Plan de auditoría para el programa de auditoría interna de la norma ISO 22000:2018 de la empresa de productos alimenticios Estrella Gourmet.

Apéndice A. Programa de auditoría interna al Sistema de Gestión de la Calidad (imágenes)Como futuros ingenieros de alimentos se debe tener capacidades y habilidades necesarias para abordar todas las necesidades que se presentan en la industria de alimentos, sin duda alguna el diplomado de profundización en sistemas de gestión de inocuidad y del ambiente para el sector alimentario a través de sus diferentes dinámicas y actividades brinda las herramientas necesarias para desarrollar satisfactoriamente el plan de auditoría para la empresa de productos alimenticios Estrella Gourmet. El grupo de trabajo, bajo los objetivos generales y específicos planteados en el presente documento, llevó a cabo una auditoría de primera parte clasificada como auditoría interna para la empresa anteriormente mencionada, bajo los requerimientos de la ISO 22000:2018 respetando también los lineamientos para ejecutar un plan de auditoría de acuerdo a ISO 19011:2018. La planeación del plan de auditoría se realizó como primer paso concluyendo las auditorías que se iban a realizar donde se definió el personal que debía ser auditado en cada proceso y el tiempo estipulado para esta actividad, posterior se evaluaron las evaluaciones de riesgos que tiene la empresa, se estipuló el cronograma y los recursos que se iban a destinar, aquí se tuvo en cuenta las fechas, se elaboró el plan de auditoría teniendo en cuenta los objetivos y alcances trazados para cada hallazgo, por último se realizó una verificación del plan de auditoría para evaluar que se tienen claros los objetivos y se cumpliera con el propósito de la auditoría.As future food engineers, they must have the necessary skills and abilities to address all the needs that arise in the food industry, without a doubt the diploma of deepening in safety and environmental management systems for the food sector through its different dynamics and activities provides the necessary tools to satisfactorily develop the audit plan for the Estrella Gourmet food company. The working group, under the general and specific objectives set forth in this document, carried out a first-party audit classified as an internal audit for the aforementioned company, under the requirements of ISO 22000:2018, also respecting the guidelines to execute an audit plan according to ISO 19011:2018. The planning of the audit plan was carried out as a first step, concluding the audits that were going to be carried out where the personnel that had to be audited in each process and the time stipulated for this activity were defined, later the risk assessments that the company has were evaluated. , the schedule and the resources that were going to be allocated were stipulated, here the dates were taken into account, the audit plan was prepared taking into account the objectives and scope outlined for each finding, finally a verification of the audit plan was carried out to evaluate that the objectives are clear and the purpose of the audit is fulfilled

Cytokine and autoantibody clusters interaction in systemic lupus erythematosus

Background: Evidence supports the existence of different subphenotypes in systemic lupus erythematosus (SLE) and the pivotal role of cytokines and autoantibodies, which interact in a highly complex network. Thus, understanding how these complex nonlinear processes are connected and observed in real-life settings is a major challenge. Cluster approaches may assist in the identification of these subphenotypes, which represent such a phenomenon, and may contribute to the development of personalized medicine. Therefore, the relationship between autoantibody and cytokine clusters in SLE was analyzed. Methods: This was an exploratory study in which 67 consecutive women with established SLE were assessed. Clinical characteristics including disease activity, a 14-autoantibody profile, and a panel of 15 serum cytokines were measured simultaneously. Mixed-cluster methodology and bivariate analyses were used to define autoantibody and cytokine clusters and to identify associations between them and related variables. Results: First, three clusters of autoantibodies were defined: (1) neutral, (2) antiphospholipid antibodies (APLA)-dominant, and (3) anti-dsDNA/ENA-dominant. Second, eight cytokines showed levels above the threshold thus making possible to find 4 clusters: (1) neutral, (2) chemotactic, (3) G-CSF dominant, and (4) IFN?/Pro-inflammatory. Furthermore, the disease activity was associated with cytokine clusters, which, in turn, were associated with autoantibody clusters. Finally, when all biomarkers were included, three clusters were found: (1) neutral, (2) chemotactic/APLA, and (3) IFN/dsDNA, which were also associated with disease activity. Conclusion: These results support the existence of three SLE cytokine-autoantibody driven subphenotypes. They encourage the practice of personalized medicine, and support proof-of-concept studies. © 2017 The Author(s)

Diseño para el consumo cultural, la innovación y la inclusión social

Esta obra presenta diversos trabajos de investigación que tienen en común propuestas de diseño desde la cultura, la inclusión y la innovación social, desarrolladas por investigadores nacionales e internacionales adscritos a diversas universidades, así como a programas de posgrado

Ten millennia of hepatitis B virus evolution

Hepatitis B virus (HBV) has been infecting humans for millennia and remains a global health problem, but its past diversity and dispersal routes are largely unknown. We generated HBV genomic data from 137 Eurasians and Native Americans dated between ~10,500 and ~400 years ago. We date the most recent common ancestor of all HBV lineages to between ~20,000 and 12,000 years ago, with the virus present in European and South American hunter-gatherers during the early Holocene. After the European Neolithic transition, Mesolithic HBV strains were replaced by a lineage likely disseminated by early farmers that prevailed throughout western Eurasia for ~4000 years, declining around the end of the 2nd millennium BCE. The only remnant of this prehistoric HBV diversity is the rare genotype G, which appears to have reemerged during the HIV pandemic

Enfermedad tiroidea autoinmune latente

Objetivo Determinar la prevalencia de autoanticuerpos tiroideos y los factores asociados en sujetos eutiroideos. Métodos Se incluyeron 300 sujetos eutiroideos, elegidos por muestreo estratificado de una cohorte inicial de 1335 individuos. La función tiroidea se evaluó midiendo los niveles séricos de TSH (0.3–4.5 ?IU / mL) y FT4 (5.2–12.7?g / dL). Los anticuerpos anti-peroxidasa (TPOAbs), anti-tiroglobulina (TgAbs) y anti-receptor de TSH (TrAbs) se evaluaron con 23 autoanticuerpos adicionales, así como con niveles de vitamina D (VitD). El análisis incluyó características sociodemográficas, clínicas y ambientales. Los datos se analizaron mediante pruebas bivariadas y multivariadas. Resultados Se observó autoinmunidad tiroidea en el 15,3% de los sujetos (TPOAbs 11,3% y TgAbs 2,0%). En seis individuos, ambos autoanticuerpos fueron positivos. Los TrAbs no se detectaron en ningún individuo. Enfermedad tiroidea familiar (? = 3.4, IC 95%: 1.2–9.5, P = 0.021), la presencia de otras enfermedades autoinmunes (? = 10.8, IC 95%: 1.6–72.9, P = 0.014) Insuficiencia de VitD ( P = 0.030), nunca fume (? = 6.9, IC 95%: 1.6–30.4, P = 0.010), beba más de 4 tazas de café (? = 3.8, IC 95%: 1.1–13.1, P = 0.036), y un mayor número de años expuestos al humo de leña ( P = 0.04) se asociaron con autoinmunidad tiroidea. En el caso de TPOAbs, enfermedad de tiroides familiar (CI ? = 4,9, 95%: 1,7 a 14,0, P = 0,003), nunca fume (? = 5,7, IC 95%: 1,4 a 21,0, P = 0.002), y beber más de 4 tazas de café (? = 3.6, IC 95%: 1.1–13.1, P = 0.047) se asociaron con su positividad. Además, la presencia de anti – SS – A / Ro52 (? = 36.7, IC 95%: 2.5–549.9, P = 0.009) y anticuerpos anti-Ku (? = 10.2, IC 95%: 1.1–100.7, P = 0.046) también se asoció con TPOAbs. La presencia de ascendencia africana (? = 10.5, IC 95%: 1.7–63.2, P = 0.01), anti – SS – A / Ro52 (? = 15.8, IC 95%: 1.2–198.6, P = 0,03), y los anticuerpos anti-CENP-B (? = 31,2, IC 95%: 1,8 a 565,9 P = 0,02) se asociaron con TgAbs. Conclusión La autoinmunidad tiroidea latente no es rara. Los factores ambientales, genéticos e inmunológicos, así como los ancestros, son factores de riesgo asociados. Estos resultados facilitarían la implementación de estrategias de detección para proporcionar un diagnóstico y tratamiento oportunos.Objective To determine the prevalence of thyroid autoantibodies and the associated factors in euthyroid subjects. Methods 300 euthyroid subjects, chosen by stratified sampling from an inception cohort of 1335 individuals, were included. Thyroid function was evaluated by measuring the serum levels of TSH (0.3–4.5 ?IU/mL) and FT4 (5.2–12.7?g/dL). Anti-peroxidase (TPOAbs), anti-thyroglobulin (TgAbs), and anti-TSH receptor (TrAbs) antibodies were evaluated with 23 additional autoantibodies as well as vitamin D (VitD) levels. The analysis included sociodemographic, clinical, and environmental characteristics. Data were analyzed by bivariate and multivariate tests. Results Thyroid autoimmunity was observed in 15.3% of the subjects (TPOAbs 11.3% and TgAbs 2.0%). In six individuals, both autoantibodies were positive. TrAbs were not detected in any individual. Familial thyroid disease (? ?= ?3.4, 95% CI: 1.2–9.5, P ?= ?0.021), the presence of other autoimmune diseases (? ?= ?10.8, 95% CI: 1.6–72.9, P ?= ?0.014) VitD insufficiency (P ?= ?0.030), never smoke (? ?= ?6.9, 95% CI: 1.6–30.4, P ?= ?0.010), drinking more than 4 cups of coffee (? ?= ?3.8, 95% CI: 1.1–13.1, P ?= ?0.036), and a higher number of years exposed to wood smoke (P ?= ?0.04) were associated with thyroid autoimmunity. In the case of TPOAbs, familial thyroid disease (? ?= ?4.9, 95% CI: 1.7–14.0, P ?= ?0.003), never smoke (? ?= ?5.7, 95% CI: 1.4–21.0, P ?= ?0.002), and drinking more than 4 cups of coffee (? ?= ?3.6, 95% CI: 1.1–13.1, P ?= ?0.047) were associated with their positivity. In addition, the presence of anti–SS–A/Ro52 (? ?= ?36.7, 95% CI: 2.5–549.9, P ?= ?0.009) and anti-Ku antibodies (? ?= ?10.2, 95% CI: 1.1–100.7, P ?= ?0.046) was also associated with TPOAbs. The presence of African ancestry (? ?= ?10.5, 95% CI: 1.7–63.2, P ?= ?0.01), anti–SS–A/Ro52 (? ?= ?15.8, 95% CI: 1.2–198.6, P ?= ?0.03), and anti-CENP-B antibodies (? ?= ?31.2, 95% CI: 1.8–565.9 ?P ?= ?0.02) were associated with TgAbs. Conclusion Latent thyroid autoimmunity is not rare. Environmental, genetic, and immunological factors as well as ancestry are associated risk factors. These results would facilitate the implementation of screening strategies in order to provide timely diagnosis and treatment

Cytokine imbalance in patients with systemic sclerosis and resilience: the key role of interleukin-6

OBJECTIVES: Resilience, the ability to respond positively to adverse events, may be influenced by long-term stressors and autoimmune/inflammatory conditions such as systemic sclerosis (SSc). Since the immune system plays a role in the development of resilience, we aimed to evaluate the relationship between a panel of cytokines and resilience in patients with SSc. METHODS: Thirty-five consecutive women with established SSc were involved in this exploratory study. Clinical characteristics, including severity of symptoms and resilience, a panel of 15 serum cytokines and 17 autoantibodies were assessed simultaneously. Multivariate methods were used to analyse the data. RESULTS: Interleukin-6 (IL-6) levels were associated with severity of symptoms (?=1.8395, p=0.04), and low resilience scores (?= -0.581120, p=0.02). Furthermore, resilience was not associated with clinical manifestations nor polyautoimmunity. Cytokine levels did not significantly differ between groups based on regular physical activity. CONCLUSIONS: The results highlight the importance of IL-6 as a key mediator in the altered cytokine network of SSc

A comprehensive analysis and immunobiology of autoimmune neurological syndromes during the Zika virus outbreak in Cúcuta, Colombia

We have focused on the epidemiology and immunobiology of Zika virus (ZIKV) infection and factors associated with the development of Guillain-Barré syndrome (GBS) and other neurological syndromes in Cúcuta, the capital of North Santander department, Colombia. Data of patients with ZIKV disease reported to the national population-based surveillance system were used to calculate the basic reproduction number (R0) and the attack rates (ARs) as well as to develop epidemiological maps. Patients with neurological syndromes were contacted and their diagnoses were confirmed. A case-control study in which 29 patients with GBS associated with ZIKV compared with 74-matched control patients with ZIKV infection alone was undertaken. Antibodies against arboviruses and other infections that may trigger GBS were evaluated. The estimated value of R0 ranged between 2.68 (95% CI 2.54–2.67) to 4.57 (95% CI 4.18–5.01). The sex-specific ARs were 1306 per 100,000 females, and 552 per 100,000 males. A non-linear interaction between age and gender on the ARs was observed. The incidence of GBS in Cúcuta increased 4.41 times secondary to ZIKV infection. The lag time between ZIKV infection and neurological symptoms was 7 days (interquartile range 2–14.5). Patients with GBS appeared to represent a lower socioeconomic status and were living near to environmentally contaminated areas. All GBS patients were positive for IgG antibodies against both ZIKV and Dengue virus, and 69% were positive for Chikungunya virus. Noteworthy, GBS was associated with a previous infection with M. pneumoniae (OR: 3.95; 95% CI 1.44–13.01; p = 0.006). No differences in antibody levels against C. jejuni, Epstein-Barr virus and cytomegalovirus were observed. High rates of cranial nerves involvement and dysautonomia were present in 82% and 75.9%, respectively. Intensive care unit (ICU) admission was necessary in 69% of the GBS patients. Most of the patients disclosed a high disability condition (Hughes grade 4). Dysautonomia was the main risk factor of poor GBS prognosis (i.e., ICU admission and disability). Thirteen patients were diagnosed with other neurological syndromes different to GBS (6 with transverse myelitis, 3 with encephalitis, 3 with peripheral facial palsy and one with thoraco-lumbosacral myelopathy). Our data confirm an increased transmission of ZIKV in Cúcuta, and provide support to the view that severe neurological syndromes are related to ZIKV disease. The complex ways by which previous infections and socioeconomic status interact to increase the risk of GBS in people infected by ZIKV should be further investigated. © 2016 The Author

Sjögren’s Syndrome and Autoimmune Thyroid Disease: Two Sides of the Same Coin

The coexistence of Sjögren’s syndrome (SS) and autoimmune thyroid disease (AITD) has been documented. However, there is no consensus whether this coexistence should be considered as the same nosological condition or as polyautoimmunity. Thus, in this monocentric retrospective study, patients with SS alone (i.e., primary) were compared with patients with SS and AITD. In addition, a discussion of previous studies including those about genetic and environmental factors influencing the development of both conditions is presented. In our series, all patients with AITD had Hashimoto’s thyroiditis (HT). No significant differences in age, gender, age of disease onset, and disease duration were found between the two groups. Lymphadenopathy and urticaria were more frequently registered in patients with SS-HT than in patients with SS alone (p less than 0.05). Anti-Ro/SSA antibodies were more frequent in the primary SS group (p = 0.01). SS-HT patients were more likely to report a positive history of smoking (p = 0.03). The clinical expression of SS varies slightly when HT coexists. Although both entities share common physiopathological mechanisms as part of the autoimmune tautology, they are nosologically different and their coexistence should be interpreted as polyautoimmunity. Further studies based on polyautoimmunity would allow establishing a new taxonomy of autoimmune diseases. © 2018, Springer Science+Business Media, LLC, part of Springer Nature

A comprehensive analysis and immunobiology of autoimmune neurological syndromes during the Zika virus outbreak in Cúcuta, Colombia

We have focused on the epidemiology and immunobiology of Zika virus (ZIKV) infection and factors associated with the development of Guillain-Barré syndrome (GBS) and other neurological syndromes in Cúcuta, the capital of North Santander department, Colombia. Data of patients with ZIKV disease reported to the national population-based surveillance system were used to calculate the basic reproduction number (R0) and the attack rates (ARs) as well as to develop epidemiological maps. Patients with neurological syndromes were contacted and their diagnoses were confirmed. A case-control study in which 29 patients with GBS associated with ZIKV compared with 74-matched control patients with ZIKV infection alone was undertaken. Antibodies against arboviruses and other infections that may trigger GBS were evaluated. The estimated value of R0 ranged between 2.68 (95% CI 2.54–2.67) to 4.57 (95% CI 4.18–5.01). The sex-specific ARs were 1306 per 100,000 females, and 552 per 100,000 males. A non-linear interaction between age and gender on the ARs was observed. The incidence of GBS in Cúcuta increased 4.41 times secondary to ZIKV infection. The lag time between ZIKV infection and neurological symptoms was 7 days (interquartile range 2–14.5). Patients with GBS appeared to represent a lower socioeconomic status and were living near to environmentally contaminated areas. All GBS patients were positive for IgG antibodies against both ZIKV and Dengue virus, and 69% were positive for Chikungunya virus. Noteworthy, GBS was associated with a previous infection with M. pneumoniae (OR: 3.95; 95% CI 1.44–13.01; p = 0.006). No differences in antibody levels against C. jejuni, Epstein-Barr virus and cytomegalovirus were observed. High rates of cranial nerves involvement and dysautonomia were present in 82% and 75.9%, respectively. Intensive care unit (ICU) admission was necessary in 69% of the GBS patients. Most of the patients disclosed a high disability condition (Hughes grade 4). Dysautonomia was the main risk factor of poor GBS prognosis (i.e., ICU admission and disability). Thirteen patients were diagnosed with other neurological syndromes different to GBS (6 with transverse myelitis, 3 with encephalitis, 3 with peripheral facial palsy and one with thoraco-lumbosacral myelopathy). Our data confirm an increased transmission of ZIKV in Cúcuta, and provide support to the view that severe neurological syndromes are related to ZIKV disease. The complex ways by which previous infections and socioeconomic status interact to increase the risk of GBS in people infected by ZIKV should be further investigated. © 2016 The Author