Maybe at risk, but not in peril – How lean implementation can help manage risk

Organizational risk often hides in the “hidden factory” where waste is produced while Lean processes are transparent and make it easier to spot risk. Attendees will learn how Lean tools and methodologies can be used to eliminate or mitigate both product and process risk. This session will also show attendees how to increase success in lean project selection and implementation through the use of Lean risk management techniques.

So what DOES Lean implementation have to do with risk management? Organizational risk often hides in the “hidden factory” where waste is produced. Lean processes are transparent and make it easier to spot risk. Lean tools and methodologies can be used to eliminate or mitigate both product and process risk. “Respect for the individual” a cornerstone of Lean is also important when it comes to risk management, from two very important perspectives – (1) protecting individuals within the organization from risk and (2) tapping into their collective knowledge to identify and mitigate existing risks. Both risk modeling and value stream mapping look at current and future states of the organization or process under review.

Risk management and Lean implementation are already naturally related and interrelated. Risk management as a process, could contain waste. Every Lean transformational or improvement project contains an element of risk in its implementation. It is not possible to accurately calculate return on investment (ROI) without assessing project risk. Additionally the more complex a process is, the greater potential risk that something could go wrong and the greater opportunity for hidden waste. In effect, managing performance successfully also means managing risk effectively.

Why You Should Attend:

Real life examples will be used to illustrate key points. Attendees will learn how a small medical device manufacturer used its process excellence (lean and six sigma) group to lead the charge in managing risk. They will learn how lean tools are used when identifying, assessing, mitigating and monitoring risk. Conversely, attendees will follow an actual Lean improvement project from beginning to end to see how risk management was incorporated into every phase. Attendees will further learn how to formally integrate these two systems for a risk reduced, more effective and more efficient environment. Using the methods presented during this session will lead attendees to increased success rates in both lean project selection and implementation. Finally, it will be shown how to place the Lean improvement program within the larger framework of ISO 9001:2015.

This subject is particularly timely subject with the conclusion of transitions to ISO 9001:2015, and its increased emphasis on risk management and demonstrating effectiveness throughout all phases of an organization’s quality management system.

What is unique about this session?
The link between lean and risk prevention while important, is one that is not often explored.

Areas Covered in the Session :

  • Introduction to lean risk management
  • Where is risk found in our products and processes
  • How lean implementation can help manage risk
  • Embedding risk management within your Lean enterprise
  • Risks unique to a Lean enterprise
Who Should Attend:

  • Lean practitioners
  • Project and Program Managers
  • Operations Managers
  • Quality Managers
  • Plant/General Managers
  • Continuous Improvement professionals


Lance B. Coleman

Lance B. Coleman has over 20 years of leadership experience in the areas of quality engineering, Lean implementation, quality and risk management in the Medical Device, Aerospace and other regulated industries. He has a degree in Electrical Engineering Technology from the Southern Polytechnical University in Marietta, GA and is an American Society for Quality Senior Member as well as, Certified Quality Engineer, Six Sigma Green Belt, Quality Auditor and Biomedical Auditor.  He is also an Exemplar Global Principal QMS Auditor.

Lance is Chair of US TAG 302 – guidelines for auditing management systems as well as a voting member of US TAG 176- quality management and quality assurance. He is the author of  “Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement and Data Analysis (Quality Press 2015)” and “The Customer Driven Organization: Employing the Kano Model (Productivity Press 2014)”, as well as many articles on quality, risk management and Lean implementation.

Additionally, Lance is an instructor for the ASQ Certified Quality Auditor Exam Preparatory and FMEA courses.  As Principal Consultant of Full Moon Consulting, he has presented, trained and consulted throughout the United States and abroad.

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  • Presentation Handout in .pdf format
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