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BUILDING CAPACITY OF SME’s ON EU FOOD & PACKAGING STANDARDS
The HACCP approach
Thessaloniki 11.06.2012
Food safety
safe guarding food from anything that could harm
the health of consumers
Legal requirement
Safety throughout food chain
Businesses must identify and control risks to food
safety (HACCP approach)
Industry anxious to maintain safety and quality
of their products
Media reaction in case of failure
Consumer concerns
Safe foods - benefits
• Satisfied/loyal
customers/consumers
• Good reputation
• Less wastage
• Good working
conditions
• Compliance with
legislation
• Compliance with
customer requirements
The cost of poor hygiene
• Food poisoning
• Bad reputation
• Customer/consumer
complaints
• Poor working conditions
• Penalties:
• Legal
• customers
Protect the consumer by preventing
contamination
Be proactive & reactive
Meet legislative requirements to produce safe
food
Meet customer demands and expectations
Brand protection
Own business and customers
Industry reputation
not a competitive issue
A documented system to ensure the safety of
foods
FSMS could be certified with an international
Standard (optional)
ISO 22000:2005
BRC
IFS
GFSI
The legal requirement is to establish a
procedure to ensure safety according to the
HACCP principles
• It is the acronym for Hazard Analysis & Critical
Control Points
• HACCP is a system which
– identifies,
– evaluates, and
– controls
hazards which are significant for food safety
In other words…..
A systematic approach…
… to identify hazards & risks…
Associated with a)the Manufacture,
Distribution & Use of a Food
And b) with DEFINITION of
preventive measures
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Effectiveness as a PREVENTIVE safety tool
Participative nature (everyone is involved)
Open system (easy to understand)
Adaptability (to any process)
Worldwide acceptance (Codex)
• Both inspection & sampling/testing approaches
are NOT effective in a food business where
hazards are non uniformly distributed
• Preventive process control based approach is
the only sensible route to assure product safety
• It takes time to obtain microbiological results
• Cannot hold in-process material waiting for test
results
• Expense & technical expertise required to
perform microbiological tests.
• Testing Only Identifies EFFECTS not the CAUSES
• Many SAMPLES are needed to obtain meaningful
information about a Batch of Food
• Be Overly Prescriptive
• Dilute Resources by Targeting BOTH Safety &
Quality Issues
• Be Viewed as a means to FIX design problems
created during product development.
Assemble the
HACCP team
Define the
Terms of
Reference
Prerequisite
programmes
• Multidisciplinary team
• Chairperson
• Experts (QA, R&D, Production,
Maintenance, etc)
• List products included in scope of plan
• List "Hazards to Consider“ Associated
with the selected Product/Process
• Procedures, including Good
Manufacturing Practices, that address
operational conditions providing the
foundation for the HACCP system
1.
2.
3.
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5.
Conduct a Hazard Analysis
Determine the Critical Control Points
Establish Critical Limits
Set up methods to monitor Critical Control Points.
Establish Corrective Actions to be taken when the process
exceeds the critical limits.
6. Establish Recordkeeping Procedures
7. Establish Verification Methods & Audit Schedule
• Basis for HACCP system
• “A step at which control can be applied effectively
and is essential to prevent or eliminate a food safety
hazard or reduce it to an acceptable level.”
• Would you hold the product if this point was not
controlled?
• If a critical limit deviation occurs product must
be held and corrective action taken.
• The number of CCP’s must be manageable.
• The vital few.
• Different facilities producing the same product
should have very similar CCP’s
• Different facilities could have different hazards
and CCP’s because of layouts, etc.
• Critical Control Points must be used for Food
Safety only
• The Goal is Hazard Elimination
From: Corlett, D.A. Pierson, M.D. 1992 - HACCP Principles and Applications.
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Criteria are supported by research and/or technical literature
and/or experience
Criteria are specific, quantifiable and provide a yes/no
response
The technology for controlling the CCP is readily available at
a reasonable cost
Monitoring is continuous and the operation is automatically
adjusted to maintain control
The potential hazard is prevented or eliminated
• Those activities other than monitoring, that
determine the validity of the HACCP plan and
that the system is operating according to plan
• Verification
• Is the HACCP plan being followed as written?
• Validation
• Is the HACCP plan scientifically and technically
sound?
Definition
• The application of the HACCP tool to the study
of a new or conceptual product or process
design during the development phase,
normally in the absence of operational data.
Exponential increase of Failure Costs
Failure cost
The later we find and try to fix
problems with our product design, the
more it costs.
Design
Manufacturing
Consumer
Why d-HACCP?
• Contributes to ‘Safe by Design’ Policy
– Ensures that we design adequate controls to
ensure a safe design- before we start making it !
• Prevents wasting money
– due to inadequate process or product design
• May be used to evaluate and decide on a
processing route
Design Control Point (DCP) vs CCP
• DCP's differ from CCPs in that they are
"generic" to a particular product group, not
specific to an individual product/process line,
• DCP's are not identified following a formal
HACCP study using "real" line data. As such
they can form the input for a detailed HACCP
study
What information is needed?
Product design
• Broad idea of formulation
• List of ingredients
• List of packaging material
types
• Specific GMP
requirements
• Microbiological predictions
(if appropriate)
Process design
• Proposed process flow
• List of all equipment
options
• Time aspects (storage
times, delays, process
times)
• Planned control and
monitoring features
How is it done?
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Identify potential hazards
Identify control that exist or will be required
Identify DCPs
State Critical Limits and propose monitoring
Where choices in process route or material
occur, evaluate each one in parallel
Food business operators shall put in place, implement and
maintain a permanent procedure or procedures based on the
HACCP principles
Documents and records should be proportional to the nature
and size of the food business to demonstrate the effective
application of HACCP Principles
Arrangements may be laid down in order to facilitate the
implementation of HACCP by certain FBOs, in particular by
allowing the use of procedures set out in guides for the
application of HACCP principles
http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_haccp_en.pdf
To identify those food businesses where flexibility would be
appropriate,
To explain the “procedure based on the HACCP principles”,
To place HACCP in the wider context of food hygiene and
prerequisite requirements,
To explain the role of guides to good practice and generic HACCP
guides, including the need for documentation, and
To identify the extent of flexibility applicable to the HACCP
principles.
FBOs should have a system in place to identify and
control significant hazards on a permanent basis and
adapt that system whenever necessary.
This can be achieved e.g.
by the correct implementation of prerequisite
requirements and good hygienic practices,
by applying HACCP principles (possibly in a simplified way),
by using guides to good practice or
by a combination of those.
Compliance with requirements of regulation
852/2004 and/or specific standards (i.e Reg
853/2004)
Not covered
Additional requirements of international standards
for the FSMS certification
Legislation
Codex Alimentarius Alinorm 97/13
GMP guides if relevant
Literature
Experience of inspector
Select a representative study (choose the most
critical product/process)
Ask the site to provide all the supporting
documentation
Has someone appropriate been given
responsibility for implementation of HACCP ?
What training has been given (or what is his/her
experience ?
How many studies ?
Does this fit logically with the range of products
and processes ?
Are all products and processes covered ?
It is clear to you (without explanation) what
products and processes are considered ?
Are the essential product characteristics given ?
Which legislation/GMP guide covers this ?
Is it clear to you ?
Is it logical (compared to the product/process
type) ?
Any special consumer groups identified (e.g
people with allergenic reaction or intolerances
?
Process not Engineering based !
Does it compare with your factory tour ?
Clearly described in sufficient detail
Realistic
Procedures, Actions, Design Features which will
prevent hazards occurring
NEVER measurements, monitoring or inspection
Verify that these measures are really in place.
Must be stated for CCPs only
Must be logically related to the hazard and it’s
control measures
Check for Legal requirements
Are they really measurable ?
Clear statement of what is to be done right
away to protect the consumer
Must be understood by all
Must be recorded and auditable
Should include some remedial action
There is a simple series of relationships that you
should see in the HACCP tables…
If the relationships are wrong or absent, then
the study won’t work.
Specific
St ep
Hazard
Specific
Cont rol
Measures
CCP ?
Survival of veget at ive
pat hogens due t o low
Past eurisat ion
t emperat ure and/or
residence t ime
Aut omat ic
Past euriser
Cont rol Syst em
CCP
Receipt of Raw
Cont aminat ion
Mat erials
Int ake
inspect ion
CCP
Vague
Monitoring
Crit ical Limit /
Target Value
CL:
Time 2 minut es
Temp 72' C
TV:
Time 3 minut es
Temp 75' C
Monit oring
Correct ive Act ion
If t emperat ure is t oo low ,
Time: by cont rol comput er
f low is divert ed unt il
Temperat ure: by cont rol
rest ored
comput er
If t ime is t oo short , f eed
Bot h cont inuous
pump speed is reduced
All related
No f oreign
bodies
Int ake inspect ion
Forces measurement
of foreign bodies
Take appropriat e act ion
?