Difference between revisions of "Journal:A quality assurance discrimination tool for the evaluation of satellite laboratory practice excellence in the context of European regulatory meat inspection for Trichinella spp."
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==Abstract== | ==Abstract== | ||
[[Trichinosis|Trichinellosis]] is a parasitic foodborne zoonotic disease transmitted by ingestion of raw or undercooked meat containing the first larval stage (L1) of the nematode. To ensure the [[Quality (business)|quality]] and safety of food intended for human consumption, meat inspection for detection of ''Trichinella'' spp. larvae is a mandatory procedure per European Union (E.U.) regulations. The implementation of [[quality assurance]] (QA) practices in [[Laboratory|laboratories]] that are responsible for ''Trichinella'' spp. detection is essential given that the detection of this parasite is still a pivotal threat to public health, and it is included in | [[Trichinosis|Trichinellosis]] is a parasitic foodborne zoonotic disease transmitted by ingestion of raw or undercooked meat containing the first larval stage (L1) of the nematode. To ensure the [[Quality (business)|quality]] and safety of food intended for human consumption, meat inspection for detection of ''Trichinella'' spp. larvae is a mandatory procedure per European Union (E.U.) regulations. The implementation of [[quality assurance]] (QA) practices in [[Laboratory|laboratories]] that are responsible for ''Trichinella'' spp. detection is essential given that the detection of this parasite is still a pivotal threat to public health, and it is included in List A of Annex I, Directive 2003/99/EC, which determines the agents to be monitored on a mandatory basis. | ||
A [[quality management system]] (QMS) was applied to slaughterhouses and game handling establishments conducting ''Trichinella'' spp. testing without official accreditation but under the supervision of the relevant authority. This study aims to retrospectively analyze the outcomes of implementing the QMS in slaughterhouses and game handling establishments involved in ''Trichinella'' testing in southern Spain. Canonical discriminant analyses (CDAs) were performed to design a tool enabling the classification of satellite laboratories (SLs) while determining whether linear combinations of measures of QA-related traits describe within- and between-SL clustering patterns. The participation of two or more auditors improves the homogeneity of the results deriving from audits. However, when training expertise ensures that such levels of inter-/intralaboratory homogeneity are reached, auditors can perform single audits and act as potential trainers for other auditors. Additionally, technical procedure issues were the primary risk factors identified during audits, which suggests that they should be considered a critical control point (CCP) (for purposes of Hazard Analysis and Critical Control Point [HACCP] evaluations) within the QMS. | A [[quality management system]] (QMS) was applied to slaughterhouses and game handling establishments conducting ''Trichinella'' spp. testing without official accreditation but under the supervision of the relevant authority. This study aims to retrospectively analyze the outcomes of implementing the QMS in slaughterhouses and game handling establishments involved in ''Trichinella'' testing in southern Spain. Canonical discriminant analyses (CDAs) were performed to design a tool enabling the classification of satellite laboratories (SLs) while determining whether linear combinations of measures of QA-related traits describe within- and between-SL clustering patterns. The participation of two or more auditors improves the homogeneity of the results deriving from audits. However, when training expertise ensures that such levels of inter-/intralaboratory homogeneity are reached, auditors can perform single audits and act as potential trainers for other auditors. Additionally, technical procedure issues were the primary risk factors identified during audits, which suggests that they should be considered a critical control point (CCP) (for purposes of Hazard Analysis and Critical Control Point [HACCP] evaluations) within the QMS. | ||
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==Introduction== | ==Introduction== | ||
[[Trichinosis|Trichinellosis]] is a worldwide foodborne zoonotic disease caused by the ingestion of the helminth ''Trichinella'' spp. Pigs, both domestic and wild, are the main reservoirs, and human infection is primarily linked to the consumption of raw or undercooked meat from infected animals without veterinary inspection. [1] Currently, this parasite continues to pose a significant threat to public health, and it is included in List A of Annex I, Directive 2003/99/EC of the European Union (E.U.) [2] on the surveillance of zoonoses and zoonotic agents, which determines the agents that have to be monitored on a mandatory basis. According to the E.U., 117 human cases have been reported during 2020, with 99 out of the 117 cases acquired within the E.U. [3] | |||
The detection of ''Trichinella'' spp. larvae during meat inspection is performed using the [[magnetic stirrer]] method of the [[artificial digestion]] technique. The method is considered the "gold standard" for ''Trichinella'' spp. detection, being "capable of consistently detecting ''Trichinella'' larvae in meat at a level of sensitivity that is recognized to be effective for use in controlling animal infection and preventing human disease." [4] Also, it is a mandatory procedure according to regulation EU 2015/1375 [5], which lays down specific rules on official controls for ''Trichinella'' in meat. This regulation also specifies equivalent techniques for ''Trichinella'' spp. larvae detection in analyzed [[Sample (material)|samples]]. | |||
As the International Commission on Trichinellosis (ICT) exposes [4], the implementation of [[quality assurance]] (QA) practices in [[Laboratory|laboratories]] performing ''Trichinella'' spp. detection is of the utmost importance, and the probability of detecting a positive case, if present, must be high (>95 or >99%) in order to ensure that there is a low or negligible risk of transmission to humans through the food chain. [6] Laboratories accredited to [[ISO/IEC 17025]] [6] for ''Trichinella'' digestion testing are required to use validated diagnostic methods to confirm that the methods are fit for the intended use. In 2019, the ICT recommended the adoption of system-wide practices for QA. [4] However, the minimum required standards for QA are determined and implemented by each local [[public health]] authority in E.U. member states. European regulation EU 625/2017 [7]—which places controls on testing and other official activities performed to ensure the application of food and feed law, as well as rules on animal health and welfare, plant health, and plant protection products—states that the regulated control of ''Trichinella'' spp. larvae presence during meat inspection should be conducted in accredited laboratories designated by the competent authority. Furthermore, laboratories solely engaged in ''Trichinella'' spp. detection in meat using the methods outlined in EU 2015/1375 [5] may be exempt from accreditation if they operate under the supervision of the competent authority. | |||
The activities performed in internal laboratories require continuous analysis and evaluation by the competent authority. Assessing [[critical control points]] (CCPs)—for example, by using a [[hazard analysis and critical control points]] (HACCP) approach—involves various aspects such as personal training, diagnostic procedure performance, and document registration, among others. Additionally, continuous monitoring of each CCP is crucial for effective ''Trichinella'' spp. detection in infected meat. [8] | |||
In 2011, the relevant authorities of the Andalusia region in southern Spain developed a [[quality management system]] (QMS) based on ISO/IEC 17025. [6] This QMS was applied to slaughterhouses and game handling establishments conducting ''Trichinella'' spp. testing without official accreditation but under the supervision of the relevant authority. The QMS not only enabled the implementation of high standards in ''Trichinella'' spp. analysis but also facilitated the identification and correction of practices that did not meet the minimum required standards. | |||
[[Canonical discriminant analysis]] (CDA) has been proposed as a statistical alternative to tailor HACCP plans that are to be applied to other substances and products for human consumption, such as bottled water, and allows for a comprehensive comparison of practices implemented across different facilities or brands. It provides valuable insights into the specific impact of combinations of factors, which can serve as pivotal points in discerning variations in practice application among these facilities or brands. Additionally, CDA facilitates the exploration of similarities and dissimilarities in the practices adopted by these facilities, unveiling clustering patterns that aid in effectively addressing potential issues. [9] To enhance the reliability of these statistical tools, CDA methods are often complemented by cross-validation techniques. This approach not only helps in pinpointing potential problems along the operational chain but also aids in characterizing the nature and associated risks of these issues. [9] CDA statistical tools are routinely followed by cross-validation techniques, which in turn can help identify issues along the chain and determine the potential nature of the issues and the risk that they imply. | |||
Therefore, the objective of this study is to retrospectively analyze the outcomes of implementing the QMS in slaughterhouses and game handling establishments involved in ''Trichinella'' testing in southern Spain. This translatable discriminant tool permits us to assess the development of QA practices across internal laboratories using DCA and the follow-up cross-validation methods. In turn, the outcomes of the present paper may provide an insight on which items or issues along the implementation of the QMS act as critical discriminant points across laboratories, thus assisting in the determination of the ''Trichinella'' risk that their occurrence and frequency may imply for the human food supply chain. | |||
==Material and methods== | |||
Revision as of 22:42, 18 December 2023
| Full article title | A quality assurance discrimination tool for the evaluation of satellite laboratory practice excellence in the context of European regulatory meat inspection for Trichinella spp. |
|---|---|
| Journal | Foods |
| Author(s) | Villegas-Pérez, José; Navas-González, Francisco J.; Serrano, Salud; García-Viejo, Fernando; Buffoni, Leandro |
| Author affiliation(s) | University of Cordoba, Junta de Andalucia |
| Primary contact | fjnavas at uco dot es |
| Year published | 2023 |
| Volume and issue | 12(22) |
| Article # | 4186 |
| DOI | 10.3390/foods12224186 |
| ISSN | 2304-8158 |
| Distribution license | Creative Commons Attribution 4.0 International |
| Website | https://www.mdpi.com/2304-8158/12/22/4186 |
| Download | https://www.mdpi.com/2304-8158/12/22/4186/pdf?version=1700532935 (PDF) |
 |
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Abstract
Trichinellosis is a parasitic foodborne zoonotic disease transmitted by ingestion of raw or undercooked meat containing the first larval stage (L1) of the nematode. To ensure the quality and safety of food intended for human consumption, meat inspection for detection of Trichinella spp. larvae is a mandatory procedure per European Union (E.U.) regulations. The implementation of quality assurance (QA) practices in laboratories that are responsible for Trichinella spp. detection is essential given that the detection of this parasite is still a pivotal threat to public health, and it is included in List A of Annex I, Directive 2003/99/EC, which determines the agents to be monitored on a mandatory basis.
A quality management system (QMS) was applied to slaughterhouses and game handling establishments conducting Trichinella spp. testing without official accreditation but under the supervision of the relevant authority. This study aims to retrospectively analyze the outcomes of implementing the QMS in slaughterhouses and game handling establishments involved in Trichinella testing in southern Spain. Canonical discriminant analyses (CDAs) were performed to design a tool enabling the classification of satellite laboratories (SLs) while determining whether linear combinations of measures of QA-related traits describe within- and between-SL clustering patterns. The participation of two or more auditors improves the homogeneity of the results deriving from audits. However, when training expertise ensures that such levels of inter-/intralaboratory homogeneity are reached, auditors can perform single audits and act as potential trainers for other auditors. Additionally, technical procedure issues were the primary risk factors identified during audits, which suggests that they should be considered a critical control point (CCP) (for purposes of Hazard Analysis and Critical Control Point [HACCP] evaluations) within the QMS.
Keywords: trichinellosis, Trichinella, laboratories, food safety, quality management system, canonical discriminant analysis
Introduction
Trichinellosis is a worldwide foodborne zoonotic disease caused by the ingestion of the helminth Trichinella spp. Pigs, both domestic and wild, are the main reservoirs, and human infection is primarily linked to the consumption of raw or undercooked meat from infected animals without veterinary inspection. [1] Currently, this parasite continues to pose a significant threat to public health, and it is included in List A of Annex I, Directive 2003/99/EC of the European Union (E.U.) [2] on the surveillance of zoonoses and zoonotic agents, which determines the agents that have to be monitored on a mandatory basis. According to the E.U., 117 human cases have been reported during 2020, with 99 out of the 117 cases acquired within the E.U. [3]
The detection of Trichinella spp. larvae during meat inspection is performed using the magnetic stirrer method of the artificial digestion technique. The method is considered the "gold standard" for Trichinella spp. detection, being "capable of consistently detecting Trichinella larvae in meat at a level of sensitivity that is recognized to be effective for use in controlling animal infection and preventing human disease." [4] Also, it is a mandatory procedure according to regulation EU 2015/1375 [5], which lays down specific rules on official controls for Trichinella in meat. This regulation also specifies equivalent techniques for Trichinella spp. larvae detection in analyzed samples.
As the International Commission on Trichinellosis (ICT) exposes [4], the implementation of quality assurance (QA) practices in laboratories performing Trichinella spp. detection is of the utmost importance, and the probability of detecting a positive case, if present, must be high (>95 or >99%) in order to ensure that there is a low or negligible risk of transmission to humans through the food chain. [6] Laboratories accredited to ISO/IEC 17025 [6] for Trichinella digestion testing are required to use validated diagnostic methods to confirm that the methods are fit for the intended use. In 2019, the ICT recommended the adoption of system-wide practices for QA. [4] However, the minimum required standards for QA are determined and implemented by each local public health authority in E.U. member states. European regulation EU 625/2017 [7]—which places controls on testing and other official activities performed to ensure the application of food and feed law, as well as rules on animal health and welfare, plant health, and plant protection products—states that the regulated control of Trichinella spp. larvae presence during meat inspection should be conducted in accredited laboratories designated by the competent authority. Furthermore, laboratories solely engaged in Trichinella spp. detection in meat using the methods outlined in EU 2015/1375 [5] may be exempt from accreditation if they operate under the supervision of the competent authority.
The activities performed in internal laboratories require continuous analysis and evaluation by the competent authority. Assessing critical control points (CCPs)—for example, by using a hazard analysis and critical control points (HACCP) approach—involves various aspects such as personal training, diagnostic procedure performance, and document registration, among others. Additionally, continuous monitoring of each CCP is crucial for effective Trichinella spp. detection in infected meat. [8]
In 2011, the relevant authorities of the Andalusia region in southern Spain developed a quality management system (QMS) based on ISO/IEC 17025. [6] This QMS was applied to slaughterhouses and game handling establishments conducting Trichinella spp. testing without official accreditation but under the supervision of the relevant authority. The QMS not only enabled the implementation of high standards in Trichinella spp. analysis but also facilitated the identification and correction of practices that did not meet the minimum required standards.
Canonical discriminant analysis (CDA) has been proposed as a statistical alternative to tailor HACCP plans that are to be applied to other substances and products for human consumption, such as bottled water, and allows for a comprehensive comparison of practices implemented across different facilities or brands. It provides valuable insights into the specific impact of combinations of factors, which can serve as pivotal points in discerning variations in practice application among these facilities or brands. Additionally, CDA facilitates the exploration of similarities and dissimilarities in the practices adopted by these facilities, unveiling clustering patterns that aid in effectively addressing potential issues. [9] To enhance the reliability of these statistical tools, CDA methods are often complemented by cross-validation techniques. This approach not only helps in pinpointing potential problems along the operational chain but also aids in characterizing the nature and associated risks of these issues. [9] CDA statistical tools are routinely followed by cross-validation techniques, which in turn can help identify issues along the chain and determine the potential nature of the issues and the risk that they imply.
Therefore, the objective of this study is to retrospectively analyze the outcomes of implementing the QMS in slaughterhouses and game handling establishments involved in Trichinella testing in southern Spain. This translatable discriminant tool permits us to assess the development of QA practices across internal laboratories using DCA and the follow-up cross-validation methods. In turn, the outcomes of the present paper may provide an insight on which items or issues along the implementation of the QMS act as critical discriminant points across laboratories, thus assisting in the determination of the Trichinella risk that their occurrence and frequency may imply for the human food supply chain.
Material and methods
References
Notes
This presentation is faithful to the original, with only a few minor changes to presentation and updates to spelling and grammar. In some cases important information was missing from the references, and that information was added. The URL to the Deloitte paper was broken; an archived version of the document was used for this version.
