Lean validation is derived from the lean manufacturing process. Simply put, lean manufacturing is the process of eliminating waste, minimizing risk and driving quality, efficiency and compliance. A common misconception is that lean is suited only for manufacturing. This is not true. Lean principles may be applied to any process that would benefit from the elimination of wasteful activities and process improvement. Lean validation thus is not a tactic or a cost reduction program, but a way of thinking and acting for today's validation team. The figure below depicts the overall strategy for lean validation.
There are five principles of lean validation derived from lean manufacturing principles. Lean validation is powered through people, processes and technology. Automation drives lean validation processes.
Principle 1 – VALUE – Lean thinking in manufacturing begins with a detailed understanding of what value the customer assigns to product and services. Lean thinking from an independent validation and verification perspective begins with a detailed understanding of the goals and objectives of the validation process and its adherence to compliance objectives. The principle of VALUE requires the validation team to therefore focus on the elimination of waste to deliver the value the end customer (your organization) in the most cost-effective manner. The computer systems validation process is designed for the purpose of assuring that software applications meet their intended use. The value derived from the validation process is greater software quality, enhanced ability to identify software defects as a result of greater focus and elimination of inefficient and wasteful processes. AUTOMATION IS THE FOUNDATION THAT FACILITATES THE ACHIEVEMENT OF THIS VALUE PRINCIPLE.
Principle 2 – VALUE STREAM – The value stream, from a lean perspective is the comprehensive product life-cycle from the raw materials through customer’s end use, and ultimate disposal the product. To effectively eliminate waste, the ultimate goal of lean validation, there must be an accurate and complete understanding of the value stream. Validation processes must be examined end-to-end to determine what value is added to the objective of establishing software quality and compliance. Any process that does not add value to the validation process should be eliminated. We recommend value stream mapping for the validation process to understand where value is added and where non-value -added processes can be eliminated. Typical "Muda" or wastes commonly revealed from validation process mapping are:
- Wasteful Legacy Processes ("we have always done it this way")
- Processes That Provide No Value To Software Quality At All
- Manual Process Bottlenecks That Stifle Processes
Principle 3 – FLOW – The lean manufacturing principle of flow is about creating a value chain with no interruption in the production process and a state where each activity is fully in step with every other. A comprehensive assessment and understanding of flow throughout the validation process is essential to the elimination of waste. From a validation perspective, optimal flow is created through the process when, for example, users have the ability to automatically create requirements from test scripts for automated traceability thereby eliminating the process of manually tracing each test script to a requirement. Another example is when a user has the ability to navigate through a software application and the test script process is automatically generated. Once generated, it is automatically published to a document portal where it is routed electronically for review and approval. All of this requires AUTOMATION to achieve the principle of FLOW. For process optimization and quality control throughout the validation lifecycle, information should optimally flow throughout the validation process in an efficient manner minimizing process and document bottlenecks with traceability throughout the process.
Principle 4 – PULL – A pull system is a lean manufacturing is used to reduce waste in the production process. Components used in the manufacturing process are only replaced once they have been consumed so companies only make enough products to meet customer demand. There is much waste in the validation process. The PULL strategy for validation may be used to reduce wastes such as duplication of effort, streamlining test case development and execution, electronic signature routing/approval and many others. Check out our blog "The Validation Post" for more information.
Principle 5 – PERFECTION – Validation processes are in constant pursuit of continuous improvement. Automation is KEY. Lean validation engineers and quality professional relentlessly drive for perfection. Step-by-step validation engineers must identify root causes of software issues, anomalies, and quality problems that affect the suitability of a system for production use. As computing systems environments evolve and become more complex and integrated, validation engineers must seek new, innovative ways to verify software quality and compliance in today’s advanced systems. Perfection cannot easily be achieved through manual processes.
AUTOMATION IS REQUIRED TO TRULY REALIZE THE VISION OF THIS PRINCIPLE.
To learn more about how these services can be put into action for Pharmaceutical and Healthcare companies and how you can GO LEAN, please click on the link below.