Title Page
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Auditee's signature : I agree with the audit findings
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SOI<br>The risk of product contamination shall be reduced or eliminated by the effective use of equipment to remove or detect foreign bodies
4.10.1 Selection and operation of foreign-body detection and removal equipment
4.10.1.1 documented assessment in association with the food safety plan (see section 2 – The food safety plan)
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A documented assessment in association with the food safety plan (see section 2 – The food safety plan) shall be carried out on each production process to identify the potential use of equipment to detect or remove foreign-body contamination.
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Typical equipment to be considered may include:
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filters and sieves
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metal detection and X-ray detection equipment
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magnets
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optical sorting equipment
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other physical separation equipment (e.g. gravity separation, fluid bed technology).
4.10.1.2 Type, location and sensitivity of the detection and/or removal method
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The type, location and sensitivity of the detection and/or removal method shall be specified as part of the site’s documented system.
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Industry best practice shall be applied with regard to the nature of the ingredient, material, product and/or packed product.
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The location of the equipment or any other factors influencing the sensitivity of the equipment shall be validated and justified.
4.10.1.3 Frequency of the testing of the foreign-body detection and/or removal equipment
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The site shall ensure that the frequency of the testing of the foreign-body detection and/or removal equipment is defined and takes into consideration:
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a) specific customer requirements
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b) the site’s ability to identify, hold and prevent the release <br>of any affected materials, should the equipment fail.
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The site shall establish and implement corrective action and reporting procedures in the event of a failure of the foreign-body detector and/or removal equipment.
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Action shall include a combination of isolation, quarantining and re-inspection of all products produced since the last successful test or inspection.
4.10.1.4 Detected foreign material
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Where foreign material is detected or removed by the equipment, the source of any unexpected material shall be investigated.
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Information on rejected materials shall be used to identify trends and, where possible, instigate preventive action to reduce the occurrence of contamination by the foreign material.
4.10.2 Filters and sieves
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Does the site use filters and sieves?
- Yes, these items are used by the site
- No, these items are NOT used by the site
4.10.2.1 Mesh size or gauge
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Filters and sieves used for foreign-body control shall be of a specified mesh size or gauge and designed to provide the maximum practical protection for the product.
4.10.2.2 Inspections of Filters and sieves
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Filters and sieves shall be regularly inspected or tested for damage at a documented frequency based on risk.
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Records shall be maintained of the checks.
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Where defective filters or sieves are identified, this shall be recorded and the potential for contamination of products investigated and appropriate action taken.
4.10.3 Metal detectors and X-ray equipment
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Does the site use Metal detectors or X-ray equipment
- Yes, these items are used by the site
- No, these items are NOT used by the site
4.10.3.2 The metal detector or X-ray equipment shall incorporate one of the following:
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an automatic rejection device, for continuous in-line systems, which shall divert contaminated product either out of the product flow or to a secure unit accessible only to authorised personnel
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a belt stop system with an alarm where the product cannot be automatically rejected (e.g. for very large packs)
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in-line detectors which identify the location of the contaminant to allow effective segregation of the affected product.
4.10.3.3 Procedures for the operation and testing of the metal detection or X-ray equipment.
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The site shall establish and implement procedures for the operation and testing of the metal detection or X-ray equipment. This shall include, at a minimum:
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responsibilities for the testing of equipment
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the operating effectiveness and sensitivity of the equipment and any variation to this for particular products
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the methods and frequency of checking the detector
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recording of the results of checks.
4.10.3.4 Metal detector testing procedures: minimum requirements
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use of test pieces incorporating a sphere of metal of a known diameter selected on the basis of risk. The test pieces shall be marked with the size and type of test material contained
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tests carried out using separate test pieces containing ferrous metal, stainless steel and typically non-ferrous metal, unless the product is within a foil container where a ferrous-only test may be applicable
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a test to prove that both the detection and rejection mechanisms are working effectively under normal working conditions
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tests of the metal detector by passing successive test packs through the unit at typical line operating speed
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checks of failsafe systems fitted to the detection and rejection systems.
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In addition, where metal detectors are incorporated on conveyors, the test piece shall be passed as close as possible to the least sensitive area of the metal detector (usually the centre of the metal detector aperture). Wherever possible, the test piece shall be inserted within a clearly identified sample pack of the food being produced at the time of the test.
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Where in-line metal detectors are used, the test piece shall be placed in the product flow wherever this is possible, and the correct timing of the rejection system to remove identified contamination shall be validated. Testing of in-line metal detectors shall be completed during both line start-up and at the end of the production period.
4.10.3.5 Minimum requirements for X-Ray testing procedures
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use of test pieces incorporating a sphere of suitable material (e.g. a typical contaminant) of a known diameter selected on the basis of risk. The test pieces shall be marked with the size and type of test material contained
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tests carried out using separate test pieces
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a test to prove that both the detection and rejection mechanisms are working effectively under normal working conditions
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tests of the X-ray equipment by passing successive test packs through the unit at typical line operating speed
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checks of failsafe systems fitted to the detection and rejection systems.
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In addition, where X-ray equipment is incorporated on conveyors, the test piece shall be passed as close as possible to the least sensitive area of the X-ray equipment (e.g. this may be close to the X-ray source or close to the X-ray equipment). Wherever possible, the test piece shall be inserted into a clearly identified sample pack of the food being produced at the time of the test.
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Where in-line X-ray equipment is used, the test piece shall be placed in the product flow wherever this is possible, and the correct timing of the rejection system to remove identified contamination shall be validated. Testing of in-line equipment shall be completed both during line start-up and at the end of the production period.
4.10.3.1 Justification for lack of Metal detectors or X-Ray equipment
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Metal detection equipment shall be in place unless risk assessment demonstrates that this does not improve food safety. Where metal detectors are not used, justification shall be documented. The absence of metal detection would only normally be based on the use of an alternative, more effective method of protection (e.g. use of X-ray, fine sieves or filtration of products).
4.10.4 Magnets
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Does the site have magnets in place?
- Yes, these items are used by the site
- No, these items are NOT used by the site
4.10.4.1 requirements for magnets
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The type, location and strength of magnets shall be fully documented.
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Procedures shall be in place for the inspection, cleaning, strength testing and integrity checks of magnets used for food safety purposes, including final product testing, e.g. to remove product contamination.
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Records of all checks shall be maintained.
4.10.5 Optical sorting equipment
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Does the site use optical sorting equipment
- Yes, these items are used by the site
- No, these items are NOT used by the site
4.10.5.1 Optical sorting equipment requirements
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Optical sorting equipment used for final product testing shall be checked in accordance with the manufacturer’s instructions or recommendations.
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Checks shall be documented.
4.10.6 Container cleanliness – glass jars, cans and other rigid containers
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A rigid container is generally any container that is inflexible and would break into separate pieces (i.e. small fragments) if pressure was applied, which could subsequently be a foreign-body hazard. These containers are normally manufactured from glass, metal or inflexible plastics or ceramics, although other materials may be used. DOES THE SITE USE THESE TYPE OF ITEMS?
- Yes, these items are used by the site
- No, these items are NOT used by the site
4.10.6.1 Procedures to minimise foreign-body contamination originating from the packaging container
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Based on risk assessment, procedures shall be implemented to minimise foreign-body contamination originating from the packaging container (e.g. jars, cans and other pre-formed rigid containers).
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This may include the use of covered conveyors, container inversion and foreign-body removal through rinsing with water or air jets.
4.10.6.2 Effectiveness of the container-cleaning equipment
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The effectiveness of the container-cleaning equipment shall be checked and recorded during each production.
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Where the system incorporates a rejection system for dirty or damaged containers, the check shall incorporate a test of both the detection and effective rejection of the test container.
4.10.7 Other foreign-body detection and removal equipment
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Does the site have other foreign-body detection and removal equipment, such as gravity separation, fluid bed technology or aspirators
- Yes, these items are used by the site
- No, these items are NOT used by the site
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Other foreign-body detection and removal equipment, such as gravity separation, fluid bed technology or aspirators, shall be checked in accordance with the manufacturer’s instructions or recommendations.
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Checks shall be documented.
