Prerequisite Program (PRP).pptx
- 1. Prerequisite Program (PRP): • Prerequisite Programs: PRP are steps or procedures including GMP & SSOP, which control the operational conditions within a food establishment and promote environmental conditions that are favorable for safe food production/Manufacturing. These are “Basic Conditions and activities” that are necessary to maintain a hygienic environment throughout the food chain The Food safety Team establishes PRPs For FSSC 22000 will also include prerequisite programs to meet the requirements of ISO/TS 22002-1 or ISO/TS 22002-4
- 2. Requirement of ISO 22002-1 & PAS 220 • Location Surrounding of facility: • Building Design, Construction & Layout of Premises • Equipment: Cleaning & Maintenance • Utilities: Air/Water/Energy • Cleaning & Sanitation of premises • Personal Hygiene & Employee facilities • Raw material procurement • Pest Control • Product Information • Storage • Rework • Waste disposal • Product recall procedure • Food Defense (VACCP/TACCP)
- 3. • Location & Construction of Facility: i. Facility shall be situated away from environmentally polluted areas like open sewage, drain, public lavatory or any factory which produces disagreeable or obnoxious odour, fumes, excessive soot, dust, smoke, chemical or biological emissions to avoid risk of contamination from external environment. In case it is already existing, appropriate control measures shall be taken. ii. The site boundaries shall be clearly identified with appropriate access control to prevent the chances of theft and sabotage. Dogs, cats or other pet animals should not be allowed to enter the premises. iii. The manufacturing premise shall not have direct access to any residential area. iv. The manufacturing premises shall be located away from flood prone area. Where the premises are located in areas prone to flooding, it is recommended that height of the manufacturing area should be suitably elevated to prevent the risks due to flooding. v. The surrounding areas of the establishment shall be kept in good order. Roads, yards, parking lots outside the factory building should be free of debris and refuse, and from any source of pollution. vi. There should not be any stagnant water surrounding the facility. Where buildings are surrounded by grassed or planted areas, a clear space should be provided between the grassed planted areas and the building. Such grassed/planted areas should be regularly tended and maintained
- 4. • Building Design, Construction & Layout of Premises: i. Plant layout should be designed, constructed and maintained in order to facilitate good manufacturing and hygienic practices. ii. The building shall provide adequate working space with a logical flow of materials, products, personnel and to the extent that is practicable physical separation of raw from processed area to prevent any cross-contamination. iii. Entry to the manufacturing area shall be through a double door airlock facility iv. Sufficient space and proper placement of equipment’s as is necessary for the maintenance of sanitary operations. v. The premises should have a proper space for inward and outward vehicle movement. Openings intending for transfer of materials shall be designed to minimize any cross contamination from foreign matter, pests, etc. have adequate controls to Designed, constructed and maintained to prevent entry of insects and rodents. vi. Walls and Partitions shall be soundly constructed of materials that are durable, cleanable, and impervious to food, grease and water with no toxic effect in product. For example: emulsion oil paint (which is easily cleanable by wiping); tiles(which are less porous and causes less crevices)., Premises shall be free of flaking paint and plaster to prevent the accumulation of dust, minimize condensation, and shredding of particles; Wall floor joints should be curved in processing and packaging areas to facilitate cleaning; Wall and pillar guards (SS) should be used to avoid daily wear and tear of the surfaces. vii. Ceilings- Shall be maintained in sound condition and constructed of materials that are durable, cleanable, and impervious to food, grease and water with no toxic effect in intended use; Shall prevent the entry of dirt, dust and pests; Shall be free from flaking paint or plaster. Overhead fixtures Shall be suitably protected so that they do not act as contaminants in case of breakage.
- 5. • Building Design, Construction & Layout of Premises: viii. Floors shall be non-slippery, sloped appropriately, to allow adequate drainage, The drainage shall flow opposite to the flow of manufacturing process flow; It should be maintained in good repair with no cracks and crevices and made of materials that are durable and easy to clean such as Epoxy coated floors or PU flooring or any other suitable flooring. The floor and the walls should not be damp or moist. ix. Doors& Window’s shall have smooth, non-absorbent surfaces, Wooden doors are not recommended as it promotes mould growth, termites with ageing, shall be easy to clean, close- fitting and with suitable precautions to prevent entry of pests, Gaps if any between the door and the floor should be closed with suitable material like rubber strips, polyurethane etc. to avoid pest entry, To ensure dust, insects, birds and animals to be kept out of the premises entry/exit points should be suitably protected with such as PVC strip /air curtains/ doors with automatic self-closing devices etc. For External opening windows, roof vents or exhaust fan, where present, shall be adequately screened to avoid any external pest ingress. Stairs, lift cages and auxiliary structures such as platforms, ladders, chutes should be so situated and constructed as not to cause contamination to product. They should also be well maintained.
- 6. • Equipment: Cleaning & Maintenance: i. Equipment and containers that come in direct contact with food (including food contact surfaces) and used for food handling, storage, processing, packing shall be: - • located, designed and fabricated so that it permits necessary maintenance and periodic cleaning. • kept in good order, repair and condition as to minimize any risk of contamination. These include free from cracks, crevices, open seams etc. • Made of impervious, corrosion free material (Stainless Steel) which do not impart any toxicity to the food material and shall be easy to clean. • Shall be placed to achieve easy and effective cleaning of adjacent areas like floors, walls, ceilings and other surfaces. ii. Equipment, containers and piping should be clearly labelled and identifiable. iii. All openings such as manholes, inlets, outlets, draining out of points, etc. should be made such that they can be locked and/or effectively sealed. iv. Manufacturing vessels, pipework, and material handling equipment are well bonded and smooth to prevent material build up and promote sanitary conditions. v. Hygienic design features may include: • Pipes shall be sloped, with no dead-legs or right-angled bends, • Domed tops, curved sides, conical bases for vessels/tanks. • Flexible hoses shall have a smooth (not ribbed) internal surface and have fittings which are sanitary and easy to connect/disconnect hoppers.
- 7. • Equipment: Cleaning & Maintenance: vi. All utensils/ container containing food products shall be covered with a properly fitted cover/lid or with a clean gauze net/ any other material. This helps to completely protect food from dust, dirt, flies and other insects. vii. There shall be appropriate facilities for cleaning and disinfecting the food contact equipment and instruments, and wherever possible Clean-In-Place (CIP) should be adopted. viii. Defective equipment shall be removed from production and quality control areas. If the equipment is such that they cannot be removed, they should be clearly indicated with their status as (NOT IN USE/ UNDER MAINTENANCE).
- 8. • Utilities: Water/Air/Energy: i. Water System- • Adequate supply of potable water shall be available to meet operational needs. • Water including steam/Ice used as a product ingredient or in contact with food of food contact surfaces or used for equipment and plant cleaning shall be potable. • Potable water quality shall be as specified in the latest edition of BIS standard on drinking water (IS 10500). Potable water shall be analyzed at least semi-annually to confirm that it meets the requirements of this standard. • Where it is necessary to store water, storage facilities including the storage tanks and water pipes shall be adequately designed, made of material that is non-toxic, corrosion resistant material and periodic cleaned and maintained to prevent contamination and records of the same should be maintained. The tanks shall be covered to prevent access by animals, birds, pests and other extraneous matter. • Where water filters are used, they shall be regularly monitored & effectively maintained. • Recycled water used in processing or as an ingredient shall not present risk of contamination. It shall be of the same standard as potable water. • Non potable water (for use in, for example, steam production, firefighting& refrigeration equipment and other similar purposes where it will not contaminate food) shall have a separate system. Non- potable water systems shall be identified and shall not connect with, or allow reflux into, potable water systems. • The material of construction of pumps, valves, storage and distribution skids shall be non-reactive, non- corrosive, non-leaching and sanitary in design. • Water lines (used in internal Cleaning & as ingredients) shall be clearly separated and identified from others. Color coding of separate pipelines for potable water and non-potable water is recommended.
- 9. • Utilities: Water/ Air/Energy: ii. Air Quality & Environmental condition: • Air quality and environment conditions shall be maintain as recommended for various areas – Most likely -ISO 8 with RLAF ISO 5, Temperature should not be more than 25° C and Relative Humidity (RH) should not be more than 60%+/- 5% or as recommended. • The air shall not flow from contaminated to clean areas, the ventilation systems shall be so designed. • Adequate Differential Pressure shall be maintained between different classified areas. Systems shall be accessible for cleaning, filter changing and maintenance. Recommended differential pressure in adjacent areas should be min 0.5 mm of Water Column (5-10 psi). • Air filters, exhaust and air intake ports shall be examined periodically for physical filter integrity. • Periodic air quality monitoring shall be in place. • Ventilation systems, natural and/or mechanical, including Heating, Ventilation and Air Conditioning (HVAC) systems or air-conditioning, air filters, exhaust fans, wherever required, shall be designed and constructed so that pre-decided conditions are maintained iii. Compressed air and other gases: • Compressed air & other gas used in manufacturing shall be maintained so as to prevent contamination. • Compressed air / gases intended for direct or incidental product contact shall be from a source approved for food contact use, filtered to remove dust, oil and water to ensure microbial quality and so shall be checked at least in a year. • It is recommended to have an oil free Compressed air system.
- 10. • Utilities: Water/Air/Energy: iv. Lighting: • Adequate natural or artificial lighting shall be provided to enable the personnel to operate in a hygienic manner. Where necessary, lighting should not be such that the resulting colour is misleading. • The intensity (that is, the lux level) should be adequate to the nature of the operation. Recommended lux level for processing areas) is at least 540 LUX, as per USFDA Food Code 2013. • Light fixtures shall be protected to ensure that materials, product or equipment are not contaminated in the case of breakages.
- 11. • Cleaning & Sanitation of premises: i. Cleaning & Sanitation: • Effective cleaning of premises and equipment must be carried out at the defined frequency and using the methods and materials specified in well-designed cleaning schedules and procedures. • Cleaning standard operating procedures (SOPs) shall be defined and records demonstrating compliance shall be maintained. • Premises should be regularly inspected for cleanliness and good housekeeping. • Cleaning materials should be stored in a separate location in order to avoid contamination • Cleaning and sanitizing programs shall be established at facility to ensure that the food-processing equipment and environment are maintained in a hygienic condition to prevent contamination of food, such as from metal shards, flaking plaster, food debris and chemicals and records of the same shall be maintained. The programme should ensure that all parts of the establishment are appropriately clean, and shall include the cleaning of cleaning equipment. • Master sanitation schedule shall be maintained for overall facility through checklists which includes: - -Areas, items of equipment and utensils to be cleaned; - Responsibility for particular tasks; - Cleaning method and frequency of cleaning; and - Monitoring arrangements for checking effectiveness of cleaning – - Person responsible for cleaning - Persons responsible for monitoring & verification of effectiveness of cleaning - In case of any deviation what correction & corrective actions being taken. - Where ever chances of microbial risk with product air count & swab test being recommended.
- 12. • Cleaning & Sanitation of premises: i. Cleaning & Sanitation: • Cleaning and disinfection chemicals shall be food grade wherever chances of it may come in direct or indirect contact through equipment’s or plant surfaces, handled and used carefully and in accordance with manufacturers’ instructions, for example, using the correct dilutions, and stored, where necessary, separated from food, in clearly identified containers to avoid the risk of contaminating food. • Cleaning shall remove food residues and dirt and it can be carried out by the separate or the combined use of physical methods, such as heat, scrubbing, turbulent flow and vacuum cleaning or other methods that avoid the use of water, and chemical methods using appropriate cleaning agents. • These facilities should be constructed of corrosion resistant materials, be easy to clean and shall have adequate supply of hot and cold potable water, where appropriate. It is recommended to have different colour for hot and cold pipes. • A validation mechanism should be in place for all cleaning program. • Cleaning procedure should generally involve- - Removing gross visible debris from surfaces. - Applying a detergent solution to loosen soil and bacterial film (cleaning) - Rinsing with water (hot water where possible) to remove loosened soil and residues of detergent. - Dry cleaning or other appropriate methods for removing and collecting residues and debris and - Where necessary, cleaning should be followed by disinfection with subsequent rinsing. • Designated area with lock & key provision should be allocated for cleaning equipment’s & chemicals. • Where ever necessary & applicable CIP procedure should be defined for equipment’s cleaning.
- 13. • Cleaning & Sanitation of premises: ii. House keeping: • A housekeeping schedule covering manufacturing and storage areas shall be maintained. • The surrounding areas including roads, parking lots and drains should be well maintained. • Walls and floors should be maintained neat and clean. Ceilings and light fixtures should be easy to clean. • Drains should be sufficiently sized and well sloped. Drains should have removable grates installed for ease of cleaning. • For 3rd party (contract) cleaning companies, the supplier should define clear scope, details of services and responsibilities. • Waste storage areas should be clearly marked and waste shall be disposed of in a timely manner.
- 14. • Personal Hygiene & Employee facilities: • Personnel hygiene facilities shall be available to ensure that an appropriate degree of personal hygiene can be maintained to avoid any cross contamination. Such facilities shall be suitably located & designated. • Facility shall have following facilities-. i. Hand washing facilities: • Facility with shot and cold or suitable temperature controlled potable water with suitable hygienic means of drying hands can be provided in such a position that the employee must pass them when entering the processing areas. This will help employees to automatically get an alert for hand washing without a miss. • Where hot and cold water are available, mixing taps should be provided. • Hand washing notices shall be posted on walls near hand wash stations. • Non- Perfumed liquid soap should be used in dispensers to wash hands as soap bars are a potential source of cross contamination. • The design of taps should be such that there is no hand contact after washing while closing the taps. Preferably, Automatic, elbow or foot operated taps are used in food manufacturing units ii. Hand drying and sanitizing facility: • Hand drier where installed should be in working condition at all the times during working hours. • Where paper towels are used, a sufficient number of dispensers and receptacles should be provided near to each washing facility. Paper towel rolls should be covered from top at all time to avoid dust and dirt on them. • Generally, and preferably, hand driers are considered better than paper towels based on cost efficiency and effectiveness. • The dustbins used to throw the used-paper towels, should be foot-operated. This avoids any direct hand contact (washed hands) to open the dustbin. • Self-drying hand sanitizer should be provided and should be used after drying of hands. This is the next step of disinfecting hands after cleaning.
- 15. • Personal Hygiene & Employee facilities: iii. Lavatories: • Lavatories shall be separate from other areas and shall not be directly connected to the production or storage areas. • Sufficient number and separate toilets/urinals for male and female should be provided. Industry best practice of 1:25 is followed for facility: employee ratio. • Adequate supply of water should be provided in toilets and urinals. Potable water should be used at the toilet wash basin stations, as the employees may need to touch food items while in production areas. • All toilet facilities should be clean and sanitized at all times of the working hours. • Toilets should be so designed so as to ensure hygienic removal of waste matter. • Toilets should be well lit and ventilated and should not open directly into food handling areas iv. Changing facilities v. Rest and refreshment room