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Standard Operating Procedures (SOPs): Why Companies Must Have Them, and Why They Need Them
Abstract
This is the first of three articles on standard operating procedures or SOPs. It explains the role of SOPs and their maintenance. The second article will talk about what SOPs an organization needs to think about and how to determine what SOPs actually need to be in place. The last article will describe how to write SOPs in clear, concise language so that processes and activities occur as they are supposed to. SOPs are the first line of defense in any inspection, whether it be by a regulatory body, a partner or potential partner, a client, or a firm conducting due diligence for a possible purchase. It does not matter what a company calls them; any document that is a “how to” falls into the category of procedures. SOPs, in fact, define expected practices in all businesses where quality standards exist.
... Dokumentovanje odluka i stečenih znanja Za pravilno upravljanje projektima neophodno je usvojiti procedure za provođenje projekta u svim fazama. Procedure definiraju skup uputstava za upotrebu osobi ili osobama, koje izvršavaju određeni zadatak, o tome šta treba učiniti, kako to učiniti, kada i kako to arhivirati [7]. Procedure treba da održe kontinuitet i kvalitet poslovanja, jer se zasnivaju na dobroj poslovnoj praksi i stručnim znanjima [8]. ...
... acquired knowledge For proper project management, it is necessary to adopt procedures for project implementation at all stages. Procedures define a set of instructions for a person or persons who are performing a specific task, informing them on what to do, how to do it, when and how to archive it [7]. Procedures should maintain business continuity and quality as they are based on good business practice and expertise [8]. ...
Project management is a complex process in which it is necessary to adequately manage the activities and processes contained in the project, in order to achieve positive business results. Each project encompasses processes that are necessary to make, in order to achieve the project product. This paper analyzes the risk management process defined
according to the guidelines of the ISO 10006:2017 standard. The quality management of the risk process analyzed in the paper can be applied to different projects, regardless of their nature and size. Based on the defined and analyzed activities within the risk process, it is possible to design procedures for managing the quality of risk process in projects. The scheme, derived from the guidelines given according to the ISO 10006:2017 standard,
provides a clear overview of the complete risk management process, from planning to the final phase of the project.
... SOPs are often mandated by industry regulations, making them legally binding. Well-structured SOPs not only ensure compliance but also promote sound business practices Gough & Hamrell (2009). Although business standards exist Aguilar-Savén (2004), the structure and documentation of SOPs are largely determined by Subject Matter Experts (SMEs), often expert in their line of business but missing the technical acumen and the time to learn and implement complex formal languages for SOPs, which are not always aligned with their business needs. ...
In this paper, we address the challenges of managing Standard Operating Procedures (SOPs), which often suffer from inconsistencies in language, format, and execution, leading to operational inefficiencies. Traditional process modeling demands significant manual effort, domain expertise, and familiarity with complex languages like Business Process Modeling Notation (BPMN), creating barriers for non-techincal users. We introduce SOP Structuring (SOPStruct), a novel approach that leverages Large Language Models (LLMs) to transform SOPs into decision-tree-based structured representations. SOPStruct produces a standardized representation of SOPs across different domains, reduces cognitive load, and improves user comprehension by effectively capturing task dependencies and ensuring sequential integrity. Our approach enables leveraging the structured information to automate workflows as well as empower the human users. By organizing procedures into logical graphs, SOPStruct facilitates backtracking and error correction, offering a scalable solution for process optimization. We employ a novel evaluation framework, combining deterministic methods with the Planning Domain Definition Language (PDDL) to verify graph soundness, and non-deterministic assessment by an LLM to ensure completeness. We empirically validate the robustness of our LLM-based structured SOP representation methodology across SOPs from different domains and varying levels of complexity. Despite the current lack of automation readiness in many organizations, our research highlights the transformative potential of LLMs to streamline process modeling, paving the way for future advancements in automated procedure optimization.
... The proposed TNR actions aimed to reduce the reproductive activity of free-roaming cats, minimize risks to human health, low levels of animal welfare, and animal mortality due to the lack of basic resources, and promote a reduction in the rate of animal renewal in a free-roaming cat colony located on private land owned by COPEL in Curitiba, Paraná. To enhance action planning, standard operating procedures (SOPs) for TNR were established based on Gough & Hamrell's (2009) methodology, which is still being applied and improved. ...
Gatos de colônia, gatos de vida livre ou gatos ferais são animais descendentes de gatos domésticos, capazes de viver e se reproduzir em vida livre. O manejo dessas populações é fundamental para o controle de zoonoses, em especial a esporotricose, e deve ser estruturado em bases legais, éticas e na ciência do bem-estar animal, além de envolvimento intersetorial, fundamental para a execução das ações de forma abrangente e efetiva. A captura, esterilização e devolução (CED) desses animais apresenta-se como uma estratégia fundamental para a estabilização populacional de colônias. O programa compreende a captura de animais por meio de armadilhas; transporte para o centro cirúrgico; avaliação clínica e adoção de condutas de saúde, conforme necessidade; esterilização cirúrgica (orquiectomia e ováriosalpingohisterectomia); registro e identificação; cuidados pós-operatórios imediatos; devolução ao local de origem e manutenção e monitoramento dos animais. O artigo aborda a aplicação de estratégias de manejo populacional de uma colônia de gatos de vida livre identificada em Curitiba por protetoras independentes de animais em uma unidade de distribuição da Companhia Paranaense de Energia (COPEL). Três ações de captura, esterilização e devolução (CED) foram realizadas entre maio e outubro de 2023, resultando na captura de 16 animais. As ações de esterilização e a capacidade organizativa da articulação intersetorial entre a COPEL, protetoras independentes e o Centro de Medicina Veterinária do Coletivo da Universidade Federal do Paraná (Centro MVC-UFPR) foram analisadas na matriz FOFA, evidenciando pontos fortes, oportunidades, fraquezas e ameaças, dados cruciais para orientar futuras intervenções.
... Примеры организации системы управления стандартными операционными процедурами описаны в периодической литературе [18][19][20][21][22]. ...
INTRODUCTION. Bioanalytical laboratories in the Russian Federation should follow the requirements of both the Good Laboratory Practices (GLP), when performing tests for non-clinical studies, and the Good Clinical Practices (GCP), when analysing samples from clinical studies. The work of such laboratories requires a separate GxP system, the Good Clinical Laboratory Practices (GCLP). However, the GCLP system has not yet been created in the Russian Federation and the Eurasian Economic Union (EAEU).
А IM. This study aimed to compare the current Russian and EAEU principles regulating the work of bioanalytical laboratories with the international GCLP principles and formulate general requirements for national laboratories.
DISCUSSION. The author analysed the current regulation of the work of bioanalytical laboratories, as well as the EAEU regulatory standards for the development and validation of analytical procedures. In addition, the study covered the international GCLP principles that govern the management of human resources, process record keeping, the development of standard operating procedures, the validation of analytical procedures, and the management of biological samples and reference standards in a laboratory. The author considered the key functions of a bioanalytical laboratory and suggested tools to manage them in compliance with the international GCLP principles and the EAEU requirements. It should be noted that scientific publications describe the international practice of applying the GCLP principles fairly well, and the experience of its implementation could be of use to Russian laboratories.
CONCLUSION. A bioanalytical laboratory that implements the GCLP principles will increase its competitiveness in the EAEU market for bioanalytical testing services and mitigate its risks of obtaining invalid data.
... Standard Operating Procedures (SOPs) are instructional mantles that tells employees of firm how to do what they do. The document defines expected practices and sets quality standards (Gough & Hamrell, 2009). According to De Treville, Antonakis and Edelson (2005), the use of Standard Operating Procedures (SOPs) that guides employees, generally improves the outcomes of production at firms. ...
The behavioral theory of the firm: foundations, tenets and relevance. The Behavioral Theory of the Firm has for over fifty years shaped a section of economic thought on the nature and functioning of the firm. In this paper, this theory is reviewed with a focus on its foundations, tenets and relevance. The paper posits that the Behavioral Theory of the Firm set out to distinguish from previously known analytical models of the firm. It drew in an interdisciplinary model and explored the firm in more diverse ways than before. The foundations of the theory, its tenets and relevance are discussed. Often traced to Richard Cyert and James March, whose A Behavioral Theory of the Firm (1963) text seemed to commence this theory, the evidence shows that their seminal work was one of several other contributions to its development. What is not in dispute is that the seeds for a Behavioral Theory of the Firm were sown at the Carnegie Mellon University in or around the mid-20th century. Broadly the Behavioral Theory of the Firm conceives the firm as a unit of production with goals, and a dominant coalition that harmonizes different interests of its stakeholders into those goals.
... In other parlance, the term is commonly used in information technology to refer to the totality of systems that are out in place to secure an organisation's IT infrastructure. It includes the specifications, processes, and standard operating procedures (SoPs) that remove, protect against, prevent, frustrate, and examine existing and potential threats (Gough & Hamrell, 2009;Barbe et al., 2016). In human society, security architecture encompasses all who work to save lives and properties, discourage and remove any threat to its peace and functioning, examine existing and potential issues. ...
Nigeria's multi-ethnic, multi-cultural, and multi-ideological nature is a complexity that should spur a synergy for development in all spheres. The theory of dissipative structures employed suggests that. Contrarily, the pursuit of individual group interests to the detriment of others leads to entropy that dissipates development and economic growth that its population needs. Ethnic and religious militia emerged in response to such problems and threats that has brought in consistent loss of lives and properties which whip the economy and country leaving the state bleeding. Militia internationalisation are important factors discussed as well. This chapter looks at the factors behind the emergence of these militias and the consequences their activities have on local economies of their regions and the national economy.
... For correct project management, it is necessary to adopt procedures for project implementation at all stages. Procedures define a set of instructions for use by a person or persons performing a specific task on what to do, how to do it, when and how to archive it [7]. Procedures should maintain business continuity and quality as they are based on good business practice and expertise [8]. ...
Project management is a complex process in which it is necessary to adequately manage the activities and processes contained in the project in order to achieve positive business results. Each project contains processes that are necessary to make in order to achieve the project product. This paper analyzes the risk management process defined according to the guidelines of the ISO 10006: 2017 standard. The quality management of the risk process analyzed in the paper can be applied to different projects regardless of their nature and size. Based on the defined and analyzed activities within the risk process, it is possible to design procedures for managing the quality of the risk process in projects. The scheme, which is derived from the guidelines given according to the ISO 10006: 2017 standard, provides a clear overview of the complete risk management process, from planning to the final phase of the project. REZIME Upravljanje projektima predstavlja složen proces prilikom kojega je potrebno adekvatno upravljati aktivnostima i procesima koje projekat sadrži kako bi se pri tome ostvarili pozitivni poslovni rezultati. Svaki projekat sadrži procese koje je neophodno izvršiti kako bi se ostvario projektni proizvod. U ovom radu analiziran je proces upravljanja rizicima definisan prema smjernicama standarda ISO 10006:2017. Upravljanje kvalitetom procesa rizika analizirano u radu može se primjenjivati za različite projekte bez obzira na njihovu prirodu i veličinu. Na osnovu definisanih i analiziranih aktivnosti unutar procesa rizika moguće je projektovati procedure za upravljanje kvalitetom procesa rizika u projektima. Šema koja je izvedena iz smjernica datih prema standardu ISO 10006:2017 omogućava jasan uvid u kompletan proces upravljanja rizicima, od planiranja do završne faze projekta. Ključne riječi: Upravljanje rizicima, ISO 10006:2017, procedure 188 1. INTRODUCTION Execution of projects entails a large number of risks and opportunities that may occur during implementation. Risks need to be managed to avoid undesirable effects on the project that could negatively affect the results of the project in the form of unforeseen waste of capital. Risk process management is a set of activities whose common goal is to identify all potential risks and treat them until the end of the project. On the other hand, if all risks are identified in the planning phase, it is possible to make decisions that will mitigate them, avoid them or even turn them into business opportunities. Risks and their effects should be observed in all key decision-making positions in the project and through all participants involved in the decision-making process [1]. Responsible persons for decision making should identify, analyze and assess risks throughout the project life cycle and use their organizational structure and administrative practices to address the risks in favor of the project [2]. In order to ensure the quality of risk process management, it is necessary to provide all the necessary information and use it for decision making. The best way to do this is to record and archive all significant information that has occurred during the execution of the project. Project complexity and organizational tradition are viewed as important factors that can influence project success [3]. Therefore, it is necessary to record all acquired knowledges, archive them and make decisions based on them in next projects, which will bring benefits in the future. The procedures define the key stages in which all relevant data and information are recorded and which serve to manage the quality of the risk process.
... Standard Operating Procedure (SOP) are formal document that explains how individuals or organizations perform tasks and document the execution of tasks 11 . SOP include step-by-step detailed instructions of the process and instructions aimed to at execute activities consistently 12 . ...
... Short, clear, logical, and doable instructions are essential for implementation. (5,10) Too much flexibility in standard operating procedures could make them ineffective and lead to violations. (5) In addition, lack of procures, contradictory procedures, obsolete procedures, incomplete procedures, overly detailed procedures, and procedures that are not followed are the pitfalls that an organisation should be cautious about in developing procedures. ...
Standard operating procedure (SOP) is detailed, written step-by-step instructions for achieving uniformity while performing specific tasks to minimize variations of repeated tasks and plays a key role in the implementation of a quality management system. It is a document that describes the procedures that will be followed to accomplish various tasks. The procedures are organic documents and best-written SOPs fail if they are not followed. Poorly written, unavailable, and inadequate SOPs hamper working processes and lead to non-compliance in the implementation of quality management systems. A well-crafted SOP offers clear direction and instruction that minimizes deviations at different times using different personnel. The SOPs should be user-friendly and describes the processes in the sequential manner in which they are intended to occur and thus leading to a logical flow of events. In this article, SOP writing is summarised in seven steps, namely (i) Preparing, (ii) Reviewing, (iii) Updating, (iv) Maintaining, (v) Distributing, (vi) Archiving, and (vii) Training.
... Both networks and hierarchies require structure, clarity, and knowledge during the crisis which can be provided by Standard Operating Procedures (SOPs). SOPs are the formal documents that describe how an individual or a unit within the organization performs a task and documents it (Gough and Hamrell, 2009). Effective SOPs provide a step-by-step guide to the person or persons using it by going to their level and functionality. ...
COVID-19 pandemic has created disruptions and risks in global supply chains. Big data analytics (BDA) has emerged in recent years as a potential solution for provisioning predictive and pre-emptive information to companies in order to pre-plan and mitigate the impacts of such risks. The focus of this study is to gain insights into how BDA can help companies combat a crisis like COVID-19 via a multi-methodological scientific study. The advent of a crisis like COVID-19 brings with it uncertainties, and Information Processing Theory (IPT) provides a perspective on the ways to deal with such uncertainties. We use IPT, in conjunction with the Crisis Management theory, to lay the foundation of the study. After establishing the theoretical basis, we conduct two surveys towards supply chain managers, one before and one after the onset of the COVID-19 pandemic in India. We follow it up with qualitative interviews to gain further insights. The application of multiple methods helps ensure the triangulation of results and hence enhances the research rigor. Our research finds that although the current adoption of BDA in the Indian industry has not grown to a statistically significant level, there are serious future plans for the industry to adopt BDA for crisis management. The interviews also highlight the current status of adoption and the growth of BDA in the Indian industry. The study interestingly identifies that the traditional barriers to implementing new technologies (like BDA for crisis management) are no longer present in the current times. The COVID-19 pandemic has hence accelerated technology adoption and at the same time uncovered some BDA implementation challenges in practice (e.g., a lack of data scientists).
... Procedure su dokumenti koji opisuju kako pojedinac ili organizacija izvršava zadatak i kako dokumentuje obavljanje tog zadatka. Procedure definišu set uputstava za upotrebu osobi ili osobama koje izvršavaju određeni zadatak o tome šta treba učiniti, kako to učiniti, kada i kako to arhivirati [7]. Svako preduzeće treba da koristi procedure za poslovanje bez obzira koliko dobro posluje i koliko smatra da za njima nema potrebe. ...
dipl.proiz. inž. Krivaja metali d.o.o. Zavidovići Prof. dr. Sabahudin Jašarević Politehnički fakultet u Zenici Fakultetska 1, Zenica, B&H Prof. dr. Suvad Isaković Politehnički fakultet u Zenici Fakultetska 1, Zenica, B&H REZIME Prilikom upravljanja kvalitetom u projektima potrebno je voditi računa o upravljanju kvalitetom projektnim procesima kroz koje nastaje projektni proizvod i kvalitetu rezultata projekta u obliku projektnog proizvoda ili usluge. Mnogi su projektni procesi definisani i analizirani od kojih postoji više podijela datih u dostupnoj literature na istu temu. Svrha ovog rada je istražiti upravljanje kvalitetom procesima nabavke u projektima prema smjernicama standarda ISO 10006:2017. Na osnovu datih smjernica prema standardu grafički su prikazane aktivnosti i njihove međuzavisnosti od početne faze projekta do završetka i primopredaje projektnog proizvoda ili usluge. Na osnovu rezultata provedenog istraživanja pravilna i dosljedna implementacija procesa nabavke prema smjernicama standarda ISO 10006:2017 značajno pomaže preduzećima da uspostave sljedivost poslovnih procesa, što im omogućava da na efikasan način realizuju postavljene projektne zadatke. Ključne riječi: upravljanje projektima, upravljanje procesima nabavke, ISO 10006:2017 ABSTTRACT When managing quality in projects, it is necessary to take into account the quality management of project processes through which the project product is created and the quality of project results in the form of a project product or service. Many project processes have been defined and analyzed of which there are several divisions given in the available literature on the same topic. The purpose of this paper is to investigate the quality management of procurement processes in projects according to the guidelines of the ISO 10006: 2017 standard.. Based on the given guidelines according to the standard, the activities and their interdependence from the initial phase of the project to the completion and handover of the project product or service are graphically presented. Based on the results of the research, the correct and consistent implementation of the procurement process according to the guidelines of the ISO 10006: 2017 standard significantly helps companies to establish traceability of business processes, which enables them to effectively implement the set project tasks.
... Standard operating procedures (SOP) are a set of steps that show how a process should be performed (Gough and Hamrell, 2009). When implemented, SOP have the ability to harmonize practices among workers and can be used to train new or existing employees (Barbe et al., 2016;Sischo et al., 2019). ...
Standard operating procedures (SOP) are increasingly required on farms participating in animal welfare assurance programs, such as the Dairy Farmers of Canada's proAction initiative and the National Dairy FARM Program in the United States. However, little is known about the use of SOP on farms and who is involved in their development. Literature from other industries shows the importance of including advisors when developing SOP. Despite veterinarians being viewed by many farmers as trusted sources of information, little is known about their involvement in SOP development. The aim of this study was to better understand: (1) what advice from researchers and veterinarians is considered when developing an SOP and (2) what factors affect advice adherence. Participants in this study were farmers (n = 9) from 6 dairy farms in the Fraser Valley region of British Columbia, Canada and their herd veterinarians (n = 5). Structured and semi-structured interviews and participant observation were undertaken from April to December 2018, and the resulting data were analyzed using thematic analysis. In relation to the first aim, we identified 3 main themes: (1) the purpose of the SOP, (2) developing an SOP, and (3) accountability and tracking of procedures. For the second aim, 5 themes emerged: (1) feasibility of the advice, (2) resources required, (3) priority of the advice, (4) other actors involved, and (5) the importance of data. Collectively, these findings suggest that a farm-specific SOP that actively tracks procedures is most beneficial, and that advice adherence is context dependent.
... These artefacts correspond to graphical indicators in an interactive dashboard interface. The manager also commonly has diagnostic mechanisms to speed up the decision process and may consult Standard operating procedures (Standard Operating Procedures -SOP) (Gough et al., 2009) suggested by the model against the input parameters of the generated diagnosis. Boyd Cycle will allow the manager to make decisions in real-time, with as many data as possible. ...
Stress at the workplace has been associated with an increase in absenteeism and presenteeism in organisations, with a high impact regarding productivity and co-worker's wellbeing at the workplace. The paper addresses such concerns by considering an approach that can act preventively by implementing a framework for early detection of stressing symptoms. The aim is to provide the organisation with a situational-awareness tool to keep the decision-maker well informed about any suspicious situation requiring the user attention, providing insights based on the co-worker wellness and specific needs, prompting in this way a healthy policy environment at the workplace. The research challenge addresses observing co-workers based on parameters associated with health indicators and understands how their physical and mental behaviour at the workplace can be affected by stress levels, including studying the impact derived from the conditions provided at the workplace environment. The paper presents an ongoing research work for early recognition of the identified risk factors, and to engage the workers in becoming proactive in their workplace. The primary goal of this model is to monitor the risk factors with impact on managing stress at the workplace. From a management viewpoint, the proposed model addresses the general theory of systems, as each variable in a system interacts with other variables so completely that cause and effect cannot be separated, as the workplace and the collaborators are linked together in order to maintain an equilibrium as is the best efficiency and efficacy at organizations. We expect to develop an integrated, systematic and dynamic model to support decision-makers (e.g., health supervisor) with the embedded knowledge required to choose the best possible intervention for the maximum benefit of the client (i.e., co-worker). The Boyd Cycle complements the decision-making process in order for health professionals to make more informed decisions in useful time. The Boyd Cycle assumes the existence of constant feedback and reorientation based on existing information and intuition, promoting the management of the workers and environment information, leading to adjustments in the workplace in real-time. The research will adopt the Design Science Research Methodology (DSRM) approach, where each informational artefact is generated to address the challenges identified for the target group. The study object for the proposed model is the health sciences with a focus on the nursing discipline and will be validated using interviews, panels of experts and later with the use of simulations.
... Estes artefactos correspondem a indicadores gráficos numa interface do tipo Dashboard interactivo. O gestor do cliente dispõe ainda de mecanismos de diagnóstico para agilizar o processo de decisão, podendo consultar os procedimentos operacionais padrão (Standard Operating Procedures -SOP) (Gough, Hamrell, Gorgh, & California, 2009) Caso o Gestor considere que o SOP proposto não se enquadra na alarmística, deverá então prescrever uma intervenção não padronizada, que alarga a perspetiva de uma intervenção operacional, para uma intervenção estratégica. Esta análise não padronizada poderá assim enveredar para uma abordagem individual, caso seja focada no colaborador e cuja situação não tenha um SOP definido, ou numa perspetiva sistémica, em que, além de não existir um SOP definido, também é uma situação que se encontra alargada a mais colaboradores, com um risco de disseminação provável na organização. ...
Resumo. O stress no local de trabalho tem sido associado a um aumento do absenteísmo e do presenteísmo nas organizações, com alto impacto na produtividade e no bem-estar dos colaboradores. O objetivo é conceber um modelo para dotar a empresa de uma ferramenta de awareness capaz de gerar insights que promovam o bem-estar dos colaboradores no local de trabalho, proporcionando maior conforto e motivação na execução das tarefas. O artigo apresenta um trabalho de pesquisa em curso que assenta numa revisão da literatura sobre mecanismos para um reconhecimento precoce de fatores de risco associados ao stress no local de trabalho de forma a mitigar o seu impacto no desempenho, motivação e produtividade dos trabalhadores. O modelo identifica um conjunto de artefactos informacionais que têm de ser orquestrados de forma a monitorizar padrões comportamentais e analisar fatores de risco que influenciam a gestão do stress. Este modelo é sustentado na teoria geral dos sistemas, e apoiado no Ciclo de Boyd permitindo ao gestor a tomada de decisões em tempo real. O modelo terá como objeto de estudo, as ciências da saúde com enfoque na disciplina de enfermagem. Palavras-chave: absenteísmo e presenteísmo; situational awareness; ciclo de Boyd; eustress e distress Monitoring stress at the workplace: a new challenge for healthcare providers Abstract. Workplace stress has been associated with an increase in absenteeism and presentism in organisations, with a high impact on productivity and the well-being of employees. The objective is to design a model to provide the company with an awareness tool capable of generating insights that promote the well-being of employees in the workplace, providing greater comfort and motivation in the execution of tasks. The article presents an ongoing research paper based on a review of the literature on mechanisms for early recognition of risk factors associated with stress in the workplace in order to mitigate its impact on workers' performance, motivation and productivity. The model identifies a set of informational artefacts that have to be orchestrated in order to monitor behavioural patterns and analyse risk factors that influence the management of stress. This model is supported by the general theory of systems and supported in the Boyd Cycle allowing the manager to make real-time decisions. The model will have an object of study, the health sciences with a focus in the nursing discipline. A temática do stress e o bem-estar no local de trabalho tem sido objeto de grande interesse na comunidade cientifica (Bae et al., 2019; Taris, 2016) com vista a estudar o impacto na produtividade da empresa. As condições no local de trabalho e a função do colaborador são frequentemente referenciadas como determinantes para um aumento do stress e, consequentemente, o seu impacto que se traduz em maior absentismo e presenteísmo com consequências financeiras bem como na produtividade da empresa/organização. Este trabalho apresenta uma abordagem acerca da
... It is essential for SOPs to be unique; only one version must exist at a given time [12] [14]. It must not be allowed for different researchers to have separate SOPs for similar but slightly different methods. ...
In recent years, large distributed collaborative projects have become
very prominent in scientific research, allowing exchanges between
laboratories located in different institutions and countries and between
various domains of competence. Particularly the work on nanotoxicity
- a field which has only been under investigation for a few years
and is still lacking regulatory framework - highlighted the need
for well-controlled methods, as well as rules for the handling and
disposal of used materials. To obtain comparable and reproducible
results of experiments conducted in a distributed context, the
standardisation and proper documentation of the applied methods is
crucial. The European project NanoDiaRA, whose aim is to develop
nanoparticles and biomarkers for the early diagnosis of inflammatory
disease, faces this situation as it involves 15 European partners and
brings together different scientific cultures and professional
backgrounds. Protocols especially developed for Superparamagnetic Iron
Oxide Nanoparticles and a management system were designed and
implemented within the NanoDiaRA project to fulfil those needs. The main
goals were the establishment of standardised Standard Operating
Procedures assuring transparency and reproducibility and the provision
of access to these protocols to every project partner, as well as their
clear allocation to carry out precise measurements and production steps.
... They can depart from the regulations provided they have a sound reason for doing so and they have documented it. They must, however, abide by their own procedures, and the Food and Drug Administration (FDA) and other regulatory bodies hold them accountable for this compliance (1). ...
This is the third of three articles on standard operating procedures or SOPs. It addresses how to write SOPs in clear, concise language so that processes and activities occur as they are supposed to. The first article addressed the need for SOPs and their value to the business unit. The second article addressed what SOPs an organization needs to think about and how to determine what SOPs to put in place. SOPs are the first line of defense in any inspection, whether it be by a regulatory body, a partner or potential partner, a client, or a firm conducting due diligence for a possible purchase. It does not matter what a company calls them; any document that is a how-to falls into the category of procedures. SOPs, in fact, define expected practices in all businesses where quality standards exist.
BJBS berencana untuk mengembangkan produk Trade Finance dengan cara pembiayaan Letter of Credit bagi perorangan atau perusahaan yang terlibat dalam transaksi ekspor dan impor. Rencana ini bertujuan untuk meningkatkan fee-based income, meningkatkan value dan posisi BJBS dan mengakomodir kebutuhan nasabah BJBS serta untuk meningkatkan kinerja pengelolaan transaksi impor dan ekspor. Permasalahan utama di BJBS adalah tidak memiliki prosedur atau tata cara pengelolaan transaksi ekspor dan impor. Oleh karena itu, BJBS membutuhkan Standard Operating Procedure (SOP) Transaksi Impor dan Transaksi Ekspor, khususnya untuk pembiayaan menggunakan Letter of Credit. Penelitian ini dilakukan untuk mengetahui langkah-langkah penyusunan SOP Transaksi Impor dan Transaksi Ekspor pada Letter of Credit. Dalam perancangan dan penyusunan SOP Letter of Credit ini, penulis menggunakan Design Thinking Method dengan menerapkan 5 proses Design Thinking yaitu Empathize, Define, Ideate, Prototype dan Implementation. Hasil yang didapat dari penerapan metode Design Thinking adalah operational review, dokumen analisis benchmarking, akad-akad yang digunakan dalam bank syariah dan dokumen SOP Transaksi Impor dan Ekspor.
Dairy farms are increasing in size and moving from family to external labor. As such, dairy farmers now have the responsibilities of a human resource manager in addition to caring for their animals. The objective of this paper was to review literature in 5 areas of human resource management of a dairy farm: (1) professional accreditation and professional development, (2) extension activities, (3) the role of the advisor, (4) standard operating procedures, and (5) employee training. Although there has been an increase in research in this area in recent years, this review identified numerous areas for future research, including the relationships between farmers and their advisors and employees, and the role of standard operating procedures on dairy farms. In addition, we suggest that future studies could benefit from increased use of participatory research methods.
Purpose: Nowadays Retailers are dealing with not only their rivals' competitions but also pressures of customers' demands, shorter product life cycles, and especially the acceleration of innovation in technology. To survive and develop, Retailers continue improving their performance through Business Process Management (BPM), which has become an essential instrument to enable their business strategies and objectives to be well-controlled and fulfilled. This paper aims to propose a format of Standard Operating Procedure (SOP) to implement BPM effectively with a task-based approach for operations activities including Merchandising, Operations, Promotion, Controlling, Personnel, Supports, and Supply-chain in retail. Design/methodology/approach: To achieve the objectives, Descriptive method was used, comprising (i) Survey approach (interview and questionnaire) to examine the frequency, attitudes, beliefs, prejudices, preferences, and opinions on how BPM was implemented with the SOP approach of interviewees, who were key persons in big retailers; and (ii) Observational approach to view performance of retailers in the business environment (real-life situation instead of laboratory) and crosscheck the result of survey. With the research results, the author may identify all most key tasks in a Retailer, which are prerequisites to establish the full set of SOPs so that BPM will be implemented efficiently. Findings: Different from previous research, this paper focuses on how SOP contributes to BPM implementation in the retail industry as well as illustrates that besides initiative process modeling, identification of key tasks in an SOP is very essential to make it clear and comprehensible for operators to follow. Although RACI/RASCI matrix 1 (Petrakova and Reusch) is used quite popularly in many organizations, it does not satisfy all requirements of Retailers to implement BPM and deploy SOP. Therefore, the proposed "TRATS" model (Task, Responsible, Approval, Time, and Standards), which are based on basic tasks in retailing, presented in task-based SOPs, may cover almost the gaps and help Retailers perform BPM more efficiently and effectively. 1 RA(S)CI stands for Responsible, Accountable, (Support), Consulting and Informed. 2 Research/practical implications: Through the research, author would like to emphasize that BMP and SOPs are well-performed only if they were easily comprehended and firmly conceived by employees, so that business objectives may be accomplished; therefore, SOPs must be detailed and comprised all operational aspects for employees to comply with. The research is also the combination of academic knowledge and practical experience of BPM implementation in terms of SOP, of which expectation becomes a reliable source and basic reference for further research in BPM as well as a guideline for Retailers to improve operations management. Originality/value: Differing from manufacturers, retailers are about people while technology cannot completely replace human skills; therefore, BPM may be presented as items of works chronologically in written, so-called "task-based SOPs", which are more comprehensible for employees to perform and accomplish the objectives of enterprises easily and efficiently. Expectedly, SOP with "TRATS" model may be useful for practitioners because it can cover almost all important aspects in BPM implementation, therefore it can help them to improve their business performance. For academics, "TRATS"-SOP (or task-based SOP") approach may be a new point for researchers who are interested in BPM of the retail industry and want to develop it in further literature.
Kantor Perwakilan Bank Indonesia Kediri adalah menjalankan kebijakan Bank Indonesia salah satu tugasnya menjaga kehandalan sistem pembayaran untuk mendukung pembangunan ekonomi daerah maupun nasional jangka panjang yang inklusif dan berkesinambungan, tentunya dalam menjalankan misi tersebut didalamnyadidukung oleh suatu tim yang dikenal management intern atau tim supporting, tentunya dalam tim tersebut terdapat beberapa permasalahan, diantaranya waktu penyelesaian pembayaran dan penyediaan data serta penyampaian data pengelolaan bahan bakar yang terlalu lama terkadang tidak sesuai dengan waktu standart yang ditetapkan. Penelitian ini menggunakan metode perbaikan proses bisnis atau Business Process Improvement (BPI). Perbaikan proses bisnis dilakukan dengan mengidentifikasi gap proses bisnis aktual dengan Surat Edaran yang dikeluarkan oleh Bank Indonesia. Hasil analisis gap akan menjadi masukan untuk analisis aktivitas dimana setiap aktivitas dikelompokkan menjadi RVA, BVA dan NVA. Perbaikan proses bisnis dilakukan dengan mengeliminasi aktivitas NVA, menstreamlining aktivitas BVA dan melakukan meminimasipada aktivitas RVA.Pada tahap pengumpulan data diperoleh 6 proses bisnis aktual untuk pembayaran kepada pihak ketiga dan penyediaan data, sedangkan untuk pengelolaan bahan bakar diperoleh 2 proses bisnis aktual. Hasil analisa aktivitas menunjukkan terdapat 10 aktivitas RVA, dan 8 aktivitas BVA dan 0 aktivitas NVA. Dari hasil penelitian didapatkan proses bisnis usulan yang telah dilakukan streamlining terdapat peningkatan efisiensi untuk pembayaran kepada pihak ketiga dan penyediaan data untuk stakeholder sebesar 36,67%, sedangkan untuk pengelolaan bahan bakar minyak sebesar 7.5%.Tools perbaikan proses bisnis yang digunakan dalam penelitian ini antara lain upgrading.Proses bisnis usulan menjadi masukan dalam penyusunan SOP.Kata kunci : Business Process Improvement, Standart Operating Procedure, Surat Edaran Bank Indonesia
The logistics of operationally executing a clinical trial are enormous. Consider a therapeutic confirmatory trial involving 5,000 subjects participating at a total of 100 investigational sites that are spread across several continents. Identifying potential subjects and then recruiting and retaining the required number is one challenge. Shipping the drug products for the clinical trial (the investigational and control drugs) to investigational sites located in various countries spread around the globe is another. Making sure that all necessary data are measured and recorded is a major task, as is managing and storing the data. And the list goes on. Of necessity, this chapter is far from exhaustive in its descriptions of operational aspects of running a clinical trial. Rather, its aim is to give you a feel of some of the challenges encountered and the ways that organizations which conduct trials function at an operational level.
The accessible, easy-to-follow guide that demystifies documentation management. When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment's notice. Written in a user-friendly Q&A style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on: Compliance with regulations in pharmaceutical, biological, and device record keeping. Electronic systems, hybrid systems, and the entire scope of documentation that companies must manage. How to write and edit documents that meet regulatory compliance. Making the transition to an electronic system, including how to validate and document the process. Anyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place-one that will stand up to any type of scrutiny.
Good clinical practice (GCP) audits and inspections can serve as valuable educational experiences. In the second of a two-part series we look at audit and inspection preparatory activities including both documentation preparation (SOPs, training materials) and personal preparation (eg, mock interviews). We look at the various stages of preparation, from continuous activities to those required in pre-inspection and post-inspection/audit periods. Adequate preparation will enable personnel to be open and communicative during interviews and generate a calm, rational and controlled company environment. © 2011 The Organisation for Professionals in Regulatory Affairs.
Standard operating procedures (SOPs) were once considered the province of the pharmaceutical industry but are now viewed as a key component of quality assurance programs. To address variability and increase the rigor of clinical data management (CDM) operations, the Cincinnati Children's Hospital Medical Center (CCHMC) decided to create CDM SOPs.
In response to this challenge, and as part of a broader institutional initiative, the CCHMC leadership established an executive steering committee to oversee the development and implementation of CDM SOPs. This resulted in the creation of a quality assurance review process with three review panels: an SOP development team (16 clinical data managers and technical staff members), a faculty review panel (8 senior faculty and administrators), and an expert advisory panel (3 national CDM experts). This innovative, tiered review process helped ensure that the new SOPs would be created and implemented in accord with good CDM practices and standards.
Twelve fully vetted, institutionally endorsed SOPs and one CDM template resulted from the intensive, iterative 10-month process (December 2011 to early October 2012). Phased implementation, which incoporated the CDM SOPs into the existing audit process for certain types of clinical research studies, was on schedule at the time of this writing.
Once CCHMC researchers have had the opportunity to use the SOPs over time and across a broad range of research settings and conditions, the SOPs will be revisited and revalidated.
This is the second of three articles on standard operating procedures or SOPs. It addresses what SOPs an organization needs to think about and how to determine what SOPs to put in place. The last article will describe how to write SOPs in clear, concise language so that processes and activities occur as they are supposed to. The first article addressed the need for SOPs and their value to the business unit. SOPs are the first line of defense in any inspection, whether it be by a regulatory body a partner or potential partner, a client, or a firm conducting due diligence for a possible purchase. It does not matter what a company calls them; any document that is a“how to”falls into the category of procedures. SOPs in fact define expected practices in all businesses where quality standards exist.
The development of standard operating procedures (SOPs) for international trails using ISO procedures and The International Conference on Harmonization-Good Clinical Practice (ICH-GCP) components, is discussed. ISO 14155 is designed for clinically investigating devices, that is a more straightforward process. The ICH-GCPs are designed for clinically investigating pharmaceuticals. The guidance of ICH-GCPs was written by industry and regulatory representatives from the United States, Europe, and Japan. SOPs ensure that the trail investigator will be trained and licensed to use the investigational device by conducting a training program. These also certify that the investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice. SOPs recommend that a corporate quality system need to follow the ICP-GCP methods for case report forms (CRFs) corrections.
Navigating device clinical trials in Europe may require creating a hybrid procedure that uses both ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects-Parts 1 and 2) and the ICH-GCPs (International Conference on Harmonization-Good Clinical Practices document number E6). The best method of conducting trials is to use neither ISO 14155 nor the ICH-GCPs, but to create a composite guidance. By using both documents to create a unique set of standard operating procedures (SOPs), device makers can satisfy the requirements for conducting trials in Europe and in the United States. Because clinical trials in Europe are often a stepping stone to gaining approval in the United States, it makes sense to follow the ISO standard. It may be best to begin with the clause in the ICH-GCPs that allows reporting exemptions for those adverse events listed in the protocol. Central monitoring can be used to verify completeness, legibility, logic, traceability, error-correction procedures, and presence of the investigator's signature.
A consistent concern when implementing a quality system for clinical research is the level of standardization and organization to impose within each department. Standard operating procedures (SOPs) and operational guidelines (OGs), describing how each member of the clinical research team should conduct the various activities associated within their department, are the framework for any quality system. SOPs provide instructions and guidance to the user on what to do and what is expected of them. Standardized procedures are important not only to provide direct instruction but also to maintain consistency between various parts of an organization involved with the conduct and reporting of clinical trials. The increased use of multinational clinical trials requires the use of a standardized approach to maintain consistent quality and results in a drug development programme. In this article, an introduction to quality systems, SOPs and how they can help in the conduct of clinical trials, provides an overview for those persons new to clinical research and the role of SOPs. Copyright © 2001 John Wiley & Sons, Ltd.
Hamrell 2. 21 CFR §211.100. Written procedures; deviations (a)(b)
- Gough
Gough, Hamrell
2. 21 CFR §211.100. Written procedures; deviations
(a)(b).