OUTLINE HACCP Safety Food Management System

I. The HACCP Concept II. HACCP History III. Codex Alimentarius IV. The Need for HACCP
1. Physical Hazards 2. Chemical Hazards 3. Biological Hazards V. The Five Preliminary Tasks of the HACCP Plan 1. 2. 3. 4. 5. Assemble the HACCP team Describe the product Identify intended use Develop a flow diagram Verification of the flow diagram

VI. The Seven HACCP Principles

1. 2. 3. 4. 5. 6. 7. Principle 1. Conduct a hazard analysis Principle 2 Identify the critical control points (CCPs) Principle 3 Establish critical limits Principle 4 Establish CCP monitoring procedures Principle 5 Establish corrective actions Principle 6 Establish procedures for verification. Principle 7 Establish documentation.

VIII. HACCP Failure

1. Training of personal 2. Sanitation 3. Good Manufacturing Practices (GMP) 4.

IX. Prerequisite Programs X. Control Measures XI. Advantages of HACCP XII. Disadvantages of HACCP

I. The HACCP Concept The Hazard Analysis and Critical Control Point (HACCP) system is a management system focused on prevention of problems in order to assure the production of food products that are safe to consume. It is based on a common-sense application of technical and scientific principles to the food production process from field to table. The principles of HACCP are applicable to all phases of food production, including basic agriculture, food preparation and handling, food processing, food service, distribution systems and consumer handling and (Stevenson,1999). The most basic concept underlying HACCP is that of prevention rather than inspection. A food grower, processor, handler, distributor or consumer should have sufficient information concerning the food and the related procedures they are using, so they will be able to identify where and how a food safety problem may occur. A HACCP pro ram deals with control of factors affecting the ingredients, product and process. The objective makes the product safe to consume and to be able to prove it. The where and how are the HA (hazard analysis) of HACCP. The proof of the control of processes and conditions is the CCP (Critical Control Point) part (Stevenson, 1999). By definition, the HACCP concept covers all types of potential food safety hazardsbiological, chemical and physical-whether they are naturally occurring in the food, contributed by the environment or generated by a mistake in the manufacturing process. While chemical hazards are still feared by many consumers and physical hazards are the most commonly identified by consumers, microbiological hazards are the most serious from a public health perspective. For this reason, while HACCP systems address all three types of hazards, a majority of the emphasis is placed on microbiological issues (Stevenson,1999). II. HACCP History HACCP was developed first to insure microbiological safety and was broadened later to include chemical and physical hazard. HACCP grew from 2 major developments: 1) WE Deming TQM systems and QM Theories. 2) HACCP system proposal by the Pillsbury Company, NASA and the US Army Laboratories based on the failure mode and effect analysis (FMEA) used in construction designs. use

Table 1.0 Overview of HACCP System History 1971 1990 Introduced in 1971 at the Conference of Food Protection Call for change in the 1990s with a tragic outbreak of E. coli 0157:H7 food borne illness in the USA resulting from the consumption of contaminated ground beef. Food Safety and Inspections Services (FSIS) developed the regulatory proposal. Later, it came to be known as the Pathogen Reduction/HACCP System Rule HACCP principles were adopted worldwide as given in Codex Alimentarius Commission and the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). Became a mandatory program for approximately 4000 seafood processors in December 1997 and also for foreign processors that ship seafood to the USA. In January 1998, the FSIS began implementing HACCP in the meat and poultry industry, completed in 2000 The Codex Committee on Food Hygiene would develop HACCP guidelines for small and/or less developed businesses (SLDB) EC 852/2004 requirement for all food businesses to adopt HACCP principles in EU. Legal Requirements to apply HACCP in food businesses (other than primary production) across EU (eg. packaging machinery and equipment, sanitary and hygiene supplier, etc.) Increased worldwide use of HACCP in food safety legislation

1997 1998 2003 2004 2006 2006+

III. Codex Alimentarius In the 1960s Codex was initiated under FAO/WHO control. It means Food Law or Code and is a collection of internationally adopted food standards presented in a uniform manner. It also includes codes of practice, guidelines and other recommended measures. It gained a greater significance since the formation of the World Trade Organization (WTO). The Codex Alimentarius Commission is committed to: 1- Protecting the health of consumers. 2- Ensuring fair practices in the food trade. 3- Facilitating international trade in food.

IV. The Need for HACCP Motivations for adopting HACCP may include the need to: 1- Reduce the incidence of foodborne disease. 2- Ensure a safe food supply for the population. 3- Promote trade in food products. What is a hazard Any biological, chemical or physical property that may cause a food to be unsafe for human consumption. (USDA, 1997). The HACCP system addresses and controls all significance hazards associated with a particular product. There are three categories of hazards that are considered in a HACCP plan: 1- Physical 2- Chemical 3- Biological (1) Physical Hazards include glass, metal, stones, wood, rubber, or pets (typically larger pets). They occur from accidental contamination and poor food handling practices that can occur at various points in the food chain from harvest to consumer (Mc Swane et. al, 2000). (2) Chemical Hazards include cleaning chemicals, pesticides, allergens, toxic metals, nitrites and nitrates, plasticizers, and packaging migration, veterinary residues and chemical additives. CH fall into two groups: 1- Naturally occurring poisons, chemicals or delerious substances (mycotoxins, afflatoxins, shellfish toxins). 2- Added poisonous chemicals or delerious substances. Focus on the following to reduce chemical hazards: 1- Purity of water 2- RM supply 3- Workers poor hygiene 4- Lack of GMP (3) Biological Hazards include food poisoning bacteria such as Salmonella, E. Coli and Bacillus cereus which are hazardous because they can survive inadequate cooking, grow to harmful levels in stored food, and spread from raw foods to ready-to-eat food (cross contamination). Pathologies come from:

Low quality RM Poor personal hygiene Environment (air, water and equipment) Inadequate cooking. Improper storage/holding ToC Improper reheating. Cross contamination Past use- by time.

Biological hazards include: 1- Harmful Bacteria 2- Viruses (hepatitis A, Norwalk virus) 3- Parasites (nematodes, tapeworms.) 4- Moulds 5- Yeasts 6- Naturally occurring toxins (mycotoxins, afflatoxins, shellfish toxins) 7- Protozoa Table 2.0 Types of bacteria as differentiated by the Gram Stain color reaction Name of Bacteria Gram negative bacteria Gram positive bacteria Yersinia enterocolitica X Salmonella typhi X (*) Ecoli 0157H7 X (effect mediated via toxins) Vibrio vilnificus X Shigella dysentaria X Staphylococcus aureus X Bacillus cereus X Listeria monocytogenes(*) X (lethal) Clostridium botulinum(*) X (lethal) Bacillus subtilus X General characteristics: (*) Exceptions to these general characteristics always exist Effect Invasive direct Mediated by a preformed toxin Onset period 24 hrs 1-6 hrs Nature Long lasting & debilitating Short lived & not usually fatal (e.g. S. aureus)

V. The Five Preliminary Tasks of the HACCP Plan HACCP is essentially a structured way of thinking about the management of food safety. The application of HACCP is compatible with the implementation of QMS, such as ISO 9000 series. It is the system of choice in the management of food safety within such systems (Anon, 2000). The seven principles of HACCP make up the Codex Alimentarius standard which is the reference for international food safety and the baseline for consumer protection. There are five preliminary tasks that need to be accomplished before the application of the HACCP principles to a specific product or process. Although the formats of HACCP plans will vary, in many cases the plans will be product and process specific.

Step 1 Assemble the HACCP Team (4-6 members): It is the team responsibility to develop the plan. The team is multidisciplinary and includes individuals from areas such as personnel, engineering, production, sanitation, quality assurance, logistics, food microbiology. Plus local personnel who are involved in the operations as they are more familiar with their variability and limitations. THIS FOSTERS A SENSE OF OWNERSHIP AMONG THOSE WHO MUST IMPLEMENT THE PLAN and is a major contributor to success, The HACCP team may need assistance and training from outside experts who are knowledgeable in the potential biological, chemical, and/or physical hazards associated with the product and the process.

Step 2 Describe the Product: Eight questions should be answered about the product: 1. Name? 2. Use? 3. Pack type? 4. Shelflife? Temperature? 5. Where will the product be sold? 6. Who is the intended consumer and what is the intended use? 7. What labeling instructions are needed? 8. Is special distribution control needed? Step 3 Identify intended use: Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g. infants, immunocompromised individuals, the elderly, etc.) Step 4 Develop a flow diagram: The flow diagram describes the process as can be seen in Figure 1.1. The purpose of the flow diagram is to provide a simple outline of the steps involved in the process.

Fig. 1.1 Generalised flow diagram of typical production process (FDA, 1999; Harrigan and Park, 1991; http://www.foodsci.purdue.edu/publications/foodsafety/ food safety-3.html).

Step 5 Verification of the Flow Diagram: It is important to check that the flow diagram is accurate by physically checking it against activities. Also that it includes exceptional items such as breakdowns, rework and cleaning. The team should also check that the flow diagram is correct for any shift pattern (Slatter,2003). After these five preliminary tasks have been completed, the seven principles of HACCP are applied (Corlett, 1998).

VI. The Seven HACCP Principles Principle 1 Conduct a hazard analysis: A hazard analysis is the identification of any hazardous biological, chemical or physical properties in raw materials and processing steps, and an assessment of their likely occurrence and potential to cause food to be unsafe for consumption (USDA, 1997). Hazard analysis is accomplished in two stages: (a) hazard identification based on a review of the origins of possible hazards and (b) hazard evaluation within the frame of the potential significance of each hazard is assessed by considering its severity (referring to health consequences) and its likeliness to occur (based on experience, epidemiological data and available information in the literature). Hazard analysis is completed by listing all significant hazards associated to each step, and all control measures that can eliminate or control these hazards to an acceptable level (Arvanitoyannis and Hadjicostas, 2001). Table 3.0 below is an example of an identified hazard.

Principle 2 Identify the critical control points (CCPs) in the process: CCPs are steps at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels (Rushing and Ward, 1999). The HACCP team should identify the steps in the production process which are essential for the elimination or significant reduction of the identified hazards from Principle 1. These CCPs are identified through the use of the decision tree (Fig. 1.2).

Figure 1.2: CCP Decision Tree

Principle 3 Establish critical limits: Once the CCPs have been determined, a critical limit or the amount of acceptable deviation has to be established for each CCP Critical limits for CCPs are expressed as numbers or specific parameters on visual observation, such as time/temperature, humidity, water activity, pH, salt concentration and chlorine level (Corlett, 1998; USDA, 1997). Critical limits are set for product safety and not product quality. In a cooked product, an example of a critical limit would be that an internal temperature of the product reaches at least 71C.

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Table 4. Excerpt for a HACCP Plan: Factors that affect the thermal destruction of enteric pathogens in a variety of beef patties

Principle 4 Establish CCP monitoring procedures monitoring results to adjust processes and maintain control. Monitoring consists of observations or measurements taken to assess whether a CCP is under control. Monitoring is used to determine when a deviation occurs at a CCP and, if it is not continuous, needs to be conducted at a frequency sufficient to ensure that the CCP is under control (Hulebak and Schlosser, 2002). The most important steps in food production to monitor are: 1. cooking 2. cooling 3. reheating 4. hot holding (Ropkins and Beck, 2000). The three basic requirements for developing monitoring procedures for the HACCP plan are: 1. defining the monitoring procedure 2. determining the frequency for monitoring 3. determining who will do the monitoring (Corlett, 1998). The following forms are representative of those needed for monitoring the HACCP system in most food plants: 1. raw material evaluation sheet 2. suppliers guarantee 3. cooker log 4. pack room inspection report

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5. cooking process validation letter 6. cooking equipment validation letter 7. equipment calibration log 8. corrective action report 9. employee training report (Corlett, 1998). Principle 5 Establish corrective actions to be taken when monitoring indicates that a particular CCP is not under control: The regulation defines corrective action as Procedures to be followed when a deviation occurs. A deviation is a failure to meet a critical limit (USDA, 1997). The purpose of corrective actions is: 1. 2. 3. 4. 5. to adjust the process, such as cooking temperatures or cooling rates to to correct the cause of the deviation to re-establish control over the process and CCP to determine the safety and proper disposition of the food being produced to maintain records of corrective actions maintain control or prevent a deviation

while a defect was occurring (Ropkins and Beck, 2000). Principle 6 Establish procedures for verification:. The verification typically consists of two phases. First, verification that the critical limits established for CCPs will prevent, eliminate or reduce hazards to acceptable limits. Second, verification that the overall HACCP plan is functioning effectively. Once critical limits at each CCP are met, minimal sampling of the final product is needed (McSwane et al., 2000). Basic verification procedures include the following: 1. initiation of appropriate verification inspection schedules 2. review of HACCP plan for completeness 3. confirmation of the accuracy of flow diagram 4. review of CCP records 5. review of records for deviations and corrective actions 6. review of critical limits to verify if they are adequate to control significant hazards

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7. validation of the HACCP plan, including on-site review 8. review of the modifications made to the HACCP plan a random sample collection and analysis 9. visual inspection of food production operations to determine that CCPs are under control 10. a review of departures from critical limits and how they were corrected (Corlett, 1998; McSwane et al., 2000). Table 5. Example of a company established HACCP verification Schedule

Principle 7 Establish documentation: The HACCP will incorporate documents such as the following: 1. the HACCP plan 2. hazard analysis 3. CCP determinations 4. CCP monitoring sheets 5. corrective actions 6. audit records 7. HACCP team meeting minutes 8. calibration records (Slatter, 2003). Table 6 is an example of a HACCP plan summary table:

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1. Support documentation such as validation records. 2. Records that are generated during the operation of the plan. After the HACCP plan is developed the conditions for its successful regular application and maintenance are the following: 1. Commitment from top management 2. Description of the individuals involved 3. Proper training of coordinator and team 4. Timeline for the activities in the initial implementation of the HACCP plan 5. Continual application of the monitoring, record keeping, corrective action procedures and other activities as described in the HACCP plan 6. Regular scheduled verification activities 7. Updating and revision as needed. VIII. HACCP Failure The HACCP system does not make food safe, but it is its correct application that can make a difference. A list, by no means complete, of some of the most common problems reported when reviewing HACCP plans: Only some of the principles are applied (mainly failure to apply Principles 4 and 5). The principles have not been applied appropriately (not identifying hazards properly). The HACCP plan is a paper exercise and is not implemented in practice. The HACCP plan is over-complicated. Critical limits that are not adequate and not supported by scientific studies. Corrective actions do not address the product involved in a deviation. Lack of coordination among responsible authorities, public and private sectors. Lack of understanding and staff training. Lack of commitment by management. Regulations and procedures that are not efficient. Insufficient education and motivation of consumers and food handlers on food protection task

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(Arvanitoyannis and Traikou, 2005; Bernard, 1998; Forsythe and Hayes, 1998; Marriott, 1997; McSwane et al., 2000; Mitchell, 1998; NACMCF, 1997).

IX. Prerequisite Programs As we said earlier that food safety is synonymous with HACCP, well here we are going to find out why Food Safety is HACCP plus (PRPs) (prerequisite programs) that are normally in place before the HACCP plan is developed. They are systems that support HACCP by taking the control of general hygiene and GMP out of the HACCP plan (Slatter, 2003). Typical PRPs are: 1- Training of personnel 2- Sanitation 3- GMP There could be others such as Supplier Quality Assurance and maintenance schedules . (1) Training of Personal Training is crucial to any food safety system. Poor staff training in food hygiene is a real threat to the safety of food. Employees should first understand what HACCP is and then learn the skills necessary to make it function properly. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP. Management should provide adequate time for thorough education and training. Personnel should be given the materials and equipment necessary to perform these tasks. Staff should have an understanding of: 1. what hazards are and their importance in food safety 2. CCPs and their role in the assurance of product safety 3. critical limits which should be met 4. corrective actions and responsibilities 5. record-keeping requirements 6. the objective of verification procedures (Slatter, 2003). It is important to link hygiene conscience with product safety from the very beginning (Engel, 1998). The trainer most often achieves the best results by keeping the talk short and by working through a set sequence of discrete steps as follows: 1. show the trainees the actual skill they are to acquire

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2. demonstrate and explain the operations involved 3. have trainees imitate the necessary actions 4. have trainees practice performing the operations 5. devote at least 50% of the session to trainee practice time (FAO, 1998). (2) Sanitation Sanitation is broadly defined by all precautions and measures, which are necessary in the production, processing, storage and distribution, in order to assure an unobjectionable, sound and palatable product which is fit for human consumption (Bakka, 1997). Sanitation is not sterilization (McSwane et al., 2000). The first step of sanitation is the pre-wash, with the objective of removing gross dirt, followed by alkaline and acid washing (to remove proteins, carbohydrates, lipids and minerals, respectively) ( Cruz et al., 2006). This dirt usually contains micro-organisms and nutrients that allow the microbes to grow (Marriott, 1997). Sanitation is accomplished by the following materials and methods: a. Heat b. Chemicals c. Radiations d. Filtration: (i) Micro (MF) (ii) Ultra (UF) (iii) Nano (NF) (iv) Reverse Osmosis (RO) (3) Good Manufacturing practices GMPs provide general rules for the manufacture, handling and preparation of various kinds of food products. It aims at safeguarding good hygienic and sensory quality traits and may be regarded as an obligation to bestow great care upon production. Industries that have adopted the GMPs have the following results amongst others: 1. complaints. 2. Better, more agreeable, cleaner and safer working environment. Better quality, safer products, decrease in incidence of consumer

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3.

Greater employee motivation and productivity and improved

psychological conditions (da Cruz et al., 2006). GMP encompasses the following: a. Personnel b. c. d. X. Control Measures Control measures are grouped into three groups as follows: ISO 22000:2005b). Examples of Control measures for the following 1. Physical Hazards: Specs for RM & ingredients, use of magnets, metal detectors and sifter screens, applying GMPs to prevent cross contamination. 2. Chemical Hazards: Use only approved chemicals, detailed specs for chemicals in use, letters of guarantee; inspect trucks that ship final product, proper labeling and storage and train employees in proper chemical handling. 3. Biological Hazards: Fermentation/pH control, time /temperature control, formulation control, drying, heating and cooking, cooling and freezing,, RM source control & inspection at receiving. XI. Advantages of HACCP 1. Application of HACCP system throughout the food chain from the primary producer to the consumer. 2. More effective use of resources, savings and more timely response to food safety problems. 3. Internationally recognized. 4. The application of HACCP systems can promote international trade by increasing confidence in food safety. PRPs that manage the basic conditions and activities Operational PRPs that manage control measures that the hazard analysis identifies as necessary to control identified hazards to acceptable levels HACCP plan to manage control measures that the hazard analysis identifies as necessary to ensure control of identified hazards to acceptable levels (CCPs; Buildings and facilities Equipment Production and process control

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5. The HACCP system allows for the identification of conceivable, reasonably expected hazards, even where failures have not previously been experienced. It is therefore particularly useful for new operations. 6. Staff and business owners gain confidence and are better equipped for informed discussion on food safety measures with food inspectors, third-party auditors, consultants, trading partners, consumers and others. 7. The development of a HACCP system can lead to improved education and awareness of staff working in SLDBs and staff members are empowered when their input is sought and valued. 8. The HACCP system has strengthened the regulatory approach to food safety by providing food control authorities with an opportunity to revisit their method of food inspection and the training provided to food inspectors. 9. More focused control on processes critical to food safety, with the flexibility to accommodate additional changes in production, quality or other specific measures, e.g. control of allergens or emerging pathogens. 10. Demonstrable improvements to food quality and safety standards, thereby reducing the potential for foodborne disease, customer complaints, wastage and damage to the reputation of the business. i. FAO/WHO, 2006a; FSA, 2001; http://www.jphpk.gov. ii. my/Agronomi/KAV/5HACCP1.pdf; http://www.unido.org/userfiles/cracknej/fgfs1.pdf; iii. Motarjemi and K aferstein, 1999). XII Disadvantages of HACCP 1. Resource-intensive during development, unless supported by extensive structure of trade associations or other industry groupings. 2. Needs to be validated for effectiveness. 3. Difficult to anticipate all hazards introduced by subtle variations on seemingly standard processes thus needs constant vigilance and updating. 4. Element of technical knowledge required to adopt them. 5. Perceived complexity and bureaucracy many smaller businesses regard HACCP as complicated and bureaucratic. 6. Lack of knowledge and adequate training many small businesses remain unaware of HACCP or lack sufficient in-house knowledge and training about the risks associated with their procedures to put in place or maintain effective HACCP-based controls.

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7. The costs of ongoing training against a backdrop of high staff turnover, typical in the industry, can also be prohibitive for many smaller food businesses (FAO/WHO, 2006a; FSA, 2001).

Supplier quality engineering

Due diligence is a term used for a number of concepts involving either the performance of source inspection or source surveillance, or the performance of quality duties such as PVA (Process Validation Assessment) or System Audits with a certain standard of care. Due diligence in supplier quality (also known as due care) is the effort made by an "SQE" (Supplier Quality Engineer) to validate conformance of product provided by the seller to the purchaser. Failure to make this effort may be considered negligence. This is conceptually distinct from investigative due diligence, involving a general obligation to identify true, root cause for non-compliance to meet a standard or contract requirement.

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