Maintain audit-readiness and reduce lead times while improving delivery of quality and compliance requirements

As the digitization of development and delivery processes grows, organization’s IT systems increasingly are the primary means through which customers experience products and services. For these organizations, compliance and auditability are prime drivers of value, creating trust with auditors and customers, and not just “background concerns." So, while implementing a pull-system that could improve the delivery of products and services to market sounds reasonably appealing, in highly regulated industries there is the unique challenge of learning to maintain audit readiness in some very different ways. Helping your oversight partners grasp how lean feedback-driven management practices can maintain or improve the stewardship of regulated product and service workflows is imperative to ensuring their audit success.

In this Learning Lab we will help Kanban practitioners build systems that produce appropriate evidence of due-diligence through automation of data collection and satisfaction measurements from end-product recipients. We will cover: lean bureaucracy, documentation and evidence alternatives, maintaining an ongoing state of audit-readiness, using lean and agile based principles and practices along with integrated and automated tools, and exploring the social contract of regulatory oversight. Many of these practices and tools have been in use 10+ years, demonstrating a proven ability to effectively mitigate risks by rigorously addressing quality and compliance goals associated with verification, validation, access control, change history, traceability, persistence, and auditing.

In the lab’s overview segment, we’ll first identify some specific real-world challenges, associated with quality and regulatory compliance requirements. We will then present examples from federal software development and pharmaceuticals, highlighting some ways these challenges were effectively addressed, and connecting where applicable to specific Kanban principles, processes, and practices. Then in the lab’s final activity segment we will provide an opportunity to experiment with one or more specific practices development teams use to dramatically reduce lead times while also improving on the delivery of quality and compliance requirements.

TAGS  regulatory, improvement, quality 

Frank Vega, KCP

Frank Vega brings 30+ years of IT/IS experience, in roles including director, software architect, technical team lead, developer, database modeler, and numerical/data analyst. In 2002 he began assisting teams with applying lean-agile processes and practices (Scrum, XP). He started using the kanban method with his teams in 2007. As a Kanban Coaching Professional (KCP), Frank leverages his “real-world” experiences to coach others with evolving and improving their processes and practices using pull system principles. His expertise includes applying flow-based metrics to effectively direct, manage, and validate changes, and using probabilistic and resampling statistical methods to develop understandable product and service delivery forecasts. Frank collaborates with leading kanban practitioners, and contributes to lean-agile and kanban communities via national conferences, and Denver area user groups. For more information, see:

Melinda Solomon, AKT

Melinda Solomon is the president and co-founder of Middlegrass Consulting. She is a training professional who has created educational programs catering to diverse international audiences in a variety of industries including pharmaceuticals, biotech, and government. She has worked with organizational transformations to implement lean principles and agile methodologies in highly regulated environments. She has designed and delivered training in more than 30 countries in support of dozens of federal agencies.

She has led the USCIS Agile Training Program for 6 years, is director of Agile on the Weekend training consortium and has taught Agile classes to over 4000 students. She specializes in communicating about responsible Agile transformation. She holds a Master’s Degree in International Education from University of Massachusetts, and is a CSM, PMP, Accredited Kanban Trainer, and was a Fulbright Fellow for the US State Department.