Title Page
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Conducted on
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Prepared by
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Location
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Auditor's signature : I agree with the audit findings
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Auditee's name
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Auditee's Job title
5.6 Product inspection, on-site product testing and laboratory analysis
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SOI<br>The company shall undertake or subcontract inspection and analyses which are critical to confirm product safety, authenticity, legality and quality, using appropriate procedures, facilities and standards.
5.6.1 Scheduled programme of product testing
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There shall be a scheduled programme of product testing which may include microbiological, chemical, physical and organoleptic testing according to risk.
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The methods, processes for obtaining product samples (including, where appropriate, their delivery to a laboratory), frequency and specified limits shall be documented.
5.6.2 Test and inspection results
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Test and inspection results shall be recorded and reviewed regularly to identify trends.
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The significance of on-site and laboratory results shall be understood and acted upon accordingly.
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Appropriate actions shall be implemented promptly to address any unsatisfactory results or trends.
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Where legal limits apply, these shall be understood and appropriate action taken promptly to address any exceedance of these limits.
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Where applicable, the measurement uncertainty associated with laboratory test results shall be considered.
5.6.3 Validation and ongoing verification of the shelf life
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The site shall ensure that a system of validation and ongoing verification of the shelf life is in place.
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This shall be based on risk and shall include sensory analysis and, as applicable, microbiological testing and relevant chemical factors such as pH and aw.
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Records and results from shelf-life tests shall verify the shelf-life period indicated on the product.
5.6.4 Pathogen testing
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Pathogen testing (including pathogens tested as part of the site’s environmental monitoring programme) shall be subcontracted to an external laboratory or, where conducted internally, the laboratory facility shall be fully segregated from the production and storage areas and have operating procedures to prevent any risk of contamination of products or production areas.
5.6.5 Testing laboratories are present on site
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Do you have testing laboratories are present on site?
- Yes, testing laboratories are present on site
- No. Testing laboratories are NOT present on site
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Where testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety. Controls shall be documented and implemented, and include consideration of:
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operating procedures to contain laboratory activities, including the design and operation of drainage and ventilation systems
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access and security of the facility
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movement of laboratory personnel
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hygiene and protective clothing arrangements
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movement of materials that may pose a risk to products, raw materials or the production area, into and out of the laboratory, including the disposal of laboratory waste
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the management and monitoring of laboratory equipment.
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Where testing activities are performed in production or storage areas (e.g. at the line tests or rapid tests), these shall be located, designed and operated to prevent product contamination.
5.6.6 Laboratory accreditation
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Where the company undertakes or subcontracts analyses which are critical to product safety, authenticity or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO/IEC 17025, including proficiency testing where applicable.
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Documented justification shall be available where accredited methods are not undertaken.
5.6.7 Reliability of non accredited test results
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Does site obtain test results through non accredited methods?
- No, all testing methods are accredited
- Yes, non accredited testing methods are used
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Procedures shall be in place to ensure reliability of laboratory results, other than those critical to safety and legality specified in clause 5.6.6. These shall include:
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use of recognised test methods, where available
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documented testing procedures
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ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required
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use of a system to verify the accuracy of test results (e.g. proficiency testing where applicable)
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use of appropriately calibrated and maintained equipment.
5.7 Product release
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SOI<br>The site shall ensure that finished product is not released unless all agreed procedures have been followed.<br><br>5.7.1<br>Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and the release has been authorised.
