Introduction
Hazard Analysis
Critical Control Point (HACCP) is a system used by the food industry to
ensure that all food consumed is safe to eat. HACCP is a systematic approach
to hazard identification, assessment of risk and control. It is a structured
approach for the control of food safety from the farm to the fork. The
concept of HACCP was first introduced during the mid 1960s when a reliable
method for manufacturing pathogen free food was required by the US space
programme.
The HACCP
concept has been successfully applied in the control of quality as well
as safety in low-acid canned foods in the USA, and many food companies
in Europe and the USA have adopted the approach. Increasingly, regulatory
bodies have recognised the usefulness of this tool and its ‘ principles
have has been incorporated into legislative requirements by both the EU,
the General Hygiene regulations for managing food safety (93/43/EEC) and
the USFDA (CPR - 123)
Until the
introduction of HACCP, end product testing was used as a means of assessing
food safety, i.e. a percentage of samples was taken for testing to find
out if the product met with the customer’s acceptance criteria. Tests used
included microbiological testing, chemical and biochemical analyses, measurements
of physical properties and sensory evaluations. However, a number of limitations
to this approach have been recognised. For example, sampling plans are
based on the probabilty of a fault being identified from a representative
number of samples being tested, to check that the end product conforms
to the standard. In reality, if a process is not working properly and sub-standard
product is being manufactured, the cause of the problem may not be identified
until several days after the fault has occurred. Many of the microbiological
tests used to demonstrate that a food is safe to eat require 3 to 5 days
incubation before results are available to prevent hazards occurring. This
has resulted in financial lossess to the food industry when product has
to be recalled or, for the the worst scenario, a consumer has contracted
food poisoning as a result of eating unsafe product.
The HACCP
approach for food safety moves away from testing of the final product,
and instead emphasises raw material and process control. Control is taken
out of the laboratory and into the processing environment. HACCP provides
a structured and systematic approach to the control of identified hazards,
which may be biological (microbiological), chemical, physical or a combination
of the three. A Critical Control Point (CCP) is a raw material, stage,
practice or operation within the process where a hazard has been recognised
and steps are in place to eliminate, prevent or reduce the possibility
of the hazard occuring. This and other definitions are included in Appendix
I.
There are
seven principles incorporated into the HACCP system (Codex 1997):
1.Conduct a hazard analysis.
Identification and description of
the product and its’ intended use. Assessment of hazards and assessment
of risks
associated with all stages and practices
of product handling and processing.
2.Determine the critical control points (CCPs) that will
eliminate or minimise the risk.
3.Establish critical limits.
4.Establish a monitoring system to demonstrate that the
CCP is under control.
5.Establish a procedure for corrective action when the
CCP is seen to be moving out of control.
6.Introduce verification procedures to confirm the effectiveness
of the HACCP plan.
7.Establish documentation and records to demonstrate
that the HACCP system is working effectively.
A thorough
understanding of the whole process is required in order to identify the
most appropriate means of monitoring CCPs. Tests where results are obtained
quickly are preferable to traditional lengthy microbiological methods,
e.g. measurement of pH level instead of counting for bacteria that produce
acid, whilst for other stages visual or sensory evaluation may be required,
e.g colour and odour of wet fish. It is therefore, important to assemble
a team of specialists who can look at the whole process from the point
of view of their own area of expertise, and who can contribute to the overall
HACCP study.
Food Safety
has been the principal aim when applying the HACCP concept to a process.
The technique was originally developed for control of microbiological hazards
but it can just as easily be applied to other areas such as chemicals contaminants
and some foreign bodies.
There are
a number of factors outside the control of handlers and processors that
can affect the safety of food. For example, in the production of vegetables
the site of the production unit can range from large mechanised farms to
smallholdings. Different cultivars have been bred for yield, disease resistance
etc. Hazardous practices, such as the use of raw sewage as fertiliser,
or allowing animals which carry bacteria, viruses and parasites, to forage
amongst crops, together with inadequate processing and storage facilities,
may increase food safety risks associated with the products. These and
other factors must be considered when planning safe management systems.
A HACCP study
is carried out in four stages: defining the scope of the study, implementing
the study and maintaining the system. It is important to establish the
scope of the study, i.e. the area to be addressed by the HACCP plan - from
the farm supplier of raw materials through to the retail outlet or consumer.
It is also paramount that management are fully supportive of the implementation
of HACCP, especially where investing money is concerned.
DEVELOPING A HACCP PLAN
This document is designed to be used as an aid for those responsible for implementing and maintaining a HACCP system. It’s scope might cover all parts of the production/growing stage of the commodity, any subsequent handling, processing or packaging of the product, as well as distribution, catering, retail and consumer handling. A flow diagram of the logical sequence for implementing HACCP is included in Appendix II.
STAGE 1 - THE HACCP TEAM
To fully understand the process and be able to identify all likely hazards and CCPs, it is important that the HACCP team is made up of people from a wide range of disciplines. There are a number of functions that the team must cover:
STAGE 2 - DESCRIBE THE PRODUCT
A full description of the product should be prepared. This should include information relevant to safety information, e.g. composition, physical/chemical structures of the raw materials and the final product, the amount of water available for microbial growth (aw), the amount of acid or alkalii in the product (pH); any treatments that will eliminate or reduce the level of micro-organisms such as heating, cooling, freezing, brining , smoking. Information regarding how the product is to be packaged, stored and transported should also be considered together with facts regarding its’ shelf life and recommended storage temperatures. Where appropriate labelling information and an example of the label should be included. An example of a form that can be used by the team is included in Appendix III.
STAGE 3 - IDENTIFY the products’ INTENDED USE
How the product is intended to be used is an important consideration, i.e. is it to be cooked before eating? Consumers like to experiment with food so it is possible for food to be consumed raw, even when the manufacturer recommends cooking before consumption. All eventualities should be considered at this stage. Target groups in the population should be identified to whom the product may present a higher risk, e.g. the young, elderly, immuno-compromised, or pregnant women.
STAGE 4 - THE PROCESS FLOW DIAGRAM
The first function of the team is to draw up a detailed flow diagram of the process. The expertise of the production specialist is important at this stage. Processes will differ in detail in different plants, and an accurate flow diagram depends on detailed knowledge of the process. An example of a process flow diagram for Criol sausage is included in Appendix IV.
STAGE 5 - ON SITE VERIFICATION OF FLOW DIAGRAM
Upon completion of the process flow diagram (PFD), members of the team should visit the manufacturing area to compare what information is present on the PFD compared to what actually happens during production. This is known as "walking the line", a step by step practice to check that all information regarding materials, equipment, controls etc. have been taken into consideration by the team during the preparation of the process flow diagram. Aspects such as time of production, deviations caused by different shift patterns, startup, shut down, cleaning and especially night shifts should be monitored.
STAGE 6 - IDENTIFICATION OF HAZARDS and consider any measures required to control the identified hazards
Effective hazard identification and risk assessment are the keys to a successful HACCP. All real or potential hazards that may occur in each ingredient and at each stage of production should be considered. Potential hazards can be identified by the following means:
STAGE 7 - DETERMINING CCPs
All ingredients
and each stage of the process are taken in turn and the relevance of each
identified hazard is considered. The team must determine whether the hazard
can increase at this stage or whether it can be reduced, prevented or eliminated.
If the hazard can be reduced, controlled, prevented or eliminated through
exerting some form of control at a particular stage, it is a CCP. A decison
tree can be used to determine CCPs, and an example of the Codex decision
tree is included in APPENDIX VI. However, the judgement and expertise of
the HACCP team are the major factors in establishing CCP.
It is important
that all CCP are controlled. When deciding on the extent to which the CCP
will be monitored, a judgement of risk must be made so that a level of
concern can be ascribed to it. There are four levels of concern:
STAGE 8 : Target Levels or critical limits
The team must next identify means by which to control the hazard at each CCP. These may include for example: chlorine levels in wash water; temperatures during storage, use of documented procedures. All must be documented as statements or included as specifications in operating manuals. Critical limits and target values should be stated wherever appropriate.
STAGE 9 : MONITORING PROCEDURES
Monitoring
is the mechanism for confirming that processing or handling procedures
at each CCP are under control. The method chosen for monitoring must be
able to detect any loss of control, and to provide information early enough
for corrective action to be taken and for loss of product to be avoided
or minimised.
Monitoring
can be carried out by observation or (although preferably continuous) by
measurement on samples taken in accordance with a statistically based sampling
plan. Monitoring by visual observation is basic but gives rapid results,
and can therefore be acted upon quickly. It is applicable to assessment
of raw materials, worker hygiene, hygiene and sanitation procedures, and
processing procedures. The most common measurements taken are time, temperature
and pH. For raw materials however, tests for toxins, additives, contaminants
and microbiological tests may also be requested and the supplier may be
required to use HACCP procedures.
STAGE 10 - CORRECTIVE ACTION
If monitoring
indicates that criteria are not being met, or that the process is out of
control, corrective action must be taken as soon as possible. The corrective
action should take into account the worst case scenario, but must also
be based on the assessment of hazards, risk and severity, and on the final
use of the product.
The specific
action will depend on the process. In a fruit and vegetable processing
system, this may included re-washing of fruit and vegetables, altering
the chlorine concentration of water, or re-cleaning of equipment. However,
the traceability system must permit the quarentining of all potentially
defetive product made while the critical limit was being infringed.
STAGE 11 - VERIFICATION
Once the HACCP
plan has been drawn up it must be reviewed before being installed, and
regularly reviewed once the system is operating. This might be a task of
the person within the company with the responsibility for Quality Assurance
(QA), e.g QA Manager. The appropriateness of CCPs and control criteria
can thus be determined, and the extent and effectiveness of monitoring
can be verified. Microbiological tests can be used to confirm that the
plan is in control and the product is meeting customer specifications.
A formal internal auditing plan of the system will also demonstrate an
ongoing commitment by the company to keeping the HACCP plan up to date,
as well as representing an essential verification activity.
Ways in which the system can be verified include:
STAGE 12 -DOCUMENTATION
Although not
specifically required by law, record keeping is an essential part of the
HACCP process. It demonstrates that the correct procedures have been followed
from the start to the end of the process, offering product traceability.
It provides a record of compliance with the limits set, and can be used
to identify problem areas. Furthermore, the documentation can be used by
a company as evidence of ..."Due Diligence Defence"... required by the
Food Safety Act 1990 (HMSO). An example of a control chart that can be
used to summarise the HACCP plan is given in Appendix VII.
There will
be documents recording the actual HACCP study, e.g. hazard identification
and selection of critical limits, but the bulk of the documentation will
be concerned with the monitoring of CCPs and corrective actions taken.
Record keeping can be carried our in a number of ways, ranging from simple
check-lists, to records and control charts. Manual and computer records
are equally appropriate, but most auditors prefer to work from paper records.
Case Study
Recent approaches towards the control of the occurrence of food-borne diseases, in developing countries, will now be illustrated. The first by a case study in Costa Rica which was funded by the UK government’s Department for International Deveolpment.
Appropriate Quality Systems for Small- and Medium-Scale Enterprises in Costa Rica
In Costa Rica,
meat and meat products are distributed to a range of consumers through
a variety of outlets including local markets, supermarkets and export markets.
The last expect and demand quality attributes that will result in the rejection
of product, with concomitant economic losses to the livestock and meat
industries, if the specified attributes are not met. Increasingly, as the
quality consciousness of the local consumer increases, the internal markets
are also very likely to impose standards of quality that will mean rejection
of meat produce that fails to meet the minimum standards. Opportunities
for adding value will also be lost if the suppliers of meat and meat products
do not adopt a more quality conscious attitude.
In collaboration
with the Centro Nacional de Ciencia y Tecnologia de Alimentos (CITA), the
introduction of appropriate quality systems for small- and medium-scale
enterprises involved the following key components:
The Hazard
Analysis Critical Control Point (HACCP) concept is a preventative and systematic
approach to hazard identification, assessment and control (see above).
However, it is costly and inappropriate to attempt to transfer methods
directly from developed to developing country meat industries and, to date,
such attempts have met with little success. However, since HACCP is an
approach and not a prescriptive system, the concept can be used to develop
tailor made systems applicable to the production and marketing of meat
products in any country.
Such systems should incorporate control systems which
combine both Good Manufacturing Practice (GMP) and HACCP. GMP is a basic
and subjective approach which addresses environmental conditions and the
control of working procedures. However, when combined with the systematic
approach used in the HACCP concept, its application results in a significant
improvement in quality, and a reduction in related food-borne illness.
Training in
HACCP and GMP was provided both in Costa Rica and in the UK, and included
first-hand experience of how the British food industry follows and applies
the legislative requirements of the EU and USA.
Collaborating Small- to Medium-Scale Meat Processors
Baseline surveys of seven representative small- to medium-scale enterprises (SMEs) were performed using a statistically-based diagnostic approach developed by the CITA Quality Assurance Group. The handling and manufacturing protocols followed by each processor were evaluated using the following attributes: raw material condition; the process; the product; hygiene; equipment condition; and quality. Figure 1.1 illustrates the range of the overall performances for the attributes(expressed as a percentage), and the overall mean performance, of the SMEs together with the overall performance of a single selected processor. It is evident that the performances varied from 18 to 48 per cent with a mean value of 32 per cent. The selected SME was associated with the lowest overall performance of 18 per cent. The performance of the SMEs, in terms of the six individual attributes, is illustrated in Figure 2.1. For ‘equipment’, for example, the performance range varied from 20 to 50 per cent, with a mean value of 38 per cent; and the selected processor showed a performance of 20 per cent for this attribute.
Appropriate Quality Systems
After the baseline
survey of the SMEs had been completed, flow diagrams describing the process
utilised by each manufacturer were prepared and the critical control points
identified.
A simplified
process summary for salami, a popular meat product manufactured in Costa
Rica is shown in Figure 3. Those constraints which were contributing to
the non-enforcement of GMP (e.g. cost and lack of understanding) were also
identified. An appropriate quality system was then designed and commissioned
for each SME, to improved the quality of the product.
Follow-up surveillance
After a two year period, the surveillance of the collaborating meat processors was repeated in order to evaluate the efficacy of the new quality systems. The results of the surveys showed a clear improvement in quality and are summarised in Figures 1.2 and 2.2. The overall mean performance of the SMEs had increased from 32 to 46 per cent (Figures 1.1 and 2.1 ), due to an increase in the performance associated with each of the six attributes (Figures 1.2 and 2.2). The selected SME demonstrated very significant increases in performance over the two year period for each of the attributes, namely - condition of raw material (20% increase), process (32%), product quality (15%), hygiene (10%), equipment (10%) and quality (15%).
End-of-project Workshop
The experiences of the participating SMEs were reported and discussed at an end-of-project workshop which enabled the project outputs, including the benefits of the improved quality systems, to be disseminated to those members of the meat industry who had not directly participated in the project.
Case study 2
DFID funded programmes in Paraguay Instituto Nacional de Tecnologia y Normas (INTN), Ecuador Instituto Nacional de Pesca (INP) and India Central Institute for Fisheries Tecnologia (CIFT) have concentrated on capacitation of training and research instututions in the HACCP concept. A train the trainers approach was followed, whereby a team of staff were trained in the principles and implementation of the HACCP concept. The teams then worked with local industries to implement the system into local food processing plants.
CONCLUSION
HACCP is a powerful and useful tool. Undertaking a HACCP study focuses the thinking of everyone involved with the product on the details of the process, and promotes a greater awareness of safety issues. Implementation of a HACCP system is not an end in itself. It requires the commitment of management and the workforce, and constant monitoring of the system is needed to ensure its success.
References
Campden Food and Drink Research Association (1992). HACCP: A practical Guide, Technical Manual No. 38.
EEC Council Directive 93/43/EEC The Hygiene of Foodstuffs, Official journal of the European Communities, July 19, 1993, No. L 175/1 - 11.
FDA The implementation of HACCP into the fisheries industry CPR 123
HMSO (1990) Food Safety Act, HMSO, LONDON, UK.
ICMSF (1986) Microorganisms in Food 2. Sampling for Microbiological Analysis: Principles and Specific applications. 2nd edition, Blackwell Scientific, Publications, Oxford.
Further Reading
Bryan, F.L. (1992) Evaluation of risk at Critical Control Points. WHO, Geneva.
Campden and Chorleywood Food Research Association (CCFRA) 1996 Assured Crop Protection.
Dillon, M. and Griffith C. (1995) How to HACCP an illustrated guide. MD Associates, South Humberside.
Dillon, M. and Griffiths, C. (1997) How to Audit verifying food control systems MD Associates, South Humberside
FAO (1995) The use of hazard analysis critical control point (HACCP) principles in food control. FAO, Rome.
FAO/WHO (1995) Application of Risk Analysis to Food Standards issues. Geneva.
FAO (1997) Risk management and food safety. FAO, Rome
ICMSF (International Commision on Microbiological Specifications for Foods) (1988) Microorganisms in foods 4: Application of the Hazard Analysis Critical Control Point (HACCP) system to ensure Microbiological Safety and Quality. Blackwell Scientific Publications, Oxford
Mortimer, S. and Wallace, C. (199*) HACCP A practical Approach. (2nd edition) Chapman and Hall, London.
Pierson, M.D. and Corlett, D.A. (1992) HACCP principles and applications. Chapman and Hall, London.
Shapton, D.A. and Shapton, N.F. (1991) Principles and Practices for the Safe Processing of Food. Butterworth Heinemann, Great Britain.
WHO (1995) Training Aspects of the Hazard Analysis Critical Control Point System (HACCP) Food Safety Unit WHO, Geneva.
WHO (1997) HACCP Introducing the Hazard Analysis and Critical Control Point System. Food Safety Unit, WHO, Geneva.
APPENDIX I: DEFINITION OF TERMS
Concern - an expert judgement on the level of threat to the consumer of a particular hazard:
(a) High Concern - If the hazard is not controlled
there is a life threatening risk.
(b) Medium Concern - A threat exists to the consumer
that must be controlled.
(c) Low Concern - Little threat exists to the
consumer, however, it should preferably be controlled.
(d) No Concern - No threat exists to the consumer.
Control - To take all necessary actions to ensure and
maintain compliance with criteria in the HACCP plan.
Control measure - Any action and activity that can be
used to prevent or eliminate a food safety hazard or reduce it to an acceptable
level.
Corrective action - Any action taken when the result
of monitoring at the CCP indicates a loss of control.
Critical control point (CCP) - a location, practice,
operation, stage or raw material at which control can be exerted to eliminate,
prevent or reduce a hazard to an acceptable level.
Hazard - a biological, chemical or physical agent in,
or a condition of, food with potential to cause harm to the consumer.
Severity - The seriousness of the hazard.
Risk - probability of the hazard occurring.
APPENDIX II - STAGES IN DEVELOPING HACCP SYSTEM
based on WHO/FNU/FOS/95.7
Assemble an HACCP team
APPENDIX III : EXAMPLE OF FORM
- description and intended used of product
| Name of product | |
| Description | |
| Packaging | |
| Conditions of storage | |
| Shelf life | |
| Instructions on the label | |
| Consumer group | |
| Recommendation further processing required before consumption |
APPENDIX IV : EXAMPLE OF FORM
- PROCESS FLOW DIAGRAM
| SALT
ADDITIVES SPICES |
ICE
|
BEEF
|
pORK AND FAT |
| weigh | weigh | weigh | weigh |
| minced | minced | ||
| bowl chopped | |||
| fILLING OF SKINS | |||
| cooking | |||
| chilling | |||
| reFRIGERATED
STORAGE |
|||
| distribution |
APPENDIX V :EXAMPLES OF HAZARDS THAT MAY BE ASSOCIATED WITH FOOD AND FOOD PRODUCTS
Table 1 : Microbiological (ICMSF 1986)
| Severe risk | Moderate risk
Potential of extensive spread |
Moderate risk
Limited or no spread |
| Bacteria
Brucella melitensis (brucellosis) Escherichia coli O157:H7 Clostridium botulinum types A, B, E and F (botulism) Clostridium perfringens type C (Enteritis necriticans) Shigella dysenteriae 1 (shigellosis, dysentery) Salmonella typhi Salmonella paratyphi types A, B and C (typhoid and paratyphoid fevers) Salmonella cholerae-suis Salmonella sendai Vibrio cholerae 01 (cholera)
Virus Hepititus A Poliovirus
Toxins Algal toxins Mycotoxins |
Bacteria
Pathogenic Escherichia coli ("traveller’s diarrhoea") Other Shigella species (shigellosis) Other Salmonella species ? -haemolytic (salmonellosis) Streptococcus groups A, C and G (septic sore throat, scarlet fever) |
Bacteria
Bacillus cereus Campylobacter fetus subsp. jejuni Clostridium perfringens type A Listeria monocytogenes (listeriosis) Staphylococcus aureus Vibrio parahaemolyticus Yersinia enterocolitica
Parasites Amoeba Giardia |
Table 2 : Chemical and Physical
Risks (CCFRA 1992)
| Chemical | Physical |
| Heavy metals
Pesticide residues Lubricants/hydrocarbons from machinery Fumes/dust Refrigerants Pest control agents Chlorophenols Sanitising agents Water additives Paints/printing inks/plasticisers
|
Natural extraneous material
e.g. stalks, leaves, seed heads, bone, skin Foreign material e.g. insect infestation, stones, glass, animal droppings, metal, plastic, wood, paper, hair, jewellery, paint, plaster Others e.g. cross-packing, sabotage
|
APPENDIX VI : EXAMPLE OF FORM -
HACCP PLAN PREPARATION
| CCPs | RISK | CRITICAL LIMITS | MONITORING - WHAT | MONITORING - HOW | MONITORING - FREQUENCY | MONITORING - WHO | CORRECTIVE ACTIONS | RECORDS | VERIFICATION |
|
|
Figure 3: A simplified process flow
diagram showing potential hazards for the production of salami
| PROCESS
|
MAIN DANGER POINTS | CORRECTIVE ACTION |
| Raw materials | ||
| MINCED BEEF (0 - 5°C) | Delays | Avoid delays, chill (0 - 5°C) |
| CHOPPED PORK AND FAT (-20°C) | Delays | Avoid delays, maintain in deep freeze (-20°C) |
| DRY RAW MATERIALS | Incorrectly stored | Store all dry materials in dry material store |
| Processing | ||
| Weigh Ingredients | Incorrect weights
Out of date ingredients |
Calibrated scales
Operate stock rotation adequate training |
| PREPARE EMULSIONS | Delays
Faulty machinery |
Avoid delays
Maintenance of equipment |
| STUFF INTO CASINGS | Poor filling
Inadequate hygiene |
Increased supervison, adequate training |
| COOKING (Internal temperature 78°C) | Incorrect temperature | Check and monitor process
Calibrated recording |
| COOLING to 5°C | Contaminated water | Use potable water |
| CHILLING to 5°C | Delays, cross contamination | Avoid delays, Good hygienic practices |
| STORAGE (0 - 5°C) | Incorrect storage temperature | Temperature control, maintain records |
| DISTRIBUTION (3 - 5°C) | Poor temperature control during transportation | Specify the use of rerigerated trucks |
| RETAIL (3 - 5°C) | Poor hygienic practicies | Adequate training |