The Guidance Document on Food Safety Management System (FSMS) for Milk and Milk Products is applicable for food businesses involved in the Dairy sector which includes all milk and milk products:
- Liquid Milk
- UHT milk, condensed milk, fermented milk and flavoured milk
- Ghee, butter, cream
- Dairy Whitener (WMP & SMP)
- Curd, yoghurt, butter milk, paneer, cheese
It is important that food handlers involved in whole supply chain of Milk and Milk products are trained appropriately to implement the good manufacturing practices and good hygiene practices to ensure food safety.
Following are just highlights of the full document
Under the heading ESTABLISHMENT – DESIGN AND FACILITIES the document explains the nature of the location and surroundings appropriate for milk and milk production facility which can provide the maximum food safety and is away from pollutants and contaminants and in a location that does not have stagnant water and which does not provide access to dogs, cats, etc.
The building design and layout shall be permanent in nature and provide protection from environmental contaminants as well as rodents, insects etc. The space within should be appropriate for smooth work flow, where each area of work like storage, processing is well demarcated. The facility must be adequately lighted and ventilated.
- Raw milk receiving section should be sufficiently separated from processing area to prevent cross contamination.
- Signboards directing the employees to wash and sanitize hands before entering and after each absence shall be installed.
- The infrastructure for cleaning tankers from outside and milk contact surface of barrel afterunloading milk has been outlined pictorially
All interior structures (including floors, walls, ceilings, doors, windows, partitions, overhead
fixtures, working surface, stairs, elevators, etc.) shall be
- soundly constructed of materials that are durable, impervious to food particles, grease and water, with no toxic effect in intended use,
- unable to provide pest harbourage, as far as practicable
- easily and effectively cleaned and where appropriate, disinfected.
- Structures where glass breakage could result in the contamination of food, shall be constructed of alternative materials or be adequately protected. Well integrated to avoid crevices.
- Hollow space shall be minimized. Gaps need to be minimized at all levels of building for steel structured buildings in particular.
- All edges must be rounded off, pillars must be chamfered and any flat surface arising out of structured must be smoothened with a slope to avoid dust accumulation at any stage.
Equipment Design and Installation
Equipment and containers that come in direct contact with milk and used for food handling, storage, processing, packing should be designed in such a way that it permits maintenance and periodiccleaning. It must be kept in good order, repair and condition as to minimize any risk of contamination. The milk manufacturing vessels, pipe-work, and material handling equipment must be bonded and smoothto prevent material build up and promote sanitary conditions. They must have the appropriate design for hygiene like
• 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.
Boiler/Steam generation/Hot water generation
The dairy processing unit shall have adequate capacity boiler/hot water generator for
generating steam/hot water to cater to the requirements of processing and allied activities.
- Boiler system shall have calibrated and have functional gauges to indicate and control temperature,pressure of the system.
- Properly designed pressure reduction station shall be in place and operational to ensuredistribution of steam of required pressure from boiler to necessary areas/equipment.
- Boiler system shall be connected to the plant facilities through well laid insulated pipes withcondensate drain channels to remove/drain off condensate water from the lines.
- The water used for steam generation shall cater to requirements prescribed in IS 4251:1967
- Steam generated from the boiler shall be filtered to remove any extraneous matter/dirt. Steamcoming into direct contact with raw/finished product shall be of culinary grade and shall befiltered through necessary micro pore filters to ensure the same.
The dairy processing unit shall have adequate mechanical refrigeration system to cater to
processing and storage requirements. There must be necessary temperature gauges, pressuregauges, strainers and filters to ensure smooth and efficient operations. The gauges and control system must be calibrated periodically. Refrigeration system must be maintained with inspection of compressor,condenser, throttle valves, evaporator coils/plate etc
Ice bank tank (IBT) system
IBT is part of the refrigeration system in dairy processing units. IBT supply chilled water. The dairy processing unit shall have necessary capacity IBT for chilling raw and processed
milk.Water used in IBT shall adhere to the standards specified in IS 4251:1967. IBT shall be equipped with calibrated temperature gauges for recording and marinating thenecessary temperatures.IBT water shall be periodically inspected for their visual quality and drained/replacedaccordingly to comply with the requirements of IS 4251:1967.
Water Treatment plant
Dairy processing units shall have functional water treatment plant. It may comprise of followingelements – Softener units, RO plants, Ultra/Nano/Micro filtration, UV/Sand/Activated charcoal filtersand should be suitable to provide water as per prescribed quality in IS 4251: 1967 and IS 10500:2012.
Chillers & Cold room
Chill rooms having adequate size with mechanical refrigeration system to maintain temperatureat the required level as per the requirements of the product shall be provided in the processingsection or outside. The entire chiller room should be maintained so there is no contamination of the stored materials.
- 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 contactsurfaces 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 analysed at least semi-annually to confirm that it meets the requirements of this standard.
Personnel Hygiene and Employee Facilities
- Personnel hygiene facilities should be adequate to maintain appropriate standards of hygiene to prevent cross contamination. There must be adequate hand washing, lavatories, changing facility, rest andrefreshment room.
- Hand washing facilities must have hot and cold temperature controlled potable water with suitablehygienic means of drying hands. 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 apotential source of cross contamination.
- Lavatories, separate for male and female employees, with adequate water supply must be available and shall be separate from other areas and shall not be directly connected to the storageand manufacturing areas.
- Changing facilities must be suitable and sufficient for personnel to change their clothes, keeptheir personal belongings and street footwear.
- Rest and refreshment room must be provided so staff can store their food and consume it there.
The establishment shall have a well-equipped in-house laboratory for testing microbiological andother chemical parameters. The testing shall be done by qualified and trained lab
persons/veterinarian/Microbiologist/Dairy technologist (s).
Separate stores for raw milk, finished products, chemicals and packing materials. Sufficient pallets areplaced for storage of products.Where necessary, adequate facilities for the storage of food, ingredients,packaging, non-food chemicals and hazardous substances (e.g. cleaning materials, lubricants, fuel) shallbe provided.
Establishment shall have suitable and adequate facilities for the transportation of raw material,finished product etc. Vehicle shall be properly maintained.
- Pre-chilling of the transport system should be done before loading wherever applicable.
- Temperature should be checked during shipping, loading and unloading
Waste disposal and drainage
Dairy has two kinds of waste disposal i.e. solid waste and liquid effluent. There shall be a
separate space in the premises for collection of waste material.
Depending on the nature of the food operations undertaken, adequate facilities shall be made availablefor heating, cooling, cooking, refrigerating and freezing of food, monitoring & recording foodtemperatures, and when necessary, controlling ambient temperatures to ensure the safety andsuitability of food.
ESTABLISHMENT – CONTROL OF OPERATIONS
These principles are intended to be applied in such a manner as to result in meeting acceptable levels ofrelevant hazards specified as Food Safety Objectives and/or related objectives and criteria, or endproduct criteria that have been established to express the level of protection for the specific situation.
Supplier Approval and Food receipt
- Vendor Quality Development Programme laying down the criteria for selection, approval, review and on-going approval should be implemented.
- All raw material, processing aids, ingredients consignments shall be procured from the vendors approved by FSSAI/FDA/ Ayush and registered or licensed from other regulatory authorities. An approved vendor should be evaluated as per the quality supplied and other relevant factors.
- Raw materials received shall be according to the storage and processing capacity of the processing plant
Storage and Material Control
The condition of product in stock shall be assessed in appropriate intervals in order to detect
deterioration due to various reasons, e.g. physical damage, shelf life, unsanitary conditions, andtemperature abuses and pest infestation, etc.
- In dairy plants, equipment should be subjected to routine microbiological monitoring to verifythe effectiveness of cleaning, e.g. milk cans,storage/holding/process/transport tank, ice cream freezer, HTST Plate Pasteurizer/ Heat Treatment pasteurizer, homogenizer and creamseparator, filing machines and filing machines nozzles etc.
- Food processing operations, flow diagram and standard operating procedures shall bedocumented, implemented and displayed at particular operations site. Standard operatingprocedures for process changeover from one kind of product to another shall be maintained andimplemented.
- Critical food processing parameters like temperature / vacuum etc. records shall be maintainedand recorded appropriately.
- Intermediate in-process samples to be tested for critical parameters and their test results shallbe maintained.
- Personnel shall put on clean protective clothing including footwear and wash their hands beforeentering.
- Cleaning schedule for equipment in the food processing sections shall be maintained to ensureentire operations are carried out in hygienic conditions.
- System shall be in place to screen/detect and prevent contamination of foods by foreign bodiessuch as glass, plastic, metal etc.
- Access to processing area by outsiders shall be restricted or controlled. Where risks areparticularly high, access to processing areas shall be only via a changing facility.
- The presence of any allergens identified in food ingredients shall be informed to consumersappropriately.
- In case steam is used directly on food during processing, the steam to be prepared from potablewater and of culinary grade.
- All manufacturing operations shall be carried out under the supervision of authorised technicalperson. Each critical step in the process relating to the selection, weighing and measuring of rawmaterial, addition during various stages shall be performed by trained personnel.
- Adequate space, preferably separated from processing areas, shall be provided for cleaning andstoring mobile equipment and utensils including the storage of cleaning materials.
- Incoming materials and finished products shall be quarantined immediately, if required, afterreceipt or processing, until they have been released for use or distribution.
- Intermediate products purchased and used as raw material shall be handled as ingredient onreceipt.
- Operations on different products shall not be carried out simultaneously or consecutively in thesame room unless there is no risk of mix-up or cross-contamination.
Allergen Control and Management
Display all the allergens at the relevant places in the processing and storage areas for awarenessamong all the employees. All raw materials that are allergens should be labelled with a tag thatstates “Allergen.”
Milk and Milk Product Packaging and Warehousing
- The packaging design and materials shall provide protection for products in order to preventcontamination, damage and accommodate required labelling as laid down under the FSS Act andthe Regulations there under. Only food grade packaging materials shall be used as primarypackaging material. Packaging materials like aluminium, tin and plastic shall conform to theIndian standards as mentioned under the FSS Regulations from time to time.
- The food packaging materials shall be inspected before use to avoid using damaged, defective orcontaminated packaging, which may lead to contamination of the product. The food businessoperator shall have effective procedures in place to confirm that contaminated packaging isproperly cleaned and sanitised before reuse, while damaged or defective are discarded, repairedor replaced, as appropriate, before re-use.
- The packaging materials or gases where used, shall be non-toxic and shall not pose threat to thesafety and suitability of food under the specified conditions of storage and use.
- The wrapping and packaging of dairy products shall take place under satisfactory hygienicconditions and in rooms provided for that purpose.
Warehouses/Plant storing products are required to ensure the integrity and safety of the product iseffectively protected.
- Receive- Upon unloading, the transport vehicle and receiving materials must be thoroughly inspected
- Storage – Products must be protected from unauthorised personnel at all times.
- Dispatch – Physical integrity of product and package must be checked and the shipping vessel inspectedfor cleanliness prior to loading a shipment.
Traceability and Recall
There must be an established and applied traceability system in place.This system shall allow the operator to trace within 24 hours the history of a specific lot fromreceipt through all stages of storage and shipping. All records must be maintained.
The Organisation shall develop & implement milk Recall Procedure in accordance with FSS (FoodRecall Procedure) Regulations, 2017.There shall be a documented and effective product recall plan in place in accordance with theFSS (Food Recall Procedure) Regulations, 2017. Such a plan shall allow the organization toeffectively locate all affected milk and milk products that may cause a potential threat to publichealth and enable the complete, rapid recall of the implicated lot of the product from the market.
Quality Control & Testing
There must be a combination of control measures to effectively control theidentified hazards in milk and milk products. The combination of control measures should be designedin a systematic way, and the chosen combination should be adapted to the hygiene status of the milk andraw materials used with consideration given to the relevant microbiological, chemical and physicalhazards of concern and to the establishment of Food Safety Objective(s) and/or related objectives andcriteria. Where appropriate control measures and/or control measure combinations must be chosen tocontrol hazards that are reasonably likely to occur, the procedures should be implemented as such inorder to minimize or prevent the likelihood of a health risk to the consumer.
Specification and Test Methods
Authorized specifications for raw material, packaging materials, In-process material, Intermediatematerial, and finished products should be maintained. The specifications should include
- A description of the materials
- The designated name of the material / product and the code reference
- Directions for sampling and testing
- Qualitative and quantitative requirements with acceptance limits
- Storage conditions and any special handling precautions
Validated methods should be used for testing of material / product. Analytical method verification should be carried out for the compendia / pharmacopeia methods. Scientifically valid test methods published internationally (e.g. AOAC, BAM, USP, FCC etc.) can also be used for testing and the manufacturer should affirm that the tests are accurate, precise and specific for its intended purpose.
Laboratory Personnelshall be appropriate in number with desired skill set.
All laboratory equipment and instrumentation shall be appropriate for the analysis required andshall be calibrated. Written standard operating procedures shall be available for each instrumentor equipment.
ESTABLISHMENT – MAINTENANCE AND SANITATION
Cleaning and sanitizing programmes shall be established at facility to ensure that the foodprocessing 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 andrecords of the same shall be maintained. The programme should ensure that all areas of theestablishment are appropriately clean, and shall include the cleaning of all equipment as well.Cleaning & Sanitation of milk processing unit should be done for all equipment and frequencyshould be based on the run time, nature of the product,CIP validation outcome, etc.
The recommended frequency should be as follows
- Raw milk unloading system, silos, pipelines, leaky pouch handling tank and pipelines -Daily
- Process milk tankers – Every time before filling
- Pasteurizer, clarifiers & separators, standardiser, homogenisers – Every 5 to 7 hours ofoperation
ESTABLISHMENT – PERSONAL HYGIENE AND EMPLOYEE FACILITIES
- Milk and milk product handlers of the manufacturing facility shall undergo a medical examination bya registered medical practitioner before joining for work and thereafter annually to ensure that theyare free from any infectious or communicable diseases. A record of these examinations shall be maintained
- Food handlers shall maintain a high degree of personal cleanliness and shall wear work clothing,head covering, and footwear that are fit for purpose, clean and in good condition. Work wear shallprovide adequate coverage to ensure that hair, beards, moustaches, perspiration, etc. cannot contaminate the product
- Milk and milk product manufacturer shall implement an effective personal hygiene programmethat identifies hygienic behaviour and habits to be followed by personnel to prevent contaminationof food.
- Personnel who work in, or enter into, areas where exposed products and/or materials are handledshall wear work clothing that is fit for purpose, clean and in good condition (e.g. free from rips, tearsor fraying material).
- Organisations should implement and display visitor control policy.The Food Business shall ensure that visitors to its food manufacturing, processing or handling areasmust wear protective clothing, footwear and adhere to the all the personal hygiene provisionsrequired for personnel required in the food business.
ESTABLISHMENT – PRODUCT INFORMATION AND CONSUMER AWARENESS
- Product information and Labelling: All packaged food products shall carry a label and requisite information as per provisions ofFood Safety and Standards Act, 2006 and Regulations made there under so as to ensure thatadequate and accessible information is available to each person in the food chain to enable themto handle, store, process, prepare and display the food products safely and correctly and the lotor batch can be easily traced and recalled if necessary.
- Consumer Awareness and complaint Handling: Information shall be presented to consumers in such a way so as to enable them to understandits importance and make informed choices. Information may be provided by labelling or othermeans, such as company websites, education programmes and advertisements, and may includestorage, preparation and serving instructions applicable to the product
ESTABLISHMENT – TRAINING AND MANAGEMENT
- All personnel shall be aware of their role and responsibility in protecting food fromcontamination or deterioration. Food handlers shall have necessary knowledge and skills toenable them to handle food hygienically.Those handling strong chemicals or potentially hazardous substances shall be trained in safehandling procedures and techniques.
- Suitable trainings shall be given to all personnel handling food to enable them to have therequired knowledge and skills in GHP and GMP for specific tasks along with personal hygienerequirements commensurate with their work activities.
ESTABLISHMENT – AUDIT, DOCUMENTATION AND RECORD KEEPING
- The FBO shall conduct a self-evaluation of the process to verify the effectiveness of theimplemented food safety system at periodic intervals through internal and external audits atleast twice in a year. Necessary corrective actions based on self-evaluation results shall be taken.
- Appropriate documentation & records of processing, production and distributions shall bemaintained in a legible manner, retained in good condition for a period of one year or the shelflife of the product, whichever is more.The important records that shall be maintained include:
- FSSAI License and Registration of Manufacturer/Supplier/Dealers/Retailers
- Pollution Control Board Certificate of plant/manufacturing unit
- Record of Discharge Effluent & its Compliance with statutory requirements – ETP Compliance
- All records of laboratory analysis
Other important features provided in the guidance document include
- GUIDANCE On SUBCONTRACTING OPERATIONS
- HACCP IMPLEMENTATION
This article contains only the highlights of the full 97 page guidance document for more details you canlog ontohttps://fssai.gov.in/home/safe-food-practices/FSMS-GUIDANCE-DOCUMENTS-FOR-THE-FOOD-BUSINESSES.html