In this chapter, several axes concerning the quality and the safety of food will be discussed. It is important to clarify these axes if one should research this field. To start, clarifying what is the definition of food safety is a must and what is meant by food safety, according to its importance, and what are the stages of the development of food safety concept throughout the food chain. Likewise, shifting to the concept of ISO 22000, the date of issue, the urgent need that derived its issue and what it includes from the requirements of food safety is a must, also management systems and the fundamentals that the system is based upon. Due to the talk in this chapter about food safety, ignoring the main foundation of food safety system which is HACCP and its effectiveness as running system to hold the safety of food cannot be done. Talking about the ISO 9000 system also will be done, and why many institutions applied both HACCP and ISO 9000, and why the HACPP system did not hold on by its own keeping the quality of the food safety management system. Demonstrating the urgent need that lead institutions concerned with applying food safety systems to the necessity of running a system such as the ISO 22000 system instead of the HACCP system alone also will be done. The characteristics of applying the ISO 22000 system over the HACCP system alone will be demonstrated. The characteristic role of applying this system in the development and advancement of the institutions working with this system shall be demonstrated. In addition to the necessity of discussing the benefits of applying the ISO 22000 on the institutions running on this system as well as the fields of its applications starting from the farm till the serving dish including all the process such as transportation, circulating and supplying the institutions with food that is to be processed, as well as the different transportation process of this food throughout the whole stages of circulating and manufacturing.
Therefore what is said earlier can be summarized and clarified by talking about the following axes:
1- Definitions of Food Safety
2- ISO 22000 Concepts
3- HACCP and ISO 9000
4- HACCP versus ISO 22000
5- ISO 22000 Advantages
6- ISO 22000 applications
3.2 Definitions of Food Safety
“Food safety” is about the prevention, elimination, or control of food borne hazards at the point of consumption. Everyday around the world, people agree on this one point-consumers need and deserve assurance that the food sold for them is safe to consume. As the food safety hazards may be introduced at any stage of the food supply chain, every company in the supply chain must exercise adequate hazard controls. In fact, food safety can be only ensured through the combined efforts of all parties in the food chain.
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Organizations within the food supply chain range from primary procedures (e.g farmers, ranchers) through food processor, storage and transportation operators, subcontracts, and all the way to retail outlets (e.g., groceries, restaurants), as well as every point and company in between. And through their products are not parts of the food we consume, makers of processing equipment, packaging materials, cleaning agents, additives/ingredients, and even service provider (e.g., equipments testers) are also integral parts of the supply chain of food safety.
Otherwise what do we mean by “Food safety” as a concept? “Safety” is an integrated concept, which comprises both quality factors, namely the extent to which it meets the needs of the people, and safety factors, the extent to which it may do harm to people¿½s health. Therefore, food Safety is a complex system engineering, which involves raw materials, activities of production and product test.(Zhu, et al., 2008), Food safety remains huge opportunity for improvement in preventing illness from known food pathogens and in responding to new and emerging food borne illnesses and threats (The ASQ the Quarterly Quality Report June 2007)(not mentioned in references). A similar description of food safety as protection of food against chemical, biological and physical factors which can endanger human health has been used by (Codex, 2003). Food safety as a concept means that foodstuffs should not be harmful to the consumer and recognizes that food safety hazards can be introduced at any stage of the food chain (GFSI Technical Committee – September 2007). The World Health Organization (WHO, 2003) and Food and Agriculture Organization (FAO) define food safety as food that is free from all hazards, whether chronic or acute, that may make food injurious to the health of the consumer. Food safety relates to the conditions and practices that preserve the quality of food and prevent contamination and food borne illnesses. Also we can conclude that food safety is related to how safe the food we eat is. Its mandate covers the transportation, manufacturing and processing, consumer safety, production of equipment for food safety, storage, delivery exportation and importation.
(WHO,2003) define food safety as: ¿½all conditions and measures that are necessary during the production, processing, storage, distribution, and preparation of food to ensure that it is safe, sound, wholesome and fit for human consumption¿½.
3.3 ISO 22000 Concepts
The process started in November 2001 with voting on the final draft in August 2005. All 34 national standard bodies that voted were positive and there were no rejections. The standard was published in September 2005 and subsequently translated for publication by national standard bodies, which are replacing national standards by ISO 22000. It has also been published as an European (CEN) standard: EN-ISO 22000 and is currently the standard in over 40 countries.
ISO 22000:2005 provides a framework of internationally harmonized requirements for the global approach that is needed. The standard has been developed within ISO by experts from the food industry, along with representatives of specialized international organizations and in close cooperation with the Codex Alimentarius Commission, the body jointly established by the United Nations¿½ Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards (ISO 22000 for safe food supply chains.
ISO 22000:2005, Food safety management systems ¿½ Requirements for any organization in the food chain, aims to ensure that there are no weak links in the food supply chain. Since its publication in September 2005, the standard has been well received by the food industry and is clearly becoming a global standard to be reckoned with. ISO 22000 has been designed with flexibility to enable a tailor-made approach to food safety for all segments of the food chain. It does not take a ¿½one size fits all approach¿½ since the standards and procedures required for high risk areas in one food sector may not be appropriate in another. For this reason, unlike other schemes, the standard does not provide a checklist methodology.
In 2005 ISO 22000 was published to be the first international food safety management standard applicable to the whole food supply chain. The aim was to ensure all parts of a supply chain, no matter their location or function, could be united under one standard. ISO 22000 requires an organization to demonstrate its ability to manage food safety hazards and provide consistently safe products that meet both customer requirements and food safety regulations. It was hailed as the ultimate opportunity to harmonies global food safety approaches.
ISO 22000 standard is considered to be the first international quality standard designed to work with all cultural prescription, statutes and regulation.ISO 22000 is dedicated to improve consumer confidence in the food product and the process. It applies to every link in the food supply chain from the farm to the table.(Joee Carroll, 2008) . ISO 22000 is an international, auditable standard that specifies the requirement of food safety management by incorporating all the elements of Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Points (HACCP) together with a comprehensive management system. (Vel, et al., 2005)
Food safety management system (FSMS) combining between Good Management Practices, Hazard Analysis and Critical Control Point (HACCP) principles and effective supplier verification and validation, ensuring that all actions possible are taken, recorded and verified to ensure safe food, which is based on the HACCP principles. This requires a company policy definition and quality manual, with definition of responsibilities for management and employees, prerequisite programs and HACCP plan implementation, and preparing pre-request programs and measures for implementing the food safety program. Preparing the HACCP team and effective recording systems, and a combination of self assessment with application of internal auditing, management review, application of all legal requirements and supplier evaluation, are other concerns in this system. (Mehrdad, 2007).So food safety management systems principally control the specific food safety hazards associated with the product and ensure compliance with food safety legislation.(L. Manning , R.N. Baines,2004). In line with all other standardized management systems, the systemic approach adopted by the ISO 22000 standard is based on the application of process management principles. A number of management philosophies, such as TQM and Six Sigma, are also based on these principles (Hammer, 2002). Core element of process management is the concept of processes. In this context, the management system of an organization can be viewed as a single large process, which may be broken down to several sub-processes (Bhuiyan and Alam, 2005). Effective management of these processes ensures effective management of the whole organization (see Armistead et al., 1999). It should be noted that in the case of ISO 22000, as mentioned in ISO/TS 22004 (giving guidelines for applying the standard), processes are considered in terms of food safety (IOS, 2005b).
A key tool for effective process management is the well known Deming cycle
Plan-Do-Check- Act (PDCA). Plan concerns the design of processes, in a way that fully specifies which activities are to be done (when, by whom and how) so as to ensure repeatability and consistency. Do cover the implementation of these activities, in accordance with the plan. Measurements of end-to-end process performance and assessment of these measurements in order to facilitate targets setting are actually part of Check. Finally, Act refers to process improvement and ensures that the critical activities are executed in the most efficient and effective manner. Processes standardization is also an important issue (see Davenport, 2005). In order to apply the PDCA cycle, ISO 22000 has adapted a requirements presentation scheme directly analogous to the ISO 9001:2000 quality systems standard. Specifically, after three initial clauses (giving scope, references and definitions) the ISO
22000 requirements are grouped into five clauses:
(1) Food safety management system;
(2) Management responsibility;
(3) Resource management;
(4) Planning and realization of safe products; and
(5) Validation, verification and improvement.
Under the first clause, the organization establishes and documents a food safety management system and defines its scope (i.e. products, processes and sites). The management responsibility clause specifies requirements covering safety policy definition, safety planning (through objectives and targets), communication issues and management review. Provision of all resources necessary for the implementation of the system is the scope of the resource management clause. In the planning and realization of safe products clause, all production processes affecting products safety need be designed and the respective safety plans developed. In fact, this clause includes most technical requirements of classical HACCP (and is the only clause drastically different from its ISO 9001 counterpart). Finally, the last clause specifies requirements which ensure system verification (i.e. the system ability to reliably deliver expected safety outcomes) and continuous improvement.(Panagiotis, 2009)
This International Standard specifies the requirements for a food safety management system that combines the following generally recognized key elements to ensure food safety along the food chain, up to the point of final consumption:
– Interactive communication.
– System management.
– Prerequisite programmes.
– HACCP principles.
Communication along the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain. This implies communication between organizations both upstream and downstream in the food chain. Communication with customers and suppliers about identified hazards and control measures will assist in clarifying customer and supplier requirements (e.g. with regard to the feasibility and need for these requirements and their impact on the end product).
Recognition of the organization’s role and position within the food chain is essential to ensure effective interactive communication throughout the chain in order to deliver safe food products to the final consumer. An example of the communication channels among interested parties of the food chain is shown in Figure (2-1).
Figure (2-1) – Example of communication within the food chain,
(ISO 22000 International Standard, 2005)
The most effective food safety systems are established, operated and updated within the framework of a structured management system and incorporated into the overall management activities of the organization.
This provides maximum benefit for the organization and interested parties. This International Standard has been aligned with ISO 9001 in order to enhance the compatibility of the two standards This International Standard can be applied independently of other management system standards. Its implementation can be aligned or integrated with existing related management system requirements, while organizations may utilize existing management system(s) to establish a food safety management system that complies with the requirements of this International Standard.
This International Standard integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps developed by the Codex Alimentarius Commission. By means of auditable requirements, it combines the HACCP plan with prerequisite programs (PRPs). Hazard analysis is the key to an effective food safety management system, since conducting a hazard analysis assists in organizing the knowledge required to establish an effective combination of control measures. This International Standard requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identified and assessed. Thus it provides the means to determine and document why certain identified hazards need to be controlled by a particular organization and why others need not. During hazard analysis, the organization determines the strategy to be used to ensure hazard control by combining the PRP(s), operational PRP(s) and the HACCP plan.
This International Standard allows an organization (such as a small and/or less developed organization) to implement an externally developed combination of control measures.
The aim of this International Standard is to harmonize on a global level the requirements for food safety management for businesses within the food chain. It is particularly intended for application by organizations that seek a more focused, coherent and integrated food safety management system.
3.4 HACCP and ISO 9000
The ISO 9000 quality management systems standards have become a major element of supplier management strategy for many multinational corporations (Birkenstock, 1999; Wasik, 1994a). Manufacturers implement the ISO 9000 standards with the intention of reaping the benefits, while customers perceive ISO 9000-registered plants as being more capable of delivering products of consistent quality (Adams, 1994; Pallett, 1994; Mehta and Wilcock, 1996). Both manufacturers and customers have indicated that companies using quality systems such as the ISO 9000 standards have several advantages over competitors that have not implemented such systems. These advantages include improved product quality and reliability, increased customer satisfaction, reduced scrap and rework, increased manufacturing efficiency, superior delivery times, rapid systematic response to change, and increased interdepartmental communication leading to increased teamwork (Adams, 1994; Bennet and Steed, 1999; Eyles, 1995; Newslow, 1997).
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ISO 9000 refers to a group of standards containing clauses directed at the quality management process of an organization. The standards define a quality framework within which a registered company must operate as a minimum criterion for a quality management system (Stringer, 1994; Surak and Simpson, 1994). To ensure their ongoing relevance, they are reviewed regularly, with the most recent revision having been published in December 2000. Attaining ISO 9000 registration does not equate with achieving a world class quality system since the ISO standards describe only the minimum criteria for a quality management system (Surak, 1999). HACCP/ISO transitions.
The ISO 9000 standards are generic and can be applied to any industry. Their purpose is to establish the existence of a documented quality system. ISO 9000 standards do not describe how a company should manage its quality system, but focus on whether a company is complying with its own written policies and procedures. Both HACCP and ISO 9000 systems are management philosophies that rely on disciplined operator control and teamwork (Wasik, 1994b). Both focus on prevention rather than retrospective inspection. However, the major difference between the two systems is the scope. HACCP is process and product oriented. HACCP is totally focused on food safety therefore quality factors should not be part of a HACCP program (Newslow, 1997).
In contrast, ISO 9000 is more systems-oriented and designed to manage quality (National Food Processors Association, 1992). ISO 9000 certification does not certify the product but merely provides confidence that a supplier¿½s quality system is capable of providing a stated product or service (Bennet and Steed, 1999). HACCP puts control mechanisms in place to ensure that the product is safe and manufactured to standards that are formulated internationally, whereas ISO 9000 requires that an organization define its own system and demonstrate that it can comply with it (Mayes, 1993).
HACCP and ISO focus on prevention. HACCP assures food safety by controlling the process. ISO 9000 ensures system conformance to the standards. These two programs have complimentary systems that reinforce and strengthen an organization¿½s overall quality system (Newslow, 1997). To be maximally effective, these plans must be tailored to the manufacturing facility, requiring management leadership and commitment, expert knowledge in program development, employee training and operator control (National Food Processors Association, 1992).
3.5 HACCP versus ISO 22000
Food quality and food safety are immersing critical issues at the international level since outbreaks of food borne illness can damage trade and tourism, and lead to loss of earnings, unemployment and litigation. Food spoilage is wasteful, costly and can adversely affect trade and consumer confidence. To cope this issue, HACCP (Hazard analysis critical control points) in which was firstly established in the USA 3 decades ago as the preventive mechanism for safety control of foods has been worldwide adopted into the production and service food industries.( Prasert, 2007).Historically, based on end product testing strategic changes towards to more preventive approach to food safety management started as early as the 1920s (Mossel et al,1995),although this strategies were largely unsuccessful. Although there was a renewed emphasis on preventative food safety in 1930s, it is only since the 1970s.That this approach has been adopted leading to the use HACCP (Bauman,1994). The hazard analysis and critical control point (HACCP) was originally developed by the Pillsbury Company, working with NASA and the US Army Laboratories at Natick, to assure that food supplied to the manned space programme was microbiologically safe (Food Safety Through the Hazard Analysis & Critical Control Point System, 1973; Bauman, 1974). Over the years it has been adopted by Codex, EU and other national and international regulatory bodies as the foundation of microbiological food safety management, allowing food manufacturers, retailers, distributors and caterers the ability to identify hazards and determine critical control points and effective control measures ( Mike, 2004). In 1998, ILSI Europe published its report on food safety management tools, which sought to describe how the tools available at the time interacted with each other. This included the use of hazard analysis and critical control point (HACCP) (Mike, 2004). There is evidence that business adopting a food safety management approach based on HACCP and pre-requisite programs (PRPs) produce better microbiological quality food (Little et al,2002;Little et al,2003).Many food companies have been developing their own HACCP plans for about a decade, following the seven HACCP principles and applying them to their circumstances in order to produce save foods. However, HACCP plans have to be so specific to the type of business and the physical layout of each site that it is not possible to have one set of HACCP standards for all companies to follow in all situations. And while HACCP plan requirements have been codified in many localities, HACCP regulations are not ¿½ and probably cannot be-made uniform. So that need to apply management system beside HACCP which make company combine between policy definition and quality manual, with definition of responsibilities for management and employees, prerequisite programs and HACCP plan implementation, and measures for implementing the food safety program. Preparing the HACCP team and effective recording systems, and a combination of self assessment with application of internal auditing, management review, application of all legal requirements and supplier evaluation, are other concerns in this system (Mehrdad, 2007).
For implementing any standardized management system, a company needs to identify and redesign its processes so as to incorporate the specifications of the respective standard. Processes interactions also need to be determined. In most cases, additional processes related with various internal operations (such as targets setting, internal audits etc.), often not previously identified and standardized, will need to be designed. As a final step, written standard operating procedures (SOPs) need to be developed, effectively describing all activities for implementing the processes (as designed) together with the respective managerial responsibilities. For the ISO 22000 standard, a safety plan according to given specifications is also required, as described in the next section. When developed, the safety plan needs to be integrated within respective SOPs for actual use.
It can be stated that ISO 22000 implementation provides a food safety system designed, operated and continuously updated (improved) as an integral part of overall organization n management. Note that classical HACCP, practically designed to operate as an effective stand-alone system, may lead to inefficient implementations, with food safety not integrated within but operating in parallel with other management systems such as ISO 9000.
This is probably one of the reason why many related studies, in order to ensure appropriate action, include all sort of measures that may directly (or indirectly) impact food safety in the HACCP plan.(Panagiotis, 2009)
Last, it is worth stressing the ISO 22000 requirement for quantitative objectives and targets. By establishing a system driven by objectives, ISO 22000 provides a solid basis for improvement and the determination of acceptable hazards levels (i.e. remaining risk). It is worth noting that, through the Food Safety Objectives (FSO) concept, public health goals may be systematically translated into quantitative operational targets for food safety management (for discussions of FSO see Stringer, 2005 Gorris , 2005).
Classical HACCP effectively specifies two safety control levels (i.e. Prerequisite
Programs (PRPs) and the HACCP plan). The differentiation between these two levels, however, is rather weak and not generally understood. As a result, most early implementation studies included both levels in the HACCP plan (see Untermann, 1999), practice which decreases system efficiency and increases safety costs (see economic analysis in Roberto et al. (2006)). The ISO 22000 standard imposed an additional control level, thus created a three-level safety control hierarchy, namely:
(2) Operational Prerequisite Programs (O-PRPs).
(3) HACCP plan.
In the following, we briefly present each of these control levels, providing specific interpretations when necessary (to cover issues where the standard specifications are unclear or inconsistent).
The PRPs define all basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain (Sub clause 3.8), by enforcing the implementation of the appropriate Good Manufacturing Practices (GMP) and Good Hygienic Practices (GHP) specifications throughout the organization. Therefore, we can generally interpret PRPs as the control measures covering the design and the basic operations of all infrastructures deployed (hardware and operating practices) and which impose specifications for the development of the system SOPs (see previous section). Typical PRPs examples include cleaning and sanitation of production equipment, maintenance, personnel selection and training, etc.
Thus, PRPs cover management activities necessary for any food organization and have a weak association with the specific food product produced. Note, however, that PRPs may control serious hazards and fully complement safety control at operational level. Operational safety control, which directly relates to the product and production process used, is accomplished by the other two control levels, namely:
(1) O-PRPs; and
(2) the HACCP plan.
ISO 22000 does not give a direct definition of the HACCP plan and defines O-PRPs as follows: O-PRPs are those PRPs identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards (Sub clause 3.9). By this definition, O-PRPs are directly related to PRPs. However, this is not consistent with the way they are subsequently treated by the standard, since both the O-PRPs and the HACCP plan are specified as the outcome of the hazard analysis that defines the measures to control the hazards essential to food safety (Sub clause 7.4.4) other that those covered by the PRPs. Adopting this view (which is fully supported by ISO/TS 22004, Sub clause 7.4.4) for the relation between the HACCP plan and O-PRPs, we still need to separate the measures entering each plan. The ISO 22000 standard specifies a set of six criteria for this separation. However, little application guidance is offered either in this standard or in ISO/TS 22004. To deal with this issue, we adopted an implementation approach where the principal criteria for hazard control categorization are: the hazard level (in terms of hazard severity and frequency of occurrence); and the feasibility of monitoring this hazard in a timely manner and enable immediate corrective actions.
Thus, hazards with more severe impact to consumer health, higher risk of occurrence and higher ability to be timely monitored are confronted by the HACCP plan. The remaining hazards are controlled by establishing appropriate O-PRPs this categorization clearly depends on the actual design of the production system.
Assume, for example, a production flow design where some hazard cannot possibly be timely controlled and should, thus, be controlled by an O-PRP. However, if this hazard impact on public health is severe, it needs to be part of the HACCP plan. Therefore, redesign of the production processes is required (e.g. a production delay may be introduced that will act as a product quarantine) in order to enable direct control of the hazard, through the HACCP plan. A final issue concerns the specific control measures incorporated in the O-PRPs and the HACCP plan. Given any process, a control measure is entirely defined by all the elements that describe the respective control loop: scope, critical parameters monitored, critical limits and corrective actions. ISO 22000 clearly stresses the need for the establishment of such a typical control mechanism both for the O-PRPs (Sub clause 7.5) and the HACCP plan (Sub clause 7.6.1). Note that specifications for particular control measures types are not given in the standard, since they are dependent on the particularities of the processes under control (Panagiotis, 2009).
3.6 ISO 22000 Advantages
Benefits of implementing a systematic and effective food safety management system (FSMS) include the following advantages:
– One common system throughout supply chain.
– Better communication throughout supply chain.
– Integrates quality management and food safety management.
– Control /reduce food safety hazard.
– Legal compliance.
– Provide recognition throughout the food supply chain as a single standard approach to food safety Can be applied independently Integrates the principles of HACCP and application steps of CODEX.
– Allow small and /or less developed organization to implement an externally developed system.
– One audit can achieve certification to cover both the food safety management system and quality management system. (Vel, et al.,2005).
As mentioned in (Food Standards Agency Report, 2007) Your FSMS will also give you the ability to achieve the following benefits:
1. Operating a FSMS increases business effectiveness.
2. Operating a FSMS can increase business profitability.
3. A FSMS is appropriate for all businesses working with food.
4. The extra time spent carrying out a FSMS is time well spent.
Through the use of your FSMS, you can remain confident that your processes are compliant and that each step in the process is closely monitored to ensure that critical limits are kept under control. Your FSMS will also give you the ability to streamline processes, reduce inefficiencies due to paper-based forms, as well as provide greater visibility into your system Most notably, using quantitative risk assessment tools, you can identify hazards more effectively, make the process more efficient, and mitigate any unforeseen risks down the food chain.
We can add that ISO 2200:2005 represents the latest step in the evolution of food safety systems beyond HACCP. It combines the five preliminary steps documentation requirements, management responsibility, resources management, planning and realization of safe product and validation, verification and improvement of FSMS and seven principles of HACCP perform hazards assessment, identify critical control points, establish critical limits, establish monitoring procedures, detail corrective actions, effective r
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