QUALITY ASSURANCE PROGRAMME GOOD MANUFACTURING PRACTICES by Syed Abdul Rahim bin Syed Abdul Rashid Chief Executive Officer WHAT IS GOOD MANUFACTURING PRACTICES? procedures to ensure products are manufactured to meet a certain quality and safety requirement these procedures describe the methods, equipment, facilities and controls for all manufactured goods GOOD MANUFACTURING PRACTICES prerequisite program for food quality and safety plans e.g. HACCP, ISO9000 GMPs -develop,implement, review and verify:in place and effective GMP programs ensure HACCP plans focus on CCPs to produce safe food MANAGEMENT RESPONSIBILITIES • understand the benefits of GMP, its implementation and coordination • know the difference between GMPs and HACCP • know the consequences of not having a good quality assurance program • ensure line workers and QC personnel are brought to a knowledge level commensurate with the needs of their jobs MANAGEMENT RESPONSIBILITIES • manager communication and employee training • provision for food safety system • facility improvement • total commitment and involvement GOOD MANUFACTURING PRACTICES Programs include: premise and environment equipment and utensils personnel sanitation facilities and operation pest control program supplies storage and distribution process control product recall programs HOW FOOD CAN BE CONTAMINATED? DIRECT CONTACT FOOD CONTACT SURFACES NON-FOOD CONTACT SURFACES SITE OR LOCATION suitable location good housekeeping- proper equipment storage,litter and waste disposal, cut grass within the vicinity of the plant buildings or structures prevent entry or harborage of pests adequate drainage general maintenance- roads, yards, and parking lot PREMISES • layout- unilateral flow • design, construction and maintenance -sufficient space -prevent contamination -facilitate cleaning -adequate lighting -adequate ventilation -adequate screening- protection against pests EQUIPMENT • design, material and construction - prevent hygienic hazards and permit easy cleaning - visible for inspection - food contact surfaces - corrosion-resistant, nontoxic, withstand cleaning and sanitizing agents - seams- smooth, tubular construction EQUIPMENT (continue) • non-food contact surfaces clean condition, well maintained • installation - facilitate easy cleaning • high risk food storage equipment • fitted with temperature measuring/ recording devices EQUIPMENT (continue) • instruments and control - temperature, pH, acidity, water activity etc. - adequate in number - maintenance, calibration • compressed air and gases from equipment - treated to prevent against contamination DISEASE CONTROL & MONITORING • • • • • • • • written policy & documented health questionnaire - upon employment medical examination communicable diseases open lesion - boils, sores, infected wounds report to supervisors medical facilities discourage visitors PERSONAL HYGIENE Personal cleanliness - hygienic practices Education and training - appropriate training Supervision - assign competent supervisors PERSONAL CLEANLINESS • protective outer garments - clean, light color and change when soiled or contaminated • gloves - disposable gloves, food grade, cotton gloves not permitted • effective hair restraints - cover all hair, beard cover • jewelry - no loose jewelry, earrings, brooches, rings and wrist watches PERSONAL CLEANLINESS • suitable footwear - shoes, gumboots • wet (foot bath) or dry lock system • proper hand wash • fingernails - clean and neatly trimmed, polish and artificial nails not allowed PERSONAL CLEANLINESS • no hand cream and other cosmetics, medicines • no smoking, eating, gum chewing, drinking water or beverages • laundry services • worker welfare - canteen/cafeteria - locker room - toilet & bath - masjid HAND WASHING before start work after absence from work station after going to toilet after handling non-food or raw material when hands are soiled or contaminated EDUCATION AND TRAINING •personnel in-charge - education and experience •food handlers and supervisors - proper food handling techniques and food safety principles e.g. Food Handling, Hygiene & Sanitation, GMP, HACCP •technical training - understand the processes and assigned tasks •refresher course & training - continuos SUPERVISION • competent supervisors • responsible - assuring compliance by all personnel with all requirements • inspection • employee improvement worksheet SANITATION FACILITIES AND SANITATION OPERATIONS SANITARY FACILITIES • Water supply must be : - sufficient, derived from a sanitary source - suitable temperature and pressure - stainless steel or food grade tanks - conduct sedimentation and microbiology tests (TPC & Coliform) SANITARY FACILITIES • Plumbing - overhead system - pipe water supply comes from the top. - carry sufficient water - provide adequate floor drainage - no back flow, cross - connection between sewage/waste water and water for manufacturing food - non-rust material - 1 1/2 days water supply (reserve) SANITARY FACILITIES • Sewage disposal - adequate and proper • Toilet facilities - adequate, easily accessible - good repair at all times - self closing doors -do not open where food is exposed to airborne contamination - main door - not wood, away from processing area - clear and proper signs SANITARY FACILITIES • Hand washing facilities - adequate,essential location - hand cleaning and sanitizing agents provided - paper towels or drying devices - foot or knee operated or sensor type taps - warm running water - proper refuse bin (foot operated) SANITARY FACILITIES • Rubbish and offal disposal - conveyed, stored and disposed properly - avoid accumulation of waste - easy cleaning SANITARY OPERATIONS General maintenance - buildings, fixtures and other facilities - utensils and equipment Cleaning & sanitation materials and toxic materials storage Pest control SANITARY OPERATIONS • Written Instructions • a Planned Cleaning Schedule • Cleaning Schedule should have details on - the equipment/area cleaned - name of person in charge - frequency - method - type of detergent and sanitizer SANITARY OPERATIONS • Dismantle Instructions (equipment) - safety precautions - standard - person who check, record and verify CLEANING PROGRAMME • a planned schedule of how, when and where cleaning will be done • include written instructions giving details of: the frequency, the method, the strength, type of detergent and sanitiser to be used, any variations, how to dismantle the equipment for cleaning, method of application CLEANING METHODS The are 5 cleaning methods: • • • • • manual soak pressure foam in-place cleaning DETERGENTS & SANITISING Types of detergents • acidic detergents • alkali detergents Methods of sanitising • steam sanitising • hot-water • chemical sanitising eg halogens, Na hypochlorite, chlorine releasing comp. , quaternary amm. comp., phenolics and other surfactants (acid anionics etc) CLEANING PROCEDURE • dry clean the entire area • wet all equipment by hosing with lowpressure water at a temperature less than 45 °C • apply a suitable detergent • rinse off detergent • apply sanitiser to all surface • rinse off surfaces with hot water at 82 °C • drain off all water on equipment and floors CLEANING REMOVABLE EQUIPMENT • dry clean • hose with warm water • immerse individually in hot water (55-60°C) containing a detergent or detergent/sanitiser • after soaking 20 mins scrub all surfaces and rinse clean with warm water • if only detergent is used than repeat step above and rinse off with water (82°C) • place all equipment in such a manner that surfaces are not touching and allows to air-dry HOW CLEAN IS CLEAN Two types of determination • organoleptic test - general appearance • microbiological test replica or contact method eg agar slice method, rodac plates and cellulose tape swab method eg agar plate swab and rinse method CLEANING AND SANITIZING MATERIALS AND TOXIC MATERIAL STORAGE • free from contamination, safe, adequate • compliance- supplier certification, examination • identified, held and stored to protect against contamination • separate locked rooms or cabinets PEST CONTROL • control of insects, rodents, birds or other vermin • effective, on-going written program • trained personnel or professional pest control • regular inspection • layout-bait or trap station PEST CONTROL • rodenticides, fumigants, insecticidesapproved by the authority, instruction on usage, dosage, collection of dead pests • proper measures to prevent crosscontamination • inspection, action, record and verify • guard and watch dogs (tied or caged) • do not feed or encourage stray animals WHAT ARE THE SIGNS OF INFESTATION? LOOK OUT FOR smell droppings smears path part of body damage maggots HOW PESTS GET INTO THE PREMISE? deliveries- raw material attracted by smell of food encouraged by employees cracks, gaps, holes drainage system windows, doors, ventilation PEST CONTROL • maintain good housekeeping • all employees trained to recognise pest infestation signs and procedures on how to prevent and control them • premise kept in good repair • traps kept clean and in good repair • proper hygienic practices • practice good stock rotation • screens at doors, windows, and other outlets SUPPLIES • • • • raw materials and other ingredients inspect, segregate, clean, store receiving area away from processing area inspection upon receipt, storage and before use • wash and clean- contaminant and minimize deterioration • store under proper condition • compliance with requirements SUPPLIES • Requirements - level of microorganisms - other hazards - physical specifications - packaging - temperature Supplier Quality Assurance (SQA) • Compliance with requirements verified by a planned and managed Supplier Quality Assurance (SQA) • SQA - agreed specifications - audits - Certificates of Analysis Supplier Quality Assurance (SQA) Specifications • develop good customer-supplier relationship • accepted criteria (quality and safety) • define all factors • limits/tolerance level Raw Material Specification • detail of supplier • description of raw material • tolerance limits • microbiological criteria • sampling plans • labeling requirements • storage and distribution conditions • pack type,size and quantity Supplier Audit • all raw materials, priority to high-risk raw materials • trained and experienced personnel/third party auditors • twice a year Supplier Audit co., add.,ownership history production site types of products adopt any food safety system on-site/contract laboratories pest control programs good personnel hygiene practices specifications of all products training transportation Certificates of Analysis (CA) • confirm raw materials have been sampled • meet all criteria • prepared by competent laboratories Packaging Material • • • • • • • comply with specification inspected, sampled and tested protected no adverse interaction stand up to subsequent treatment provide necessary characteristics and integrity carry information required PROCESS CONTROL all operations conducted in accordance with adequate sanitation principles quality control operations overall sanitation production procedures- do not contribute contamination from any source testing methods- chemical, microbiology and extraneous material contaminated or suspect food Raw materials and other ingredients inspected stored washed or cleaned not contaminated holding identification MANUFACTURING OPERATIONS food manufacturing -control physical factors and manufacturing operations measures to destroy or prevent growth of undesirable microorganisms work in progress effective measures to protect finished food MANUFACTURING OPERATIONS adulterated food mechanical manufacturing steps heat blanching batters, breading, sauces, gravies, dressings and other similar preparations hard foreign objects- sieves, traps, metal detectors, magnets, etc. MANUFACTURING OPERATIONS filling, assembling, packaging and other operations water activity pH- 4.6 or below ice- safe non-human food- animal feed or inedible products STORAGE • all raw materials and other supplies inspected upon receipt or unloading • end products inspected prior loading • storage area designed and constructed to protect against contamination STORAGE Raw materials • proper conditions (temperature, humidity) • frozen raw materials kept at - 4OC or below (do not allow thawing) • appropriate stock rotation • pest control programs Raw materials(continue) • • • • • • sufficient space cleaning and sanitizing programs labelled (batch no., date-marked) well ventilated adequate lighting (110 lux) building, all equipment, vehicles and fixtures maintained End Products • stored and handled to prevent deterioration • returned, defective products identified and isolated • stock rotation • adequate lighting • pest control programs • cleaning and sanitizing programs • well ventilated End Products • High risk food: - refrigerated foods at 2-4 0C or below - frozen foods in frozen state - hot foods at 60 0C or above - heat treating acid foods in hermetically sealed containers (ambient temperature) INSPECTION ELEMENTS TO CONSIDER freshness temperature colour odour contamination infestation packaging labelling Non Food Chemicals • kept in dry, well ventilated, locked room • separate from food handling areas • stored in clean, clearly marked containers (secondary containers) • trained personnel (handle & dispense) • fire appliance TRANSPORT inspected (damage, infestation etc.) cleaned and sanitized properly loaded, arranged and unloaded constructed with suitable material temperature control security precautions Product complaints Product recall programs PRODUCT RECALL PROCEDURES written and tested product recall program written recall procedures - person responsible- recall team - step-by-step procedures described - product traceability- product coding - distribution records - means of notifying customers, retailers or wholesalers - means of coordinating recall with regulatory agencies PRODUCT RECALL PROCEDURES take the complaint and obtain information (forms and procedures) do not admit liability evaluate the complaint - small token - involve regulators, outside advisors thorough investigation Product Recall Procedures (continue) means of notifying the regulatory agency - reason of recall - product identification - total amount of recalled product - areas of distribution be cooperative Product Recall Procedures (continue) Regulatory agency may: take samples prevent the sale of product require medical and lab examinations of employees exclude suspect employees from food handling duties order the facility to be closed Product Recall Procedures (continue) • deal with the media • regular analysis, summarizing and review of reports • take proper preventative measures • avoid recurrence CORRECTIVE ACTIONS Recalled product may be: disposed reworked quarantined DOCUMENTATION define materials, operations and products record and communicate information reduce risk of errors arising from oral communication defect product traceability permit investigation DOCUMENTATION GMP manual Structure: - Quality Manual - Operating Procedures - Support Documentation DOCUMENTATION STRUCTURE Quality Manual Operating Procedures Support Documentation DOCUMENTATION Quality Manual policy statements on the way a company intends to carry out its business Operating Procedures what a company does and how it achieves stated policies Support Documentation how a company carries out what it says it does (in detail) DOCUMENTING PROCEDURES • what we do • defines process by which a task is carried out • Structure: Objectives and scope Definitions and references Responsibilities Procedure details SOP (Standard Operating Procedures) • • • • • what to do, who does it and when not static; continuously adjusted simple training aid prevent ‘subject-to-change-withoutnotice’ situation • provide written standard for audits • effective;detail,simplicity and practicality SUPPORT DOCUMENTS • • • • • • • • Working Instruction Codes of Practice User Manuals Technical Documentation Job Description Job Specification Forms Checklists THANK YOU
