HACCP Certification

Contents

What is HACCP?

Principles of HACCP

Implementation of HACCP

HACCP and ISO 9000

1. What is HACCP?

HACCP is an abbreviation for the Hazard Analysis Critical Control Point system,

which is synonymous with food safety management. It is “a system which identifies,

evaluates, and controls hazards which are significant for food safety.” HACCP is a system

that gives confidence that food safety is being managed effectively. The system looks for

hazards, or anything that could go wrong regarding product safety, and implements controls

subsequently to ensure that the product will not cause harm to the consumer.

HACCP was developed originally as a microbiological safety system in the early days

(1960s) of the US manned space programme, as it was vital to ensure the safety of food for

astronauts. The Pillsbury Company working alongside the National Aeronautics and Space

Administration (NASA) of the United States and the US Army Laboratories developed the

original system.

A “hazard” as used in the HACCP system is defined as “a biological, chemical or

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

A “Critical Control Point” (CCP) is “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”.

HACCP is based on the principle that hazards affecting food safety can be either

eliminated or minimized by prevention during production rather than by inspection of the

finished product. Its goal is to prevent hazards at the earliest possible point in the food chain.

The HACCP approach can be applied right from harvest to the point of consumption. Adding

HACCP to traditional inspection and quality control activities would lead to a preventive

quality assurance system in a company. Companies using the HACCP system will be able to

provide greater confidence about food safety to consumers as well as to food regulatory

authorities.

In many food processing industries established ways of operating, including methods of

food processing and handling have become entrenched. The application of HACCP may

require a fundamental change in the culture or attitudes of those involved in food processing.

A good example is the need to establish a written procedural manual and for written records.

In many industries there is no tradition of written procedures or records of quality or safety

parameters, indeed the skill of the individual in many food processing situations is what is “in

their head”. HACCP requires a fundamental change in attitudes, focused record keeping and

documentation, even though many of the procedures to be documented themselves may

remain unchanged. Similarly, those attempting to implement HACCP may find it difficult to

grasp the concept of risk-based food safety controls, particularly if they have been

accustomed to controls based on pre-specified physical parameters that may bear little

resemblance to the particular characteristics of the food processing operation in which they

are involved. It is very important that all the people working in the company understand the

HACCP system and that they maintain it. The adoption of HACCP simply to satisfy a

regulatory requirement has the potential to lead to failure in that company.

The HACCP system and guidelines for its application were developed by the Codex

Committee for Food Hygiene on the Codex Alimentarius Commission, a joint Food

Standards Programme of the Food and Agriculture Organization (FAO) of the United

Nations, and the World Health Organization (WHO). The HACCP system and guidelines

were published in 1993 and revised in 1997.

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2. Principles of HACCP

The HACCP system consists of seven principles, which outline how to establish,

implement and maintain a HACCP plan for the operation under study.

Principle 1

Conduct a hazard analysis. Identify potential hazards associated with all stages of the

production, using a flow diagram of the steps in the process. Assess the likelihood of

occurrence of the hazards, and identify preventive measures for their control.

Principle 2

Identify/Determine the CCPs. Determine the points/procedures/operational steps that can be

controlled to eliminate the hazards, or minimize the likelihood of occurrence, or reduce the

hazards to an acceptable level.

Principle 3

Establish Critical Limits (target levels and tolerances), which must be met to ensure the

CCPs are under control. They must involve a measurable parameter and may also be known

as the absolute tolerance or safety limit for the CCP.

Principle 4

Establish a system to monitor control of the CCP by scheduled testing or observation.

Principle 5

Establish the corrective action to be taken when monitoring indicates that a particular

CCP is moving out of control. Corrective action procedures and responsibilities for their

implementation need to be specified.

Principle 6

Establish procedures for verification to confirm that the HACCP system is working

effectively. Verification procedures must be developed to maintain the HACCP system and

ensure that it continues to work effectively.

Principle 7

Establish documentation concerning all procedures and records relating to the

application of these principles. Records must be kept to demonstrate that the HACCP

system is operating under control and that appropriate corrective action has been taken for

any deviations from the Critical Limits.

HACCP is not a “stand-alone” system. Good hygiene practices and other prerequisites

for food processing as well as strong management commitment are also necessary; HACCP is

not a substitute for these. Training is another essential requirement for a successful HACCP

system. As an aid to developing specific training to support a HACCP plan, prepare working

instructions and procedures that define the tasks of the operating personnel at each critical

control point.

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3. Implementation of HACCP

HACCP is a system that assists organizations to identify potential food safety hazards

in the entire food supply chain and to take preventive measures for their control. HACCP

focuses on the prevention of hazards rather than relying on end product testing. The

following sequence of 12 steps, included in the guidelines developed by the Codex

Committee on Food Hygiene, is the recommended approach to develop a HACCP

programme.

Step 1: Assemble HACCP team

Set up a multi-disciplinary team that includes representatives from production, sanitation,

quality control, food microbiology, etc. This team should be assigned specific segments of

the food chain to be covered in the HACCP system, and be entrusted with developing a

HACCP system as described from Step 2 onwards. Top management must give its full

support to the team. If the required expertise is not available within the company, bring in

help from a consultant.

Step 2: Describe product

Draw up a full description of the product for which the HACCP plan is to be prepared,

including product composition, structure, processing conditions, packaging, storage and

distribution conditions, required shelf life, instructions for use, etc.

Step 3: Identify intended use

Identify the intended use of the product by the end-user or consumer. You need to determine

where the product will be sold as well as the target group (e.g. institutional catering, homes

for senior citizens, hospitals, etc.).

Step 4: Construct flow diagram

You need to carefully examine the product/process and produce a flow diagram around which

to base the HACCP study. Whatever the format you choose, study all the steps involved in

the process – including delays during or between the steps from receiving the raw material to

placing the end-product on the market – in seque nce, and present them in a detailed flow

diagram with sufficient technical data. In the diagram, you might also want to include the

movements of raw materials, products, wastes, a plan of working premises, equipment layout,

product storage and distribution, and of employee moves or changes.

Step 5: On-site confirmation of flow diagram

The HACCP team should confirm the processing operation against the flow diagram during

all stages and hours of operation and amend the flow diagram if necessary.

Step 6: List all potential hazards associated with each step, conduct a hazard analysis,

and consider any measures to control hazards

Using the flow diagram, the team should list all the hazards – biological, chemical or physical

– that may reasonably be expected to occur at each process step, and describe the preventive

measures that can be used to control such hazards (for example, the use of air curtains, hand

and feet washing at entrance to processing areas, wearing of head gear, use of good

manufacturing practices [GMP]/standard operating procedures [SOP]/ sanitation standard

operating procedures [SSOP], etc.).

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Step 7: Determine Critical Control Points (CCPs)

You may wish to use a decision tree with “yes” or “no” answers to facilitate the

determination of CCPs (See Annex A). When applying the decision tree, you need to remain

flexible and use common sense to avoid, wherever possible, unnecessary control points

throughout the whole manufacturing process. If you identify hazards at a step where control

is necessary for safety and no preventive measures exist at that step, you need to modify the

process at that step, or at an earlier or a later stage, to include a preventive measure. For

example, in a slaughterhouse, covering carcasses with a sanitized cloth to preve nt infection

by flies is a preventive measure at the carcass stage, which substitutes for a preventive

measure such as washing the prepared meat at the next stage, as it will not be possible to

disinfect the meat at this stage, i.e., during cutting or mincing operations.

Step 8: Establish critical limits for each CCP

You need to establish critical limits for each CCP. They are normally derived from

specifications included in the food legislation of a country or in national or international

standards (e.g. moisture levels in milk powder, or pH level and chlorine limit in potable

water, etc.). When limits are not taken from regulatory standards (e.g. frozen storage

temperature) or from existing and validated guides of good manufacturing practices, the

HACCP team should ascertain the validity of such limits relative to the control of identified

hazards and critical points.

Step 9: Establish a system of monitoring each CCP

Monitoring is the scheduled measurement or observation of a CCP to determine conformance

to its critical limits. The monitoring procedures must be able to determine loss of control, if

any, at the CCP (e.g. improper control of the temperature that may lead to faults in the

functioning of a pasteurization unit in a dairy plant). Monitoring for CCPs needs to be done

rapidly, as they later relate to on-line processes, and there is usually no time for lengthy

analytical testing. Physical and chemical measurements are often preferred as these can be

done rapidly and can frequently indicate microbiological control of the product.

The programme of observations or measurements should properly identify for each critical

point:

·  Who is to perform monitoring and checking;

·  When monitoring and checking are performed; and

·  How monitoring and checking are performed.

All records and documents associated with monitoring CCPs must be signed by the person(s)

doing the monitoring.

Step 10: Establish corrective actions

The HACCP team should develop specific corrective actions and document them in the

HACCP plan for each CCP in the HACCP system so that they can deal with deviations when

they occur. Such corrective action should include:

·  Proper identification of the person(s) responsible for implementation of a corrective

action;

·  Actions required to correct the observed deviation;

·  Action to be taken with regard to products manufactured during the period when the

process was out of control; and

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·  Written records of measures taken.

The actions must ensure, for example, that the CCP has been brought under control, that

procedures or conditions that created the out-of-control situation have been corrected, and the

food affected, disposed off safely, etc.

Step 11: Establish verification procedure

Develop a verification procedure to ensure that the HACCP system is working correctly. The

procedure should include the frequency of verification, which should be conducted by a

responsible and independent person. Examples of verification include auditing methods,

random sampling and analysis, etc.

Step 12: Establish documentation and record keeping

The HACCP system requires efficient documentation and accurate record keeping. For

example, hazard analysis, identified CCPs and their limits (including revisions, if any) should

be documented. Examples of records are CCP monitoring records, records of deviation found

and corrective action taken on them, etc.

HACCP and ISO 9000

The food industry is highly regulated by local, national and international laws relating

to food safety. More so, consumers are very careful in their buying decisions relating to raw

or processed foods. Consumers usually feel more confident when they have evidence of

quality management during the manufacturing of food and drink products, in addition to

supervision by food regulators.

The ISO 9000 family of standards is generic in nature and has been developed to assist

organizations of all types and sizes that wish to implement and operate a quality management

system (QMS). There are no restrictions on its implementation by any sector of industry,

including the food and drink industry. Large and small companies that process and/or

package food products worldwide have implemented ISO 9000 and obtained third-party

certification. These companies may also use HACCP or similar systems as part of their

quality assurance system. Some companies are using both ISO 9000 and HACCP as an

integrated food safety and quality management system.

ISO 9000 focuses on customer needs and expectations, and one of the most important

customer expectations is to have safe food products. Applying HACCP within an ISO 9000

QMS can result in a food safety system that is more effective than applying ISO 9001 or

HACCP separately. The emphasis of both systems is prevention rather than correction of

problems or deficiencies after they occur. A company implementing a HACCP system does

not have to comply with ISO 9001 but it is desirable.

The seven principles of HACCP can be integrated with ISO 9001:2000 requirements, as

explained below:

QMS documentation

When developing documentation for ISO 9001 (such as a Quality Manual, quality

system procedures, work instructions, quality plans, etc.), also take into account HACCP

Principle 7, which requires you to establish documentation on all procedures and records, to

ensure that requirements concerning food safety aspects are integrated at the documentation

stage.

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Management responsibility

When defining the requirements conce rning management responsibility (e.g. quality

policy, quality objectives, planning, customer focus, communication, responsibility and

authority), you can incorporate the requirements of Principle 1 (conducting a hazard

analysis), Principle 2 (determining critical control points [CCPs]) and Principle 4

(establishing a system to monitor CCPs).

For example:

·  In the quality policy, stress that the organization is fully aware of its problems within the

food chain, by referring to food production, hygiene and safety;

·  Consider the HACCP plan while carrying out QMS planning; and

·  Make all personnel aware of the role they play in achieving stated policies and

objectives and in meeting customer requirements for both food safety and quality.

Resource management

When managing resources for ISO 9000 (e.g. human resources, infrastructure, work

environment, and other services), ensure that you have provided resources for preventing

hazards (HACCP Principle 1) and resources to monitor the control of CCPs (Principle 4). For

example:

·  The design and maintenance of the work area has a major effect on food safety;

·  Appropriate maintenance of equipment can also ensure that hazards do not affect the

food production process;

·  Effective sanitary and hygiene conditions in the processing area, including drainage,

pest control, segregation of wastes, health screening of employees, provision of

appropriate work wear (coats, boots, head gears, etc.) are essential for food products.

Product realization processes

In your product realization processes (e.g. planning, identification and review of

customer requirements, design and development, purchasing and operational controls), you

can integrate several HACCP principles, e.g. Principle 1 (identifying hazards), Principle 2

(determining CCPs), Principle 4 (establishing a system to monitor control of CCPs), etc. For

example:

·  Incorporate the HACCP study and CCPs into the product realization planning process.

·  Identify potential users and consumers for each product. Give careful consideration to

the special requirements of groups of consumers such as babies, children, patients,

elderly people, etc.

·  Determine specific customer and regulatory requirements such as control limits of

pesticides, residues, and heavy metals; test methods, etc.

·  Make food safety paramount when developing new products. Consult regulatory

requirements relating to the product during product development.

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·  In purchasing processes, check suppliers’ capability to adhere to critical limits at critical

control points for raw materials, equipment, cleaning chemicals, transport services,

laboratory testing services, warehousing, distribution, etc.

·  In your HACCP plan, include the identification of product and its traceability at each

stage of processing to ensure compliance with legal requirements for batch/lot

traceability control on raw materials and packaging materials.

·  Include controls identified in your HACCP plan for storage handling, delivery

conditions of the product including temperature/humidity control, shelf life, hygiene,

and infestation controls.

·  Processes such as pasteurization and sterilization, require well-defined process

conditions, trained personnel, adequate machinery and equipment to reduce reliance on

end-product testing.

·  The verification of measuring and monitoring devices in the food industry is crucial, and

may require data from inter-laboratory studies.

Measurement, analysis and improvement

In measuring, analyzing and improving the processes of ISO 9000, you can address

HACCP Principle 3 (establishing critical limits), Principle 4 (establishing a system to monitor

control of CCPs), Principle 5 (establishing corrective action) and Principle 6 (establishing a

verification procedure to check effective operations).

·  A monitoring plan is the output of a HACCP plan. It should include monitoring of

product, process, services, environmental aspects concerning food safety, etc. Measurement

and monitoring records are the backbone of a documented HACCP system, as the records

provide evidence that a product is within defined acceptance limits.

·  The overriding principle behind the establishment of a HACCP system is to ensure that

products are produced safely. It is argued that “after-the-fact inspection” will not contribute

to this principle, and therefore gathering information as to whether the controls identified

and executed have been successful or not is extremely important. The results of the

monitoring exercises will show whether the control steps have been effective.

General

The QMS requirements of training, internal audit and management review ensure the

effective operation and measurement of the HACCP system through internal audit; periodic

review of audit results and other data by top management ensures that the HACCP system

will continue to provide the des ired results, i.e. the provision of safe food to its consumers.

The HACCP approach and the ISO 9000 QMS are complementary. For companies that

have not yet settled on setting up a QMS but have decided to adopt HACCP for controlling

food safety requirements, it is advisable to first develop a HACCP system and then integrate

it into a QMS, when the company decides to adopt ISO 9000. Those companies that have

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already set up a QMS conforming to ISO 9001 may use the HACCP approach to upgrade

their quality planning to include food safety issues, if this has not already been done.

National HACCP system standards

National HACCP system standards have been developed in many countries.

Certification bodies provide third-party certification to companies that implement such

standards. For example, Det Norske Veritas (DNV), an international certification body,

provides an accredited Food Safety Management System certification to Danish Standard DS

3027, Requirements of Food Safety according to HACCP.

The Bureau of Indian Standards (BIS) provides two certification schemes to the food

industry, the first for a HACCP system alone, and the second for a combined HACCP and

ISO 9000 system:

·  Food Safety Certification against Indian Standard IS 15000:1998,Food Hygiene - Hazard

Analysis and Critical Control Point (HACCP) - System and Guidelines for its Application.

·  The HACCP-based Quality Management System Certification provides for two

certifications through one audit; certification of the quality system to Indian Standard IS/ISO

9000, and certification of HACCP to IS 15000:1998.

5. HACCP in international trade

It is important for SMEs in the food processing business to use HACCP: firstly because

of internal benefits like reducing the risk of manufacturing and selling unsafe products and

thus providing better confidence to consumers; and secondly, because food regulatory

authorities in many countries are adopting or likely to adopt HACCP as a part of their food

regulations. By implementing HACCP, you will have opportunities to e xport to such markets.

Some examples are given below:

·  In the United Kingdom, the Food Safety Act, 1990, and the Food Hygiene Inspection

Codes of Practice both include HACCP.

·  Canada has developed a Food Safety Enhancement Programme (FSEP) to encourage the

establishment of HACCP -based procedures in all registered establishments in the agricultural

and food processing sectors.

·  The Australian Quarantine and Inspection Service (AQIS) has developed a new

inspection system known as Food Hazard Control System (FHCS).

·  In the USA, the Food Adviser to the Center for Food Safety and Applied Nutrition has

recommended that the US Food and Drug Administration (FDA) encourage and eventually

require HACCP for the entire food industry. The FDA revised the Food Code in 1993,

making it compatible with HACCP concepts. From December 1997, all fish and fishery

products produced and marketed in the USA have had to comply with HACCP requirements.

FDA verifies HACCP plans prepared by producers. This also applies to imports of fish and

fishery products into the USA. Importers are required to obtain HACCP plans from the

concerned producers (exporters) in the exporting country and submit them to FDA for

verification. In addition, many HACCP principles are already in place in the FDA-regulated

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low-acid canned food industry. The juice industry is subject to HACCP regulation according

to a staggered schedule since January 2002. The US Department of Agriculture has required

the use of HACCP in meat and poultry processing plants since Janua ry 1999. FDA published

the Fish and Fishery Products Hazards and Controls Guide in September 1996 to assist

processors in the development of their HACCP plans, identify hazards and formulate control

strategies for those hazards. FDA is now considering deve lopment of regulations that would

establish HACCP as the food safety guideline throughout other areas of the food industry.

·  In the European Union (EU), EU Council Directive No. 93/43/EEC of 14 June 1993 on

Hygiene of Foodstuffs requires that food business operators should develop HACCP -based

systems for ensuring food safety. This Directive further suggests that member states may

develop codes of practice for specific food industries and adopt EN 29000 (the European

equivalent of the ISO 9000 series) to implement the general rules of hygiene and guides to

good hygiene practices. The European Commission Decision of 20 May 1994 (94/356/EC)

requires a system of “own checks” for the production and sale of fishery products in EU

countries. This decision also applies to imports. “Own check” means all those actions aimed

at ensuring and demonstrating that a fishery product satisfies the requirements of the above

decision. The “own check” included in this decision contains HACCP requirements. The EU

has also decided that HACCP plans prepared by producers/exporters are verified by an

authority nominated by the European Union. For example, in India, EU authorities have

nominated the Export Inspection Council, a statutory body under the Ministry of Commerce,

to verify exporters’ HACCP plans.

·  HACCP third-party certification on a voluntary basis exists in Australia, New Zealand,

some countries of Europe, India, Brazil, etc. It has also started in some countries in the

Middle East, South Asia and Latin America.

As shown above there are many different ways in which HACCP as a concept is

implemented into regulatory food safety requirements. In some cases, for example the United

States, detailed HACCP plans may be specified, the basic elements of which food processors

must translate and implement in their own operations. In other cases there may be a general

requirement to implement HACCP -based food safety controls, for example for certain

products in the European Union. In such cases, food processors must demonstrate that they

have an effective HACCP system in place, although the specific way in which the system is

implemented and operated is flexible. Further, in some cases a full seven-point HACCP

system may be required, including verification, whilst in others a six-point system, without a

specific requirement for verification, may be required. It should be emphasized, however, that

a properly implemented HACCP system, which will continue to operate effectively over

time, requires the full seven steps.

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ANNEXES

A. Example of decision tree to identify CCPs

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B. List of selected websites where information about HACCP can be obtained

Ø Codex Alimentarius Commission of the Food and Agricultural Organisation (FAO)

of the United Nations. http://www.codexalimentarius.net. This site contains

information on Codex Standards as well as other standards including HACCP.

Ø U.S. Food and Drug Administrat ion web site available from

http://vm.cfsan.fda.gov/~lrd/haccp.html. This site gives useful information on

HACCP principles and application guidelines.

Ø National Center for Food Safety and Technology (NCFST) - Consortium of

academia, industry, and government working together in Illinois, USA, to ensure the

safety and quality of the nation's food supply. http://www.iit.edu/~ncfs/

Ø The Society for Food Hygiene Technology in the United Kingdom. A group of

professional people who recognised the need for an organisation to cover the interests

and views of everyone involved in food hygiene in its widest application throughout

the food chain. http://www.sofht.co.uk

Ø The Seafood Network Information Centre web site providing information

including generic HACCP plans and current progress in the area of seafood HACCP.

http://seafood.ucdavis.edu/pubs/99resources.htm.

C. List of selected documents on HACCP

a. Documents downloadable free from the Internet

Strategies for Implementing HACCP in Small and/or Less Deve loped Businesses (1999),

World Health Organization (WHO), Avenue Appia 20, 1211 Geneva 27, Switzerland, Tel:

DEFINITIONS

CCP Decision Tree:

A sequence of questions to assist in determining whether a control point is a CCP.

Control:

(a) To manage the conditions of an operation to maintain compliance with established criteria.

(b) The state where correct procedures are being followed and criteria are being met.

Control Measure:

Any action or activity that can be used to prevent, eliminate or reduce a significant hazard.

Control Point:

Any step at which biological, chemical, or physical factors can be controlled.

Corrective Action:

Procedures followed when a deviation occurs.

Criterion:

A requirement on which a judgement or decision can be based.

Critical Control Point:

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 maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard.

Deviation:

Failure to meet a critical limit.

HACCP:

A systematic approach to the identification, evaluation, and control of food safety hazards.

HACCP Plan:

The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

HACCP System:

The result of the implementation of the HACCP Plan.

HACCP Team:

The group of people who are responsible for developing, implementing and maintaining the HACCP system.

Hazard:

A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

Hazard Analysis:

The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.

Monitor:

To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.

Prerequisite Programs:

Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.

Severity:

The seriousness of the effect(s) of a hazard.

Step:

A point, procedure, operation or stage in the food system from primary production to final consumption.

Validation:

That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.

Verification:

Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

HACCP PRINCIPLES

HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:

Principle 1: Conduct a hazard analysis.

Principle 2: Determine the critical control points (CCPs).

Principle 3: Establish critical limits.

Principle 4: Establish monitoring procedures.

Principle 5: Establish corrective actions.

Principle 6: Establish verification procedures.

Principle 7: Establish record-keeping and documentation procedures.