High Hygiene Category BRC internal Audit (Section 5) Version 6

5.1 Product development Documented product development or modification procedures shall be in place to ensure the production of safe and legal products to defined quality parameters.

5.1.1 Customer requirements relating to the design,development, specification, manufacture, and distribution of the product shall be documented and agreed with the customer. <br>This shall take into consideration process requirements and end use, when possible.<br>Any critical-use parameters shall be identified and defined; for example, barrier requirements, max/min use temperature, machine running, use of recycled materials, and testing requirements ( including migration, where relevant).<br>Special attention shall be paid to any materials that are required or requested to be manufactured from recycled materials, to ensure that they are both appropriate and legal.

5.1.2 The site shall clearly define and document when production trial is required. <br> The site shall determine the outputs and success criteria required from a production trial, and any changes and/or additions made to materials, processing characteristics or equipment as a result of the trial. <br> <br>Where appropriate, production trials shall be carried out and testing shall validate that manufacturing processes are capable of producing a safe and legal product to defined quality parameters. New products or product changes shall be subject to suitable evaluation to ensure that required safety and quality parameters can be achieved.

5.1.3 The company shall ensure that production is carried out using defined operating conditions which result in safe and legal products to defined quality parameters.

5.1.4 Where required by the customer, a technical product specification shall be prepared and, where possible, agreed with the customer or brand owner before the production process begins

5.1.5 Samples as agreed with the specifier shall be retained for future reference

5.1.6 A documented procedure shall be in place to address the transfer of customer specifications or requirements to the site's own systems. This shall include (but is not limited to): <br> <br>1) validation of accuracy of data transferred. <br>2) how changes to customer specifications are updated and communicated <br>3) how the agreed requirements for customers testing methods are met. <br>4) evaluation of how changes made to the customer specifications affect the technical product specification (see clause 5.1.1). <br> <br>Settings derived from successfully conducted production trials or equipment installations shall be transferred accurately to process control documentation

5.2 Graphic design and artwork control<br>Artwork and all pre-press processes conducted by the site shall be managed to ensure loss of information and variation from customer specification is eliminated.

5.2.1 The site shall have a documented artwork management procedure covering the activities for which the site has responsibility. This may include, but is not limited to:<br>1) collation of information to be included into artwork<br>2) receipt of artwork files from the customer<br>3) verification of completed artwork and approval by the customer<br>

5.2.2 A process shall be in place to seek formal acceptance and approval of final product concepts and artworks by the specifier.<br>The outcome shall be documented.<br>

5.2.3 Where appropriate, print trials shall be carried out and testing shall validate that the agreed product quality and print standards can be consistently achieved.

5.2.4 Printing equipment such as plates, silk screens, anilox rollers, cylinders, and blankets shall be verified as being correct to specification and artwork version or agreed master prior to use, and fully traceable to the customer's approved origination materials.

5.2.5 Customer -approved reference material, including artwork masters and color standards used during print runs, shall be controlled to ensure minimization of degradation and shall be returned to appropriate storage after use. <br> <br> The site shall have a policy to address requirements for renewal of approved masters, as necessary.

5.2.6 The site shall have a documented procedure for managing changes to artwork and print specifications to manage obsolete artwork and printing materials.<br>

5.2.7 Where artwork files and approved masters are in electronic form, these shall be suitably protected to prevent loss or malicious intervention.

5.3 Packaging Print Control<br>Where packaging materials are printed or decorated, documented procedures shall be in place to ensure that the information is fully legible and correctly reproduced to customer specification and complies with any legal requirements

5.3.1 An assessment shall be carried out of the pre-press activity, print process and handling of printed packaging (product) to identify:<br>1) risks of loss of essential information<br>2) mixing of printed product<br>Controls shall be established and implemented to reduce the risks identified.

5.3.2 Printing plates, cylinders, cutting dies, print blankets, and any other printing equipment shall be appropriately stored to minimize damage.

5.3.3 Each print run shall be approved against the agreed standard ( or master sample). This shall be recorded

5.3.4 a system shall be in place to detect and identify printing errors during the run and to sort these errors from the acceptable printed material.

5.3.5 Where composite print is used ( a mixture of different designs printed together), a process shall be in place to ensure effective segregation of differing print variants.

5.3.6 Samples of printed packaging shall be retained together with production records for a period of time to be agreed with the customer/specifier/brand owner.

5.3.7 Any unused printed product shall be accounted for and either disposed of or identified and appropriately stored.

5.3.8 Lighting in print inspection cabinet and other means of print/color checking shall be agreed with the customer or conform to accepted industry standards.

5.4 Process Control<br>documented procedures shall be in place to ensure effective quality assurance of operations throughout the process.

5.4.1 The hazard and risk management team shall identify and record all potential product defects that are reasonably expected to occur at each step in relation to the product and process. The hazards considered shall include, where applicable: <br>1) product quality defects, 2) Defects that may have an impact on the functional integrity and performance of the final product in use. 3) defects which result in the production of products which are outside customer-specified quality parameters.

5.4.2 A review of the manufacturing and, where applicable, printing process shall identify manufacturing process control points that can prevent or limit the risk of producing products with quality defects.

5.4.3 For each manufacturing process control point, machine settings or process limits shall be established and documented-the process specification.

5.4.4 Where equipment settings are critical to the safety or legality of the product, changes to the equipment settings shall only be completed by trained and authorized staff. Where applicable, controls shall be password-protected or otherwise restricted.

5.4.5 A bill of materials and process specification (including manufacturing process control points) shall be available for each batch or lot during production

5.4.6 documented process checks shall be undertaken at start-up, following adjustments to equipment and periodically during production, to ensure products are consistently produced to the agreed quality specification

5.4.7 A documented clearance procedure shall be in place to ensure that at start-up the line is clear of all previous work and production documents.

5.4.8 In the event of changes to product composition, processing methods or equipment, the site shall, where appropriate, re-establish process characteristics and validate product data to ensure product safety, legality, and quality are achieved.

5.4.9 The documented line clearance procedure shall include: <br>1) the roles of persons involved in line clearance. 2) areas where materials can become trapped. 3) Validation of the line clearance. 4) sign-off for continuing production. The line clearance procedure shall be fully implemented for each production run.

5.5 Calibration and control of measuring and monitoring devices<br>The site shall be able to demonstrate that measuring and monitoring equipment is sufficiently accurate and reliable to provide confidence in measurement results

5.5.1 The site shall identify and control in-line and off-line measuring equipment used to monitor critical control points (where applicable) and product safety, quality, and legality. This shall include as a minimum:<br>1) A documented list of equipment and its location<br>2) An identification code and calibration due date<br>3) prevention from adjustment by unauthorized staff<br>4) protection from damage, deterioration and misuse.

5.5.2 All identified measuring equipment shall be checked and adjusted at a predetermined frequency, based on risk analysis. This shall be carried out by trained staff to a defined method to ensure accuracy within defined parameters. All results shall be documented. Where possible, calibration shall be traceable to a recognized national or international standard. where a traceable calibration is not possible, the site shall demonstrate the basis by which standardization is carried out.

5.5.3 Corrective action and reporting procedures shall be established and documented in the event of the monitoring and testing procedure identifying any failure of product inspection, testing or measuring equipment. Any such failures shall be subject to an assessment of potential risk; subsequent action may include a combination of isolation, quarantine, and re-inspection of products produced since the last acceptance test of the equipment. <br>The site shall conduct a root cause analysis into the equipment failure and implement the appropriate corrective action.

5.6 Product inspection, testing and measuring<br>The company shall undertake appropriate inspections and analyses that are critical to product safety, legality, integrity and quality.

5.6.1 Quality checks shall be carried out to demonstrate that the finished product is within the tolerances laid down in the agreed product specification and conforms to any critical technical/legal requirements. The frequency of checks and sampling shall be in accordance with industry-accepted practice or customer requirements and based on risk analysis <br>The site shall define how samples used for checking in-process quality are disposed of. This may be by returning to stock, regrinding/recycling, or segregation and disposal.

5.6.2 Hazard and risk analysis principles shall be used to determine the need for in-line product testing equipment to ensure product safety, quality, and legality.

5.6.3 The accuracy of in-line equipment shall be specified (with permitted tolerances), having due regard to the product parameter being controlled.<br>

5.6.4 The company shall establish, document, and implement procedures for the operation, routine monitoring and testing of all equipment used in product inspection, testing, and measurement. This shall include:<br>1) frequency and sensitivity of checks<br>2) authorization of trained personnel to carry out specified tasks<br>3) documentation of test results<br>

5.6.5 Routine off-line quality checks shall be carried out at appropriate stages in production to demonstrate that the product is within the tolerances laid down in the agreed product specification.<br>A system, which includes off-line or randomized quality checks, shall be in place to identify and remove non-conforming product for removal or divert it out of the product lot.

5.6.6 In-line testing equipment critical to product quality or safety shall incorporate a system to identify non-conforming product for removal or divert it out of the product flow.

5.6.7 Test methods, analytical methods and customer-approved reference samples(where required)shall be of the most recent version and be available in the laboratory or where off-line testing is conducted. Samples shall be suitably stored to avoid degradation.

5.6.8 The test methods used by the site in both on-line and off-line testing shall be validated to ensure their sensitivity, reproducible and range, in addition to any other relevant criteria. Where standardized tests are used, the site shall ensure prescribed methodologies are followed. Where testing shows out-of -specification results, a documented procedure for investigating these results shall be established and followed to determine whether the cause is non-conforming product or a testing failure.

5.6.9 Where automated inspection equipment (e.g. vision systems) is used to check print or other material features, the site shall establish and implement procedures for the operation and testing of the equipment to ensure that it is correctly set up and capable of alerting or rejecting the packaging when it is out of specification.<br>As a minimum, testing of the equipment shall be completed at:<br>• the start of the production run<br>• the end of the production run<br>• a frequency based on the site’s ability to identify, hold and prevent the release of any implicated materials should the equipment fail (e.g. during the production run or when changing batches of raw materials).<br>The site shall establish and implement procedures in the event of a failure in the equipment (e.g. a documented and trained manual checking procedure).<br>

5.6.10 Where the company undertakes or subcontracts an analysis critical to product safety or legality, the laboratory or subcontractors shall have gained recognized laboratory<br>accreditation or operate in accordance with the requirements and principles of ISO 17025 for the test undertaken (General requirements for the competence of testing and calibration laboratories). Documented justification shall be available where accredited methods are not undertaken.<br>The significance of the laboratory results shall be understood and acted upon accordingly.<br><br>

5.7 Control of non-conforming products<br>The site shall ensure that out-of-specification product is clearly identified and effectively managed to prevent unauthorized release

5.7.1 Clear procedures for the control of out-of-specification or non-conforming materials shall be in place, documented and understood by all personnel. These shall include the effective identification and management of materials before a decision has been made on their final disposition.

5.7.2 Non-conforming materials shall be assessed and a decision taken to reject, accept by concession, rework or put to alternative use. The decision and reasons shall be documented.

5.8 Incoming goods<br>The site shall ensure that incoming goods are appropriately checked for contents, packaging integrity, and potential contamination.

5.8.1 The site shall document a raw materials and intermediate product intake procedure to ensure that incoming goods match purchase or product specifications. This may take the form of:<br>1) Purchase orders<br>2) Delivery notes

5.8.2 There shall be a procedure for the inspection of loads on arrival to ensure that products are free from pest infestation, contamination or damage and are in a satisfactory condition.<br>Unloading areas for bulk deliveries shall be clearly identified and designed to prevent product mix-ups.<br>Regarding raw materials, all complaints or defects identified by the site shall be recorded and investigated (including root cause analysis) and the results of the investigation documented.<br>

5.8.3 The site shall have a procedure for the acceptance of raw materials. This may include a valid certificate of analysis (CoA) or testing.<br>All raw materials awaiting the results of in-house testing or verification of data shall be held until released for use.<br>

5.8.4 Receipt documents and/or product identification shall facilitate correct stock rotation of goods in storage and, where appropriate, ensure materials are used in the correct order and within the prescribed shelf life.

5.8.5 The site shall have a system in place to validate all raw materials and intermediate products prior to their introduction to the process.<br><br>

5.9 The handling, management, and storage of all materials and products shall minimize the risk of contamination or malicious intervention, and protect product safety, quality, legality.

5.9.1 Procedures to maintain product safety and quality during storage shall be risk-based, understood by the relevant staff, and implemented accordingly. They shall include, as appropriate:<br>• instructions for the packing of finished product<br>• segregation of products where necessary to avoid cross-contamination (physical, microbiological or allergenic), mixing of sorts, or taint<br>• storage of product/materials off the floor and away from walls<br>• specific handling or stacking requirements to prevent product damage.<br>

5.9.2 All materials, work in progress and finished product shall be properly identified and protected during storage by appropriate packaging to protect them from contamination.

5.9.3 Storage, including off-site storage, shall be controlled to protect the product from contamination, including taint or odor and malicious intervention. Where off-site storage is used, the same site standards requirements apply as for on-site storage.

5.9.4 Finished or intermediate product storage shall meet customer requirements (with regard to first in, first out (FIFO), where applicable), with dispatch after positive release.<br>Where external storage of finished product is required, the product shall be suitably protected.<br>

5.9.5 Packaging used for storage or dispatch of intermediate or finished products, such as pallets, shall be appropriately protected if stored outside and inspected for signs of damage or contamination prior to use.

5.9.6 In order to prevent contamination, documented procedures shall be in place to appropriately segregate raw materials, intermediate products, and finished products.

5.9.7 The site shall ensure that hazardous chemicals are handled in such a way that risk to product safety, quality and legality is minimized.

5.9.8 Material intended for recycling shall be appropriately protected against contamination hazards.

5.10 Dispatch and transport<br>The dispatch and transport of raw materials and finished products shall be undertaken in a manner that minimizes the risk of contamination or malicious intervention and maintains product safety, legality, and quality.

5.10.1 The company shall have procedures for the dispatch and transport of products, which shall include:<br>• any restrictions on the use of combined loads (e.g. where materials from other companies are in the same transport)<br>• requirements for the security of products during transit, particularly when vehicles are parked and unattended away from a designated storage depot.<br>

5.10.2 All products and materials shall be identified and either protected during distribution by appropriate external packaging or transported under conditions to protect the product form contamination. This shall include the risk of taint or odor and of malicious intervention.

5.10.3 All pallets shall be checked. Damaged, contaminated, or unacceptable pallets shall be discarded. Wooden pallets that come into direct contact with finished products or raw materials shall not be allowed to contaminate the product. Wooden pallets, if used shall be sound, dry, clean, and free from damage and contamination.

5.10.4 All company-owned vehicles used for deliveries shall be included in the documented cleaning schedules and kept clean and in a condition to minimize the risk of product contamination.

5.10.5 All delivery vehicles and shipping containers shall be subject to a documented hygiene-checking procedure before loading.

5.10.6 Where the company employs third-party contractors, there shall be a contract or agreed terms and conditions. All the requirements specified in this section shall be clearly defined in the contract or the company shall be certificated to the Global Standard for Storage and Distribution.<br>Where this is not possible, with general carriers, the packaging shall be adequate to protect the product against damage, contamination hazards, taint and odour.<br>

5.10.7 Vehicle drivers shall comply with the site rules relevant to this Standard.<br>Access to the site for third-party transport personnel shall be controlled and, where possible, facilities provided to negate the need to enter storage or production areas