Hoja1HACCP MANUFACTURING AUDIT STANDARD AUDIT GUIDELINES No.1Senior Management Committment:The companys senior management must provide the human and financial resources required to implement the processes of the quality management system and the food safety plan as per this audit checklist. 1) Organisational charts to demonstrate each department are adquatley resourced including QA. 2) The most senior manager on site must be present during the audit opening and closing meeting as a minimum. 3)There must be an appointed dedicated person to manage audit corrective actions. 4) 100% of corrective actions from the previous audit must be complete. 2HACCP: The HACCP study must be developed by a multi-disciplinary team. Staff appointed as HACCP team members must have specific training on HACCP principles. )The HACCP team must be documented within HACCP program. 2) The HACCP team must consist of members of the Technical team, production and engineering. 3)Team leader must have a recognised external HACCP based certificate. 4) Team members training can be external or internal by the competent HACCP team leader. 5) Training material and team members training assessment and record must be on file. 3The HACCP team must have a designated team leader who has demonstrable competence in HACCP. The HACCP team leader (the person who develops the HACCP program / the key QA representative on site) must be able to demonstrate their competency in HACCP either through having attended a course, or through their level of knowledge of HACCP principles as demonstrated by the quality of the HACCP study. 4A full description of the product must be in place. The products supplied should be included within this description. The product description should detail, 1) product description2) type, 3) packaging, 4) storage 5) distribution conditions 6) primary shelf life (manufacture recommended shelf life and conditions) and secondary shelf life (restaurant product shelf life) if applicable 5The intended use for the product must be defined within the program. The usage of the food by the ultimate consumer needs to be taken into account when assessing risks. All protein must be fully cooked. This must be covered as part of a background statement forming part of the HACCP study. 6The site must have process flow diagrams which cover each product supplied. The process flow diagrams must show interactions and sequence of all process steps as well as introduction of utilities and other contact materials (e.g. packaging).7The process flow diagram must have been formally signed off by members of the HACCP team. This may be via signing of the flow diagrams or within a HACCP meeting document.8The hazard analysis must be based on a likelihood and severity of a risk assessment. The likelihood and severity risk assessment may be in the form of a numerical model.9A documented hazard analysis must be available for all physical, chemical, and microbiological hazards. The HACCP study will be expected to have included an assessment of physical, chemical and microbiological risks. 10For each hazard identified, critical control points must be determined. A decision tree or similar may be used to demonstrate if a hazard will be a CCP11Critical limits must be defined to ensure that the product is safe. The 2.10 process must be capable of operating consistently within the defined limitsTarget, upper and lower limits need to be documented for each CCP. Review of records will show if the tolerances are consistently met. 12Monitoring procedures must be established for each CCP to ensure compliance with the critical limits. CCP's are monitored according to the documented procedures.The company needs to be able to demonstrate that established procedures are in place for each CCP and through records of checks that monitoring is being carried out at the defined frequency and that results are within defined and acceptable limits. For example where cooking is a critical control point, records of cooking temperature need to be available and the minimum acceptable cooking temperature clearly defined. 13Corrective actions must be documented in the event of a CCP deviation. Corrective actions in the event of any CCP's deviation must be documented. Operatives following the documented procedures correctly. 14The operation of the HACCP plan must be validated to confirm that it is effective. (e.g. If a sanitising chemical is used at 200ppm, effectivity can be demonstrated by challenge testing at differing strengths and back up with microbiological information) Verification of the CCPs can be in the form of known published data, supplier documented recommendation or companies own challenge testing. 15The HACCP plan must be reviewed at a pre-determined frequency (minimum annually) or prior to changes of product/process which may affect product safety Auditor will review minutes of HACCP meeting to ensure any changes have been appropriately assessed.16Raw Materials Testing - There must be a documented procedure for raw material recieving. All raw materials must be checked by trained staff and records maintained. On raw materials where COA's are utilized, periodic validation testing of stated analyses is conducted. Raw material procedures must give clear detail for receiving all materials and ingredients and include 1) Vehicle condition acceptance. 2) method of verifying compliance to specification (such as COA's, key attribute sheets) 3) sampling plan detailing testing frequency and methods. 5) corrective action should a product be out of specified tolerances. 6) Training record for staff recieving raw material must be provided. 7) When COA is used as acceptance, evidence that the COA has been compared to specification for compliance. 17Intake records must be detailed document and retained. Temperature Check (where required)Visual check on the vehicle (including load security)Packaging IntegrityCoding informationCheck for evidence of pest activityPallet ConditionCertificates of compliance / conformanceRecords must encompass all of the documented requirements for all raw material deliveries and forms must include the following: Temperature Check (where required)2) Visual check on the vehicle (including load security)3) Packaging Integrity4) Coding information5) Check for evidence of pest activity6) Pallet Condition7) Certificates of compliance / conformance18A suitable stock rotation system must be in place (FIFO based on expiration date). IFO (First In First Out). Documented procedure outlining the method of stock rotation, stock must be rotated using a manufacture date (not receiving date), if no manufacture date is available the expiry or lot code can be used. Auditor must look for evidence of product being used / delivered out of rotation. 19Record Keeping - Documented procedure for the retention of records should be in place and as minimum should be the shelf life of the product. Documented procedure in place. The retention time for records shall be established with due consideration to legislative and customer requirements as a minimum this would be expected to be for the shelf life plus a period reflecting the time period in which a customer or legal complaint could be instigated. 20Key records - as a minimum CCP monitoring documents, ingredient batch sheets, product delivery, temperature monitoring, production start up and cleaning sign off records must be counter signed /verified.Counter signatories role is to ensure that all relevant sections are correctly completed and any for any deviations, corrective actions are implemented.21Corrective and preventative action. There must be a documented procedures which records, investigates, analyzes and corrects the cause of non conformity against all standard requirements relating to product and process safety, legality and quality.This Sectin should be summarised at the end of the audit. Corrective and preventative action procedures must be in place for each programs outlined in the audit e.g. pest control, HACCP, sanitiation and GMP etc. The corrective and preventative action procedures must include as a minimum the following: 1) Issue raised 2) investigation 3) analyse 4) corrective action 5) responsibility at each step.22Corrective actions must be logged with all appropriate details of the issue, action taken, assigned responsibility, timescales for completion, status and final sign off and date. (examples: Out of tolerance results for process, microbiological testing, pest control sign off, mock recall, serious breach of GMP, internal audit findings)Records may be in the form of non conformance / Corrective action reports or logs and detail all the requirements. Any corrective action deviations for all audit sections will be recorded under this clause. Records must include the following elements: 1) Issue 2) action taken 3) assigned responsibility 4) Reasonable timescales for completion 5) status 6) final sign off of completion and within timescales and date (final sign off must be different to assigned responsibility) 23Management of incidents, withdrawals and recalls. -Procedures must be in place to manage all incidents which could affect food safety, legality, or quality The product recall procedure would be expected to include the following elements:1) identification and location of suspect product. 2) the reconciliation and disposition of recovered product. 3) Notification of contact. 4) decision protocol defining when and if a regulatory agency will be notified 5) outline of responsibilities for individuals on supplier recall team.24Key primary and secondary 24/7 contact information must be maintained as a minimum for: Internal contacts (Supplier recall team)Customers Suppliers (raw materials and services) Government / Enforcement bodiesThe 24/7 Key contact information must be current, easily accessible to all authorised staff members in the event of an incident and kept as hard copies in the recall program. 'Contact list' refers to the following lists: Internal contacts (Supplier recall team) Customers Suppliers (raw materials and services) Government / Enforcement bodies NOTE: must be provided with a copy of the supplier recall team contact list.25A mock recall (or mock incident) must be undertaken by the site to test the effectiveness of and understanding of the Recall Plan and Incident Management Procedures (minimum annually). The site is expected to conduct their own mock within the following guidelines: 1) minimum annual basis. 2) the mock recovery must trace either and ingredients or a food contact packaging to ingredient supplier(s), finished product and first external customer within 2 hours. 3) date and time test intitiated and completed. 4) overview of records and evidence that were reviewed to obtain the amounts of product involved. 5) Summary of calculations. 6) the effectiveness of the test including amount of product recovered. 7) A documented review by the recall team. 8) A review of issues uncovered or opportunities to improve the system. 9) a provision for re- testing any part of the mock recovery system that fails within 60 days. 26As part of the mock recall, the site must be able to demonstrate that the traceability system allows product be traced one step forward and one step back to all processes including rework, work in progress and packaging within 2 hours. Documentation will include traceability documents and completed communication documents.The auditor will validate the suppliers's ability to trace product to be traced one step forward and one step back to all processes including rework, work in progress and packaging to 100% within 2 hours. The auditor will select a finished product by product code and ask the supplier to trace the product to first external customer (one step forward). And using the same finished product and select a minimum of 1 ingredient and food contact packaging, traced back to the supplier (one step back). 27Traceability Documented procedures must be in place to enable traceability one step forward and one back through out the process. Identification at all stages must be transparent.Procedures must include: 1) methods to ensure traceability throughout each stage of the process. This includes each stage of the process from the receipt of raw materials through shipment to the first external customer. 2) Identification of what records are used for traceability. 3) What specific tracebility information is on each record. 4) Who is responsible for completing each record (can be by job title) 5) How packaging and raw materials are coded. 6) Method to link each ingredient and food contact packaging material to finished product lots. 7) Methods used to code finished product with month/day/year/lot etc 8) Method used to track production codes shipped to each external customer. 28Where any re-working operation is performed, traceability must be maintained. Also the site must guarantee that where re-work is used within a process it does not affect the safety or legality of the finished product (e.g. ingredient declaration / declared allergen). Rework procedures must include the following elements: 1) how work in process is handled and added back to production. 2) how to control the addition of rework and work in process so the product continues to conform to specification and functional requirements. 3) Temperature limits for temperature sensitive products. 4) time limits for product awaiting rework. 5) maximum add back and / or rework rate allowed. 6) methods to ensure temperatures, counts and measurements are maintained during the rework process. 7) how rework is traced through the system and finished products. 8) documentation related to rework. 29Internal Audits - The site must have a documented system for internal audits. As a minimum the internal audits must cover the following areas at least annually:- HACCPAllergen Controls (where applicable)Process Controls (where applicable)Sanitation programSite SecurityGMP including facility conditionInternal audits must be undertaken on the following areas at least annually:1) HACCP2) Allergen Controls (where applicable)3) Process Controls (where applicable) 4) Sanitation program5) Site Security6) GMP including facility condition The reports will highlight conformity as well as non conformity and follow the usual steps as laid out in the corrective action section of the standard. 31Customer Complaints - Complaints must be investigated in detail by competent personnel. The complaint investigation should determine whether the complaint is specific to a particular product/ batch or a wider issue.Customer complaint collation should be in a standardised format which must include the following elements: 1) Nature of complaint 2) date and product details. 3) Investigation details including determination whether the complaint is specific to a particular product / batch or a wider issue. 4) timescales for completion / response to customer. 5) Corrective actions where required. 32Supplier Selection: There must be an effective process in place for approving suppliers of ingredients and food packaging materials. Supplier approval procedures must be in place The approval of suppliers must be based on a product risk assessment. Procedures for supplier approval should include clear methods for initial and ongoing assessment (i.e. in house checks, certificates of analysis, supplier assessment questionnaires) and the methods and frequency of assessment should be based on risk. The approval of new and existing suppliers of raw materials and packaging shall be based on risk and could include the following components :- Historical experience of the supplier Supplier questionnaires Supplier audits either directly or via third parties Supplier certification to the GFSi benchmark such as BRC / IFS. An up-to-date approved supplier list should be in-place. The company should maintain an updated list of approved suppliers. The site must have systems in place for handling contingency raw materials/suppliers. Evidence of contingency sytems to be demonstrated to auditor Specifications - Specifications must be available for all ingredients, finished products and for all food contact packaging. Specifications must be available Specified parameters detailed within the specification (including in line weights and compositional controls) must be monitored in accordance with specification and records maintained. A selection of documented on line and archived records will be selected production runs by the auditor. Where raw material specifications are provided in the suppliers format these shall be assessed to ensure that they adequately specify the parameters critical to the safety and performance of the ingredient. External Site Standards - The premises must be designed, constructed and maintained to control the risk of product contamination and comply with all relevant legislation. Local activities which could have an adverse affect could include; derelict buildings, rubbish dumps, wasteland etc. presenting a harbourage for rodents; adjacent water courses at risk of flooding. This is a general assessment of the building type and it's suitability in terms of fabrication and location. External areas must be kept clean, organized, and free from unnecessary items that could provide potential pest harbourage. Areas must be free from high weeds, standing water and trash. Any external storage such as old engineering parts or pallets must be properly organised. Trash containers and waste compactors must be suitably covered. Site Security - All access points into the establishment should be secured by guards, alarms, cameras or other security hardware. Supplier must demonstrate how the chosen method is effective. Auditor will observe access points during the audit to ensure there are no breaches in site security Doors, windows, roof openings, vent openings, trailer bodies, railcars and bulk storage tanks should be secured (e.g. locks, seals, sensors) at all times. Outside storage tanks for materials and potable water supply should be protected from, and monitored for, unauthorized access. Visitors, guests and other non-plant employees (contractors, sales people, truck drivers, etc.) should be restricted to non-product areas unless accompanied by an authorized plant representative. Access to in-plant laboratory facilities should be strictly controlled. Comprehensive and validated security and disposal procedures should be in place, particularly for the control of reagents, hazardous materials and live cultures of pathogenic bacteria. The auditor should verify compliance to the following: 1) Access to in-plant laboratory facilities are strictly controlled to authorized personnel; 2) The facility is designed so there is a separation that will prevent laboratory practices from having a detrimental effect on manufacturing; 3) Personnel adhere to good laboratory practices, e.g. no eating, drinking or smoking or eating and storage of food and drink are allowed; 4) Testing equipments are well maintained; 5) media, prepared media, reagents and chemcials are labelled & used within their shelf life; 6) Media prepared media, reagents and chemicals are dated when opened or prepared; 7) Validated Security & Disposal procedures for control of reagents, hazardous materials and lives cultures of pathogenic baterica; 7) Material disposal records & sign off Returned goods should be examined for evidence of possible tampering before salvage or use in rework. Records should be kept on the use of all returned goods in rework. Facility has procedures and method to ensure returned goods are in "wholesome" condition before salvage or use in rework:1) determining the number of cases represented by each product sampling and testing. This is to ensure all returned products between acceptable tests is captured2) Identify, segregate and hold return goods as raw materials, packaging or finished products; 3) Tes methods4) Identify appropriate responsibility and provisions for sign-off on product release 5) defining methods of rework (maximum rework level is 5% assuming specification parameters are met)6) Defining testing for rewokred product to vefify compliance tospecification /Quality Assurance Program7) Records (including product name, quantity, batch code etc must be kept on the use of all returned goods in rework Factory Layout - Suitable space must be provided within the factory in order to conduct all operations and to ensure product safety and integrity. The auditor will verify that the process flow does not allow cross contamination for example between raw and cooked foods and high and low risk personnel. Suitable facilities must be provided for washing equipment, trays and utensils and must be located to prevent product contamination. Washing of equipment etc will be in a segregated area or when there is no production and risk of contamination to product. Sinks must be adequately labelled. The building will be maintained in a good state of repair such that there is no imminent risk of contamination. In general the internal and external condition of the building must be well maintained and not pose a risk to food safety. This is a more general clause and specific areas are dealt with in their own sections such as walls, floors, ceilings. Finished products are stored to prevent cross contamination. Finished products are not at risk of contamination from operations, fabrication, cleaning, maintenance or other ingredients/ materials on site. High Risk / High Care Operations - Suitable segregation must be in place between raw and cooked/finished products and production activities in order to prevent cross contamination. Segregation of high risk / high care areas should be by physical barriers. In some exceptional, tightly controlled circumstances segregation of raw and cooked products by time and space may be accepted. Time and space segregation will be discouraged and only accepted as a temporary measure as long as it is tightly controlled. All suppliers must plan to have physical segregation Protective clothing worn by staff within the high-risk / high care area must be visually distinctive from other protective clothing. Fabrication - Walls - Walls must be designed, constructed, finished and maintained to prevent the accumulation of dirt, to reduce condensation, mould growth and to facilitate cleaning. If signs are placed onto the walls they must be fully sealed to prevent possible mould growth. The walls in rooms where foods are prepared treated or processed, must be kept in a sound condition and shall be easy to clean and where necessary disinfect. The walls should have a smooth impervious finish. Tiling should be avoided but, if present, should be in good condition with no cracks or loose tiles. Painted surfaces should be in a good state of repair and free from flaking paint. Ledges should be kept to a minimum to avoid dust collection. Vulnerable wall surfaces or corners should be protected from damage with metal plating or barriers properly sealed to prevent debris accumulation. For any recurring issues in relation to walls/floors and ceilings, all points may be awarded if there are frequent inspections to monitor the issues and a risk assessed corrective action approach is maintained with there being no risk to food safety. Wall / floor junctions and corners should be coved / curbed to facilitate cleaning. Cavities in the surface of walls should be avoided to prevent debris from lodging and pest harbourage. The floors in rooms where foods are prepared treated or processed, shall be kept in a sound condition and shall be easy to clean and where necessary disinfect. Floors should be constructed of materials, which are impervious, hard wearing, repairable and resistant to chemical attack.Mezzanine floors and walkways should be completely sealed and have adequate sidewalls to prevent contamination of product below. For any recurring issues in relation to floors, all points may be awarded if there are frequent inspections to monitor the issues and a risk assessed corrective action approach is maintained with there being no risk to food safe Drains must be accessible for cleaning and fitted with screens or traps to prevent pest entry and odours. Drains must be clean and screens must be present and intact Fabrication Ceiling - Ceilings and overheads must be designed, constructed, finished and maintained to prevent the accumulation of dirt, reduce condensation, mould growth and facilitate cleaning. In rooms with high ceilings which are difficult to clean or maintain, line covers should be fitted over open product to reduce the risk of contamination. For any recurring issues in relation to walls/floors and ceilings, all points may be awarded if there are frequent inspections to monitor the issues and a risk assessed corrective action approach is maintained with there being no risk to food safety Fabrication Doors - All external doors must be kept closed when not in use and effectively proofed against pests. If strip curtains are fitted, they must be maintained, kept clean and effectively proofed against pests. Fabrication - Lighting - Lights and light bulbs are adequate in number and strength to effectively illuminate the entire production facility. Lights within production and storage areas should be protected by shatter proof covers and / or sleeves (on the light tubes / bulbs). Where lights are not protected then these must be covered as part of a glass management program. Fabrication - Ventilation - Ventilation and extraction systems must be effective at preventing condensation, excessive dust, pest entry, and not pose a risk to product. No evidence of excessive dust and condensation observed. Exhaust fans to the outside are adequately screened and equipped with self-closing shutters. The systems must prevent pest entr Fabrication - Windows - Where windows are designed to be opened for ventilation purposes, they must be adequately screened to prevent the entry of pests. Glass windows in production areas must be protected against breakage. Where windows are not protected then they must be covered as part of a glass management program. The protection of glass windows must be adequate to prevent splinters of glass entering production areas should the window be broken. This may be achieved by the use of adhesive plastic sheeting or wire reinforced glass. Utilities - Water used as an ingredient of products or for cleaning must be from a potable water source. In areas were the local water supply is not safe, systems must be in place for filtration/ sterilization of the water supply. Systems used to filter / sterilize water must be regularly maintained and records kept. Water / steam / air / ice which come into contact with food must be monitored at least an annually. Chemical and microbiological analysis of water takes place min. annually. Water samples should be taken at point of use. Water test must include: 1) Total Plate Count, 2) Coliform, 3) E. Coli, 4) Nitrates / Nitrites, 5) Heavy metals - lead and mecury, 6) Off flavour and odour. For filtration / sterilisation systems, maintenance records including 1) date of last check, 2) condition of equipment and filter, 3) corrective action where filters have needed repair or replacement, 4) the signature of individual who performs the maintenance Equipment - All equipment must be designed and constructed to enable hygienic cleaning and maintenance. It must be maintained in a good condition to prevent contamination. Equipment and fittings (e.g folk lifts) must be easily accessible for ease of cleaning and servicing. Lifting equipment must be stored away from food products when not in use where applicable Battery charging areas must be segregated away from product storage areas where possible Maintenance - A system of planned maintenance must be in place for all key pieces of equipment, specifically those critical to product safety, legality and quality. Planned maintenance may be done internally or via contracted services. Maintenance undertaken internally should be documented in the form of a plan and records maintained.For equipment that is maintained under external contracts evidence of contractual agreements must be available. Measures to ensure that product safety, legality and quality is not jeopardized during maintenance activities must be in place. A system must be in place to verify that an area is clean after maintenance work has taken place. A job sheet sign off to detail work done and a 'sign back' system to ensure that the equipment is in a sanitary condition to return to production. Lubricants / Greases which may come into contact with product to be Procedures / Records of a food grade nature.MSDS will be available. A system must be in place to segregate food grade and non food grade Records lubricants. Maintenance areas must be clean and well maintained. Any idle machinery must be cleaned, stored and organized to prevent pest harbourage.All tools and parts must be controlled. A system must highlight and initiate an investigation if a tool or part is missing.A procedure for reconciling pars and tools after maintenance is performed. All parts and tools must be accounted for by checking a list or signature on records indicating all parts and tools are reconciled. String, wire, tape, etc are not used for permanent repairs. Documentation is in place for temporary repairs showing date of repair.Temporary repairs must be rectified in a reasonable timeframe - it is expected that there will be a record of ordering parts along with expected delivery dates. Chemical Control - All chemicals must be suitably stored and labelled. MSDS sheets to be available for all chemicals on site. Storage areas used for all potentially harmful chemicals used on site e.g. Pesticides, caustic soda, cleaning chemicals, should be lockable and access restricted. Bundied areas should be provided around oil tanks. Acid and alkaline materials should be stored securely and separately. MSDS sheets must be available for all chemicals on site during the audit. Metal / Sieve / Filter Control / Magnet - Knife, blade, scissors, magnet and needle control must be in place. Documented procedure detailing 1) the control of these items, 2) detailing type and 3) frequency of checks and 4) corrective actions. Sieving/Filtering/ Magnets must be inspected forintegrity at pre-defined documented intervals as identified in the risk assessment and recorded. Sieve and magnet tailings must be recorded and monitored. Inspection records must include: 1) date and item, 2) findings, 3) corrective action, 3) status, 4) sign off Glass / Brittle Plastic and Ceramic Controls - Glass items other than packaging materials for finished product must not be brought into production areas. A detailed procedure must be in place for the management of glass, brittle plastic and ceramic breakages. Documented report must be available for glass/brittle plastic and ceramic breakage and adequate cleaning Procedure to include the following elements: 1) handling of all lights and glass within the facility including production, warehouse and storage, 2) handling of glass breakage within the facility; 3) any brittle or hard plastic that is broken in a location where it could impact the product, 4) computer or video monitor should be covered with a plastic film to prevent shattering; 5) handling of non-tempered / non-protected office glass; 6) Where products are packed into glass containers, bottles and jars specific glass breakage procedures must be in place. 7) System for staff to report glass / brittle plastic and ceramic breakage. In addition, Documented Reports must be available. Wood Control - The use of wooden pallets within the site production and storage areas are suitably controlled. Other wooden items must be eliminated such as wooden handle broom etc. A written wood control policy is required detailing handling of wooden pallets and other wood items. Facility should not use damaged wooden pallets in production and storage of food items. A inspection must be carried to check pallet condition before use in the facility LEVEL 2Sanitation - Sanitation Program must be in place (Master Sanitation Schedule) which ensure appropriate standards of hygiene are maintained in all areas at all times and that the risk of contamination is minimized. The level of sanitation throughout the site will be observed and assessed accordingly. The Sanitation program must include: 1) frequency of cleaning; 2) responsibility; 3) defined methods and procedure for each task; 4) cleaning products and concentration used; 5) individual accountability and sign off for each task completed; 6) cleaning procedures are designed and ordered to prevent potential contamination of products and re- contamination of clean areas; 7) Cleaning equipment and utensils must be colour coded and specific to the area (raw Vs cooked); 8) Sanitizer / Cleaner concentration used. In addition, auditor will observe the sanitation is sufficient and not causing potential / imminent contaminati Documented cleaning procedures (SSOP) must be in place and maintained for building, utilities, plant and all equipment. Documentation that shows sanitation has occurred (e.g.. sign off sheets) must be maintained. Cleaning procedures should include: 1) equipment, 2)methods and 3) frequency of cleaning; 4)required chemicals and concentrations. Cleaning procedures should be of sufficient detail for cleaning to be carried out to a consistent acceptable standard. This may require detail of breakdown of equipment for cleaning purposes. In addition, sign off sheet for each individual cleaning task completed and matches the frequency in the Master Sanitation Schedule. A pre-operational inspection program must be established to include daily inspection of equipment. Pre-operational inspection program includes documented visual inspection and confirmation of equipment / production area is clean. LEVEL 2Sanitation equipment must be used as intended. Equipment must be colour coded for its area of intended use. These must be stored separately from one another and captive to that area. Cleaning equipment should be fit for use and if laundered must be suitably controlled. Sanitation Equipment must be intact, clean and colour coded for intended use. Microbiological testing of environmental surfaces is utilized and documented, to monitor the effectiveness of cleaning and/or sanitation procedures. Written program must include the following elements: 1) a plan to test all food contact areas; 2) frequency of testing; 3) acceptance criteria; 4) follow up action and retesting where applicable; 5) records of findings LEVEL 2The effectiveness of cleaning and disinfection procedures must be verified and recorded (e.g. environmental bioluminescence swabbing (ATP) or visual assessment). The effectiveness of cleaning may be assessed by inspection or by microbiological or ATP systems as appropriate to the risk. Records shall be maintained of cleaning assessments. Cleaner/sanitizer concentration and application comply with sanitation program. A system to routinely verify chemical dosing strength must be in place. 1) Sanitizer and cleaning chemical concentration must match the frequency outlined in the Sanitation Program; 2) Automatic system must be routinely calibrated as per the manufacturer's suggested frequency; 3) Test strips or kits may be used for verification of sanitizer and cleaning chemical concentration; 4) Cleaning chemical and sanitizer concentration must be reported on a list that is signed and dated each time a manual mixture is made; 5) Records will be in place to demonstrate routine testing including CIP procedure. Raw materials and finished products are covered or otherwise protected during clean-up Waste Control - Adequate system to be in place to control the disposal of waste. (e.g. Cardboard, general trash, inedible waste) Waste disposal must meet legal requirements, and licensed contractors must be used where applicable. The terms of the contract with the waste disposal company should include reference to the contractors responsibility to meet legislative requirements. A letter from the contactor External and internal waste containers and compactors must be managed in a way to minimize risk of product contamination and covered where applicable. Waste containers must be cleaned at an appropriate frequency Particular consideration should be given to pest control implications of external waste collection containers. Pest Control - The company must be responsible for minimizing the risk of pest infestation on site. Regular inspections of the site by competent personnel must be conducted to monitor the pest control activities. Pest Control Program must include the following elements: 1) designated Pest Control Company or Operators; 2) Frequency of scheduled service; 3) A full list of pesticides; 4) current Master Pest Control Map (dated within the last 12 months); 5) liability insurance certificate; 6) Company license (where applicable or members of an approved pest control association); 7) Certification for the PCO. All Pest Control resources must be suitably competent, certified and insured (according to local legislation). Where pest control operations are carried out by the companys own personnel training records must be available to demonstrate the competence of all pest control operators. Certificates etc must be on file and suitably in date. The frequency and type of visits should take into account the type of pest risk. Records of all pest inspections must be kept. The frequency of inspection and treatment of premises to eradicate or deter infestation shall be based on the product risk, age design and location of buildings and equipment. In general it would be expected that inspection/treatment visits should be carried out at least 8 times per year. The contract should have provision for additional treatments where required to eradicate any infestation which may occur. An up to date pest control device map showing both internal and external bait points and monitoring devices must be in place and must be reviewed annually. Pest Control Map must include the following elements: 1) location of pest control devices; 2) numbered; 3) dated; 4) identification of pest control devices. Auditor should verify the actual location and number of the pest control devices against the map. LEVEL 2No evidence of pest activity within any of the process or non process areas. All areas must be free from reoccurring/existing internal pest activities. There must be no evidence of the following: 1) No recurring/existing rodent activities; 2) and/OR nesting birds; 3) no evidence of live animals & insects on products, ingredients or packaging; 4) no evident of excreta/pellets; 5) no evident of rodent damaged ingredient bags; 6) no decomposed rodents or any other animals (traps must be checked often as per the freqency outlined in the pest control program). All Pest Control resources must be suitably competent, certified and insured (according to local legislation). Where pest control operations are carried out by the companys own personnel training records must be available to demonstrate the competence of all pest control operators. Certificates etc must be on file and suitably in date. The frequency and type of visits should take into account the type of pest risk. Records of all pest inspections must be kept. The frequency of inspection and treatment of premises to eradicate or deter infestation shall be based on the product risk, age design and location of buildings and equipment. In general it would be expected that inspection/treatment visits should be carried out at least 8 times per year. The contract should have provision for additional treatments where required to eradicate any infestation which may occur. An up to date pest control device map showing both internal and external bait points and monitoring devices must be in place and must be reviewed annually. Pest Control Map must include the following elements: 1) location of pest control devices; 2) numbered; 3) dated; 4) identification of pest control devices. Auditor should verify the actual location and number of the pest control devices against the map. LEVEL 2No evidence of pest activity within any of the process or non process areas. All areas must be free from reoccurring/existing internal pest activities. There must be no evidence of the following: 1) No recurring/existing rodent activities; 2) and/OR nesting birds; 3) no evidence of live animals & insects on products, ingredients or packaging; 4) no evident of excreta/pellets; 5) no evident of rodent damaged ingredient bags; 6) no decomposed rodents or any other animals (traps must be checked often as per the freqency outlined in the pest control program). Effective pest proofing measures need to be in place to prevent possible entry of pests. (E.g. fly screen, bristle strips etc) Effective location of pest control devices and use of bristle strips and fly screen etc) Pest control devices must be effective, well maintained and are applicably located. Electric Fly Killers are located away from exposed food products and ingredients (at least 3 meters or approximately 10 feet), cleaned regularly and bulbs changed annually for Electric Fly Killers (i.e. Electric Fly Killers not above product). As a guide, 1)Internal traps should be positioned at 8 meters intervals (25 feet); External traps shall be positioned at 15 meters (50 feet) intervals; 2) Freezers and coolers shall have traps located within 2 meters (6 feet) on both sides of entry doors (both inside and outside of the doorway); 3) Traps should be positioned against the wall; 4) Interior of traps, bottom of glue boards shall have service labels dated and initial after each treatment by the PCO (electronic scan methods are acceptable). 5) EFK UV bulbs must be changed at least annually. Bait stations must be of tamper resistant construction, secured in place if required by regulation, suitable for the location and located to prevent possible contamination. In the event of an infestation (in either process / non process areas) there must be a full program of follow up visits to ensure complete eradication of the issue. This should be detailed in the contract or procedures. Transport - Suitable measures must be in place to control and monitor temperature sensitive products through the distribution chain. Records of temperatures must be maintained according to the company's record retention policy. Records must include the following elements: 1) Out-bound trailer pre- cooling temperature is at least 5 degC (41F) for refrigerated items and -12 degC (10F) for frozen items; 2) List of product delivered; 3) Product temperatures are recorded before loading; 4) Product temperature at delivery or restaurants Each vehicle must be checked for cleanliness and strong odours before loading and maintained in good repair. Records of the checks conducted prior to loading must be maintained according to the company's record retention policy. Records must indicate the requirements have been checked, signed and dated by designated personnel. Internal and third party transportation procedures must include vehicle breakdown and loss of temperature control. Procedure must detail: 1) the action of driver must take to report of vehicle breakdown or the refrigeration breakdown and 2) timescale for vehicle / product recovery; 3) Product temperature measurements upon delivery; 4) Corrective action for out-of-tolerance product temperature at any point of delivery. Finished product must be shipped on a first in first out basis. Auditor will check the despatch records to ensure FIFO is practiced. Handling requirements for specific materials - Procedures must be in place to control any materials with specific implications for product safety, legality or quality, where applicable* [e.g. known allergens, vegetarian, GMO (in areas of the world where the use of GMO is restricted by legislation), products where provenance is important. ] *Not applicable is not an option for level 2 supplier. Any allergens or other specific material relevant to the market being supplied must be identified by the supplier and where applicable and where required, procedures must be in place to verify and control. Risk assessments must be carried out and control measures implemented to prevent cross contamination by known allergens. Control methods are effective and include the following: 1) Facility has determined if it has any food allegens in the facility 2) Processing order or change over procedures specifically address ensuring allergens are not transferred to a non-allergen containing product 3) Sanitation procedures and practices do not allow cross contamination of allergens to non allergen products 4) Ingredient weighing / handling practices do not allow for cross contamination of allergens to non-allergen products and ingredients Example of food allergens are : peanuts, soybeansm milk, eggs, fish, crustacean, tree nuts, and wheat. Additional allergens may be identified by local requirements / regulations and must be included. LEVEL 2Foreign Body Detection (metal detection / X-ray)- Foreign body detection equipment must be in place unless it can be justified that it is not necessary. For no foreign body detection equipment, a risk assessment must be in place to justify absence. The sensitivity of detection must be in line with best practice with regards to the nature of the food. The company must be able to demonstrate how the sensitivity level has been deduced. The foreign body detector must incorporate a suitable rejection mechanism. The rejection mechanism can be a divert valve, line stop (with alarm), belt retraction or arm push mechanism and should be diverted to a suitably secure container. The operation of the foreign body detector must be verified by the site on a regular basis (as a minumum hourly basis). The auditor will verify the effectiveness of metal detection testing during the audit. In the event of a metal detection failure all product produced since the last satisfactory metal detector check must be rechecked. Records must contain the following: 1) Product name and date 2) identification of metal detector. 3) Quantity of product to be rechecked. 4) Person responsible for recheck 5) Result of recheck. 6) Sign off by supervisor. Non Conforming Product / Hold Procedures - The site must have a documented non conforming product procedure. This will include: Release by concessionOn hold / Quarantine Customer returns ReworkProduct Rejection Specified designated areas. Identification of personnel responsible for initiation, evaluation and release /disposal of held product.The procedure contain the following elements:1) Release by concession (e.g shelf life extension of expired product) 2) On hold / Quarantine3) Customer returns4) Rework5) Product Rejection6) Specified designated areas and product identification (e.g hold tag). 7) Identification of personnel responsible for initiation, evaluation and release / disposal of held product. Facility will maintain documentation with regard to quantities of held product, evaluation of held product, approval/release for use to the production area (where applicable), and final disposition of product. This can be in the form of computerised stock management system, a database or paper records. LEVEL 2Product will be properly tagged or otherwise physically identified on the exterior surface, to prevent potential shipment. An acceptable alternative would be situations where bar coding is in place to prevent shipment of product designated on hold by computer and where no physical tagging is in place Product Inspection and Testing - Product testing must be conducted in accordance with recognised methods and by an accredited laboratory where applicable* (*accredited laboratory where applicable is compulsory for a level 2 supplier) Laboratories used must be suitably accredited where applicable (compulsory for level 2) to conduct each test and using recognized test methods. Where applicable the site must keep retention samples for all production runs for the shelf life of the product. The expectation is that retention samples are kept, any deviation will be agreed with theCertified.Temperature Control - Temperatures of refrigerated and freezer storage areas must be checked and recorded at least 3 times a day. For automated systems there must be a process of review and sign off. Temperature records must be maintained. The auditor must verify that all temperature control measures are effective: 1) Procedures define the process by which the facility temperatures are monitored and documented in each critical area : coolers, freezers, cool docks, blast chilling or any storage trailers where temperature senitive ingredients and products are stored, 2) Temperature records must be maintained, where temperature sensitive ingredients and products are stored, manually "at least 3 times" a day if no automated temperature graph recorder is used. If an automated, continuous on-line temperature graphs recorder is used, facility temperatures shall be manually taken and recorded and sign off "once daily". 3) For temperature sensitive products / ingredients, product temperatures shall be documented before products are shipped.4) Docks must be enclosed and cooled to less than 500F / 100C if temperature sensitive items are shipped. Quantity / Weight / Volume Control - An appropriate mechanism for quantity/ weight / volume control must be in place and appropriate records kept. Records must be maintained by the site to demonstrate that legal requirements have been achieved where appropriate* (*where appropriate is not an option for a level 2 supplier For example for minimum and average weight systems an automatic check weigher system may be used or individual weights taken and recorded at pre determined frequencies. Records must contain the following: 1) Date and product name 2) Target weight of product, weight control method (average/ minimum / gross / net) including packaging tare weights where applicable. 3) Weight tolerances 4) Time of checks 5) Actual product weights (may be in the form of a printout if automated) 6) Corrective actions taken in the event of weights being out of tolerance) Calibration - All measuring equipment critical to product safety, legality or quality must be calibrated by an external company (to a nationally recognized standard) at a predetermined frequency and an appropriate certificate of calibration be available. Calibration program must be in place for establishing and maintaining calibration and accuracy of key testing and measuring equipment used in QA labs and in manufacturing, storage and distribution. The following elements must be included: 1) Identify all key mesauring equipment including all equipment used to measure a product attribute products as outlined in the specifications . This shall include autoclave whereas on-site micro. test is carried out and thermal detector/s. 2) Maintaining schedules for calibration testing3) Documented methods and frequency of calibration4) Identifying appropriate reference standards 5) Record / certificates of calibration must be up to date and maintained. A system of internal verification of the accuracy of measuring equipment at appropriate frequencies between calibration intervals must be in place. 1) Identify all key mesauring equipment including all equipment used to measure a product attribute products as outlined in the specifications .2) Maintaining schedules for calibration testing 3) Documented methods and frequency of calibration 4) Daily checks before production for thermometers and scales used in the process, including floor scales, filled load cells, and quality testing scale5) Establishing procedures for proper maintenance of reference standards (for example master calibration thermometer/ stamped weights) 6) Records must be maintained. A master calibration log must be maintained by the site. A master calibration log must be maintained by the site and include the following:1) Measuring Equipment, 2) Calibration Frequency, 3) Scheduled Date for Calibration, 4) Date of Calibration, 5) Status LEVEL 2There will be at least annual internal/external correlation studies conducted between individuals performing the same testing in order to maintain consistency of testing. Microbiological and chemical proficiency based test must be in place with an accredited laboratory. LEVEL 2GMP - Personal Hygiene - The site must have documented GMP program and Self-audits on GMPs are conducted monthly, at a minium, and include corrective action. 1) A written GMP program must encompass all the GMP requirements , for employee, visitors and contractors. (In addition to the local Regulatory Requirements shall be used as a basis for requirements). 2) The GMP's must be displayed in prominent staff areas or as appropriate 3) Self audits on GMP must be conducted min. every month. Results of the audits and the corrective action must be recordedNOTE: Issues relating to corrective actions not completed must be scored Eating and drinking must only be permitted within designated areas and is not permitted in storage and production areas. Smoking must only be permitted within designated areas and not permitted in storage or production areas. The site must have clearly defined rules in terms of the wearing of jewellery. The company's hygiene rules must make reference to the wearing of perfume / make up / false nails / nail polish. The plaster / bandage used for cuts and grazes must be waterproof suitably coloured, company issued and metal detected where applicable Training - All employees have received an appropriate induction training, including an element of food hygiene and food safety. The employees training program must include the following elements: 1) New employees must be trained in GMP and food safety before commencement of work (work safety within 3 months).2) GMPs, Food Safety, Work Safety Training materials; 3) Competency assessment, e.g. quiz; 4) Training records of all employees Personnel must be specially trained to the requirements of their job role that has an impact on controlling the KPIs and be able to demonstrate competence. (e.g. CCP checks, chemical concentration checks, foreign body detection) The training program must include the following elements: 1) Job titile and job summary; job training methods;responsible parties for training; Training effectiveness and competency assessment, e.g. Quiz; Training records A system for annual employee refresher training must be in place. (e.g. this can take the form of a competency test where applicable) 1) Schedule for annual employee refresher training inlcuding GMPs, Food Safety, Work Safety, Job training that has an impact on controlling the KPIs; 2) Training assessment; 3) Training records Health and Wellness - The Company must have a procedure for the notification by employees, including temporary employees, of any relevant infectious disease or conditions which they may have be suffering or have been in contact. A return to work procedure must be in place. There will be a system for checking and sign off by a competent line manager for return to work forms, records will be available. (Details of the policy will be in general GMP section The Company must have in place a documented system for pre- employment health and wellness screening where applicabl There will be a system for checking and sign off by a competent line manager for visitor forms. Form and records must be in place. A system for health and wellness check of visitors to the site must be in place. GMP sign in sheet should be in place for visitors and contractors. There will be a system for checking and sign off by a competent line manager for visitor forms. Forms and records must be in place. Staff Facilities - Suitable changing facilities must be provided for staff. A dedicated changing area must be provided for personnel working in any high-risk area. Suitable and sufficient hand washing facilities must be provided at the access to and at other appropriate points within the production areas. Suitable temperature water, bactericidal soap, and hand drying facilities must be made available Toilet facilities must be equipped with hand wash station and soup AND not open directly into production, packing or storage areas. Staff facilities (lunch room, restrooms, lockers, etc.) must be maintained in a clean and sanitary condition. Protective Clothing - appropriate company issued clothing for food handlers and others working in or visiting food handling areas must be provided and cover personal clothing above the knees. Clothing used in high risk areas is identifiable. High risk / high care protective clothing must be put on and removed in a designated changing area. Protective clothing must be maintained in clean condition and laundered regularly either on site against specified wash parameters or off site by an external approved laundry. Protective clothing should not be worn outside of the production and warehouse area where applicable. Hair / beards must be fully covered. A tightly knit hair net must be provided for confining hair / beards. Suitable footwear must be worn where appropriate. (foot covers are permitted).

REMOVE CLAUSE