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The HACCP approach

BUILDING CAPACITY OF SME’s ON EU FOOD & PACKAGING STANDARDS

Thessaloniki 11.06.2012

Food safetysafe guarding food from anything that could harm the health of consumers

Legal requirementSafety throughout food chainBusinesses must identify and control risks to food safety (HACCP approach)

Industry anxious to maintain safety and quality of their productsMedia reaction in case of failureConsumer concerns

Protect the consumer by preventing contamination

Be proactive & reactiveMeet legislative requirements to produce safe foodMeet customer demands and expectationsBrand protection

Own business and customersIndustry reputation

not a competitive issue

A documented system to ensure the safety of foodsFSMS could be certified with an international Standard (optional)

ISO 22000:2005BRCIFSGFSI

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…..

• 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.

1. Conduct a Hazard Analysis2. Determine the Critical Control Points3. Establish Critical Limits4. Set up methods to monitor Critical Control Points.5. 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

• 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

From: Corlett, D.A. Pierson, M.D. 1992 - HACCP Principles and Applications.

• 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

Design Manufacturing Consumer

The later we find and try to fix problems with our product design, the more it costs.

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?

How is it done?

• 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 principlesDocuments and records should be proportional to the nature and size of the food business to demonstrate the effective application of HACCP PrinciplesArrangements 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

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, andTo 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

LegislationCodex Alimentarius Alinorm 97/13GMP guides if relevantLiteratureExperience 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 detailRealistic

Procedures, Actions, Design Features which will prevent hazards occurringNEVER measurements, monitoring or inspectionVerify that these measures are really in place.

Must be stated for CCPs onlyMust be logically related to the hazard and it’s control measuresCheck for Legal requirementsAre they really measurable ?

Clear statement of what is to be done right away to protect the consumerMust be understood by allMust be recorded and auditableShould 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.

Step HazardControl

MeasuresCCP ?

Critical Limit / Target Value

Monitoring Corrective Action

Pasteurisation

Survival of vegetative pathogens due to low temperature and/or residence time

Automatic Pasteuriser Control System

CCP

CL:Time 2 minutesTemp 72'CTV:Time 3 minutesTemp 75'C

Time: by control computerTemperature: by control computerBoth continuous

If temperature is too low, flow is diverted until restoredIf time is too short, feed pump speed is reduced

Receipt of Raw Materials

ContaminationIntake inspection

CCPNo foreign bodies

Intake inspection Take appropriate action

MonitoringVague Forces measurementof foreign bodies

?

Specific Specific

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