Code Of Practice. Prevention of Foreign Body Contamination

Transcription

1 Code Of Practice Prevention of Foreign Body Contamination

2 Amends from V1 to V2 2.1 amended 2.2 Amended- key requirements from COP elimination detection systems included Aspiration after 2.5 new 2.6 amended 2.8 amended 8 All sections- new 3.3 auditing removed Removed- section 3 numbers amended 3.3 amended 3.4 training moved to section Section re-named to Handling Glass & Hard, Brittle Plastic Containers and amended 3.8 removed 4.1 Re-worded 5.1 amended 5.4 amended 8 All sections- new Page 2 of 13

3 Contents Page No. 1. Introduction & Objective 3 2. Risk Assessment 4 3. Glass & Hard (Brittle) Plastic 6 4. Wood 8 5. Metal 9 6. Plastic Miscellaneous Validation, Verification & Monitoring INTRODUCTION & OBJECTIVE Foreign Bodies are one of the leading causes of customer complaints. They have the ability to harm customers, can cause choking, severe pain and potentially death. The aim of this COP is to ensure appropriate risk assessments, preventative measures and controls are in place to prevent foreign body contaminants entering Woolworths products. As a minimum the site must have documented risk assessments and corresponding policies and procedures for potential foreign body hazards, including glass and glass like material (hard & brittle plastic), metal, wood, paper & cardboard, maintenance debris, personal effects, insects & pests, soft plastic is required. Irrespective of the use of foreign object detection systems, and a suitable complaint investigation and trend monitoring system must be in place. Foreign body audits must be completed at a frequency based on risk. A full documented risk assessment should be used to identify potential foreign matter hazards as part of the factory HACCP system and the corresponding policies and procedures drawn up to control the potential hazards. This document supports the Supplier Excellence Program and is intended to provide further clarity and guidance on implementation of these requirements. The intention of this document is that it is not to be used in isolation but as a supplement to the full requirements of the Supplier Excellence Program (or if you have a GFSI Standard in place, to that standard). To help identify how the requirements must be met for each clause a P, R or O will be indicated under the columns headed PRO. These columns indicate whether the requirement is met through: Page 3 of 13

4 P = Procedure. R = Record. O = Observation. - A documented procedure that has been fully implemented. - Documented and accurately completed records. - Compliance will be checked through observation. 2. Risk Assessment P R O Section No. Requirement Compliance P R 2.1 The Supplier must carry out as a minimum a risk assessment of: Glass and Hard (Brittle) Plastic in production & storage areas. The risk assessment should include details of the location of the material, its condition and proximity to ingredients/raw materials, product, packaging or production equipment, and likelihood of product contamination in the event of breakage. The use of wood within the sites production and storage areas. The type, use and positioning of metal tools, implements and equipment in the production and storage areas, this may include metal that is used within the product i.e. metal cans, bag clips etc. Plastic films and bags i.e. raw materials films, disposable PPE, WIP bags, product bags, etc. The use of cardboard and paper Maintenance procedures, including tools, lubricants, cloths, gloves Hygiene procedures for personal effects. Insects, rodents and other smaller live or dead contaminants Raw materials The expectation is that this risk assessment will be completed using HACCP principles and be documented in the HACCP plan R O 2.2 Elimination and detection of foreign objects All steps must be taken to identify, avoid, eliminate and control the risks of foreign object contamination. The risk assessment will determine the requirement for a foreign object detection and removal system that is appropriate for the product being processed. e.g. metal detection for solids or filters for liquids. Processes must be designed to prevent foreign object contamination of the finished product. Examples may include enclosing the product, rinsing or washing the product, and inverting finished product packaging prior to filling. Where elimination/detection systems are used the company must apply Industry best practice and establish limits for detection based on the type of product and its packaging as well as the position of the detector in the process. The system must operate at the optimum setup and validation records must be available to demonstrate how the Page 4 of 13

5 optimum setup is established. Systems that rely on other external factors such as line speed must consider optimum set up in the validation process. Where multiple detection systems are utilised (such as sieves and metal detector), validation records must include both systems and it should demonstrate how the limitation of one detection system is being covered by the other. The system must be located at the appropriate point of the process to effectively remove the target foreign body and this location recorded. The setup can be maintained without periodic adjustment. Other external factors that may affect the efficiency of the system must also be able to be maintained without periodic adjustment (e.g. orbital force on the vibrating screen and temperature). R O 2.3 The site must develop a register of necessary items permitted to be used in specified processing areas. Controls must be implemented to manage compliance to the list, including compliance by visitors and contractors. O 2.4 Equipment used in the process must be suitable for use, durable, and used in the way originally designed. Unauthorised modified equipment can present a foreign object risk and must not be permitted. Multiple use containers must be assessed for suitability prior to each re-use. P R 2.5 There must be a system in place for all staff to report a foreign object finding. A detailed procedure must be in place to handle incidents when a foreign body is found in product (e.g. during a GMP audit or reported as a complaint) or the potential for foreign object contamination is discovered. As a minimum the following must happen. All reported incidents must be documented and resolved as appropriate such that product is protected from the contamination risk, all investigations must involve liaison with raw material suppliers where appropriate. A full documented investigation must take place to ensure the source of the contamination is identified and that the risk of other materials being contaminated is assessed. Foreign object findings must be documented and trended to establish any common sources. Corrective actions must be put in place to prevent a reoccurrence, the root cause and corrective actions must be documented. Asp A Foreign Object finding (during production or as a justified severity one complaint) should trigger a review of the hazard analysis to ensure the significance of the type of object and location found has not changed, ie. does the severity and likelihood elevate this from a CP to a CCP? P R 2.6 Foreign object audits must be implemented The foreign object audits must incorporate a bag/bucket audit. The frequency of this assessment must be based on risk i.e. nature of product / process, type and history of contaminants found, levels of complaint etc. The results of the assessment must be documented and subject to management review. Bag audits must be trended to monitor progress and targets set to drive continuous improvement. Page 5 of 13

6 Where a risk is identified, the product must be protected and short-term and long-term corrective action implemented and documented. ASP Bag/ Bucket audits are conducted at varying times during production. These audits should be conducted by staff who do not usually work in the area being audited. P O 2.7 Packaging containers supplied with raw materials (e.g. buckets containing wet raw materials) should not be re-used. These items must only be re-used where the durability of the item can be demonstrated, the use is as intended and there is no contamination risk to product. R 2.8 Start-up checks must be carried out of the production line and the immediate environment on each occasion before production commences. The area must be checked for immediate product contamination risks and may include for example: Condition of glass like materials Line cleanliness Machinery present and functioning: with no loose nuts, bolts, screws, etc. Conveyors will be checked to ensure no missing pieces or shredding along their sides. Any missing pieces will be recorded, monitored and their replacement planned by maintenance. Required equipment available Required people dressed as per site policy for the product about to be produced. Any WIP (Work in Progress) containers have been checked for integrity (and where applicable, identified and removed from the production area for disposal). The start-up check is to be documented and signed by the manager responsible for the area. Elimination detection systems must be fully operational at the start of production, and frequency of ongoing checks to be determined as per HACCP plan. 3. Glass, Glass Like Materials & Hard (Brittle) Plastic P R O Section No. Requirement Compliance O 3.1 Glass, Glass Like Materials & Hard (Brittle) Plastic in production and storage areas must be replaced with suitable alternatives where possible. Where this is not possible the item must be protected and monitored. P R 3.2 A site risk assessment must be completed for the prevention of contamination of product with Glass, Glass Like Materials & Hard (Brittle) Plastic Controls must be developed, documented and implemented to address the risks identified. These must include the Page 6 of 13

7 P R 3.3 Glass Breakage following as a minimum: Policies for exclusion of risk materials into open food processing areas. Procedures for maintenance and cleaning of risk materials to prevent accidental breakage e.g. changing of a glass light fitting (globe) or cleaning light fittings. All Glass, Glass Like Materials & Hard (Brittle) Plastic in production and storage areas must be listed on a register and how they are controlled must be developed and maintained. The register must show the location, number of items, type of item and its condition e.g. lights on ceiling in a defined area and whether they are intact, cracked, piece missing. The condition of all items on the register must be regularly assessed on a frequency derived from the site risk assessment. This check must be recorded. Photographic evidence may be used of any existing damage, if immediate repairs are not possible. The use of sealed breakage kits. Breakage kits must contain all items readily required in the event of a breakage such as copies of the breakage procedures, cleaning equipment suitable for use, and sign off documentation. Conditions of glass and hard plastic items on machinery or immediately above or around a process line may be checked as part of the pre-op daily start up sheet, this would be acceptable as part of a daily audit. Any issues raised must be investigated to establish if the glass breakage procedure has been followed and if not, whether product has been put at risk. A detailed procedure must be in place for the management of Glass, Glass Like Materials & Hard (Brittle) Plastic breakages. This must include: Details of cleaning methods and equipment Stopping of production Restriction of movement through the affected area Quarantine of all food and packaging materials possibly contaminated. A record of product, codes, and quantities to be logged for reference. Designation of the size of area to be isolated and searched for fragments of glass or glass-like materials (depending on location and type of breakage) Report to management Clean up of breakage and disposal/cleaning of cleaning equipment Safe removal of glass from area Repair or replacement of damaged item The checking of PPE (including footwear) and changing if necessary Completion of an incident log and sign off that production can restart, by a responsible/senior person. Where practical, piecing fragments back together to try to determine whether all of the glass has been accounted for. A sample of broken glass must be retained in a safe manner. Corrective action to prevent reoccurrence High pressure water, compressed air hoses or vacuum cleaners are not to be used as these are known to increase the Page 7 of 13

8 dispersion of the broken material. P R 3.4 Handling Glass & Hard, Brittle Plastic Containe rs O 3.5 Raw Materials P R 3.6 Glass Replace Where product packaging materials pose a safety risk (e.g. glass jars), special handling procedures must be in place to prevent product contamination covering; Intake checks General handling e.g. inversion using air or water blow/wash steps and coverage of line to prevent broken glass being spread around area. Specific cleaning methods must be detailed for the packing line where breakages occur before the packs are sealed or during the sealing process. Records must be maintained of packaging failures and corrective actions taken. The records must include the time of the breakage and the exact location. The quantity of product disposed must be recorded. For plastic packaging material, abuse/challenge test on packaging at different stages (e.g. frozen state, during transit, thawed state, etc) must be conducted, drop height and drop weight must be considered as well to determine if the packaging can withstand the possible mishandling during the end to end supply chain. (Exception: Product crates.) Where plastic crates are used for storage or distribution of raw materials, work in progress or finished product, the Supplier must demonstrate crate condition and use controls are implemented to prevent contamination risk of product. Where raw materials are supplied in high risk packaging (e.g. glass jars or bottles and it is demonstrated as unavoidable) controls must be implemented to prevent product contamination. There must be dedicated, segregated areas for the storage of these containers both as raw materials in the warehouse, in production and packed finished product. Consideration must be given to the movement of these materials to and from storage areas i.e. material and product flow and how breakage incidents can be minimised during the movement of risk materials. Where possible, glass replacement must be carried out outside production hours. Records should be kept of any glass replacement work in production areas. Page 8 of 13

9 ment 4. Wood P R O Section No. Requirement Compliance P O 4.1 The use of Wood in production and storage areas where possible must be eliminated (e.g. hand tools, pencils, clip boards, furniture, brooms, etc.). Where this is not possible the use must be minimised and suitably controlled. P R O 4.1 Wood in the Product O 4.2 Pallets Wood must not be permitted in open food areas unless it is an integral part of the product e.g. skewers in a kebab, cheese ripening shelves, wood chips for smoking. Where this is the case, procedures must be developed and implemented for the specific control of this hazard. Policies for the exclusion of wood into open food handling or processing areas must be documented and implemented. All wood items in open product areas must be free from damage and splinters. Where the use of wooden items is unavoidable and suitable alternatives are not available, it must be demonstrated all other options have been considered, and subsequent control measures must be documented and implemented. Controls for wood used in processing must be based on risk assessment and must include as a minimum Intake checks Inspection for splinters or other damage Procedures for handling a breakage Pallets destined for Woolworths depots, must be in a good condition and not pose a contamination risk., e.g. protruding nails etc. Wooden pallets and pallet debris must be controlled to prevent contamination risk of product. Where wooden pallets are utilised, product must be protected from contamination by wood or wood splinters e.g. by use of a slip sheet or other physical barrier. Areas where wood is allowed must be clearly marked. Page 9 of 13

10 5. Metal P R O Section No. Requirement Compliance P R 5.1 There must be appropriate measures in place for the prevention of metal contamination. A policy must document and describe the procedures implemented for the control of metal objects used in production e.g. knives, needles, cutting blades, stirring implements. A record of inspection for damage of these items must be completed and documented. Safe storage for this equipment must be available and used for equipment not in use. Where metal is used in the process or integral to the product (e.g. bag clips, cans, lids, or other packaging/containers) then it must be suitably controlled. Controls may include; Reconciliation of numbers Inspection of conditions before and after production runs P O 5.2 If canned ingredients are required to be opened for use, there must be a documented and implemented procedure to manage risks associated with this process. P R O 5.3 Raw materials must be purchased in packaging free from metal closures e.g. staples. P R O 5.4 Equipment P R O 5.5 Engineering Knife, blade, scissors, needle and sharp implement controls must be in place and include: Company issued, captive, identified and registered knives blades and scissors must be used, all knives/scissors will be numbered to ensure that they can be accounted for. No snap blade knives to be used. Knives, blades and scissors must only be used for the task which they were designed for. Equipment must be accounted for and the condition checked and recorded by a suitably qualified independent person (minimum start and end of production) Procedures for handling a breakage and disposing of used/damaged equipment Knife and blade sharpening should take place away from production areas. Knife sharpening with steels is acceptable in production areas provided they are not used over product, where sharpening devices are fixed within butchery/processing areas, the location and use must not pose a risk of contamination. Knives must been cleaned and sanitized prior to use after grinding or sharpening. Knives and blades must not be stored in personal lockers, ideally shadow boards, magnetic holders or secure clean storage areas should be used. Knife blocks or plastic scabbards, may only be used for temporary storage Engineering activities must be controlled to avoid compromising product safety or quality. The following controls must be in place: Startup checks of equipment must identify damaged or missing parts Page 10 of 13

11 In the event of damage or loss, all parts must be accounted for and the incident logged, Corrective Action must be taken to prevent re-occurrence. Potential transfer of metal contamination from engineering areas must be suitably controlled (e.g. swarf mats) Wire brushes and scourers must be in good condition and stored away from production process or below product height when not in use. After use the area where the wire brushes or scourers were used must be inspected Mobile engineering workstations must not be used in open food areas. 6. Plastic P R O Section No. Requirement Compliance P R O 6.1 There must be appropriate measures in place for the prevention of plastic contamination. R O 6.2 Equipment Where soft / flexible plastics are used for disposable protective clothing, in production, or for packaging of raw materials these must be risk assessed for potential plastic contamination of the finished product. Plastics must be contrast coloured. Film gauges to be specified to avoid the potential for entrapment or tearing. Opening and resealing methods must minimise the risk of potential contamination. e.g. the use of scissors or sharp knife and not tearing, linked to a bag opening procedure. The site must work with its raw material suppliers to ensure raw materials are delivered in the most appropriate packaging for use. Where frozen raw materials are wrapped in plastic the frozen goods must be tempered or defrosted for the whole and complete removal of the plastic before use in a product or process. The correct type, grade and colour and quality of material must be selected for each application (e.g. WIP containers, PPE) consideration should be given to o Freezing o Blast chilling o Abrasion or impact damage o Washing o Exposure to hygiene chemicals (acids and alkalis) P R O 6.3 The use of food containers (e.g. product trays, bags etc.) to store other materials must not be permitted. Where packaging materials pose a product safety risk, special handling procedures must be in place to prevent product contamination or spoilage. Page 11 of 13

12 Packaging Records must be maintained of packaging failures and appropriate corrective actions. 7. Miscellaneous P R O Section No. Requirement Compliance P R O 7.1 Equipment R O 7.2 Paper /Cardboard All pens used in production, storage and packing areas must be site issued, one piece and of a contrasting colour Staples, hole punches, drawing pins etc. Must not be used in production, packing or storage areas. The number of miscellaneous items should be kept to a minimum and must be retained in a closed container with an inventory. Required miscellaneous items and utensils must be site issued and of a contrasting colour, detectable where possible and reconciled pre and post production e.g. calculators, rulers, scoops A risk assessment must be conducted prior to the use of cardboard and paper in production areas. Cardboard must be minimised on site and not used in open product handling areas unless unavoidable e.g. cores for sealing film. Where raw materials are packaged into cardboard, safe knives must be provided for opening product such that cardboard is not torn. The use of paper packaging and labels in processing areas must be minimised and controlled. A paper sack opening and resealing or decanting procedure must be developed, documented and implemented to prevent the contamination of product with packaging materials during opening. Tags (of any materials) used in production areas must be controlled and detectable where possible. P R O 7.3 Labels The type condition and location of any labels used must not pose a risk of contamination. Paper labels in open food areas must be kept to a minimum. Paper labels must be controlled and must be in a contrasting colour to product. Where possible luggage type metal detectable labels should be used 8. Validation, Verification & Monitoring P R O Section No. Requirement Compliance 8.1. Detection The test pieces used in the validation of the elimination/detection system must be representative of the Page 12 of 13

13 System Validation 8.2 Verification & Monitoring 8.3 Training product/raw material going down the line (e.g. shape and density). Actual product/raw material must be used The product/raw material must have passed through the elimination/detection system before they are used to ensure that they do not contain foreign objects. The product/raw material must be clearly identified and at the same temperature as the standard products passing down the line. Where possible, the worst case scenario product/raw material should be used. The test must be representative of how product/raw material would normally travel through the elimination/detection system (same speed, flow rate and depth) The test pieces should be identified and traceable The most appropriate test pieces should be used for the product/raw material being tested. All checks on the elimination/detection system must be documented and signed by the trained personnel who has carried out the check. THE ACTUAL TIME OF THE CHECK MUST BE RECORDED, the checks should include: Date, Shift, Operator responsible. Product name, size, quantity of run, identification (batch or date code). Start of production, during production (at a defined frequency) and end of production. Details of the checks (e.g. what was checked? How was it checked?). The strength or size details must also be recoded. Amount of rejects (count, weight or volume) Corrective actions for any failed checks. Investigation on any rejected product from production. Magnets must be kept magnetically clean All employees must be briefed on the material handling procedures during induction. All production/hygiene managers and engineers must be trained to understand and apply these procedures and those of any elimination/detection systems used. Page 13 of 13