, toxicological knowledge
 technological knowledge
description of production and processes
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conditions for a successful managing of the
HACCP-concept
• not complicated
• not involved into the quality system
• HACCP must be easy to manage
• simple handling
• effective control of relevant hazards
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conditions for a successful managing of
HACCP
introduction of HACCP
understanding of terminology
personal and establishment conditions
preparation of the staff
training
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further conditions for the implementation
of a HACCP-system
good hygiene practice
cooperation, patience
supported by management
acceptance by the personnel
involvement of the staff
time/costs/benefit
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What Is HACCP?
Hazard Analysis and Critical Control Point
The HACCP system is solely related to
FOOD SAFETY and not PRODUCT
QUALITY
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HACCP based system
HACCP does not replace GHP
or existing documentation
but it is more effective
and aims at a better food safety
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• Example Guideline in cold stores:
•
•
•
•
•
- unloading and acceptance
- handling (e.g. freezing)
- internal transport
- storing
- loading and delivery
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•
•
•
•
•
•
freezing
melting
labelling
quality check
delivery
unpack
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food
frozen
cooled
open
meat/fish
cooled
packed
meat/fish
point of
reception
CP
CCP
cont. micro
CCP
cont. micro
handling
CP
CCP
cont. micro
CCP
cont. micro
internal
transport
CP
CP
CP
storing
CP
CP
CP
loading
CP
CP
CP
delivery
CP
CP
CP
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7 principles of HACCP
principle 1
Hazard Analysis
principle 2
principle 3
principle 4
principle 5
principle 6
principle 7
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Prinzip 1: hazard analysis
Hazard Identification
 Identify SIGNIFICANT biological, chemical
or physical hazards and their causes at
each step in the production process
and their potential to damage consumers’ health
Risk Assessment
 Probability of occurence
 importance for health
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Principle I: Hazard analysis (and risk assessment)
Chemical hazards
Contaminants
 heavy metals
 PCB
 radio nuklides
Residues
 animal drugs
 c + disinfection
 pesticides
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Principle I: Hazard analysis (and risk assessment)
biological hazards
Bacteria
• Salmonella
• Staphylococcus aureus (toxin)
• E. coli
• Listeria monocytogenes
• Bacillus cereus (toxin)
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Principle I: Hazard analysis (and risk assessment)
biological hazards
Bacteria
• Yersinia enterocolitica
• Vibrio cholerae
•
• Campylobacter jejuni
• Mycobacterium bovis
• Brucella spp.
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Principle I: Hazard analysis (and risk assessment)
biological hazards
Yeasts/Moulds
•Mycotoxins
• esp. aflatoxins
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Factors affecting growth of
bacteria in food

Temperature

Time

pH

Water activity (aw)

Oxygen tension

Preservatives

Microbial interactions
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mh 35
Temperature range for growth of
pathogenic bacteria
Temperature°C
Salmonella
Campylobacter
E. coli
S. aureus
C. botulinum (proteolytic)
C. botulinum (non-proteolytic)
B. cereus
1=
Mesophilic
2 = Psychrotrophic
mh 36
Min.
Opt.
Max.
5
30
10
6.5
10
3.3
4
35 - 37
42
37
37 - 40
47
47
48
48
50
25 - 37
48 - 501
432
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30 - 35
Principle I: Hazard analysis (and risk assessment)
Physical hazards
Splinters
 metal
 glass
 wood
other foreign bodies
 synthetic materials
 pieces of metal
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risk of bacterial infections and
intoxications of or by food
source of contaminations
 ecology of micro-organisms
Contamination
way of contamination
 production of raw materials
 treatment / technology
 hygiene (personnel, plant etc.)
Propagation
intrinsic factors
 aw-value, pH-value
extrinsic factors
 temperature
 atmospheric influences
process factors
 influence of production technology
on intrinsic and extrinsic factors
implicit parameters
 interaction of micro-organisms
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risk assessment
3. detection of occurence of damages
probability of occurence is to be estimated:
a) conditions within the relevant environment
b) crossing of organisms in the environment
c) kind and quantity of the organisms
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7 principles of HACCP
principle 1
Hazard Analysis
principle 2
Critical Control Points
(CCP)
principle 3
principle 4
principle 5
principle 6
principle 7
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Decision tree
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principle 2: implementing of CCP´s
CCP: step at which a hazard can be controlled in a
process
CCP must fulfill following criteria:
 specific for the hazard
 measures must eliminate the hazard
 elimination must be verifiable
 suitable corrective actions
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principle 2: implementing of CCP´s
Microbiological testing is seldom an effective mean
of monitoring CCPs (time to obtain results).
Monitoring of CCPs can at best be accomplished
through physical and chemical tests and through
visual observations.
Microbiological criteria may verify that the HACCP
system is working.
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7 principles of HACCP
principle 1
Hazard Analysis
principle 2
Critical Control Points (CCP)
principle 3
Critical Limits
principle 4
principle 5
principle 6
principle 7
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principle 3: limits for CCP´s
limits:
conditions allowing to control a process
limits must not be exceeded or
undergone
by the results products can be devided into
acceptable and unacceptable
As an optimum limits can be measured or checked
continuously and the keeping of the limits can be
assured!
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7 principles of HACCP
principle 1
Hazard Analysis
principle 2
Critical Control Points (CCP)
principle 3
Critical Limits
principle 4
Monitoring
principle 5
principle 6
principle 7
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principle 4: monitoring system of CCP´s
Monitoring plan
scope: clarification, whether limits
are kept
z. B. check of temperature/time
documentation in the control plan!
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7 principles of HACCP
principle 1
Hazard Analysis
principle 2
Critical Control Points (CCP)
principle 3
Critical Limits
principle 4
Monitoring
principle 5
Corrective Actions
principle 6
principle 7
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principle 5: corrective action
In case of unsatisfaction of a CCP
 exceeding a certain limit
Aim:Identification and elimination
of the deviation
Advice for managing of bad products
correction/rework
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principle 5: corrective action
Purpose:
to prevent foods which may be hazardous
from reaching consumers.
Therefore:
 determine and correct the cause of noncompliance
 determine the disposition of non-compliant
product
 record the corrective actions that have been
taken
 Specific corrective actions should be developed in
may 2014
advance for each CCP Ramallah
and included
into the HACCP plan
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7 principles of HACCP
principle 1
Hazard Analysis
principle 2
Critical Control Points (CCP)
principle 3
Critical Limits
principle 4
Monitoring
principle 5
Corrective Actions
principle 6
Verification
principle 7
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principle 6: verification
checking the suitibility of the HACCP-concept
 testing of end-products
checking of the documentation
intern and extern audits
 if needed revision of the systeme
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principle 6: verification
 must be sufficient to for the confirmation of
HACCP
 frequency of verification depends
on the business
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7 principles of HACCP
principle 1
Hazard Analysis
principle 2
Critical Control Points (CCP)
principle 3
Critical Limits
principle 4
Monitoring
principle 5
Corrective Actions
principle 6
Verification
principle 7
Documentation
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principle 7: documentation
as few as possible, as much as needed
HACCP-plan
 responsabilities
 description of the product
 intended use of the product
 hazards to control
 flow diagram of CCP´s
 critical limits
 corrective actions
 testing systeme
 documentation of results
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•
checking at CP in certain intervals
•
suitable checking devices
•
checking odour, colour, shape of food
•
check of the packaging
•
SOP for these checks
•
documentation of these checks
Controlled by responsible person
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Example Milk :
Brucellosis, Tuberculosis
Is the hazard relevant ?
Hazard analysis
Risk assessment
Heat treatment
Controlling, CCP
On-line automatic
Temperature measurement
Monitoring
72-75°C / 15-30 sec.
Automatic return
of the milk (3-way valve)
Phosphatase determination
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Critical limits
Corrective measure
Verification
documentation
 existing advices, production plans
 documentation of temperatures
 own checks (microbiolog. etc.)
 on-site-visits, audits
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• temperature
• temperature measurement devices
• documentation of temperature
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Bacterial growth curve
Toxic
- - - - - - - - - - - -+++++++++++
Spoils
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
9
8
+ + +
Time to spoilage
7
6
5
4
3
2
1
0
Time
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Lag phase Log phase
mh 12
Stationary phase
obstacles for HACCP I
production is not HACCP compatible
too many CCPs
too few CCPs
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obstacles for HACCP II:
wrong principles
no control possible
no correction possible
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obstacles for HACCP III:
HACCP-systeme too complicated
GHP is insufficient
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advantages of the HACCP-concept
 improved health protection
 common standards
 preparation of a chain of security
 transparency and traceability
 fulfilling FBO’s responsibility
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disadvantages of the HACCP-concept
 time and efforts for the introduction
 know how needed, as well for small businesses
 expenses for documentation
 documentation does not guarantee
a living systeme
 checks by the competent authority ineffective
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Thank you for listening!
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