Values of xij and Ri.
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More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
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These aspects of forest fire are the subject of this book. I realize, however, that the contents in it can only be an incentive for the reader to learn more, in an interesting aspect. I assume that this book will be valuable to researchers as well as students who are interested in different aspects connected to forest fires, not only from the ecological point of view but also from the social one. 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He also works as a Honorary Senior Research Fellow at Birmingham University, UK, Lecturer at the Postgraduate European Institute, and has worked as Senior Manager in Accenture (2013-2014). He obtained his European PhD with a maximum distinction. He is a holder of the Runner Prize for Management Science and Engineering Management Nominated Prize (2020), Advancement Prize (2018), First International Business Ideas Competition 2017 Award (2017), Runner (2015), Advancement (2013) and Silver (2012) by the International Society of Management Science and Engineering Management (ICMSEM), and Best Paper Award in the international journal of Renewable Energy (Impact Factor 3.5) (2015). He has published more than 150 papers (65 % ISI, 30% JCR, and 92% internationals), some recognized as follows: “Applied Energy” (Q1, as “Best Paper 2020”), “Renewable Energy” (Q1, as “Best Paper 2014”), “ICMSEM” (as “excellent”), “International Journal of Automation and Computing” and “IMechE Part F: Journal of Rail and Rapid Transit” (most downloaded), etc. He is an author and editor of 25 books (Elsevier, Springer, Pearson, Mc-GrawHill, IntechOpen, IGI, Marcombo, AlfaOmega, etc.), and 5 patents. He is also an Editor of 5 International Journals and Committee Member of more than 40 International Conferences. He has been a Principal Investigator in 4 European Projects, 6 National Projects, and more than 150 projects for universities, companies, etc. He is an European Union expert in AI4People (EISMD) and ESF. He is Director of www.ingeniumgroup.eu. 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He is currently working as an Assistant Professor at the College of Computer Science and Information Technology, King Faisal University, in Saudi Arabia since 2008. He has contributed well in King Faisal University for achieving ABET Accreditation, by working as a member and Secretary for Accreditation and Quality cell for more than 08 years. He takes care of versatile operations including teaching, research activities, leading ERP projects, IT consultancy and IT management. He headed the department of IT, and administered the Prometric center in the Institute of Business and Technology (BIZTEK), in Karachi Pakistan. He has worked as a consultant for Network and Server Management remotely in Apex Canada USA base Software house and call center.\n\nDr. Noor Zaman has authored several research papers in indexed journals\\\\international conferences, and edited six international reputed Computer Science area books, has many publications to his credit. 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Certainly, with the advent of globalization, the market has become more competitive, because it has opened the opportunity for new competitors. This does not necessarily mean risk for the survival of local businesses, but a challenge that they must consider. This challenge relates to the need to create greater consumer loyalty to products and services, greater suitability of the product to the consumer’s needs and greater concern about the social impact of the company. Moreover, this global scenario represents some opportunities for the companies to act in the new markets. It is clear that this action will depend mainly on the quality of their own products and services offered.
However, first, the concept of product quality is not so immediate and obvious. Although not universally accepted, the definition for quality with greater consensus is that "suitability for the consumer usage." This definition is comprehensive because it includes two aspects: characteristics that lead to satisfaction with the product and the absence of failures. In fact, the main component consists of the quality characteristics of the product features that meet the consumers\' needs and thus it provides satisfaction for the same. These needs are related not only to the intrinsic characteristics of the product, such as the sensory characteristics of a food product, but also to its availability in the market with a compatible price and in a suitable packaging. The other part is the absence of faults, which is related to the characteristics of the product according to their specifications, making the consumer inspired by the reliability of the product, i.e., the consumer is sure that he will acquire a safe product, without health risks, and with the properties claimed on the label.
For these objectives to be achieved it is required an efficient management of quality, which implies continuous improvement activities at each operational level and in every functional area of the organization. The quality management combines commitment, discipline and a growing effort by everyone involved in the production process and fundamental techniques of management and administration, with the goal of continuously improving all processes. For that, the industries need to be structured organizationally, establish policies and quality programs, measure customers’ satisfaction and even use more quality tools and methodologies. Specifically for the food industry, also involves the knowledge and application of techniques and programs for product safety.
With all that, the purpose of this chapter is to describe the potential use of quality tools in food companies. The study initially intends to contextualize the quality management in the food industry and the activities related to the quality function. In addition, support tools related to quality control in process will be suggested with practical examples of application.
It can be said that each company has a particular stage of maturity on the issue of quality management. In general they tend to evolve in four stages, the similarity of ages or how the quality management in the world has evolved over the years. Thus, it is important to highlight these stages of evolution of quality that began with the inspection of products, have passed the statistical quality control, the stage of quality systemic management until the strategic quality management.
Garvin, a scholar of quality management, highlights four ages or stages through which the way to manage the quality has evolving over time in the U.S [1]. The first stage of development was called "era of inspection." In this stage the quality control of products was limited to a focus on corrective inspection, i.e., was a way to check the uniformity of the final product by separating the non-conforming products. According to Garvin in the U.S. only in 1922 the inspection activities were related more formally with quality management, after the publication of the book “The Control of Quality in Manufacturing”. For the first time, the quality was seen as managerial responsibility having distinct and independent function in the companies.
Later, the year of 1931 was a milestone in the quality movement and the beginning of the second phase, the Statistical Quality Control. This phase had a preventive approach, centered on the monitoring and control of process variables that could influence in the final product quality through the development of statistical tools for sampling and process control.
The next phase was called Quality Assurance, that was associated with broader control and prevention, which sought through systematic management, ensure quality at all stages of obtaining the product. The quality management became a practice restricted to industrial production management applied to all production support functions. In the U.S., this time started in the late 50\'s when the quality of the instruments have expanded far beyond the statistics, now covering the quantification of quality costs, total quality control, reliability engineering and zero defect.
Finally, quality management has been incorporated within the strategic scope of organizations, this phase called Strategic Management of Quality. It represented a vision of market-oriented management, i.e., with a view of opportunities before the competition and customer satisfaction, where market research has become more important for evaluating the market needs and how the competition stands. The strategic approach is an extension of its predecessors, but with a more proactive approach.
Several scholars of quality management are unanimous in emphasizing that the companies in general, and also the food industry, through its organizational structure, the policies adopted, the focus given to the business and the practice of quality control, demonstrate a certain degree of maturity in how to manage quality. Some companies may present practices related to more advanced stages, mature, such as quality assurance and strategic quality management, others may prove more practices related to inspection and process control. Through observation of tools and methods currently adopted in the food industry, it can be inferred that this quality management company is based on the characteristics of a particular stage of the quality evolution.
For example, the control of the raw material and products for inspection, with special attention to satisfy the governmental health rules, is a characteristic of the inspection stage. Likewise, the product control only by laboratory analysis is a feature of this stage. Moreover, quality control practices in process, application of statistical methods for quality control and the adoption of Good Manufacture Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP) denote that the company has a slightly broader approach that inspection, i.e., a more preventive approach control in the production process. But when practice inspection and process control are well established in the company and efforts are directed towards continuous improvement, it can be inferred that the company is evolved into a system of quality assurance. Practices consistent with this era are shown by performing quality audits in different sectors of the company, adoption of quality systems across the supply chain and also implementation of programs for the development of quality suppliers of products and services. Companies that take a strategic quality management are those that use market research and specific indicators to measure customer satisfaction, such as consumer complaints, returns by wholesalers for the time of the product in the inventory and sales below target. Further, evaluate their products compared to competitors\' products and apply techniques of sensory analysis to compare products and find sensory qualities required by the market. Concerned to improve their production processes, automate production lines and constantly launch new products into the market.
In general, the operating system of quality control in the food industry must meet some specific tasks. One of the tasks is to ensure compliance with sanitary standards and compliance requirements of the legislation, including with regard to food safety standards, the Good Manufacturing Practices (GMP) and the system Hazard Analysis and Critical Control Points (HACCP). For this, there is need for procedures to control insects, rodents, birds and other pests, and procedures for cleaning and sanitizing equipment, industrial plant and storage areas. Still, personal hygiene of staff working on process lines and proper habits on food handling should be implemented and monitored to ensure that food safety standards are met. In cooperation with the departments of production, research and development, engineering or operations, the department of quality control analyzes manufacturing processes to "Hazard Analysis and Critical Control Points." The integrity and safety of food products should be ensured through the identification and assessment of all unit operations of the process in order to prevent potential contamination and adulteration that could expose consumers to health risks.
In cooperation with the department of research and development (R&D), production, purchasing and sales, should be prepared written specifications for raw materials, ingredients, packaging materials, other supplies and finished products. Furthermore, should be established in writing form and in cooperation with the departments of production and R&D the procedures for each unit operation of all manufacturing processes of the fashion industry that can be implemented in processing lines. The participation of staff from other departments of the company occurs by the virtue of their expertise in relation to consumer demands or knowledge of product technology and process, and the participation of the operators of the process, because of its experience in the production.
The quality control personnel works in different laboratories performing physical, chemical, microbiological and sensory properties of raw materials, ingredients, packaging materials and finished products. They also work in the factory or processing areas, collecting samples for performance evaluation processes, unit operations, sanitary conditions or levels, verifying compliance with the requirements of food safety and all other operating specifications. It is the responsibility of the department of quality control implementation of Statistical Quality Control (SQC), in which statistical techniques are applied to assessments of control for scientific analysis and interpretation of data. The SQC\'s functions include the selection of sampling techniques, control charts for attributes and variables, the use of analysis of variance and correlation, among other statistical tools. The methods, procedures and selection of instruments used to measure quality attributes of products and processes are the responsibility of the department of quality control. These techniques can be developed for specific purposes within the production process, to product development or troubleshooting and optimization standards.
The quality control personnel must interact cooperatively with the personnel of the standards and inspection agencies to ensure that the official food law is understood and met. It should also watch the production department in its efforts to increase revenues, reduce losses and improve efficiency of operations. It should also develop, conduct and assist in an organized program, training of supervisors, operators and workers in general, into specific concepts of quality.
The development of an appropriate plan of "recollect" adulterated or defective product in marketing channels and the planning of internal traceability of products is also a function of the quality control department. Another assignment of quality control includes reviewing and responding to consumer complaints.
Thus, faced with so many responsibilities, it remains to note that the dynamics of intervention and performance of those who are responsible for the quality department is paramount to the success of the food industry and customer satisfaction.
The quality management applies systems and tools that are intended to assist the implementation of quality-oriented way to improve the product and the process, increasing the levels of quality business and ensuring customer\'s satisfaction.
The purpose of this topic is to describe some tools, techniques and systems that have been more widely used in quality management in the food industry. Besides the methods mentioned, there are others that could be employed by companies. The choice of which implement depends on the company\'s strategies and know-how of its employees.
The issue of food safety has been in the public eye as never before. Foodborne disease has an enormous public health impact, as well as significant social and economic consequences. It is estimated that each year foodborne disease causes approximately 76 million illnesses, 325,000 hospitalizations and 5,000 deaths in the U.S., and 2,366,000 cases, 21,138 hospitalizations and 718 deaths in England and Wales [2]. Thus, many food safety programs have been published in order to ensure safe food production and consumer protection.
Safety food programs can be set as the measures to be taken to ensure that food can be eaten without adversely affect to the consumer’s health. These measures aim to prevent food contamination, such contamination are chemical, physical or microbiological. The programs commonly used in this area are Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), British Retail Consortium (BRC) and Global Food Safety Initiative (GFSI), frequently found in the food industry, are obligatory by law, and others are implemented voluntarily by the food chain members [3].
The Good Manufacturing Practices program is composed of a set of principles and rules to be adopted by the food industry in order to ensure the sanitary quality of their products. The GMP program came at the end of the last century when the U.S. pharmaceutical industry began to define optimal manufacturing practices based on technological knowledge available. In the late 60\'s, organizations such as the WHO (World Health Organization) and the Food and Drug Administration of the United States, the FDA (Food and Drug Administration) adopted the program as a minimum criterion recommended to the manufacture of food products under adequate sanitation conditions and routine inspection. Later in 2002, FDA forms Food GMP Modernization Working Group and announces effort to modernize food GMP´s [4].
The rules establishing the so-called Good Manufacturing Practices involves requirements for industry’s installations, through strict rules of personal hygiene and cleanliness of the workplace to the description in writing form of all procedures involved in the product. These standards are characterized by a set of items summarized below.
The projects and industry facilities, in addition to requirements engineering/architecture, must meet requirements to ensure food safety, such as the installation of devices to prevent the entry of pests, contaminated water, dirt in the air, and still be designed to avoid the accumulation of dirt or physical contamination of food that is being manufactured. The equipment and the entire apparatus of materials used in industrial processing should be designed from materials that prevent the accumulation of dirt and must be innocuous to avoid the migration of undesirable particles to foods. On the production line, the procedures and steps for handling the product have to be documented, in order to ensure the standardization of safety practices. Also running records should be implemented as evidence that the job was well done.
Otherwise, the cleaning and sanitizing phases are inherent to the processing and handling of foods, and thus programs for execution on a routine and efficiently must be implemented. Similarly, is required a plan for integrated pest control in order to minimize access vector and reduce the number of possible focus of insects, rodents and birds.
Regarding food handlers, the GMP recommend that training should be given and recycled so the concepts of hygiene and proper handling are assimilated as a working philosophy and fulfilled to the letter.
A control of raw materials should be developed with suppliers, not only in the laboratory, but in a gradual and continuous improvement work, where food security is split with suppliers. Guidelines for the safe packaging of raw materials, inputs and finished products should be followed and extended to the storage and loading area, and to the transportation that reach the consumer.
The Good Manufacturing Practices have wide and effective application when all the elements cited are effectively deployed.
HACCP is a system based on prevention of hazards to the industry to produce safe food to consumers. The HACCP involves a complete analysis of the dangers in the systems of production, handling, processing and consumption of a food product. HACCP is widely acknowledged as the best method of assuring product safety and is becoming internationally recognized as a tool for controlling food-borne safety hazards [3].
In short, this system has a systematic and scientific approach to process control, designed to prevent the occurrence of failures, ensuring that the controls are applied in processing steps where hazards might occur or critical situations. For this, the HACCP system combines technical information updated with detailed procedures to evaluate and monitor the flow of food into an industry.
The new sanitary requirements and quality requirements dictated by the main international markets, led since 1991, to the deployment experimental stage of the HACCP. There are new rules governing the international market, established during the Uruguay Round of Trade Negotiations and applicable to all member countries of the World Trade Organization (WTO). The Codex Alimentarius has become the regulatory body for matters of hygiene and food safety in the WTO. The Codex Alimentarius reflects an international consensus regarding the requirements for protection of human health in relation to the risks of foodborne illness. This measure is accelerating the process of harmonization of food laws of the countries, process that is oriented concerning food security, with the recommendation of the use of the system Hazard Analysis and Critical Control Point, to ensure food safety.
Generally the HACCP system initially involves the creation of a multifunctional team, supported by senior management of the company, and the characterization of all food products that will be included in the system. Also a set of programs, such as Good Manufacturing Practices (GMP) and Sanitation Standard Operating Procedures (SSOP) are universally accepted as prerequisites for the implementation of the HACCP system and therefore should be consolidated. Only then each step of the production process of a product will be analyzed for the possibility of a chemical, physical and microbiological contamination. Thereafter preventive measures are described and identified the Critical Control Points (CCPs). For each critical point is necessary to establish critical control limits, which allow the monitoring of hazards. As there is always a possibility of failure, it is essential to provide corrective measures in order to ensure the process return into a controlled situation. It should also establish procedures for verification of CCP´s and their respective records. After the HACCP plan drawn up, it is validation occur through discussions among team members [5].
Finally, the HACCP plan is disseminated to the production employees and for those responsible for assessing the products quality on the factory floor. Internal and external audits are recommended for periodic maintenance and continuous improvement of the system [5].
Standardization is a management tool involved in the preparation, training and control standards within the company. Such standards are documents containing technical specifications or specific criteria that will be used as a guide in order to ensure that products, processes and services are designed with quality [6]. The main objective of a program of standardization for the food industry is to minimize the variations in quality of production. For this, it is necessary to provide means to standardize both the operational and analytical procedures, as raw materials, machinery and equipment used in the manufacturing process.
The patterns are instruments that indicate the goal and procedures for accomplishment of the work and can be classified as follows:
Standards of Quality (SQ): refer to the parameters related to quality of products, raw materials and inputs.
Operation Standards: describe the manufacturing process of a product, the technical parameters of control by the operators and operating procedures. These are divided into Standard Process Technician (SPT) and Operational Procedure (OP). The first document describes the process of manufacture of a product, the quality characteristics and the control parameters. Operating procedures standards are prepared by managers and operators to achieve the objectives proposed in the SPT and SQs.
Standards Inspection: describe methods and criteria for assessing the degree of success achieved in carrying out an activity, compared to planned levels of quality for the product. The inspection may occur in the process, the finished product and in the raw material.
Through standardization it is achieved greater standardization of products, improved productivity and product quality, cost reduction, simplification and optimization of production processes, increase the technical capacity of operators of process, greater job security, reduction of inventory levels of raw materials and inputs, reducing the preparation time of the machines and self-management by the workers.
Also noteworthy is that the patterns facilitate the transfer of knowledge since all the people and functional units involved in a particular pattern should collaborate, as far as possible, be trained in their preparation and for their use.
The PDCA originated in the 30´s in the laboratories of the United States, becoming known in the fifty decade due to the expert quality, Deming, who was responsible for implementing and disseminating tools of control and quality management in several countries. The PDCA cycle is a method of managerial decision-making to ensure the achievement of goals related to a process, product or service [7].
The letters that form the acronym PDCA mean Plan, Do, Check, Action. The Plan (P) consists in establishing goals, and procedures to achieve them. The stage Do (D) consists in performing the tasks as planned and collect data that will be used in the step control. Thus, in the stage of "implementation" are essential trainings at work. Check (C) consists of comparing the results achieved with the planned goals through quality control tools. Finally, Action (A) is to act correctively in the process in order to correct an unexpected result.
As can be seen in Figure 1, a schematic representation of PDCA cycle translates the dynamism steps purposes. The conclusion of a turn in the cycle continues back to the beginning of the next cycle, and so on. Following in the spirit of continuous quality improvement, the process can always be renewed and a new change process can be started. Continuous improvement occurs the more times the PDCA cycle is run, and optimizes the execution of processes, enables cost reduction and increases productivity. Moreover, the gradual and continuous improvements add value to the project and ensure customer satisfaction.
PDCA Cycle
In using the PDCA method may be necessary to use various tools, such as the basic tools for process control as stratification, check sheet, Pareto chart, cause and effect diagram, and scatter plots, histograms, control charts. Other techniques could include analysis of variance, regression analysis, design of experiments, process optimization, multivariate analysis and reliability [8].
Within the food industry, the PDCA cycle can be applied to the standardization or improvement of any product, process or activity the support the production, such as the standardization of procedures for cleaning and sanitizing, pest control, production processes, or improvement in the set-ups of equipment, reduction in losses in production, among others.
The concept of traceability of products originated in the aeronautical and nuclear industries and it is widely practiced in industries. The tool aims to locate the source and the root causes of a particular problem of quality or safety, by the information recorded from a particular product, regardless of the stage of production where it is - whether raw material, in-process product or finished product. Through the traceability of products is possible to develop prevention and improvement actions, so that a specific problem does not occur again.
Traceability can cover only internal actions of the company, or otherwise, may be complete, when it involves the entire chain of production, allowing identifying even basic raw material that led to the final product and locations outside the company where finished products are stored. Consideration as the consumer safety, as the demands of the institutional environment and the costs of implementation of the traceability system will define the scope more suited to be deployed by the company.
The Statistical Quality Control uses statistical tools to control a product or process. To do this, it works with data collection and the interpretation thereof, acting as a fundamental tool to solve problems in critical product and process. Thus, ensures the quality sector the product conformity with the specifications defined as ensures the production sector the information needed for effective control of manufacturing processes providing subsidies to decision making in purchasing processes, receiving raw materials and shipment of products and also in reducing cost and waste. From the identification of the market requirements it is collected sufficient statistical information necessary for the development of new products and assists in monitoring the quality profile of competing products.
Although not a mandatory requirement in the food industry, statistical quality control can prove beneficial to organizations in the sector regardless of their particular specialism and size [9]. According Grigg, the initiatives of training of new graduates entering the industry in the principles of quality assurance and statistical methods and training the existing workforce and management in applying statistical control procedures to processes will make this methods more use of it than they are [9, 10].
The industrial statistic includes descriptive statistics, process capability analysis, measurement system analysis, basic graphics as histogram, scatter, box-plot, Pareto diagram, cause and effect, design of experiments, linear regression and correlation, multiple regression, hypothesis testing, confidence intervals, analysis of variance, analysis of process capability, among other tools [8]. It also covers the sampling techniques and control charts that will be described below, to be very useful to inspection and process control.
The inspection process is to analyze or examine units of a product in order to verify with its quality characteristics are in accordance with technical or contractual specifications. Upon inspection of the product by sampling units are randomly selected to compose the sample batch. Depending on the number of defectives in the sample or the level of quality, that lot is accepted or rejected. Thus, sampling allows, by analysis of a small part of the whole or lot it is possible to draw conclusions about the rest not inspected. Therefore, in the sampling inspection an absolute conclusion about the quality of the lot will never be achieved, there is always a risk rate inherent in the sampling plan and dependent on its discriminatory power.
The current continuous improvement programs that evolve throughout the production chain, call for reducing the use of inspection techniques for the evaluation of the product or process, based on the idea that efforts should focus on "getting it right" in the first time and not in check it, then add value to the product, if it was done properly. However, these inspection techniques for acceptance have restored the importance of quality of audits.
There are two types of sampling plans, sampling plans by attributes and sampling plans by variables. The sampling rate by attributes consists in classifying units of a product just as acceptable or unacceptable based on the presence or absence of a particular feature in each unit qualitative inspected. The results of the inspection by attributes are expressed in terms of defective/not defective, conforming/nonconforming. In the inspection by variable the characteristics or indicators of quality of the product unit are analyzed and the results are expressed by some continuous numeric scale. While inspection by attributes takes values from the set of integers, inspection by variable takes values in the set of real numbers [11, 12]. Upon inspection by attributes the probability of acceptance of the lot is based on Poisson Probability Distribution. The Poisson Probability Distribution is sometimes used to approximate the binomial distribution when the sample size (n) is too large and the proportion of defectives (p) is small. Otherwise, the use of sampling plans by variable assumes that the Normal Probability Distribution fits well with the distribution of the values of the quality characteristic under study.
Inspections by sampling can be used in finished products, raw materials, manufacturing operations, products in intermediate stages of processing, stored materials, among others. There are situations when only one plan by variable applies, for example, when the buyer will accept the product, but will pay different prices depending on the level of product quality. Also when the analysis result of the product will be expressed as quantitative values. For example, in the determination of chemical composition, weight, volume, and physical and rheological measurements. Therefore, measures such as pH, acidity by titration, soluble solids, fat, objective measurements of color and texture, among others, are typical of the sampling variable. The sampling by attributes can be implemented when it wanted to analyze a quality parameter in qualitative terms. Thus they are quite applied, for example, in visual analysis of packaging, the presence of dirt and physical damage in fruit and vegetables.
The following hypothesis test is linked to inspection for acceptance:
Being “p” the proportion of defectives that the process produces. If the process is in control properly, this ratio is around p0 (hypothesis H0 true). The risk α, also known as producer\'s risk is likely rejection of a batch of a process whose average is equal to p0 defective, that is, the risk that the producer suffers as a result of inspection or analysis of sample can lead to a rejection of a good plot (which meets the specifications). The risk β, also known as consumer\'s risk is the probability of acceptance of a batch of a process in which the proportion of defectives is greater than p0, i.e., the result of inspection or analysis of the sample can lead to the acceptance of a batch inadequate; i.e., which does not meet the specifications [13].
A single sampling plan by attributes is defined by two parameters: sample size and acceptance number. The likelihood of acceptance of batches relates to the sample size, the severity in the acceptance criterion and the quality level of the products being analyzed in relation to the predetermined quality parameter [11]. In the sampling plans by variables, the probability of acceptance is related to the quality level of the product under examination and depends on the average of the quality parameter in question and its variability. It also depends on the severity criterion for acceptance of the lot [12].
Finally, it is worth noting that the Codex Alimentarius recommends the use of the ISO 2859 series relating to the procedures for sampling by attributes and the ISO 3951 series for the procedures for sampling by variables [14].
The formal start of statistical process control occurred around 1924, when Shewhart developed and applied control charts at Bell Telephone Laboratories, a telephone company in the United States [1, 7, 13]. As in the entire production process variability occurs, Chart Control or Control Chart, or Map Control, aims to monitor these changes in processes, as well as to evaluate the stability of this process and eliminate or control the causes of variations. A Control Chart (Figure 2) consists of a Central Line (CL), is a pair of control limits: one above Upper Control Limit (UCL) and one below, Lower Control Limit (LCL), and characteristic values marked on the graph. If these values are within limits, without any particular trend, the process is considered under control. But if the points relate outside the control limits or submit an atypical arrangement, the process is judged out of control.
Variability in process may be classified into two types: the variability caused by random or common cause, which are inherent in the process and will be present even considered that this process is fully standardized. If only this kind of cause is acting in the process, it is said that the manufacturing process remains in statistical control. The other type of variability is caused by remarkable and special causes that arise sporadically due to a particular situation which causes the process to behave in a completely different way than usual, which can result in a displacement of the quality level. Thus, it is said that the process is out of statistical control.
The manufacturing control is exercised by the manufacturer during the industrialization process. The goal is to maintain the quality of the product satisfactorily uniform, preventing the production of items outside specification. The proofing that the process is in control or not is, made by examining unit samples taken periodically out of the production line. If the process is under control, samples that present variability corresponding to samples taken from a normal population, i.e., the variability is attributable only to product that is the sample. The "under control process" supposes, therefore, that the quality characteristic of all units produced has Normal Probability Distribution (Figure 3). Moreover, it also implies that this distribution remains stable, i.e., that its two parameters, medium (μ) and standard deviation (σ), remain constant, which is verified by extracting a sequence of samples. So it is said that in a process under statistical control, the variability is attributed solely to random causes. These causes of variation do not cause appreciable variation in product quality; its elimination is impossible or anti-economical, and therefore, random causes are considered a natural part of the manufacturing process [8].
A typical control chart [8]
The Normal Distribution consists of an essential notion in statistical quality control rational. It is known that the items of a Normal Distribution (average μ and standard deviation σ) are distributed around the average, approximately by the following proportions: 68% of the values in the range μ ± σ, 95% in interval μ ± 2σ and 99.7% in the range μ ± 3σ. Consequently, differences between an observed value X and the average μ, greater than ± 3σ are separated, three times to every 1000 observations, and therefore, the range of variability "normal" in the process under control is μ-3σ and μ+3 σ (Figure 3).
When the variability becomes "abnormal" changes in the quality characteristics of the product are sensitive. The causes of modification can be discovered and are therefore called "identifiable causes". These causes require prompt corrective action, in order to eliminate them. In these situations the samples indicate that the manufacturing process has changed and that the units were produced out of control. Some typical situations in process out of control occur when can be seen points outside the control limits. This is the clearest indication of lack of control of a process, which requires an immediate investigation of the cause of variation. Also can happened of points of the chart represent a trend, which consists of a continuous motion of the points of the control chart in one direction (ascending or descending). Also there is a configuration in sequence in several successive points of the control chart shown in only one side of the center line (eight or more consecutive points on one side of the center line). Another approach is the normality of the control limits, where 2 out of 3 consecutive points are outside the limits of 2σ [8].
Scheme of Normal Probability Distribution
The food industry use control charts in different ways depending upon their level of maturity in statistical thinking [15]. In a survey conducted in UK food industry, revealed that while there are large differences in process types, quality priorities and key measures among different sub-sectors of the industry, the use of control charts was broadly similar. This generally extended to the use of control charts for recording or monitoring product net weight and volume data [15].
There are two types of quality control charts: control charts for variables and control charts for attributes, which will be described below.
Control charts for variables are named due to the fact that the quality characteristic being analyzed is expressed by a number on a continuous scale measures. Some examples of control charts are to yield a formulation, to verify the volume of a drink during their bottling, the soluble solids of a sweet after its cooking and the time to deliver a product to the customer.
Some control charts for variables most commonly used are: chart of the average (x), chart of amplitude (R), chart of standard deviation (s). When a quality characteristic of interest is expressed by a number on a continuous scale of measurement, the two control charts most used are the chart of the average (x) and a chart of variability (R or s). The two charts should be employed simultaneously.
Although the benefits of the application of control charts can be obtained in various situations of the food industry, the construction of the charts by variables will be exemplified by a typical situation of the food industry, in a packing operation. Imagine that a poultry slaughterhouse want to control the process of packaging of poultry cuts. In practice, the parameters average μ and standard deviation σ are unknown and must be estimated from sample data. The procedure to estimate μ and σ is to take m preliminary samples, each containing n observations of quality characteristic considered. These samples, known as rational subgroup should be taken when one believes that the process is under control and the operating conditions kept as uniform as possible. It is usual to consider m = 20 or 25 at least and n = 4, 5 or 6 [7,8].
The procedure for construction of the chart is:
Collect the data
Table 1 shows the values xij, weight of “j” cutting belonging to “i” sample, for 25 rational subgroup size of 4 (m = 25 and n = 4). Therefore, “i” varies from 1 to 25 and “j” from 1 to 4. The sections were collected when the machine was operating within normal procedure, i.e. no stops or apparent defects.
\n\t\t\t\tSamples\n\t\t\t | \n\t\t\t\n\t\t\t\txi1\n\t\t\t\t\n\t\t\t | \n\t\t\t\n\t\t\t\txi2\n\t\t\t\t\n\t\t\t | \n\t\t\t\n\t\t\t\txi3\n\t\t\t\t\n\t\t\t | \n\t\t\t\n\t\t\t\txi4\n\t\t\t\t\n\t\t\t | \n\t\t\t\n\t\t\t\tRi\n\t\t\t\t\n\t\t\t | \n\t\t
1 | \n\t\t\t250,11 | \n\t\t\t250,30 | \n\t\t\t249,50 | \n\t\t\t248,60 | \n\t\t\t1,70 | \n\t\t
2 | \n\t\t\t248,00 | \n\t\t\t248,60 | \n\t\t\t249,78 | \n\t\t\t250,15 | \n\t\t\t2,15 | \n\t\t
3 | \n\t\t\t249,19 | \n\t\t\t250,02 | \n\t\t\t250,84 | \n\t\t\t250,84 | \n\t\t\t1,65 | \n\t\t
4 | \n\t\t\t251,29 | \n\t\t\t248,86 | \n\t\t\t251,00 | \n\t\t\t249,39 | \n\t\t\t2,43 | \n\t\t
6 | \n\t\t\t249,33 | \n\t\t\t251,80 | \n\t\t\t249,65 | \n\t\t\t248,31 | \n\t\t\t3,49 | \n\t\t
7 | \n\t\t\t250,26 | \n\t\t\t248,56 | \n\t\t\t250,43 | \n\t\t\t251,21 | \n\t\t\t2,65 | \n\t\t
8 | \n\t\t\t250,31 | \n\t\t\t249,11 | \n\t\t\t249,54 | \n\t\t\t249,95 | \n\t\t\t1,20 | \n\t\t
9 | \n\t\t\t250,72 | \n\t\t\t250,80 | \n\t\t\t249,35 | \n\t\t\t249,35 | \n\t\t\t1,45 | \n\t\t
10 | \n\t\t\t250,21 | \n\t\t\t248,78 | \n\t\t\t248,99 | \n\t\t\t250,20 | \n\t\t\t1,43 | \n\t\t
11 | \n\t\t\t251,21 | \n\t\t\t251,45 | \n\t\t\t249,34 | \n\t\t\t250,55 | \n\t\t\t2,11 | \n\t\t
12 | \n\t\t\t249,22 | \n\t\t\t250,43 | \n\t\t\t250,45 | \n\t\t\t250,78 | \n\t\t\t1,56 | \n\t\t
13 | \n\t\t\t251,89 | \n\t\t\t250,87 | \n\t\t\t249,65 | \n\t\t\t249,00 | \n\t\t\t2,89 | \n\t\t
14 | \n\t\t\t250,98 | \n\t\t\t249,01 | \n\t\t\t249,51 | \n\t\t\t249,51 | \n\t\t\t1,97 | \n\t\t
15 | \n\t\t\t249,00 | \n\t\t\t249,00 | \n\t\t\t251,45 | \n\t\t\t250,00 | \n\t\t\t2,45 | \n\t\t
16 | \n\t\t\t249,98 | \n\t\t\t249,55 | \n\t\t\t249,67 | \n\t\t\t249,23 | \n\t\t\t0,75 | \n\t\t
17 | \n\t\t\t248,88 | \n\t\t\t250,43 | \n\t\t\t249,76 | \n\t\t\t249,11 | \n\t\t\t1,55 | \n\t\t
18 | \n\t\t\t251,65 | \n\t\t\t249,76 | \n\t\t\t249,12 | \n\t\t\t250,32 | \n\t\t\t2,53 | \n\t\t
19 | \n\t\t\t248,65 | \n\t\t\t248,32 | \n\t\t\t249,00 | \n\t\t\t250,12 | \n\t\t\t1,80 | \n\t\t
20 | \n\t\t\t248,12 | \n\t\t\t248.15 | \n\t\t\t249,45 | \n\t\t\t249,67 | \n\t\t\t1,55 | \n\t\t
21 | \n\t\t\t251,13 | \n\t\t\t250,21 | \n\t\t\t249,11 | \n\t\t\t247,88 | \n\t\t\t3,25 | \n\t\t
22 | \n\t\t\t250,44 | \n\t\t\t251,17 | \n\t\t\t250,01 | \n\t\t\t250,01 | \n\t\t\t1,16 | \n\t\t
23 | \n\t\t\t250,12 | \n\t\t\t251,98 | \n\t\t\t251,13 | \n\t\t\t251,93 | \n\t\t\t1,86 | \n\t\t
24 | \n\t\t\t248.56 | \n\t\t\t248.90 | \n\t\t\t248,20 | \n\t\t\t248,98 | \n\t\t\t0,78 | \n\t\t
25 | \n\t\t\t248,12 | \n\t\t\t248,45 | \n\t\t\t248,90 | \n\t\t\t250,16 | \n\t\t\t2,04 | \n\t\t
Values of xij and Ri.
Calculate the amplitude of each sample Ri
See the values of Ri in Table 1.
Calculate the average amplitude of the sample R
Thus the value of R (average amplitude) is R = 1,93.
Establish the boundaries of the amplitude chart (Chart of R):
The values of D4 and D3 are tabulated [7, 8]. Thus, D4 = 2,282 and D3 = 0.
Therefore:
Build the chart of amplitude (Figure 4).
Analyze the chart.
Analyze the behavior of the points on the chart of amplitude and verify if the process is in statistical control. If necessary, recalculate the chart boundaries after the abandonment of the points there are out of control. Repeat this procedure until the control state is reached.
Analyzing the Figure 4, it can be seen that all points present within normal behavior. Now it is necessary to build the chart of average (x). To do this:
Calculate the average xi of each sample (Table 2).
Calculate the global average
Calculate the control limits of the chart average.
The value of A2 is a constant tabulated [7, 8]. Thus, A2 = 0,729.
Thus:
Chart of Amplitude (R) (25 points)
Construct of the average chart (Figure 5).
Chart of Average (x)
Interpret the chart of average built.
Analyze the behavior of the points on the average chart and whether the process is in statistical control. If necessary, recalculate the chart boundaries after the abandonment of the points there are out of control. Repeat this procedure until the control state is reached.
Analyzing the Figure 5, it can be seen that point 23 is above the UCL and therefore should be eliminated. The boundaries must be recalculated and a new chart of amplitude must be drawn (Figure 6).
New limits of the graph of the average (x) after removal of the subgroup 23.
\n\t\t\t\tSamples\n\t\t\t | \n\t\t\t\n\t\t\t\txi1\n\t\t\t\t\n\t\t\t | \n\t\t\t\n\t\t\t\txi2\n\t\t\t\t\n\t\t\t | \n\t\t\t\n\t\t\t\txi3\n\t\t\t\t\n\t\t\t | \n\t\t\t\n\t\t\t\txi4\n\t\t\t\t\n\t\t\t | \n\t\t\t\n\t\t\t\txn\n\t\t\t\t\n\t\t\t | \n\t\t
1 | \n\t\t\t250,11 | \n\t\t\t250,30 | \n\t\t\t249,50 | \n\t\t\t248,60 | \n\t\t\t249,63 | \n\t\t
2 | \n\t\t\t248,00 | \n\t\t\t248,60 | \n\t\t\t249,78 | \n\t\t\t250,15 | \n\t\t\t249,13 | \n\t\t
3 | \n\t\t\t249,19 | \n\t\t\t250,02 | \n\t\t\t250,84 | \n\t\t\t250,84 | \n\t\t\t250,22 | \n\t\t
4 | \n\t\t\t251,29 | \n\t\t\t248,86 | \n\t\t\t251,00 | \n\t\t\t249,39 | \n\t\t\t250,14 | \n\t\t
6 | \n\t\t\t249,33 | \n\t\t\t251,80 | \n\t\t\t249,65 | \n\t\t\t248,31 | \n\t\t\t249,77 | \n\t\t
7 | \n\t\t\t250,26 | \n\t\t\t248,56 | \n\t\t\t250,43 | \n\t\t\t251,21 | \n\t\t\t250,12 | \n\t\t
8 | \n\t\t\t250,31 | \n\t\t\t249,11 | \n\t\t\t249,54 | \n\t\t\t249,95 | \n\t\t\t249,73 | \n\t\t
9 | \n\t\t\t250,72 | \n\t\t\t250,80 | \n\t\t\t249,35 | \n\t\t\t249,35 | \n\t\t\t250,06 | \n\t\t
10 | \n\t\t\t250,21 | \n\t\t\t248,78 | \n\t\t\t248,99 | \n\t\t\t250,20 | \n\t\t\t249,55 | \n\t\t
11 | \n\t\t\t251,21 | \n\t\t\t251,45 | \n\t\t\t249,34 | \n\t\t\t250,55 | \n\t\t\t250,64 | \n\t\t
12 | \n\t\t\t249,22 | \n\t\t\t250,43 | \n\t\t\t250,45 | \n\t\t\t250,78 | \n\t\t\t250,22 | \n\t\t
13 | \n\t\t\t251,89 | \n\t\t\t250,87 | \n\t\t\t249,65 | \n\t\t\t249,00 | \n\t\t\t250,35 | \n\t\t
14 | \n\t\t\t250,98 | \n\t\t\t249,01 | \n\t\t\t249,51 | \n\t\t\t249,51 | \n\t\t\t249,75 | \n\t\t
15 | \n\t\t\t249,00 | \n\t\t\t249,00 | \n\t\t\t251,45 | \n\t\t\t250,00 | \n\t\t\t249,86 | \n\t\t
16 | \n\t\t\t249,98 | \n\t\t\t249,55 | \n\t\t\t249,67 | \n\t\t\t249,23 | \n\t\t\t249,61 | \n\t\t
17 | \n\t\t\t248,88 | \n\t\t\t250,43 | \n\t\t\t249,76 | \n\t\t\t249,11 | \n\t\t\t249,55 | \n\t\t
18 | \n\t\t\t251,65 | \n\t\t\t249,76 | \n\t\t\t249,12 | \n\t\t\t250,32 | \n\t\t\t250,21 | \n\t\t
19 | \n\t\t\t248,65 | \n\t\t\t248,32 | \n\t\t\t249,00 | \n\t\t\t250,12 | \n\t\t\t249,02 | \n\t\t
20 | \n\t\t\t248,12 | \n\t\t\t248.15 | \n\t\t\t249,45 | \n\t\t\t249,67 | \n\t\t\t249,08 | \n\t\t
21 | \n\t\t\t251,13 | \n\t\t\t250,21 | \n\t\t\t249,11 | \n\t\t\t247,88 | \n\t\t\t249,58 | \n\t\t
22 | \n\t\t\t250,44 | \n\t\t\t251,17 | \n\t\t\t250,01 | \n\t\t\t250,01 | \n\t\t\t250,41 | \n\t\t
23 | \n\t\t\t250,12 | \n\t\t\t251,98 | \n\t\t\t251,13 | \n\t\t\t251,93 | \n\t\t\t251,29 | \n\t\t
24 | \n\t\t\t248.56 | \n\t\t\t248.90 | \n\t\t\t248,20 | \n\t\t\t248,98 | \n\t\t\t248,59 | \n\t\t
25 | \n\t\t\t248,12 | \n\t\t\t248,45 | \n\t\t\t248,90 | \n\t\t\t250,16 | \n\t\t\t248,91 | \n\t\t
Values of xij and xn.
Chart of Average (x) (without the 23th subgroup)
Place the final charts of amplitude and average in the production line.
Note that for control of the packaging process of cuts of poultry, it chart has to be placed without padding, only with the UCL, CL and LCL, so that operators or responsible for quality control of packaging can monitor the process.
Periodically review the values of the control limits.
It is not always by means of measurements that assess the quality of a product. For example, the color of a biscuit or of a sweet can be evaluated sensorially and the result is expressed as conforming or not conforming to a specified standard. Or, a PET bottle can be classified as not defective if it is whole in its structure or defective if it is crushed or broken.
Control charts for attributes can be: chart of the proportion of defective items (Chart p), chart of the total number of defects (Chart np), chart of number of nonconformities in the sample (Chart C) and the chart of number of nonconformities by inspection unit (Chart u) [8, 13].
Also here the construction of a chart for attributes will be exemplified. Suppose a manufacturer industry of biscuits decides to build a control chart p to visually check whether the product color after baking, was established as a standard for quality control. The number of defective products is presented in Table 3 and is important to note that the samples were numbered according to the date of production.
\n\t\t\t\tDate\n\t\t\t | \n\t\t\t\n\t\t\t\tLot\n\t\t\t | \n\t\t\t\n\t\t\t\tNº. Biscuit inspectionated\n\t\t\t | \n\t\t\tDefective items (xi) | \n\t\t\t\n\t\t\t\tProportion of defective items (p)\n\t\t\t | \n\t\t
01/mai | \n\t\t\t1 | \n\t\t\t200 | \n\t\t\t7 | \n\t\t\t0,035 | \n\t\t
02/mai | \n\t\t\t2 | \n\t\t\t200 | \n\t\t\t9 | \n\t\t\t0,045 | \n\t\t
03/mai | \n\t\t\t3 | \n\t\t\t200 | \n\t\t\t4 | \n\t\t\t0,02 | \n\t\t
04/mai | \n\t\t\t4 | \n\t\t\t200 | \n\t\t\t5 | \n\t\t\t0,025 | \n\t\t
05/mai | \n\t\t\t5 | \n\t\t\t200 | \n\t\t\t6 | \n\t\t\t0,03 | \n\t\t
06/mai | \n\t\t\t6 | \n\t\t\t200 | \n\t\t\t9 | \n\t\t\t0,045 | \n\t\t
07/mai | \n\t\t\t7 | \n\t\t\t200 | \n\t\t\t5 | \n\t\t\t0,025 | \n\t\t
08/mai | \n\t\t\t8 | \n\t\t\t200 | \n\t\t\t6 | \n\t\t\t0,03 | \n\t\t
09/mai | \n\t\t\t9 | \n\t\t\t200 | \n\t\t\t6 | \n\t\t\t0,03 | \n\t\t
10/mai | \n\t\t\t10 | \n\t\t\t200 | \n\t\t\t4 | \n\t\t\t0,02 | \n\t\t
11/mai | \n\t\t\t11 | \n\t\t\t200 | \n\t\t\t6 | \n\t\t\t0,03 | \n\t\t
12/mai | \n\t\t\t12 | \n\t\t\t200 | \n\t\t\t7 | \n\t\t\t0,035 | \n\t\t
13/mai | \n\t\t\t13 | \n\t\t\t200 | \n\t\t\t4 | \n\t\t\t0,02 | \n\t\t
14/mai | \n\t\t\t14 | \n\t\t\t200 | \n\t\t\t6 | \n\t\t\t0,03 | \n\t\t
15/mai | \n\t\t\t15 | \n\t\t\t200 | \n\t\t\t7 | \n\t\t\t0,035 | \n\t\t
16/mai | \n\t\t\t16 | \n\t\t\t200 | \n\t\t\t8 | \n\t\t\t0,04 | \n\t\t
17/mai | \n\t\t\t17 | \n\t\t\t200 | \n\t\t\t8 | \n\t\t\t0,04 | \n\t\t
18/mai | \n\t\t\t18 | \n\t\t\t200 | \n\t\t\t4 | \n\t\t\t0,02 | \n\t\t
19/mai | \n\t\t\t19 | \n\t\t\t200 | \n\t\t\t7 | \n\t\t\t0,035 | \n\t\t
20/mai | \n\t\t\t20 | \n\t\t\t200 | \n\t\t\t6 | \n\t\t\t0,03 | \n\t\t
Number of defective biscuits in samples of 100 units
Collect the data
Collect m samples of size n. In general m = 20 or 25 at least. Collect the samples at successive intervals and record observations in the order they were obtained (Table 3).
Calculate the average proportion of defective items p (average).
Xi is the number of defective items in the “i” sample.
Calculate the control limits.
The LCL is not considered when the value is negative.
Draw the control limits. Mark left-hand vertical axis in the scale for horizontal axis p and the number of samples. Draw lines to represent full UCL, CL and LCL (Figure 7).
Chart p (proportion of defective products in the sample)
Mark the points on the chart.
Represent on the chart the m values of p (Figure 7).
Interpret the graph constructed.
To analyze the behavior points on the graph, and verify that the process is in statistical control. If necessary, recalculate the chart boundaries after the abandonment of the points there are out of control. Repeat this procedure until the control state is reached.
Check if the control state reached is appropriate to the process. If so, adopt the current control chart. Note that for control of the biscuit color, it chart has to be placed without padding, i.e., only with the UCL, CL and LCL.
Periodically review the values of the control limits.
In the \'50s, the quality control was employed in Japan, by an intensive use of statistical techniques. However, the excessive emphasis on statistical techniques led to some problems, such as low interest shown by senior management of companies, by the quality control, which remained a movement of ground and plant, i.e., to engineers and workers [16].
In 1954 JUSE invited the engineer Juran, one of the masters of quality management, to deliver seminars to senior management. From the visit of Juran, the Quality Control came to be understood and used as an administrative tool, which represented the beginning of the transition of Statistical Quality Control for Total Quality Control as is currently practiced, involving the participation of all sectors and employees[16].
The quality management system proposed by the Japanese model shows how basic features to the participation of all sectors and all company employees in the practice of quality control, constant education and training for all levels of the organization, circles activity of quality control, audits, use of basic and advanced statistical techniques and national campaigns to promote quality control.
The TQC ideas developed by the Japanese were broadcast around the world, being this model capable of being deployed in companies of various sectors, with appropriate adjustments to the corporate culture.
While the movement occurred in Japan by TQC, in Europe there was a movement around an organizational structure whose purpose was to develop standards for manufacturing, trade and communication in European countries for the increased levels of quality of activities. Thus, in 1947 the International Organization for Standardization was founded, based in Geneva, Switzerland. And in terms of quality control there was difficulty to unify standards that ensure that a product had been manufactured under quality criteria, after several trials, in 1989, was published the standard ISO 9000. The goal was to establish requirements for a quality management system, the implementation of which would extend to all types and business segments. The requirements of the series represented the consensus of different countries of the world.
More specifically, ISO 9001 deals with the requirements of the quality management system for an organization to produce compliant products and get customer satisfaction. Within the rules of the certification ISO 9001, there are specific requirements regarding the responsibility and involvement of management with the quality system, requirements for preparing and controlling of the documentation, for the critical analysis of contracts and selection of suppliers, to traceability and processes control, for measurement, for inspection and testing, analysis of nonconformities and for continuous improvement, for audits and training.
As ISO 9001 is a rule of general character it contains requirements to serve the most various sectors, it is necessary, once adopted by the food industry, some aspects can be considered in some cases insufficient. There\'s not in the standard, explicit references to the risks to consumer health, the safe products, the nutritional values, the critical control points, the good manufacturing practices. Food security can be seen as failures risk of deterioration and damage as a result of careless handling and storage inconvenient and not because of contamination and loss of sensory and nutritional values. Thus management systems for food safety have also been employed to address this need [17].
Aiming to harmonize the international level, the various guidelines related to food safety systems, it was developed the ISO 22000:2005 - Food Safety Management systems - Requirements for any organization in the food chain. This applies the principles of a plan Hazard Analysis and Critical Control Points (HACCP) programs along with prerequisites, such as Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP). The standard has a similar format to the standard of ISO 9001 Quality Management. This similarity allows organizations to implement the specifics of food management system integrated to the quality management system. In this context the ISO 22000 presents as fact the benefits of being recognized internationally, to apply to all elements of the food chain and fill for the food sector, the gap between ISO 9001 and HACCP.
The ISO 22000 standards specifies the requirements to a safety management system that combines elements of food management system to ISO 9001 templates, as already said, and interactive communication, since communication along the supply chain is essential to ensure that all relevant safety hazards of food are identified and controlled. Finally, through concrete measures, tangible and that can be checked in audits, ISO 22000 combines the HACCP plan with prerequisite programs (PRP), since they are keys to an effective management system of food safety.
The ISO 22000 considers that the safety of food is related to the presence of hazards in food at the time of consumption. And because of the dangers that can occur at any stage of the supply chain, the security must be ensured at all levels of the supply chain. So it should be applied to producers of animal feeds and other agricultural products, food manufacturers, packaging, transportation and food warehouses to suppliers of retail and food services. So for its strong integrator character, the success of the implementation depends largely on the acceptance of the various links in the supply chain. Other barriers may arise in terms of local practices and investment cost.
The concept of 6-Sigma system was developed by Motorola in the mid 80´s. The 6-Sigma program involves the application of statistical methods to business processes, guided by the goal of eliminating defects. The 6-Sigma focuses on quality improvement (eg, waste reduction) to help organizations produce better, faster and more economical. More generally, the program focuses on defect prevention, reduction of cycle times and cost savings. Unlike careless cost cutting, which reduce the value and quality, Six Sigma identifies and eliminates costly waste, i.e., that do not add value to the customers. With this, the company increases operational efficiency reduces costs, improves quality, increases customer satisfaction and increases profitability [18, 19].
Sigma (σ) is a letter of the Greek alphabet used by statisticians to measure the variance in any process. The performance of a company is measured by the sigma level of their business processes. Organizations that employ the Six Sigma method aim to achieve 3.4 defects per million on manufactured products. This methodology is based on the implementation of a system based on the measurement and monitoring of processes so that deviations from \'normality\' are avoided as much as possible.
The Six Sigma methodology is composed by a broad set of tools and techniques for quality improvement, among which there is a strong application of statistical tools and techniques. The cycle of phases, called DMAIC (Define, Measure, Analyze, Improve, Control) is used as a guide for professionals (mainly black belts and green belts) to implement projects that meet the goals most daring and radical pre-set by the company. The DMAIC can be resumed as follows:
Define: define problems and situations to be improved, including the goals of the activities, as they will be the company\'s strategic objectives.
Measure: to establish valid and reliable measurements for information and data.
Analyze: analyze the information captured in order to identify ways to eliminate the gap between the current performance of the system or process and the desired goal. It should apply statistical tools to aid analysis.
Increment: deploy processes, it can use management tools of projects or planning and managing to deploy a new approach,
Control: control the improved processes in order to generate a continuous improvement cycle.
The statistical aspects of six sigma must complement business perspectives and challenges to the organization to implement six sigma projects successfully.In the list of tools and statistical techniques of DMAIC, are included: descriptive statistics, principles of sampling, control charts, process capability analysis, measurement system analysis, basic charts (histogram, scatter, box-plot, Pareto, etc..), cause and effect diagram, statistical process control (SPC), design of experiments, linear regression and correlation, multiple regression, hypothesis testing, confidence intervals, analysis of variance, capability process analysis, among others [18-20].
Factors influencing successful six sigma projects include management involvement and organizational commitment, project management and control skills, cultural change, and continuous training. It is a methodology that crosses the entire company, i.e., it is not the isolated involvement of a team, but the involvement of all in the pursuit of the implementation of continuous improvement and customer satisfaction [19, 20].
The adoption of the Six Sigma methodology as a quality program in all agribusiness chain in general is still new, but it is important to highlight the potential of this method for improving the quality of food products and reduce production costs.
The competitiveness of a company can be seen as a reflection of the strategies adopted as a means to adapt to the prevailing standards of competition in the markets in which the organization operates. Certainly, quality is a key factor for the food industry acts in a market increasingly globalized. For that companies must establish competitive strategies and develop an appropriate internal structure.
From these assumptions, this chapter talked about the important aspects and also specific to quality management in the food industry. The reality of each company, in financial terms, cultural, organization and motivation, will determine the degree of maturity and efficiency in quality management. What can be concluded is that the competitive advantage certainly goes through the constant search for new tools and learning management systems that improve the quality of processes and services and consequently the products offered by the food industry.
Epilepsy is defined by recurrent, spontaneous seizures arising from hyperexcitable neurons in the brain. Yet despite a wide array of anti-epileptic drugs and the option of surgery, approximately one-third of children and adults with epilepsy continue to experience drug-resistant seizures [1]. Many of these patients may be candidates for a ketogenic diet, a well-established, non-pharmacologic therapeutic option proven to improve seizure control in epilepsy [2, 3].
The origins of ketogenic diets derive from the ancient practice of fasting [4], widely acknowledged as effective in treating epilepsy since the 5th century BC; indeed, until the 19th century, epilepsy was believed to be a disease of “eating too much” [5]. Depending on a person’s body fat stores, fasting can be maintained for a considerable length of time (the record for a single continuous fast is 382 days) [6]. However, since everyone must eventually eat, fasting is not a feasible long-term solution for seizure control in epilepsy.
In 1921, Wilder addressed this problem by developing a high-fat, low-carbohydrate diet designed to mimic the metabolic profile of fasting [4]. The high-fat, low-carbohydrate nature of the diet elevated blood ketones and lowered blood glucose levels, producing a metabolic profile similar to that of a multi-day fast. Unlike fasting, Wilder’s diet provided adequate long-term nutrient intake, thus preventing malnutrition and promoting healthy long-term growth and development. Since the diet increased hepatic ketogenesis, it became known as a “ketogenic diet.”
In essence, a ketogenic diet is any high-fat, adequate-protein, low-carbohydrate diet that forces the body to burn fats—not carbohydrates—as the primary energy source [7, 8]. During this process, the liver converts fats into ketone bodies, or “ketones” (organic molecules that readily serve as energy substrates for non-hepatic organs, particularly brain, heart, and skeletal muscle) [9]. The three endogenous ketones are acetone, acetoacetate, and beta-hydroxybutyrate (BHB) [7]; BHB is the primary blood ketone. During a sustained ketogenic diet, the blood BHB level is elevated, and lies within the range of 0.5–8 mmol/L, constituting a state of “physiological ketosis” (in contrast to pathological ketoacidosis, which is associated with a blood BHB level of 15–20 mmol/L or higher, and a concomitant lowering of blood pH) [10].
Ketogenic diets appear to improve seizure control through a variety of mechanisms that collectively stabilize neuron synaptic function (Table 1) [7, 8]. It is not known whether the key mediators of improved seizure control are the ketones themselves, or additional metabolic changes induced by the diets [11].
General mechanism | Specific mechanism |
---|---|
Enhanced neuron energetics | Enhanced neuron ATP production |
Stimulated mitochondrial biogenesis | |
Reduced neuron excitability | Hyperpolarized potassium channels |
Altered glutamate to GABA ratio | |
Increased extracellular adenosine | |
Direct antiseizure effects | Ketone-mediated antiseizure effects |
Raised medium-chain fatty acids | |
Reduced glucose metabolism | |
Other mechanisms | Reduced oxidative stress |
Reduced inflammation |
Mechanisms through which ketogenic diets may stabilize synaptic function.
ATP = adenosine triphosphate; GABA = γ-aminobutyric acid.
The most conspicuous metabolic change induced by a ketogenic diet is elevated blood ketone levels [7]. While it is well-documented that ketones enhance neuron energetics, accumulating evidence suggests they may also play direct and indirect roles in reducing neuron excitability, exerting direct antiseizure effects, and decreasing generation of reactive oxygen species and inflammatory mediators [7, 8, 11]. Thus, there are multiple avenues by which ketones may contribute to improved seizure control; they are not just “energy molecules” [11].
Ketones enhance intracellular adenosine triphosphate (ATP) levels and bioenergetic capacity by increasing mitochondrial oxidative phosphorylation [12]. The oxidation of acetoacetate and BHB feeds acetyl-CoA directly into the Krebs cycle through anaplerosis (the replenishing of depleted metabolic cycle intermediates) [7], which increases the turnover of the Krebs cycle, generating additional protons and electrons that are channeled to the electron transport chain where they may be used to enhance ATP production [12].
Ketones may also inhibit neuronal excitability. ATP-dependent potassium channels, which hyperpolarize the cell membrane, are activated by ketones, decreasing spontaneous cell firing rates [13]. Moreover, acetoacetate concentrations well within the range produced by a ketogenic diet inhibit vesicle loading of the excitatory neurotransmitter glutamate, resulting in reduced glutamate release into the synapse and enhanced synthesis of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) [14]. It is thought that the ensuing altered glutamate to GABA ratio reduces neuron excitability.
Studies dating back to the 1930s also support the direct antiseizure effects of ketones [15, 16]. In mice, acetone and acetoacetate raise seizure thresholds, resulting in fewer seizures [15, 16]. Although BHB did not appear to contribute to antiseizure effects in these earlier studies, more recent studies indicate that BHB probably does play a direct antiseizure role, and that its effects may have been previously missed for methodological reasons [11].
Lastly, ketones may influence seizure control by lowering cell oxidative stress and inflammation [11]. BHB inhibits histone deacetylases (enzymes that remove acetyl groups from lysine residues on histones, allowing DNA to wrap tightly and preventing gene expression), resulting in upregulated anti-oxidant genes and reduced oxidative stress in kidney cells [17]. Moreover, BHB inhibits the assembly of the immune sensor nucleotide oligomerization domain (NOD)-like receptor protein 3, a multi-protein complex that controls the release of various inflammatory mediators [18].
Emerging evidence suggests that a number of additional metabolic changes induced by ketogenic diets may also contribute to enhanced neuron energetics, reduced neuron excitability, and direct antiseizure effects, improving seizure control [7, 8].
Ketogenic diets can improve seizure control in patients with mitochondrial disorders [19]. This observation may be partly explained by the action of the medium-chain fatty acid, decanoic acid, on peroxisomal proliferator-activated receptor γ, which stimulates neuronal mitochondrial biogenesis [19]. The increased mitochondrial biomass enhances neuron ATP production capacity and cell energy reserves.
Ketogenic diets may also alter brain levels of the neurotransmitter adenosine. The disruption of adenosine signaling induces seizures; this effect is reversible by a ketogenic diet [20]. This observation suggests that the diet increases extracellular adenosine levels, activating inhibitory adenosine A1 receptors and reducing neuron hyperexcitability [7].
Lastly, ketogenic diets may exert direct antiseizure effects by raising medium-chain fatty acid levels and decreasing glucose metabolism [7, 8]. The medium-chain fatty acid, decanoic acid, blocks seizure-like activity in animals [21]. Moreover, since the antiseizure effects of ketogenic diets can be rapidly reversed by glucose infusions, decreased glucose metabolism is thought to contribute to seizure control. The mechanism for this effect could be partially explained by the observation that ketogenic diets induce a reduction in glycolysis, subsequently repressing the expression of brain-derived neurotrophic factor, a known pro-convulsant [7].
To date, four major, “conventional” ketogenic diets are supported by published evidence in the treatment of children and adults with epilepsy (Table 2) [2, 3]. The primary difference between each diet lies in the ratio of fat to protein plus carbohydrate, described by weight or by calorie intake.
Ketogenic diet | Macronutrient ratio (by weight) | Macronutrient ratio (by calorie intake) |
---|---|---|
CKD | Fat 80% | Fat 90% |
Protein 12% | Protein 6% | |
Carbohydrate 8% | Carbohydrate 4% | |
MCT diet | Fat 60% | Fat 75% |
Protein 16% | Protein 10% | |
Carbohydrate 24% | Carbohydrate 15% | |
MAD | Fat 50% | Fat 65–70% |
Protein 35% | Protein 25–30% | |
Carbohydrate 15% | Carbohydrate 5% | |
LGIT diet | Fat 40% | Fat 60% |
Protein 45% | Protein 30% | |
Carbohydrate 15% | Carbohydrate 10% |
Conventional ketogenic diets supported by published evidence in treating epilepsy.
CKD = classic ketogenic diet; MCT = medium-chain triglyceride; MAD = modified Atkins diet; LGIT = low glycemic index treatment.
Created by Wilder in the 1920s [1], the CKD is the oldest of all ketogenic diet therapies and in its purest form consists of 80% fat by weight (roughly equivalent to 90% fat by caloric intake), translating to a 4:1 ratio of fat to protein plus carbohydrate, although a 3:1 ratio or lower can often be used [2]. In the CKD, the fat source consists predominantly of long-chain fatty acids, obtained from standard foods.
In an effort to make the ketogenic diet more palatable, the MCT diet was introduced in the 1970s [22]. In its original form, the MCT diet is 60% fat by weight (roughly 75% fat by caloric intake), with fat sourced from MCT oils. Since medium-chain fatty acids yield more ketones per kilocalorie compared to long-chain fatty acids, the MCT diet allows for a lower overall fat intake, and a greater intake of protein and carbohydrate, compared to the CKD. A number of patients are prone to gastrointestinal side-effects on this diet, so a modified MCT diet was created in the 1980s, consisting of 30% medium-chain fatty acids plus 30% long-chain fatty acids by weight [23].
In the early 2000s, the MAD was shown to be effective in treating epilepsy [24]. The MAD is approximately 50% fat by weight (65–70% fat by caloric intake), translating to a 1:1 ratio of fat to protein plus carbohydrate, although no set ratio is mandated; it may even approach a 4:1 ratio [2]. The MAD eases up on the protein and carbohydrate restrictions imposed by the CKD and MCT diet, and does not require food weighing.
The LGIT, roughly 40% fat by weight (60% fat by caloric intake), was introduced in the early 2000s as a treatment for epilepsy [25]. The design of the LGIT was based on the hypothesis that stable glucose levels contribute to the seizure control conferred by ketogenic diets. The LGIT allows for relatively liberal levels of protein and carbohydrate intake, emphasizing carbohydrates with glycemic indices less than 50.
Unfortunately, many children throughout the world still lack access to a pediatric epilepsy center containing a specialized ketogenic service with both inpatient and outpatient management options [2]. Such a service should consist of a pediatric neurologist, nurse, dietitian, and ideally case managers, psychologists, social workers, and pharmacists [2, 26].
Ketogenic diets in children are strongly indicated in drug-resistant epilepsy, two disorders of brain metabolism, and several other seizure disorders (Table 3) [2]. There is virtually no age restriction as to when the diet may be commenced; in fact, infants younger than 2 years may be an ideal age group [27].
General disorder | Specific disorder |
---|---|
Drug-resistant epilepsy | 2010 ILAE definition |
Disorders of brain metabolism | GLUT1 DS |
PDHD | |
Specific seizure disorders | Angelman syndrome |
Complex I mitochondrial disorders | |
Doose syndrome | |
Dravet syndrome | |
FIRES | |
Formula-fed | |
Infantile spasms | |
Ohtahara syndrome | |
Super-refractory status epilepticus | |
Tuberous sclerosis complex |
Epilepsy disorders in children for which a ketogenic diet may be strongly indicated.
ILAE = International League Against Epilepsy; GLUT1 DS = glucose transporter type 1 deficiency syndrome; PDHD = pyruvate dehydrogenase complex deficiency; FIRES = febrile infection-related epilepsy syndrome.
In 2010, the International League Against Epilepsy (ILAE) defined drug-resistant epilepsy as the failure of adequate trials of two appropriately chosen, tolerated, and used anti-epileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom [28]. The drugs must have been appropriate for the seizure type, tolerated at therapeutic doses, and given a reasonable period of time to work (at least 6 months) [29] before declaring drug resistance.
When drug-resistant epilepsy is declared, further anti-epileptic drug trials or epilepsy surgery may be helpful [30]. However, even after carefully excluding confounding factors and optimizing the drug approach, subsequent trials have only a slight (about 5%) chance of inducing seizure remission [31]. Surgery should always be considered in children with drug-resistant epilepsy, especially when a lesion concordant to the epilepsy is detected on imaging [30], but many children are not surgical candidates due to a generalized or multifocal epilepsy syndrome, or nonresectable location of ictal onset.
When drug trials and surgery are no longer feasible, a ketogenic diet is indicated [2]. Numerous studies have demonstrated the efficacy and safety of using ketogenic diets to treat drug-resistant epilepsy in children, but until the previous decade there were no randomized controlled trials. Since 2008, four published randomized controlled trials have compared the efficacy of a ketogenic diet with continued medications or a placebo arm in children with drug-resistant epilepsy [32, 33, 34, 35].
The first randomized controlled trial compared the efficacy of a CKD versus no diet intervention in 145 children with drug-resistant epilepsy [32]. After 3 months, 28 children (38%) in the CKD group had a greater than 50% seizure reduction compared to four children (6%) in the control group. One weakness of the study was its unblinded design, with both patients and assessors aware of the group allocations.
The following year, a randomized controlled trial was published in 20 children with drug-resistant Lennox-Gastaut syndrome [33]. All patients were fasted 36 hours and then randomized to receive either a CKD plus a daily solution containing 60 g glucose per day or a solution containing saccharin (an artificial sweetener); the aim of the design was to ensure that both patients and assessors remained blinded to treatment. To the surprise of the investigators, both groups had positive blood BHB levels after 6 days, indicating that the glucose solution did not suppress physiological ketosis. Perhaps as a result of this, the study demonstrated only a borderline, non-statistically significant reduction in seizures in the saccharin arm.
The next randomized controlled trial compared the efficacy of a MAD versus no diet intervention in 102 children with drug-resistant epilepsy [34]. Surgical candidates were not excluded. After 3 months, 52% of children in the MAD group had a greater than 50% seizure reduction compared to 11.5% of those in the control group. A weakness of the study was its unblinded design, with both patients and assessors aware of the group allocations.
The most recent randomized controlled trial compared the efficacy of a ketogenic diet (CKD or MCT diet) versus no diet intervention in 57 children and adolescents with drug-resistant epilepsy [35]. None of the patients were eligible for surgery. After 4 months, 13 children (50%) in the ketogenic diet group had a greater than 50% seizure reduction compared to 4 children (18.2%) in the control group.
Pooling the results from these randomized controlled trials suggests that 40–50% of children experience a greater than 50% seizure reduction after 3–4 months on a ketogenic diet, compared to 10–15% of children receiving no dietary intervention. Given these encouraging results, many epilepsy specialists advocate that ketogenic diets be used earlier in the management of children with drug-resistant epilepsy [2].
Since ketogenic diets induce a shift away from glycolytic energy production towards mitochondrial oxidative phosphorylation, they are the treatment of choice in two childhood disorders of impaired brain glucose metabolism: glucose transporter type 1 deficiency syndrome (GLUT1 DS) and pyruvate dehydrogenase complex deficiency (PDHD) [2]. In both cases, the ketones produced by the diet bypass the metabolic defects, serving as an alternative energy source for the brain.
GLUT1 DS results from impaired glucose transport across the blood-brain barrier due to mutations in the SLC2A1 gene, which encodes the glucose transporter, GLUT1 [36]. Clinically, GLUT1 DS is characterized by cognitive impairment, mixed seizure types, and a complex movement disorder. The vast majority of children with GLUT1 DS achieve seizure freedom with a CKD, which should be introduced as early as possible and continued through to adulthood [36]. The CKD may be difficult to tolerate in older children and adolescents, in which case the MAD is also effective [2]. In GLUT1 DS, ketogenic diets may also enhance the child’s alertness, and they frequently improve the movement disorder [36].
In PDHD, pyruvate is unable to be metabolized into acetyl-CoA, resulting in abnormal mitochondrial metabolism and lactic acidosis [37]. Clinically, PDHD is characterized by seizures, severe encephalopathy, and—usually—death during childhood. The CKD is effective and safe in PDHD, and appears to increase longevity and improve mental development [37]. However, severe forms of PDHD may not be appropriate for the diet if quality of life is not improved [2].
Ketogenic diets should be considered early in the management of children with seizure disorders that consistently demonstrate a 60–70% improvement in seizure control, well above the “usual” 40–50% improvement [2]. These disorders include Angelman syndrome, complex I mitochondrial disorders, Doose syndrome, Dravet syndrome, febrile infection-related epilepsy syndrome (FIRES), formula-fed infants or children, infantile spasms, Ohtahara syndrome, super-refractory status epilepticus, and tuberous sclerosis complex [2].
Once the child is selected for a ketogenic diet, a medical and nutritional evaluation is both strongly advised (Table 4) [2, 26]. In addition to the caregiver (usually a parent), anyone else who will be helping institute the diet should attend.
Evaluation | Steps |
---|---|
Medical | Assess baseline epilepsy state and comorbidities |
Identify psycho-socioeconomic, cultural, and religious factors | |
Review anti-epileptic drugs and medications | |
Provide blood glucose and ketone monitor; show how to use | |
Order investigations | |
Nutritional | Assess baseline physical parameters |
Select most appropriate conventional ketogenic diet | |
Provide supplements | |
Educate caregiver |
Preparing a child (and caregiver) for a ketogenic diet.
A medical evaluation should be performed by a pediatric neurologist experienced in managing ketogenic diets in children, and include an assessment of the child’s epilepsy, comorbidities, psychological and socioeconomic factors, medications, and investigations [2].
First, the pediatric neurologist must assess the child’s baseline epilepsy state and any comorbidities that may complicate a ketogenic diet. Seizure symptomatology and frequency should be documented in sufficient detail so as to later gauge diet efficacy on seizure control. Potential complicating comorbidities include gastrointestinal issues (such as gastroesophageal reflux and constipation), hypercholesterolemia, low weight gain, kidney stones, chronic metabolic acidosis, and cardiomyopathy [2]. Once identified, most comorbidities can be preventatively managed.
Second, it is critical to identify psychological, socioeconomic, cultural, and religious factors that may affect the child’s diet [2]. Challenging behavior traits in the child or caregiver should be addressed early. Since many patients with epilepsy are of lower socioeconomic status, an appraisal of the family environment, including finances, is essential before deciding to proceed; even if deemed adequate, the caregiver must be made aware of the impact of a ketogenic diet on time and resources, including separate meal preparation from the rest of the family and increased costs [26]. It is also necessary to consider the family’s cultural and religious background, which may result in some recipes being more suitable than others [2].
Third, the child’s medications should be reviewed. Generally, blood levels of common anti-epileptic drugs are not significantly altered by a ketogenic diet, therefore dose adjustments are not required. However, it may be worth considering dose reductions in the case of valproate, zonisamide, and topiramate; although these drugs are generally safe alongside a ketogenic diet, there have been rare instances of hepatotoxicity and secondary carnitine deficiency with valproate, as well as chronic metabolic acidosis and a slight increase in kidney stones with zonisamide and topiramate [2]. All medications should be reviewed for carbohydrate content, which may necessitate a switch to lower carbohydrate preparations [26].
Fourth, the child and caregiver should be provided with a means of self-monitoring the diet, which critically provides feedback as to how effectively the child is achieving physiological ketosis [2]. Traditionally, this has been done using urine ketone dipstick testing, but it is now possible to prescribe a blood glucose and ketone monitor in many countries. The former is less expensive and avoids finger pricks, but the latter is easier, more specific, and more accurate [38]. Unless there is a compelling reason to measure urinary ketones, a blood glucose and ketone monitor should be prescribed and the caregiver instructed on its use.
Finally, investigations should be ordered before commencing a ketogenic diet in a child, primarily to rule out contraindications (a ketogenic diet is absolutely contraindicated in disorders of fat metabolism, including carnitine deficiency, carnitine palmitoyltransferase I and II deficiency, any of the short, medium, or long-chain acyl dehydrogenase deficiencies, and porphyria) [2]. Basic laboratory investigations include complete blood count, electrolytes, liver and kidney function tests, fasting lipid profile, calcium, vitamin D, serum acylcarnitine profile, and a urinalysis [2]. Baseline anti-epileptic drug levels can be measured, although few concerns for drug-diet interactions exist. A recent EEG and MRI brain should be obtained to identify potential surgical candidates. Further tests, such as ECG and renal ultrasound, may be ordered as clinically indicated.
A nutritional evaluation should be performed by a dietitian experienced in managing ketogenic diets in children, and include an assessment of baseline physical parameters, selection of the most suitable ketogenic diet, and education of the caregiver on what to expect with the diet.
Baseline weight, body-mass index, and height are routinely measured (in infants, head circumference is also measured) [2]. The child’s recommended calorie and fluid intake should be calculated, as well as the desired fat to protein to carbohydrate ratio. Food aversions and allergies must be clearly documented.
When selecting a conventional ketogenic diet for a child, the most important factor to consider is the family environment, rather than perceived diet efficacy [2]. The CKD is highly effective for seizure control, but restrictive and time-consuming; depending on the family environment, it may be more feasible to implement the MCT diet, MAD, or LGIT diet. Regarding diet efficacy, the CKD appears to be superior to the MAD in infants under 2 years of age, whereas both are equally effective in older children [27]. For the transition to adolescence, the MAD and LGIT diet are less restrictive and more appropriate; the LGIT diet may not provide an adequate level of ketosis to treat GLUT1 DS and PDHD, although it is highly effective in Angelman syndrome [2, 39]. For infants and children on enteral feeds, ketogenic diets can be administered in liquid form, which may be more convenient and efficacious [2].
Given the limited fruit, vegetable, and calcium content in conventional ketogenic diets, supplementation with a carbohydrate-free multivitamin containing minerals, as well as supplementation with calcium and vitamin D, is considered mandatory in children [26]. No particular recommendations exist for supplementing a ketogenic diet with magnesium, selenium, carnitine, laxatives, probiotics, or exogenous ketones [2, 26].
Caregiver education is essential; the caregiver needs to understand exactly what is required of them to implement the diet. A classroom-based format, with several different caregivers present, can be advantageous [26]. The dietitian should demonstrate how to identify sources of fat, protein, and carbohydrate, how to count net carbohydrate (total carbohydrate minus fiber) for those on a MAD, how to identify foods with a low glycemic index for those on an LGIT diet, and how to navigate potential pitfalls [26]. Helpful additional resources should be provided [40, 41] and any expectations addressed.
Once the child and caregiver have been prepared, it is time to implement the diet (Table 5) [2]. The pediatric ketogenic service should take on a strong supportive role, aiding the caregiver as much as possible in troubleshooting problems.
Stage | Steps |
---|---|
Initiation | Decide whether to initiate as inpatient or outpatient |
If inpatient, decide on induction fast and diet introduction | |
If outpatient, provide clear instructions to caregiver | |
Maintenance | Caregiver monitors seizure control and ketone levels |
Review at 1, 3, 6, 9, 12 months, and 6-monthly after | |
Monitor for adverse effects | |
Cessation | Identify when diet should be ceased (if ever) |
If to be ceased, consider switching to another ketogenic diet | |
If to be ceased, decide on rate of diet cessation |
Implementing a ketogenic diet in a child with epilepsy.
Currently, it is recommended that the CKD be initiated with the child in hospital [2]. The advantages of an inpatient admission include the ability to closely observe the child, medically intervene if necessary, and provide more time to educate the caregiver on how to maintain the diet upon returning home.
Traditionally, a 12–24 hours fast has been used to commence the diet in an inpatient setting [2]. Fasting may lead to a quicker onset of seizure reduction, which may be useful in refractory status epilepticus [2]. However, induction fasts do not improve ketosis or seizure control at 3 months, and fasted children experience weight loss, hypoglycemia, and acidosis more frequently, which may increase the length of hospital stay [42]. Thus, although an induction fast should be considered, most pediatric ketogenic services no longer routinely fast children, and none recommend fasting infants under 2 years of age [2].
Regardless of whether an induction fast is utilized, several approaches may be used to introduce the CKD in hospital [2]. One approach involves starting the diet at one-third or one-half of the final calorie level, increasing the calories by one-third or one-half over several days until full calorie intake is achieved, keeping the fat to protein to carbohydrate ratio constant. Another approach is to start with full calorie intake, but increase the ratio of fat to protein plus carbohydrate daily, from 1:1 to 2:1 to 3:1 to 4:1, allowing the child to gradually adapt to the increasing fat intake. Yet another approach is to simply commence the CKD at full calories and a 4:1 ratio on the first day, which does not appear to prolong hospital stay, increase adverse effects, or decrease diet efficacy at 3 months.
In older children, the CKD may be initiated as an outpatient, the advantages of which include reduced family stress and fewer hospital-associated costs [2]. Most pediatric ketogenic services also routinely initiate the less-restrictive MAD and LGIT diet in the outpatient setting. If a graded introduction is required at home, clear instructions must be given to the caregiver on how to do so.
Once initiated, ketogenic diets tend to work rapidly and effectively, with 75% of children responding within 14 days [43]. Complete seizure freedom often occurs within several months of initiation, although it may take up to 18 months [44]. The caregiver should monitor the child’s ketone levels (ideally, the blood BHB level) daily for the first several weeks, then two or three times a week once readings consistently show the child to be in physiological ketosis. Most pediatric ketogenic services recommend a blood BHB level of 4–6 mmol/L, although this is not based on clinical evidence [3]. If seizure control or ketone levels are not responding as expected, a 3-day food diary may be useful to discover potential oversights in diet implementation.
The pediatric neurologist and dietitian should be in frequent phone or email contact with the caregiver during the initial weeks of the diet, with additional follow-up visits occurring at 1, 3, 6, 9, and 12 months, and every 6 months thereafter [2]. The pediatric neurologist should document the child’s seizure response, and regardless of any improvement, resist altering their anti-epileptic drugs unless necessary; alterations may make it difficult to gauge diet efficacy on seizure control. Recommended follow-up tests include complete blood count, electrolytes, liver and kidney function tests, fasting lipid profile, calcium, and vitamin D [2]. Since ketogenic diets and anti-epileptic drugs may predispose a child to osteopenia, some pediatric ketogenic services perform a bone density scan after 2 years on the diet [2]. The dietitian should monitor the child’s physical parameters and nutritional intake at every visit. Ketogenic diets have a diuretic effect and fluid content in the food may be lessened, therefore fluid hydration must be monitored, and increased if necessary [26].
Both the caregiver and the pediatric ketogenic service must monitor the child for adverse effects. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and constipation appear in up to 50% of children on the CKD, but are easily remedied by increasing fluid, salt, and fiber intake [2]. Hyperlipidemia is common, with raised triglyceride and low-density lipoprotein (LDL) levels seen in up to 60% of children on the CKD, but the increase is usually transient and normalizes within 1 year; if desired, the LDL can be lowered by altering the types of fats ingested (for example, by increasing olive oil and decreasing saturated fats) [2]. Moreover, ketogenic diets may slightly inhibit a child’s growth; adjustments in calorie intake may compensate. Kidney stones may occur in 3–7% of children on the CKD, but can be prevented with oral citrates [2]. Ultimately, such common adverse effects are rarely sufficient reasons to discontinue the CKD, but rarer adverse effects such as cardiomyopathy, prolonged QT interval, and pancreatitis may provide sufficient reason to do so.
Upon ceasing a ketogenic diet, the long-term benefits on seizure control often outlast the diet itself. In children who become seizure-free on a ketogenic diet, 80% will remain so after diet cessation [45], an effect that can persist for many years.
The child’s ketogenic diet should be maintained for at least 3 months before passing judgment on its efficacy in seizure control [2]. The exception to this rule is if the seizures worsen for longer than 1–2 weeks after commencing the diet, or if a serious adverse effect occurs—in either case, it may be wise to discontinue the diet sooner.
If a child experiences the “usual” greater than 50% seizure reduction, the ketogenic diet is usually discontinued after 2 years [2]. In new-onset infantile spasms, the diet can be ceased at 6 months [46]. In drug-resistant epilepsy in which seizure control is virtually complete (over 90% seizure reduction) and GLUT1 DS, the diet can be carried into adulthood [2]. Older children may start to see their diet as overly restrictive; if it effectively controls the seizures, it may be switched over to another type of ketogenic diet (for example, from a CKD or MCT diet to a MAD or LGIT diet).
A child’s ketogenic diet should be ceased gradually (over several months) [2]. In the case of the CKD, the ratio can be reduced by decreasing the ratio of fat to protein plus carbohydrate monthly, from 4:1 to 3:1 to 2:1 to 1:1, allowing the child to gradually adapt to the decreasing fat intake, followed by the reintroduction of regular foods. However, it is usually still possible to cease the diet more rapidly (over several weeks) without negative consequences, although some children may experience a higher risk of increased seizures during the tapering-down period. If medically necessary, ketogenic diets can be stopped abruptly; this is best done in hospital.
Few epilepsy centers in the world offer a dedicated adult ketogenic service [3]. Such a service should consist of a neurologist, nurse, dietitian, and ideally a psychologist and social worker [3, 47].
Ketogenic diets in adults are indicated in drug-resistant epilepsy and certain seizure disorders (Table 6); they may be used in adults of all ages [47].
General disorder | Specific disorder |
---|---|
Drug-resistant epilepsy | 2010 ILAE definition |
Disorders of brain metabolism | GLUT1 DS |
PDHD | |
Specific seizure disorders | JME |
Lennox-Gastaut syndrome | |
Rett syndrome |
Epilepsy disorders in adults for which a ketogenic diet may be indicated; this list is not comprehensive.
ILAE = International League Against Epilepsy; GLUT1 DS = GLUT1 deficiency syndrome; PDHD = pyruvate dehydrogenase complex deficiency; JME = juvenile myoclonic epilepsy.
In 2010, the ILAE defined drug-resistant epilepsy as the failure of adequate trials of two appropriately chosen, tolerated, and used anti-epileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom [28]. Since adults may suffer from drug-resistant epilepsy for decades, many adult patients have already failed multiple trials of anti-epileptic drugs over their lifetime.
Further anti-epileptic drug trials and epilepsy surgery may be feasible options in adults with drug-resistant epilepsy [30]. However, subsequent drug trials confer only a slight (about 5%) chance of inducing seizure remission [31]. Surgery should always be considered, but some eligible adults may not be ready to pursue surgery [48], and many others will not be eligible due to a generalized or multifocal epilepsy syndrome, or nonresectable lesion of ictal onset.
When drug trials and surgery are not feasible, a ketogenic diet may be indicated [48]. Many single-arm studies have demonstrated the efficacy and safety of ketogenic diets in treating drug-resistant epilepsy in adults, but to date there are no randomized controlled trials of a ketogenic diet in adults with drug-resistant epilepsy.
Surprisingly, a 1930 study remains the largest retrospective case series to examine a ketogenic diet in adults with epilepsy [49]. In this study, 100 adolescents and adults with epilepsy were treated with a CKD. After 1–46 months, 56% of patients had a greater than 50% seizure reduction.
In 2014, a review of all subsequently published ketogenic diet studies in adults with drug-resistant epilepsy was published [50]. Five studies examined the use of a CKD to treat a combined total of 47 adults with drug-resistant epilepsy. After 3–26 months, 15 patients (32%) had a greater than 50% seizure reduction, with 24 patients (51%) stopping the diet before study completion. Another five studies examined the use of a MAD to treat a combined total of 85 adults with drug-resistant epilepsy. After 3–12 months, 24 patients (28%) had a greater than 50% seizure reduction, with 36 patients (42%) stopping the diet before completion. For both diets, most patients withdrew due to culinary and social restrictions.
In 2016, the largest observational study of a ketogenic diet in adults with drug-resistant epilepsy was published, in which 106 patients were treated with a MAD [48]. After 3 months, 38 patients (36%) had a greater than 50% seizure reduction, with 47 patients (44%) not completing the study, largely due to diet restrictiveness.
Pooling the results from these single-arm studies suggests that 30–40% of adults with drug-resistant epilepsy experience a greater than 50% seizure reduction after 3 or more months on a ketogenic diet. While these results are encouraging, they emanate from single-arm studies; moreover, 40–50% of adults stopped their diet before study completion. Clearly, randomized controlled trials involving less restrictive ketogenic diets are needed in adults with drug-resistant epilepsy.
Ketogenic diets remain standard treatments for disorders of impaired brain glucose metabolism in adults [47]. In GLUT1 DS, ketogenic diets have been shown to confer seizure freedom in up to 90% of patients, including adults [47]. The prognosis in more severe forms of PDHD may be poor, but less severely affected individuals may benefit from a ketogenic diet as they transition to adulthood.
In addition to GLUT1 DS and PDHD, ketogenic diet therapy may be warranted in several seizure disorders often seen in adults, including juvenile myoclonic epilepsy (JME), Lennox-Gastaut syndrome, and Rett syndrome [48]. JME is particularly common, representing 5–10% of all epilepsy cases, and typically manifests in adolescence or early adulthood with a combination of myoclonic jerks or seizures, absence seizures, and generalized tonic-clonic seizures. In two separate case series, 60–70% of adolescents and adults with JME experienced a 50% seizure reduction after 3 months of MAD therapy [51, 52].
Once the adult has been selected for the diet, a medical and nutritional evaluation is advised (Table 7) [3, 47]. If possible, a cohabiting partner (spouse or family member) should accompany the adult to the evaluations, and ideally participate in the diet alongside them.
Evaluation | Steps |
---|---|
Medical | Assess baseline epilepsy state and comorbidities |
Identify psycho-socioeconomic, cultural, and religious factors | |
Elucidate level of commitment | |
Review anti-epileptic drugs and medications | |
Provide blood glucose and ketone monitor; show how to use | |
Order investigations | |
Nutritional | Assess baseline physical parameters |
Select most appropriate conventional ketogenic diet | |
If none appropriate, offer a non-conventional ketogenic diet | |
Provide list of foods for social settings | |
Provide supplements | |
Educate patient |
Preparing an adult (and partner) for a ketogenic diet.
A brief medical evaluation should be performed by a neurologist with experience managing ketogenic diets in adults, and should include a history of the epilepsy, comorbidities, psychological and socioeconomic factors, level of commitment to the diet, medications, and investigations [47].
First, the neurologist must ascertain the adult’s baseline epilepsy state and any comorbidities that may complicate their ketogenic diet. The symptomatology and frequency of the various types of seizures should be documented in sufficient detail so as to later gauge diet efficacy on seizure control. Potentially complicating comorbidities include hypercholesterolemia, underweight body-mass index, kidney stones, osteopenia or osteoporosis, gastrointestinal issues (such as gastroesophageal reflux and constipation), cardiomyopathy, and diabetes [3]. Adults with type 1 diabetes can safely pursue a ketogenic diet, but must be closely monitored as their insulin requirements often decline, putting them at risk of hypoglycemia if they do not adjust their insulin doses accordingly [53]. Adults with type 2 diabetes may also start a ketogenic diet [3]; in fact, such adults may be ideal candidates.
Second, it is critical to identify psychological, socioeconomic, cultural, and religious factors with the potential to disrupt the adult’s ketogenic diet [3]. Diet adherence in adults may be endangered by any number of factors, including personality traits, alcohol habits, income, cultural influences, and religious preferences; each must be realistically appraised before the adult and ketogenic service commit to the diet.
Third, the adult’s level of commitment to ketogenic diet therapy must be elucidated. Diet modification often involves a major change in lifestyle, therefore anything less than a full commitment is likely to fail. If the adult holds any reservations about commencing the diet, these should be explored; if unsolvable, the adult may not yet be ready for the diet. The neurologist should counsel the adult on how to deal with inevitable “mixed messages” regarding the purported negative aspects of high-fat diets from friends, family, and even other medical professionals. Lastly, it can be helpful to emphasize the additional positive aspects of a ketogenic diet, such as beneficial effects on cognition, energy, and mood [47].
Fourth, the adult’s medications should be reviewed. In general, anti-epileptic drug blood levels are not altered by a ketogenic diet, therefore dose adjustments are not usually required. However, for the same reasons as in children, exceptions might be made in the case of valproate, zonisamide, or topiramate [2]. All medications should be reviewed for carbohydrate content, which may necessitate a switch to lower carbohydrate preparations [47].
Fifth, the adult should be provided with a means of self-monitoring their diet, which critically provides feedback as to how effectively they are achieving physiological ketosis. In adults, it is best to prescribe a blood glucose and ketone monitor given that this method is easier, more specific, and more accurate than urine dipstick testing [38]. The adult should be shown how to use the monitor.
Finally, investigations should be ordered to rule out contraindications to a ketogenic diet (as a rule, it is not necessary to screen for disorders of fat metabolism in adults, unless the history suggests otherwise) [47]. Laboratory investigations include complete blood count, electrolytes, liver and kidney function tests, fasting lipid profile, calcium, vitamin D, and a urinalysis [3]. Given that the effects of a ketogenic diet on pregnancy are not known [3], pregnancy testing may be indicated in women of childbearing age. Baseline anti-epileptic drug levels can be measured, although few concerns for drug-diet interactions exist. A recent EEG and MRI brain should be obtained to identify potential surgical candidates. Given that ketogenic diets and anti-epileptic drugs may predispose adults to osteopenia, a baseline bone density scan may be wise. Further tests, such as ECG and renal ultrasound, are ordered as clinically indicated.
A nutritional evaluation should be performed by a dietitian experienced in managing ketogenic diets in adults, and ought to include an assessment of baseline physical status, a decision as to which is the most appropriate ketogenic diet option for that adult, and education about their chosen ketogenic diet.
Baseline weight and body-mass index should be measured and recommended calorie and fluid intake calculated, including the desired ratio of fat to protein to carbohydrate [48]. Food aversions and allergies must be clearly documented.
When selecting which conventional ketogenic diet to use, the most important factors to consider in adults are culinary and social restrictions [48, 50]. Since the CKD is the most restrictive of the four, it is rarely a viable long-term option in adults (unless given as a formula). The MCT diet is slightly less restrictive, but still not viable in most adults due to the copious quantities of MCT oil and resulting gastrointestinal side-effects. The MAD and LGIT are less restrictive conventional options in adults, but both are still associated with considerable dropout rates [54]. Thus, although conventional ketogenic diets should be offered, the adult may not be motivated to pursue any of them; this will negatively impact diet implementation.
If conventional ketogenic diets do not appeal to the adult, a fifth option, that of a non-conventional ketogenic diet, can be considered. Such a diet might consist of dietitian-verified recipes obtained from trusted ketogenic diet books and websites, a major advantage of which is that it can be specifically tailored towards the adult’s food preferences, reducing the perception that their diet is restrictive. It is now possible to prepare a variety of ketogenic diets, including vegetarian and culturally-tailored ketogenic diets (theoretically, as long as a ketogenic diet sustains physiological ketosis, it is “ketogenic”). Given that each conventional ketogenic diet is decades old (nearly a century old in the case of the CKD), a newer, less restrictive, patient-tailored ketogenic diet is appealing to many adults, although it must be emphasized that evidence for such a diet in epilepsy may be lacking.
Since many adults with epilepsy are of lower socioeconomic status, the dietitian must strive to minimize any socioeconomic impediments that may disrupt their ketogenic diet. Social activities are to be encouraged, but they can also jeopardize the diet; it is extremely helpful if the dietitian provides a list of appropriate food options relevant to most restaurants and social gatherings that will inform the adult as to what they can and cannot eat, so as not to disrupt the diet. For meals made at home, the dietitian should recommend foods that are both within the adult’s budget range as well as readily available at their local food markets.
Given the limited fruit, vegetable, and calcium content in many ketogenic diets, adults should be commenced on a carbohydrate-free multivitamin [3, 47]. Some ketogenic services also supplement adults with calcium, vitamin D, and magnesium [3, 47].
Lastly, education is essential; the adult needs to understand exactly what is required of them to implement their diet. A classroom-based format, with multiple adult patients present, can be advantageous [26]. The dietitian should demonstrate how to identify sources of fat, protein, and carbohydrate, how to count net carbohydrate (total carbohydrate minus fiber) for those on a MAD or non-conventional ketogenic diet, how to identify foods with a low glycemic index for those on an LGIT diet, and how to navigate potential pitfalls [26]. Helpful additional resources should be provided [55] and any expectations addressed.
Once the adult has been prepared, their chosen diet can be implemented (Table 8) [47]. The ketogenic service should provide as much support as the adult needs, but also encourage them to develop a sense of “ownership” over their diet, thus conferring a feeling of empowerment over their epilepsy.
Stage | Steps |
---|---|
Initiation | Decide whether to initiate as inpatient or outpatient |
If inpatient, decide on induction fast and diet introduction | |
If outpatient, provide clear instructions to caregiver | |
Maintenance | Adult self-monitors seizure control and ketone levels |
Review at 3 and 6 months, and 6-monthly after | |
Monitor for adverse effects | |
Document beneficial effects | |
Cessation | Identify when diet should be ceased (if ever) |
If to be ceased, consider switching to another ketogenic diet | |
If to be ceased, decide on rate of diet cessation | |
If relevant, consider diet cessation and driving |
Implementing a ketogenic diet in an adult with epilepsy.
In younger and disabled adults, it may be more appropriate to initiate a ketogenic diet as an inpatient [48]. The advantages of an admission include the ability to observe the patient and medically intervene if needed, and provide more time to educate the caregiver on how to maintain the diet upon returning home. In general, fasting is not employed in adults, although an induction fast might be useful if a quicker response is required (for example, if the adult is having multiple daily seizures, an induction fast might lessen the interference of the epilepsy on the initiation of the diet) [48]. The same graded approach used to introduce the diet in children may also be used in adults [48].
In most cases, adults with epilepsy can initiate their ketogenic diet as an outpatient, especially if they have selected the MAD, LGIT diet, or a non-conventional ketogenic diet. In most adults, it is not necessary to employ a graded approach when initiating a ketogenic diet at home, but if required then clear instructions should be provided on how to do so.
Ketogenic diets often work rapidly, within days [43]. The adult should regularly monitor their blood BHB level daily for the first several weeks, then two or three times a week once readings indicate that constant physiological ketosis has been achieved. There are no firm recommendations regarding optimal blood BHB levels in adults [3], although aiming for at least 2 mmol/L at all times seems reasonable. If seizure control or ketone levels are not responding as expected, a 3-day food diary may be useful to discover potential oversights in diet implementation.
The neurologist or dietitian should be in regular phone or email contact during the initial weeks of the diet, with multidisciplinary follow-up visits at 3 and 6 months, and every 6 months thereafter [3]. The neurologist should document the adult’s seizure response to the diet; regardless of any improvement, anti-epileptic drugs should not be altered unless necessary, as alterations may make it difficult to gauge diet efficacy on seizure control. Recommended follow-up tests include complete blood count, electrolytes, liver and kidney function tests, fasting lipid profile, calcium, and vitamin D [47]. If osteopenia is a concern, a bone density scan may be warranted every 5 years or less [47], and bone protection therapy prescribed as needed. The dietitian should monitor weight, nutritional intake, and fluid hydration at every visit, and alter each as required.
Adverse effects may occur in adults on a ketogenic diet, but are generally transient, and rarely serious enough to necessitate stopping the diet [47]. The two most common adverse effects in adults are hyperlipidemia and weight loss [48]. Raised LDL levels are seen in least one-quarter of adults with epilepsy [48]. However, triglyceride levels often decline, and HDL levels usually increase [47]. Moreover, among healthy adults following a low-carbohydrate diet, the LDL increase is due to increased LDL particle size rather than particle number, which may be associated with a lower risk of atherosclerosis [56]. Furthermore, LDL and total cholesterol levels typically normalize within a year of commencing the diet [57], and return to baseline within 3 months of stopping it [50]. Weight loss is also common on a ketogenic diet, seen in at least one-fifth of adult with epilepsy [48], but since many such adults are overweight or obese, this adverse effect is often desired and beneficial [47]. Other adverse effects, such as kidney stones and osteopenia or osteoporosis, are rare in adults [47].
Benefits other than seizure control may also occur with a ketogenic diet, including improved arousal, alertness, concentration, energy, and mood [3, 47]. Moreover, adults on a ketogenic diet often report increased quality of life scores [58]. Given that many adults with epilepsy suffer from impaired quality of life, these additional benefits may be significant and should be documented.
Unlike children, the long-term benefits on seizure control in adults with epilepsy may not outlast dietary therapy [59]. Further studies are needed to determine if this is the case for all adults.
It is customary to maintain a ketogenic diet for at least 3 months before passing judgment on its efficacy in seizure control [3]. The exception to this rule is if the seizures worsen for longer than 1–2 weeks after commencing the diet, or if a serious adverse effect occurs—in either case, it may be wise to discontinue the diet sooner.
If the adult experiences a greater than 50% seizure reduction and no serious adverse effects, their ketogenic diet can be maintained indefinitely [3]. If the adult starts to perceive their diet as overly restrictive, yet it remains effective at controlling seizures, it can be switched over to another type of ketogenic diet.
Most ketogenic diets in adults are ceased slowly, over weeks or months on an individual basis [3], although many can be ceased abruptly without negative consequences. The sole exception may be the CKD, which can be ceased gradually by decreasing the ratio of fat to protein plus carbohydrate weekly or monthly, from 4:1 to 3:1 to 2:1 to 1:1, followed by the reintroduction of regular foods.
An important consideration during diet cessation is the effect on driving restrictions. If a ketogenic diet has conferred complete seizure freedom for a long enough period of time such that the adult has returned to driving, stopping the diet applies the same driving restrictions as when anti-epileptic drugs are altered or modified [3].
Historically, ketogenic diets have been utilized as “end of the line” therapeutic options in children and adults with epilepsy. However, given recent advances in the possible mechanisms through which these diets improve seizure control and the growing evidence base supporting their use in epilepsy, this is changing. Significant challenges to the more widespread use of ketogenic diets in children and adults with epilepsy remain, most conspicuously a lack of access to ketogenic services in many regions of the world. Moreover, the culinary and social restrictions associated with conventional ketogenic diets are barriers to their use in adults. If these issues can be addressed, there may come a day when ketogenic diet therapies are utilized more widely, as first-line options alongside drugs and surgery, in the management of children and adults with epilepsy.
The author is grateful for the support of Waikato Hospital, Hamilton, New Zealand.
The author declares no conflict of interest.
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',metaTitle:"Terms and Conditions",metaDescription:"These terms and conditions outline the rules and regulations for the use of IntechOpen Website at https://intechopen.com and all its subdomains owned by Intech Limited located at 7th floor, 10 Lower Thames Street, London, EC3R 6AF, UK.",metaKeywords:null,canonicalURL:"/page/terms-and-conditions",contentRaw:'[{"type":"htmlEditorComponent","content":"By accessing the website at www.intechopen.com you are agreeing to be bound by these Terms of Service, all applicable laws and regulations, and agree that you are responsible for compliance with any applicable local laws. Use and/or access to this site is based on full agreement and compliance of these Terms. All materials contained on this website are protected by applicable copyright and trademark laws.
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\\n"}]'},components:[{type:"htmlEditorComponent",content:'By accessing the website at www.intechopen.com you are agreeing to be bound by these Terms of Service, all applicable laws and regulations, and agree that you are responsible for compliance with any applicable local laws. Use and/or access to this site is based on full agreement and compliance of these Terms. All materials contained on this website are protected by applicable copyright and trademark laws.
\n\nThe following terminology applies to these Terms and Conditions, Privacy Statement, Disclaimer Notice, and any or all Agreements:
\n\n“Client”, “Customer”, “You” and “Your” refers to you, the person accessing this website and accepting the Company’s Terms and Conditions;
\n\n“The Company”, “Ourselves”, “We”, “Our” and “Us”, refers to our Company, IntechOpen;
\n\n“Party”, “Parties”, or “Us”, refers to both the Client and ourselves, or either the Client or ourselves.
\n\nAll Terms refer to the offer, acceptance, and consideration of payment necessary to provide assistance to the Client in the most appropriate manner, whether by formal meetings of a fixed duration, or by any other agreed means, for the express purpose of meeting the Client’s needs in respect of provision of the Company’s stated services/products, and in accordance with, and subject to, the prevailing laws of the United Kingdom.
\n\nAny use of the above terminology, or other words in the singular, plural, capitalization and/or he/she or they, are taken as interchangeable.
\n\nUnless otherwise stated, IntechOpen and/or its licensors own the intellectual property rights for all materials on www.intechopen.com. All intellectual property rights are reserved. You may view, download, share, link and print pages from www.intechopen.com for your own personal use, subject to the restrictions set out in these Terms and Conditions.
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\n\nWithout prior approval and express written permission, you may not create frames around our web pages or use other techniques that alter in any way the visual presentation or appearance of our website.
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\n\nThese Terms and Conditions are governed by and construed in accordance with the laws of the United Kingdom and you irrevocably submit to the exclusive jurisdiction of the courts in London, United Kingdom.
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I received a B.Eng. degree in Computer Engineering with First Class Honors in 2008 from Prince of Songkla University, Songkhla, Thailand, where I received a Ph.D. degree in Electrical Engineering. My research interests are primarily in the area of biomedical signal processing and classification notably EMG (electromyography signal), EOG (electrooculography signal), and EEG (electroencephalography signal), image analysis notably breast cancer analysis and optical coherence tomography, and rehabilitation engineering. I became a student member of IEEE in 2008. During October 2011-March 2012, I had worked at School of Computer Science and Electronic Engineering, University of Essex, Colchester, Essex, United Kingdom. In addition, during a B.Eng. I had been a visiting research student at Faculty of Computer Science, University of Murcia, Murcia, Spain for three months.\n\nI have published over 40 papers during 5 years in refereed journals, books, and conference proceedings in the areas of electro-physiological signals processing and classification, notably EMG and EOG signals, fractal analysis, wavelet analysis, texture analysis, feature extraction and machine learning algorithms, and assistive and rehabilitative devices. I have several computer programming language certificates, i.e. Sun Certified Programmer for the Java 2 Platform 1.4 (SCJP), Microsoft Certified Professional Developer, Web Developer (MCPD), Microsoft Certified Technology Specialist, .NET Framework 2.0 Web (MCTS). 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