The Food Safety Plan – H.A.C.C.P Terms of reference: This linear HACCP plan covers the manufacture of an apple yogurt product, packaged in a pot. It will start at raw materials intake through to dispatch of processing plant. The HACCP plan will cover final product safety and will look at the following hazards: Physical Glass and hard brittle plastic Metal Chemical Pesticide residues in fruit Chemical residues associated with the packaging materials Chemical residues associated with cleaning Biological Unwanted bacteria yogurt, raw milk and fruit. The company has in place a number of effective prerequisite programs including: Cleaning and Sanitising Pest Control Personal Hygiene Requirements Staff Training The company complies with the following acts of legislation Regulation (EC) No 178/2002 of the European Parliament and of the Council Regulation (EC) No 852/2004 of the European Parliament and of the Council And the following codes of practice/guidelines documents were used in developing this HACCP plan: Campden BRI HACCP: A Practical Guide (Fourth edition). Guideline No 42 British Retail Consortium Global Standard for Food Safety (Issue 6) Department of Health Guidelines for the Safe Production of Heat Preserved Foods Institute of Food Science and Technology Food & Drink Good Manufacturing Practice, A Guide to its Responsible Management. Codex Alimentarius Food Hygien Basic Texts (Third Edition) 1.1 The HACCP food safety team 1.1.1 The HACCP plan is developed and managed by Fab Foods’ multi-disciplinary food safety team which includes those responsible for quality/technical, production operations, engineering and other relevant functions. The team leader has an in-depth knowledge of HACCP and is able to demonstrate competence and experience. The team members have specific knowledge of HACCP and relevant knowledge of product, process and associated hazards. In the event of the company not having appropriate in-house knowledge, external expertise will used, but day-to-day management of the food safety system remains the responsibility of the company. HACCP Team Member Responsibility Quality Assurance Carries out systematic measurements, comparison with BRC standard, monitoring of processes and an aims to prevent error. Quality Control Reviews the quality of all factors involved in production with focus on process outputs. Production Specialist contribute details of what actually happens on the production line throughout all shift patterns Engineer Provides information on the operating characteristics of the process equipment under study and the hygienic design of equipment and buildings Microbiologist Understands the microbiological hazards and risks associated with the product. Others Including; specialist equipment operators, hygiene manager, ingredient and packaging buyers, distribution manager, maintenance and calibration operators. External HACCP Members If knowledge is not available in-company, consultation with an eternal resource will be carried out. Table 1: Breakdown of Fab Food’s HACCP Team and Responsibilities. All persons are trained in HACCP and repeat the training annually. Below is a table showing how Fab Foods operates an organised structure of the HACCP team. Table 2: Fab Foods operation of an organised structure of the HACCP team. 1.2 Prerequisite programmes 1.2.1 Fab Foods has established and maintains environmental and operational programmes necessary to keep an environment suitable to produce safe and legal food products Prerequisite programmes include: Cleaning and Sanitising Pest Control Personal Hygiene Requirements Staff Training Process Step Hazard Prevention Control Limits Monitor Method Monitor Frequency Record Sheet Person Responsi ble Corrective action Validation ENVIRONMENTAL HYGIENE Environ mental Hygiene Presence of listeria/ Salmonell a Environm ent swabs Listeria/sa lmonella absent ISO approved methods Weekly monthly/ Quarterly Pathogen file QC Manager Full investigati on, re clean and re swab area Weekly review of pathogen file by QC HYGIENIC HANDLING OF INGREDIENTS * Milk, * Starter Cultures (S.thermo philus& L.burglari ous) * Fruit (diced apples) *Stabiliser (pectin) * Flavour Enhancers Presence of pathogeni c microorga nisms Pathogen screening Below pathogen limits SOP Testing procedure for investigati on of pathogens Weekly Pathogen screening monitorin g sheet QC Manager In case of pathogen presence immediate rejection of product. Presence of pathogeni c microorga nisms CLEANING, MAINTENANCE & PERSONNEL HYGIENE AT PRIMARY PRODUCTION Cleaning, Maintena nce & Personnel Hygiene at Primary Productio n Physical /Micro contamina tion Cleaning procedure s Clean areas, swab enterobact eria <10 Hygiene inspection , swabs Weekly Hygiene records Cleaning records Maintenan ce records Technical Manager Areas not cleaned correctly, revisit areas with operator, reclean and reswab Weekly review of hygiene cleaning and maintenan ce LOCATION Location of Factory Cross contamina tion Productio n area segregated Segregate d area Visual NA NA Technical Productio n areas must be segregated , if this is violated, investigat e reason Internal and external audits PREMISES Design, layout, Internal Structure s & Fittings Physical /Micro contamina tion Food grade walls and equipment Clean & undamage d Visual and Hygiene and housekeep ing audits Ongoing. Hygiene and Housekee ping Audits Technical Action log created. Actions monitored continuou sly Internal and external audits EQUIPMENT Food Control & Monitori ng Equipme nt Physical /Micro contamina tion Audit/Vis ual Inspection Clean & undamage d Visual and Hygiene and housekeep ing audits Ongoing. Hygiene and Housekee ping Audits QC manager Hygiene and household records created. Continuou s monitorin g. Internal and external audits Containe rs For Waste & Inedible Substanc es Physical /Micro contamina tion Clean colour coded waste containers Correct colour, clean and undamage d Visual and Hygiene and housekeep ing audits Clean daily Hygiene and Housekee ping Audits Productio n Monitorin g log created. Daily monitorin g of waste containers FACILITIES Water Storage Legionella contamina tion Legionella testing Absent External company sample and test All areas at least twice annually Water storage records Quality Control Officer Investigat e if legionella found in water, risk access product Legionella file Personal Hygiene/c aptive clothing Physical /Micro contamina tion Hand washing/c aptive clothing Correct hand washing procedure s and change of clothing in productio n areas Visual hand swabs, and Hygiene and housekeep ing audits On- going/qua rterly Hygiene records All Employee s Report deviations to supervisor /manager Action log Temperat ure Control Product contamina tion Temperat ure monitorin g Temperat ure specificati ons Calibrated thermome ters As per schedules Temperat ure Records QC manager Report deviations to QC manager Weekly audit of temperatu re records CLEANING MANAGEMENT Cleaning Program mes Contamin ation due to ineffective hygiene procedure Spray with acidic solution after clean on filler inside surfaces Surface hygiene tests Surface hygiene tests After each cleaning cycle Cleaning logs Productio n operators Do not proceed with productio n until satisfactor y hygiene has been achieved Weekly review of cleaning logs. Internal/e xternal audits Cleaning Program mes Contamin ation due to ineffective hygiene procedure CIP and hand cleaning procedure s Cleaning carried out to correct time, temperatu re and sanitizer strength Visual inspection s, sanitizer checks and swabbing regimes As per cleaning scheduled/ frequencie s Cleaning logs Operators/ Team leaders/Te chnical Do not proceed with productio n until satisfactor y plant hygiene has been achieved. Weekly review of cleaning logs. Internal/e xternal audits PEST CONTROL SYSTEMS Pest Control Microbiol ogical, Physical or chemical risks associated with pests. Pestguard Plus contract in place with Rentokil All evidence of pest activity reported and controlled. Pest Control Technicia n Pest control technician -monthly visits Rentokil File reports. Technical Manager All pest control actions & corrective actions taken reported to technical manager. Rentokil report. WASTE MANAGEMENT Waste Managem ent Rubbish provides environme nt for pest harborage. Rubbish cleared on a regular and routine basis. All rubbish to be removed. Hygiene & Housekee ping Audit schedule in place. Once per month Waste transportat ion document ation Any reports of visual sightings of waste/deb ris in the productio n area or surroundi ng areas. Waste coordinati ng officer Action log created and issued to Technical Manager Waste document ation file. PERSONAL CLEANLINESS Hygiene Policy Non- complianc e with general hygiene practises Fully document ed Hygiene Code of Practice compiled from Customer Codes of Practice and Good Manufact uring Practices. 100% complianc e by all site personnel. Hygiene & Housekee ping Audit schedule in place. Quarterly Hygiene records Technical Manager Action log created and issued to General Manager Hygiene and Housekee ping audit Personnel hand swabbing regime in place for productio n area. Monthly Hygiene records Technical manager Re swab and if positive discuss hygiene policy with the operator Hygiene and Housekee ping audit Visitors Visitors not aware of the site hygiene requireme nts. Unfit/unw ell visitors enter site. Rules for Visitors Procedure in place. Sign in at reception. Sign in agreement to follow company rules while on site. No unfit visitors allowed in high risk areas of factory. Hygiene rules Each visitor. Visitors Book Reception ist Vistors must meet the correct safety citeria to be allowed access to the premise Annual audit of visitor records Table 3: Fab Foods Prerequisite Process. Cleaning and Sanitising The order of operation for cleaning/sanitizing of food product contact surfaces is Rinse Clean Rinse Sanitize. The company uses a number of types of cleaning. Mechanical Cleaning. Often referred to as clean-in-place (CIP). Requires no disassembly or partial disassembly. Clean-out-of-Place (COP). Can be partially disassembled and cleaned in specialized COP pressure tanks. Manual Cleaning. Requires total disassembly for cleaning and inspection. Following cleaning, sanitization is completed, types include; Thermal Sanitization involving the use of hot water or steam for a specified temperature and contact time. Chemical Sanitization involving the use of an approved chemical sanitizer at a specified concentration and contact time. Cleaning and Sanitization is carried out to remove unwanted matter on food-contact surface, referred to as Food Soil. Detergents and cleaning compounds are composed of mixtures of ingredients that interact with soils in several ways: Physically active ingredients alter physical characteristics such as solubility or colloidal stability. Chemically active ingredients modify soil components to make them more soluble and, thus, easier to remove. Example of cleaning agents used are Alkaline Builders, Acid Builders, Water Conditioners, Oxidizing Agents, and Enzyme-based detergents. The below table is used when selecting cleaning agent to use. Surface Deposit Cleaning Solubility Sugar Water soluble Fat Alkali soluble Protein Alkali soluble Starch Water soluble, Alkali soluble Monovalent Salts Water soluble; Acid soluble Table 4: Surface Deposit vs. the Cleaning Solubility Examples of sanitizers include; Chlorine, Iodophors, Quarternary ammonium compounds, Acid anionic, Fatty Acid, Peroxyacetic acid The below table can be used when selecting cleaning agent to use Chlorine Iodophors Quarternary ammonium compounds Acid anionic Fatty Acid Peroxyacetic acid Corrosive Corrosive Slightly corrosive Noncorrosive Slightly corrosive Slightly corrosive Slightly corrosive I rritating to skin Irritating Not irritating Not irritating Slightly irritating Slightly irritating Not irritating Effective at neutral pH Yes Depends on type In most cases No No Yes Effective at acid pH Yes, but unstable Yes In some cases Yes, below 3.0-3.5 Yes, below 3.5- 4.0 Yes Effective at alkaline pH Yes, but less than at neutral pH No In most cases No No Less effective Affected by organic material Yes Moderately Moderately Moderately Partically Partially Affected by water hardness No Slightly Yes Slightly Slightly Slightly Residual antimicrobial activity None Moderate Yes Yes Yes None Cost Low High Moderate Moderate Moderate Moderate I ncompatibilities Acid solutions, phenols, amines Highly alkaline detergents Anionic wetting agents, soaps, and acids Cationic surfactants and alkaline detergents Cationic surfactants and alkaline detergents Reducing agents, metal ions, strong alkalies Stability of use solution Dissipates rapidly Dissipates slowly Stable Stable Stable Dissipates slowly Maximum level permitted by FDA without rinse 200ppm 25ppm 200ppm Varied Varied 100-200ppm Water temperature sensitivity None High Moderate Moderate Moderate None Foam level None Low Moderate Low/Moderate Low None Phosphate None High None High Moderate None Soil load tolerance None Low High Low Low Low Table 5: Comparison of the Chemical and Physical Properties in commonly used Sanitizers It is important that the clean, sanitized equipment and surfaces drain dry and are stored dry so as to prevent bacteria growth. Necessary equipment must also be cleaned and stored in a clean, sanitary manner. Cleaning/sanitizing procedures are evaluated for adequacy through evaluation and inspection procedures. Adherence to prescribed written procedures (inspection, swab testing, direct observation of personnel) are continuously monitored, and records maintained to evaluate long- term compliance. (Schmidt, 2000) All areas regarding Cleaning and Sanitizing must be documented and signed in appropriate specification sheets. Pest Control Pest Control is carried out to eliminate the entry of insects and rodents into the food processing premises. Pests include: Rodents (Rats, Squirrels, Mice etc.) Cockroaches, Flies, Ant, Birds and other vertebrates. Control of Pests in done by an outside service provided by Rentokil. (Hazel House, Millennium Park, Naas, Co Kildare, 1890 333 888). Poisoned Bait, Traps, Electrical Discharge system, Repellents, Pitfall traps and Sticky insect traps are among the controls put in place by Rentokil. In addition to this: The exterior of the premises is well-maintained by designated maintenance staff, lawns are mowed once a week and any debris which could be a possible nesting place for rodents/insects are removed. Evidence of pests such as dropping are examined for. The interior and exterior of processing plant is inspected twice weekly to ensure that no pests have begun to congregate. Pest control is included on the factory daily schedule. Drains onsite are fitted with rodent traps. All entrances to the factory are effectively concealed from pests when closed. In the event that a pest is found on the premises immediate action must be taken. Incident should be immediately reported to supervisor. Product recall may be necessary. All areas regarding Pest Control must be documented and signed in appropriate specification sheets. Personal Hygiene Requirements / Staff Training The below ‘house’ rules are in place as well and in conjunction with H.A.C.C.P. Staff are trained upon entry and annually by an official body which comply with the FSAI’s Guide to Food Safety Training Level 1 and Level 2. Prerequisite Control Measure All staff in contact with food items must confirm they are free of disease before they are employed. Require new staff members to complete a questionnaire about their medical situation and/or arrange for them to be tested for infectious diseases. All staff in contact with food items must wear protective clothing. Clean white cotton/polyester overalls or coats for all staff in contact with unpackaged food are provided and dry cleaned. Staff are prohibited staff who are experiencing vomiting or diarrhoea or have infected wounds on their hands or lower arms from handling unpackaged food items. If a person has these symptoms either send them home until they are better or move them to an area when they do not handle unpackaged food items. Provide adhesive medical dressings for staff to put over any wounds, cuts or abrasions on hands or lower arms Ensure that staff put on disposable hair nets, and beard nets (where applicable) before putting on their protective clothing. It is company policy to arrange for staff to be inducted and trained to do this. Use gloves that are fit for purpose. Glove sizes are available to take into account the different sized hands/ The gloves should be tight fitting but not so tight as to be uncomfortable. Disposable gloves have are designed for use with food. For tasks such as cleaning or pest control use rubber, non-disposable, thick gloves. Staff must remove protective clothing before going to the toilet. The facility is designed so staff must outer layer of protective clothing - prior to going to the toilet. This will include installing hooks on which to hang the clothes coming off. Provide facilities for staff to store outdoor clothes and personal effects. Install lockable cabinets in the changing facility. Staff must to wash hands regularly especially after bathroom, food or smoke breaks; after handling waste or uncooked food items and after sneezing or touching their faces. Signs are placed in bathrooms and in entrances to the processing areas reminding people to wash their hands Eating, drinking or chewing of gum in food processing areas is prohibited. It is policy that eating, drinking or chewing of gum in food processing areas is prohibited. A canteen is provided for such activities. Staff should not sneeze over food items. Staff are trained to turn away and sneeze into the crook of their arm or into hands over their face. Afterwards they should blow their nose with tissues & wash their hands Wearing of any jewellery in food processing areas is prohibited. This includes watches, ring, earrings, necklaces bracelets and hairpieces. All staff must sign a declaration saying they will abide by this policy. Visitors are asked to remove jewellery. Signs to doorways leading into processing areas remind people they should remove jewellery. Table 6: Personal Hygiene Requirements / Staff Training & Control Measures. 1.3 Description of the product 1.3.1 The scope of each HACCP plan, includes the products and processes covered, including Composition, e.g. raw materials, ingredients, allergens, recipe Origin of ingredients Physical or chemical properties that impact food safety, e.g. pH, aw Treatment and processing, e.g. cooking, cooling Packaging system, e.g. modified atmosphere, vacuum Storage and distribution conditions, e.g. chilled, ambient Target safe shelf life under prescribed storage and usage conditions Instructions for use, and potential for known customer misuse, e.g. storage, preparation. Process/Product type: Yogurt Product name: Absolutely Apple Composition: Skim milk, skim milk powder, apple fruit, preservatives, bacterial cultures ( Important product characteristics aw, pH, preservatives, processing How it is to be used: Direct consumption Packaging: Plastic cup and foil – sealed Shelf life: 2 weeks Where it will be sold: Retailers Labelling instructions: Within legal limits, as per BRC standards. Special storage and distribution control: Refrigerated at < 5°C Table 7: Product Description 1.3.2 Fab Foods ensures that the HACCP plan is based on comprehensive information sources, which are referenced and available on request. It uses: the latest scientific literatures historical & known hazards associated with specific food products relevant codes of practice recognized guidelines food safety legislation relevant for the production and sale of products customer requirements. 1.4 Identified intended use 1.4.1 The intended use of the product by the customer is described, defining the consume target groups, including the suitability of the product for vulnerable groups of the population (e.g. infants, elderly, allergy sufferers). 1.5 Construction a process flow diagram 1.5.1 The prepared flow diagram covers each product, product category or process. This sets out all aspects of the food process operation within the HACCP scope, from raw material receipt through to processing, storage and distribution. It contains the following: plan of premises and equipment layout raw materials including introduction of utilities & other contact materials, e.g water, packaging sequence and interaction of all process steps outsourced processes and subcontracted work process parameters potential for process delay rework and recycling low/high-care/high-risk area segregation finished products, intermediate/semi-processed products, by-products and waste. Path of Milk CCP 1 Divert of Product where applicable 2. Mixing Hopper 12. Holding of yogurt in holding tanks 21. Cold Storage,<5°C 22. Dispatch 18. Blast Chilled 20.Trayed/palletised 6a. Preheating of Milk in Pasteuriser 6c. De-aeration 6b. Homogenisation 17. Metal Detection 3b Incoming Packaging/ingredients 9. Cutting of yogurt ph 4.6 1.Organic Milk Storage Silo 6,7,8 4. Filtration 8. Incubation 36°-43°C Waste Milk to Effluent 10.Filtration 0.5mm 11. Cooled 25° -30°C 3. Addition of dry Ingredients (SMP, NaC) fromambient storage 7. Inoculation - addition of Cultures from freezer Packaging in warehouse 13. Fruit addition from ambient storage 15a. Lid & pot deboxing 19. Sleeves & trays packaging 5. Pumping of milk through balance tank 6d.Pasteurisation 93˚ C x 4min 14. Addition & mixing of fruit & yogurt 16.Filling, sealing & dating of yogurt pots 15b.Pot & lid packaging Waste yog to effluent plant & packaging to recycling/skip Unit Operations Milk storage Silo When the milk is received after passing quality testing. The milk is pumped from the tanker to the milk storage silos. Here the milk should be stored at <7˚C and held for no longer than 72 hours. Silos are agitated to make sure that the entire volume remains cold and that the milk fat does not separate from the milk. When the silo is empty, it is Cleaned In place with specific agents before the next milk from tankers are received. Mixing Hopper Milk from the silo is then passed in to the mixing hopper, where ingredients which were stored at ambient temperature, such as calcium and vitamins are added to the milk to be enriched. It provides gentle agitated to distribute the ingredients to form a precise liquid. It provides cooling so the milk stays under 7˚C. Filtration The type of filtration technology used in the industry is Microfiltration which is a low pressure- driven membrane filtration process, which is based on a membrane with an open structure allowing dissolved components to pass while most non-dissolved components are rejected by the membrane. In the dairy industry, microfiltration here which is used for bacteria reduction and fat removal in milk and whey as well as for protein and casein standardisation. The size of the membrane is 1.4µm. This is an essential process step to protect flavour, ensure nutritional value, and prevent microbial or physical contamination. It allows a product to have a specified fat content and for total fat and solids content. The type of membrane used in this filtration system is ceramic. They are resistant to temperature, chemicals and are easy to clean. Balance tank The milk is then pumped in to a balance tank or float tank. The tank is equipped with a float valve. The purpose of this is to keep the milk at a constant level and to maintain a constant supply of milk to the regeneration section of the pasteuriser. Pasteurisation Milk which is still at 4˚C is pumped from the balance tank into the regeneration section of the plate heat exchanger, where it is heated. The plate heat exchanger contains a series of stainless steel plates stacked together with spaces in between them. The spaces are the forming chambers which hold the milk as it passes through. The milk will increase from 4˚C to 72˚C for effective pasteurisation. This is held for 15 seconds and then chilled again to 4˚C. In the regeneration section the heat of the pasteurised milk is used to warm up the cold milk. Therefore the outgoing hot milk is the heating medium for the cold raw milk. The cold milk is the cooling medium for the hot milk, as it is used to cool down the hot milk from 72˚C to 4˚C. This all takes place in the plate heat exchanger where counter current flow is the most effective way of heat exchange. When the cold milk meets the oncoming hot milk, and is heated up, it is then passed through the holding tube which is long enough to last at least 15 seconds. Here the milk is being pasteurised. It flows to the regeneration section where it warms up the cool milk coming in and then off to the cooling section which is the final section. The divert valve on the processing unit is used for diversion of any liquid that may be under the pasteurisation temperature. In this case if it’s under 72˚C the milk is brought back to the regeneration section and pasteurised again. Pasteurisation is a thermal processing technique whereby milk is exposed to a time / temperature combination of 72˚C for 15 seconds. This will make the product safe for human consumption. Pasteurisation does not affect chemical, physical or organoleptic characteristics of the milk. The primary function of pasteurisation is a food safety function. However, as well as destroying pathogenic bacteria, pasteurisation will also destroy spoilage bacteria and denature enzymes. This has the effect of extending the shelf-life of milk, both chemically and microbiologically. Therefore pasteurisation is a critical control point in the process. A Phosphastase test must be carried out to show pasteurisation was effective.(<350mU/L = Pass) All tests are recorded. Raw milk contains acid and alkaline phosphatases. These enzymes catalyse the hydrolysis of certain phosphate esters. The thermal stability of alkaline phosphatase (AP) in milk is slightly higher than that of Microbacterium tuberculosis. AP is inactivated by heating milk to 72C and holding for 15seconds. Inactivation of AP ensures the destruction of Microbacterium tuberculosis. Adequately pasteurised milk will be phosphate negative. Homogenisation Homogenisation process allows two immiscible liquids to become mixed. This is achieved by turning one of the liquids into a state consisting of extremely small particles distributed uniformly throughout the other liquid. When the milk is fed through the homogeniser, the workhead generates high shear rates. The milk is forced through a small passage at high velocity. The disruption of the fat globules is due to turbulence and cavitation. While milk is forced through, the large fat globules are broken down into smaller ones. Resulting in a size of 2-5 microns. This results in a stable emulsion, better mouth feel of the product, reduced sensitivity to lipid oxidation. Deaeration Deaeration is the removal of oxygen and other dissolved gassed in the product. This is to prevent/avoid undesirable changes in the final end product. Not only free air can be removed but also mechanical air. Deaeration of a product can result in an oxygen level of <1ppm. This improves product quality and shelf life. Inoculation of culture starters After deaeration of the milk, the temperature is maintained, The milk here is getting ready for yogurt production. This heat treatment is to denature about 80% of the whey proteins, particularly β-lactoglobulin, which in turn reacts with the κ casein to form a more stable micelle, and, to produce yoghurt with increased body and viscosity the starter cultures with are used are, Lactobacillus bulgaricus and Streptococcus thermophiles. Incubation/holding tanks The milk is held for the fermentation process to be carried out. This occurs at a temperature around 45˚C. Cutting of yogurt pH These bacteria form a symbiotic starter culture to ferment milk. By creating the starter culture it increases the production of lactic acid in the fermentation process. Streptococcus thermophilus starts to grow first dropping the milks pH from 6.6 to 5.0, and produces carbon dioxide and lactic acid. These products stimulate Lactobacillus bulgaricus to grow and further drop the pH to 4.2. The sugar found in milk is lactose, when the starter culture is added to milk it breaks the lactose into glucose. After the sugar glucose is formed it. Then it is fermented into lactic acid by the microorganisms. The lactic acid decreases the pH of the milk and causes the casein, protein found in milk, molecules to denature and stick together. The milk then curdles to produce yogurt Filtration Filtration of yogurt can remove the excess whey from fermentation process and gasses which were produced form the starter cultures. This improves quality and shelf life of the product. Filtration membrane used in this process is 0.5mm. Yogurt Holding Tanks After filtration the yogurt is cooled and then passed into yogurt holding tanks. The tanks here keep the yogurt at the right temperature under atmospheric pressure. The yogurt is gently agitated to keep the yogurt mixed with no whey separation and to keep a good consistency for the product. Metal Detection Metal detection is a very important procedure in the manufacturing process. The yogurt is frequently checked using a pipeline metal detector prior to final processing and final packaging. The product is normally pumped through a non-metallic pipeline which passes through the detector. Removal of contaminated product is achieved through the use of automated reject valves which divert the product flow out of the process. Any high viscosity products that are being produced which have the potential to solidify in the pipeline, there are heated pipelines and valves are used, to limit pipe blockages. This will remove all contaminated substances from the product, resulting in a high quality and safe product. Blast Chilling Blast chillers/freezers rapidly chill foods from a temperature of 140˚C to 40˚C in less than two hours. As for yogurt, this will be even less. Blast chillers are ideal for chilling foods quickly that are made on a daily basis. Blast chillers and freezers have powerful fans that create a fast even air flow that is very cold. It uses a high-powered refrigeration system to blast the cold air laterally over the product at high speed, extracting heat at an optimum rate, whilst maintaining food quality. After the chill or freeze cycle is complete, the equipment switches into Hold mode to keep the food at the required temperature. Traying/Packaging After the yogurt has been chilled, it is then ready to be put into yogurt pots. These are single yogurt pots chosen for this product. The machine used here is the Automatic Rotary Type Cup Filling & Sealing Machine SP-2502. Cups fall into the holders on the machine, there are two stacks of yogurt cups, were two falls each time into the individual holders. These are then passed along to the dust and blow suction system. This takes away any access particles away from the cup. It passes on to a UV sterilizer, this kills all microbes that may be present in the cups which could have got contaminated during storage. It provides a sterile environment for the yoghurt. It moves on to the piston filler where the cup fills up with the chilled yogurt from the blast chillier. The amount of yogurt is poured out is calibrated on the machine. The cups are ready to be sealed, they are flushed with nitrogen, and the oxygen is reduced so that a longer shelf life can be obtained from the product. The yogurt cup is then sealed, brought to the out feed system of the machine where a lever comes down and sucks the yogurt filled cups out on to the vender belt to the labelling machine. The yogurt cups pass though the labelling machine, where is puts on a sleeve around the yogurt cup, stating all the requirements, such as yogurt name and nutritional information. A label is also stuck on the lid of the yogurt stating the best before date. Cold storage/Dispatch The yogurts are taken of the labelling line and are stored at 4˚C in trays/ boxes in cold storage rooms. These are now ready to be picked up by the truckers through dispatch. A physical test is done before any of the yogurts are dispatched. The Yogurt is now sold to consumers. 1.6 Verification of flow diagram 1.6.1 The HACCP food safety team verifies the accuracy of the flow diagrams by on-site audit and challenge at least annually. Daily and seasonal variations are considered and evaluated. Records of verified flow diagrams are maintained. 1.7 List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards 1.7.1 The HACCP food safety team identifies and records all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities. This includes hazards present in raw materials, those introduced during the process or surviving the process steps, and allergen risks. It also takes account of the preceding and following steps in the process chain. Fab Foods uses Risk Analysis to establish Hazards and uses it in conjunction with Food Standards such as Food Safety Requirements, HACCP, Good Manufacturing & Hygiene Practices and Total Quality Management to put an effective Food Management programme in place. Table 8: Risk Analysis in conjunction with Food Standards such as Food Safety Requirements, HACCP, Good Manufacturing & Hygiene Practices and Total Quality Management. 1.7.2 The HACCP food safety team conducts a hazard analysis to identify hazards which need to be prevented, eliminated or reduced to acceptable levels. Consideration are given to the following: likely occurrence of hazard severity of the effects on consumer safety vulnerability of those exposed survival and multiplication of micro-organisms of specific concern to the product presence or production of toxins, chemicals or foreign bodies contamination of raw materials, intermediate/semi-processed or finished product. Where elimination of the hazard is not practical, justification for acceptable levels of the hazard in the finished product shall be determined and documented. 1.7.3 The HACCP food safety team considers the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Where the control is achieved through existing prerequisite programmes, this is stated and the adequacy of the programme to control the hazard is validated. Step Process step Hazards Control measures Critical limits Monitoring procedure Corrective action 1(a) Raw Milk (Receive Milk) Presence of micro- organisms Microbiologi cal analysis. Keep records for each tanker route Bactoscan results Raw milk procedure Reject milk if not to microbiologic al limits 1(b) Raw milk (Release tests) Antibiotics Foreign material Rosa test Kundrat test ATK test In-line filter. Inspect tanker before offloading. Quality of gaskets Negative No damage gaskets Raw milk procedure Raw milk procedure Reject milk Follow up Daily tanker inspections 1(c) Raw milk (Cooling) Microbial Temperature Milk Cooled to < 3 o C Cold chain procedure Maintenance of ice banks 1(d) Raw milk (Silo relase) Microbial Chemical risk Temperature and time Cleaning Milk to be kept at minimum of 3 o C Within parameters Cold chain procedure GMP Maintenance of silos Quarterly check by supplier of chemicals 2(a) Cream separation Chemical risk Cleaning Within parameters GMP SOCP Quarterly check by supplier of chemicals 3(a) Homogenisatio n Chemical risk Cleaning Within parameters GMP SOCP Quarterly check by supplier of chemicals 4(a) Pasteurisation Microbial Temperature and time Temperatur e and time GMP WI GLP Re-pasteurise 4(b) Pasteurisation (Transfer of milk to holding tank) Microbial Cleaning Wash not more than 24 h before Visual on PC display Wash 5 Loading milk for mixing Microbial Cleaning Wash not more than 24 h before Visual on PC display Wash 6 Powder mixing Physical foreign material Production and process control Wash not more than 24 h before Visual on PC display Wash 7 T105 to storage tank Microbial Cleaning Wash not more than 24 h before Visual on PC display Wash 8 Pasteurisation and homogenisation process Microbial Time and temperature Pasteurisati on Temperature & time Temperatur e and recorder and visual on PC display Empty pasteuriser and repeat washing and sanitisation 9 Cooling down to maturation temperature and ferment addition Microbial Temperature Temperature Temperatur e and recorder and visual on PC display Too high: can be cooled with ice water; too low; stop the process 10 Maturation and breaking of curd Microbial Cleaning Wash not more than 24 h before Visual on PC display Wash 11 Cooling down, smoothing with filter and transfer to storage tank Microbial Cleaning Wash 1 hour before Visual on PC display Wash 12 Addition of sterile apple fruit pieces Microbial Cleaning Wash 24 h before Visual on PC display Wash 13 Packing Microbial Cleaning Wash 24 h before Visual on PC display Wash 14 Storage Microbial Lab test < 4ºC 24 h Viscosity Coliform Count Visual on PC display 15 Dispatch Microbial Temperature < 4ºC Pre-cool temperatur e Visual on PC display 1.8 Determination of the critical control points (CCP) 1.8.1 For each hazard that requires control, control points are reviewed to identify those that are critical. CCPs are those control points which are required in order to prevent or eliminate a food safety hazard or reduce it to an acceptable level. If a hazard is identified at a step where control is necessary for safety but the control does not exist, the product or process shall be modified at that step, or at an earlier or later step, to provide a control measure. Fab Foods implements a system by which critical points can be identified. Table 9: Decision Tree used by company to establish Critical Control Points. Simplified Decision Tree YES NO NO YES CCP Not CCP Not CCP Ref: Advi sed by the Chartered Insti tute of Envi ronmental Heal th (C.I.E.H) U.K. Q2. Is there a later step at which this hazard is or can be controlled? (Under your control) Would a loss of control at this point result in a realistic risk of illness or injury? Results of Decision Tree for CCP Determination Step Process step Hazards Control measures Control point 1(a) Raw Milk (Receive Milk) Presence of micro- organisms Microbiological analysis. Keep records for each tanker route CP 1(b) Raw milk (Release tests) Antibiotics Foreign material Rosa test Kundrat test ATK test In-line filter. Inspect tanker before offloading. Quality of gaskets CCP CCP 1(c) Raw milk (Cooling) Microbial Temperature CP 1(d) Raw milk (Silo relase) Microbial Chemical risk Temperature and time Cleaning CP GMP 2(a) Cream separation Chemical risk Cleaning GMP 3(a) Homogenisatio n Chemical risk Cleaning GMP 4(a) Pasteurisation Microbial Temperature and time CCP 4(b) Pasteurisation (Transfer of milk to holding tank) Microbial Cleaning GMP 5 Loading milk for mixing Microbial Cleaning GMP 6 Powder mixing Physical foreign material Production and process control GMP 7 T105 to storage tank Microbial Cleaning GMP 8 Pasteurisation and homogenisation process Microbial Time and temperature CCP 9 Cooling down to maturation temperature and ferment addition Microbial Temperature CCP 10 Maturation and breaking of curd Microbial Cleaning GMP 11 Cooling down, smoothing with filter and transfer to storage tank Microbial Cleaning GMP 12 Addition of sterile apple fruit pieces Microbial Cleaning GMP 13 Packing Microbial Cleaning GMP 14 Storage Microbial Lab test CP 15 Dispatch Microbial Temperature CP Fab Foods recognises the below as Critical Control Points in the production of the product. 1. The presence of antibiotics, and foreign material in raw milk, 2. Effective pasteurisation and homogenisation, 3. Maintaining the correct fermentation Temperatures 1.9 Establishment critical limits for each CCP 1.9.1 For each CCP, the appropriate critical limits are defined in order to identify clearly whether the process is in or out of control. Critical limits include: measurable wherever possible, e.g. time, temperature, pH supported by clear guidance or examples where measures are subjective, e.g. photographs. 1.9.2 The HACCP food safety team validate each CCP. Documented evidence show that the control measures selected and critical limits identified are capable of consistently controlling the hazard to the specified acceptable level. 1.10 Establishment of a monitoring system for each CCP 1.10.1 A monitoring procedure is established for each CCP to ensure compliance with critical limits. The monitoring system is able to detect loss of control of CCPs and wherever possible provides information in time for corrective action to be taken. Means of monitoring include: online measurement offline measurement continuous measurement, e.g. thermographs, pH meters etc. where discontinuous measurement is used, the system ensures that the sample taken is representative of the batch of product. 1.10.2 Records associated with the monitoring of each CCP include the date, time and result of measurement and are signed by the person responsible for the monitoring and verified, as appropriate, by an authorised person. Where records are in electronic form there is evidence that records have been checked and verified. 1.11 Establishment a corrective action plan 1.11.1 The HACCP food safety team specifies and documents the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend towards loss of control. This includes the action to be taken by nominated personnel with regard to any products that have been manufactured during the period when the process was out of control. 1.12 Establishment of verification procedures 1.12.1 Procedures of verification are established to confirm that the HACCP plan, including controls managed by prerequisite programmes, are effective. Examples of verification activities include: internal audits review of records where acceptable limits have been exceeded review of complaints by enforcement authorities or customers review of incidents of product withdrawal or recall. Results of verification are recorded and communicated to the HACCP food safety team. Critical Control Points Management Critical Control Point (CCP) Significan t Hazard Critical Limits for each preventat ive measure Monitoring Correcti ve actions Records Verificati on What How Frequenc y Who Presence of Antibiotics in raw milk Allergic reactions to residues, Developm ent of resistant strains of bacteria, Removes starter cultures See Table 11 Below Presence of antibiotic s Mainly Beta- Lactam DSM Delvo- Test & Charm Test On each batch of milk in all tankers, silos, cream vats, fermentati on tanks. On site micro lab. Reject & Dispose, inform Farm Liaison Officer and the Dep.t of Agricult ure Corrective action log. Antibiotic testing log. Milk & Yogurts quality log. For each batch processed the QA superviso r will review each log Presence of foreign material in raw milk Can cause physical, biological and/or chemical adverse effects. Foreign material must be absent in milk. Presence of Foreign Matter ISO 5538:200 4 Milk - Inspectio n by attributes On each batch of milk in all tankers, silos, cream vats, fermentati on tanks. On site micro lab. Remove or Reject & Dispose, inform Farm Liaison Officer and the Dep.t of Agricult ure Corrective action log. Antibiotic testing log. Milk & Yogurts quality log. For each batch processed the QA superviso r will review each log HTST Pasteurisat ion If not carried out correctly, harmful spoilage m/org can grow 72°C for 20 seconds TVC <1,000 cfu/ml on day 1; <5,000 cfu/ml on day 12 Temperat ure 0 C Presence of cfus per ml of the sample Check & sign-off on continuou s chart recorder Every 2 hours Pasteurize r Operator Empty pasteuris er and repeat washing and sanitisati on Corrective action log. Pasteurisat ion testing log. Milk & Yogurts quality log. For each batch processed the QA superviso r will review each log Maintainin g the correct Fermentati on Temp. Microbial 25 – 30 o C Temperat ure 0 C Temperat ure and recorder and visual on PC display Every 30 minutes Fermentat ion Superviso r Too high: can be cooled with ice water; too low; stop the process Corrective action log. Fermentati on testing log. Yogurt quality log. For each batch processed the QA superviso r will review each log Table 10: Critical Control Points Management including; Significant Hazard, Critical Limits, Monitoring, Corrective actions, Records, and Verification Table 11: Comparison of the EU maximum residue limits (EEC Regulation 2377/90 and amendments) with the sensitivities of the microbial inhibition assays for the detection of antibiotics in milk. 1.13 HACCP Plan Overview Step Process step Hazards Control measures Control point Critical limits Monitoring procedure s Corrective action 1(a) Raw Milk (Receive Milk) Presence of micro- organisms Microbiologi cal analysis. Keep records for each tanker route CP Bactoscan results Raw milk procedure Reject milk if not to microbiologic al limits 1(b) Raw milk (Release tests) Antibiotics Foreign material Rosa test Kundrat test ATK test In-line filter. Inspect tanker before offloading. Quality of gaskets CCP CCP Negative No damage gaskets Raw milk procedure Raw milk procedure Reject milk Follow up Daily tanker inspections 1(c) Raw milk (Cooling) Microbial Temperature CP Milk Cooled to < 3 o C Cold chain procedure Maintenance of ice banks 1(d) Raw milk (Silo relase) Microbial Chemical risk Temperature and time Cleaning CP GMP Milk to be kept at minimum of 3 o C Within parameters Cold chain procedure GMP Maintenance of silos Quarterly check by supplier of chemicals 2(a) Cream separation Chemical risk Cleaning GMP Within parameters GMP SOCP Quarterly check by supplier of chemicals 3(a) Homogenisatio n Chemical risk Cleaning GMP Within parameters GMP SOCP Quarterly check by supplier of chemicals 4(a) Pasteurisation Microbial Temperature and time CCP Temperatur e and time GMP WI GLP Re-pasteurise 4(b) Pasteurisation (Transfer of milk to holding tank) Microbial Cleaning GMP Wash not more than 24 h before Visual on PC display Wash 5 Loading milk for mixing Microbial Cleaning GMP Wash not more than 24 h before Visual on PC display Wash 6 Powder mixing Physical foreign material Production and process control GMP Wash not more than 24 h before Visual on PC display Wash 7 T105 to storage tank Microbial Cleaning GMP Wash not more than 24 h before Visual on PC display Wash 8 Pasteurisation and homogenisation process Microbial Time and temperature CCP Pasteurisati on Temperature & time Temperatur e & recorder & visual on PC display Empty pasteuriser and repeat washing and sanitisation 9 Cooling down to maturation temperature and ferment addition Microbial Temperature CCP Temperature Temperatur e and recorder and visual on PC display Too high: can be cooled with ice water; too low; stop the process 10 Maturation and breaking of curd Microbial Cleaning GMP Wash not more than 24 h before Visual on PC display Wash 11 Cooling down, smoothing with filter and transfer to storage tank Microbial Cleaning GMP Wash 1 hour before Visual on PC display Wash 12 Addition of sterile apple fruit pieces Microbial Cleaning GMP Wash 24 h before Visual on PC display Wash 13 Packing Microbial Cleaning GMP Wash 24 h before Visual on PC display Wash 14 Storage Microbial Lab test CP < 4ºC 24 h Viscosity Coliform Count Visual on PC display 15 Dispatch Microbial Temperature CP < 4ºC Pre-cool temperatur e Visual on PC display Table 12: HACCP Plan Overview (where CP = Control Point, CCP = Critical Control Point, GMP = Good Manufacturing Practice, SOCP = Standard Operating Cleaning Procedure) 1.14 HACCP documentation and record keeping 1.14.1 Documentation and record keeping are sufficient to enable the company to verify that the HACCP controls, including controls managed by prerequisite programmes, are in place and maintained. Doc & Record Ingredients Product safety Processing Packaging Storage and distribution Deviations and corrective actions Supplier certification - documenting compliance with processor’s specifications along with Certificates of Analysis Data and records to establish the efficacy of barriers in maintaining product safety Records from all monitored CCP’s Records indicating compliance with specifications of packaging materials Temperature records Indicating approved revisions and changes in ingredients, formulations, processing, packaging and distribution control Processor audit records verifying supplier compliance Data and records establishing the safe shelf life of the product, as age of product can affect safety Records verifying the continued adequacy of the process Records indicating compliance with sealing specifications Records showing that no product is shipped after shelf life date Storage temperature records for all ingredients Documentation of the adequacy of the processing procedures from a knowledgeable process authority Storage temperature records for temperature sensitive ingredients Table 13: Documentation and Record keeping of the HACCP standard. Documents used to control HACCP: Sample documents and records from I.S. 340:2007 1.15 Review of the HACCP plan 1.15.1 The HACCP food safety team reviews the HACCP plan and prerequisite programmes annually and prior to any changes which may affect product safety. Changes can include change in raw materials or supplier of raw materials change in ingredients/recipe change in processing conditions or equipment change in packaging, storage or distribution conditions change in consumer use emergence of a new risk, for example adulteration of an ingredient developments in scientific information associated with ingredients, process or product. Appropriate changes resulting from the review shall be incorporated into the HACCP plan and/or prerequisite programmes, fully documented and validation recorded.