Standard operating procedures: a proposed framework for management and implementation
DOI:
https://doi.org/10.15675/gepros.3047Keywords:
Standard Operating Procedures, Operational Efficiency, Regulatory Compliance, Quality, Organizational InnovationAbstract
Objective: The objective of this article is to analyze the applicability, benefits, and challenges of Standard Operating Procedures (SOPs) in different organizational contexts, proposing a framework for their implementation, management, and adaptation. Theoretical framework: The research is based on literature regarding process standardization, operational efficiency, regulatory compliance, and innovation. It addresses the contributions of SOPs to organizational stability and the challenges related to resistance to change, administrative complexity, and the need for constant updates. Methodology/Approach: The study adopted an exploratory and descriptive approach, based on a systematic literature review (SLR). A total of 58 scientific articles were analyzed to identify evidence on the implementation, management, and effectiveness of SOPs. The findings were categorized into five main themes, which serve as the foundation for the development of the proposed framework. Results: The results indicate that SOPs play a key role in reducing variability, increasing predictability, and fostering organizational innovation. However, their adoption faces challenges such as employee resistance and the need for continuous adaptation. The proposed framework provides guidelines to overcome these barriers and maximize the benefits of SOPs, allowing their application across different sectors. Contributions, Practical and Social Implications: This article presents a structured model to facilitate the implementation and management of SOPs, contributing to improvements in operational efficiency, regulatory compliance, and innovation. It also provides insights for managers seeking to optimize processes and promote greater organizational engagement, ensuring business sustainability and competitiveness. Originality/Value: The value of this study lies in consolidating practices and challenges related to SOPs into an adaptable framework, addressing the lack of systematic guidelines for their continuous management. The proposed approach enhances flexibility in the application of these procedures, balancing standardization and innovation, and making the model relevant for various organizational contexts.
References
Abbott, K. W., & Snidal, D. (2021). The governance triangle: Regulatory standards institutions and the shadow of the state. In: The Spectrum of International Institutions. Routledge.
Arciniegas, J. S. (2019). Compliance: norms as an instrument and a threat to the administration. Cuadernos De Administración, 35(65), 118–130. https://doi.org/10.25100/cdea.v35i65.7748
Ball, P., & Lunt, P. (2018). Lean eco-efficient innovation in operations through the maintenance organisation. International Journal of Production Economics, 219, 405–415. https://doi.org/10.1016/j.ijpe.2018.07.007
Balzano, J. C. (2024). China Food and Drug Law: Policy, Practice, and Future Directions. Springer.
Barbosa, L. C. F. M., de Oliveira, O. J., Machado, M. C., Morais, A. C. T., Bozola, P. M., & Santos, M. G. F. (2022). Lessons learned from quality management system ISO 9001:2015 certification: practices and barrier identification from Brazilian industrial companies. Benchmarking an International Journal, 29(8), 2593–2614. https://doi.org/10.1108/BIJ-07-2021-0382
Barenji, R. V., Hariry, R. E., Demirkol, D., & Daim, T. U. (2024). Research landscape analysis for quality in Pharma 4.0 era. Technology in Society, 76, 102472. https://doi.org/10.1016/j.techsoc.2024.102472
Bonnín Roca, J., Vaishnav, P., Morgan, M. G., Mendonça, J., & Fuchs, E. (2017). When risks cannot be seen: Regulating uncertainty in emerging technologies. Research Policy, 46(7), 1215–1233. https://doi.org/10.1016/j.respol.2017.05.010
Cabri, G., & Fioretti, G. (2022). Flexibility out of standardization. International Journal of Organization Theory & Behavior, 25(1/2), 22–38. https://doi.org/10.1108/IJOTB-11-2020-0197
Cerezo-Narváez, A., García-Jurado, D., González-Cruz, M. C., Pastor-Fernández, A., Otero-Mateo, M., & Ballesteros-Pérez, P. (2019). Standardizing innovation management: An opportunity for SMEs in the aerospace industry. Processes, 7(5), 282. https://doi.org/10.3390/pr7050282
Chakkol, M., Selviaridis, K., & Finne, M. (2018). The governance of collaboration in complex projects. International Journal of Operations & Production Management, 38(4), 997–1019. https://doi.org/10.1108/ijopm-11-2017-0717
El-Khalil, R., Leffakis, Z. M., & Hong, P. C. (2020). Impact of improvement tools on standardization and stability goal practices: An empirical examination of US automotive firms. Journal of Manufacturing Technology Management, 31(4), 705–723. https://doi.org/10.1108/jmtm-08-2019-0289
EMA. European Medicines Agency. (2020). Good Manufacturing Practice (GMP). https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice
Engkus, E. (2023). Enhancing public services in the West Java Provincial Government: unraveling challenges, defining essence, and proposing solutions. Journal of Current Social and Political Issues, 1(2), 54–61. https://doi.org/10.15575/jcspi.v1i2.475
EUR-Lex. European Union Law. (2004). Regulamento (CE) n.º 852/2004 do Parlamento Europeu e do Conselho, de 29 de Abril de 2004, relativo à higiene dos géneros alimentícios. European Union.
FDA. Food and Drug Administration. (2024a). Current Good Manufacturing Practice (CGMP) Regulations. Silver Spring.
FDA. Food and Drug Administration. (2024b). Facts About the Current Good Manufacturing Practice (CGMP). Silver Spring.
Fiorello, M., Gladysz, B., Corti, D., Wybraniak-Kujawa, M., Ejsmont, K., & Sorlini, M. (2023). Towards a smart lean green production paradigm to improve operational performance. Journal of Cleaner Production, 413, 137418. https://doi.org/10.1016/j.jclepro.2023.137418
Folch-Calvo, M., Brocal-Fernández, F., González-Gaya, C., & Sebastián, M. A. (2020). Analysis and characterization of risk methodologies applied to industrial parks. Sustainability, 12(18), 7294. https://doi.org/10.3390/su12187294
Gonzales-Gemio, C., Cruz-Cázares, C., & Parmentier, M. J. (2020). Responsible Innovation in SMEs: A Systematic Literature Review for a Conceptual Model. Sustainability, 12(24), 10232. https://doi.org/10.3390/su122410232
Herrera, M. E. B. (2016). Innovation for impact: Business innovation for inclusive growth. Journal of Business Research, 69(5), 1725–1730. https://doi.org/10.1016/j.jbusres.2015.10.045
Hole, G., Hole, A. S., & McFalone-Shaw, I. (2021). Digitalization in pharmaceutical industry: What to focus on under the digital implementation process? International Journal of Pharmaceutics: X, 3, 100095. https://doi.org/10.1016/j.ijpx.2021.100095
Hollmann, S., Frohme, M., Endrullat, C., Kremer, A., D’Elia, D., Regierer, B., & Nechyporenko, A. (2020). Ten simple rules on how to write a standard operating procedure. PLoS Computational Biology, 16(9), e1008095. https://doi.org/10.1371/journal.pcbi.1008095
Jalundhwala, F., & Londhe, V. (2023). A systematic review on implementing operational excellence as a strategy to ensure regulatory compliance: a roadmap for Indian pharmaceutical industry. International Journal of Lean Six Sigma, 14(4), 730–758. https://doi.org/10.1108/ijlss-04-2022-0078
Kabeyi, M. J. B. (2019). Organizational strategic planning, implementation and evaluation with analysis of challenges and benefits for profit and nonprofit organizations. International Journal of Applied Research, 5(6), 27–32. https://doi.org/10.22271/allresearch.2019.v5.i6a.5870
Kadir, A. (2021). Analysis of the effect of standard operational procedures, internal supervision on employee performance at the regional tax and level management agency of tapin district in rantau. International Journal of Economics, Business and Accounting Research (IJEBAR).
Kalenda, M., Hyna, P., & Rossi, B. (2018). Scaling agile in large organizations: Practices, challenges, and success factors. Journal of Software Evolution and Process, 30(10), e1954. https://doi.org/10.1002/smr.1954
Kasiri, L. A., Cheng, K. T. G., Sambasivan, M., & Sidin, S. M. (2017). Integration of standardization and customization: Impact on service quality, customer satisfaction, and loyalty. Journal of Retailing and Consumer Services, 35, 91–97. https://doi.org/10.1016/j.jretconser.2016.11.007
Khairunnisa, N., Latief, Y., & Riantini, L. S. (2020). Standard operational procedure (SOP) auditing process in integrated management system to improve the efficiency of organizational performance. IOP Conference Series Earth and Environmental Science, 426(1), 012018. https://doi.org/10.1088/1755-1315/426/1/012018
Khanzada, F. (2024). Conformity Assessment: Relevance of Quality in the Age of Industry 4.0. In: Handbook of Quality System, Accreditation and Conformity Assessment. Springer.
Khosroniya, M., Hosnavi, R., & Zahedi, M. R. (2024). Enhancing Operational Performance in Industry 4.0: The Mediating Role of Total Quality Management and Total Productive Maintenance at Zarharan Industrial Complex. International Journal of Industrial Engineering and Operational Research, 6(1), 96–122.
Kong, L., Hu, K., & Verma, R. (2022). Service Chains’ Operational Strategies: Standardization or Customization? Evidence from the Nursing Home Industry. Manufacturing & Service Operations Management, 24(6), 3099–3116. https://doi.org/10.1287/msom.2022.1111
Kontogiannis, T., Leva, M. C., & Balfe, N. (2017). Total Safety Management: Principles, processes and methods. Safety Science, 100, 128–142. https://doi.org/10.1016/j.ssci.2016.09.015
Kotsanopoulos, K. V., & Arvanitoyannis, I. S. (2017). The role of auditing, food safety, and food quality standards in the food industry: A review. Comprehensive Reviews in Food Science and Food Safety, 16(5), 760–775. https://doi.org/10.1111/1541-4337.12293
Kumar, S., & Bhatia, M. S. (2021). Environmental dynamism, industry 4.0 and performance: Mediating role of organizational and technological factors. Industrial Marketing Management, 95, 54–64. https://doi.org/10.1016/j.indmarman.2021.03.010
Li, F. (2020). The digital transformation of business models in the creative industries: A holistic framework and emerging trends. Technovation, 92–93, 102012. https://doi.org/10.1016/j.technovation.2017.12.004
Lindsay, C., Findlay, P., McQuarrie, J., Bennie, M., Corcoran, E. D., & Van Der Meer, R. (2017). Collaborative innovation, new technologies, and work redesign. Public Administration Review, 78(2), 251–260. https://doi.org/10.1111/puar.12843
Lorenz, A., Raven, M., & Blind, K. (2019). The role of standardization at the interface of product and process development in biotechnology. The Journal of Technology Transfer, 44(4), 1097–1133. https://doi.org/10.1007/s10961-017-9644-2
Maritan, F. B., Soliani, R. D., Ferreira, G. C., Junior, Satrapa, H. F. M., & Florentino, M. M. G. (2024). Regional development through innovation: a proposal for a technological hub framework. Revista de Gestão e Secretariado (Management and Administrative Professional Review), 15(10), e4255. https://doi.org/10.7769/gesec.v15i10.4255
Mentel, U., & Hajduk-Stelmachowicz, M. (2020). Does standardization have an impact on innovation activity in different countries? Problems and perspectives in management, 18(4), 486–503. https://doi.org/10.21511/ppm.18(4).2020.39
Metz, D., Ilieș, L., & Nistor, R. L. (2020). The Impact of Organizational Culture on Customer Service Effectiveness from a Sustainability Perspective. Sustainability, 12(15), 6240. https://doi.org/10.3390/su12156240
Mokogwu, C., Achumie, G. O., Adeleke, A. G., Okeke, I. C., & Ewim, C. P.-M. (2024). A leadership and policy development model for driving operational success in tech companies. International Journal of Frontline Research in Multidisciplinary Studies, 4(1), 1–14. https://doi.org/10.56355/ijfrms.2024.4.1.0029
Naidoo, M., & Gasparatos, A. (2018). Corporate environmental sustainability in the retail sector: Drivers, strategies and performance measurement. Journal of Cleaner Production, 203, 125–142. https://doi.org/10.1016/j.jclepro.2018.08.253
Panayiotou, N. A., Stergiou, K. E., & Chronopoulos, V. (2022). Implementing a Lean Six Sigma standardized toolset in a manufacturing company: a case study. International Journal of Productivity and Performance Management, 71(4), 1164–1187. https://doi.org/10.1108/ijppm-08-2020-0423
Patel, A. S., & Patel, K. M. (2021). Critical review of literature on Lean Six Sigma methodology. International Journal of Lean Six Sigma, 12(3), 627–674. https://doi.org/10.1108/IJLSS-04-2020-0043
Pop, G. I., Titu, A. M., & Pop, A. B. (2023). Enhancing aerospace industry efficiency and sustainability: Process integration and quality management in the context of industry 4.0. Sustainability, 15(23), 16206. https://doi.org/10.3390/su152316206
Rebelo, M. F., Santos, G., & Silva, R. (2016). Integration of management systems: towards a sustained success and development of organizations. Journal of Cleaner Production, 127, 96–111. https://doi.org/10.1016/j.jclepro.2016.04.011
Rebelo, M. F., Silva, R., & Santos, G. (2017). The integration of standardized management systems: managing business risk. International Journal of Quality & Reliability Management, 34(3), 395–405. https://doi.org/10.1108/ijqrm-11-2014-0170
Reif, J. A. M., Kugler, K. G., & Brodbeck, F. C. (2019). The regulatory power of standardized business processes. Business Process Management Journal, 25(5), 1126–1144. https://doi.org/10.1108/bpmj-12-2017-0353
Ribeiro, R. (2020). Teorias da Administração. Senac.
Rodríguez-Pérez, J. (2014). The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals. ASQ Quality Press.
Rodríguez-Pérez, J. (2018). Human Error Reduction in Manufacturing. ASQ Quality Press.
Sangwa, N. R., & Sangwan, K. S. (2018). Development of an integrated performance measurement framework for lean organizations. Journal of Manufacturing Technology Management, 29(1), 41–84. https://doi.org/10.1108/jmtm-06-2017-0098
Silva, C., Magano, J., Moskalenko, A., Nogueira, T., Dinis, M. A. P., & Pedrosa e Sousa, H. F. (2020). Sustainable Management Systems Standards (SMSS): Structures, Roles, and Practices in Corporate Sustainability. Sustainability, 12(15), 5892. https://doi.org/10.3390/su12155892
Singh, V. K., Kumar, R., Joshi, C. V., & Poddar, S. (2023). Improving operational performance with world class quality (WCQ) technique: A case in Indian automotive industry. Materials Today: Proceedings, 72, 1561–1567. https://doi.org/10.1016/j.matpr.2022.09.387
Sithambaram, J., Nasir, M. H. N. B. M., & Ahmad, R. (2021). Issues and challenges impacting the successful management of agile-hybrid projects: A grounded theory approach. International Journal of Project Management, 39(5), 474–495. https://doi.org/10.1016/j.ijproman.2021.03.002
Situmorang, H. E., Rini, E. S., & Pujangkoro, S. (2022). Implementation of Standard Operational Procedure (SOP) for Services, Government Policy and Information Technology of Communication on Improving Public Satisfaction of Balai Karantina Pertanian Kelas II Medan. International Journal of Research and Review, 9(1), 461–469. https://doi.org/10.52403/ijrr.20220152
Sjödin, D., Parida, V., Palmié, M., & Wincent, J. (2021). How AI capabilities enable business model innovation: Scaling AI through co-evolutionary processes and feedback loops. Journal of Business Research, 134, 574–587. https://doi.org/10.1016/j.jbusres.2021.05.009
Soliani, R. D., De Oliveira, D. A., Da Silva, M. E., Da Conceição Nascimento Pontes, J., De Andrade Gonçalves, S., Teixeira, M. a. C., Lopes, D. C., & Drumond, T. D. R. (2024a). Development of competencies for industry 4.0: a professional training framework. Observatório De La Economía Latinoamericana, 22(12), e8158. https://doi.org/10.55905/oelv22n12-091
Soliani, R. D., Matos, A. L. T. de, Júnior, J. B. de C., Pires, S. R. I., & Argoud, A. R. T. T. (2021). Desenvolvimento de fornecedores: O exemplo de uma empresa do setor sucroenergético. Revista de Administração e Negócios da Amazônia, 13(1), 146–164. https://periodicos.unir.br/index.php/rara/article/view/6029
Soliani, R. D., Pereira, R. D. S., De Freitas, C. G., & Pereira, F. S. (2024b). Gamification in Supply Chain Management (SCM) education: a practical experience with the Beer Game. Caderno Pedagógico, 21(2), e2865. https://doi.org/10.54033/cadpedv21n2-104
Urbinati, A., Chiaroni, D., Chiesa, V., & Frattini, F. (2020). The role of digital technologies in open innovation processes: an exploratory multiple case study analysis. R and D Management, 50(1), 136–160. https://doi.org/10.1111/radm.12313
Viardot, E., Mccarthy, I. P., & Chen, J. (2021) Standardization in a digital and global world: State-of-the-art and future perspectives. IEEE Transactions on Engineering Management, 68(1), 11–17. https://doi.org/10.1109/tem.2020.3006302
Wada, K. (2020). The Evolution of the Toyota Production System. Springer.
WHO. World Health Organization. (2017). China policies to promote local production of pharmaceutical products and protect public health. European Commission, World Health Organization.
Zoo, H., De Vries, H. J., & Lee, H. (2017). Interplay of innovation and standardization: Exploring the relevance in developing countries. Technological Forecasting and Social Change, 118, 334–348. https://doi.org/10.1016/j.techfore.2017.02.033
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 Letícia da Silva Rufino, Thais Diniz Reis Drumond, Douglas Marques Luiz, Rodrigo Duarte Soliani
This work is licensed under a Creative Commons Attribution 4.0 International License.
O(s) autor(es) do artigo autorizam a publicação do texto na revista e garantem que a contribuição é original e inédita, não estando em processo de avaliação em outra(s) revista(s). As opiniões, ideias e conceitos emitidos nos textos são de inteira responsabilidade do(s) autor(es), não sendo a revista responsável por tais conteúdos.
Os editores da revista reservam o direito de efetuar ajustes textuais e de adequação às normas da publicação, caso necessário.
Os autores mantêm os direitos autorais sobre o trabalho e concedem à revista o direito de primeira publicação, sendo o trabalho simultaneamente licenciado sob a Attribution 4.0 International (CC BY 4.0), o que permite o compartilhamento do trabalho com reconhecimento da autoria e publicação inicial nesta revista.
Os autores têm autorização para firmar contratos adicionais, separadamente, para distribuição não-exclusiva da versão do trabalho publicada nesta revista (ex.: publicar em repositório institucional ou como capítulo de livro), com reconhecimento de autoria e publicação inicial nesta revista.
