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1 Governance and commitment

1.1 Policy

  • 1.1.1 The senior management shall develop, implement and maintain a corporate policy, which shall include, at a minimum :<br>- food safety and product quality<br>- customer focus<br>-food safety culture.<br>This corporate policy shall be communicated to all employees and shall be broken down into specific objectives for the relevant departments.

  • 1.1.2 All relevant information related to food safety, product quality and authenticity shall be communicated effectively and in a timely manner to the relevant personnel.

1.2 Corporate structure

  • 1.2.1 The senior management shall ensure that employees are aware of their responsibilities related to food safety and product quality and that mechanisms are in place to monitor the effectiveness of their operation. Such mechanisms shall be clearly identified and documented.

  • 1.2.2 The senior management shall provide sufficient and relevant resources to meet the product and process requirements.

  • 1.2.3 The department responsible for food safety and quality management shall have a direct reporting relationship to the senior management. An organisational chart shall be available, showing the structure of the company.

  • 1.2.4 The senior management shall ensure that all processes (documented and undocumented) are known by the relevant personnel and are applied consistently.

  • 1.2.5 The senior management shall have a system in place to ensure that the company is kept informed of all relevant legislation, scientific and technical developments, industry codes of practice, food safety and product quality issues, and that they are aware of factors that can influence food defence and food fraud risks.

  • 1.2.6 The senior management shall ensure that the certification body is informed of any changes that may affect the company’s ability to conform to the certification requirements. This shall include, at a minimum:<br>• any legal entity name change<br>• any production site location change.<br>For the following specific situations:<br>• any product recall<br>• any product recall and / or withdrawal by official order for food safety and / or food fraud reasons<br>• any visit from health authorities which results in notifications and / or penalties issued by authorities the certification body shall be informed within three (3) working days.

1.3 Customer focus

  • 1.3.1 A process shall be in place to identify fundamental needs and expectations of customers. The feedback from this process shall be used as input for the company's continuous improvement.

1.4 Management review

  • 1.4.1 The senior management shall ensure that the food safety and quality management system is reviewed at least annually, or more frequently if significant changes occur. Such reviews shall include, at a minimum:<br>- a review of objectives and policies including elements of food safety culture<br>- results of audits and site inspections<br>- positive and negative customer feedback<br>- process compliance<br>- authenticity and conformity issues<br>- status of corrections and corrective actions<br>- notifications from authorities.

  • 1.4.2 Actions from the management review shall be clearly aimed at supporting improvement.<br>The management review shall assess follow-up actions from previous management reviews and any change that could affect the food safety and quality management system. The management review shall be fully documented.

  • 1.4.3 The senior management shall identify and regularly review (e.g. by internal audits or on-site verification) the infrastructure and work environment needed to conform to product requirements.<br>This shall include, at a minimum :<br>- buildings<br>- supply systems<br>- machines and equipment<br>- transport<br>- staff facilities<br>- environmental conditions<br>- hygienic conditions<br>- workplace design<br>- external influences (e.g. noise, vibration).<br>The results of the review shall be considered, with due consideration to risks, for investment planning.

2 Food safety and quality management system

2.1 Quality management

2.1.1 Document management

  • 2.1.1.1 The food safety and quality management system shall be documented and implemented, and shall be kept in one location (food safety and quality manual or electronic documented system).

  • 2.1.1.2 All documents shall be clearly legible, unambiguous and comprehensive. They shall be available to the relevant personnel at all times.

  • 2.1.1.3 A documented procedure shall exist for the control of documents and their amendments. All documents which are necessary for compliance with the product requirements shall be available in their latest version. The reason for any amendments to documents, critical to the product requirements, shall be recorded.

2.1.2 Records and documented information

  • 2.1.2.1 Records and documented information shall be legible and genuine. They shall be maintained in a way that subsequent revision or amendment is prohibited. If records are documented electronically, a system shall be in place to ensure that only authorised personnel have access to create or amend those records (e.g. password protection).

  • 2.1.2.2 All records and documented information shall be kept in accordance with legal and customer requirements. If no such requirements exist, records and documented information shall be kept for a minimum of one year after the specified shelf life. For products which have no shelf life, the duration of record and documented information keeping shall be justified and this justification shall be documented.

  • 2.1.2.3 Records and documented information shall be securely stored and easily accessible.

2.2 Food safety Management

2.2.1 HACCP Plan

  • 2.2.1.1 The basis of the company’s food safety management system shall be a fully implemented, systematic and comprehensive HACCP based plan, following the Codex Alimentarius principles and any legal requirements of the production and destination countries which may go beyond such principles. The HACCP plan shall be specific and implemented at the production site.

  • 2.2.1.2 The HACCP plan shall cover all raw materials, packaging materials, products or product groups as well as every process from incoming goods up to dispatch of finished products, including product development.

  • 2.2.1.3 The company shall ensure that the HACCP plan is based upon scientific literature, or expert advice obtained from other sources, which may include: trade and industry associations, independent experts and regulatory authorities. This information shall be maintained in line with any new technical process development.

  • 2.2.1.4 The company shall ensure that in the event of changes to raw materials, packaging materials, processing methods, infrastructure and/or equipment, the HACCP plan is reviewed to assure that product safety requirements are complied with.

2.2.2 HACCP team

  • 2.2.2.1 Assemble HACCP Team:<br>The HACCP team shall have the appropriate specific knowledge and expertise and be a multidisciplinary team which includes operational staff.

  • 2.2.2.2 Those responsible for the development and maintenance of the HACCP plan shall have an internal team leader and shall have received adequate training in the application of the HACCP principles and specific knowledge of the product and processes.

2.2.3 HACCP analysis

  • 2.2.3.1 Describe product:<br>A full description of the product including all relevant information on product safety shall exist, such as:<br>-composition<br>-physical, organoleptic, chemical and microbiological characteristics<br>-legal requirements for the food safety of the product<br>-methods of treatment, packaging, durability (shelf life)<br>-conditions for storage, method of transport and distribution.

  • 2.2.3.2 Identify intended use:<br>The intended use of the product shall be described in relation to the expected use of the product by the end consumer, taking vulnerable groups of consumers into account .

  • 2.2.3.3 Construct flow diagram:<br>A flow diagram shall exist for each product, or product group, and for all variations of the processes and sub-processes (including rework and reprocessing). The flow diagram shall be dated, and after the determination of control measures, clearly identify each CCP and other control measures. In the event of any changes, the flow diagram shall be updated.

  • 2.2.3.4 On-site confirmation of the flow diagram:<br>Representatives of the HACCP team shall verify the flow diagram, by on-site verifications, at all operation stages and shifts. Where appropriate, amendments to the diagram shall be made.

  • 2.2.3.5 Conduct a hazard analysis for each step:<br>A hazard analysis shall be conducted for all possible and reasonably expected physical, chemical (including radiological and allergens) and biological hazards. The analysis shall also include hazards linked to materials in contact with food, packaging materials and hazards related to the work environment.. The hazard analysis shall consider the likely occurrence of hazards and the severity of their adverse health effects. Consideration shall be given to the specific control measures that shall be applied to control each hazard to control each hazard.

  • 2.2.3.6 Determine critical control points and other control measures:<br>The determination of relevant CCPs and other control measures shall be facilitated by the application of a decision tree or other tool(s), which demonstrates a logical reasoned approach.

  • 2.2.3.7 Establish critical limits for each CCP:<br>For each CCP, the appropriate critical limits shall be defined and validated to clearly identify when a process is out of control.

  • 2.2.3.8 Establish a monitoring system for each CCP

  • 2.2.3.8.1 Specific monitoring procedures in terms of method, frequency of measurement or observation and recording of results, shall be established for each CCP to detect any loss of control at that CCP. Each defined CCP shall be under control.<br><br>Monitoring and control of each CCP shall be demonstrated by records.

  • 2.2.3.8.2 Records of CCP monitoring shall be verified by a responsible person within the company and maintained for a relevant period.

  • 2.2.3.8.3 The operative personnel in charge of the monitoring of CCPs and other control measures shall have received specific training/ instruction.

  • 2.2.3.8.4 Control measures, other than CCPs, shall be monitored, recorded and controlled by measurable or observable criteria.

  • 2.2.3.9 Establish corrective actions:<br>In the event that the monitoring indicates that a particular CCP or control measure other than CCP is not under control, adequate corrective actions shall be taken and documented. Such corrective actions shall also take into account any action taken relating to non-conforming products and identify the root cause for the loss of control of CCPs.

  • 2.2.3.10 Establish verification procedures:<br>Procedures of verification shall be established to confirm that the HACCP plan is working correctly. Verification of the HACCP plan shall be performed at least once a year.<br>Examples of verification activities include:<br>- internal audits<br>- analyses<br>- sampling<br>- deviations<br>- complaints<br><br>The results of this verification shall be incorporated into the HACCP plan.

  • 2.2.3.11 Establish documentation and record keeping<br>Documentation related to the HACCP plan shall be in place.<br>Examples of documentation include:<br>-hazard analysis<br>-determination of CCPs and other control measures<br>-determination of critical limits<br>-processes, procedures<br><br>Examples of records include:<br>-outcome of CCPs and other control measures monitoring activities<br>-observed deviations and implemented corrective actions.

3 Resource Management

3.1 Human resources

  • 3.1.1 All personnel performing work that affects product safety, quality and legality shall have the required competence appropriate to their role as a result of education, work experience and/ or training.

  • 3.1.2 The responsibilities, competencies and job descriptions for all job titles, with an impact on food safety and product quality shall be clearly defined, documented and in place. Assignment of key roles shall be defined.

3.2 Personal hygiene

  • 3.2.1 Documented requirements relating to personal hygiene shall be in place and shall include, at a minimum, the following areas:<br>- hair and beards<br>- protective clothing (including their conditions of use in staff facilities)<br>- hand washing, disinfection and hygiene<br>- eating, drinking and smoking<br>- actions to be taken in case of cuts or skin abrasions<br>- fingernails, jewellery and personal belongings (including medicine)<br>- notification of infectious diseases and conditions impacting food safety via a medical screening procedure.<br><br>The requirements shall be based on hazard analysis and assessment of associated risks.

  • 3.2.2 The requirements for personal hygiene shall be in place and applied by all relevant personnel, contractors, and visitors.

  • 3.2.3 Compliance with personal hygiene requirements shall be checked regularly.

  • 3.2.4 Visible jewellery (including piercing) and watches shall not be worn. Any exceptions shall have been comprehensively evaluated by hazard analysis and assessment of associated risks and shall be effectively managed.

  • 3.2.5 Cuts and skin abrasions shall be covered with a coloured plaster/bandage different from the product colour. Where appropriate:<br>- plasters / bandages shall contain a metal strip<br>- single use gloves shall be worn.

  • 3.2.6 In work areas where wearing headgear and/or beard snood (coverings) is required, the hair shall be covered completely to prevent product contamination.

  • 3.2.7 Clearly defined usage rules shall exist for work areas/ activities where it is required to wear gloves (coloured differently from the product colour).

  • 3.2.8 Suitable protective clothing shall be available and in sufficient quantity for each employee.

  • 3.2.9 All protective clothing shall be thoroughly and regularly laundered in-house or by approved contractors or by employees. This decision shall be justified by risk assessment. Defined requirements shall ensure, at a minimum:<br>- sufficient segregation between dirty and clean clothing at all times<br>- defined laundering conditions on water temperature and detergent dosage<br>- avoidance of contamination until use.<br><br>The effectiveness of the laundering shall be appropriately monitored.

  • 3.2.10 In case of any health issue or infectious disease that may have an impact on food safety, actions shall be taken in order to minimise contamination risks.

3.3 Training and instruction

  • 3.3.1 The company shall implement documented training and/or instruction programs with respect to the product and process requirements and the training needs of the employees, based on their job, and shall include:<br> - training contents<br> - training frequency<br> - employee’s task<br> - languages<br> - qualified trainer/tutor.

  • 3.3.2 The documented training and/or instruction shall apply to all personnel, including seasonal and temporary workers and employees from external companies, employed in the respective work area. Upon employment, and before commencing work, they shall be trained/instructed in accordance with the documented training/instruction programs.

  • 3.3.3 Records of all training/instruction events shall be available, stating:<br> - list of participants (including their signature)<br> - date<br> - duration<br> - contents of training<br> - name of trainer/tutor.<br><br>A procedure or program shall be in place to prove the effectiveness of the training and/or instruction programs.

  • 3.3.4 The contents of training and/or instruction shall be regularly reviewed and updated when necessary. Special consideration shall be given, at a minimum, to these specific issues:<br>- food safety<br>- food fraud<br>- product quality<br>- food defence<br>- food related legal requirements<br>- product/process modifications<br>- feedback from the previous documented training/instruction programs.

3.4 Staff Facilities

  • 3.4.1 The company shall provide suitable staff facilities, which shall be proportional in size, equipped for the number of personnel, designed and controlled so to minimise food safety risks. Such facilities shall be kept in a clean and good condition.

  • 3.4.2 Product contamination risks by food and drink and/or foreign materials shall be minimised. Consideration shall be given to food and drink from vending machines, canteen and/or brought to work by personnel.

  • 3.4.3 Changing rooms shall be located to allow direct access to the areas where food products are handled. If this is not possible, preventive measures shall be in place to minimise product contamination risks. Where necessary, outdoor clothing and protective clothing shall be stored separately.

  • 3.4.4 Toilets shall neither have direct access nor pose contamination risks to an area where food products are handled. Toilets shall be equipped with adequate hand washing facilities. Sanitary facilities shall have adequate natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area shall be avoided.

  • 3.4.5 Hand hygiene facilities shall be provided and shall adress, at a minimum:<br>- adequate number of wash basins<br>- suitably located at access points to and/or within production areas<br>- sole use for cleaning hands only.<br>The necessity of similar equipment in further areas (e.g. packing area) shall be based on hazard analysis and assessment of associated risks.

  • 3.4.6 Hand hygiene facilities shall provide:<br> - running potable water at an appropriate temperature<br> - appropriate cleaning and disinfection equipment<br> - appropriate means for hand drying.

  • 3.4.7 Where the processes require a higher standard of hygiene, the hand washing equipment shall provide, in addition:<br>- hand contact-free fittings<br>- hand disinfection<br>- waste container with hand contact-free opening.

  • 3.4.8 Based on hazard analysis and assessment of associated risks, a program shall be in place to control effectiveness of hand hygiene

  • 3.4.9 Where it is justified by risk assessment, cleaning and disinfection facilities shall be available and used for boots, shoes and further protective clothing.

4 Operational processes

4.1 Contract Agreement

  • 4.1.1 All requirements related to food safety and product quality, within the defined agreement with customers, and any revision of these clauses, shall be communicated to and implemented by each relevant department.

  • 4.1.2 In accordance with customer requirements, the senior management shall inform their affected customers, as soon as possible, of any issue related to product safety or legality, including non-conformity/ies identified by competent authorities.

4.2 Specification and Formulas

4.2.1 Specifications

  • 4.2.1.1 Specifications shall be available and in place for all finished products. They shall be up to date, unambiguous and in compliance with legal and customer requirements.

  • 4.2.1.2 A procedure to control the creation, approval and amendment of specifications shall be in place and shall include, where required, the acceptance of the customer(s). Where required by customers, product specifications shall be formally agreed.<br>This procedure shall include the update of finished product specification in case of any modification related to:<br>- raw materials<br>- formulas/recipes<br>- processes which impact the finished products<br>- packaging materials which impact the finished products.

  • 4.2.1.3 Specifications shall be available and in place for all raw materials (ingredients, additives, packaging materials, rework). Specifications shall be up to date, unambiguous and be in compliance with legal requirements and, if existing, with customer requirements.

  • 4.2.1.4 Specifications and/or their contents shall be available on site for all relevant personnel.

  • 4.2.1.5 Where customers specifically require that products are “free from” certain substances or ingredients (e.g. gluten, pork, etc.), or that certain methods of treatment or production are excluded (e.g. GMOs), verifiable procedures shall be in place.

4.2.2 Formulas/Recipes

  • 4.2.2.1 Where there are customer agreements related to:<br>-product recipe (including raw materials characteristics)<br>-process<br>-technological requirements<br>-packaging<br>-labelling these shall be complied with.

4.3 Product development/ Product modification/ Modification of production processes

  • 4.3.1 For each new development or modification of products, a hazard analysis and assessment of associated risks shall be conducted.

  • 4.3.2 The product development/ modification process shall result in specifications about formulation, packaging requirements, manufacturing processes and process parameters related to the fulfilment of product requirements. This includes factory trials and product testing.<br>The progress and results of product development/modification shall be recorded.

  • 4.3.3 Shelf-life tests or adequate validation through microbiological, chemical and organoleptic evaluation, shall be carried out and consideration shall be given to product formulation, packaging, manufacturing and declared conditions.<br>In accordance with this evaluation, the shelf-life shall be established.

  • 4.3.4 A procedure shall be in place to ensure that labelling complies with current legislation of the destination country/ies and customer requirements.

  • 4.3.5 Recommendations for preparation and/ or use of food product instructions shall be established, where appropriate.

  • 4.3.6 The company shall demonstrate through studies and/ or perform relevant tests to validate nutritional information or claims which are declared on labelling, throughout the shelf life of the products.

  • 4.3.7 In the event of changes to process characteristics or product formulation, including rework and/or packaging materials, the company shall ensure that the food safety and product quality requirements are complied with. Labelling shall be reviewed and adapted when necessary.

4.4 Purchasing

  • 4.4.1 The company shall control purchasing processes to ensure that all externally sourced raw materials, semi-finished products, packaging materials and services, which have an impact on food safety and product quality, conform to defined requirements.

  • 4.4.2 A procedure for the approval and monitoring of suppliers (internal and external) shall be in place.<br>The approval and monitoring procedure shall contain clear assessment criteria, such as:<br>-audits performed by an experienced and competent person<br>-certificates of analyses<br>-supplier reliability<br>-complaints<br>-required performance standards.

  • 4.4.3 The results from the supplier assessments shall be reviewed regularly and this review shall be justified by risk assessment.<br>Records of the reviews and the consequential actions of assessment shall be documented.

  • 4.4.4 The purchased raw materials, semi-finished products and packaging materials shall be checked in accordance with the existing specifications and, justified by risk assessment, for their authenticity. The schedule of these checks shall take into account, at a minimum, defined food safety and product quality risks.<br>The frequency and/or scope of sampling shall be based on:<br>-the impact of the raw materials, semi-finished products and packaging materials on the finished product<br>-the supplier's status.

  • 4.4.5 The purchased services shall be checked in accordance with the existing specifications.<br>The schedule of these checks shall take into account, at a minimum:<br>-the defined service requirements<br>-the supplier's status (according to its assessment)<br>-the impact of the service on the finished product.

  • 4.4.6 Where a company outsources part of product processing and / or primary packaging and/or labelling, the company shall have it documented in the food safety and quality management system and ensure control over such processes to guarantee that food safety and product quality are not compromised. Control of such outsourced processes shall be identified and documented. When required by the customer, there shall be evidence that he has been informed and has agreed to such outsourced process.

  • 4.4.7 A written agreement shall be in place, covering the outsourced processes and describing any arrangements made in connection with it, including in process controls, sampling and analyses.

  • 4.4.8 The company shall approve the supplier of the outsourced processes through:<br> - certification against IFS Food or other GFSI recognised food safety certification standard or<br>- documented supplier audit, performed by an experienced and competent person, which shall include, at a minimum, requirements for food safety, product quality, legality and authenticity

4.5 Product packaging

  • 4.5.1 Based on hazard analysis, assessment of associated risks and intended use, the company shall define the key parameters for the packaging materials in detailed specifications complying with the current relevant legislation and other relevant hazards or risks.<br>The company shall check and verify the suitability and existance of functional barrier(s) of the consumer unit packaging material for each relevant product tests/analysis such as:<br>-organoleptic tests<br>-storage tests<br>-chemical analyses<br>-migration test results.

  • 4.5.2 For all packaging materials which could have an impact on products, certificates of conformity shall exist which attest conformance with legal requirements. In the event that no specific legal requirements are applicable, evidence shall be available to demonstrate that packaging materials are suitable<br>for use. This applies for packaging materials which could have an influence on raw materials, semi-finished and finished products

  • 4.5.3 The company shall ensure that the used packaging and labelling corresponds to the product being packed and comply with agreed customer product specifications. This shall be regularly checked and documented.

4.6 Factory location

  • 4.6.1 The company shall investigate the extent to which the factory environment (e.g. ground, air) may have an adverse impact on food safety and product quality. Where it is established that product safety and/or quality could be compromised, appropriate control measures shall be implemented. The effectiveness of the implemented measures shall be periodically reviewed (e.g. extremely dusty air, strong smells).

4.7 Factory exterior

  • 4.7.1 All external areas of the factory shall be clean, tidy and maintained in good condition. Where natural drainage is inadequate, a suitable drainage system shall be installed.

  • 4.7.2 Outdoor storage shall be kept to a minimum. Where goods are stored outside, it shall be justified by risk assessment to ensure that there are no contamination risks or adverse effects on food safety and quality.

4.8 Plant layout and process flows

  • 4.8.1 A site map covering all buildings of the facility shall be available.<br>Plans shall be in place that clearly describe the process flows of :<br>- finished products<br>- packaging materials<br>- raw materials<br>- personnel<br>- waste<br>- water.

  • 4.8.2 The process flow, from receipt of goods to dispatch, shall be established, reviewed and where necessary, modified to ensure that the microbiological, chemical and physical contamination risks of raw materials, packaging material, semi-finished and finished products are avoided. The cross-contamination risks<br>shall be minimised through effective measures.

  • 4.8.3 In the case of areas sensitive to microbiological, chemical and physical risk(s) which is/are justified by risk assessment, they shall be designed and operated to ensure product safety is not compromised.

  • 4.8.4 Laboratory facilities and in-process controls shall not affect product safety.

4.9 Production and storage premises

4.9.1 Constructional requirements

  • 4.9.1.1 Premises where food products are prepared, treated, processed and stored shall be designed and constructed to ensure food safety.

4.9.2 Walls

  • 4.9.2.1 Walls shall be designed and constructed to prevent the accumulation of dirt, reduce condensation and mould growth, and facilitate cleaning.

  • 4.9.2.2 The surfaces of walls shall be in good condition and easy to clean; they shall be impervious and wear-resistant to minimise product contamination risks.

  • 4.9.2.3 The junctions between walls, floors and ceilings shall be designed to facilitate cleaning.

4.9.3 Floors

  • 4.9.3.1 Floor covering shall be designed to meet production requirements and shall be in good condition and easy to clean. Surfaces shall be impervious and wear-resistant.

  • 4.9.3.2 The hygienic disposal of water and other liquids shall be ensured. Drainage systems shall be easy to clean and designed to minimise the product contamination risks (e.g. entry of pests, areas sensitive to transmission of odour or contaminants).

  • 4.9.3.3 Water or other liquids shall reach drainage, using appropriate measures without difficulties. Puddles shall be avoided.

  • 4.9.3.4 In food handling areas, machinery and piping shall be arranged so that waste water, if possible, to flow directly into a drain.

4.9.4 Ceilings/overheads

  • 4.9.4.1 Ceilings (or, where no ceilings exist, the inside of roofs) and overhead fixtures (including piping, cableway, lamps etc.) shall be constructed to minimise the accumulation of dirt and condensation and shall not pose any physical and/or microbiological contamination risks.

  • 4.9.4.2 Where false ceilings are used, an access to the vacant area shall be provided in order to facilitate cleaning, maintenance and inspections for pest control.

4.9.5 Windows and other openings

  • 4.9.5.1 Windows and other openings shall be designed and constructed to avoid the accumulation of dirt and shall be maintained in good condition.

  • 4.9.5.2 Where there are contamination risks, windows and roof glazing shall remain closed and fixed during production.

  • 4.9.5.3 Where windows and roof glazing are designed to be opened for ventilation purposes, they shall be fitted with easily removable, good condition pest screens or other measures to avoid any contamination.

  • 4.9.5.4 In areas where unpackaged products are handled, windows shall be protected against breakage.

4.9.6 Doors and gates

  • 4.9.6.1 Doors and gates shall be in good condition and easy to clean. They shall be constructed of non-absorbent materials to avoid:<br>-splintering parts<br>-flaking paint<br>-corrosion.

  • 4.9.6.2 External doors and gates shall be constructed to prevent the access of pests; they shall be self-closing, unless nonessentiality is justified by risk assessment.

  • 4.9.6.3 Plastic strip curtains, separating the internal areas shall be in good condition and easy to clean.

4.9.7 Lighting

  • 4.9.7.1 All production, storage, receipt and dispatch areas shall have adequate levels of light.

4.9.8 Air conditioning/Ventilation

  • 4.9.8.1 Adequate natural and/or artificial ventilation shall be in place in all areas.

  • 4.9.8.2 If ventilation equipment is installed, filters and other components shall be easily accessible and checked, cleaned or replaced as necessary.

  • 4.9.8.3 Air conditioning equipment and artificially generated airflow shall not compromise product safety and quality.

  • 4.9.8.4 Dust extraction equipment shall be installed in areas where considerable amounts of dust are generated.

4.9.9 Water

  • 4.9.9.1 Water which is used as an ingredient in the production process, or for cleaning, shall be of potable quality at the point of use and supplied in sufficient quantity; this also applies to steam and ice used within the production area.

  • 4.9.9.2 Recycled water which is used in the process, shall not pose a contamination risks.

  • 4.9.9.3 The quality of water (including recycled water), steam or ice shall be monitored following a sampling plan on hazard analysis and assessment of associated risks.

  • 4.9.9.4 Non-potable water shall be transported in separate, properly marked piping. Such piping shall neither be connected to the drinking water system nor allow the possibility of reflux, to avoid contamination of potable water sources or factory environment.

4.9.10 Compressed air and gases

  • 4.9.10.1 The quality of compressed air that comes in direct contact with food or primary packaging material shall be monitored based on hazard analysis and assessment of associated risks. If gases are used, they shall demonstrate adequate safety and quality through a declaration of compliance and shall be<br>suitable for the intended use.

  • 4.9.10.2 Compressed air shall not pose contamination risks.

4.10 Cleaning and disinfection

  • 4.10.1 Based on hazard analysis and assessment of associated risks, cleaning and disinfection schedules shall be available and implemented. These shall specify:<br>- objectives<br>- responsibilities<br>- the products used and their instructions for use<br>- dosage of cleaning and disinfection chemicals<br>- the areas to be cleaned and/ or disinfected<br>- cleaning and disinfection frequency<br>- documentation requirements<br>- hazard symbols (if necessary).

  • 4.10.2 Cleaning and disinfection shall result in effectively cleaned premises, facilities and equipment. Defined methods shall be adequately implemented, documented and monitored.

  • 4.10.3 Monitoring records for cleaning and disinfection shall be available.

  • 4.10.4 Only qualified personnel shall be allowed to undertake cleaning and disinfection. The personnel shall be trained and retrained to carry out the cleaning and disinfection schedules.

  • 4.10.5 The effectiveness of the cleaning and disinfection measures shall be verified and justified by risk assessment. The verification shall be based on an appropriate sampling schedule and shall consider:<br>- visual inspection<br>- rapid testing<br>- analytical testing methods.<br>Resultant corrective actions shall be documented.

  • 4.10.6 Cleaning and disinfection schedules shall be reviewed and modified, in the event that changes occur products to products, processes or cleaning and disinfection equipment, if necessary.

  • 4.10.7 The intended use of cleaning and disinfection utensils shall be clearly identified. Cleaning and disinfection utensils shall be used in a way that avoids contamination.

  • 4.10.8 Safety Data Sheets and instructions for use shall be available for chemicals and cleaning and disinfection agents. Personnel responsible for cleaning and disinfection shall be able to demonstrate their knowledge of such instructions, which shall always be available on site.

  • 4.10.9 Cleaning and disinfection chemicals shall be clearly labelled, used and stored appropriately, to avoid contamination.

  • 4.10.10 Cleaning and disinfection activities shall be carried out in periods of non production. If this is not possible, these operations shall be controlled in order not to affect the products.

  • 4.10.11 Where a company hires a third-party service provider for cleaning and disinfection activities, all requirements specified above shall be clearly defined in the service contract.

4.11 Waste management

  • 4.11.1 A waste management procedure shall be in place to avoid cross contamination.

  • 4.11.2 All local legal requirements for waste disposal shall be met.

  • 4.11.3 Food waste and other waste shall be removed as quickly as possible from areas where food is handled. The accumulation of waste shall be avoided.

  • 4.11.4 Waste collection containers shall be clearly marked, suitably designed, in a good state of repair, easy to clean, and where necessary disinfected.

  • 4.11.5 If a company decides to separate food waste and to reintroduce them into the feed supply chain, adequate measures or procedures shall be implemented to prevent a contamination or deterioration of this material.

  • 4.11.6 Waste shall be collected in separate containers in accordance with the intended means of disposal. Such waste shall be disposed by authorised third parties only. Records of waste disposal shall be kept by the company.

4.12 Foreign material risk mitigation

  • 4.12.1 The products being processed shall be protected against physical contamination, which includes but is not limited to:<br>- environmental contaminants<br>- oils or dripping liquids from machinery<br>- dust spills.<br>Special consideration shall also be given to product contamination risks caused by :<br>- equipment and utensils<br>- pipes<br>- walkways<br>- platforms<br>- ladders.<br>If, for technological characteristics and/or needs, it is not possible to protect the products, appropriate control measures shall be defined and applied.

  • 4.12.2 Based on hazard analysis and assessment of associated risks, procedures shall be in place to avoid contamination with foreign material. Contaminated products shall be treated as non-conforming products.

  • 4.12.3 Where metal and/or other foreign material detectors are required, they shall be installed to ensure maximum efficiency of detection in order to avoid subsequent contamination. Detectors shall be subjected to regular maintenance to avoid malfunction.

  • 4.12.4 The adequate accuracy of all equipment and methods designed to detect and/or eliminate foreign material, shall be specified. Functionality checks of such equipment and methods shall be carried out regularly. In case of malfunction or failure, corrective actions shall be defined, implemented and documented.

  • 4.12.5 Potentially contaminated products shall be isolated. Access and actions for the further handling or checking of these isolated products shall be carried out only by authorised personnel according to defined procedures. After this check, contaminated products shall be treated as non-conforming products.

  • 4.12.6 In areas where raw materials, semi-finished and finished products are handled, the use of glass and/or brittle materials shall be excluded; however where the presence of glass and/or brittle materials cannot be avoided, the risks shall be controlled and the glass and/or brittle materials shall be clean and pose<br>no risks to product safety.

  • 4.12.7 Based on hazard analysis and assessment of associated risks, preventive measures shall be in place for the handling of glass packaging, glass containers or other kinds of containers in the production process (turn over, blow, rinse, etc.). After this process step there shall be no further contamination risks.

  • 4.12.8 Procedures shall be in place describing the measures to be taken in case of glass breakage and/or brittle material. Such measures shall include identifying the scope of goods to be isolated, specifying authorised personnel, cleaning the production environment and releasing the production line for continued production.

  • 4.12.9 Breakages of glass and brittle material shall be recorded. Exceptions shall be justified and documented.

  • 4.12.10 Where visual inspection is used to detect foreign materials, the employees shall be trained and operative changes shall be performed at an appropriate frequency to maximise the effectiveness of the process.

  • 4.12.11 In areas where raw materials, semi-finished and finished products are handled, the use of wood shall be excluded; however where the presence of wood cannot be avoided, the risks shall be controlled and the wood shall be clean and pose no risks to product safety

4.13 Pest monitoring and control

  • 4.13.1 Site infrastructure and operations shall be designed and built to prevent pest infestation.

  • 4.13.2 The company shall have adequate pest control measures in place which shall be in compliance with local legal requirements and shall take into account, at a minimum:<br>- factory environment (potential pests)<br>- type of raw material/finished products<br>- site plan with area for application (bait map)<br>- constructional designs susceptible for pest activity, such as ceilings, cellars, pipes, corners<br>- identification of the baits on site<br>- responsibilities, in-house/ external<br>- agents used and their instructions for use and safety<br> - frequency of inspections<br>- rented storage if applicable.<br>The pest control measures shall be based on hazard analysis and assessment of associated risks.

  • 4.13.3 Where a company hires a third-party service provider for pest control, all requirements specified above shall be clearly defined in the service contract. A person at the company shall be appointed and trained to monitor the pest control measures. Even if the pest control service is outsourced, responsibilities for the necessary actions (including ongoing supervision of pest control activities) shall remain within the company.

  • 4.13.4 Pest control inspections and resulting actions shall be documented. Implementation of actions shall be monitored and recorded. Any infestation shall be documented and control measures taken.

  • 4.13.5 Baits, traps and insect exterminators shall be fully functioning, sufficient in number, designed for purpose, placed in appropriate positions and used in a way that avoids any contamination risks.

  • 4.13.6 Incoming deliveries shall be inspected on arrival for the presence of pests. Any findings shall be recorded.

  • 4.13.7 The effectiveness of the pest control measures shall be monitored, including trend analysis, to allow timely appropriate actions. Records of this monitoring shall be available.

4.14 Receipt and storage of goods

  • 4.14.1 All incoming goods, including packaging materials and labels, shall be checked for conformity against specifications and a determined inspection plan. The inspection plan shall be justified by risk assessment. Records of those inspections shall be available.

  • 4.14.2 The storage conditions of raw materials, semi-finished, finished products and packaging materials shall correspond to product specification and shall not have any negative impact on other products. This shall be defined in an implemented and maintained system.

  • 4.14.3 Raw materials, packaging, semi-processed, finished products shall be stored so as to minimise the contamination risks or other negative impact.

  • 4.14.4 Appropriate storage facilities shall be available for the management and storage of working materials, process aids, and additives. The personnel responsible for the management of storage facilities shall be trained.

  • 4.14.5 All products shall be clearly identified. Use of products shall be undertaken in accordance with the principles of First In/ First Out and/ or First Expired/ First Out.

  • 4.14.6 Where a company hires a third-party storage service provider, the service provider shall be certified against IFS Logistics or any other GFSI recognised certification standard covering the respective scope of activity. If not, all relevant requirements equivalent to the company’s own storage practices shall be fulfilled and this shall be clearly defined in the respective contract.

4.15 Transport

  • 4.15.1 The conditions inside the vehicles, such as:<br>- absence of strange smells<br>- high dust load<br>- adverse humidity<br>- pests<br>- mould<br>shall be checked before loading and documented to ensure compliance with the specified conditions.

  • 4.15.2 Where goods are transported at certain temperatures, the temperature inside the vehicles shall be checked and documented before loading.

  • 4.15.3 Procedures to prevent contamination during transport, including loading and unloading, shall be in place. Different categories of goods (food/ non-food) shall be taken into consideration, if applicable.

  • 4.15.4 Where goods are transported at certain temperatures, maintaining the adequate range of temperatures during transport shall be ensured and documented.

  • 4.15.5 Adequate hygiene requirements for all transport vehicles and equipment used for loading/unloading (e.g. hoses of silo installations) shall exist. Measures taken shall be recorded.

  • 4.15.6 The loading/unloading area shall be appropriate for its intended use. They shall be constructed in a way that:<br>– the risks of pest intake is mitigated<br>– products are protected from adverse weather conditions<br>– accumulation of waste is avoided<br>– condensation and growth of mould are prevented<br>– cleaning can be easily undertaken.

  • 4.15.7 Where a company hires a third-party transport service provider, the service provider shall be certified for IFS Logistics or any other GFSI recognised certification standard covering the respective scope of activity. If not, all relevant requirements equivalent to the company’s own transport practices shall be fulfilled and this shall be clearly defined in the respective contract.

4.16 Maintenance and repair

  • 4.16.1 An adequate maintenance plan shall be in place, maintained and documented, that covers all critical equipment (including transport) for compliance with product requirements. This applies both to internal maintenance activities and service providers. The plan shall include responsibilities, priorities and due dates.

  • 4.16.2 Product requirements and prevention of contamination shall be ensured during and after maintenance and repair work. Records of maintenance and repair work shall be kept.

  • 4.16.3 All materials used for maintenance and repair shall be fit for the intended use and shall not pose contamination risks.

  • 4.16.4 Failures and malfunctions of plant and equipment (including transport) that are essential for food safety and quality, shall be identified, documented and reviewed to enable prompt actions and to improve the maintenance plan.

  • 4.16.5 Temporary repairs shall be carried out not to compromise food safety and product quality. Such work shall be documented and a short-term deadline set for eliminating the issue.

  • 4.16.6 Where a company hires a third-party maintenance and repair service provider, all the company specified requirements regarding material, equipment and operational rules shall be clearly defined, documented and maintained in the service contract, to prevent any product contamination.

4.17 Equipment

  • 4.17.1 Equipment shall be suitably designed and specified for the intended use. Before commissioning, it shall be verified that the product requirements are complied with.

  • 4.17.2 For all equipment and utensils with direct food contact, a certificate of conformity shall be in place, which confirms compliance with legal requirements.<br>In case no specific legal requirements are in place, evidence shall be available, such as:<br>- certificate of conformity<br>- technical specifications<br>- manufacturer's self-declaration to demonstrate that they are suitable for the intended use.

  • 4.17.3 Equipment shall be located to allow effective cleaning and maintenance operations.

  • 4.17.4 The company shall ensure that all product equipment is in a condition that shall not compromise food safety and product quality.

  • 4.17.5 The company shall ensure that in the event of changes to equipment, the process characteristics are reviewed in order to assure that the product requirements, as agreed with customers, are complied with.

4.18 Traceability

  • 4.18.1 A traceability system shall be in place that enables the identification of product lots and their relation to batches of raw materials and primary packaging materials. The traceability system shall incorporate all relevant records of:<br>- receipt<br>- processing<br>- use of rework<br>- distribution.<br>Traceability shall be ensured and documented until delivery to the customer.

  • 4.18.2 The traceability system shall be tested on a periodic basis, at least annually and each time the traceability system changes. The test samples shall represent the complexity of the company´s product range. The test records shall verify upstream and downstream traceability (from delivered products to raw materials, and vice versa). The traceability of the finished product shall be performed within four (4) hours maximum.

  • 4.18.3 Test results, including the timeframe for obtaining the information, shall be recorded and where necessary appropriate actions shall be taken. Timeframe objectives shall be defined and be in compliance with customer requirements.

  • 4.18.4 The traceability system shall identify the relationship between batches of final products and their labels.

  • 4.18.5 Traceability shall be ensured at all stages, including work in progress, post treatment and rework.

  • 4.18.6 Labelling of semi-finished or finished product lots shall be made at the time when the goods are directly packed to ensure a clear traceability of goods. Where goods are labelled at a later time, the temporarily stored goods shall have a specific lot labelling. Shelf life (e.g. best before date) of labelled goods shall be established using the original production batch.

  • 4.18.7 If required by the customer, identified representative samples of the manufacturing lot or batch number shall be stored appropriately and kept until expiration of the “Use by” or “Best before” date of the finished product and if necessary, for a determined period beyond this date.

4.19 Allergen risk mitigation

  • 4.19.1 Raw material specifications that identify allergens requiring declarations relevant to the country of sale of the finished products shall be available. The company shall maintain a continuously up-to-date listing of all raw materials containing allergens used on the premises. This shall also identify all blends and formulas to which such raw materials containing allergens are added.

  • 4.19.2 Based on hazard analysis and assessment of associated risk, preventive and control measures shall be in place from receipt to dispatch, to ensure that potential cross contamination of products by allergens is minimised. The potential cross contamination risks related to:<br>-environment<br>-transport<br>-storage<br>-raw materials<br>shall be considered.<br>Control measures shall be verified.

  • 4.19.3 Finished products containing allergens that require declaration shall be declared in accordance with legal requirements. Accidental or technically unavoidable cross-contaminations of legally declared allergens and traces shall be labelled. The decision shall be based on a hazard analysis and assessment of associated risks. The potential crosscontamination with allergens from raw materials processed in the company shall also be taken into account on the product label.

4.20 Food Fraud

  • 4.20.1 The responsibilities for a food fraud vulnerability assessment and mitigation plan shall be clearly defined. The responsible person(s) shall have the appropriate specific knowledge and have the full commitment from the senior management.

  • 4.20.2 A documented food fraud vulnerability assessment shall be undertaken on all raw materials, ingredients, packaging materials and outsourced processes, to determine the risks of fraudulent activity in relation to substitution, mislabelling, adulteration or counterfeiting. The criteria considered within the vulnerability assessment shall be defined.

  • 4.20.3 A documented food fraud mitigation plan shall be developed, with reference to the vulnerability assessment, and implemented to control any identified risks. The methods of control and monitoring shall be defined and implemented.

  • 4.20.4 The food fraud vulnerability assessment shall be regularly reviewed, at least annually, and/or in the event of increased risks. If necessary, the food fraud mitigation plan shall be revised/updated accordingly.

5. Measurements, analysis, improvements

5.1 Internal audits

  • 5.1.1 The company shall have an effective internal audit program in place which shall cover at least all the requirements of the IFS Standard.<br>Scope and frequency of internal audits shall be determined and justified by risk assessment. The internal audit program shall also apply to off-site storage locations owned or rented by the company.

  • 5.1.2 Internal audits of activities, which are critical to food safety and product quality, shall be carried out at least once a year.

  • 5.1.3 The auditors shall be competent and independent from the audited department.

  • 5.1.4 Internal audit results shall be communicated to the senior management and to persons responsible for the concerned activities. Necessary corrective actions and a schedule for implementation shall be determined, documented and communicated to the relevant person. All corrective actions resulting from the internal audits shall be verified.

5.2 Site factory inspections

  • 5.2.1 Site and factory inspections shall be planned and carried out for topics such as:<br>- constructional status of production and storage premises<br>- external areas<br>- product control during processing<br>- hygiene during processing and within the infrastructure<br>- foreign material hazards<br>- personnel hygiene.<br>The frequency of inspections shall be justified by risk assessment and be based on the history of previous experience.

5.3 Process and working environment validation and control

  • 5.3.1 The criteria for process and working environment validation and control shall be clearly defined.<br>Where the control of process and working environment parameters (temperature, time, pressure, chemical properties, etc.) are essential to ensure the food safety and product quality requirements, such parameters shall be monitored and recorded continuously and/ or at appropriate intervals.

  • 5.3.2 All rework operations shall be validated, monitored and documented. These operations shall not affect the food safety and product quality requirements.

  • 5.3.3 Procedures shall be in place for prompt notification, recording and monitoring of equipment malfunction and process deviations.

  • 5.3.4 Process validation shall be performed using the collected data that is relevant for food safety and the processes. If substantial modifications occur, a re-validation shall be carried out.

5.4 Calibration, adjustment and checking of measuring and monitoring devices

  • 5.4.1 The company shall identify and record the measuring and monitoring devices required to ensure compliance with food safety and product quality requirements. Their calibration status shall be recorded. Measuring and monitoring devices shall be legally approved if required by legisltation.

  • 5.4.2 All measuring devices shall be checked, adjusted and calibrated at specified intervals, with a monitoring system. This system shall be in accordance with defined, recognised standard/ methods and within relevant limits of the process parameters values. The results of the checks, adjustments and calibrations shall be documented.

  • 5.4.3 All measuring devices shall be used exclusively for their defined purpose. Where the results of measurements or the status of the device indicate a malfunction, the device in question shall be immediately repaired or replaced. Where necessary, corrections and corrective actions on processes and products shall be carried out.

5.5 Quantity control monitoring

  • 5.5.1 The company shall define compliance criteria to control lot quantity. A frequent and methodological strategy for quantity control shall be in place to meet legal requirements of the destination country/ies and customer specifications.

  • 5.5.2 Checks shall be implemented and recorded, according to a sampling plan which ensures a proper representation of the manufacturing lot. Results of these checks shall be compliant with defined criteria for all products ready to be delivered.

5.6 Product and process analysis

  • 5.6.1 Testing plans, for internal and external analysis shall be justified by risk assessment to ensure that product safety, quality, safety, legal and specific customer requirements are met. The plans shall cover topics, such as:<br>- raw materials<br>- semi-finished products,<br>- finished products<br>- packaging materials<br>- contact surfaces of processing equipment<br>- relevant parameters for environmental monitoring.<br>All test results shall be recorded.

  • 5.6.2 Analyses, which are relevant for food safety, shall preferably be performed by laboratories with appropriate accredited programs/ methods (ISO/IEC 17025). If the analyses are performed internally or by a laboratory without the appropriate accredited programs/ methods, the results shall be verified on a regular basis by laboratories accredited to these programs/methods (ISO/IEC 17025).

  • 5.6.3 Procedures shall exist which ensure the reliability of the internal analyses results, based on officially recognised analysis methods. This shall be demonstrated by ring tests or other proficiency tests.

  • 5.6.4 Results of analyses shall be evaluated promptly by competent personnel. Appropriate corrective actions shall be undertaken for any unsatisfactory results. The analytical results shall be reviewed regularly in order to identify trends and, when necessary, corrective actions shall be taken.

  • 5.6.5 Where internal analyses or controls are undertaken, these shall be carried out in accordance with defined procedures by trained and approved personnel, in defined areas or laboratories, using appropriate equipment.

  • 5.6.6 For verification of the quality of the finished product, internal organoleptic tests shall be carried out regularly. These tests shall be in accordance with specifications and related to the impact on respective parameters of product characteristics. The results of these tests shall be documented.

  • 5.6.7 The testing plan shall be regularly reviewed and updated, based on results, changes to legislation or issues that may have an impact on product safety, quality or legality.

5.7 Product release

  • 5.7.1 A procedure for quarantine (blocking/hold) shall be in place that is justified by risk assessment. The procedure shall ensure that only raw materials, semi finished and finished products and packaging materials conforming to product requirements, are processed and dispatched.

5.8 Management of complaints from authorities and customers

  • 5.8.1 A procedure shall be in place for the management of product complaints and of any written notification from the competent authorities –within the framework of official controls-, any ordering action or measure to be taken when non-compliance is indetified.

  • 5.8.2 All complaints shall be registered, readily available and assessed by competent staff. Where it is justified, appropriate actions shall be taken immediately.

  • 5.8.3 Complaints shall be analysed with a view to implementing appropriate actions to avoid the recurrence of the nonconformity

  • 5.8.4 The results of complaint data analysis shall be made available to the relevant responsible persons.

5.9 Management of incidents, product withdrawal, product recall

  • 5.9.1 A procedure shall be implemented and maintained for management of incidents and potential emergency situations with an impact on food safety, quality and legality. It shall include, at a minimum:<br> - the decision making process<br> - the nomination of a person, authorised by the company and permanently available, to initiate the incident management process in a timely manner<br>- the nomination and training of an incident management team,<br> - an up to date alert contact list including customer information, sources of legal advice, contacts availability,<br>-a communication plan including authorities.

  • 5.9.2 An effective procedure for the withdrawal and/or the recall of all products shall be in place. This procedure shall include a clear assignment of responsibilities and a comprehensive information policy for customers and consumers.

  • 5.9.3 The procedures for management of incidents and product withdrawal/recall, shall be subject to regular internal testing, at least once a year. This test shall be carried out to ensure the effective implementation and operation of the full procedure and shall include the verification of the updated contact data.

5.10 Management of non-conformities and non-conforming products

  • 5.10.1 A procedure shall be in place for the management of all nonconforming raw materials, semi-finished products, finished products, processing equipment and packaging materials. This shall include, at a minimum:<br>- defined responsibilities<br>- isolation/ quarantine procedures<br>- risk assessment<br>- identification including labelling<br>- decision about the further usage like release, rework/post treatment, blocking, quarantine, rejection/disposal.

  • 5.10.2 The procedure for the management of non-conforming products shall be understood and applied by all relevant employees.

  • 5.10.3 Where non-conformities are identified, immediate actions shall be taken to ensure that food safety and product quality requirements are complied with.

  • 5.10.4 Finished products (including packaging) that are out of specifications shall not be placed on the market under the corresponding label, unless a written approval of the brand owner is available.

5.11 Corrective actions

  • 5.11.1 A procedure shall be in place for the recording and analysis of non conformities and non-conforming products, with the objective to avoid recurrences by preventive and/or corrective actions. This may include a root cause analysis.

  • 5.11.2 Corrective actions shall be clearly formulated, documented and undertaken as soon as possible to avoid the further occurrence of non conformities. The responsibilities and the timescales for corrective actions shall be clearly defined.

  • 5.11.3 The effectiveness of the implemented corrective actions shall be assessed and the results of the assessment documented.

6 Food defence plan

  • 6.1 The responsibility for the food defence plan shall be clearly defined. Those responsible shall have the appropriate specific knowledge and training, and have full commitment from the senior management.

  • 6.2 A food defence plan and procedure shall be developed based on probability and be implemented in relation to assessed threats. This shall include:<br>- legal requirements<br>- identification of critical areas and/or practices and policy of access by employees<br>-visitors and contractors<br>- all other appropriate control measures.<br>The food defence plan shall be reviewed at least annually, and updated when appropriate.

  • 6.3 The test on the effectiveness of the food defence plan and the related control measures shall be included in the internal audit and the inspection plan.

  • 6.4 A documented procedure shall exist for managing external inspections and regulatory visits. Relevant personnel shall be trained to execute the procedure.

Completion

  • Other Comments

  • Recommended Actions

  • Name and Signature of Auditor

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