Lean CSV Requirements And Planning – How To Reduce Waste, Increase Value, And Maintain Compliance

This article delves into optimizing the Computer System Validation (CSV) lifecycle by applying lean methodologies to eliminate waste and enhance value. Building on previous discussions about Lean CSV, it concentrates on the initial phase of the CSV lifecycle, emphasizing waste reduction while maintaining compliance. Key terms include "lean," a method for eliminating process waste, and "value stream," a technique to improve the flow of information or materials in product or service creation.

The article identifies eight types of waste—Defects, Over-production, Waiting, Non-utilized talent, Transport, Inventory, Motion, and Extra processing (DOWNTIME)—and offers corrective actions to mitigate these wastes. It also aligns with Six Sigma principles, focusing on the importance of People, Process, and Product in waste reduction.

In the Requirements/Planning Phase, the article underscores the importance of aligning system requirements development with project planning. It provides a table of typical tasks and deliverables for this phase, along with considerations for waste reduction. Practical examples of corrective action implementation are given to illustrate how to achieve lean processes.

Learn more about the importance of continuous improvement in reducing effort, time, cost, and defects to stay competitive and produce high-quality products by reading the full article below.