There should be sufficient personnel at all levels with the ability, training, experience and, where necessary, the professional and technical qualifications appropriate to the tasks assigned to them and commensurate with the size and type of the food business. Their duties and responsibilities should be clearly explained and recorded as job descriptions with associated organisation charts or by other suitable means. Training should cover not only key tasks, but also good manufacturing practice (GMP) generally, and the importance of, and factors involved in, personal hygiene. Personal hygiene protocols are a key prerequisite to ensure GMP.
17.1 Manufacturing companies vary widely in character, size and structure, whether they are independent or part of a group, and, in the latter case, the extent to which the character of their operations is subject to central control. There are also wide differences in terminology and job titles in different companies. These circumstances make it impossible to adopt rigid generalisations about the titles of key personnel but the principles outlined in this chapter are of importance, and the terms ‘production manager’, ‘quality control manager’ and ‘purchasing manager’ are used here for the sake of convenience, but may equally well be read as ‘general manager’, ‘operations manager’, ‘technical manager’, ‘quality assurance manager’, ‘procurement manager’ rather than the job title, as the responsibilities of the departments concerned.
17.2 Two key personnel are the production manager and the quality control manager, who should be two different people, neither of whom is responsible to the other, but who both have a responsibility to collaborate in achieving product safety, legality and the required product quality. A third key person is the purchasing manager, who has a special responsibility for ensuring that raw materials/ingredients are purchased in compliance with specifications, and for collaborating to that end with the quality control manager. A supplier quality assurance protocol that includes supplier performance monitoring should be developed for the manufacturing company following collaboration between the purchasing manager and the quality control manager (see Chapter 23).
17.3 Persons in responsible positions should have sufficient authority to discharge their responsibilities, which should be clearly defined (see 17.8). In particular, the quality control manager should be able to carry out his/her functions impartially and in accordance with the Institute of Food Science & Technology (IFST) Code of Professional Conduct (http://www.ifst.org).
17.4 The quality control manager should possess appropriate professional and scientific/technological qualifications, and experience in food safety, food legality and food quality control. She/he should also possess interpersonal skills so that she/he can effectively communicate food safety, legality, integrity and quality criteria at all levels within the organisation.
17.5 Key personnel within the manufacturing organisation should be provided with an adequate number and calibre of supporting staff. A formal human resource appraisal should be undertaken with consideration given to the requirements of developing, validating, implementing, monitoring, revalidating and verifying the hazard analysis critical control point (HACCP) plan(s), the food safety management system (FSMS), the food integrity management system (FIMS) and the quality management system (QMS) and associated quality plans. These formalised systems may be separate or may be integrated into one formal documented system. The human resource appraisal review should include the identification of the human resources required to implement these system(s) consistently and effectively. A further review should be undertaken, minimally each year or more frequently when operational circumstances change that impact on the resource requirement needed. These reviews and any associated actions should be documented.
17.6 Key personnel within the manufacturing organisation should be direct employees of the company. Persons contracted, but not employed directly by the company, may be retained to provide advice or to carry out special projects, but should not be regarded as filling key personnel positions. During the approval process for contract personnel, it is important to determine the level of qualifications, current validity of membership of professional bodies and the status of continuous professional development (CPD), and, wherever possible, seek references from previous clients.
17.7 Persons should be designated to take up the duties of key personnel during the absence of the latter. This should be formally documented, and the organisation must be able to demonstrate that deputies are competent to undertake the role when required.
17.8 The ways in which those responsibilities that can influence product safety, legality, integrity and quality and the authority to discharge them are distributed among key personnel may vary with different manufacturers. What is essential in all organisational arrangements is that responsibilities should be clearly defined and allocated and areas of authority delineated. These arrangements should be properly understood and respected by all concerned. This may be documented in job descriptions/specifications, organisation charts or alternative documents.
17.9 The quality control manager should have the authority to establish, validate, implement and verify all food safety, legality, integrity and quality control procedures, to approve materials and products, and to withhold approval from any material or product that does not comply with the relevant specification. In some organisations, withholding of approval amounts to absolute rejection; in others, it amounts to provisional rejection subject to confirmation by the general management or the managing director; in yet others, it may be absolute rejection in certain defined serious cases, and provisional rejection in others. In exercising authority in the foregoing ways, the quality control manager, subject to the proper discharge of responsibilities, is under obligation to do everything possible to minimise and preferably prevent any disruption of production and/or distribution arrangements and schedules, and to provide prompt information and advice to production personnel to help maximise conformance with specification, and, in the case of non‐conformance, to provide advice on rectification or reworking if possible. The quality control manager should, where required, identify whether the rejection is on the grounds of legislative, food safety or quality criteria to ensure suitable advice to production staff and to enable appropriate corrective action. The quality control manager has a leading role in defining preventive action where weaknesses in the QMS/FSMS/FIMS and/or compliance in practice with the QMS/FSMS/FIMS have been identified and non‐conforming product has not yet been produced. The production manager should fully support such initiatives and enable preventive action to be implemented and effective.
17.10 The production manager should have responsibility for manufacturing resources, including processing areas, personnel, equipment, operations and records, and for using these resources to produce, in accordance with the master manufacturing instructions or equivalent, the programmed quantities of products conforming to the relevant quality specifications and within the budgeted cost. In addition, the production manager usually has some responsibilities that are shared, or exercised in liaison with, the quality control manager and other personnel. The production manager should be a member of the HACCP team and should participate in the development and acceptance of specifications, particularly the master manufacturing instructions and the finished product specifications, and in the training of production personnel. She/he should liaise with the quality control manager in ensuring an optimum manufacturing environment, in particular in relation to controlling and minimising extrinsic hazards (food safety hazards arising from the processing area, personnel, equipment and operations), hygiene and for quarantining and rectification of any non‐conforming product. The production manager should not have authority to use any raw materials or intermediates that have not been approved for use, unless a concession has been formally agreed with the quality control manager or designate.
17.11 The quality control manager should have an advisory role in the choice of suppliers of raw materials, packaging and services (see Chapter 23).
17.12 In the recruitment and selection of staff, due regard should be given to the required prerequisite skills and the potential suitability of the candidate for the task in hand. For example, persons of clean and tidy and methodical nature may be more likely to appreciate the principles required in the hygienic handling and storage of food and the implementation of the FSMS, FIMS and the QMS, than those who are not. Similarly, potential employees should be appropriately qualified for the requirements of the task as defined in the job description/specification.
17.13 Training is necessary to enable personnel at all levels within the organisation to understand their responsibilities and improve their knowledge and skills. Effective training will also improve individual performance and reduce the level of supervision required. Training will only be effective when the provision of knowledge develops thorough understanding and is relevant to the individual’s tasks and responsibilities. The implementation of the knowledge acquired by individuals requires management support, including appropriate opportunity to practise skills, ensure motivation and provide effective supervision. It should be noted that while a certificate of attendance at an internal/external training course is of value, that value is limited if it cannot be verified that the person(s) attending such training can effectively implement the skills and knowledge gained in practice in the manufacturing environment. Similarly signatures on a training record demonstrate training has taken place, but do not in themselves provide evidence of ongoing staff competence. Therefore the internal audit programme needs to include in its scope the verification of personnel competence at all levels of the organisation as well as the presence of training certificates, especially where their work activities can affect food safety, legality, integrity and quality.
Training records should be maintained and they should provide as a minimum details of the nature and content of the training undertaken, the date and duration of the training activity, the identity of the trainer and the signatures of the trainee to verify training has taken place and the trainer to confirm that the training was effective and the individual is competent. Individuals should only be signed off subsequent to the training course or activity when they have demonstrated this competence in all aspects of the job role to the satisfaction of the trainer or designate. Some job roles will require specific training, for example individuals involved in chemical handling, machine operating and pest control, and this must be documented and signed off again by the relevant person to demonstrate that the individual has attained a minimum level of competence. The initial and ongoing level of competence of the trainers should also be identified and documented by the manufacturing organisation in order to verify that they can provide appropriate training and knowledge transfer to staff. If agency staff are used, then their training and the competence of the agency trainers must be verified as suitable before they commence work. Additional site‐specific training will be required in addition to familiarise agency staff with the specific aspects of the manufacturing process and the food safety, legislative and quality controls in place on the site. Full consideration should be given to the risk of using agency staff at critical control points (CCPs), critical quality points (CQPs) and critical legislative points in the manufacturing process with respect to their suitability and degree of competence for the role. Use of agency staff should form a component of the risk assessment process in ensuring the FIMS system is appropriate and effective.
17.14 All production and quality control personnel should be trained in the principles of GMP, and in the practice and underlying principles of the tasks assigned to them. Similarly, all other personnel (e.g. those concerned with maintenance or services or cleaning) whose duties take them into manufacturing areas or have a bearing on manufacturing activities should receive appropriate training. Records should be kept of the training of each individual. Where individuals are working at CCPs as defined in the HACCP plan and/or have responsibility for the effective implementation of prerequisite programmes (PRPs) or food integrity countermeasures, the manufacturing organisation must develop and implement training programmes to ensure that these individuals have appropriate levels of competence, skills and knowledge to support the effective adoption of the HACCP plan, QMS, FSMS and FIMS. Similarly, those individuals working at CQP and critical legislative points such as label printing, quantity control (weight, volume, count) and points of control of provenance, assured status and identity control should have appropriate training and supervision to ensure that they are competent, they understand their job role and its importance, and that legislative requirements are consistently met.
17.15 Training should be in accordance with programmes approved by the production manager and the quality control manager. Training should be given at recruitment (usually termed induction training) and repeated, augmented and revised as necessary. The degree of an individual’s knowledge and understanding of the content and application in the workplace of the information contained in the induction training should be tested and verified before individuals can commence work unsupervised. It is essential to consider developing a ‘buddy system’ for new employees during induction so they can receive on‐the‐job training and support. In the event of non‐conformance by staff with procedures and work instruction then retraining should be undertaken as required. Records of induction training should be retained for all personnel, and with returning seasonal workers induction training should be undertaken each season, with particular emphasis on changes in legislation, customer requirements and emerging food safety, legality, integrity and quality issues. Both in training itself and with regard to the need for personnel to be able to understand and follow written instructions and procedures, notices and so on, particular attention should be given to overcoming language, numeracy or literacy difficulties. Recommendations for the content of induction and supplementary hygiene training programmes are contained within the Industry Guides to Good Hygienic Practice.1 These guides were initially developed in accordance with Article 5 of the EC Directive on the Hygiene of Foodstuffs (93/43/EEC) Regulation (EC) No. 852/2004 and continue to apply after 1 January 2006, and continue to remain compatible with the objectives of the new legislation. Many older guides may not necessarily cover all of the revised requirements, and to date they have not all been reissued as revised guides. Ten guides have been subsequently published that address the following sectors: mail order food, wholesale distribution, sandwich bars and similar food outlets, flour milling, vending and dispensing, bottled water, sandwich manufacturing, whitefish processors, spirit drinks and retail. While not all the guides are in sectors defined as a manufacturing process, manufacturing organisations need to be aware of the requirements of subsequent sectors in the supply chain that they supply in order to ensure supply chain compliance.
17.16 Periodic assessments of the effectiveness of training programmes should be made, and checks should be carried out to confirm that designated procedures are being followed. Training programmes can be evaluated by a number of techniques, including:
17.17 Training should be reinforced by adequate supervision, mentoring and support, regular performance reviews, refresher training at designated intervals, posters and notices, reviewing the results of routine microbiological monitoring and quality performance with personnel and recognising good practice. Refresher training is required where any element of the QMS, FIMS or FSMS changes, especially the induction programme, so that all staff are consistently trained to the same level. The time period as to when a person is deemed competent and thus needs less supervision is dependent on the individual and requires ongoing review by the relevant member of management. The organisation should develop an electronic training database, or a paper‐based or electronic training matrix, to control the training requirements for the organisation. The training matrix, or equivalent, should state the current level of training for all staff. It should identify for a specific job role what level of training and competence is required in terms of internal and external training and the current level of training of all staff in that job role. This will assist the organisation in undertaking a training needs analysis to identify those who require further training for the first time or in the form of refresher training. The training matrix should therefore identify those staff currently in the induction phase and receiving training, those individuals who are signed off as competent, but may need refresher training and those who are deemed able to train others. The training matrix should be reviewed at designated intervals. If as a result of review and/or other audit activities inconsistencies in training and competence are identified, appropriate preventive or corrective action needs to be determined and then implemented. The details of the training matrix review and any subsequent preventive or corrective action should be recorded and records retained as a demonstration of due diligence. Formal employee appraisals should also be undertaken. These employee appraisals should include ongoing performance monitoring and should determine if there are any areas where the individual concerned requires further development support and/or training.
17.18 Where employment is terminated for any reason, consideration should be given to any possible risks arising through disaffection or simple lack of continuing interest and commitment from the employees concerned, and appropriate precautions taken as necessary.
17.19 Many important aspects of hygiene are also dealt with in Chapters 10 and 19. It is essential that all personnel are appropriately trained in relevant aspects of food hygiene. Regulation (EC) No. 852/2004 of 29 April 2004 on the hygiene of foodstuffs, as amended, came into automatic force in all Member States on 1 January 2006, and continued the requirement of earlier legislation that food business operators should ensure:
Sections 17.20–17.22 refer particularly to ensuring high standards of personal hygiene of all concerned with the production processes and all persons entering production areas, including quality control personnel, product development personnel, engineers and maintenance personnel, inspectors, senior management, contractors and visitors.
17.20 Instruction should not be regarded as an adequate substitute for training, which provides not only information on what should be done, but an understanding of why it is important. Training should embody the requirements of personal hygiene, the reasons why they are important and the fact that they are legal requirements. Adequate facilities and resources must be provided to enable personnel to comply fully with those requirements.
17.21 In the UK, the manufacturer must comply with the requirements of EU Regulation (EC) No. 852/2004 and EU Regulation No. 853/2004, which are also tabulated in Schedule 2, Specified Community Provisions, in the Food Hygiene (England) Regulations 2006 and in the equivalent Scotland, Wales and Northern Ireland Regulations (or with any regulations that may at any future time supersede these regulations). EU Regulation (EC) No. 852/2004 states that every person working in a food‐handling area is to maintain a high degree of personal cleanliness and is to wear suitable, clean and, where necessary, protective clothing but does not specify the detail of personal hygiene requirements. However, the following should be regarded as essential:
17.22 It is the responsibility of the quality control manager to ensure that personal hygiene policies and protocols have been developed and that good hygienic practice has been explained to, and is fully understood by, employees, visitors and contractors. Managers should communicate the policies and protocols to all personnel and demonstrate full management commitment to the requirements, advise employees, visitors and contractors of their legal obligations under European Union (EU) and UK food hygiene legislation to report any infectious or potentially infectious conditions, and exclude infectious or potentially infectious food handlers as specifically required by EU legislation. Managers should continuously review whether there are any barriers to good personnel hygiene practice and remove them where necessary. These include ensuring that:
Managers should follow appropriate action, including retraining, with staff who exhibit unhygienic practices.
17.23 The site should develop and implement a sickness reporting procedure, which identifies the actions to be taken should an individual fall ill either before or during his/her period of work. All staff should notify the manufacturing business in the event that they or a person they have been in contact with is suffering from or carrying an illness that could cause a food poisoning or food‐borne illness outbreak before they commence work. The FSA Food Handlers: Fitness to Work – Regulatory Guidance and Best Practice Advice for Food Business Operators 2009, published in May 2009, identifies best practice in this area. Procedures should be in place should an individual fall ill at work in terms of reporting procedures, and these should form part of induction training. Procedures should also be implemented for managing any spillage of bodily fluid spillages, for example vomiting and bleeding, within the production and storage areas. Bodily spill kits are available that can be used and then disposed of in a way that minimises the risk of contamination. All contaminated products should be disposed of, as appropriate.
17.24 The employment of agency staff should be in compliance with the legal requirements operating in the country where the manufacturing site is situated. In the UK, employment agencies that operate in food processing must hold a valid Gangmaster and Labour Abuse Authority (GLAA) approval. The onus is on the manufacturer to check at routine intervals that the agencies’ approval has not been revoked. In order to manage this effectively, a formal procedure should be in place with responsibilities defined as to who will coordinate and implement the procedure and, if required, appropriate corrective action. The training requirements outlined in this chapter apply as equally to agency staff as they do to employed staff. If training and medical records are held by the agency, they should be routinely verified as appropriate by the quality control manager or designate. If the agency is responsible for the laundering of protective clothing, then they should comply with all necessary controls (see 17.21h for more information).
17.25 It may be a requirement of retail customers as a prerequisite to supply that the manufacturer complies with the Ethical Trading Initiative (ETI) Base Code, SA 8000 or another third‐party standard. It is best practice for manufacturers where this is a requirement to ensure that their suppliers comply with the relevant ethical trading standard(s) as well. It may also be a supply chain requirement for a manufacturer to be a member of the Supplier Ethical Data Exchange (Sedex) as well as having a formal Sedex Members Ethical Trade Audit (SMETA). For further details see Chapter 18.
17.26 Training in food integrity management and to create awareness of the potential for food crime and illicit behaviour is necessary to enable personnel at all levels within the organisation to understand their personal responsibilities and improve their knowledge and skills in this area of GMP. Training to ensure that there is adequate understanding of organisational whistleblowing procedures should be undertaken and there should be verification activities carried out to measure the degree of understanding at all levels of management. For more details see Chapters 5 to 7.
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