BRC GLOBAL STANDARDS SELF-ASSESSMENT TOOL Welcome to the BRC Global Standards Self-Assessment tool We hope that you will find this useful when preparing your site for an audit against the BRC/IOP Global Standard for Packaging and Packaging Materials issue 4. This tool will be applicable for all BRC/IOP Global Standard for Packaging and Packaging Materials issue 4 audits. How to use the BRC Global Standards Self-Assessment tool This tool is designed to help you assess your operation against the requirements of the Standard and help prepare you for your certification audit. The checklist covers each of the requirements of the Standard and may be used to check your site’s compliance with each of these requirements. The checklist also allows you to add comments or identify areas of improvement in the empty boxes provided at the end of each section. While we hope that this tool is useful in helping you prepare for your audit it should not be considered as evidence of an internal audit and will not be accepted by auditors during an audit. Training The BRC Training Academy has courses available to improve the understanding of the requirements for the BRC/IOP Global Standard for Packaging and Packaging Materials issue 4 and may be useful for the person using the BRC Global Standards Self-Assessment Tool. For further information on the courses available please visit www.brctrainingacademy.com Further Information If you have any further questions about the BRC Global Standards Self-Assessment Tool or the BRC Global Standard for issue 4 please do not hesitate to contact the BRC Global Standards team Email – brcglobalstandards@brc.org.uk Telephone – 020 7854 8939 Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 1 Senior Management Commitment and Continual Improvement 1.1 Product safety and quality management policy Requirement No REQUIREMENT Statement of Intent The senior management shall commit the company to producing products to the specified quality and which are safe and legally compliant. 1.1.1 The policy shall state the company’s intention to meet its obligation to produce safe and legally compliant products to the specified quality, and its responsibility to its customers. This shall include the commitment for review and continuous improvement. 1.1.2 The company’s senior management shall ensure the policy is communicated to all staff involved with activities relating to product safety, legality, regulatory compliance and quality Conforms Comments/Actions 1.2 Senior management commitment FUNDAMENTAL The company’s senior management shall demonstrate that they are fully committed to the implementation of requirements of the Global Standard for Packaging & Packaging Materials. This shall include provision of adequate resources, effective communication and systems of management review to effect continual improvement. Opportunities for improvement shall be identified, implemented and fully documented. Statement of Intent 1.2.1 The company’s senior management shall ensure that product safety and quality objectives are measurable, established, documented, monitored and reviewed. 1.2.2 The company’s senior management shall have a system in place to ensure that the company is kept informed of all relevant legislative, PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page2 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool scientific and technical developments, and industry codes of practice applicable in the country of manufacture and, where known, the country in which the packaging material will be sold. 1.2.3 The company shall ensure that the materials manufactured comply with the relevant legislation (including any legislation concerning the use of recycled content) in the country of manufacture and in which the products are intended to be sold and/or ultimately used, where known. 1.2.4 The company’s senior management shall ensure that non-conformities identified at the previous audit against the Standard are effectively actioned. 1.2.5 The company shall have a current, original copy of the Standard available on site. 1.2.6 Where the company is certificated to the Standard they shall ensure that recertification audits occur on or before the audit due date indicted on the certificate. Comments/Actions 1.3 Organisational structure, responsibilities and management authority Statement of Intent The organisational structure shall be clear, with defined responsibilities, and key staff shall be aware of their responsibilities with regard to packaging safety and quality. 1.3.1 The company shall have an up-to-date organisation chart demonstrating the structure of the company. 1.3.2 Within the management team there shall be a designated competent manager and deputy with the responsibility for coordinating compliance with the Standard. 1.4 Management review PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page3 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool Statement of Intent Opportunities for continuous improvement of the product safety and quality programme shall be identified and effectively implemented through management reviews of the product safety system and results. 1.4.1 The review process shall be undertaken at appropriate planned intervals, as a minimum annually. 1.4.2 The review process shall include the evaluation of: 1.4.3 2 previous management review documents and action plans internal, second-party and third-party audits customer performance indicators, complaints and feedback incidents, corrective actions, out-of-specification results and nonconforming materials resource requirements. Records of management reviews and action plans shall be documented. Hazard and Risk Management System 2.1 Hazard and risk management team Statement of Intent The hazard and risk management system shall be managed by a multidisciplinary team competent in hazard and risk analysis. 2.1.1 The multidisciplinary team shall have a designated team leader who shall be able to demonstrate competence and experience of hazard and risk analysis. In the event that the company does not have the appropriate expertise inhouse, external expertise shall be sought and used to develop and review the hazard and risk management system. However, the day-to-day management shall remain the responsibility of the company. Comments/Actions PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page4 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 2.2 Hazard and risk analysis FUNDAMENTAL The company shall establish the effectiveness of its prerequisite programmes through a hazard and risk analysis and identify and implement any further risks to the safety and legality of products. Statement of Intent 2.2.1 The scope of the hazard and risk analysis shall be clearly defined and shall cover all products and processes included within the intended scope of certification. 2.2.2 The hazard and risk analysis team shall maintain awareness of and take into account: historical and known hazards associated with specific processes, raw materials or end use of the product relevant codes of practice or recognised guidelines legislative requirements. 2.2.3 A full description of the packaging produced by product or product group and its intended use shall be documented. 2.2.4 A process flow diagram shall be prepared for each product, product group or process. This shall include each process step from the receipt of raw materials to dispatch to the customer. The process flow shall as a guide include, as relevant: receipt and approval of art work receipt and preparation of raw materials such as additives, inks and adhesives each manufacturing process step the use of rework and post-consumer recycled materials any subcontracted operations customer returns. The accuracy of the process flow shall be verified by the hazard and risk analysis team. 2.2.5 The hazard and risk analysis team shall identify and record all potential hazards that are reasonably expected to occur at each step in relation to the product and process. The hazards considered shall include, where relevant: PO49 Issue 1 Revision 1 Released 17/2/2012 First issue foreign objects chemical contamination (e.g. taint, odour, allergen, component transfer from inks, varnishes and glues) Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page5 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool hazards that may have an impact on the functionality of the final product in use. 2.2.6 The hazard and risk analysis team shall identify control measures necessary to prevent, eliminate or reduce each hazard to acceptable levels. 2.2.7 For each hazard that requires control, the control points shall be reviewed to evaluate if existing prerequisites are effective in providing control. Where greater controls are required to the prerequisite programmes, improvements shall be implemented to ensure control is achieved. 2.2.8 A review of the hazard and risk management system shall be carried out at least once per year and following any significant incidents or when any process changes. The review shall include a verification that the hazard and risk analysis plan is effective and may include a review of: complaints product failures recalls product withdrawals results of internal audits of prerequisite programmes results from external third-party auditors. Comments/Actions 2.3 Exemption of requirements based on risk analysis 2.3.1 The hazard and risk analysis study shall be fully supported by the implementation of the prerequisites set out in requirements clauses 4 to 6. However, the hazard and risk analysis may indicate that some of the requirements are not applicable. These shall be documented and regarded as proposed exemptions for review at audit. Acceptance or rejection of the proposed exemptions shall be recorded in the auditor’s report. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page6 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 2.3.2 The company shall keep recorded exemptions to the Standard under review and provide documented evidence of this review at subsequent audit. Comments/Actions 3. Product Safety and Quality Management System 3.1 Product safety and quality manual Statement of Intent The company shall have a manual which describes how the requirements of the Standard are met. These requirements shall be fully implemented, reviewed at appropriate planned intervals and improved where necessary. 3.1.1 The product safety and quality manual shall contain an outline of working methods and practices or references to where such an outline is documented. 3.1.2 The manual or relevant components shall be readily available to key staff. Comments/Actions 3.2 Customer focus and contract review Statement of Intent The company shall ensure that customer needs and expectation with respect to quality and safety are identified and met, and that communication channels are clear. 3.2.1 Customer requirements relating to the design, development, specification, manufacture and distribution of the product shall have been agreed with the customer and where appropriate documented and agreed prior to PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page7 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool order fulfilment. Comments/Actions 3.3 Internal audits FUNDAMENTAL The company shall establish through a programme of internal audits that the implementation of the requirements of the Standard are in place, appropriate and complied with. Statement of Intent 3.3.1 Internal audits shall be planned and their scope and frequency shall be established in relation to the risks associated with the activity. Audits shall be scheduled so that all aspects of the Standard are audited at least annually. 3.3.2 Audits shall be conducted by personnel who are competent, and sufficiently independent from the department being audited to ensure impartiality. 3.3.3 Deficiencies and details of non-conformities shall be notified to appropriate supervisory staff and corrective action implemented within a specified and appropriate time period. 3.3.4 The completion of corrective action shall be recorded and verified. 3.3.5 Conformity as well as non-conformity shall be clearly identified and verified within the internal audit report. Comments/Actions 3.4 Supplier approval and performance monitoring Statement of Intent The company shall ensure that suppliers of goods and services are operating in a manner that ensures that product quality and safety is not compromised and specifications can be achieved. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page8 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 3.4.1 The company shall have a documented supplier approval procedure and continual assessment programme in place, based upon risk analysis. 3.4.2 The procedures shall include clear criteria for the assessment and approval of new suppliers. Assessment may take the form of: supplier audits supplier certification with a scope covering the products supplied e.g. against the appropriate BRC Global Standard supplier questionnaires. 3.4.3 Records of supplier assessment and necessary actions shall be maintained and reviewed. 3.4.4 The company shall define how exceptions are handled, e.g. the use of products or services where assessment or approval has not been undertaken. Assessment may take the form (on a batch or delivery basis) of: certificate of analysis declaration of compliance. Comments/Actions 3.5 Subcontracting of production Statement of Intent Subcontractors shall be effectively managed to prevent any risk of contamination or damage and ensure product is produced to specification. 3.5.1 The use of subcontractors and the status of the subcontractor with respect to the Standard shall be notified to the brand owner and/or customer. 3.5.2 Suppliers of subcontracted services shall be approved in accordance with the procedures in clause 3.4. 3.5.3 Where any production processes are subcontracted, the risks to the quality and safety of the product shall be assessed. Any risks shall be communicated to relevant personnel and effectively managed. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page9 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 3.5.4 Clear specifications shall be agreed for all work outsourced to a subcontractor. Controls shall be in place for checks on finished work to ensure the safety and quality meets specification. Comments/Actions 3.6 Documentation control Statement of Intent Documentation essential to the management and control of product safety, legality and quality shall be relevant, controlled and available, as the correct version, to the appropriate personnel. 3.6.1 Documents shall be sufficiently detailed to enable their correct application by appropriate personnel. They shall be readily accessible to relevant staff at all times. 3.6.2 All changes and amendments to documents critical to product safety, legality or quality system procedures shall be authorised, recorded, and obsolete documentation shall be removed, archived and replaced with the current version. Comments/Actions Specifications 3.7 FUNDAMENTAL Statement of Intent Appropriate specifications shall exist for raw materials, intermediate and finished products, and any product or service that could affect the integrity of the finished product. 3.7.1 Specifications shall be suitably detailed, accurate and shall ensure compliance with relevant product safety and legislative requirements. 3.7.2 The company shall seek formal agreement of specifications with relevant parties. Where specifications are not formally agreed then the company PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page10 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool shall be able to demonstrate that they have taken steps to put an agreement in place. 3.7.3 Trademarks for application on packaging materials shall, where appropriate, be formally agreed between relevant parties. Comments/Actions 3.8 Record keeping Statement of Intent The company shall maintain records to demonstrate the effective control of product safety, legality and quality. 3.8.1 The records shall be legible, genuine, appropriately authorised and retained in good condition for an appropriate defined time period. Comments/Actions Traceability 3.9 FUNDAMENTAL Statement of Intent The company shall have a system in place to identify product batches and to trace and follow all raw materials through processing to the distribution of the finished product to the customer. Records shall be retrievable in a timely manner. 3.9.1 An appropriate system shall be in place to ensure that the customer can identify a product or production lot number for the product for the purposes of traceability. 3.9.2 The system shall be tested to ensure traceability can be determined from raw materials to the finished product and vice versa. This test shall take place at least annually. Comments/Actions PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page11 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 3.10 Complaint handling Statement of Intent All complaints made by customers and consumers shall be recorded and investigated. Corrective actions where required shall be implemented and recorded. 3.10.1 Actions appropriate to the seriousness and frequency of the problems identified shall be carried out promptly and effectively by appropriately trained staff. Comments/Actions 3.11 Management of incidents, product withdrawals and recalls Statement of Intent The company shall have a plan and systems in place to effectively manage incidents and if required the withdrawal or recall of products, in order to ensure that all potential risks to the quality and hygiene and legality of products are controlled. 3.11.1 The company shall provide written guidance and training for relevant staff regarding the type of event that would constitute an incident. A documented incident reporting procedure shall be in place. 3.11.2 The company shall effectively manage the incident to prevent release of product where safety or quality may have been affected. 3.11.3 A product withdrawal/recall procedure shall be documented, practical to implement and regularly reviewed. This shall include as a minimum: PO49 Issue 1 Revision 1 Released 17/2/2012 First issue identification of the key personnel involved in assessing potential withdrawal/recall incidents with clear identified responsibilities a communications plan including methods of informing customers and, where necessary, regulatory bodies in a timely manner corrective action and business recovery Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page12 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 3.11.4 review of any withdrawals or recalls to implement appropriate improvements as required. The product withdrawal/recall procedure shall be tested on at least an annual basis and used to evaluate the procedure and implement improvement. Comments/Actions 4. Site Standards 4.1 External standards Statement of Intent All grounds within the site shall be finished and maintained to an appropriate standard. 4.1.1 Consideration shall be given to local activities and the site environment which may have an adverse impact on the integrity of the finished product. Measures shall be taken to prevent contamination. 4.1.2 The external areas shall be maintained in good order. Grounds shall be regularly tended and well maintained and potential pest-harbouring areas shall be identified and monitored. 4.1.3 The building fabric shall be maintained to minimise potential for pest entry, ingress of water and other contaminants. External silos, pipe work or other access points for the product and/or raw materials shall be appropriately sealed and secured. 4.1.4 Where natural drainage is inadequate, external drainage shall be installed. Drains shall be properly protected to prevent entry of pests. 4.1.5 External traffic routes, under site control, shall be maintained in good repair to avoid contamination of the product. 4.1.6 Where external storage of raw materials is necessary these shall be protected from contamination as required. Comments/Actions PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page13 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool Building fabric Raw material handling, preparation, processing, packing and storage areas 4.2 Statement of Intent The internal site, buildings and facilities shall be suitable for the intended purpose. All utilities to and within the production and storage areas shall be designed, constructed, maintained and monitored to effectively control the risk of product contamination. 4.2.1 Walls, floors, ceilings (including suspended ceilings) and pipe work shall be maintained in good condition and shall facilitate cleaning. 4.2.2 Suitable and sufficient lighting shall be provided for a safe working environment, correct operation of processes, effective inspection of the product and cleaning. 4.2.3 Potential sources for the ingress of pests, such as drain openings or windows opened for ventilation, shall be suitably pest proofed. 4.2.4 Where they pose a risk to the product, glass windows shall be protected against breakage. 4.2.5 Suitable and sufficient ventilation shall be provided. Comments/Actions 4.3 Utilities Statement of Intent Product cleanliness and integrity shall not be compromised by the location, construction and delivery of the utilities to and within the production and storage areas. 4.3.1 All water used in the processing of the products or equipment cleaning shall be potable or suitably treated to prevent contamination. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page14 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 4.3.2 Air, compressed air or other gases that come into direct contact with the packaging shall present no risk to product safety or quality and comply with any relevant legal regulations. Comments/Actions 4.4 Security Statement of Intent Product and process integrity shall be assured through appropriate site security provision. 4.4.1 Based on risk assessment, a procedure shall be in place to address the security of the site and products and establish, implement and maintain a system to reduce or eliminate the identified risk. 4.4.2 Access to the site by employees, contractors and visitors shall be controlled, through designated entrances, and a visitor reporting system shall be in place. 4.4.3 Staff shall be trained in site security procedures and encouraged to report or challenge unidentified or unknown visitors. 4.4.4 Contractors involved in maintenance or repair shall be supervised by a qualified person, and a nominated staff member shall be responsible for their activities. 4.4.5 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. 4.4.6 Site IT systems shall be adequately controlled and backed up. Comments/Actions PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page15 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 4.5 Layout and product flow Statement of Intent Premises and plant shall be logically designed, constructed and maintained. 4.5.1 The process flow from intake to despatch shall be arranged to minimise the risk of contamination or damage to the product. 4.5.2 Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out properly under hygienic conditions. 4.5.3 Work in progress shall be identified clearly and adequately protected. Comments/Actions 4.6 Equipment Statement of Intent Product safety, legality and quality shall be ensured through the use of appropriate equipment that shall be properly designed and maintained. 4.6.1 Newly installed equipment shall be properly specified before purchase. Equipment shall be constructed of appropriate materials and be of a suitable design to ensure it can be effectively cleaned and maintained. New equipment shall be tested and commissioned prior to use, and a maintenance programme established. Comments/Actions 4.7 Maintenance PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page16 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool Statement of Intent Proper maintenance and monitoring of all equipment critical to product safety, quality and legality shall ensure consistent high levels of product safety, functionality and quality. 4.7.1 A condition-based or preventative maintenance programme shall be in place covering all items of equipment and plant that are critical to product safety, quality and legality. 4.7.2 Maintenance work shall not place the product at risk. After breakdown or maintenance, machinery shall be thoroughly checked before recommencing production. 4.7.3 Temporary repairs/modifications using tape, cardboard, etc. shall only be permitted in emergencies and where product contamination is not at risk. Such modifications shall be subject to a time limit and shall be recorded and scheduled for correction. 4.7.4 Engineering workshops shall be controlled to prevent contamination risks to the product, e.g. provision of swarf mats where workshops open directly into production areas. Comments/Actions 4.8 Staff facilities Statement of Intent Staff facilities shall be sufficient to accommodate the required number of personnel, and designed and operated to minimise the risk of product contamination. Such facilities shall be kept in a good and clean condition. 4.8.1 Suitable and sufficient hand-washing facilities shall be available to enable cleaning of hands before commencing work and as necessary during the PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page17 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool course of work. 4.8.2 Toilets shall be adequately segregated and shall not open directly into storage, processing or production areas. Toilets shall be provided with hand-washing facilities comprising: sufficient quantity of warm water unscented liquid soap single-use towels or suitably designed and located air driers advisory signs to prompt use (including consideration of appropriate languages). 4.8.3 Eating, drinking and smoking shall not be allowed in locker and changing rooms. 4.8.4 Facilities for visitors and contractors shall comply with the company’s hygiene policy. Comments/Actions 4.9 Housekeeping and cleaning FUNDAMENTAL Housekeeping and cleaning systems shall be in place, which ensure that appropriate standards of cleanliness are maintained and that risk of contamination to the product is minimised. Statement of Intent 4.9.1 Good standards of housekeeping shall be maintained, which shall include a ‘clean as you go’ policy. 4.9.2 The cleaning of production equipment and internal surfaces of storage and production facilities shall be effectively managed using cleaning schedules. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page18 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 4.9.3 Cleaning chemicals shall be fit for purpose, suitably labelled, secured in closed containers and used in accordance with manufacturers’ instructions. Materials and equipment used for cleaning toilets shall be segregated from those used elsewhere Comments/Actions 4.10 Waste and waste disposal Statement of Intent Suitable facilities shall be in place for the storage and disposal of process and other waste. 4.10.1 Where appropriate, waste shall be categorised according to legislative requirements based on the intended means of disposal (such as recycling) and segregated in appropriate designated waste containers. 4.10.2 Where agreed with the customer, substandard trademarked materials shall be rendered unusable through a destructive process. If transferred to a third party for destruction or disposal, that third party shall be a specialist in appropriate waste disposal and shall provide records of material destruction. Comments/Actions 4.11 Pest Control Statement of Intent The company shall be responsible for minimising the risk of pest infestation on the site. 4.11.1 A preventive pest control programme shall be maintained covering all areas of the site under the company’s control. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page19 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 4.11.2 The company shall either contract the services of a competent pest control organisation or shall have appropriately trained staff for the regular inspection and treatment of the site to deter and eradicate infestation. 4.11.3 A pest control manual shall be maintained including: 4.11.4 detailed records of pest control inspections, recommendations and of any pest activity details of pest control products used and instructions for their use a site plan showing the location of pest control devices. In the event of infestation, immediate action shall be taken to eliminate the hazard. Action shall be taken to evaluate the potential for contamination or damage to packaging and checks instigated before release. Comments/Actions 4.12 Transport, storage and distribution Statement of Intent The risk of contamination of raw materials and finished products shall be minimised whilst in transport, storage or distribution. 4.12.1 All finished products and materials transferred between premises shall be fully identified and protected during transit and storage. 4.12.2 Receipt documents and/or product identification shall facilitate correct stock rotation of goods in storage. 4.12.3 Deliveries of incoming goods shall be visually checked for packaging integrity and potential foreign body contamination. 4.12.4 All pallets shall be checked. Damaged, contaminated or unacceptable pallets shall be discarded. Wooden pallets, if used, shall be sound, dry, clean and free from damage and contamination. 4.12.5 Work in progress shall be suitably labelled and covered to ensure proper identification and prevent damage. 4.12.6 Material intended for recycling shall be appropriately protected against contamination hazards. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page20 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 4.12.7 All vehicles used for deliveries shall be in a condition to minimise the risk of product contamination. 4.12.8 All company-owned vehicles used for deliveries shall be visually checked for cleanliness before loading. Unsatisfactory lorries shall not be loaded. 4.12.9 Where the company employs third-party contractors there shall be a contract or agreed terms and conditions. Where this is not possible, with general carriers, the packaging shall be adequate to protect the product against damage, contamination hazards, taint and odour. 4.12.10 Storage, including off-site storage, shall be controlled to protect the product from contamination. Comments/Actions 5. Product and Process control 5.1 Product design and development Statement of Intent Product design and development processes shall be in place to ensure the production of safe and legal products to defined quality parameters. 5.1.1 Customer requirements shall be defined and agreed prior to undertaking development, where possible, taking into consideration process requirements and end use. 5.1.2 A product specification shall be prepared and, where possible, agreed with the customer or brand owner before the production process begins. 5.1.3 A process shall be in place to ensure final product concepts and artwork are formally accepted by the specifier, where possible. 5.1.4 Production trials, where appropriate, shall be carried out and testing shall validate that manufacturing processes are capable of producing a safe PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page21 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool and legal product and that agreed product quality/print standards can be consistently achieved. 5.1.5 The company shall ensure that the product design processes, procedures and records of design together result in the development of specifications for each manufacturing process step to ensure the production of safe and legal products of the prescribed quality. Comments/Actions 5.2 Packaging print control Statement of Intent Processes shall be in place to ensure that print quality meets agreed specifications and critical print content such as allergen/safety/legal information is fully legible and correctly printed. 5.2.1 An assessment shall be carried out of the print process and handling of printed packaging (product) to identify: risks of loss of essential information mixing of printed product. Controls shall be established and implemented to reduce the risks identified. 5.2.2 Printing plates, other print equipment and reproduction media shall be fully traceable to the customer’s approved origination material. 5.2.3 Printing plates shall be appropriately stored. 5.2.4 Each print run shall be approved against the agreed standard (or master sample). This shall be recorded. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page22 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 5.2.5 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. 5.2.6 Where composite print is used (where a mixture of different designs are printed together), a process shall be in place to ensure effective segregation of differing print variants. 5.2.7 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. 5.2.8 Any unused printed product shall be accounted for and either disposed of or identified and appropriately stored. 5.2.9 Personnel carrying out print quality control shall be appropriately trained, aware of the importance of consumer safety information and adequately supervised. 5.2.10 Lighting in print inspection cabinets and other means of print/colour checking shall be agreed with the customer or be to accepted industry standards. Comments/Actions 5.3 Process control FUNDAMENTAL The production process shall be controlled through effective quality assurance of operations to ensure packaging materials can be consistently produced to the quality specified by customers. Statement of Intent 5.3.1 The company shall undertake a review of the manufacturing and, where applicable, printing process to identify critical manufacturing process control points that could affect the quality of the products produced. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page23 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 5.3.2 For each critical manufacturing process control point, machine settings or process limits shall be established and documented – the process specification. 5.3.3 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. 5.3.4 A clearance procedure shall be in place to ensure that at start up, the line is clear of all previous work and production documents. 5.3.5 In the event of changes to product composition, processing methods or equipment, the company shall, where appropriate, re-establish process characteristics and validate product data to ensure product safety, legality and quality are achieved. Comments/Actions 5.4 Product inspection and analysis Statement of Intent The company shall use appropriate procedures and facilities when undertaking or subcontracting inspection and analyses critical to product safety, legality and quality. 5.4.1 Quality checks shall be carried out at appropriate stages in production to demonstrate that raw materials, work in progress and the finished product are within the tolerances laid down in the agreed product specification. 5.4.2 Personnel undertaking quality checks and analyses shall be suitably trained and shall be competent to carry out the work. 5.4.3 Procedures shall be in place to ensure the reliability of test results. 5.4.4 Frequency of checks shall be in accordance with industry-accepted practice or customer requirements and based on risk analysis. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page24 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 5.4.5 Where the company undertakes or subcontracts analyses critical to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO 17025 (General Requirements for the Competence of Testing and Calibration Laboratories). Documented justification shall be available where accredited methods are not undertaken. Comments/Actions 5.5 In-line testing and measuring equipment Statement of Intent In-line measuring or product testing equipment, where used, shall be tested and maintained to ensure it is effective in ensuring product safety integrity and quality. 5.5.1 The accuracy of in-line equipment shall be specified having due regard to the product parameter being measured and controlled. 5.5.2 The company shall establish and implement procedures for the operation, routine monitoring and testing of equipment. Comments/Actions 5.6 Calibration Statement of Intent Where specialist measuring is required to assess compliance with product safety and legality, the devices shall be maintained and calibrated. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page25 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 5.6.1 Measuring equipment used to monitor critical manufacturing process points and the product’s compliance with relevant legal requirements and specifications shall be identified and calibrated. 5.6.2 Calibration shall be traceable to a recognised national standard. Where such a traceable calibration is not possible, the company shall demonstrate the basis by which standardisation is carried out. Comments/Actions 5.7 Control of non-conforming product Statement of Intent The company shall ensure that out-of-specification product is clearly identified, labelled and quarantined. 5.7.1 Clear procedures for the control of out-of-specification or non-conforming materials shall be in place and understood by all authorised personnel. This shall include the effective labelling or quarantining 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 or authorise to be reworked or for an alternative use. The decision and reasons shall be documented. 5.7.3 Corrective actions shall be implemented to avoid recurrence of the nonconformance Actions taken shall be documented. Comments/Actions 5.8 Foreign body contamination control PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page26 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool Statement of Intent The company shall be able to demonstrate that effective controls are in place to ensure product is protected from contamination during production and storage. 5.8.1 Foreign body control 5.8.1.1 Based on risk assessment, the company shall identify, control and manage potential risks from physical contamination. 5.8.1.2 Based on the likelihood and risk of glass contamination, all bulbs and strip lights, including those on flying insect control devices, shall be protected. 5.8.1.3 Where glass breakage occurs a responsible person shall be placed in charge of the clean-up operation and shall ensure that no other area is allowed to become contaminated due to the breakage. Any product that has become contaminated shall be segregated and disposed of. All breakages shall be recorded in an incident report. Comments/Actions 5.8.2 Sharps control 5.8.2.1 There shall be a documented policy for the control of the use of sharps. 5.8.2.2 Sharp blades, equipment and tools shall not be left in a position that allows them to contaminate the product. 5.8.2.3 Snap-off blade knives shall not be used. Comments/Actions PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page27 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 5.8.3 Chemical control Statement of Intent Controls shall be in place to prevent contamination from chemical hazards. 5.8.3.1 Chemicals including cleaning materials, lubricants and adhesives shall be of the appropriate grade and be suitably controlled to prevent contamination of the product. Comments/Actions 6. Personnel Raw materials handling, preparation, processing, packing and storage areas 6.1 Training and competence FUNDAMENTAL The company shall ensure that all employees are adequately trained, instructed and supervised commensurate with their activity and are competent to undertake their job role. Statement of Intent 6.1.1 All personnel, including temporary personnel, shall be appropriately trained prior to commencing work and adequately supervised throughout the working period. 6.1.2 The company shall routinely review the competencies of staff and provide PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page28 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool relevant training as appropriate. Records of training shall be maintained. Comments/Actions 6.2 Access and movement of personnel Statement of Intent The company shall ensure that access and movement of personnel, visitors and contractors shall not compromise product safety and quality. 6.2.1 There shall be a plan of the site, which defines access points for personnel, travel routes and staff facilities. 6.2.2 If it is necessary to allow access through production areas, designated walkways shall be provided that ensure there is adequate segregation from materials. Comments/Actions 6.3 Personal Hygiene Statement of Intent The company’s personal hygiene standards shall be documented and adopted by all personnel, including visitors to the production facility. These standards shall be developed with due regard for risk of product contamination. 6.3.1 The company shall have a documented jewellery policy. 6.3.2 Personal items and belongings including personal mobile phones shall not be taken into production areas without the permission of the management. PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page29 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool 6.3.3 Eating (including the eating of confectionery and chewing of gum or tobacco), drinking and smoking shall not be allowed in production or storage areas. 6.3.4 Drinking of water from purpose-made dispensers and/or by using disposable conical cups or spill-proof containers may be allowed, provided it is confined to a designated area away from equipment. Comments/Actions 6.4 Protective Clothing Statement of Intent The risk of product contamination from clothing, hair or personal items shall be minimised. 6.4.1 Appropriate clean protective clothing that cannot contaminate the product shall be worn. Where no need for protective clothing has been established by risk assessment, it shall be fully justified and guidance provided to staff on any limitations to personal clothing to prevent a contamination risk to the product. 6.4.2 Where protective clothing is used it shall be kept adequately clean. Changes of clothing shall be available as required. 6.4.3 Where protective clothing is used, clean and dirty clothing shall be segregated and controlled to prevent cross contamination 6.4.4 Disposable protective clothing, if used, shall be subject to adequate control to avoid product contamination. Comments/Actions PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page30 Technical Manager Global Standard for Packaging and Packaging Materials Issue 4 : February 2011 BRC Global Standards Low Risk Self-Assessment Tool PO49 Issue 1 Revision 1 Released 17/2/2012 First issue Self-Assessment Tool Low Risk Responsible Joanna Griffiths Page31 Technical Manager