AN INTRODUCTION TO HACCP FOR FISH PROCESSORS

The HACCP system, which is science based and systematic, identifies specific hazards and measures for their control to ensure the safety of food. HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing.

A HACCP system is capable of accommodating change, such as advances in equipment design, processing procedures or technological developments; and can be applied throughout the food chain from the primary producer to final consumer.

HACCP when implemented is a management system for ensuring safety of products prepared in an establishment.

All companies have management systems, such as financial management, personnel management, production management and quality management systems. Quality management systems may be simple, such as the processors unwritten understanding of the process (no organized system), or complex such as the ISO 9000 series or Total Quality Management (TQM). The application of HACCP is compatible with the implementation of quality management systems and is the system of choice in the management of food safety within such systems. Although TQM, ISO 9000 and HACCP are compatible, one does not replace the other. HACCP systems must be considered as essential for any enterprise that deals with fishery products whether or not other organized management systems are in place, therefore HACCP systems must be capable of operating independently of other quality management systems.

Though HACCP is intended for the control of safety, its principles can be applied to non-safety hazards such as the prevention of economic fraud in relation to labelling, grading, weights, etc., or other aspects of food quality. Consider incorporating the HACCP system into your present quality control programme. A description of various quality management systems is given in Annex I.

"I PROCESS FISH IN ASIA. WHY SHOULD I WORRY ABOUT IT?"

REGULATORY AUTHORITIES

Regulatory authorities for food products have a duty to ensure that foods offered to the consumer are at least safe to eat. In the past they have required a positive approach of using Good Manufacturing Practices (GMP), producing food in a hygienic manner, and by inspection of finished product. It is now realized that inspection of finished product gives a poor control over the safety of foods, therefore regulatory agencies are increasingly requiring that establishments take a preventative approach to safety based on the principles of HACCP. This requirement might be incorporated in primary legislation on food control, or be applied by executive action of the regulatory authority. The management of the establishment must then be able to produce for the regulatory authority a documented HACCP plan, and be able to demonstrate that the plan is being effectively implemented. Thus HACCP is more than a management tool, it is an inspection tool.

EXPORTS !

Anyone exporting fish products to Europe or North America will have to implement such a programme. If you cannot demonstrate to the satisfaction of regulating agencies in importing countries that you have an effective programme operating in your processing plant(s), importers will not be permitted to accept your products.

THE DEMAND FROM IMPORTING COUNTRIES IS HERE

exports will need to be certified
they were processed in a plant with an approved HACCP plan in operation.
The plant must also meet international requirements for construction and hygiene.

The United Nations food standard group Codex Alimentarius Commission has recommended HACCP's adoption as a system for ensuring the safety of foods and the prevention of foodborne diseases. They have also developed a series of Codes of Practice for fisheries products upon which GMP's can be based. Throughout the world, the World Trade Organization's Agreement on the Application of Sanitary and Phytosanitary Measures and the Technical Barriers to Trade are being acted upon, and governments and industry are being urged to facilitate implementation of these agreements and to bring about equivalency, harmonization and transparency so as to minimize any barriers to international trade.

DOMESTIC MARKET !

"WHY BOTHER WITH HACCP?"

Processors have no choice if they wish to enter export markets, but there are positive benefits in using HACCP, it is not just something one does because one is forced. It also:

"WHAT DO I DO?"

Firstly, you need to review existing programmes to verify if all the prerequisite requirements are met and all the necessary controls and documentation are in place. Prior to the development of HACCP plans, there is a requirement for establishments to have developed, documented and implemented programmes to control factors that may not be directly related to manufacturing controls but support the HACCP plans. These programmes are called prerequisite programmes and need to be effectively monitored and controlled before attempting to put any HACCP plan in place. Prerequisite programmes may be defined as universal steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food.

HACCP plans apply to specific products and to specific processes, and are in addition to appropriate food safety legislation by the responsible authority having jurisdiction, and codes of practice for hygiene or any codes of good manufacturing practice that might be in force for the establishment as a whole.

Various prerequisite programme areas may include:

Prerequisite programmes are the foundation of the HACCP plans and must be adequate and effective. For example, when Sanitation Standard Operating Procedures (SSOP's) are in place, HACCP can be more effective because it can concentrate on the hazards associated with the food or processing and not on the processing plant environment. However, when aspects of hygiene directly impact food safety, it may be more appropriate for those hygiene controls to be handled within the HACCP plan. If any portion of a prerequisite programme is not adequately controlled, then additional critical control points would have to be identified, monitored and maintained under the HACCP plans. Effective prerequisite programmes will simplify HACCP plans and will ensure that the integrity of HACCP plans are maintained and that the manufactured product is safe.

Secondly, determine if other Control Points such as Defect Action Points (DAP's) exist. These are a point(s), step(s) or procedure(s) applied during processing that ensure compliance to regulations in force. DAP's could be determined through a "Regulatory Hazard Analysis", which will identify the regulatory requirements that specific products and processes must respect.

Finally, commence with the development of your HACCP system.

The first thing in developing a HACCP system is a COMMITMENT from the management. Without the support of top company officials such as the owner, director or CEO, HACCP is not likely to become a company priority or to be effectively implemented. The second thing is to ensure the workforce can be committed, HACCP requires a team approach. Once you are committed, you can start to develop a HACCP system.

HACCP definitions can be found in Annex II.

The HACCP Plan is the written document that describes and defines the procedures to be followed for ensuring the safety of a product or process, and is developed by applying the principles of HACCP:

7 PRINCIPLES to setting up an effective HACCP system:

1. Conduct a hazard analysis of all possible Food Safety Hazards that are likely to occur in your processing operation - based on the species being processed and the process used, and analyze the risks related to those hazards;
   
2. Determine the Critical Control Points (CCPs) in the process, at which a failure of some sort could make food unsafe if proper Control is not exercised;
   
3. Establish critical limit(s) to the parameters of the process associated with each identified CCP - that is, boundaries that are used to judge whether an operation is producing safe products;
   
4. Establish a system to monitor control of the CCP to keep track of how the process is performing;
   
5. Establish the corrective action to be taken when monitoring indicates that a partiuclar CCP is not under control;
   
6. Establish procedures for verification to confirm that the HACCP system is working effectively and for a review whenever there are changes to the system;
   
7. Establish documentation concerning all procedures and records appropriate to these principles and their application (to satisfy regulators, importers, etc. that you are operating your plant in accordance with HACCP principles).
   
   

Those are the General Principles. But what does it mean specifically?

SETTING UP A HACCP SYSTEM -

A logic sequence for the application of HACCP is given in DIAGRAM I.

Task 1:

A. PUT TOGETHER A TEAM with knowledge and expertize required for the specific product line you are considering. For example:

• someone who understands the biological, chemical or physical hazards connected with a particular product group, from the quality control point of view
  
• production people with good working knowledge of the technical process of manufacturing the particular product(s) who understand what actually happens on your production line
  
• a technician with good working knowledge of hygiene requirements and of your processing operation (plant/equipment) or others with special knowledge (microbiology, hygiene, food technology, plant construction/ maintenance, operations, market requirements, etc.)

• one individual on the team may have knowledge in several or all areas
  
• if you do not have staff with expertise in a particular area, seek advice in guides of good manufacturing practices, or from well qualified specialists.
  (Be careful: an unqualified "expert" can damage your product reputation.)
  

B. THE SCOPE OF THE HACCP PLAN SHOULD BE IDENTIFIED. The scope should describe which segment of the food chain is involved and the general classes of hazards to be addressed.

• all classes of hazards or only selected classes.

TASK 2: DESCRIBE THE PRODUCT:

• what is in it (raw materials, ingredients, additives, etc.)?
  
• what are its structure & physical characteristics (solid, liquid, gel, Aw, etc.)?
  
• how is it processed (heating, freezing, drying, salting, smoking) and to what extent?
  
• how is it packaged (hermetic, vacuum, modified atmosphere, etc.)?
  
• what are the conditions for storage & distribution?
  
• what is the required shelf life (including "sell by" date and "best before" date)?
  
• what are the instructions for use?
  
• are there any particular microbiological or chemical criteria?
  
  

TASK 3: STATE THE INTENDED USE FOR THE PRODUCT:

• who are the target consumers?
  
• how is it anticipated that they will prepare and use the product?
  
• are there any special considerations (for example if the product is to be used in institutions or by travellers, etc., or are there dangers in use for any vulnerable groups in the population who might obtain the product)?
  
• are specific requirements imposed by the importer or the importing country?
  
  

TASK 4: DEVELOP A FLOW DIAGRAM:

TASK 5: CONFIRM the flow diagram and all recorded details:

TASK 6: IDENTIFY POTENTIAL HAZARDS FOR EVERY STEP INVOLVED IN MAKING YOUR PRODUCT, CONDUCT A HAZARD ANALYSIS, AND CONSIDER ANY PROCEDURES TO CONTROL IDENTIFIED HAZARDS.


"WHAT IS A HAZARD?"

The HACCP team should list all of the hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture, and distribution until the point of consumption.

Examples of hazards are:

Biological hazards which include pathogenic microbes (parasites, bacteria, viruses), toxigenic plants and animals, and products of decomposition (histamine).

Chemical hazards which include, among others, natural toxins, pesticides, cleaning compounds, veterinary drug residues (antibiotics), heavy metals, and unapproved food and colour additives.

Physical hazards which include objects - such as bones, metal fragments, glass, and stones - that may cut the mouth, break teeth, cause choking, or perforate the alimentary tract.

For each stage shown on the Flow Chart ask:

Is there anything in the raw materials, ingredients used or the product itself or in the way they are handled and processed that could cause harm to health?

Some regulatory authorities may require that the HACCP system should include compliance with regulations concerning aspects of consumer protection other than safety. In this case, this could be dealt with by adding to the definition of a hazard a phrase such as: "or which renders the product non-compliant with mandatory requirements for the product".

The HACCP team should next conduct a hazard analysis to determine which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food.

In conducting the hazard analysis the following should be included:

• the likely occurrence of hazards and severity of their adverse health effects;
• the qualitative and/or quantitative evaluation of the presence of hazards;
• survival or multiplication of microorganisms of concern;
• production or persistence in foods of toxins, chemicals or physical agents; and
• conditions leading to the above.
  

Some things are easier to say than do, and for this reason the advice of an expert is recommended.

In essence, the hazard analysis consists of asking a series of questions which are appropriate to the specific food process and establishment. The hazard analysis must consider factors which may be beyond the immediate control of the processor. For example, product distribution may be beyond the immediate control of the processor, but information on how the food will be distributed could influence, for example, how the food will be processed. During the hazard analysis, the potential significance of each hazard should be assessed by considering its risk and severity. Risk is an estimate of the likely occurrence of a hazard. The estimate of risk is usually based upon a combination of experience, epidemiological data, and information in the technical literature. Severity is the seriousness of a hazard. The HACCP team has the responsibility to decide which hazards are significant and must be addressed in the HACCP Plan.

Sometimes too many hazards are identified. Only genuinely significant safety hazards need be controlled: that is, if it is reasonably likely to occur, and if not properly controlled, it is likely to result as an unacceptable health risk to consumers. Hazards for which regulatory action levels, tolerances, or other limits have been established, an "unacceptable health risk" is the risk that the limit has been exceeded, not the mere presence of the substance a detectable level.

During the hazard analysis, safety concerns must be differentiated from quality concerns. The term hazard in this document is limited to safety, and this is what must be addressed in the HACCP Plan. Quality concerns should be incorporated in another control system running in parallel with the HACCP system.

IDENTIFICATION OF CONTROL MEASURES

The HACCP team must now consider what control measures, if any, exist which can be applied for each hazard. Control measures are actions and activities that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level. More than one control measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified control measure. Examples of control measures are:

Biological Hazards:

Time/temperature control, thermal processing, cooling and freezing, fermentation and/or pH control, addition of salt or other preservatives, drying, source control (eg: obtaining raw materials from non-contaminated sources), hygienic practices.

Chemical Hazards:

Source control (vendor certification and raw materials testing), production control (proper use and application of food additives, etc.)

Physical Hazards:

Source control, Production control (use of metal detectors, etc.)

Note: Control measures might already be in place at the step under consideration, in fact the step might be there as a control measure, but the team should review the effectiveness of this measure, and consider other measures. General hygiene procedures like wearing protective clothing, washing hands, cleaning floors, should not be considered control measures in this context as it is not usually specific to a particular product or process. Such hygiene measures are difficult to control in the sense used in HACCP, and should be covered under the establishment's control program relating to conforming with hygienic requirements and GMP's.

The HACCP team should document its findings, the nature of the hazard(s) and risk, and its conclusions on control measures.

Task 7: DETERMINE CRITICAL CONTROL POINTS

A Critical Control Point (CCP) is a step at which control can be applied to prevent or eliminate a food safety hazard or reduce it to an acceptable level. It is not always easy to decide if a step is a CCP. The main consideration is that the control measure should be a property of the product at that step, or a feature of the process being carried out at that step, that can be measured and can be manipulated and controlled. The intent of HACCP is to focus control at CCPs. If a hazard has been identified at a step where control is necessary for safety, and no control measure exists at that step, or any other, then the product or process should be modified at that step, or at any earlier or later stage, to include a control measure.

The determination of a CCP in the HACCP system can be facilitated by the application of a decision tree, DIAGRAM II, which indicates a logic reasoning approach. The use of a decision tree should be used for guidance, but its application should be flexible, given the nature of the operation. While this model has been found to be useful to explain the logic and depth of understanding needed to determine CCPs, it is not specific to all food operations (eg. slaughter) and therefore it should be used in conjunction with professional judgement, and modified in some cases. Training n the application of the decision tree is recommended.

Other approaches may be used, for example the decision tree outlined below in which five questions are asked about hazards at each process step, or a modification of this procedure given in DIAGRAM III.

Date:

Approved by:

1) Could the hazard be fully controlled by prerequisite programme(s)?

If yes - identify how the hazard will be controlled and proceed to the next identified hazard. If no - proceed to the next question.

2) Could (a) Control Measure(s) be used by the operator at any process step?

This asks whether or not the operator could use a control measure at this step or anywhere else in the establishment to control the identified hazard. If yes - clearly describe what the control measure(s) is(are) that the operator could use. If no - identify how the identified hazard will be controlled before or after the manufacturing process.

3) Is it likely that contamination with the identified hazard could occur in excess of the acceptable level or could increase to an unacceptable level? In other words, is it likely that this hazard could impact on the safety of the product?

This refers both to the probability (likelihood) and the seriousness, and is a judgement call of risk assessment that must be based on all of the information that has been gathered. If yes - proceed to the next question. If no - proceed to the next identified hazard in the process.

4) Is this process step specifically designed to eliminate or reduce the likely occurrence of this identified hazard to an acceptable level?

"Specifically designed" is any procedure or step in a food process that is designed to specifically address the identified hazard. If yes - it automatically becomes a CCP. If no - proceed to the next question. Note, this question applies to processing steps only, for incoming materials as delivered write "no".

5) Will a subsequent step eliminate the identified hazard or reduce its likely occurrence to an acceptable level?

This question is designed for those hazards which are known to represent a human health threat or could increase to an unacceptable level, and for which a subsequent process step will control the identified hazard. If yes - proceed to the next identified hazard. If no - this process step becomes a CCP for this hazard, proceed to the next identified hazard.

Different facilities preparing the same food can differ in the risk of hazards and the points, steps, or procedures, which are CCPs. This can be due to differences in each facility such as layout, equipment, selection of ingredients, or the process that is employed. Generic HACCP plans can serve as useful guides; however, it is essential that the unique conditions within each facility be considered during the development of a HACCP Plan.

An example of a hazard analysis worksheet is given in DIAGRAM IV.

The CCP might also be a control point (CP) for controlling a non-safety aspects of the operation; CPs should be included in a parallel quality management system and not in the HACCP Plan.

NOW THAT YOU HAVE IDENTIFIED THEM...

TASK 8: ESTABLISH CRITICAL LIMITS FOR THE CONTROL MEASURE.

A Critical Limit is a criterion which separates acceptability from unacceptability. These parameters, if maintained within boundaries, will confirm the safety of the product.

A critical limit must be specified for each control measure at each CCP. In some cases, more than one critical limit will be specified at a particular CCP.

Criteria often used include temperature, time, moisture level, pH, water activity, available chlorine, and sensory parameters such as visual appearance and texture.

Examples of critical limits are:

Critical limits may be derived from a variety of sources, such as government regulations and guidelines, both in your own and in the importing country, or international codes of practice, industry guidelines, literature surveys, experimental studies and/or through the advice of experts with working knowledge of the industry. Finally, you should validate that the critical limit(s) will control the identified hazard before the HACCP system is finalized and implemented.

IF YOU HAVE FOLLOWED THESE PROCEDURES, YOU HAVE...

1. Identified all possible food safety hazards that are likely to occur in your facility
   
2. Established critical control points in the process, at which hazards can be controlled
   
3. Established critical limits for control measures at every CCP, so that employees know if the product or a process falls below the minimum limits required to ensure food safety
   
   

TASK 9: SET UP A MONITORING AND CHECKING SYSTEM AT EACH CRITICAL CONTROL POINT

• a scheduled programme of observations and measurements is essential, to ensure the specific critical limits you set (TASK 8) are met
  
• this programme must describe clearly (so those responsible for carrying it out understand it) the methods to be used, the frequency observations are to be made or measurements taken, and the recording procedures that are to be used
  
• if you do not make observations or take measurements continuously, you must establish a frequency that will provide reliable information in time for corrective action to be taken
  
• the programme must clearly and precisely describe for every critical control point:
  
• WHO will perform monitoring, checking and/or measuring?
  
• WHAT will be monitored, a measurement or observation?
  
• WHEN will monitoring, checking and/or measuring be carried out?
  
• HOW will monitoring, checking and/or measuring be done?
  
• observations or measurements must be able to detect loss of control at critical points, and provide information in time for your employees to take corrective action to prevent violating the critical limits
  
• where possible, process adjustments shoud be made when monitoring results indicate a trend toward loss of control at a CCP, these adjustments should be taken before a deviation occurs
  
• monitoring should be rapid, and does not have to be complex or involve laboratory analysis. For example, microbiological analyses are often not necessary to control microbiological hazards. Moreover they are slow. More rapid methods can be used for checking the effectiveness of cleaning, etc. Physicochemical tests or sensors and observations are normally the methods of choice
  
• Data derived from monitoring must be evaluated by a designated person(s) with knowledge and authority to carry out corrective actions when indicated.
  
  

TRAINING

Training of personnel is an essential element for the effective implementation of HACCP. Food processing includes line workers, quality control personnel and management, each sub-group requires qualitatively and quantitatively different knowledge to be effective in minimizing hazards. In addition to training and knowledge in their area of competence, prerequisite requirements such as personnel hygiene and GMPs, there is a need for specific training in HACCP and HACCP related duties, for example:

Line workers are the personnel who are directly responsible for food processing, preparation and storage. They are concerned with a segment of a sequence of operations that leads from raw material to finished product. These persons should know:

• The nature of the control required at their point in the process, and how to monitor CCP of operations within their responsibility
  
• The procedures necessary to report deviations from control specifications, and the importance of maintaining proper records
  
• As an aid in developing specific training to support a HACCP plan, working instructions and procedures should be developed which define the tasks of the operating personnel to be stationed at eah CCP.
  

Quality control personnel have much wider technical responsibility than line workers. They must be conversant with the techniques required to monitor CCPs, their interpretation, the recommendations emanating therefrom and proper maintenance of the QC records; ie they should know:

• how to perform and interpret all chemical, physical and microbiological analysis relevant to their operation; and why these are relevant to the operation
  
• the objectives of the HACCP system and in particular the importance of monitoring to determine whether a process is under control, and the prescribed action to be taken when monitoring results indicate the process is going out of control and the procedure for reporting this to the person in authority to determine the nature of action required
  
• how to investigate the most likely causes of process deviations, and, if the solution is not readily apparent, the procedure for obtaining additional help
  
• how to maintain and transmit pertinent QC records
  

To management falls the responsibility for understanding the benefits of HACCP, its implementation and coordination. It is not expected their level of technical knowledge will exceed that of their employees with respect to Quality Control and HACCP, but that their appreciation of this mandates that an overall control programme be established. Management should know:

• that the HACCP programme focuses on those points that are critical to the operation, that it is through monitoring of CCPs that it can be determined whether a process is under control, and that the microbiological and economic consequenses of a process being out of control can be enormous
  
• where the responsibility and knowledge level of the line workers, QC personnel and technical experts begin and end, and that it is their responsibility to ensure that line workers and QC personnel are brought to a knowledge level commensurate with the needs of their jobs
  
• the value of showing the results of a HACCP monitoring programme to legal and regulatory authorities
  
  

TASK 10: ESTABLISH A PLAN TO CORRECT PROBLEMS THAT MAY BE IDENTIFIED BY TASK 9

• this plan must be prepared and implemented in advance so that there will be no delay in taking corrective action
  
• the plan can be developed by the HACCP team and should clearly show:
  
• specific corrective actions for each CCP in order to deal with deviations when they occur and how it will be carried out in order to fix or correct the cause of non-compliance and put the CCP back into control.
  
• who will be responsible for taking the corrective action
  
• what will be done with products manufactured during the period the process was "out of control" ie: proper disposition of the affected product
  
• how written records of all corrective actions taken will be kept, deviation and product disposition procedurs must be documented in the HACCP record keeping
  
  

TASK 11: SET UP A PROCESS TO VERIFY AND REVIEW, TO ENSURE THAT YOUR HACCP SYSTEM WORKS EFFECTIVELY, AND CONTINUES TO WORK EFFECTIVELY THROUGH ANY CHANGES MADE

The HACCP system is a management system for assuring the safety of products made in the establishment. Like any management system, you must be certain that it is working effectively. This verification will take several levels. A quality assurance manager should review the system daily to check that it is operating satisfactorily and to resolve any immediate problems. At other intervals, there should be more in-depth studies to see that the system is operating as planned.

• The HACCP team should describe in detail what methods and procedures will be used to verify that your system is working effectively
  

Examples of methods that might be used to VERIFY:

• random sampling and analysis (microbiological analysis), and trend analysis
  
• reinforced analysis or tests at selected critical control points
  
• intensified analysis of intermediate or final products
  
• take surveys on actual conditions during storage, distribution, sale, and use of products
  

Examples of Verification Procedures:

• inspection of operations, confirmation that CCPs are kept under control
  
• validation of critical limits, with specialists, experts and standards setting organizations
  
• review of deviations from the set critical limits, corrective actions, and product dispositions
  
• audits of the entire HACCP system and its records, that is a systematic and independent examination through on-site observations and a record review to determine whether activities stated in the HACCP plan are being done.
  

Verification should confirm that the HACCP system established is suitable for the product line being processed. Where possible, validation activities should include actions to confirm the efficiency of all elements of the HACCP plan.

Also, after time and with appropriate frequency, there should be verification that the provisions set for the system are being properly applied. The frequency of verification should be sufficient to confirm that the HACCP system is working effectively.

Verification may be done by plant management, or with external (consulting/analysis) agencies or in collaboration with government inspection authorities depending on the country's requirements for HACCP systems.

Whenever there are changes to your handling/processing procedures, raw materials, additives, etc., it will be necessary to review the system you have set up, to make sure it is valid despite the changes.

Examples of changes that will make it necessary to review your system:

• increased process deviation reports
  
• change in factory layout and/or environment(s) or change in processing equipment

• change in cleaning and disinfecting procedures/materials, etc.
  
• change in packaging, storage or distribution conditions
  
• change in consumer use
  
• receiving any information on a new hazard associated with the product
  

If the review shows that your HACCP system must be revised, changes must be fully integrated into all written documents and the record-keeping system, so that accurate, up-to-date information on your system is always available.

TASK 12: ESTABLISH DOCUMENTATION AND AN EFFECTIVE SYSTEM FOR MAINTAINING RECORDS

As we have seen, KEEPING RECORDS is what makes a HACCP system work.

• at every CRITICAL CONTROL POINT, where checks are made or measurements are taken, information must be written down in an orderly way.
  
• this information must be presented in a way that clearly and quickly tells everyone responsible for maintaining the system if the critical limits are being maintained, because if they are not, immediate, effective action must be taken.
  
• All records and documents associated with monitoring CCP's must be signed by the person(s) doing the monitoring and by a responsible reviewing official(s) of the company.
  
• you will have to be able to refer to your records to verify that your HACCP system is working effectively, and to demonstrate to local government inspection authorities, importers in other countries to whom you wish to sell your products, and even the importing countries' inspection authorities that you have an effective programme working in your plant. At any time they might audit your system.
  
• records you need to keep are: the HACCP Plan and support documentation used in developing the plan, such as the hazard analysis, CCP determination and critical limit determination; records of critical control point monitoring (associated with ingredients, product safety, processing, packaging, storage and distribution); records of deviations and associated corrective actions; records of verification activities and modifications to the HACCP system; and of course the nature, coding and disposition of the product. The later is important for product traceability.
  

An example of a HACCP Plan form is given in DIAGRAM V.

It's the records that track the hour-to-hour and month-to-month adherence to the plan.
It's the records that provide the big picture.
It's the records (and action taken on them) that ensure the continuous flow of safe food.

Some Governments will have regulations that you will have to follow, if you want your HACCP system to be recognized. Others may not. The point is...

HACCP is not a stand alone control system, it is part of a larger system of control procedures.

HACCP plans apply to specific products and to specific processes, and are in addition to appropriate food legislation by the responsible authority having jurisdiction, and codes of practice for hygiene or any codes of good manufacturing practice that might be in force for the establishment as a whole (ie. prerequisite programmes).

Every species, product and process will have its own plan with its own specific CCP's.

Every company must develop its own plan (or plans).

Good record-keeping will keep your operation working effectively, provide traceability and verify to auditors that the system is working.

It is both a system of self-inspection and control, and government inspection; when required, your government's Inspection Services will periodically conduct audits of your HACCP system, to assure themselves and the importing countries that a system is working to prevent hazards to food safety.

Importers in countries to whom you are selling your products may have to verify that you are following your HACCP system; this may include on-site inspection, review of your records, and review of your government's activities; in some countries it is a legal requirement.

The "flow of product" in a plant is very important. If you have a well laid out, streamlined plant it will be easy to put in place an effective, smooth-working HACCP system. If you have a congested, mixed-up production line and you have to shift product from one section to another and back again, it will be more difficult, you must meet prerequisite requirements.

The entire concept is based on developing highly specific operating plans tailored to particular production lines. Thus there may be substantial differences in the plans, criteria, monitoring procedures and all other aspects of HACCP systems developed by different companies producing the same product. The most effective HACCP system will be one built with the assistance of the employees involved, they will take more pride in their "own" system than one developed by someone else.

You will need to educate your employees in the HACCP system.

Regulatory authorities are mainly concerned with SAFETY; you have an additional concern -- QUALITY!

To ensure that the QUALITY that is critical to your product is maintained, consider merging the HACCP plan with your overall quality control programme, and include it all in your operating instructions, which provide the guide for producing your products correctly.

WITH A HACCP SYSTEM YOU:

1. IDENTIFY POTENTIAL HAZARDS TO THE PRODUCTION OF SAFE FOOD
   
2. DETERMINE WHERE AND WHEN THEY ARE MOST LIKELY TO OCCUR
   
3. TAKE NECESSARY STEPS TO PREVENT THEM FROM HAPPENING, OR TO CORRECT THEM IF THEY DO OCCUR
   
   

References

This text is based on:

The draft Hazard Analysis and Critical Control Point (HACCP) system and guidelines for its application. Appendix II of the report of the twenty-ninth session of the Codex Committee on Food Hygiene 21 - 25 Nov 1996 Washington DC. Alinorm 97/13A CAC;

Hazard Analysis and Critical Control Point System. The National Advisory Committee on Microbiological Criteria for Foods. International Journal of Food Microbiology, 16 (1992) 1 - 23;

National Seafood HACCP Alliance. HACCP: Hazard Analysis and Critical Control Point Training Curriculum 2nd Edition, North Carolina Sea Grant publication UNC-SG-02, N. C. State University 1997;

Agriculture Canada, Food Safety Enhancement Program Manual Vol 1 - 3, 1992 - 1994;

Training Considerations for the Application of the Hazard Analysis Critical Control Point System to Food Processing and Manufacturing. (WHO/FNU/FOS/93.3) WHO 1993;

Howgate, Peter. personal communication and paper: Guidelines for HACCP in Fresh and Frozen Fish Processing April 1996;

Comments received on the first draft text of this manual prepared in 1994, and the second draft prepared in May 1996.

International Commission on Microbiological Specifications for Foods. Micro-organisms in Foods 4: Application of the hazard analysis critical control point (HACCP) system to ensure microbiological safety and quality. Blackwell Scientific Publications 1988;

Limpus, L. G. Ed. Training Course on HACCP Competencies: QC and Plant Managers/Supervisors Facilitators Guide, in preparation. ASEAN-Canada Fisheries Post-Harvest Technology Project - Phase II. 1997;

Suwanrangsi, Sirilak et al. Canned Tuna Quality Control Management Manual. ASEAN-Canada Fisheries Post-Harvest Technology Project - Phase II, Singapore/Thailand 1995;

Mortimore, Sara and Wallace, Carol. HACCP: A practical approach. Chapman & Hall. 1994;

Downing, Donald. A Complete Course in Canning (13th edition): Book II Microbiology, Packaging, HACCP & Ingredients. CTI Publications, Inc. Maryland 1996;

ASEAN-Canada Fisheries Post-Harvest Technology Project - Phase II. Report of the ASEAN-Canada Fisheries Post-Harvest Technology Project End-of-Project Conference 16 - 18 September 1996;

Report of the Fifth Session of the Codex Committee on Food Import and Export Inspection and Certification Systems 17 - 21 February 1997 Sydney, Australia. Alinorm 97/30A CAC 1997.

Quality Control, Quality Management systems, HACCP and Inspection

There is much confusion within the industry over the various terms relating to quality management. As stated earlier, all companies have management systems, either simple or complex to control quality of their product ie: quality control. As the quality control function advanced over the years, it split into two, Quality Assurance and Quality Control. According to ISO definitions, "Quality Assurance (QA) are all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality". In other words, QA is a strategic management function which establishes policies, adapts programmes to meet established goals and provides confidence that these measures are being effectively applied; while "Quality Control (QC) are operational techniques and activities that are used to fulfil requirements for quality", ie: a tactical function which carries out the programmes established by the QA. However, as both functions are necessary to operate, the term Quality Control is used throughout this text for both QA and QC.

As the food industry, like other industries, continued to improve quality and production operations to improve profitability, new management tools were incorporated into companies quality control programmes. In the 1970's a management tool called Quality Circles was developed. Its principle was the involvement of workers who have shared areas of responsibility. These workers attend classes in group communication processes, quality strategies, and measurement and problem-solving techniques. This training encourages the workers to discuss and evaluate quality problems, recommend solutions and take corrective action. In the 1980's a management tool called Total Quality Management (TQM) became popular. TQM is a systematic way of guaranteeing that organized activities happen the way they are planned; it is a management discipline concerned with preventing problems from occurring by creating the attitudes and controls that make prevention possible. In the late 1980's, a management tool was developed to control the flow of goods between nations, the ISO 9000 series of standards. The two main roles of the ISO 9000 series are to provide guidance for suppliers of all types of products who want to implement effective quality systems in their organizations or to improve their existing quality systems and provide generic requirements against which a customer can evaluate the adequacy of supplier's quality system.

HACCP is another quality management tool. It was first developed in the 1960's by the Pillsbury Company in response to the food safety requirements imposed by National Aeronautic and Space Administration (NASA) for "space foods" produced for manned space flights. Working alongside NASA and the US army laboratories at Natick, the engineering system Failure, Mode and Effect Analysis (FMEA) which looks at what could potentially go wrong at each stage in an operation along with possible causes and the likely effect, before deploying effective control mechanisms, was adapted to the production of food. Like FMEA, HACCP looks for hazards, or what could go wrong, but in the product safety sense. Control and management systems are then implemented to ensure that the product is safe and cannot cause harm to the consumer.

The HACCP concept was first presented to the world in 1971, following which the US Food and Drug Administration promulgated low-acid and acidified canned food regulations based upon HACCP concepts. After this, due to the time and expertise required to set up HACCP programmes, except for a few large companies and canners, HACCP was not widely used in the food industry. However, in 1985 a study commissioned by several US agencies strongly endorsed HACCP and recommended that regulators and industry both utilize HACCP because it was the most effective and efficient means of assuring the safety of the food supply. Based on these 1985 recommendations, the HACCP concept developed nationally and internationally. In 1988 the International Commission on Microbiological Specification for Foods published a book on HACCP, and in 1990 the Codex Alimentarius Commission (CAC) Codex Committee on Food Hygiene (CCFH) started to prepare a draft guideline for the application of the HACCP system. This guide has evolved somewhat over the years as it has moved through the various stages of the Codex adoption procedure. This manual is based on the latest draft at step 8 of the procedure, ready for adoption by the CAC.

Why then HACCP and not TQM or ISO 9000? HACCP is compatible with the implementation of such quality management systems and is the system of choice in the management of food safety within such systems. TQM and ISO 9000 are generally recognized by customers, HACCP is recognized by governments. Although TQM, ISO 9000 and HACCP are compatible, one does not replace the other. More importantly, HACCP is an internationally recognized inspection system. The signing of the World Trade Organization (WTO) Agreement has resulted in worldwide initiatives to remove internal and external trade barriers marked by the gradual elimination of non-tariff trade barriers; equal regulatory treatment of domestic and imported product; actions to ensure domestic regulations are consistent with tenants of trading agreements; transparency in all aspects of food legislation and regulations; and harmonization of domestic standards with international standards such as those of the CAC, unless higher levels of protection can be justified. The Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) noted that it was inappropriate for the CAC to endorse a particular quality assurance system, and that food safety issues were satisfactorily addressed by adherence to good manufacturing practices and to HACCP principles, the guidelines for which had been already adopted by Codex; and the application of the HACCP system adequately addressed the needs of the WTO Sanitary and Phytosanitary (SPS) Agreement.

Government recognition of HACCP as the most effective means of managing food safety is increasing on a world-wide basis; and more countries, both importing and producing, are making HACCP mandatory. There has been some concern that there is a danger in customization of HACCP programmes by governments or industries due to valid social, economic and cultural reasons which could lead to challenges in negotiating equivalence agreements. The solution is to ensure that the basic HACCP programme, as outlined in this manual, is incorporated into the existing quality control or inspection programme.

Inspection and quality control deals with more than food safety. Regulators, consumers and clients do not only want safe food, they want food of acceptable quality, properly labelled and which has an actual weight that matches the weight designation which appears on the label. HACCP is an excellent, though narrowly defined food safety system that does not deal with quality or economic fraud. These additional factors must be considered in the manufacturers quality control programme which should cover at least the following four items:

- Prerequisite Programmes: universal requirements - construction, equipment, sanitation, grounds, recall, etc.

- CCPs: established through HACCP

- Control Points (CPs) for quality: established through Quality Hazard Analysis

- Defect Action Points; established through Regulatory Hazard Analysis - identifies regulatory quality and fair marketing practices (eg. labelling and weight requirements that products must meet)

HACCP was designed for food safety and safety should always come first, but the HACCP techniques are flexible and can be applied to other areas such as product quality, work practices and to products outside the food industry. The key issue is to make sure you do not try to do too much and end up with a complicated system which is difficult to control (eg. quality, legality and safety mixed together in the same system). Instead, the same techniques can be applied separately to establish distinct systems which are equally effective and easy to manage within your quality control programme.

The CCFICS in its Draft Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems, states that the principles of HACCP developed by the CCFH provide a systematic basis for the identification and control of hazards so as to ensure the safety of food. The use of a HACCP approach by food businesses should be recognized by governments as a fundamental tool for improving the safety of foodstuffs. The voluntary utilization of quality control by food businesses should also be encouraged in order to achieve greater confidence in the quality of products obtained. If safety and/or quality control tools are used by food businesses, the official inspection and certification systems should take them into account in particular through the adaption of their control methodologies. Governments do, however, retain the fundamental responsibility to ensure by official inspection and certification the conformity of foodstuffs to requirements. The degree to which industry effectively utilizes quality control procedures can influence the methods and procedures by which government services verify that requirements have been met, where official authorities consider such procedures to be relevant to their requirements.

Control (verb):

To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.

Control (noun):

The state wherein correct procedures are being followed and criteria are being met.

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 to be taken when the results of monitoring at the CCP indicate a loss of control.

Critical Control Point (CCP):

A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical Limit:

A criterion which separates acceptability from unacceptability.

Deviation:

Failure to meet a critical limit.

Flow diagram:

A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.

HACCP:

A system which identifies, evaluates, and controls hazards which are significant for food safety.

HACCP Plan:

A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration.

Hazard:

A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Hazard Analysis:

The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan.

Monitor:

The act of conducting a planned sequence of observations or measurements of control parameters to access whether a CCP is under control.

Step:

A point, procedure, operation or stage in the food chain including raw materials, from primary production to final production.

Validation:

Obtaining evidence that the elements of the HACCP plan are effective.

Verification:

The application of methods, procedures, and tests and other evaluations, in addition to those used in monitoring to determine compliance with the HACCP plan.

To assist in developing your HACCP programmeme we are providing some examples of defects, tolerances, sampling plans, and forms. The following is taken from the compulsory requirements of DFO Canada in their QMP for finned fish.

a fish presented in a whole, dressed, or bled form is considered defective if there is any trace of fuel oil or other critical contamination or the flesh odour is indicative of decomposition or taint. Where decomposition is detected by a distinct and persistent odour associated with spoilage ie: hydrogen sulphide, faecal, ammonia, fruity, vegetable, putrid, sour, musty or odours associated with decomposed fish; taint is detectable by distinct and persistent odours of oxidised oils (rancid) or abnormal odour associated with feed; and critical contamination is the presence of any material or distinct and persistent odour or flavour of any material which has not been derived from fish and which poses a threat to human health (glass, solvents, fuel oil, pharmaceuticals, antibiotics, etc.).

Lot acceptance will be based on the sampling plan found (on the next page). In cases where each fish is subject to culling or grading, the sampling plan need not apply. Those lots sampled and found to have a defect level greater than 10% must be culled or reworked prior to being processed. Those lots with a defect level of 10% or less may be processed provided that defective units are removed on-line. The defect tolerance for pharmaceutical or chemical residues resulting from treatments on aquaculture finfish products is zero unless specified by (the competent authority having jurisdiction).

The following procedures shall be used in determining the condition of each fish in the sample:

• Each fish is examined for contamination by fuel oil or other critical contamination source likely to be a threat to human health.
• An assessment is made of flesh odour by making a cut across the back of the fish such that the cut surface of the exposed flesh can be evaluated for decomposed or tainted conditions which are distinct and readily detectable. Note: In cases where the final product form of the species is the fresh or frozen dressed state, the samples will only be cut as a last resort to determine the condition of the fish.
• In the case of ungutted fish, examination of the belly walls will be used as an indication of the degree of decomposition of the fish.
  

All lots of raw fish coming into or landed at a fish processing plant must be inspected at the identified critical points of inspection to ensure that they are derived from raw materials that meet the minimum (regulatory) requirements.

Processors of aquaculture finfish products must maintain records for all lots of aquaculture finfish coming into the processing plant to ensure they adhere to the prescribed withdrawal periods for any treatments which have been used.

The sample size, (the number of fish to be inspected) is determined by randomly sampling at least 10 fish from the lot to determine the average weight of each fish. Divide the average weight into the estimated or actual weight of the lot to be examined to determine the total number of fish in the lot. Based on the total number of fish the following sampling schedule shall be applied:

*the minimum number of defective units needed to reject the lot. Once the rejection number has been exceeded, the inspection may be stopped. Please note: this plan does not apply to lots of fish that were hand culled or graded individually.

Example of Incoming Shipment Inspection Form (not from DFO)

A number of generic HACCP models have been developed by the ASEAN-Canada Fisheries Post-Harvest Technology Project and by other organizations. These can be used as examples or guidelines for various processes/product types. Once selected, specific generic model(s) can be used as a starting point or template for further customization to reflect a particular plant environment and specific product. Generic models were not designed to be used as is in a plant. They must be adapted to reflect the specific conditions in a given plant. It is the responsibility of the HACCP team to ensure that all hazards specific to a food processing operation have been identified and controlled. It is possible that additional hazards may be identified as a result of customizing the HACCP generic models.

ASEAN-CANADA FISHERIES POST-HARVEST TECHNOLOGY PROJECT - PHASE II Generic Models

We are using one example for guidance only; and it is not necessarily complete. The example is from the Project manual, "Canned Tuna Quality Management Manual" developed by Thailand. We would appreciate any comments and suggestions for making this model and the text of this publication better. Please send information to: