Module 2. Food safety and quality management systems

Lesson 10


10.1 Introduction

HACCP is a system that relies on process controls to minimize food safety risks in the food processing industry. It is useful to think of HACCP as a preventative food safety system and not a traditional quality control inspection system. HACCP is an international food safety system that deals with the control of factors affecting the ingredients, product and processing of food. It is widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food. The goal of HACCP is to identify biological, chemical and physical hazards and to include preventive measures throughout the process which would stop these hazards before they begin. These measures would, in turn, prevent unsafe food from reaching the consumer. Significant hazards for a particular food product are identified after a review of all the processing steps and use of scientific information. The steps at which these hazards can be controlled are identified and critical limits, such as process temperatures and hold times, at key process steps are set. Monitoring procedures are implemented to evaluate conformance with these critical limits. Should the process fall outside these limits, pre-planned corrective actions are taken to prevent the potentially defective product from entering the commerce stream. In addition, the HACCP system relies on extensive verification and documentation to assure that food safety has not been compromised during any step. Thus, HACCP provides a structure for assessing risks or what could go wrong and for putting the controls in place to minimize such risks.

10.2 History of HACCP

The Pillsbury Company encountered this dilemma in the 1960’s in its attempts to fulfill several food production contracts with the US Army and the National Aeronautics and Space Administration (NASA). NASA in particular had very stringent microbiological acceptance criteria, not wanting to risk the illness of an astronaut during a space mission. In essence, nothing short of 100% product testing could assure NASA that a particular packet of food was safe to consume. It was obvious to all involved that product testing could not be used to guarantee food safety. A much better system of food safety assurance was required. HACCP is a preventive system in which food safety can be designed into the product and the process by which it is produced. It is a system of product design and process control. The HACCP system of food safety is very effective at controlling identified hazards. Most importantly, it does not rely upon product testing to assure food safety. HACCP system used to assure 100% safety of the food to be used in space was developed in 1960 it was published and documented in 1971 in USA. HACCP is in use worldwide and has been endorsed by the joint FAO/ WHO Codex Alimentarius Commission in 1985 based on its successful industrial application; HACCP became mandatory programs in all meat and poultry plants in 1994. The HACCP program has been implemented in the nation’s processing plants with January 2000 as deadline.

10.3 HACCP and Food Regulation

The US Food and Drug Administration (FDA) used HACCP-based principles when setting up their low-acid food canning regulations in the 1970s. In 1995 the FDA issued regulations that made HACCP mandatory for fish and seafood products and in 2001 they issued regulations for mandatory HACCP in juice processing and packaging plants. In addition, a voluntary HACCP program was implemented in 2001 for Grade A fluid milk and milk products under the cooperative federal/ state National Conference on Interstate Milk Shipments (NCIMS) program. The FDA has also implemented pilot HACCP programs for a variety of other food processing segments as well as for retail foods. HACCP has also been implemented by the USDA. In 1998, USDA's Food Safety and Inspection Service (FSIS) mandated HACCP for the nation's meat and poultry processing plants. The US food processing industry will inevitably be faced with more mandatory HACCP programs under FDA and USDA/FSIS regulations in future. The HACCP system has also been implemented under regulations in other countries (e.g., Europe, Canada, Australia and New Zealand) and is a high priority program under Codex Alimentarius, the world food standards authority. In India, quality control with regard to food products are being enforced through various regulatory mechanisms like the Prevention of Food Adulteration Act (PFA), Agriculture Grading and Marketing (AGMARK), Fruit Products Order (FPO), etc. The Bureau of Indian Standards (BIS) has recently launched a HACCP certification programme for the food industry. The Mother Dairy of Delhi and the Punjab Cooperative Milk Federation have received HACCP certificates. The Agriculture and Processed Food Export Development Agency (APEDA) has helped mango processing units in Andhra Pradesh in implementation of HACCP. While efforts are being made to implement HACCP in the organised sector of the food industry, there is a need to implement HACCP in the unorganised sector also as it accounts for 70-80% of food produced and processed in India.

10.4 Steps and Principles of HACCP Concepts

The HACCP concept is based on the seven principles of the Codex Alimentarius as laid down in Article 5 of the Regulation (EC) 852/ 2004 on the hygiene of foodstuffs. The HACCP concept must be regularly reviewed to ensure that it is always up to date. The HACCP concept must be updated according to reflect any changes to the product or the manufacturing process as well as new scientific discoveries concerning potential risks.

Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system. During hazard identification, evaluation and subsequent operations in designing and applying HACCP systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern and epidemiological evidence relative to food safety. The intent of the HACCP system is to focus control at CCP’s. Redesigning of the operation should be considered if a hazard which must be controlled is identified but no CCP’s are found. HACCP should be applied to each specific operation separately. CCP’s identified in any given example in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application or might be of a different nature. The HACCP application (Fig. 10.1) should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying HACCP to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation. The development of an HACCP concept involves the following steps:


Fig. 10.1 Codex alimentarius logic sequence

10.4.1 Establishment of a multi disciplinary HACCP team

The HACCP team is formed of specialists from the areas of production, quality assurance, food law and development. The team members have appropriate training and knowledge of the application of HACCP principles in practice. The HACCP team should report directly to the company’s management. When a dairy embarks upon implementing HACCP system, it becomes necessary to gather together as much expertise and experience on the discussion table as possible including involvement of top management. As development of HACCP based food safety management programme requires a multi-disciplinary team effort, it should include expertise in veterinary health, production, microbiology, toxicology, public health, food technology, environmental health, chemistry and engineering according to the particular study. This cross-functional expertise is necessary to adequately analyze all physical, chemical and biological hazards through the food chain. If the people drawn in the team are not specialists and are not properly trained and experienced, HACCP system is unlikely to be effective.

The HACCP team should have knowledge, experience and attributes to correctly:
  • Identify potential food hazards.
  • Evaluate the existing system and data in a logical manner,
  • Assign levels of severity and risk to identified hazards.
  • Analyze problems and recommend controls, criteria and procedures for monitoring and verification to bring lasting solutions to recurring problems, recommend appropriate corrective actions when deviations occur.
  • Communicate both within the team and with people across all levels of the dairy.
  • Predict the success of the HACCP plan.
  • It is necessary to have right blend of people in the HACCP team. The team should normally have five to eight people depending on the size of the organization and complexity of operations.
10.4.2 Product description

The product description contains such information as product characteristics, product composition, Storage requirements, placing on the market. The dairy should describe its product(s). The description should include the major raw materials, food ingredients, preservation and packing materials used and their impact on food safety. This can also include a brief description of how the process occurs and/ products are made and stored. It would be useful if hazards that may exist either in ingredients or in packing material are identified. A description of the method of distribution includes type of transport and any special consideration to maintain product safety. For example, ice cream is described as a frozen ready to eat product containing both pasteurized and unpasteurized components. The skim milk powder, butter, sugar and water are pasteurized while the flavourings, nuts and chocolate are added without further heat processing. Air is also whipped into the product at freezing. Separate HACCP plan should be made for each product. But if two or more products have the identical raw material, ingredients, process operations, packaging, storage and distribution, they can be clubbed together in one HACCP plan.

10.4.3 Identify intended use

This intended use should be based on the expected uses of the product by the end user or consumer. It should be indicated how the product is to be used including if it is to be fully cooked before consumption, what preparations will be needed, what will be serving requirements, shelf life, etc. If consumer has special consideration such as infant or geriatrics it should be made clear so that necessary emphasis may be given to safeguard their special interest. For instance ice cream is consumed without further processing by general population including high risk groups but infant milk food is meant for infants and is given special consideration.

10.4.4 Construct a process flow diagram

The HACCP team constructs a detailed process flow diagram for each product indicating critical steps of control. Each step within the specified area of operation is analyzed for the particular part of the operation under consideration to produce the flow diagram. When applying HACCP system to a given operation, consideration is given to steps preceding and following the specified operation. The process flow diagram is used as the basis of the hazard analysis and should therefore contain sufficient technical detail for the study to progress. Each step within the specified area of operation should be analyzed for the particular part of the operation under consideration to produce the flow diagram.

10.4.5 On-site verification of process flow diagram

When the process flow diagram is complete, it is verified by the HACCP team at site to confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram where appropriate. This is partly an in office exercise and partly on site activity. In office exercise includes dissecting the process stage and discussing the implications of process parameters and then they are verified at the site. The verification of the flow diagram at site is done by actually walking through the plant to check the accuracy and completeness and make sure that the steps listed on the diagram describe what really occurs in producing the product. It would be useful if a plant layout is also available because a bad layout may provide avenues for cross contamination from raw material to products, facilities to products and persons to product. This should also form part of on-site verification.

10.4.6 Conduct hazards analysis (principle 1)

When the process flow diagram is completed and verified, the HACCP team conducts a hazard analysis and lists all the biological, chemical and physical hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture and distribution until the point of consumption. When conducting the hazard analysis, consideration must be given to the impact of raw materials, ingredients, manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, consumer populations at risk and epidemiological evidence relative to food safety. The team should then identify in the HACCP plan which hazards are of such nature that their elimination or reduction to acceptable levels is essential to the production of safe food. The team must then consider what preventative measures, if any, exist which can be applied for each hazard. Preventive measures are those action and activities that are required to eliminate hazards or reduce their impact or occurrence to acceptable levels. More than one preventive measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified preventative measure.

10.4.7 Identify the critical control points (principle 2)

A critical control point is a point/procedure where a food safety hazard can be prevented, eliminated or reduced to acceptable levels. The identification of a CCP in the HACCP system is facilitated by the application of a decision tree. All hazards that may be reasonably expected to occur, at each step, should be considered. If a hazard has been identified at a step where control is necessary for safety and no preventive 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 preventive measure. Application of the decision tree determines whether the step is a CCP for the identified hazard. For the identification of CCP's, a decision tree can be used. Each process step and each identified hazard must be considered, in sequence, using the decision tree (Fig. 10.2)


Fig. 10.2 Example of decision tree to identify CCPs (Answer questions in sequence)

10.4.8 Establish critical limits for each CCP (principle 3)

Since the critical control points define the boundaries between safe and unsafe products, it is vital that they are specified at the correct levels and validated at each criterion. The HACCP team should therefore fully understand the criteria governing safety at each CCP in order to set the appropriate critical limits. Critical limits much be specified for each preventive measure. In some cases more than one critical limit will be elaborated at a particular step. Criteria often used include measurements of temperature, time, moisture level, pH, and available chlorine and sensory parameters such as visual appearance and texture.

10.4.9 Establish a monitoring system for each CCP (principle 4)

Monitoring is one of the most important aspects of the HACCP system. It is the scheduled measurement of a CCP relative to its critical limits. The monitoring procedures must be able to detect loss of control at the CCP and provide information in time for corrective action to regain control of the process. Data derived from monitoring must be evaluated by a designated person with knowledge and authority to carry out corrective actions when indicated. If monitoring is not continuous, then the frequency of monitoring must be sufficient to ensure that the CCP is under control. Most monitoring procedures for CCPs will need to be done rapidly because they relate to on line processes and there will not be time for lengthy analytical testing. Physical and chemical measurements are often preferred to microbiological testing because they may be done rapidly and can often indicate the microbiological control of the product. All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and by a responsible reviewing official of the company.

10.4.10 Establish corrective actions (principle 5)

Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations when they occur. The actions must ensure that the CCP has been brought under control. Actions taken must also include proper disposition of the non conforming product. Deviation and product disposition procedures must be documented in the HACCP record keeping. Corrective action should also be taken when monitoring results indicate a trend towards loss of control at a CCP. Action should be taken to bring the process back into control before the deviation leads to a safety hazard.

10.4.11 Establish verification procedures (principle 6)

The HACCP system should include verification procedures to provide assurance that HACCP system is being complied with on day to day basis. This can be done most effectively by using audit method. Monitoring and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine if the HACCP system is working correctly. The frequency of verification should be sufficient to confirm that the HACCP system is working effectively. For examples of verification activities include
  • Review of the HACCP system and its records,
  • Review of deviations and product dispositions,
  • Confirmation if CCPs are under control,
  • Validation of established critical limits.
10.4.12 Establish record keeping and documentation (principle 7)

Efficient and accurate record keeping is essential to the application of a HACCP system. Records need to be kept of all areas which are critical to product safety to demonstrate that the HACCP system is in compliance with the documented system. Documentation of HACCP operation at all steps should be included and assembled in a HACCP plan. Records are useful in providing a basis for analysis of trends as well as for internal investigation of any food safety incidents which may occur. It is extremely useful to allocate a unique reference number to each HACCP record. The types of records that might be retained are as follows:
  • HACCP plan,
  • Modification to HACCP plan,
  • CCP monitoring records,
  • Deviations and associated corrective action,
  • Training records,
  • Audit records,
  • HACCP system
10.5 Example of a Worksheet


The Codex General Principles of Food Hygiene has recommended a Hazard Analysis and Critical Control Point (HACCP) based approach as a means to enhance food safety and has indicated how to implement the principle 1. The HACCP concept was developed in the 1960’s as a system to ensure the safety of food products. The HACCP can be defined as a system which identifies, evaluates and controls hazards which are significant for food safety. Its introduction signaled a shift in emphasis from end product testing to preventive control at all stages of food production. The HACCP system was initially developed for use by food processors for preventing food-borne hazards. However, the application of the HACCP system has been expanding to form a basis for regulated food control and as a standard for international food trade. It is being promoted internationally as a preventive system of hazard control that is considered to be the most effective and efficient way to ensure food safety. It is an action oriented programme to identify and reduce food-borne diseases. The Principles of the HACCP system set the basis for the requirements for the application of HACCP, while the guidelines for the application provide general guidance for practical application. Since the publication of the decision tree by Codex, its use has been implemented many times for training purposes. In many instances, while this tree has been useful to explain the logic and depth of understanding needed to determine CCPs, it is not specific to all food operations, e.g., slaughter and therefore it should be used in conjunction with professional judgment and modified in some cases.
Last modified: Monday, 1 October 2012, 5:03 AM