Code of Practice Version 2 Metal Detection and X-Ray Systems

Transcription

1 Code of Practice Version 2 Metal Detection and X-Ray Systems

2 Contents Page No. 1. Introduction & Objective 3 2. Risk Assessment & General Requirements 4 3. Location 5 4. Sensitivity 6 5. Detection Operation & Testing Requirements 7 Appendix 1 10 Appendix 2 13 Appendix INTRODUCTION & OBJECTIVE Foreign bodies are one of the leading causes of customer complaints. The aim of this COP is to ensure that where metal detection & x-rays systems are in place to detect foreign body contaminants from raw materials and production processes (such as sieving, crushing, cutting, mincing, mixing and packing), they are appropriate, validated & verified and working as intended. Metal Detection & X-Ray systems must not be used as a replacement for risk assessments, preventative measures or other control measures before scanning by these detection systems. Refer to COP - Prevention of Foreign Object Contamination. For further guidance on the functionality of metal detectors and X-Ray inspection there are guides produced by the manufacturers (e.g. Fortress Technology, Safeline) which outline the specific types of detector available and which type of detector is suited to which application. This document supports the Woolworths Supplier Excellence Food Manufacturing requirements and is intended to provide further clarity and guidance on the 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 Woolworths Supplier Excellence Food Manufacturing requirements (or if you have a GFSI Standard in place, to that standard). Page 3 of 14

3 To help identify how the requirements must be met for each clause of the Industry Standard - Supply Chain Service Providers a P, R, O has been indicated in the column between each clause number and the detailed description of the Standard Requirements. P = Procedure: A documented procedure that has been fully implemented. R = Record: Documented and accurately completed records have been maintained. O = Observation: Compliance will be checked through observation of practices or adherence to procedures. Clause Section P R O Requirement No. 2 Risk Assessment & General Requirements 2.1 Risk Assessment 2.2 General Requirements P R To determine the requirement for metal detection/x-ray and the format it should take, the Supplier must carry out as a minimum a risk assessment as per Section Code of Practice - Prevention of Foreign Body Contamination R O The metal or foreign body detector must incorporate the following features: An automatic rejection device or an alarmed belt-stop system. Belt stop systems must only be used where automatic rejection devices are not appropriate i.e. cause product damage or is not suitable for the product (Large Bulk Hams). The belt stop must only be able to be re-started by trained authorised personnel. The automatic rejection device must reject product into a locked container accessible only to authorised personnel. Pipeline detectors (e.g. pipeline detectors for fluids) must identify the location of the contaminant and divert affected product to a segregated part of the process. The affected product may only be accessed by authorised personnel R O Detector fail safe systems where fitted must be challenged at regular intervals (minimum start and end of production day) to make sure they are functioning effectively. Reject Confirmation Sensor Bin Full Door Lock Air Pressure Low Search Head Failure Photo electric cell pre search head Reject check Sensor Compliance (Y/N add comments) Page 4 of 14

4 2.2.3 R O For beverages including bottled waters, soft drinks, sparkling mineral waters, long life juices, cordials, fresh milk in bottles and cartons, UHT and Combi-bloc products, the following applies: Satisfactory filter points and sizes used through a risk assessed and validated study and; Regular filter checks (ensure filter checks are within hold and release period for production run) and; There must be a system in place for regular filter integrity checks and site is able to demonstrate that deviations are followed up with appropriate corrective actions. Satisfactory bottle/container/uht packaging cleaning process on line and; A clear process for control of fill/vent tubes As an example control of fill/vent tubes could be through design (strong welds, not able to fit into container) or an on-line vent tube detector. Fill/vent tubes are expensive pieces of equipment and it is generally clear when one is missing as liquid will spray. Some sites may also use different fill/vent tubes for different products and perform a count when conducting a changeover and; Risk Assessment to determine and controls in place to manage any possible metal contamination via equipment or structures in the vicinity of the filling operation (e.g. nuts and bolts via cap hopper/shute, etc) Section 3 Location Clause No. P R O Requirement R O Metal detection/x-ray inspection systems should be located at the end of the product packaging process or as close as possible to the finished packing point and in-line with the main production flow. Individual packs must be checked where possible. If individual packs are unable to be checked this must be approved by the Woolworths Quality Specialist in writing R O Some processes may use metal detection/x-ray inspection systems upstream in the process for quality or equipment protection purposes. This COP relates to the final Critical Control Point (CCP) metal detection system. If finished pack metal detection/x-ray inspection is not a CCP it must be agreed with the Woolworths Quality Specialist in writing. Compliance (Y/N add comments) Page 5 of 14

5 Section Clause No. P R O Requirement 4 Sensitivity 4.1 Sensitivity P Where detection or removal systems are used the company must apply industry best practice and establish critical limits for detection based on the type of product and its packaging as well as the position of the detector in the process. The detection system must operate at the maximum workable sensitivity and validation records must be available to demonstrate how this sensitivity was established. 4.2 Settings R O The metal detector/x-ray must be specified as appropriate for the products that are being examined and meet the following parameters; The sensitivity can be maintained without periodic adjustment. The detector gives minimal false signals and does not reject good product. The detector does not go blind after detecting a large metal piece. Detection in different orientations; test pieces are usually round which has similar properties in any orientation, whereas wire or needle type foreign bodies need to be tested in different orientations to ensure maximum effectiveness of the detector R Sites must have a documented record of the optimum achievable levels of sensitivity for the equipment being used. The smallest test pieces (e.g. Fe, Non Fe, SS, Glass) which can be consistently detected without a high level of false rejects. 4.3 Security O All foreign Body detection equipment must have adequate security devices, so only authorised personnel have access to alter settings. Compliance (Y/N add comments) Page 6 of 14

6 Section Clause No. 5 Detection Operation & Testing Requirements 5.1 Detector Verification (Checks) P R O Requirement P R O The supplier shall establish and implement documented procedures for the operation and testing of the metal detection or X-ray equipment. Test methods used shall be via defined methods (See Appendix 1 & Appendix 3 for methodology) or via methods derived from risk assessment and validation studies or as recommended by supplier. Compliance (Y/N add comments) Operational Test methods must ensure the following: Actual products must be used as test packs and represent the product going down the line (e.g. shape and density) The test packs must have passed through the detector before they are used to ensure that they do not contain foreign objects. The test packs must be clearly identified and at the same temperature as the standard products passing down the line. Where possible the worst case scenario packs should be used. The test pieces should be identified and be traceable to a definable standard with certification. Type of test pieces e.g. Sticks or cards can be used, the most appropriate for the product being tested should be chosen R O Memory Test: The objective of this test is to challenge the effectiveness of the reject system so that it does not blanket reject, (See Appendix 2 for methodology). The test packs used in the validation of the detector must be representative of the products going down the line (e.g. shape and density). Actual products shall be used as test packs. The test packs must have passed through the detector before they are used to ensure that they do not contain foreign objects. The test packs must be clearly identified and at the same temperature as the standard products passing down the line. Where possible the worst case scenario packs should be used. The test pieces should identified and be traceable to a definable standard with certification. Sticks or cards can be used, the most appropriate for the product being tested should be chosen. Page 7 of 14

7 5.2 Detector Failure P R O The foreign body detector must be fully operational at the start of production. An effective testing method must be in place. Testing and calibration of the detection equipment must be carried out at a regular nominated frequency. Detectors must be checked, as a minimum; at the beginning of production, at a risk assessed frequency during production (as documented in the HACCP plan), after any interruptions at the end of production (of Woolworths products) Any deviation from the above must be agreed in writing with the Woolworths Quality Specialist P R O All checks on the metal detection/x-ray inspection system must be recorded and signed by the trained individual 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, as per HACCP plan and end of production. Test piece size and type (e.g. Fe, Non Fe, SS, glass). Number of rejects. Fail safe checks (where applicable). Corrective actions for any failed checks. Investigation on any rejected product from production. Conformation of metal checks should be recorded as Pass/P or Fail/F. Ticks and dashes must be avoided P R O Procedures must be documented and implemented which specify corrective action in the event of machine failure (whether due to failure to detect a test piece or failure to reject product). All staff with operational access to the machinery must be trained in these procedures. Any test piece which fails to be detected or fully rejected is considered to be a failed test. The line must be stopped (where possible) and product isolated from the last good check. All material that has been checked since the previous satisfactory test must be isolated and retested through a unit that has been confirmed to be working correctly. The equipment must be fixed by a trained member of staff or qualified engineer prior to production restarting. The re-testing of product which has been isolated after a test failure must be documented on the metal detection/x-ray records. Page 8 of 14

8 5.3 Rejected Product P R If product is rejected it must be investigated for contamination. Post investigation if the product is temperature controlled or delicate it should be disposed of due to the risk of temperature abuse. If multiple rejections are observed the line should be stopped for investigation as to whether there is a product issue or is it a machine malfunction. Where there are multiple rejects off a line, the line should be stopped for investigation. If a combined metal detection/check weighing system is used, the system must be set up so that the metal detector rejection overrides the weight rejection if the two occur together P R Ideally all rejected product should be disposed of, however if there is a high level of rejected product it should be successfully passed through the metal detector 3 times in DIFFERENT ORIENTATIONS. If it fails on one of these occasions it should be investigated for metal contamination and disposed. If the product passes 3 times it can be accepted, but the reason for the high level of false rejections must be investigated. 5.4 Training R O All staff involved with foreign body detection systems must have documented training not only in the technical and operational aspects of the detector being used but also in the principles of foreign body detection to ensure a full understanding of the purpose of the tests being carried out. Page 9 of 14

9 Appendix 1 The test shall be representative of how products would normally travel through the detector (same speed and spacing between packs). The test piece shall pass through the detector as close to the centre of the aperture within the test pack. A) All 3 test packs (Ferrous, Nonferrous and Stainless Steel) should pass through the detector one after each other with normal spacing/line speed. The line should be running and the test packs introduced in the places of 3 un-inspected packs where possible. Page 10 of 14

10 B) Consecutive leading and trailing edge checks shall be completed in long (>100mm) packs to ensure that rejection mechanisms can successfully reject. Page 11 of 14

11 C) For Ferrous in Foil Detectors two test packs are required including two ferrous test pieces of the same size. Page 12 of 14

12 Appendix 2 Product Testing - Memory Test The test piece shall pass through the detector as close to the centre of the aperture within the test pack. The test shall be representative of how products would normally travel through the detector (same speed and spacing between packs). The test packs must be sent through the metal detector with a standard pack in between (which has already passed through the metal detector). This must be carried out at the start and should be carried out at the end of a shift and be documented. The objective of the test is to challenge the effectiveness of the reject system so that it does not blanket reject. It is a failed test if any of the test packs are not rejected. If a standard pack is rejected the line must be stopped and the issue should be investigated e.g. timing of reject mechanism. (STD) (STD) DETECTOR HEAD If a machine struggles to not reject good packs, advice should be sought from the equipment manufacturer. The capability of the machine may be dependent on the line speed. If the system is not capable of complying with this requirement, documentary evidence is required from the equipment manufacturer. Agreement to not conduct the test is required from Woolworths Quality Specialist. If a site wishes to combine the consecutive and memory test into one test, the procedure below is recommended: (STD) (STD) DETECTOR HEAD Page 13 of 14

13 Appendix 3 Test pieces should ideally be placed in the product flow and successful rejection observed. In instances where placing a test piece in the product flow is not practical, the system may be tested by inserting test pieces between the pipeline and the detection head (in the direction of product flow) and observing the reject mechanism. Page 14 of 14

14 Amendments 1. Introduction & Objective No change 2. Risk Assessment & General Requirements Removed requirement for Risk Assessment to be signed off by Quality Specialist 3. Location No change Criteria for establishing best practice moved to Section Alternative measures for beverages included. 4. Sensitivity Criteria for best practice moved from Section Detection Operation & Testing Requirements Added clarification to requirements for documented procedures and test methods Added clarification for foreign body detector checks and regular testing and calibration Appendix 1 Appendix 2 Appendix 3 No change No change No change Page 15 of 14