ISO PRE REQUIREMENT PROGRAMS CHECK-LIST

Transcription

1 RINA AUDIT CHECKLIST (Nr.... of...) FSSC ISO Requirements and additional FSSC Requirements Company Production site: Audit type: Preaudit: Stage 1 Stage 2: Surveillance: Recertification: Other:. Report Nr. Date: Auditor: Nr. Par ISO PRE REQUIREMENT PROGRAMS CHECK-LIST Verified PREVIOUS INSPECTION 1 Have the corrective actions specified in relation to previous remarks been implemented? 2 Is the RINA certification logo used in compliance with the Rule and is the FSSC properly publicized? 3 Have changes been made to the FSSC? Specifications for services and the organization shall ensure that all services ( including utilities, transport and maintenance) which are provided and may have an impact on food safety? Shall specify requirements? Shall be described in documents to the extent needed to conduct hazard analysis? Shall be managed in conformance with the requirements of technical specification for sector PRP s? There are the supervision of personnel in application food safety principles? The organization shall ensure the effective supervision of personnel in the correct application of food safety principles and practices commensurate with their activity? There are the specific regulatory requirements? There are the management of inputs? 4 Construction and layout of buildings 4.1 General Requirements: 4 Are buildings designed, constructed and maintained for food processing operations? 5 Are buildings and facilities of sound construction and in good repair? 6 Are associated the food safety hazards with those operations and the potential sources of contamination from the plant environs? 4.2. Environment 7 Is the establishment located in an area that is free from environmental contaminants? 8 Food production is carried out in areas where potentially harmful substances do not enter the product? 9 Is the effectiveness of measures taken to protect against potential contaminants from local environment reviewed periodically? 4.3. Locations of establishments 10 Are the boundaries clearly identified? 11 Is access to the establishment controlled? 12 Is the outside area maintained in good repair and vegetation tended to, or removed? Is any standing water observed in the roads, yards and parking areas? 5 Layout of premises and workspace 5.1. General requirements 13 The internal layouts are designed, constructed and maintained to facilitate good hygiene and manufacturing practices? 14 Movement patterns of materials, products and people, and the provision of equipment, are designed to protect from potential sources of contamination? 5.2. Internal design, layout and traffic patterns 15 Are buildings and facilities laid out in such a way as to allow for a proper process flow from receiving to storage of goods? 16 There is the physical separation of raw materials from processed areas? 17 Are openings intended for transfer of materials designed to minimize entry of foreign matter and pests? 5.3 Internal structures and fittings 18 Are process area walls and floors washable or cleanable? Are materials resistant to the cleaning system applied? 19 The joints between floors and walls and corners are designed for easy cleaning? 20 Are floors sufficiently sloped for liquids to drain? 21 The floor wall junctions in working areas are rounded? 22 Are ceilings and overhead fixtures designed to minimize build up of dirt and condensation? 23 Are external opening windows, roof vents and fans where present screened? 5.4. Location of equipment 24 Is equipment designed and located so as to facilitate good hygiene practices monitoring? FORM-SYS03-FSMS-03 - CHECK LIST FSSC_EN_ /1

2 25 Is equipment located to permit access for operation, cleaning and maintenance? 5.5. Laboratory facilities 26 Are microbiology laboratories designed, located and operated so as to prevent contamination (people, buildings and products)? 27 Are in-line and on-line test facilities controlled to minimize risk of product contamination? 5.6 Temporary / mobile premises and vending machines 28 Are temporary structures designed, located and constructed to avoid pest harbourage and potential contamination of products? 29 Are hazards associated with temporary facilities assessed and controlled? 30 Are hazards associated with vending machines assessed and controlled? 5.7. Storage of food, packaging materials, ingredients and non-food chemicals 31 Do facilities used to store ingredients, packaging and products provide protection from dust, condensation, drains, waste and other sources of contamination? 32 Are storage areas dry and well ventilated? 33 Are monitoring and control of temperature and humidity applied where required? 34 Are storage areas designed or arranged to allow segregation of raw materials, work in progress and finished products? 35 Are all materials and products stored off the floor and with sufficient space between the material and the walls to allow inspection and pest control activities to be carried out? 36 Are storage areas designed to allow maintenance and cleaning? 37 Are storage areas designed to prevent contamination and minimize deterioration? 38 Are separate secure, locked or access controlled storage areas provided for cleaning chemicals and other hazardous substances? 39 Exceptions are documented for plant material, loose in the system of food safety management. 6 Utilities air, water, energy 6.1 General requirements 40 Are the provision and distribution routes for utilities to and around processing and storage areas designed to minimize the risk of product contamination? 41 Are utilities quality monitored to minimize product contamination risk? 6.2 Water supply 42 Is the supply of potable water sufficient to meet the needs of the production process(es)? 43 Are specified water quality requirements such as facility for storage, distribution and control of temperature, where required, available? 44 Does water used as a product ingredient, including as ice or steam or in contact with products or product surface, meet specified quality and microbiological requirements? 45 Is water used for cleaning or applications where there is an indirect product contact (e.g. Jacketed vessels, heat exchangers) meet specified quality and microbiological requirements? 46 Are checks conducted on chlorinated water to ensure residual chlorine level at the point of use remains within specified limits? 47 Does non-potable water have a separate supply system that is labelled and is not connected to the potable water system and is prevented from reflux into the potable system? 48 The water that may come into contact with the product flowing through tubes that can be disinfected? 49 There are measures to prevent the reflux system of non-potable water? 6.3 Boiler chemicals 50 Are boiler chemicals approved food additives which meet relevant additive specifications? OR 51 Are additives safe for use intended for human consumptions and approved by the relevant regulatory authority? 52 Are boiler chemicals stored in a separate; secure (locked or otherwise access controlled) area when not in use? 6.4 Air quality and ventilation 53 Has the facility established requirements for filtration, humidity (RH%) and microbiology of air used as an ingredient or for direct product contact? 54 Has a control system been put in place where the temperature and / or humidity are deemed critical? 55 Is the control system monitored? 56 Is ventilation provided to remove excess or unwanted steam, dust, odours and condensation? 57 Is ventilation provided to facilitate drying after wet cleaning? 54 Is air supply quality controlled to minimize risk from airborne microbiological contamination? 58 Are protocols for air quality monitoring and control established in areas where product which support growth or survival are exposed? 59 Are ventilation systems designed and constructed such that air does not flow from contaminated or raw areas to clean areas? 60 Are specified air pressure differentials maintained? 61 Are air delivery systems accessible for cleaning, filter changing, and maintenance? 62 Are exterior air intake ports examined periodically for physical integrity? 6.5 Compressed air and other gases 63 Are compressed air, carbon dioxide, nitrogen and other gases used in manufacturing and / or filling maintained so as to prevent contamination? FORM-SYS03-FSMS-03 - CHECK LIST FSSC_EN_ /2

3 64 Are gases intended for direct or incidental product contact (including those used for transporting, blowing or drying materials, products or equipment) approved for food contact use? 65 Are gases intended for direct or incidental product contact (including those used for transporting, blowing or drying materials, products or equipment) filtered to remove dust, oil, and water? 66 Where oil is used for compressors, is the oil food grade? 67 Are requirements for filtration, humidity and microbiology specified? 68 Use of oil free compressors is recommended? 6.6 Lighting 69 Does the lighting provided allow personnel to operate in a hygienic manner? 70 The intensity of light is appropriate to the nature of the transaction? 71 Are light fixtures protected to ensure that materials, product, or equipment are not contaminated in the case of breakage? 7 Waste disposal 7.1 General requirements 72 Are systems in place to ensure that waste materials are removed and disposed of in a manner which prevents contamination of products or production areas? 7.2 Containers for waste and inedible or hazardous substances 73 Are containers for waste and inedible or hazardous substances clearly identified for their intended purposes? 74 Are containers for waste and inedible or hazardous substances constructed of impervious material which can be readily cleaned and sanitized? 75 Are containers for waste and inedible or hazardous substances closed when not in immediate use? 76 Are containers for waste and inedible or hazardous substances locked where the waste may pose a risk to the product? 7.3 Waste management and removal 77 Is waste accumulating in food handling or storage areas? 78 Are removal frequencies managed to avoid accumulations? 79 Is waste removed daily? 80 Are labelled materials, products or printed packaging designated as waste disfigured or destroyed to ensure that trademarks cannot be reused? 81 Are removal and destruction carried out by approved contractors? 82 Are records of destruction retained? 7.4 Drains and drainage 83 Are drains designed, constructed and located so that the risk of contamination of materials or products is avoided? 84 Do drains have the capacity to remove flow loads? 81 Do drains pass over processing lines? 82 Does drainage flow from a contaminated area to a clean area? 8 Equipment suitability, cleaning and maintenance 8.1 General requirements 85 Is food contact equipment designed and constructed to facilitate cleaning, disinfection and maintenance? 86 Are contact surfaces affected by the intended product or cleaning system? 87 Is food contact equipment constructed of durable materials able to resist repeated cleaning? 8.2 Hygienic design 88 Does equipment meet established principles of hygienic design such as having smooth, accessible, cleanable surfaces and self draining in wet process areas? 89 Does equipment meet established principles of hygienic design such as the use of materials compatible with intended product and cleaning or flushing agents? 90 Does equipment meet established principles of hygienic design such as framework not penetrated by holes or nut and bolts? 91 Are piping and ductwork cleanable, drainable, and with no dead ends? 92 Is equipment designed to minimize contact between the operator s hands and the products? 8.3 Product contact surfaces 93 Are product contact surfaces constructed from materials designed for food use? 94 Are product contact surfaces impermeable and free from rust or corrosion? 8.4 Temperature control and monitoring equipment 95 Is equipment used for thermal processes able to meet the temperature gradient and holding conditions given in relevant product specifications? 8.5 Cleaning plant, utensils and equipment 96 Are wet and dry cleaning programmes documented to ensure that all plant, utensils and equipment are cleaned at defined frequencies? 97 Do the programmes specify what is to be cleaned (including drains)? 98 Do the programmes specify who is responsible? 99 Do the programmes specify the method of cleaning, the use of dedicated cleaning tools, removal or disassembly requirements and methods for verifying the effectiveness of the cleaning? 8.6 Preventive and corrective maintenance FORM-SYS03-FSMS-03 - CHECK LIST FSSC_EN_ /3

4 100 Is there a preventive maintenance program in place? 101 Does the preventive maintenance program include all devices used to monitor and / or control food safety hazards? 102 Is corrective maintenance carried out in such a way that production on adjoining lines or equipment is not at risk of contamination? 103 Are maintenance requests which impact product safety given priority? 104 Do temporary fixes put product safety at risk? 105 Does a request for a permanent repair included in the maintenance schedule where a temporary fix is related to product safety? 106 Are lubricants and heat transfer fluids food grade where there is a risk of direct or indirect contact with the product? 107 Does the procedure for releasing maintenance equipment back to production include clean up, sanitizing where specified, and pre-use inspection? 108 Do local PRP requirements apply to maintenance areas and maintenance activities in process areas? 109 Are maintenance personnel trained in the product hazards associated with their activities? 9 Management of purchased materials 9.1 General requirements 110 Is purchase of materials which impact food safety controlled to ensure that the suppliers can meet specified requirements? 111 Are incoming materials verified against specified purchase requirements? 9.2 Selection and management of supplies 112 Is there a defined process for the selection, approval and monitoring of suppliers? 113 Is the process used to manage suppliers justified by hazard assessment including final risk to the finished product? 114 Is the suppliers ability to meet quality and food safety expectations, requirements and specifications taken into consideration? 115 What are the methods by which the suppliers are assessed? 116 Are suppliers monitored to ensure continued approval status? 9.3 Incoming material requirements (raw / ingredients / packaging 117 Are seals on delivery trucks checked? 118 Are delivery trucks verified to ensure they are free from infestation, dirt and any contaminants? 119 Are delivery trucks transporting ingredients that require temperature control, properly equipped with functioning temperature control devices? 120 Are incoming materials inspected, tested or covered by COA or COC? 121 Are incoming materials verified against specified requirements prior to being accepted? 122 Are records of verification kept? 123 How does the establishment prevent the unintended use of nonconforming materials? 124 Are incoming materials that do not conform to specified requirements segregated? 125 Are records kept on incoming materials that do not meet specified requirements? 126 Are access points to bulk receiving capped and kept under lock? 127 Are unloading of bulk materials only done after verifying that the materials meet specified requirements? 10 Measures for prevention of cross contamination 10.1 General requirements 128 Are programmes in place to prevent, control and detect contamination? 129 Are measures to prevent physical, chemical (including allergens) and microbiological contamination part of the programmes? 10.2 Microbiological requirements 130 Are hazard assessment carried out to determine potential microbiological contamination sources? 131 Are areas with potential microbiological contamination sources identified? 132 Does the hazard assessment take into consideration the followings where appropriate and necessary: (a) Separation of raw materials and finished products? (b) Structural segregation between raw and finished? (c) Access control with requirements to change into required workwear? (d) Traffic patterns including people, materials, equipment and tools? (e) Air pressure differentials? 10.3 Allergens management 133 Are allergens present in the product declared on the labels? 134 Are allergens that may be present through cross contact declared on the label or a may contain warning present on the label? 135 For products intended for further processing and that contain or may contain allergens, is there a declaration with the shipment? 136 Is there an allergen management program in place for handling raw material, finished product, rework and work in progress? FORM-SYS03-FSMS-03 - CHECK LIST FSSC_EN_ /4

5 10.4 Physical contamination 137 Is there a procedure for handling glass or brittle material? Employees who handle food have received special training in the field of allergens and associated production practices? 138 Are records of glass breakage maintained? 139 Are measures in place to prevent, control and detect any potential physical contaminants? 11 Cleaning and sanitizing 11.1 General requirements 140 Are cleaning and sanitizing programmes established? 141 Are programmes monitored for continuing suitability and effectiveness? 11.2 Cleaning and sanitizing agents and tools 142 Are facilities maintained in a condition which facilitates cleaning and or sanitation? 143 Is equipment easily accessible for cleaning? 144 Are cleaning and sanitizing agents and chemicals clearly identified and used in accordance with manufacturer s instructions? 145 Are cleaning and sanitizing chemicals food grade or approved for use in food processing establishments? 146 Can tools be a source of contamination? 11.3 Cleaning and sanitizing programmes 147 Does the organization have a cleaning and sanitation programme? 148 Has the cleaning programme been validated to ensure that all parts of the establishment and equipment are cleaned / sanitized to a defined schedule? 149 Does the cleaning and /or sanitizing programmes specify the followings: (a) Areas, items of equipment and utensils to be cleaned and / or sanitized (b) Responsibility for the tasks (c) Cleaning / sanitizing method and frequency (d) Monitoring and verification arrangements (e) Post clean inspections (f) Pre-start inspections 11.4 Cleaning in place (CIP) systems 150 Are CIP systems separated from active product lines? 151 Are parameters for CIP systems defined and monitored including type, concentration, contact time and temperature of any chemicals used? 11.5 Monitoring sanitation effectiveness 152 Are cleaning and sanitation programmes monitored for effectiveness? 12 Pest Control 12.1 General requirements 153 Are activities to mitigate risks of pest activity such as cleaning, inspection of trucks and incoming materials etc. implemented? 12.2 Pest control programmes 154 Does the organization have a nominated person or contractor that manages the pest control programme? 155 Does the pest control programme identify target pests, methods of control? 156 Is there a documented pest control program? 157 The staff has been trained? 158 Does the documented programme specify what chemicals are to be used where? 12.3 Preventing access 159 Are buildings maintained in good repair? 160 Are access points such as holes, drains, etc. sealed? 161 Are external doors, windows or ventilation openings screened to prevent entry of insects? 12.4 Harbourage and infestations 162 Is the area around the facilities free from food and water? 163 Are infested materials handled in such a way as to prevent contamination or propagation? 164 Are potential pest harbourage when encountered removed? 165 Are outside spaces used for storage protected from pest damage such as bird s droppings? 12.5 Monitoring and detection 166 Are there schematic diagram(s) indicating where traps and bait stations are located? 167 Are traps and detectors located in key locations? 168 Are detectors and traps designed and located to prevent potential contamination? 169 Are detectors and traps of solid construction and impact resistant? 170 Are detectors and traps inspected at regular intervals to identify pest activity? 171 Are results of inspections analysed to identify trends? FORM-SYS03-FSMS-03 - CHECK LIST FSSC_EN_ /5

6 12.6 Eradication 172 Are eradication measures put in place immediately after an infestation is found? 173 Are operators applying pesticides trained and have valid applicator licenses? 174 Are records of pesticide used maintained on file? 175 Do records of application identify the type, concentrations used and when and where applied? 13 Personnel hygiene and employee facilities 13.1 General requirements 176 Are hygiene rules and personal behaviour contingent on the hazard posed to the process or product? 177 Are visitors and contractors required to comply to documented hygiene requirements? 13.2 Personnel hygiene facilities and toilets 178 Does the establishment provide adequate numbers. locations and means of hand washing, drying and sanitizing? 179 Is there an adequate supply of hot and cold or temperature controlled water, and soap and or sanitizer? 180 Are sinks designated for hand washing, separate from sinks for food use or equipment cleaning stations? 181 Does the establishment provide an adequate number of toilets with hand washing, drying and or sanitizing facilities? 182 Does the establishment have hygienic facilities that do not open directly onto production, packaging or storage areas? 183 Does the establishment have adequate changing facilities for personnel? 184 Are the changing facilities located in such a way as to minimize the danger of workwear being contaminated during the walk to the work area? 13.3 Staff canteens and designated eating areas 185 Are staff canteens and designated areas for food storage and consumption situated in locations away from production areas? 186 Are precautions taken to minimize cross contamination between staff food consumption areas and production areas? 187 Are staff canteens managed to ensure hygienic storage of ingredients? 188 Are staff canteen(s) managed to ensure hygienic preparation, storage and serving of prepared foods? 189 Is employees own food stored and consumed in designated areas? 13.4 Workwear and protective clothing 190 Do personnel who work in areas where exposed food products and / or materials are handled wear clothing fit for purpose? 191 Is workwear free from rips, tears or fraying materials? 192 Is clothing mandated for hygienic purposes used for any other purposes? 193 Does workwear have buttons? 194 Does workwear have outside pockets above the waist? 195 Does workwear provide adequate coverage against hair, perspiration, etc? 196 Are gloves in use clean and in good conditions? 197 Are hair, beards and moustaches covered? (Note: unless hazard analysis indicate otherwise) 198 Are shoes worn in processing areas fully enclosed and made of non absorbent material? 199 Work clothing are washed in standard and at intervals suitable for the intended use of the heads? 200 Is personal protective equipment maintained in good hygienic condition? 13.5 Health status 201 Do employees in food contact operations undergo medical examination before employment? (Note: subject to legal restrictions in the country of operation). 202 Are additional medicals carried out at defined intervals? (Note: subject to legal restrictions in the country of operation) Illness and injuries 203 Do employees report to management illnesses that may result in contamination to the food being processed? (Note: subject to legal restrictions in the country of operation) 204 Are restrictions to handling food or food contact materials, applied to people known to be infected with, or carrying a disease or illness transmissible through food? 205 Are personnel with or burns required to cover them? 206 Is there a policy for reporting of loss of dressings? 13.7 Personal cleanliness 207 Are personnel in production areas required to wash and or sanitize hands: (a) before starting any food activities? (b) immediately after using the toilet or blowing the nose? (c) immediately after handling potentially contaminated material? 208 Are finger nails kept clean and trimmed? 13.8 Personal behaviour FORM-SYS03-FSMS-03 - CHECK LIST FSSC_EN_ /6

7 209 Is smoking, eating and chewing permitted in designated areas only? 210 Is there a policy with regards to wearing of jewellery in food processing areas? 211 Are personal items such as smoking materials and medicines kept in designated areas only? 212 Are nail polish, false nails and false eye lashes restricted in food processing and food handling areas? 213 Are personal lockers kept free from rubbish and soiled clothing? 214 Are employees allowed to keep contact tools and equipment in their personal lockers? 14 Rework 14.1 General requirements 215 Is rework stored, handled and used in such a manner that product safety and quality are maintained? 216 Is rework easily traceable? 14.2 Storage, identification and traceability 217 Is stored rework protected from exposure to microbiological, chemical and physical contamination? 218 Is rework containing allergens segregated from regular non-allergen materials? 219 Is rework traceable throughout the process? 220 Are traceability records for rework maintained? 221 Do records for rework materials contain all the necessary information for traceability? 14.3 Rework usage 222 Where rework is added to product in-line, is the acceptable quantity, type and conditions of the rework known? 223 Are the process step, method of addition, and any required pre-processing stages defined? 224 Where rework activities involve removing the product from filled or wrapped packages, are precautions taken to ensure that the product is not contaminated with packaging materials? 15 Product recall 15.1 General requirements 225 Is there a system in place to identify and segregate products that fail to meet required food safety standards? 226 Does the traceability system allow for the removal of products that fail to meet required food safety standards? 15.2 Product recall requirements 227 Does the organization maintain a current list of key contacts members of the recall team? 228 Is there a procedure to handle recalls? 229 In the event of a recall due to immediate hazards, is there a procedure to review products produced under similar and same conditions? 230 Does the procedure for recall consider public warnings if the product being withdrawn poses immediate health hazards? 16 Warehousing 16.1 General requirements 231 Are materials and products stored in clean, dry and well ventilated locations? 232 Are materials and products protected from potential sources of contaminants such as dust, odour, fumes etc Warehousing requirements 233 Are conditions in warehouses controlled to ensure product integrity? 234 Are products stacked in such a way as to prevent damage to the bottom layers? 235 Are chemicals and waste materials stored separately from raw materials and finished products? 236 Are nonconforming materials segregated from conforming materials? 237 Is a quarantine area designated for storing nonconforming materials? 238 Does the organization practice FIFO or FEFO? 239 Are gasoline or diesel powered fork lift used in food ingredient or product storage areas? 16.3 Vehicles, conveyances and containers 240 Are vehicles, conveyances and containers in good state of repair and clean? 241 Do vehicles, conveyances and containers provide protection against damage or contamination to the product? 242 If trucks, conveyances and containers are used to carry food and non-food products, is there a procedure to ensure that there is no possibility of contamination? 243 Are bulk containers in use dedicated to food use only? 244 Are bulk containers dedicated to specific materials where required? 17 Product information/consumer awareness 17.1 General requirements 244 Is information on storage, preparation and serving provided to the consumer? 245 Can the consumer make an informed decision on the information provided to them? 17.2 Labelling of pre-packaged foods 246 Are procedures in place to ensure the application of correct labels to the products? 18 Food defence, biovigilance and bioterrorism 18.1 Has the organization assessed the hazards to products posed by potential acts of sabotage, vandalism or terrorism? FORM-SYS03-FSMS-03 - CHECK LIST FSSC_EN_ /7

8 247 Have protective measures been put in place to guard against potential acts of sabotage, vandalism or terrorism? 18.2 Access controls 248 Are sensitive areas within the establishment access controlled? Reference: FSSC part 1 appendix 1A 1 Specifications for services. The organization shall ensure that all services (including utilities, transport and maintenance) which are provided and may have an impact on food safety have been defined? It has specified requirements? It has described in documents to the extent needed to conduct hazard analysis? It s managed in conformance with the requirements of technical specification for sector PRPs? 2 Supervision of personnel in application food safety principles The organization ensure the effective supervision of personnel in the correct application of food safety principles and practices commensurate with their activity? Specific regulatory requirements The organization assure that specifications for ingredients and materials take account of any applicable regulatory requirements [e.g. control of prohibited substances]? Management of inputs The organization implement a system to assure that analysis of inputs critical to the confirmation of product safety is undertaken. The analyses shall be performed to standards equivalent to those described in ISO 17025? Annexes: Nr.... sheets for Audit Observation Recording Auditor Signature: FORM-SYS03-FSMS-03 - CHECK LIST FSSC_EN_ /8