Artigos

Conteúdo (article):

INSTRUMENTOS PARA AVALIAÇÃO E CLASSIFICAÇÃO DE BOAS PRÁTICAS DE FABRICAÇÃO DE ALIMENTOS: UMA REVISÃO INTEGRATIVA

INSTRUMENTS FOR ASSESSING AND CLASSIFYING FOOD GOOD MANUFACTURING PRACTICES: AN INTEGRATIVE REVIEW

INSTRUMENTOS PARA LA EVALUACIÓN Y CLASIFICACIÓN DE LAS BUENAS PRÁCTICAS DE MANUFACTURA DE ALIMENTOS: UNA REVISIÓN INTEGRADORA

Ana Helena Moretto Capobiango¹
Letícia Lopes Vieira²
Dayane de Castro Morais3
Elizangela da Silva Miguel4
Sílvia Oliveira Lopes5
Silvia Eloíza Priore6
Glauce Dias da Costa7

1Nutricionista, Msc, doutoranda em Ciência da Nutrição na Universidade Federal de Viçosa, ana.capobiango@ufv.br; ORCID: 0000-0003-0348-4015
2Nutricionista, Msc em Ciência da Nutrição na Universidade Federal de Viçosa, doutoranda em Nutrição e Saúde da Universidade Federal de Minas Gerais, leticialopesvieira09@gmail.com; ORCID: 0000-0001-9410-8044
3Nutricionista, MSc, Doutora e Pós-Doutoranda em Ciência da Nutrição pela Universidade Federal de Viçosa, dayane.morais@ufv.br ORCID: 0000-0001-6439-7009
4 Nutricionista, MSc pelo programa de Pós-Graduação em Agroecologia, Doutora e Pós-Doutoranda em Ciência da Nutrição pela Universidade Federal de Viçosa, elizangela.miguel@ufv.br ; ORCID: 0000-0002-2434-5068
5 Nutricionista, MSc pelo programa de Pós-Graduação em Agroecologia, Doutora e Pós-Doutoranda em Ciência da Nutrição pela Universidade Federal de Viçosa, silvia.lopes@ufv.br ; ORCID: 0000-0002-6755-8610
6 Nutricionista pela Universidade Federal do Rio de Janeiro, residência em Saúde Pública pela Escola Nacional de Saúde Pública - ENSP/FIOCRUZ, especialização em Saúde Pública pela Faculdade de Saúde Pública/USP, mestrado e doutorado em Nutrição pela Universidade Federal de São Paulo/Escola Paulista de Medicina, sepriore@ufv.br ; ORCID: 0000-0003-0656-1485
7 Nutricionista, Mestre e Doutora em Ciência da Nutrição pela Universidade Federal de Viçosa e Pós-Doutora pela Universidade de Edimburgo; glauce.costa@ufv.br ; ORCID: 0000-0002-2630-194X

Resumo: Identificar instrumentos de boas práticas de fabricação de alimentos na literatura, considerando suas metodologias e classificação de risco sanitário para estabelecimentos alimentícios. Trata-se de uma revisão integrativa que buscou documentos publicados nos anos de 2000 a 2022 em PubMed, Web of Science e Scopus. Como critério de inclusão, foram selecionados aqueles documentos que utilizaram instrumento para classificação do risco sanitário em estabelecimentos alimentícios, nos idiomas de português, inglês e espanhol, sendo artigos originais, de revisão, resoluções e normas. Foram incluídos 13 documentos de diferentes países que realizaram a classificação de risco sanitário de estabelecimentos que manipulam ou produzem alimentos, instrumentos estes com características distintas. Nota-se a falta de padronização na metodologia de classificação do risco sanitário e fragilidades que podem afetar a segurança do alimento e saúde do consumidor. A fim de melhorar a eficácia, é necessário atualizar e direcionar as resoluções para cada local de aplicação, além de reestruturar políticas públicas e estudos científicos para validar e padronizar instrumentos para a vigilância sanitária em diversos níveis.
Palavras-chave: Boas Práticas de Fabricação, Alimentos, Segurança dos Alimentos, Lista de Verificação, Serviços de Alimentação

Abstract: The aim of this integrative review was to identify instruments for assessing good manufacturing practices for food in the literature, focusing on the methodologies used and health risk classification for food establishments. Searches were performed of PubMed, Web of Science, and Scopus for documents published between 2000 and 2022. The inclusion criteria were original review articles, resolutions and standards addressing instruments assessing food GMP and presenting risk classification written in English, Portuguese and Spanish. Thirteen records from different countries were included that classified health risks in establishments handling or producing food using different instruments. The findings reveal a lack of standardization of methodologies for classifying health risks and shortcomings that can adversely affect food safety and consumer health. To improve effectiveness, it is necessary to review resolutions, developing specific standards for each type of establishment, and restructure public policies and research to validate and standardize health surveillance instruments across different levels.
Keywords: Good Manufacturing Practices, Food, Food Safety, Checklist, Food Services

Resumen: Identificar instrumentos de Buenas Prácticas de Manufactura de Alimentos en la literatura, considerando sus metodologías y clasificación de riesgos para la salud de los establecimientos de alimentos. Se trata de una revisión integradora, y la búsqueda se realizó en PubMed, Web of Science y Scopus, y en documentos publicados desde 2000 hasta 2022. Como criterio de inclusión, se seleccionaron documentos que utilizaron un instrumento para clasificar el riesgo sanitario en establecimientos de alimentos, en los idiomas portugués, inglés y español, siendo artículos originales, revisiones, resoluciones y normas. Se incluyeron 13 documentos de diferentes países que clasificaron el riesgo para la salud de los establecimientos que manipulan o producen alimentos, instrumentos con diferentes características. Existe una falta de estandarización en la metodología para clasificar los riesgos y debilidades para la salud que pueden afectar la inocuidad de los alimentos y la salud de los consumidores. Para mejorar la efectividad, es necesario actualizar y dirigir las resoluciones a cada lugar de aplicación, además de reestructurar las políticas públicas y los estudios científicos para validar y estandarizar los instrumentos de Vigilancia de la Salud en los diversos niveles.
Palabras clave: Buenas Prácticas de Manufactura, Alimentos, Inocuidad de los Alimentos, Lista de Cotejo, Servicio de Alimentos

INTRODUCTION
Foodborne illnesses (FBIs) currently affect approximately 600 million people worldwide every year, with 420,000 deaths being attributed to eating contaminated food¹. Quality control during food production and processing is crucial to guaranteeing food and nutritional safety. Regulation of food production processes is therefore essential to ensure safe products for consumers and prevent the spread of FBIs among the population1,2,3.
Thus, food production process monitoring instruments play an important role in health promotion and disease prevention.
Health surveillance is essential for population health, focusing on identifying, analyzing and resolving possible risks that threaten food safety and human health. Surveillance includes a diverse range of actions, including control and prevention measures, which are essential to guarantee food quality and safety and thus protect society from potential health risks4,5.
The monitoring of health risks along the food supply chain is guided by different standards. Internationally, the benchmark is International Organization for Standardization (ISO) 31000, produced in collaboration with the Food and Agriculture Organization of The United Nations (FAO) and World Health Organization (WHO), while at national level Brazil uses resolutions issued by the collegiate board of the National Health Surveillance Agency (ANVISA): RDC 275 (October 21, 2002) and RDC 216 (September 15, 2004), which set out food good manufacturing practices (GMPs) and standard operating procedures (POPs)6,7,8.
Health surveillance in Brazil and other countries such as Chile and the United Kingdom employs a food GMP checklist during the inspection process undertaken by health inspectors or food establishment owners. The checklist established by RDC 275/2002 facilitates the identification of shortcomings, with the aim of classifying the health risk of establishmensts6. The methodology based on RDC 275 proposed by Stedefeldt et al. (2013)9 classifies health risk into three groups according to compliance with the items, as follows: group 1 – 76-100%; group 2 – 51-75%; and group 3 – 0-50%.
However, the lack of measurement criteria and instrument validation processes and challenges in monitoring production routines hamper the effective implementation of current legislation, compromising food safety. There is therefore an urgent need for research that assesses the instruments used in different countries and support data consistency to facilitate the standardization of risk classification in the face of globalization.
The aim of this review was therefore to identify and analyze instruments assessing food GMP, focusing on methodological characteristics and health risk classification adopted for food establishments. By providing a comprehensive comparative overview of these instruments it is intended to contribute to future research and the review of health risk criteria in different countries.
METHODOLOGY
PROTOCOL AND REGISTRATION
We conducted an integrative review involving the following recommended stages: formulation of the guiding question; definition of inclusion and exclusion criteria; data collection; study assessment; interpretation of results; and presentation of the review in a synthesized manner10,11.
The guiding question was “What are the instruments used to evaluate and classify food good manufacturing practices?”. The following additional questions were also used: “What are the methodological characteristics of these instruments?” and “What health risk classification is used for places that handle or manufacture food?”.
For the purposes of this review, the acronym PVO (population, variables and outcome) was adopted, where P = food manufacturing or handling establishments, V = food good manufacturing practices instruments and O = the health risk classification used in each instrument. This integrative review was registered in the Open Science Framework under DOI 10.17605/OSF.IO/BAFWQ.
SEARCH STRATEGY AND STUDY SELECTION
Searches were performed of the following databases: PubMed, Web of Science and Scopus. English and Portuguese descriptors were used and combined using the Boolean operators AND/OR as follows: “Good manufacturing practices” OR “Boas práticas de fabricação” AND “Food” OR “Alimentos” OR “Segurança Alimentar” OR “Food safety”, “Food services” OR “Segurança do alimento” AND “Checklist” OR “Checklist” OR “Evaluation of research programs and tools” OR “Avaliação de programas e ferramentas de pesquisa” OR “Surveys and questionnaires” OR “Pesquisas e questionários” AND “Food legislation” “Legislação de alimentos” (Supplementary File 1).
Backward searches were performed of the citations in the selected records, together with manual searches of the resolutions in the area of food inspection used by ANVISA.

ELIGIBILITY CRITERIA AND DATA ANALYSIS
The searches were performed between September 2023 and November 2023. The following inclusion criteria were used to determine eligibility: original review articles, resolutions and standards addressing instruments assessing food GMP and presenting risk classification written in English, Portuguese and Spanish.
The retrieved records were exported to Rayyan QCRY® to exclude duplicates. Title and abstract and full-text screening were then performed independently by two researchers (LLV and AHMC). Any disagreements were resolved by consensus by the two researchers after re-reading the article in question. After resolving the disagreements, the researchers presented the selected studies.
The following information was extracted from the records selected for review: author(s), year of publication, type of study, country, instrument used and risk classification adopted for the evaluation of food GMP, place of application and number of items. Data selection and extraction were performed blindly by two researchers (LLV and AHMC) using MicrosoftTM Excel.
RESULTS
The initial search yielded 1,621 documents, 10 of which met the inclusion criteria. The backward search of citations and manual search of resolutions identified three more records, meaning that this integrative review included a total of 13 records (Figure 1).
The included records comprised articles (n = 10) and resolutions (n = 3) published between 2000 and 2022. The studies were conducted in Brazil (n = 7)12,13,14,17,20,21,23, the Philippines (n = 1)18, China (n = 1)19 and Ethiopia (n = 1)22, while the resolutions were from Brazil (n = 1)7, Chile (n = 1)15 and the United Kingdom (n = 1)16.
The selected studies used cross-sectional designs, and the overall classification of evidence was level IV24. The food GMP assessment instruments were applied in a variety of settings, including food services17,19,21,22,23, a restaurant12, a university restaurant13, a school canteen14, street food vendors18 and establishments selling fruit juices and coconut water20.
All selected records presented a food GMP evaluation instrument – consisting of a checklist or a checklist together with a socioeconomic questionnaire – and classified the health risk of food handling and manufacturing practices.
The records show that in the Philippines, China and Ethiopia specific instruments were used, complying with the standards set in each country for the assessment of health risk. Brazil has a resolution that provides a standard instrument in the form of a checklist. However, five of the studies in Brazil used the resolution but validated a different checklist11,16,19,20,22, three used the country’s standard legislation7,11,20 and five did not report validated instruments or instruments undergoing a validation process12,13,17,18.
Figure 1

All the records contained a checklist for the assessment of food GMP12,13,14,15,16,17,18,19,20,22,23 or food safety18 divided into blocks of relevant items. A total of 12 instruments were assessed, consisting of between 11 and 182 items with the following response categories: yes or no16,19,20,21; yes, no or not applicable12,13,14,18,21; fully complies to not applicable15; by statistical analysis17; and Likert scale23 (Boxes 1 and 2).
Health risk classification was performed in different ways with the aim of guaranteeing food safety. In some studies, classification was based on compliance in the food handling process7,12,14,15,16, 18,19, while in others compliance percentages were used for specific aspects of health and the handling process (water supply, structure, pest control, among others)13,20,21.
It is important to note that the main aim of the studies included in this review was to assess food GMP and food safety in different contexts. The studies also sought to classify health risk based on food handling and manufacturing compliance criteria. However, some studies developed and validated an instrument or used instruments already known in the literature.
Box 1
Box 2

DISCUSSION
Most of the records in this integrative review were studies undertaken in Brazil using RDC 216/2004, which addresses food GMP along the supply chain, from receipt of raw materials/ingredients to consumption. Despite this limitation, with the aim of comparing instruments in different countries, this review also included studies from other continents such as South America, Asia, Africa and Europe, thus contributing to existing literature on the use of health risk classification instruments and providing data that can help promote advances in food safety in these countries.
All the studies used a checklist, and some complemented the list with a questionnaire. It should be noted however that there is a difference between using a checklist on its own and in combination with a second instrument, as the latter includes questions that go beyond the checklist items that are self-administered or answered during an interview. Both methods are used in national and international research to classify health risk and provide various benefits, including their low cost and ease of application. They can also be mutually complementary, since questions about actions involving the food supply chain can explore certain verifiable items25, providing additional information to inform health surveillance and help relevant bodies in other countries promote effective health regulation and the provision of safe food, preventing FBIs26.
The articles and documents included in this review present a variety of instruments. Some were adapted from existing resolutions or standards in the respective countries, while others were developed by the authors, all with the common aim of classifying the health risk of food establishments or assessing compliance with items in food handling or manufacturing facilities. It is worth noting that certain modifications were made, especially by the authors of the studies in Brazil. These modifications were made to tailor the instruments to specific food establishments, given that the main resolutions in Brazil6,7 are general and certain establishments such as school canteens and street food vendors have specific characteristics that differ greatly to the facilities of a commercial restaurant, for example13. Likewise, not all items are applicable to all types of services. For example, unlike other establishments, fruit juice and coconut water vendors do not undertake food pre-preparation, preparation and storage19.
Instrument modification can be a limitation, as authors without previous training may prioritize items they believe to be relevant to a given setting without the support of an evidence base, leading to a gap in the health risk assessment.
In addition, checklists with a particularly large number of items – more than 100 – may be time-consuming or adversely affect user understanding. On the other hand, long lists6,7 can be more comprehensive, encompassing all items of health risk for a particular setting. However, the use of shorter lists with less than 100 items enables fast and efficient inspection, being the most feasible evaluation alternative27,28.
As mentioned above, the variety of health risk classification instruments can influence the items included in checklists. Thus, each establishment should follow the relevant municipal, state and national guidelines, adapting to specific local needs. For this reason, whether extensive or not, the real applicability of these checklists lies in the fact that they are developed to ensure GMP and the production of safe food for the population29.
The findings of this review show that the studies conducted in Brazil were based on the standards developed by ANVISA outlined in the resolutions governing compliance with food GMP30. The use of these methods therefore provides a detailed understanding of the practices adopted, enabling an in-depth analysis of the items, highlighting those that may require greater attention in the context of food security31. However, both resolutions are relatively old, which may limit their current relevance given changing consumption patterns and considering the complexity of the food supply chain32.
The studies in other countries follow domestic standards, presenting instruments designed to control food GMP in order to ensure safe food for the population and prevent the spread of FBIs, which is a global goal1. However, while based on the resolutions in place in the respective countries, the items used in these studies are not standardized, including those applicable to the same types of establishments, and different methodologies are used to classify health risk. This poses significant regulatory challenges33, affecting health surveillance work processes34 and the actions of health regulatory bodies in these countries.
Furthermore, the lack of standardization of health risk assessment can lead to inconsistent results and weaknesses in communication that affect food safety35,36. We therefore suggest that authors pay attention to essential items, which should not be modified as they can play an important role in risk classification.
Although most studies used excellent instruments adapted from or developed based on each country’s legislation, not all instruments were validated. This step is essential to ensure that instruments are capable of accurately assessing desired aspects, ensuring reliable and comparable results37,38.
The documents included in this review constitute a compilation of data accumulated over a 20-year period. One of the strengths of this review is the emphasis on the evolution of health risk classification, focusing on compliance and the application of instruments across different contexts. Another strength is the inclusion of studies from different continents that used a variety of instruments assessing food GMP and metrics for classifying the health risk of establishments. However, the choice of classification instrument depends on the study objective, where the instrument will be applied and, above all, having the knowledge to use it critically, following the standards for effective application and coherent classification.
However, the inclusion of a diverse range of studies may also be a limitation, as the variety of methodologies presented hampers instrument standardization. This compromises the consistency of action in this area. It is therefore suggested that efforts are stepped up to review the documents that guide this work process34.
CONCLUSION
It is concluded that there is a need to assess and classify health risks in food handling and manufacturing establishments in order to control practices and prevent the spread of FBIs. It is suggested that resolutions and standards are constantly reviewed to maintain hygiene and cleanliness and guide the application of specific standardized instruments tailored to each context and type of establishment.
There is a clear need for further research aimed at rethinking and restructuring instruments used in this area and public policies to promote the creation and/or review of instruments and guide their application. It is also important to develop research that promotes the standardization and validation of instruments used by health surveillance agencies and other food safety and inspection agencies at local, state and federal level in the respective countries.
One of the limitations of this review is the lack of publications describing health risk classification of food establishments, meaning that these instruments are underexplored in the literature, with research failing to present comprehensive information to inform health surveillance, negatively affecting food safety and, consequently, population health. Furthermore, the year of publication of the studies included in this review were considerably different, and practices, regulations and health risk contexts may have varied significantly over time and across regions, especially in the different types of food establishments where the instruments were applied, limiting comparison and exploratory data analysis.

ACKNOWLEDGEMENTS
We are grateful to the Federal University of Viçosa’s Nutrition Science Graduate Program (PPCN/UFV), National Council for Scientific and Technological Development (CNPq), Coordination for the Development of Higher Education Personnel (CAPES – funding code 001) and Minas Gerais State Research Foundation (FAPEMIG) for awarding a doctoral scholarship, enabling full-time dedication to this research.

FUNDING
This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

DECLARATION OF INTEREST
The authors have no conflicts of interest to declare.

DATA AVAILABILITY
Data are available upon request.

REFERENCES
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