Innovation within regulated sectors demands compliance, traceability, and validation, making it conducive to plan-driven project management approaches. However, the increasing level of innovation often makes traditional methods incompatible. Hybrid models have emerged as promising solutions to balance this trade-off. One such practice involves integrating quality management practitioners to validate deliverables produced by agile teams. This study examines the efficacy of this approach within the product development context of an automotive company operating under regulatory constraints. The findings demonstrate positive impacts on delivery planning, monitoring and control, assessment, and knowledge management. Positive contributions include critical analysis of compliance requirements, continuous improvement of deliverables and documentation, and the team’s proficiency in regulatory mandates. However, dependence on quality specialists can pose a barrier and potentially lead to negative impacts.

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Combining Quality and Agile: A Contribution to Hybrid Models in Regulated Environments

  • Herua Luis Soares da Silva,
  • Daniel Capaldo Amaral,
  • Isabela Neto Piccirillo

摘要

Innovation within regulated sectors demands compliance, traceability, and validation, making it conducive to plan-driven project management approaches. However, the increasing level of innovation often makes traditional methods incompatible. Hybrid models have emerged as promising solutions to balance this trade-off. One such practice involves integrating quality management practitioners to validate deliverables produced by agile teams. This study examines the efficacy of this approach within the product development context of an automotive company operating under regulatory constraints. The findings demonstrate positive impacts on delivery planning, monitoring and control, assessment, and knowledge management. Positive contributions include critical analysis of compliance requirements, continuous improvement of deliverables and documentation, and the team’s proficiency in regulatory mandates. However, dependence on quality specialists can pose a barrier and potentially lead to negative impacts.