Abstract: Achieving Regulatory and Industry Standards Compliance with the Lean-Agile at Scale
Many systems in aerospace, defense, automotive, medical, banking, and other industries have an unacceptable social or economic cost of failure. These systems are also subject to extensive regulatory oversight and rigorous compliance standards. Historically, organizations building these systems have relied on comprehensive quality management systems and stage-gate based waterfall life-cycle models to reduce risk and ensure compliance. These same organizations are now adopting lean-agile methods, and are struggling to understand how their existing stage-gate compliance activities participate in a lean-agile flow of value.
In this presentation, Dr. Harry Koehnemann with 321Gang and Dr. Steve Mayner from Scaled Agile, Inc. will show how to align the goals and practices of those who build high-assurance systems with those who must assure those systems. They will demonstrate how several lean-agile principles produce better compliance outcomes by:
- Taking an incremental approach to creating and assessing compliance information
- Including compliance teams and their concerns in the product development ecosystem to collaborate on planning, executing, assessing, and adapting.
- Incorporate compliance in agile quality practices – automating, adapting, continuously improving, etc.
- Integrating V&V and compliance activities into iterative development flow
Learning Outcomes: - Explain how compliance objectives in high assurance environments are aligned with Lean-Agile principles and practices
- Know the distinctions between PRODUCT and PROCESS compliance requirements
- Improve compliance, verification, and validation outcomes through iterative and incremental implementation
- Understand organizational alignment and collaboration strategies for early and continuous feedback on compliance
- Apply specific technical practices that increase quality and compliance through automation
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