Lean Methodology Overview
Looking to apply Lean Methodology practically but not sure where to start? Although originally developed by manufacturing groups, Lean Management techniques can be implemented in a Quality & Regulatory setting to reduce or minimize waste. Lean Methodology is a way of optimizing the people, resources, effort, and energy of your organization toward creating value for the customer. It is based on two guiding tenets: continuous improvement and respect for people.

Lean Methodology can involve reducing wait times, inventory, and process times, while placing a strong emphasis on quality, continuous improvement, and just-in-time delivery. To provide context and explore the application of Lean Management techniques, a relevant case study is presented below, which focuses on the use of goal setting and process-mapping.

Case Study
Say that Surveyor Closing Meeting input included suggestions for improving document retrieval wait time. Using the Inspector’s feedback as the ‘customer voice’, the aim is to lower document retrieval wait times during Regulatory Inspections. The existing process is analyzed and the following workflow is mapped out:

The process involves initiating an inspection, requesting evidence of compliance through document review, locating the required documents, requesting transportation of the documents from an off-site repository, transporting the forms to the inspection site, and producing the forms as part of regulatory compliance.


In this instance, the ‘customer’ is understanding and willing to wait. To maximize the inspection schedule, the focus is on lowering document transport time, which is the most time-consuming. This frees up the agenda for a stellar opening presentation, detailing the site’s recent Continuous Improvement Projects. The aim is also to gather an audience for Q/A with the regulator during the closing meeting.

To bring this to life, changes are committed to, including:

  • Re-locating pertinent files and documents to a temporary on-site location using the window since the recent Inspection as a timeframe
  • Building a potent inspection team, complete with document/EOC support
  • Organizing the files in anticipated ‘packages’ for easy reference. For example, all CAPA, effectiveness checks and management review forms are housed together for deviation review.
  • Leveraging document scanning or various portable document formats (PDF files) to your advantage. Have these organized and readily available for viewing per your organization’s policies.

Now, the revised process of regulatory inspection involves a more streamlined approach: initiating the inspection, requesting evidence of compliance or document review, and having the inspection support team locate and retrieve the required files. Once the files are retrieved, the forms are produced as part of regulatory compliance.

By implementing this new approach, the team is able to lower document retrieval wait times during regulatory inspections, resulting in improved efficiency and effectiveness of the process. The success of this approach is recognized and appreciated by the regulatory auditor, which ultimately strengthens the team’s quality assurance stance. Furthermore, the continuous improvement approach employed in this process, which involves analyzing data, processes, patterns, trends, and anomalies, is a fundamental aspect of sound quality management. This approach helps the team to identify areas for improvement and implement changes that can enhance the quality of their work, ultimately leading to better compliance and increased customer satisfaction.


In conclusion, it is important for firms to periodically evaluate the efficiency of their processes. Conducting mock inspections and remediation tasks proactively can help ensure that the firm is running smoothly and can be prepared for FDA Inspections.

FDAQRC is a valuable resource that can help teams with mock inspections, QMS system updates, and other regulatory compliance processes. By working with FDAQRC, groups can improve their regulatory compliance processes and increase their chances of success. Be sure to read our other Industry Insights for more information, including Quality Culture.

This insight was provided by FDAQRC’s Project Manager, Amanda White.
Amanda is an accomplished professional with over 10 years of industry experience and is Lean Six Sigma Black Belt Certified (LSSBB). Drawing from her extensive background in operationally lean environments, including quality spaces, GcLP settings, and healthcare, Amanda concludes that applying Lean concepts to the industry is a novel approach that supports problem-solving.

“I enjoy this topic and find it relevant because when you pair effectiveness, streamlining and continuous improvement with a Quality approach, you boost productivity, revenue, client interactions as well as employee morale & loyalty. Additionally, I think applying Lean concepts to our industry is novel and supports problem-solving”