Hazard analysis approaches for certain small retail establishments in view of the application of their food safety management systems
2017; Wiley; Volume: 15; Issue: 3 Linguagem: Inglês
10.2903/j.efsa.2017.4697
ISSN1831-4732
AutoresAntonia Ricci, Marianne Chemaly, Robert Davies, Pablo Salvador Fernández Escámez, Rosina Gironés, Lieve Herman, Roland Lindqvist, Birgit Nørrung, Lucy J. Robertson, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, Helene Wahlström, Ana Allende, Lars Barregård, Liesbeth Jacxsens, Kostas Koutsoumanis, Moez Sanaa, Theodoros Varzakas, Katleen Baert, Michaela Hempen, V. Rizzi, Yves Van der Stede, Declan Bolton,
Tópico(s)Risk Perception and Management
ResumoEFSA JournalVolume 15, Issue 3 e04697 Scientific OpinionOpen Access Hazard analysis approaches for certain small retail establishments in view of the application of their food safety management systems EFSA Panel on Biological Hazards (BIOHAZ), EFSA Panel on Biological Hazards (BIOHAZ)Search for more papers by this authorAntonia Ricci, Antonia RicciSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorPablo Salvador Fernández Escámez, Pablo Salvador Fernández EscámezSearch for more papers by this authorRosina Girones, Rosina GironesSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorBirgit Nørrung, Birgit NørrungSearch for more papers by this authorLucy Robertson, Lucy RobertsonSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorEmma Snary, Emma SnarySearch for more papers by this authorNiko Speybroeck, Niko SpeybroeckSearch for more papers by this authorBenno Ter Kuile, Benno Ter KuileSearch for more papers by this authorJohn Threlfall, John ThrelfallSearch for more papers by this authorHelene Wahlström, Helene WahlströmSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorLars Barregård, Lars BarregårdSearch for more papers by this authorLiesbeth Jacxsens, Liesbeth JacxsensSearch for more papers by this authorKostas Koutsoumanis, Kostas KoutsoumanisSearch for more papers by this authorMoez Sanaa, Moez SanaaSearch for more papers by this authorTheo Varzakas, Theo VarzakasSearch for more papers by this authorKatleen Baert, Katleen BaertSearch for more papers by this authorMichaela Hempen, Michaela HempenSearch for more papers by this authorValentina Rizzi, Valentina RizziSearch for more papers by this authorYves Van der Stede, Yves Van der StedeSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this author EFSA Panel on Biological Hazards (BIOHAZ), EFSA Panel on Biological Hazards (BIOHAZ)Search for more papers by this authorAntonia Ricci, Antonia RicciSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorPablo Salvador Fernández Escámez, Pablo Salvador Fernández EscámezSearch for more papers by this authorRosina Girones, Rosina GironesSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorBirgit Nørrung, Birgit NørrungSearch for more papers by this authorLucy Robertson, Lucy RobertsonSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorEmma Snary, Emma SnarySearch for more papers by this authorNiko Speybroeck, Niko SpeybroeckSearch for more papers by this authorBenno Ter Kuile, Benno Ter KuileSearch for more papers by this authorJohn Threlfall, John ThrelfallSearch for more papers by this authorHelene Wahlström, Helene WahlströmSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorLars Barregård, Lars BarregårdSearch for more papers by this authorLiesbeth Jacxsens, Liesbeth JacxsensSearch for more papers by this authorKostas Koutsoumanis, Kostas KoutsoumanisSearch for more papers by this authorMoez Sanaa, Moez SanaaSearch for more papers by this authorTheo Varzakas, Theo VarzakasSearch for more papers by this authorKatleen Baert, Katleen BaertSearch for more papers by this authorMichaela Hempen, Michaela HempenSearch for more papers by this authorValentina Rizzi, Valentina RizziSearch for more papers by this authorYves Van der Stede, Yves Van der StedeSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this author First published: 02 March 2017 https://doi.org/10.2903/j.efsa.2017.4697Citations: 14 Correspondence: biohaz@efsa.europa.eu Requestor: European Commission Question number: EFSA-Q-2015-00593 Panel members: Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo Salvador Fernández Escámez, Rosina Girones, Lieve Herman, Kostas Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Antonia Ricci, Lucy Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, and Helene Wahlström. Acknowledgements: The BIOHAZ Panel wishes to thank the following for the support provided to this scientific output: the CONTAM Panel: Jan Alexander, Lars Barregård, Margherita Bignami, Beat Brüschweiler (from 23 June 2016), Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Lutz Edler, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Carlo Stefano Nebbia, Isabelle Oswald, Annette Petersen, Vera Maria Rogiers (until 9 May 2016), Martin Rose, Alain-Claude Roudot, Tanja Schwerdtle, Christiane Vleminckx, Günter Vollmer, Heather Wallace. The Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output. Adopted: 18 January 2017 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Under current European hygiene legislation, food businesses are obliged to develop and implement food safety management systems (FSMS) including prerequisite programme (PRP) activities and hazard analysis and critical control point principles. This requirement is especially challenging for small food retail establishments, where a lack of expertise and other resources may limit the development and implementation of effective FSMS. In this opinion, a simplified approach to food safety management is developed and presented based on a fundamental understanding of processing stages (flow diagram) and the activities contributing to increased occurrence of the hazards (biological, chemical (including allergens) or physical) that may occur. The need to understand and apply hazard or risk ranking within the hazard analysis is removed and control is achieved using PRP activities as recently described in the European Commission Notice 2016/C278, but with the addition of a PRP activity covering 'product information and customer awareness'. Where required, critical limits, monitoring and record keeping are also included. Examples of the simplified approach are presented for five types of retail establishments: butcher, grocery, bakery, fish and ice cream shop. Summary The European Commission (EC) requested that the European Food Safety Authority (EFSA) provides a scientific opinion on hazard analysis approaches within food safety management systems (FSMS) for small retail establishments, specifically a butcher shop, a grocery, a bakery, a fish shop and an ice cream shop as summarised in the flow diagrams (Section 3.3). Given the difficulties these small retailers have in developing and implementing effective FSMS, including prerequisite programme (PRP) activities and hazard analysis and critical control point (HACCP) principles, the EC specifically requested (1) the formulation of guidelines on how to identify the most relevant biological hazards and, if relevant, chemical (including allergens) and physical hazards at each step in these enterprises; (2) the provision of guidance on methodology for hazard ranking (within HACCP), and the selection of the most appropriate method(s) for each type of retail activity; (3) the provision of guidance on how to select, implement and validate the most efficient approaches to control the hazards identified (considering critical control points (CCP), PRPs, critical limits and monitoring systems); and (4) to use the guidelines developed in (1)–(3) to identify and rank the hazards in each of the five retail establishments and to describe appropriate control activities for the hazards identified (including PRPs, control points and CCPs) and, where appropriate, indicate critical limits and monitoring systems. The primary methods used to develop this scientific opinion included a review of the relevant scientific and grey literature, including previous EFSA opinions, such as the EFSA BIOHAZ Panel opinion on the development of a risk-ranking toolbox, and expert discussion within the working group. The latter was informed by guidelines and information provided on good hygiene practice (GHP), HACCP and FSMS by EC, Codex Alimentarius, Food and Agriculture Organization of the United Nations (FAO), etc. Based on the literature review, the history and legislative framework of FSMS, with particular focus on HACCP, were initially examined and the constraints to implementing effective FSMS in small retail food businesses identified, including food safety culture/climate, staff expertise and turnover, cost, documentation/record keeping, development of CCPs, verification of the FSMS and supplier control. It quickly became apparent that retail is only one step in the agri-food chain and often the critical control activity, e.g. cooking occurs at a different stage in this chain. Thus, for example, if a butcher shop receives beef carcasses contaminated with Salmonella spp., the butcher can undertake activities such as correct chilling, cleaning, storage of raw meat separate from ready-to-eat (RTE)/cooked and other activities to control growth and cross-contamination, thereby preventing an increase in risk to the consumer, but will not be able to apply an intervention that will eliminate the Salmonella organisms. Food safety should therefore be practised at all stages in the food chain and food processors should only source raw materials from producers with fully operational and inspected (e.g. using audit certificates) FSMS. The literature survey was also used to identify and describe biological, chemical and physical hazards. Allergens were considered in addition to other chemical hazards as they are a major and ever increasing issue for food businesses and affect a sensitive subpopulation, whereas other chemical hazards impact the whole population. PRP activities and HACCP principles were then described. Given the problems for small retail businesses in developing and implementing effective FSMS, the overriding principle in answering the Terms of Reference (TORs) was to develop guidelines for a hazard analysis approach (hazard identification, ranking and control options) that were easy to understand and implement. Thus, when answering the TORs, the current (classical) approach was first described and, based on the same principles, a simpler, more user-friendly, but equally effective hazard analysis methodology/approach was developed ('simplified' approach). In hazard identification, for example, flow diagrams summarising the stages involved in the retail establishment were used in both approaches. However, the new simplified approach did not require a detailed description of the activities at each stage but instead used the flow diagrams to guide the development of a 'Small Food Retailer Food Safety Management System (SFR-FSMS)' presented as a table. The development of tabulations throughout this opinion represents the new simplified approach to food safety management for the target retail establishments. Moreover, it was considered sufficient for the retailer to know whether or not a biological, chemical or physical hazard or allergen might occur at each stage without necessarily describing each specific hazard in detail, but instead realising that a failure to undertake key control activities, such as correct chilled storage or separation of raw from RTE/cooked products, etc. could contribute to increased exposure of the consumer to the hazard. Classical qualitative, semi-quantitative, and fully quantitative methods for hazard ranking are described. In the classical approach, hazard ranking is used to inform the type of control activities required; hazards ranked as high require a specific intervention at a CCP to control them. In contrast, it is considered, based on the hazard analysis, that all the hazards that occur in the food retailers targeted in this opinion could be controlled using PRPs. Thus a simplified approach, that does not require hazard ranking, is presented. The next stage in the development of the 'SFR-FSMS' was to assign PRPs to control the hazards that may occur at each stage, as identified in the flow diagrams. These PRPs were based on those described in the Commission Notice 2016/C 278/01, but with the inclusion of an additional PRP 'product information and customer awareness' (PRP 13). Most PRP activities are based on qualitative and not quantitative parameters and thus are evaluated as being 'acceptable' or 'unacceptable'. Cleaning, for example, may be based on visual inspection. Other PRPs (e.g. cooking or chilling) are based on quantitative parameters (e.g. temperature) and their correct application may be assured by setting critical limits that must be achieved to ensure food safety. In the simplified approach the former PRPs based on qualitative parameters do not require record keeping but for the latter based on quantitative parameters, monitoring is required to ensure critical limits are achieved and records should be kept to demonstrate compliance. In the final section (Section 3.3) the 'simplified approach' was applied to the five target small food retail establishments. 1 Introduction 1.1 Background and Terms of Reference as provided by the European Commission 'In accordance with Regulation (EC) No 852/2004 on hygiene of foodstuffs, all food business operators (FBO) must comply with general hygiene requirements (Good Hygiene Practices, GHP) laid down in the Annexes I (primary production and associated operations) or II (other FBOs) of the Regulation. In addition, FBO, other than primary producers, must put in place, implement and maintain a permanent procedure or procedures based on the Hazard Analysis and Critical Control Points (HACCP) principles (Article 5). The GHP, together with good manufacturing practices (GMP) and traceability provisions are considered as prerequisite programmes (PRPs), which, together with the procedures based on the HACCP principles, must result in an integrated food safety management system (FSMS) for each business operator. A risk-based approach covering sector-relevant (micro-)biological, chemical and physical hazards is essential. The establishment and implementation of such FSMS requires knowledge and resources which is not always available in small food enterprises. The Regulation explicitly refers to the need of flexibility for the application of procedures based on the HACCP principles in case of small businesses. In particular, it is necessary to recognise that in certain food businesses, it is not possible to identify critical control points (CCPs) and that, in some cases, GHP or PRPs in general, can replace the monitoring of CCPs (recital 15). The nature and the size of the food business must be taken into account when verifying compliance with the procedures based on the HACCP principles (Art 5(4)(a)). Food retailers (e.g. restaurants, butchers, bakeries, caterers, groceries, pubs, etc.) are often small enterprises and therefore flexibility as well as scientific input to apply a risk-based FSMS is very much needed for the retail sector. The Commission already published in 2005 a Guidance document on the implementation of procedures based on the HACCP principles, and facilitation of HACCP principles in certain food businesses. Recently, the Food and Veterinary Office (FVO) of the Commission Directorate General Health and Food Safety carried out a desk study, fact-finding missions and consultations of Member States and private stakeholders' organisations on a state of play of the implementation of HACCP in the European Union (EU) and areas for improvement. The FVO Report provides several suggestions for improvement, including guidance on hazard analysis and setting of CCPs. Flexibility on FSMS starts from the principle that each food business needs to comply at least with relevant PRPs and carry out a hazard analysis using a risk-based approach. In such hazard analysis, hazards identified as major risks in the specific food establishment may result in CCPs, while less important hazards may be controlled by the PRPs. On 9 January 2015, EFSA published an external scientific report on risk ranking for prioritisation of feed and food-related issues (EFSA supporting publication 2015:EN-170). The report reviews methodologies for ranking of risks on the basis of their anticipated human health impact. Based on the characteristics of the individual methods and the method categories, an overarching framework (decision tool) was developed for the selection of the appropriate method(s) for risk ranking. Several of the reviewed methods have been used in hazard analysis carried out within the frame of identifying important hazards for procedures based on the HACCP principles, e.g. Risk matrices: – Chapter on 'Semi-quantitative risk characterisation' in 'Risk Characterization on microbiological hazards in food', WHO, FAO Microbiological Risk Assessment Series 17 (ISSN 1726-5274) – Jacxsens L, Devlieghere F, Uyttendaele, M, 2009. Quality management systems in the food industry. ISBN 978-90-5989-275-0. Decision tree: – See Diagram 2 of the Annex to the Codex Alimentarius 'General Principles of Food Hygiene' (CAC/RCP 1-1969) In order to facilitate the implementation of FSMS by certain retailers, typically small enterprises, it is appropriate to develop generic hazard analysis using the most appropriate methodology for risk ranking. Such hazard analysis should include at least hazard identification, hazard assessment (risk ranking) and the selection of most appropriate control measures. Five specific retail activities, from which a generic flow chart is provided in the appendix, have been selected as examples for providing guidance on hazard analyses for these activities, subject to adaptation to each individual retail establishment. The Opinion could also provide input for the EU position at the planned revision of the Codex Alimentarius 'General Principles of Food Hygiene' (CAC/RCP 1-1969), including the Annex on HACCP. Terms of Reference EFSA is asked to provide a Scientific Opinion on a hazard analysis approach for certain small retail establishments in view of the application of their FSMS. In particular, starting from generic flow diagrams with processing steps for respectively a butcher shop, a grocery, a bakery, a fish shop and an ice cream shop in the appendix to the mandate, EFSA is requested: To formulate guidelines on how to identify the most relevant biological hazards and if relevant chemical, including allergens and physical at each step in the enterprises; To provide guidance on methodology for hazard ranking (within HACCP) and select most appropriate method(s) for each type of the selected retail activities; To provide guidance on how to select, implement and validate the most efficient approaches to control hazards (considering CCP, PRPs, critical limits and monitoring system); Using the guidance developed in TOR 1, 2 and 3, to identify and rank the hazards in each of the five retail establishments and to describe appropriate control activities for the hazards identified including PRPs, control points and CCPs and, where required, indicate critical limits and monitoring systems. When carrying out the analysis and making recommendations, EFSA should consider that mostly these small retailers are limited with regard to knowledge and resources. EFSA should take into account proportionality to the nature and size of the enterprise as laid down in Regulation (EC) No 852/2004.' 1.2 Interpretation of the Terms of Reference The Terms of Reference (TORs) have been interpreted to include: (1) the development of generic guidelines to identify the hazards that should be controlled within a FSMS in retail establishments; (2) the development of guidance for hazard ranking in the frame of FSMS; (3) the development of guidelines for the effective control of hazards through PRP and/or HACCP type systems; and (4) the application of these guidelines (1–3, above) to hazard identification, ranking and control in five small retail establishments including butcher, grocery, bakery, fish and ice cream shops. Food safety hazards include biological, chemical and physical hazards. Although the primary focus of this opinion is on biological hazards, the latter are also covered. Biological hazards include bacteria, viruses, parasites and fungi. For each of the five retail establishments the biological hazards that may occur at each step in the processes used (as identified in the flow diagram) are identified. Control options are presented, including an explanation as to whether these should be part of the PRP or HACCP plan. Chemical hazards include contaminants, veterinary drug residues, pesticide residues, cleaning chemical residues, allergens, additives and migration from food contact materials. For the purposes of this opinion the broad categories of chemical hazards are identified but information on specific chemicals/compounds is not provided. Allergens are discussed separately. Physical hazards include those intrinsically present in the food, for example bones of parts thereof in fish and meat products, etc., and extrinsic physical hazards such as metal, glass, wooden splinters, etc. As with the chemical hazards, the broad categories of physical hazards are presented including the step(s) in the process where they might occur and potential control activities provided. Retail is defined by Regulation (EC) No 178/20021 as 'the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets'. Small/micro businesses are usually independently owned and operated with limited size in terms of staff and turnover. The exact definition varies depending on the country and function of the definition: small businesses are defined by EC Recommendation 2003/361 on the basis of staff head count and turnover or balance sheet total. Thus 'small' businesses are defined as having less than 50 employees, a turnover or balance sheet total of €10 million or less. 'Micro' businesses are defined as having less than 10 employees (but in many cases may have as few as two to three employees), with a turnover or balance sheet total of €2 million or less. A business or firm that is part of a larger group should be included in the head count, turnover or balance sheet data from that company. The small retail establishments (butcher, grocery, bakery, fish and ice cream shops) covered by this opinion are typically 'micro' business. The nature of the small company can also be defined by the qualities they generally share: they serve local customers; have a limited share of the available market; are owned by one person, or by a small group of people; are managed by their owners who deal with all management issues, usually with little other help; and they are independent businesses not parts of, or owned by, larger companies (Taylor, 2001). 1.3 Additional information 1.3.1 Introduction to the assessment In order to minimise the risks associated with the consumption of food, every part of the food chain must be controlled to prevent or, where prevention is not possible, to minimise contamination. This control is achieved using FSMS. Each FSMS is company/enterprise-specific and is the result of the implementation of various quality assurance and legal requirements (Jacxsens et al., 2011). A preventive FSMS should provide a proactive rather than a reactive approach to food safety through continuous management system monitoring, verifying and making corrections before a hazard occurs. FSMS implemented in companies include PRPs including good agricultural practices (GAPs), GMPs, and GHPs as well as HACCP based on national and international as well as public and private standards and guidelines (CAC, 2003; Jacxsens et al., 2009). A FSMS in a retail business should be focused on the continuous identification of hazards and the implementation of specific activities to achieve active managerial control of the risk factors contributing to foodborne illness. However, developing, applying and updating FSMS (PRP and HACCP) at the retail stage of the food chain present several difficulties including a lack of understanding, inconsistencies between guidance documents, lack of resources (especially in small and micro retail enterprises), inconsistency in inspection/audits, a lack of flexibility, inadequate training, difficulties in identifying critical control points (CCP), and issues with monitoring, corrective actions and record keeping. Moreover, even when a PRP and HACCP plan are in place, their successful implementation is reliant on the shared attitudes, values, beliefs, and hygiene behaviours of the staff (Griffith et al., 2010). Thus PRP and HACCP effectiveness is dependent on a strong business food safety culture (Wallace et al., 2012, 2014). 1.3.1.1 History and legislation The concept of HACCP dates back to the 1960s when the Pillsbury Company developed this system to assure the safety of food for astronauts on the first manned space flights. The current HACCP approach for food businesses was defined by the Codex Alimentarius Commission (CAC), which is responsible for implementing the Joint Food and Agriculture Organization (FAO) of the United Nations and World Health Organization (WHO) Food Standards Programme. On 14 June 1994, HACCP was introduced into European Food Legislation (Council Directive 93/43/EEC on the hygiene of foodstuffs). Current food safety legislation is designed to ensure the safety of food and protect consumers. Thus, regulations such as EC 178/2002 (the general principles and requirements of food law), EC 852/2005 (hygiene rules),2 EC 853/2004 (hygiene rules for food of animal origin),3 EC 854/2004 (official controls on products of animal origin intended for human consumption),4 EC 882/2004 (official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules),5 EC 2073/2005 (microbiological criteria for foodstuffs)6 and EC 1881/2006 (setting the maximum levels for certain contaminants in foodstuffs),7 regulate food safety in the food chain from farm to retail. The general approach to food safety is based on HACCP (Article 5 of Regulation (EC) No 852/2004 requires food business operators (FBO) to put in place, implement and maintain a FSMS based on HACCP principles) and good hygiene conditions and practices based on a PRP that covers such areas as cleaning and disinfection/sanitation, maintenance of equipment and buildings, personnel hygiene and training, pest control, plant and equipment, premises and structure, services (e.g. ice, steam, ventilation, water, etc.), storage, distribution and transport, supplier control, waste management and zoning (physical separation of activities to prevent food contamination). 1.3.1.2 The challenges in implementing PRPs and HACCP in small and micro retail establishments Although the fundamentals of PRPs and HACCP have been defined for many years, implementation of effective FSMS in some food businesses still presents a challenge (Fielding et al., 2005; Sun and Ockerman, 2005; Celaya et al., 2007; Violaris et al., 2008). Even though the inability to control food safety hazards inevitably results in customer complaints, recalls, and foodborne outbreaks (Hedberg et al., 2006; Lianou and Sofos, 2007), partial implementation of FSMS is common with many food businesses lacking a full PRP and HACCP system. Common failings include a lack of PRPs (e.g. Celaya et al., 2007), inadequate CCPs (e.g. Fielding et al., 2005; Hielm et al., 2006; Domenech et al., 2008), insufficient monitoring systems (Walker et al., 2003a), poor compliance with procedures (e.g. Azanza and Zamora-Luna, 2005) and the absence of documentation (Nguyen et al., 2004) (based on Luning et al., 2011). In extreme cases, the PRP and/or HACCP plan may be reduced to a 'tick-the-box' exercise (Wallace et al., 2014). The development and implementation of effective PRPs and HACCP, as part of the FSMS, is dependent on overcoming a complex mix of managerial, organisational and technical hurdles (Taylor, 2001). Large food companies, with significant financial, technical and managerial resources, are more likely to have operational HACCP plans (Gormley, 1995; Mortlock et al., 1999). In contrast, small and micro companies are less likely to invest in hygiene a
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